How to Watch the Biggest Science Story of 2017

Posted by Leah Lowthorp on January 19th, 2017

Close up of several strands of DNA in blue color

Less than three weeks into the new year, gene editing is already set to be one of the biggest stories of 2017.

CRISPR, the latest gene-editing tool, allows scientists to make changes to DNA faster, cheaper, and easier than ever before. There has been an explosion in the number of researchers using this technique over the past two years, and the coming year is sure to see more.

Media coverage of gene editing is also likely to be extensive. And if past experience is a guide, it will include lots of hype and ample confusion. In an effort to provide clarity, here are three key points to watch out for.

1) Germline gene editing and “3-person IVF” are not the same

The first 3-person in vitro fertilization (IVF) (aka “mitochondrial replacement”) birth was reported in September, where a baby with DNA from three people was delivered in Mexico by a New York-based fertility doctor seeking to avoid US regulation. Since then, there has been a tendency in the media to conflate the technique with gene editing.

On New Year’s Day, for example, NPR published a piece on 3-person IVF with the headline “Unexpected Risks Found in Editing Genes to Prevent Inherited Disorders.” After recognizing the error, NPR changed the headline to “Unexpected Risks Found in Replacing DNA to Prevent Inherited Disorders.”

While both germline gene editing and 3-person IVF are technically forms of human germline modification, or the genetic modification of human reproductive cells or embryos, they are completely different procedures.

Gene editing removes, inserts, and/or replaces nuclear DNA sequences in a living organism. Human germline gene editing means changing the nuclear DNA of a human egg, sperm, or embryo. The prospect of using genetic engineering for the purpose of controlling which traits are passed down to future generations has long raised major concerns worldwide. Foremost among these are that 1) this would have unalterable and largely unpredictable biological effects on resulting children and their future offspring; and 2) this would have disastrous social consequences if, as many believe, engineering genes thought of as “superior” exacerbated existing forms of inequality and discrimination.

By contrast, 3-person IVF refers to a range of techniques that don’t alter DNA sequences at all. Instead, they take apart and recombine fragments of reproductive cells in a process that is actually more similar to cloning than to gene editing. The primary goal of 3-person IVF is to prevent the transmission of a small subset (about 15% of cases) of mitochondrial disease, which can be passed from mother to child. In these cases, it is caused by mutations in a cell’s mitochondria, numerous organelles outside of the cell’s nucleus that have their own set of genes. 3-person IVF works not by transferring mitochondria, as the misnomer “mitochondrial replacement” implies, but by transferring the nucleus of an intending mother’s egg (or the nucleus of a fertilized embryo) into a mitochondria-rich donor egg that has had its nucleus removed. Inheriting nuclear DNA from the intending mother and father, and mitochondrial DNA from the egg provider, the child would thus be genetically related to three people. If that child were female, all future offspring would also inherit the changes.

As I’ve written before, 3-person IVF leads us down a slippery slope toward  a wider acceptance of germline gene editing for reproduction. One way to avoid this risk is by recognizing that the two procedures are completely different.

2) There is a big difference between somatic and germline gene editing, and between germline gene editing for research and reproduction

Another common mistake  in the media is treating somatic and germline gene editing as the same, and conflating the different uses of germline gene editing.

In Newsweek's recent cover story, “Gene Genie: Scientists Can Edit Your DNA to Cure What Ails You…Unless you Live in America,” Madhumita Murgia begins with the success story of Layla Richards, the first person cured of leukemia through “gene editing”. But Richards isn’t the main focus of the story. The bulk of the article focuses on gene editing in human embryos. For the casual reader, there is no distinction between the two cases. But that’s the problem.  

Richards’ case refers to somatic gene editing, or gene therapy, which alters the genetic sequences of an individual’s non-reproductive cells in order to treat an existing medical condition. A major concern about using somatic gene editing to treat diseases is ensuring the procedures are safe, effective, and accessible. Earlier attempts at gene therapy, using older genetic engineering techniques, were largely unsuccessful, and, in the well-known case of Jesse Gelsinger, caused a tragic and unnecessary death.

By contrast, germline gene editing refers to editing human reproductive cells or embryos. This poses unique ethical questions because, unlike somatic gene editing, germline changes would be inherited. Germline gene editing thus has to grapple with what these changes mean for a future generation.

A second often-overlooked distinction is the different ways germline gene editing is used: for research or for reproduction.

Germline gene editing for research will not result in a pregnancy; by contrast germline gene editing for reproduction has to account for the future generations that will be affected. Using a genetically altered human embryo to initiate a pregnancy, which would affect the genes of the resulting child and all future generations, is currently outlawed in more than 40 countries worldwide. Widespread international prohibitions on modifying the genes that are passed down through generations were put in place out of concerns about safety, human rights, and the potential for high-tech eugenics. CGS supports a prohibition on all forms of germline gene editing for reproduction.

The Newsweek article is one of a number of instances in which these distinctions have been blurred in the media. Making them clear is crucial to public understanding of the medical, policy, and social implications involved.

3) “Designer babies” remain a serious concern

Several recent articles emphasize that scientists do not yet understand enough about the human genome to begin creating so-called “designer babies,” or children whose genes have been changed to “enhance” them physically or behaviorally (see here, here and here). While this is true, it does not mean that there’s nothing to worry about, or that concern about inheritable genetic modification is a “sideshow” in the CRISPR debate, as Vox recently stated.

As Rob Stein at NPR notes, “The concern here is that if you [edit the DNA of human embryos] for medical research, what’s to stop other scientists to try to do it for other reasons, like, for example, to try to create designer babies that are taller or smarter or better athletes?”

Stein adds that “the concern is that this could open the door to someday creating genetic haves and have-nots.”

This has been a serious concern since inheritable genetic engineering was first imagined. With recent advances in gene editing, it’s true now more than ever. The fast-moving, commercially motivated nature of CRISPR technology means that a world where the affluent can afford genetic “enhancements” is an uncomfortably real possibility. Combined with reporting that most scientists think “editing embryos will probably be a clinical option one day,” broad societal debate about human gene editing and its implications for the future of humanity is urgently needed.

In a world where technologies such as CRISPR have the power to exacerbate social inequalities in unprecedented ways, it is essential that the public understand the nuances of this emerging technology in order to make informed decisions about what we do or do not want for our future. Gene editing for reproduction is a social and political matter, not just a scientific one, and there is simply too much at stake to move forward without broad inclusion of the wider public.   

Previously on Biopolitical Times:

Image via Pixabay

CGS Board Member Leads Redress Call for California Survivors of Eugenic Sterilization

Posted by Marcy Darnovsky on January 16th, 2017

Book cover of Alexandra Minna Stern's book Eugenic Nation: Faults and Frontiers of Better Breeding in Modern America. Pictured is a geographical view of the United States, overlapped with chromosome painting.

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Scholars researching California’s twentieth-century legacy of eugenic sterilization, led by University of Michigan professor and Center for Genetics and Society Advisory Board member Alexandra Minna Stern, are urging state legislators to consider reparations for survivors of this abusive chapter in California’s history.

An estimated 20,000 people underwent compulsory sterilization in state institutions from 1909, when California passed its eugenics law, well into the 1950s. According to the study published in the American Journal of Public Health, based on painstaking analysis of historical records, the research team estimates that as many as 831 people sterilized under that law are alive today.

“The remaining survivors of California’s eugenic sterilization program deserve further societal acknowledgement and redress,” the researchers wrote.

And the researchers emphasize that “time is of the essence”: According to their estimates, the average age of the survivors is 87.9 years.

“We suggest that interested stakeholders, including public health advocates, legislators, reproductive justice and disability rights activists, and survivors willing to come forward, move quickly to ensure that California takes steps toward reparations and full accountability for this past institutional and reproductive injustice.”

Their efforts aren’t being ignored. The findings have drawn media attention from high-profile outlets including The Atlantic, the New York Times, NPR Weekend Edition, Scientific American, and the Los Angeles Times. Much of the coverage highlights the call for California officials to make serious efforts to identify the survivors and consider offering them monetary compensation. Such reparations programs have been established with bipartisan support in North Carolina and Virginia, which had similar eugenic sterilization programs.

Stern’s research on eugenics has spanned more than a decade. In 2005, she published Eugenic Nation: Faults and Frontiers of Better Breeding in Modern America examining eugenics in the American West. She has continued her work by investigating the race, gender, class, and disability status of California’s sterilization victims; documenting the disproportionate number of patients with Spanish surnames who were sterilized; and focusing on stories of efforts by families and patients themselves to challenge sterilization procedures.

Stern has also worked to bring public awareness to the stories and meanings of eugenics in California. She helped CGS and other organizations plan a 2012 symposium at UC Berkeley Law, Eugenics in California: A Legacy of the Past?, and at San Francisco State University’s Future Past: Disability, Eugenics, and Brave New Worlds event in 2013, and spoke at both.

Stern has also participated in several of CGS’s Talking Biopolitics conversations. In 2013, she and journalist Corey Johnson discussed an episode of sterilization abuse in California women’s prisons between 2006 and 2010 that Johnson had revealed while working with the Center for Investigative Reporting. She joined medical historian Nathaniel Comfort in 2015 to talk about the implications of the quest for “human perfection” in an age of rapidly advancing genetic technologies. And last year, Stern interviewed the producers and director of No Más Bebés, a documentary about immigrant women in Los Angeles who sued county doctors, the state of California, and the US government after they were coerced into sterilizations while giving birth during the 1960s and 70s.

The hundreds of eugenic sterilization survivors in California alone make plain the echoes of America’s eugenic past that still reverberate in the present. Coming to terms with this legacy will serve not just the individuals subjected to eugenic sterilization, but all of us who must confront its continuities today.

Previously on Biopolitical Times:

Image via University of California Press

We Launched a New Website! Surrogacy360

Posted by Kiki Zeldes, Biopolitical Times guest contributor on December 14th, 2016

Six women (members of Women's Rehabilitation Center in Nepal) are gathered in a circle, intently listening and discussing.
Members of Women's Rehabilitation Center in Nepal lead community discussions on international surrogacy

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This blog was cross-posted from Our Bodies, Our Blog, the blog of Our Bodies, Ourselves.

As the journey to create a family takes more individuals and couples outside their own country in search of less-expensive surrogacy arrangements, it’s easy to find websites offering, for a fee, to broker such arrangements – and difficult to find information not tied to commercial interests. 

Want to know what’s even harder? Finding informative analysis that’s completely transparent about the process and the risks facing all parties: intended parents, paid egg providers, surrogates (or gestational mothers), and children.

In an effort to fill this information gap, Our Bodies Ourselves teamed up with the Center for Genetics and Society to develop, an educational website that provides factual information for people considering parenthood through international commercial surrogacy.

The site launched today. We hope you’ll take a look and send us your feedback.

Why Surrogacy360 – and why now? From women in Central America and South Asia – often marginalized socially, politically, and financially in their community – to educated young women in the United States recruited for genes/eggs perceived as superior, increasing numbers of women are becoming involved in contractual third-party reproduction. The market for their services is global, largely unregulated, and growing. This is leaving a dangerous vacuum, in which women on all sides are persuaded by financial and other incentives in the absence of safety data and redress.

At the other end of these arrangements, there are accounts of intended parents (those that hire gestational mothers) being duped by fertility clinics and recruiting agents. Surrogacy360 scrutinizes the health, legal, and ethical issues affecting everyone involved in the surrogacy relationship – and does so with every effort to respect the decisions of intended parents and include them in the conversation.

“Surrogacy360 speaks to people considering surrogacy who are looking for honest information about the realities and risks of third-party reproduction – not just the rose-colored stories featured in the marketing materials of fertility clinics and brokers,” said Marcy Darnovsky, executive director of the Center for Genetics and Society. “This website is for them, and for everyone concerned about the increasingly stratified market in human reproduction.”

The site answers basic questions about surrogacy, defines commonly used terms, and explains the legal landscape. There’s a resource section with the latest academic articles, reports, and news stories from around the world. It will be updated regularly, and you can sign up on the resource page to get the latest updates delivered to your in-box.

Surrogacy360 has no commercial interests or conflicts. Content is peer-authored and reviewed by known experts in the field, including individuals working on health care law, human biotechnology, and reproductive justice. 

The need for this information has never been greater, said Sally Whelan, program director of the Our Bodies Ourselves Global Initiative. Many assisted reproductive technologies (ARTs) and the social arrangements they encourage are developing largely under the public radar. 

“A revolution in human reproduction – the likes of which we have never seen – is now here,” said Whelan. “This new and exciting, far-reaching and innovative era presents unprecedented opportunities in family formation for people with infertility, the LGBTQ community, unmarried couples, and single individuals.”

“At the same time, for others – especially the women who provide their services in contractual third-party reproduction – it can pose unparalleled risks and create new global inequities within a largely unregulated, multi-billion dollar business,” she added.

Ayesha Chatterjee, program manager of the Our Bodies Ourselves Global Initiative, said Surrogacy360 is the only site addressing this dichotomy head-on.

“Given that ARTs and related practices like international commercial surrogacy are embedded in complex global dynamics, robust commercial enterprises, and entrenched social inequities,” said Chatterjee, “the key question becomes: How we can make use of the enormous benefits of ARTs and related arrangements while ensuring we do not do so at the risk of our own and others’ health and human rights? That question guides our work and the inclusiveness of the information we provide.”

The time to raise awareness is now – first, among consumers of ARTs and those who serve in contractual reproductive arrangements, followed by those in the sectors of public health, medicine, policy, education, human rights, and reproductive justice. Otherwise, around the world and across social and economic spectrums, women of reproductive age will be denied the information they must have for truly informed consent; intended parents will remain beholden to industry practices that are unsound; and children born of these arrangements will continue to face health and legal risks.

For more information, including press materials, see the Surrogacy360 press release.

Image via Our Bodies, Ourselves.

Biopolitical News of 2016

Posted by Pete Shanks, Leah Lowthorp & Marcy Darnovsky on December 13th, 2016

Colorful graphic of

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The biggest surprise of the year was probably the birth, in Mexico, of a baby who was conceived following controversial mitochondrial manipulation (“3-parent IVF”). The location was chosen by a New York-based fertility doctor who noted that in Mexico “there are no rules.” Since 3-person IVF is technically a form of inheritable genetic modification, one big question is whether its increasing use and normalization will open the door to wider acceptance of gene editing for human reproduction.

The gene editing shockwaves of 2015 – when Crispr was first applied in human embryos, and controversy about the prospect of using it for human reproduction became explicit – developed into a somewhat more predictable flood of activity and comment in 2016. The big, and unfortunate, news here is perhaps the non-news: the absence of any significant efforts to encourage public participation in deliberations about whether powerful new genetic manipulation tools should be used in efforts to control the traits of future children and generations.

The most consequential news of the year for biopolitics as for so much else may well turn out to be the US presidential election result, but the consequences themselves remain somewhat unclear. Trump’s comments about having “the right genes” are ominous warning signs, which are perhaps getting worse, as partly described below.

Cross-border commercial surrogacy was in the news this year because of scandals, disputes, and changes in the laws of several nations where it had taken hold. Commercial pressures were particularly apparent in the slick marketing being used to promote egg freezing among young women with no fertility problems. In California, the fertility industry failed in its effort to overturn the state ban on paying women more than expenses to obtain their eggs for research.

The Center for Genetics and Society (CGS) continues to monitor these and related developments, and attempts to encourage their responsible use and effective societal governance. Many of the following issues inevitably blend into each other, but here is a brief overview of the most important biopolitical developments of 2016, roughly grouped by topic:

3-Person IVFlack and white photo of an adult holding a baby in their arms.

This year saw the highly controversial move of experimental 3-person in vitro fertilization (IVF), also known as mitochondrial manipulation, mitochondrial replacement, and nuclear genome transfer, from the lab to the clinic.

The year began with a U.S. National Academy of Medicine report on the ethics of using 3-person IVF for the purpose of preventing mitochondrial disease. The committee decided that the procedure should be ethically permissible under certain conditions, among them a restriction to implanting only male embryos in order to limit risks to future generations. The report acknowledged that 3-person IVF “does not address a medical need” as it “would not treat an existing person for a disease, illness, or condition.”

The UK’s Human Fertilisation and Embryology Authority (HFEA) released a report based on its scientific review of the procedures, and rejected the male embryo limitation. The HFEA will consider approving 3-person IVF for clinical use on December 15.

In May a phenomenon was discovered that might prove to be a roadblock to using 3-person IVF to prevent the births of children affected by mitochondrial disease. The issue is that at least in some cases, carried-over “faulty” mitochondrial DNA (mtDNA) multiply faster than donor mtDNA, eventually taking over the donor egg and thus defeating the purpose of the risky procedure.  

In the last quarter of 2016, the world witnessed a series of shocking developments in multinational rule-evasion surrounding 3-person IVF, with the first child born in Mexico to dodge the ongoing regulatory process in the US. Other pregnancies were subsequently reported around the world (see here and here). The clinic that delivered the first baby in Mexico has reported plans to use 3-person IVF in 20 pregnancies in the first half of 2017.

Within a few short months, we have seen a slippery slope unfold right before our eyes from use of the experimental technique to prevent the births of children with mitochondrial disease to its use to treat infertility.

Gene Editing for Reproduction
acial features of young baby are shown, with transparency of genetic c

In April, researchers in China attempted to enhance nonviable embryos with limited success. Another team in Sweden was revealed to be working in the same area, but on viable embryos. The UK authorized gene-editing experiments on potentially viable embryos, to be destroyed after seven days of development. Later in the year, scientists in the UK urged extending the legal limit of experimental development of human embryos from 14 to 28 days, which may be considered next year.

This and other gene-editing debates, particularly including those around human germline modification, percolated through the press. This collection of magazine covers makes the stakes of the controversy clear. The Spectator, a British publication, was perhaps the bluntest: Its cover announced that “Eugenics is back.”

Given the magnitude of its consequences, it’s no surprise that we saw heated debate in the news media about the prospect of human gene editing for reproduction. Key 2016 articles and commentaries, and the year’s Biopolitical Times posts on the topic, are collected on the CGS website resource page about human germline editing.

The National Academies of Sciences’ committee on human gene editing held several public meetings this year, and publication of its “consensus study” is expected early next year. In the UK, the Nuffield Council issued Genome Editing: an ethical review, which is likely to be useful resource for future discussion.

The battle over Crispr patents provided a side-show throughout the year. Time magazine tactfully lumped “the Crispr pioneers” together on its short list for Person of the Year (which went to Trump). The legal decision may come next year.

Meanwhile, at the end of the year, a new scientific report pinpointed multiple anomalies that lead to the long-documented failure rate of clones, specifically in cows. This understanding might possibly lead to improvements (not immediately) but the authors stressed “the need for a strict ban on human cloning for any purposes.”

Egg RetrievalA woman in a polka dot blouse lounging on a couch looks directly in the camera with the text "Hey, how's your fertility doing?" in bright font.

The risks and realities of egg retrieval procedures seemed to attract a bit more media attention this year, though the stories in two top US newspapers ran with headlines in the form of questions: Do women who donate their eggs run a health risk? in The Washington Post and Should young women sell their eggs? in The New York Times. Both stories mentioned the organization We Are Egg Donors, profiled here, along with other prominent critics, some of whom issued their own call to protect the health of women undergoing egg retrieval. A sharp increase in serious short-term complications of egg retrieval in the UK, where such data is at least collected, also made news.

Health risks are, of course, a concern whether the eggs being harvested are destined for the provider’s own pregnancy attempt, for donation or (far more often) sale to someone else, or for the freezer. The push for egg freezing continued apace in 2016, with slicker marketing  and dedicated cocktail parties by start-ups in the US and public subsidies in Japan in a misguided effort to boost its falling birth rates. Debate about the risks and effectiveness of egg freezing also persisted. On the distribution side of the business, freezing means that eggs are now part of a “hidden global supply chain” that also includes frozen sperm and embryos.

Additional demand for eggs came from researchers who want them as raw materials for their work. In California, researchers can reimburse women for expenses related to the retrieval procedure, but can’t pay them beyond that. A repeat attempt to overturn that rule, sponsored by the fertility industry, failed again this year after indications that Governor Jerry Brown would again veto the bill, and in the face of opposition by CGS and other social justice organizations.

A heternormative couple looks down at the ground, which features a world map of 7 continents.

While it’s no longer news that contract pregnancy is a global phenomenon and a booming transnational business, headlines about the twists and turns of commercial surrogacy continue to appear. One media theme in 2016: the shifts in the laws of several countries that have decided to resist the spread of cross-border commercial surrogacy. At the beginning of the year, the global surrogacy industry began moving into Cambodia after prohibitions or restrictions were established in India, Nepal, Thailand, and Mexico. Before long, headlines began remarking on the Dwindling Options for Surrogacy Abroad; by year’s end, Cambodia too had banned commercial surrogacy.

Another major media focus featured disputes among parties to surrogacy arrangements, and scandals of varying types and magnitudes. One of this year’s stories – headlined Surrogate mother who sold same babies twice sentenced for fraud – was about a French woman who told one set of commissioning parents that the child she had been carrying for them was stillborn, and made a deal for the baby with other parents. Another case pit a 47-year-old woman pregnant with triplets against their intending father who said he couldn’t afford to raise three children, mixing the politics of abortion into the controversy about commercial surrogacy. Other accounts surfaced about children born via surrogacy who have been abandoned by commissioning parents because of what some news coverage called “defects,” echoing 2014 headlines about “Baby Gammy.”

Media reports about inter-country surrogacy as a lucrative business, or about the financial implications for those involved, were less common. A couple of stories did note the spike in demand for surrogacy in the US and in Japan by wealthy Chinese couples after China lifted its one-child policy. Another presented evidence that many Indian women who have worked as surrogates to improve their family’s standard of living wind up with “little to show for their efforts.”

All of these issues and more were discussed this year at a number of reproductive rights and justice meetings, including the Baby Markets 10th Anniversary International Congress, Making Families: Transnational Surrogacy, Queer Kinship, and Reproductive Justice, and Inter-country medically assisted reproduction: Conceiving a human rights ethic of care.

Stem Cells

For a while, this seemed to be the year in which stem-cell scams finally got the attention they deserved, thanks mostly to stem-cell researcher Paul Knoepfler and bioethicist Leigh Turner of UC Davis and the University of Minnesota respectively. They identified 570 clinics around the country, most of which were selling unapproved procedures. The initial media reaction was shock, and there was some hope that the FDA would enforce strict new guidelines

Unfortunately, the “21st Century Cures Act,” which President Obama signed into law on December 13th, was a major blow to the FDA’s system of clinical trials, and the Trump administration seems likely to promote “use at your own risk” treatments.

Moonshots & Medicine
llustrated image of a scalpel instrument.

President Obama, who in his 2015 State of the Union proposed a Precision Medicine Initiative, in his 2016 message announced a Cancer Moonshot, inspired by Vice President Biden, whose son died of brain cancer. With unusual swiftness, a Task Force was created, headed by Biden, and produced an ambitious report. The recommendations in the report were largely funded by the 21st Century Cures Act.

Big data is an important part of these initiatives, and federal funding is beginning to flow. How effective personalized medicine will be remains somewhat open to question, both scientifically and because people are, well, cantankerous: studies are beginning to show that gene testing does not much influence behavior.

Synthetic Human Genome?

Saving the worst for last, 2016 saw a serious proposal for “HGP-Write” — the creation of a human genome from scratch. This was most thoroughly discussed at a closed-door, invitation-only meeting at Harvard in May that turned out to be something of a public relations disaster. But this work is certainly progressing, and it would not be surprising if some of the funding were secret.

Images via Pixabay

Slippery Slopes and Biological Curve Balls: Updates on 3-person IVF

Posted by Leah Lowthorp on December 13th, 2016

Black and white image of woman's silhouette looking at her phone while pushing baby carriage in a European city

In September the world learned of a US fertility doctor who had gone to Mexico where “there are no rules” in order to arrange the birth of a child conceived using 3-person in vitro fertilization (IVF), technically a form of human germline modification, to prevent mitochondrial disease. In October we learned that 3-person IVF is being used experimentally in the Ukraine to treat infertility.

In November we saw four additional important developments:

1) The media got 3-person IVF all wrong

On November 1, Reproductive Biomedicine Online published “Setting the Record Straight,” the journal’s editorial response to the “shoddy scientific journalism” surrounding an article in the very same issue. The article in question was a report on the apparent health of children born in the late 1990s and early 2000s using cytoplasmic transfer, a 3-person IVF precursor (see here for CGS’s take on the media coverage of that article). Published in the immediate aftermath of the Mexico and Ukraine cases, most media reports took it as evidence that current 3-person IVF techniques (pronuclear and spindle transfer) are safe. Railing against this misinterpretation, the editor argues that:

the technique of cytoplasmic transfer in the late 1990s is so different from those of pronuclear or spindle transfer as to make the apparent normality of the offspring born through the former technique of little relevance in the context of (the latter).

In other words, the media got it all wrong—the study doesn’t prove anything about the current or future safety of experimental 3-person IVF techniques.

2) Slippery slope: Disease prevention to fertility treatment

With all focus in September on the use of 3-person IVF to prevent mitochondrial disease, the slippery slope toward the multi-billion dollar fertility industry and a potential normalization of human inheritable genetic modification is unfolding right before our eyes. On November 10, a study co-authored by Shoukhrat Mitalipov, who has developed and promoted one of the 3-person IVF variations, was published in Stem Cell proposing the introduction of 3-person IVF technology as a fertility treatment. Characterized by one of the co-authors as “just one additional advance over IVF,” the new study promises a two-for-one deal for aging women to “increase the yield … available for transfer from a single stimulation cycle.”

As opposed to other 3-person IVF techniques that transfer the nucleus from an intending mother’s egg into a donor egg from which the nucleus has been removed, the new variant would use the genetic material from an intending mother’s polar bodies, small cells produced during oogenesis that contain nuclear DNA but that typically don’t develop into eggs that can be fertilized. Reconstructed eggs generated with this so-called “polar body nuclear transfer” technique would pose as much risk to any resulting child as other 3-person IVF methods, and the overt shift toward using such a biologically extreme procedure to address basic infertility is deeply troubling.

3) Moving ahead at all costs

On November 30, the UK’s Human Fertilisation and Embryology Authority (HFEA) released their Fourth Review by an independent panel of experts, examining the safety and efficacy of 3-person IVF techniques for the purpose of avoiding serious mitochondrial disease. The review recommends “cautious use” of these techniques for “carefully selected patients” in cases “where there are no acceptable alternatives” such as pre-implantation diagnosis (PGD), and supports mitochondrial DNA (mtDNA) haplotype matching as a precautionary measure. It concludes that reversion, the phenomenon whereby carried-over “faulty” mtDNA multiply faster than donor mtDNA and eventually take over the donor egg, does not pose a serious risk despite evidence to the contrary. It also rejects a U.S. National Academy of Medicine report that recommends limiting clinical research to the transfer of male embryos so as to avoid inheritable genetic modification, and emphasizes the importance of long-term follow-up.

The Science Media Center issued a collection of expert reactions to the review the same day that was predominantly celebratory. Dr. David J. Clancy of Lancaster University, however, strongly questioned the panel’s seeming impetus to move forward at all costs, even in light of serious ongoing safety concerns. He wrote:

[3-person IVF]’s sole benefit is to allow affected women to have healthy children who bear half their genes. The best alternative is IVF by donor egg... [T]he evidence now suggests that, at some point, producing a child who will suffer from mitochondrial disease is a certainty. Are we, as a society, OK with that?

The HFEA is set to consider the issue at a meeting on December 15.

4) A biological curve ball

Also on November 30, another study co-authored by Mitalipov was published in Nature that suggests that reversion (see #3 above) is a serious problem related to “mismatches” between the mitochondrial DNA of the intending mother and that of the egg-provider. The authors propose an as-yet-tested system of mtDNA replication-rate matching that would allow the egg provider’s mitochondria to remain dominant in the developing embryo. Karen Weintraub’s coverage in Scientific American recognized the hurdle this poses for clinical uses of 3-person IVF technology, describing it as “a biological curve ball” that shows that mitochondrial diseases “can come back to sicken a child, even when 99 percent of the mother’s own mitochondria are eliminated.” Most media reports, however, managed to spin this setback as progress (see here, here and here).

Within the span of only a few short months, we have seen a disturbing trend toward the normalization of an experimental technology that is still widely considered unsafe, and whose implications for future generations are yet unknown. CGS and others have criticized the clinical application of 3-person IVF, even to prevent the transmission of mitochondrial disease, because of the potential serious health consequences for resulting children and future generations, because safer options for creating families are already available, and because allowing mitochondrial manipulation in humans could open the door to other forms of human inheritable genetic modification, banned in more than 40 countries worldwide. 

Previously on Biopolitical Times:

Image via Pixabay

Trump, Science and Social Justice

Posted by Pete Shanks on December 8th, 2016

President elect Trump is standing at a podium, looking above.

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It has not escaped our notice that the specific process we have witnessed in the last month immediately suggests a possible alteration of the regulatory and ideological landscape. As with genomics, however, the devil is in the details and many of them remain obscure. Some general outlines have emerged, and they are frightening to anyone who cares about social, economic or environmental justice.

It seems certain that the Electoral College will confirm Donald Trump as the winner of the Presidential Election, although a few “faithless electors” might cast protest votes. It is absolutely certain that Hillary Clinton won the popular vote; at this writing, she is leading by 2,7 million votes and seems likely to have attracted more votes than any Presidential candidate in history except then-Senator Obama in 2008. Nevertheless, Trump and Vice-President-elect Mike Pence are not only claiming a mandate, they are backing their talk up with extraordinarily reactionary appointments.

In part, this may be down to Trump’s inexperience: He seems to be picking people he knows. And GeneralsReuters is running a list of top appointments, and Nature had a useful summary of possible science-related appointees last week. But what other criteria does he have?

Eugenics, apparently:

All men are created equal; well, it’s not true, ’cause some are smart, some aren’t. …  You have to have the right genes. … I’m a gene believer … I'm proud to have that German blood. There’s no question about it. Great stuff.

And white supremacy. Of course, that is denied, for instance by a founder of The American Conservative:

The United States is entering into [a] period of demographic transformation, where whites, politically and demographically dominant for all of the nation’s history, will become a smaller majority, and perhaps then a plurality. Whether this transformation will be assimilative or anti-white, peaceful or violent, remains to be seen. Those in the upper reaches of the Democratic Party throwing around loose charges of “white supremacism” are certainly doing nothing to make it go smoothly.

So what’s the nice, polite way to describe Steve Bannon, set to be Trump’s Senior White House Counselor, and former chairman of what the Southern Poverty Law Center has called a “white ethno-nationalist propaganda mill”? The New York Times gave it a go:

Mr. Bannon is in some ways a perplexing figure: a far-right ideologue who made his millions investing in “Seinfeld”; a former Goldman Sachs banker who has reportedly called himself a “Leninist” with a goal “to destroy the state” and “bring everything crashing down.” He has also called progressive women “a bunch of dykes” ...

Nope, can't be done.

But science, of course, is politically neutral. (Just the facts, ma’am.) So it should not be a concern that the Environmental Protection Agency will be run by a “close ally” of the fossil fuel industry, Scott Pruitt. Or that the Health and Human Services Secretary, Tom Price, has been focusing for years not just on dismantling the Affordable Care Act but also barring funds for Planned Parenthood; and opposing abortion. Or that running the Centers for Medicare and Medicaid Services will be Seema Verma, a close advisor of Pence, who worked to make Indiana’s Medicaid plan "one of the most punitive in the country.” 

It could get worse. The Food and Drug Administration may go to Jim O’Neill, a colleague of the execrable Peter ThielBloomberg notes:

O’Neill also could push the agency in new directions. In a 2014 speech, he said he supported reforming FDA approval rules so that drugs could hit the market after they’ve been proven safe, but without any proof that they worked, something he called “progressive approval.”

What could possibly go wrong? (Don’t all speak at once.) We should note that this is apparently a trial balloon. Scott Gottlieb of the American Enterprise Institute is said to be the other candidate. He has some FDA experience, under George W. Bush, but the editor of the New England Journal of Medicine said in 2005:

Gottlieb has an orientation which belies the goal of the FDA.

A quick glance at his Forbes columns shows he really hasn’t changed. But he regularly appears on Fox News, so Trump may know who he is.

The Union of Concerned Scientists are concerned enough to organize a 2300-signature letter, supporting “unfettered science.” Heads of 29 scientific societies (including the AAAS) politely called for a meeting to advise Trump. Another ad-hoc group of scientists called “Not Who We Are” has their own open letter, with climate scientist Michael Mann at the head of the list of signatories. They are all right, of course, but may be, um, waving into the wind.

To be fair, as we must, there is one surprising suggestion: Four key Republicans in Congress, all chairs of committees or important subcommittees, sent a letter to Trump urging the President-elect to keep Francis Collins as Director of the National Institutes of Health. Since Collins is a gentleman, there is no word of this on his blog or Twitter feed. But really, why would he need the grief?

Update: Francis Collins said on Friday, December 9, that he was flattered by the letter and would consider it a privilege to remain in his post.

Previously on Biopolitical Times:

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Review of Blame: A Novel

Posted by Abby Lippman, Biopolitical Times guest contributor on November 28th, 2016

Book cover of Blame by Tony Holtzman. Black and white illustration, in bird's eye perspective, of a maze with mice.

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Because it is a central theme of this novel, it seems appropriate for me to start this review with my own “conflict of interest” – or as I prefer to see it, my “competing interest.” So I note that my parents and Tony's parents were friends when we were young children and though he and I were never friends, we were colleagues in adulthood insofar as we attended the same medical/human genetics meetings and conferences and kept in touch with our separate critiques of these issues, even discussing them, when we met.

Readers, therefore, can make their own assessments of my comments about Blame as to whether or not they are “fair” or even unbiased. Readers should also know that though I have a long history of writing and publishing book reviews, both in print and online, with only one exception these have been works of non-fiction; critiquing a novel is something I vowed not to do once the first was complete, but here I am....

Enough about me; the book is what is important here, and it is an important book – especially for those who are not trained in or otherwise familiar with human/medical genetics and the range of ethical, social, legal, and political issues raised by the applications of what is learned in a lab. It is a novel of fiction and a novel of science, often eerily portraying not only what is happening now but what is possibly very soon to come as new technologies are normalized, “monetized,” and enter “ordinary” medical practice.

Blame is fueled by these issues, with the characters propelled by the concerns raised and their own ambivalences about what is “right” and useful to do. It is a kind of hybrid book, combining an introduction into the intrigues of (and intriguing nature of) genetic research with a compelling story of (some) good people who go – and are led – astray. Thus, while the characters are well-limned, they can at times seem to represent an issue at least as much as appear to be fully-fleshed individuals.  

As a result, the reader may feel, as I did, deeply drawn to but still hungry to know more about the central figure and his wife, in order to better understand just why he (a solid scientist doing careful research) and she (a strong woman with feminist leanings) do what they do. Unfortunately, to provide details here would likely give more away what readers should better discover for themselves. 

Watching the characters who incarnate a range of roles (investigative journalist, African-American woman harmed in a commercially-funded clinical trial, university administrators and faculty, et al.) also affects us strongly on gut levels but can nevertheless sometimes seem forced to meet Holtzman's political agenda when the latter is given priority over the deep development of characters per se.  Why do some key players make the turns in behavior and in practices that they do? Hubris? Insecurity?  Money? Love? All are at play, and we don't necessarily need these all spelled out. Yet while it's very clear that the central characters do change, it might enrich the novel if the why of this was easier to sense without feeling that some turns are plot-driven to make a point. 

But despite these quibbles, no doubt the book is a page-turner and the reader is driven along.

There is also no doubt that Holtzman has a stand on the issues he raises, a stand I probably almost entirely share with regard to the evils of profit-driven science, the corruption of academia and corrosive effects on science (and people and relationships) that ensue, the hyped promises of predictive medicine, the dilution of fully informed consent, and the lingering oppression of societal racism. He brings all this, including their historical grounding, into the novel with clarity and expertise.  And accompanying all this are generally easily digested details of genome analysis, medical interventions, and other “science” matters. As background these are essential elements of Blame; however, when these are foregrounded, they risk becoming ersatz major “characters.” This, in turn, can make some of the fictional people simply potential “issue-bearers,” embodiments, that is – but possibly with bodies that are thinner-than-needed to fully satisfy a reader.

Because it is a challenge for a reviewer to talk of the actual “plot” of the book without revealing its  ending, and wanting not to spoil the experience for readers, I will only note that there is lots here to keep a reader engaged and turning pages, perhaps even in one sitting. Blame is properly titled; much and many bear this load in the novel's exploration of how genetic testing of asymptomatic people can reveal DNA patterns suggestive of the later appearance of highly undesired diseases (in this book Alzheimer); of how lucrative for companies it can be to patent these DNA segments/patterns for the commercial development of tests they can sell; etc. To this are added references to other sources of blame: past racist research, sexual harassment, spousal violence, the lifestyles of rich and privileged whites in the US, inadequate even lax regulations and laws related to genetics and genetic technologies in law and legal regulations....a full set of the blameworthy from which to choose.

This book is as important to read and then discuss with others to foster the important public input into  decision-making re how genetic technologies are developed, funded, used, provided, and governed, as it is to read simply for oneself: it will surely give everyone several hours of pleasurable page-turning. I hope these two “applications,” the collective and the private, will merge– and Blame will be an essential basis for this merging as science continues to seek ways to read our futures and to extend lives. While a work of fiction, Blame is definitely not science-fiction.

Abby Lippman has spent decades following developments in applied genetic and reproductive technologies. Her main interests as a feminist researcher, writer and activist center on women's health and the politics of health. She is also Professor Emerita in the Department of Epidemiology, Biostatistics and Occupational Health at McGill University.

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18 Years Later: First Update on Children Born Using 3-person IVF Precursor

Posted by Leah Lowthorp on October 27th, 2016

On October 26, an Associated Press story broke with the headline, “The Kids are All Right: Children with 3-Way DNA are Healthy.” Riding the wave of recent controversies surrounding 3-person in-vitro fertilization (IVF) in Mexico and the Ukraine, the widely syndicated article plainly misrepresents the source study, which as we shall see, is not at all certain of the reliability of its results.

On October 24, Reproductive BioMedicine Online published the first follow-up study of children born in the late 1990s and early 2000s using a precursor to 3-person IVF known as cytoplasmic transfer. Developed for age-related infertility, this technique, also known as ooplasmic transfer or transplantation, involves injecting mitochondria-rich cytoplasm from donor eggs into the eggs of intending mothers prior to fertilization. Fertility doctors used this experimental technique in human subjects without clinical trials, with at least two dozen babies born as a result. In 2001, researchers from St. Barnabas Medical Center in New Jersey published a study announcing live births resulting from this procedure, and claiming the world’s “first case of human germline modification.”

Scientists, medical professionals, and public interest advocates raised a number of serious concerns at the time, ranging from the children’s increased risk of severe mitochondrial disease resulting from mitochondrial heteroplasmy to ethical concerns about human inheritable genetic engineering. Shortly after the study was published, the U.S. FDA halted the procedure, citing lack of evidence of safety and efficacy and requiring clinics to seek the agency’s approval to continue. No such request was made at the time, and no formal studies to track the effects of this technique upon the resulting children were conducted.

The recent Reproductive BioMedicine Online study documents an attempt to follow up on the seventeen children, now ranging in age from 13-18, born as part of the St. Barnabas Medical Center research cited above. The study is inconclusive due to a number of serious limitations, including the fact that it is based entirely on limited email surveys completed only by parents. None of the children participated in the survey, nor were they subject to any follow-up testing. In fact, only one of them has been informed of their participation in this experimental procedure. In addition, the parents of quadruplets that represent 25% of the total number of children never replied to the survey. 

The authors are open about the flaws of their study, writing that it “is limited because the information from the quadruplet delivery is essential for providing firm conclusions,” and that their findings “are based on subjective assessment criteria and no standardized instruments were used.” In the end, the researchers conclude that they were unable to discern an effect of cytoplasmic transfer on the children, but attach the clear disclaimer, “but the power of the investigation was low.”

In light of this, it is disappointing that media coverage of the study was so unbalanced and celebratory. Mostly syndications of the Associated Press story mentioned above, it both severely downplayed the study’s frankly-stated limitations, and misconstrued the authors’ tentative conclusion as evidence that not only this specific technique but somehow all forms of mitochondrial manipulation are safe.

Previously on Biopolitical Times:

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3-person IVF and Infertility: What Kind of Slippery Slope is This?

Posted by Leah Lowthorp on October 26th, 2016

3-person IVF and Infertility: What Kind of Slippery Slope is This?

Reacting to two breaking news stories about 3-person in vitro fertilization (IVF) in less than two weeks, Paul Knoepfler, professor and stem cell researcher at UC Davis, recently tweeted:

On September, 27, 2016, news broke that NYC-based fertility doctor John Zhang and his team had delivered a baby the previous April that they created using a controversial mitochondrial manipulation technique, also known as 3-person IVF, that results in an embryo with DNA from three people. The baby was born in Mexico in order to avoid US regulation, as Zhang explicitly admitted. Despite the multiple violations of medical ethics involved, the media craze that followed largely heroized Zhang, depicting him as a doctor altruistically seeking to prevent the transmission of mitochondrial disease.

The prevention of mitochondrial disease has been the core justification cited all along for permitting these controversial, high-risk techniques that represent a form of inheritable genetic engineering, also known as human germline modification.

Yellow sign showing stick figure falling with text: DANGER Slippery Slope Keep AwayOn October 10, news broke that Valery Zukin, a fertility doctor at the Nadiya Clinic in Kiev, Ukraine, had used 3-person IVF not to lower the risk of mitochondrial disease, but as a treatment for infertility.

The media in this case was surprisingly quiet, perhaps because Zukin had supplied no published evidence of his claim, although the BBC did publish a somewhat critical piece entitled “3 person baby ‘race’ dangerous.”

On October 19 Nature News reported a claim that yet another baby conceived using some kind of mitochondrial manipulation technique has been born, this time in China. A paper is said to be under review at another journal.

What kind of slippery slope is this? It’s been clear from the beginning of the controversy surrounding 3-person IVF that it would be difficult to control its commercial uses beyond disease prevention. This is especially true when it comes to introducing  these genetic manipulation techniques into the multi-billion-dollar global fertility industry, a venture that could be extremely lucrative for all involved. 

To what extent has anticipation of this possibility been part of the story from the start? While we can’t know for sure, here are several points that might help make this connection:

  • In the late 1990s and early 2000s, a precursor to 3-person IVF known as ooplasmic transfer, also known as cytoplasmic transfer, was developed for age-related infertility and put into use without clinical trials. In 2001, the U.S. FDA stopped the procedure after at least two dozen babies had been born, citing lack of evidence of safety and efficacy. No such evidence was produced at the time. On October 24, 2016, Reproductive BioMedicine Online published the first follow-up study of these children. Despite the inconclusive nature of the study, which the authors admit is based on limited, subjective survey data from only 75% of the children’s parents, and with zero follow-up testing of the children themselves, they conclude that the procedure has not produced any long-term effects.
  • In February 2012, Shoukhrat Mitalipov, professor at the Oregon Health & Science University, filed a patent for maternal spindle transfer (MST) as a technique for providing prenatal treatment for mitochondrial disease in humans. In November 2012, he founded MitoGenome Therapeutics to reportedly commercialize his work.
  • On February 25 and 26, 2014, the FDA held a public meeting to discuss using 3-person IVF techniques for “the prevention of  transmission of mitochondrial disease or treatment of infertility”. Although the FDA does not make information from its applications public, this strongly suggests that someone applied for permission to conduct clinical trials towards both of these aims.
  • In January 2015, Mitalipov and MitoGenome Therapeutics teamed up with Chinese stem cell banking company Boyalife and the Korean company H-Bion, led by disgraced cloning researcher turned dog-clone entrepreneur Hwang Woo-suk, to start a lab in China. In a Nature News article, Mitalipov described the collaboration as a way to move his 3-person IVF research forward, stating, “Fertility and mitochondrial disease are a big clinical opportunity.”
  • In February 2015, Mitalipov confirmed that he had requested permission from the FDA to conduct two clinical trials using 3-person IVF techniques in the United States, the first to treat mitochondrial disease and the second to treat age-related infertility.
  • In February 2016, John Zhang of New York City-based New Hope Fertility Center released a video in which he lauded the technique’s usefulness as a fertility treatment, only briefly mentioning its potential use in the prevention of mitochondrial disease (see video at 3:05). This video was released only a few months before Zhang and his team delivered the aforementioned baby in Mexico for a Jordanian couple at risk of transmitting Leigh Syndrome.
  • In September 2016, Norbert Gleicher, a fertility specialist at the Center for Human Reproduction in New York City, says he sought a meeting with the FDA to discuss 3-person IVF for U.S. patients, including as a treatment for infertility.

CGS and others have criticized moving forward with 3-person IVF, even to prevent the transmission of mitochondrial disease, because of the unknown health consequences for resulting children and future generations, because safer options for forming families are already available, and because permitting mitochondrial manipulation in humans could open the door to other forms of human inheritable genetic modification. Throughout the policy considerations in the US and the UK about these techniques, the notion that they would be taken up as a treatment for infertility has been downplayed as unlikely or even fanciful. Yet here we are. When fame and fortune come into play, the slide can become very slippery indeed.

Previously on Biopolitical Times:

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Dangers of an Unscientific Policy Process:
Why the UK’s legalization of “three-person babies” should not be the model for CRISPR

Posted by Jessica Cussins, Biopolitical Times guest contributor on October 25th, 2016

Dangers of an Unscientific Policy Process: Why the UK’s legalization of “three-person babies” should not be the model for CRISPR

Several researchers around the world have now turned the CRISPR genome editing craze towards human embryos, reigniting questions around the feasibility, legality, and morality of creating genetically modified humans. Some have suggested that we look for guidance to the United Kingdom’s policy process for “mitochondrial replacement,” also known as “three-person IVF,” which culminated in the world’s first legalization of a procedure that is technically a form of heritable human genetic modification in 2015.

How did the UK come to enable techniques that arguably contradict a policy in force throughout Europe for more than 15 years?

Having followed the process for several years, I would argue that we can learn a great deal from its history, but more specifically in what not to do moving forward in the CRISPR policy debate. In this blog, I will try to explain why.

I am a UK citizen who generally respects Britain’s regulatory models. However, I believe this process failed to live up to its self-image of openness and transparency. The experience taught me that science and technology hold such ingrained cultural and economic capital that people often hear any concern raised – even when it comes from other scientists – as “anti-science” or “anti-technology.” Moreover, it taught me that simple stories can become so compelling and satisfying that they do not bend, even in the presence of critical new information.

In this case, a consequential law was altered on the basis of a group of scientific methods whose human health and safety consequences have not been vetted, and could end up harming those they were designed to help. For those of us paying attention, this was not a great surprise. There were readily apparent data suggesting this outcome all the way through. The question is, why was this not enough to have shifted the policy process when it mattered? And how can we protect the children now being created around the world by researchers recklessly racing to beat the UK at its own game?

First, some breaking news

On September 27, a US team of fertility doctors told New Scientist they had produced a child at a clinic in Mexico whose starting cells were engineered using what they described as “spindle nuclear transfer”, otherwise known as the maternal spindle transfer (MST) mitochondrial manipulation technique. The team was led by Dr. John Zhang (based in New York City; working in Mexico because “there are no rules there”) who performed the procedure for a Jordanian couple at risk of transmitting Leigh syndrome.

Two weeks later on October 10, New Scientist broke a second set of claims from Valery Zukin, a fertility doctor working in Kiev, Ukraine. Zukin claimed he had used the pronuclear transfer (PNT) technique and implanted the resulting embryos in two women currently pregnant in their third trimesters.  Unlike the Zhang team, Zukin claimed he was using mitochondrial manipulation techniques to address “embryo arrest,” a general infertility issue not directly related to mitochondrial DNA mutations.

On October 19,  Nature News reported on further commentary from Zhang and Zukin at recent fertility conferences, and also broke the news that a scientific journal was considering whether to publish a paper documenting the use of mitochondrial manipulation techniques to produce a live birth in China. The same day, Zhang published a brief report in Fertility and Sterility.

These developments are arguably not unpredictable in the wake of the reckless hype and minimization of the techniques’ unknowns that occurred in the UK.

Second, some background on UK law

According to the UNESCO International Bioethics Committee who considered these issues in its follow-up to the UN’s Universal Declaration on the Human Genome and Human Rights, and the Council of Europe’s Convention on Human Rights and Biomedicine (the “Oviedo Convention”), human germline modification is considered medically unnecessary human experimentation that is contrary to human dignity. UNESCO recommends a moratorium on human germline engineering, and 29 nations have ratified the legally binding Oviedo Convention prohibiting the same.

The United Kingdom, like every country that has considered regulation on the matter, has a legal prohibition against making genetic modifications to human sperm, eggs, or embryos because such changes alter the human germline and thus every human born thereafter (as opposed to somatic gene therapies, which only affect a single consenting individual.)

However, a group of researchers at Newcastle University working on somatic cell nuclear transfer (i.e. cloning to create embryonic stem cells for therapies) thought that they might be able to use the same mechanism for a more immediate human application. There are a small number of women – in the range of 1 in 5,000–10,000 – who have what is called mitochondrial disease. This covers a number of issues that impact the functioning of the mitochondria, leading to wildly divergent conditions and outcomes. In about 15% of these cases, the problem is caused by the mitochondrial genome (which has 37 genes of its own and makes up a small fraction of the estimated 20,000 genes present in every cell of our bodies.)

Mitochondrial DNA is passed on solely through the maternal line, so if a large proportion of a woman’s mitochondrial DNA carries mutations, she may be at risk of passing them on to her children. Researchers at Newcastle (as well as several others around the world) came up with the hypothesis that in these cases, women who wanted to have genetically related children, but avoid this risk of mitochondrial disease transmission, could use nuclear transfer.

How do the techniques work?

A specialist would remove eggs from the intending mother’s body, and obtain eggs from another healthy woman, then combine them to use the nucleus from the first with the mitochondria and cytoplasm from the second. At some point sperm would be directly injected. Any resulting child would thus end up with DNA from three people (leading to this technique being referred to as “three-person IVF” or to the creation of “three-person embryos”). Scientists have tended to prefer the terms “mitochondrial replacement” or “nuclear genome transfer.”

Does this sound complicated? It is. Technically, legally, socially, and morally. But complicated doesn’t get laws changed. And, given that these techniques result in a genetically modified embryo, which is illegal in the UK, these scientists had to lobby for a change in the law in order to continue their work clinically. So they did lobby, for numerous years. And, in February 2015, they succeeded in carving out an exception to the law for this specific purpose.

It now turns out that their “pronuclear transfer” technique doesn’t work as expected. Mutated mitochondria can still carry over, and can lead to a host of problems. No child has yet been born using the PNT technique, but Valery Zukin claims two such children are expected in Ukraine in early 2017 (see breaking news above). The same cannot be said for the similarly under-researched MST technique which was reportedly used by John Zhang (using the term “spindle nuclear transfer”) to bring the child born on April 6, 2016 into existence. Even as these cases were being reported, researchers were searching for new variations that might avoid the numerous safety concerns surfacing in animal model research using these two techniques.

What kinds of problems emerged before the UK decision, and who knew about them?

The Human Fertilisation and Embryology Authority (HFEA) is the UK’s regulatory body for UK fertility clinics and for research involving human embryos. It led the charge to change UK law in order to enable embryo engineering licenses. Its process for assessing “mitochondrial replacement” included three separate reviews of the scientific methods over four years, and one public consultation to gauge public sentiment. Were members of the HFEA aware of any concerns?

The short answer is yes. A number of civil society groups, including the Center for Genetics and Society, raised concerns with them on numerous occasions, as did many scientists and researchers.

For example, in March 2014, David Keefe, The Stanley H. Kaplan Professor and Chair of the Department of Obstetrics and Gynecology at NYU Langone Medical Center, wrote to the HFEA to inform them of his concerns. He told them that his own lab, which was the first to report using mitochondrial manipulation techniques in mammals, had determined it to be unsafe for use in humans. He wrote:

Our own group moved away from this research because PGD [preimplantation genetic diagnosis] provides a relatively safe alternative to MR [mitochondrial replacement] for the majority of patients, and because vexing concerns linger about the safety of MR, including the safety of reagents employed during MR, carryover of mutant mtDNA during MR and disruption of interactions between mtDNA and nuclear DNA (nDNA).

For more information on the kinds of concerns raised by scientists around the world, see this compilation from the Center for Genetics and Society.

The HFEA’s own scientific reports also turned up some issues. For example, the first scientific review determined primate testing to be a necessary pre-requisite to human testing. A subsequent review found that a group of US researchers had tried PNT technique in primates and that it didn’t work. Instead of heeding this red flag, the HFEA simply dropped the primate requirement altogether.

Moreover, the HFEA defined their public consultation as highlighting “broad support” for the techniques in question. However, independent analysis of the consultation found that the majority of people who responded to the only open segment were actually against the law being changed at that time for a range of scientific and ethical concerns. That did not stop the HFEA from claiming the opposite, or from pushing forward.

So, how was the law changed?

The problems with the UK policy process seem to stem from a number of factors. For one thing, it apparently involved a commitment to the story that had taken hold, to a pre-determined end goal. While that goal surely began with the desire to help women with a rare disease, it seemed to become primarily a question of changing the pre-existing law. Everything was done in order to see that law changed. The time, money, and resources spent throughout multiple sectors of society were enormous.

As a particularly telling case in point, there was the sustained effort to control the language used in the public debate. The common term “mitochondrial replacement” is itself a euphemism because it is not the mitochondria, but the nucleus containing more than 20,000 genes, that is transferred. One scientist commented early on that such “scientifically inaccurate descriptions have been instrumental in easing the way to public acceptance of these manipulations.”

Perhaps even more brazenly, the Government’s Department of Health later came out with the position that the technique did not constitute “genetic modification”. This led to other scientists straight-out accusing the Government of dishonesty in its efforts to gain support for these techniques.

An additional factor enabling this process was a mistaken cultural assumption held by some policymakers, that helped them to hear all objections as “theoretical religious concerns.” This allowed them to diminish the myriad technical, social, and ethical concerns being voiced. One evolutionary biologist at an evidence hearing held by the UK Parliament’s Science and Technology Committee in October 2014 tried to raise his concerns about the techniques’ safety and efficacy at the meeting. He tweeted afterwards:

Thought on @CommonsSTC meeting: what's the point of funding, performing, publishing and requesting scientific evidence if it's then ignored?
— Ted Morrow (@ted_morrow) October 22, 2014

I described my own frustrations about this meeting in a blog at the time here.

A third factor that enabled the law to be changed seems to have stemmed from pride in seeing the UK as an innovation hub in the biomedical sciences, and in embryology in particular. At the evidence hearing, for example, Conservative MP Jane Ellison stated that she is “extremely proud” that Britain is a “pathfinder” and “innovator” with a “well-respected regulatory regime.” Similar sentiments were frequently voiced as part of the argument for proceeding.

What can we learn from this?

In the end, public trust has been compromised and patient’s hopes were repeatedly raised and then dashed, and now are being stoked again with the recent birth announcements – despite a startling lack of safety evidence about the health consequences for the resulting children. In my mind, this is exactly the kind of thing that threatens one’s position as a “respected” “pathfinder.”

But this turn of events was not necessary, and we can learn from the experience.

Because policy tends to move so much slower than technological innovation, it can be tempting to push for policy changes before important specifics are determined or tested. But the goal in creating policy around consequential science and technology must be to make it as responsive to changes in the data (both technical and social) as possible. If a new drug for Zika shows promise, its approval should be sped up; if it turns out that an alternative method for preventing transmission of disease is preferable, then that alternative should be pursued instead. When the technology is particularly risky or ethically problematic, its use should be especially carefully considered, and any potential alternatives taken very seriously.

We must continuously work to make sure we are driven by real, human needs. The push for technology for its own sake (or for the general sake of research or innovation) can be powerful, but it must not be the primary driver of public policy.

In this case, commitment to a thorough and adaptive learning process would have spotted failures and inefficiencies of the mitochondrial manipulation techniques much earlier on, and probably pivoted resources towards improved preimplantation genetic diagnosis as the safer and more efficacious method to prevent the transmission of mitochondrial disease. This kind of continuous learning may seem like more work up front, but it will save money, time, and maybe even lives in the long run.

The way we tell stories matters. The world’s first legalization of a form of heritable human genetic modification will always be a precedent. And how that history is recorded could have profound implications for how the future unfolds. The global consequences of the UK’s breach of a scientific and ethical global consensus are only beginning to be felt.

What should we do about CRISPR?

As the world scrambles to determine how best to govern human applications of genome editing, people are seeking instructive precedents. Many are looking to the UK’s “mitochondrial replacement” policy process as a prime model.

In a Cell report titled, “Going Germline: Mitochondrial Replacement as a Guide to Genome Editing,” Eli Y. Adashi and I. Glenn Cohen, professors of Brown Medical School and Harvard Law School respectively, provide just one example. They write:

Both [techniques] must contend with breaching the germline barrier. Both entail the manipulation of a human embryo. Both must address significant safety concerns. Both must engage a skeptical public… Applying the principles relied upon in the regulatory evaluation of [mitochondrial replacement] will go a long way toward assuring that the prospect of therapeutic genome editing in the human is the subject of a thorough, inclusive, ethical, safety-minded, and confidence-inspiring process.

Compared to the US context of piecemeal efforts by the FDA, but no explicit regulatory body for fertility clinics and embryo research, the existence in the UK of the HFEA and public consultations represent important improvements. But this process was far from exemplary. The creation of policy for the most consequential emerging technologies would benefit enormously from a commitment to scientific rigor, openness to a diversity of views, and adaptability.

Although the UK’s process for legalizing “mitochondrial replacement” may seem robust on its surface, the reality was that all dissenting views and unfavorable scientific results were sidelined, if not ignored. A façade of “rigor” that enables those in power to cherry-pick data and orchestrate public opinion may in fact be the most dangerous option of all. This is particularly true when the hype engineered to support legislative change is exported by forum-shopping doctors who seek to work in countries where “there are no rules”. When it comes to crafting policies for CRISPR germline genome editing, we must do better to put first the health, safety, and ethical treatment of women and children. We will need greater transparency and respect for inclusive debate to guide us towards responsible innovation in the life sciences.

Previously on Biopolitical Times:

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Just What We Need: Slicker Infertility Marketing

Posted by Gina Maranto, Biopolitical Times guest contributor on October 21st, 2016

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The most unsettling line in the recent Forbes article on the ambitious infertility startup Prelude comes about halfway through. “The IVF industry in the United States,” writes Miguel Helft, “has everything private equity likes—scale (about $2 billion annually) and growth (more than 10% a year), along with being fragmented and having outdated marketing.” 

In an era with precious few opportunities for double digit returns, why not turn the reproductive health sector into the next big thing by furthering its consolidation and selling services using lifestyle content?  “Hey,” Prelude’s hipster-chic splash page calls out, “how’s your fertility doing?” 

A woman in a polka dot blouse lounging on a couch looks directly in the camera with the text "Hey, how's your fertility doing?" in bright font.

If that piques your interest, scrolling down takes you on a kind of virtual stroll through the streets of Williamsburg, Wicker Park, or the Mission District, where you encounter edgily coifed, tatted, and bespectacled folk who presumably are spending as much time thinking about their reproductive fitness as they do their next Americano or Kimchi taco.  But you’ll find scant information about financial, psychological, or medical risks of egg retrieval (unless you count the presumed donor pictured alongside the quotation “I was worried about the discomfort, but seriously, it was no worse than a bikini wax—and for a much higher purpose”) or about failure rates after eggs are thawed and implanted.  Everything is upbeat and empowering, geared toward the “millennial mindset of health, wellness, and control.”

Prelude is targeting 20 to 30 year olds and the main product it’s selling them is their own eggs and sperm on ice.  The site proclaims, “If you are in your 20s or early 30s, there is no better time than now to bank your eggs and sperm. They are stretchy and full of reproductive life force, just like you!” (Must be all that hot bikram yoga, huh?) 

A woman with spectables and a backpack in a city street looks into the camera, with the text "Press Pause" in bright font.

With $200 million in funding, Prelude founder, chairman, and CEO Martin Varsavsky, who bills himself as a “serial tech entrepreneur,” laid the foundation of the company by acquiring controlling stakes in one of the largest IVF clinics in the country, Reproductive Biology Associates in Atlanta, which in 2016 had net sales of just over $5 million; and their partner, My Egg Bank, which gives would-be parents access to frozen eggs through a network of infertility clinics.  Already profitable, Prelude also offers a product line for 40-somethings in the form of “screened donor eggs.”  Helft writes that Prelude’s aim is “to take [egg and sperm freezing] mainstream, giving it scale and Silicon Valley pizzazz.” 

It all puts one in mind of nothing so much as the international market in animal sperm and embryos.  Reproductive technology in animals far predates that in humans: British scientist Walter Heape (himself a serial entrepreneur) produced the first successful mammalian embryo transfer in 1890 with rabbits.  By the mid-1960s, animal sperm banks could be found around the world, and one study estimated that the cattle industry had by then performed artificial insemination on 59 million cows, 47 million ewes, 1 million sows, 125,000 mares, 56,000 goats, and 4 million turkeys.  Businesses like Bovine Elite, Cattle Visions, and Cattle Genie are part of a multimillion-dollar global trade in cattle semen and embryos that has all but eliminated traditional mating and led to stacked pedigrees and reduced genetic variability.   (One Wisconsin bull who sired some 500,000 offspring made national headlines when he died.)

While American Society of Reproductive Medicine guidelines currently suggest limiting the use of a single male’s sperm to 25 recipients (there are no suggested limits for donor eggs or embryos), what’s to say we won’t see the human version of cattle breeding as marketing takes precedence and consumer demand drives clinical practice?  History provides ample evidence of the ways in which global capital tends to push enterprises toward greater scale and homogeneity—from fast food to pop culture to higher education.

Fifty years from now, historians could look back and see that Prelude, along with other egg banking and IVF-clinic networks duking it out for international market share, laid the groundwork for branded gametes and embryos, all under the soothing guise of offering customers “insurance” on their reproductive viability. 

Gina Maranto is a fellow at the Center for Genetics and Society. She is Director of Ecosystem Science and Policy and Coordinator of the Environmental Science and Policy program at the University of Miami's Leonard and Jayne Abess Center. Her articles, opinion pieces, and reviews have appeared in Discover,The Atlantic Monthly, Scientific American, The New York Times, and other publications. She is the author of Quest for Perfection: The Drive to Breed Better Human Beings.


Previously on Biopolitical Times:

Images via Prelude Fertility and Pixabay

World Bioethics Day: Human Dignity and Human Rights

Posted by Leah Lowthorp on October 19th, 2016

Untitled Document The first World Bioethics Day, sponsored by the UNESCO Chair in Bioethics, is taking place on October 19. This year’s theme of Human Dignity and Human Rights will be celebrated in 55 countries worldwide (see here for a list of participating countries and here for a list of planned events).

While most countries are hosting one or two World Bioethics Day events, India has planned a whopping 29. The only event scheduled in the United States is at Indiana University Northwest, which will include presentations on bioethics and human rights and a screening of “No Más Bebés,” a documentary about Mexican-American women who were coercively sterilized at Los Angeles County-USC Medical Center in the 1960s and 1970s. (Filmmakers Virginia Espino and Renee Tajima-Peña joined CGS on the UC Berkeley campus in 2016 to screen the film as a part of the Being Human in a Biotech Age series. They were also interviewed for the CGS online series Talking Biopolitics by eugenics scholar and CGS advisory board member Alexandra Minna Stern, see here and on YouTube.)

Human dignity and human rights, in addition to being the theme of this first annual World Bioethics Day celebration, form the primary framework of most of the international and national legislation worldwide that prohibits inheritable genetic modification, also known as human germline modification. The most notable among these is the Council of Europe’s 1997 Convention on Biomedicine and Human Rights (see here for a global list of national legislation banning inheritable genetic modification).

It is surprising that human genetics has such a low profile among the list of World Bioethics Day events. 2015 and 2016 have seen unprecedented technological developments with troubling implications for human germline modification – such as the public policy controversies surrounding reproductive applications of gene editing and human experimentation with mitochondrial manipulation techniques (or “three-person IVF) in Mexico and the Ukraine.

Out of 88 events today, only one sponsored by the Bosnia and Herzegovina Unit features genomics as its main theme. Five others, two in Italy and one each in Slovenia, Macedonia, and India, will include individual presentations on the wider topic of human genetics. The Bosnia and Herzegovina event is Bioethics in the Era of Genomics and Personalized Medicine, an international conference that will take place in Sarajevo on October 28.

Previously on Biopolitical Times:

Image via UNESCO

7 Highlights from Nuffield Council’s Review on the Ethics of Genome Editing

Posted by Jessica Cussins, Biopolitical Times guest contributor on October 18th, 2016

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The UK Nuffield Council on Bioethics’ recently released report, Genome Editing: an ethical review  (full version available here) is the most substantial and thorough assessment of its kind. It delves deeply into the ethical, social, and political underpinnings and implications of genome editing, and touches on related, converging technologies including synthetic biology, gene drives, and de-extinction. A second report with ethical guidance regarding the use of genome editing for human reproduction is due in early 2017 from a Council working group chaired by Karen Yeung

This first report will be an important reference for people across disciplines for some time, and I will not do justice to its scope and breadth here. However, I want to draw attention to just seven concepts that are particularly helpful and illuminating, as much for their framing of the questions at stake as for their content. I briefly summarize each point, and select key quotes from the report.

1. On emerging technology and innovation

Contrary to frequent assumptions, innovation in science and technology is neither linear, autonomous, nor pre-destined. It is continuously co-produced in relation to a complex intersection of actors, institutions, market-drivers, and serendipity. Momentum and sunk costs can however encourage adherence to certain technological pathways, meaning the choice of paths we take should not be undertaken blindly, or lightly.

“A commonplace but now largely discredited perspective viewed science as a resource from which innovators draw, leading to new technological innovations that provide social or commercial benefits, such as increased wellbeing and productivity. The flaws in this ‘linear model’ are generally thought to stem from its failure to give due attention to the complexity of innovation processes, the importance of feedbacks, the role of markets and other actors, and the effects of uncertainty and serendipity. Science now tends to be seen less the wellspring of technological innovation than a ‘co-producer’ along with these other forces and actors.” (15)

“The factors that act to attract, secure and consolidate investment may also have the effect of confirming a course for innovation, creating both ‘lock in’ of contingent technological forms and forward momentum along a particular technological pathway. The reasons for this include factors such as sunk costs, learning effects, increasing returns to scale, high transaction costs associated with any change of direction and the mutual adaptation between technologies and associated conditions of use, including the structure, governance and practice of institutions, and not excluding social conditions, normative rules and standards, and public acceptance.” (18)

2. On the “editing” metaphor

Discussion of “genome editing” as opposed to “genetic modification” or “genetic engineering” has a re-framing effect that serves to distinguish the newer technological capabilities as more “precise,” as well as to diminish their consequences by avoiding connotation with such loaded terms as “GMO.” The “editing” metaphor instead conjures images of easily altered language or computer code.

“Whether intentionally or not, the ‘editing’ metaphor distinguishes the approach from less ‘precise’ forms of genetic ‘engineering’ and, simultaneously, distances it from their associated connotations, including the range of public responses that these terms typically excite. The editing metaphor also plays on characterisations of the genome as the ‘book of life’ containing ‘sentences’ (genes) made up of a ‘genetic alphabet’ of four ‘letters’ (A, C, G and T, the initial letters of the four chemical bases comprising DNA) that were common around the time of the Human Genome Project. The editing metaphor transfers easily to the more contemporary image of modifying computer code. The metaphor suggests not only the type but also the significance of the intervention: it is technical, is not dependent on scale (as it applies equally to changes large or small) and is seen as corrective or improving (at least in relation to the editor’s vision).

“In this way, the concept of editing has a certain thickness, whereby, while apparently descriptive, it implies a tacit evaluative judgement. It also implies an editor (the one who does the editing) and, by deeper implication, may distinguish the editor, who merely corrects and improves, from a putative, creative ‘author’. But whether authorship is assigned to a divinity or not, the implication is that the work of editing is trivial in comparison.” (19-20)

3. On the public interest

Science and technology are intimately connected with the public interest. They are forged through public funding and support, and they act upon and within the world, with impacts on the well-being and welfare of the public. 

“There is a public interest in research for at least two main reasons. The first is to the extent that a great deal of research in the academic sector is publicly funded, from money collected through general taxation. This implies a public interest in the fact that this money is spent in a way that reflects public priorities and pursues them with the greatest possible efficiency. The second, more profound, reason is that products and practices, processes and tools produced by the application of knowledge gained through research may have a direct or indirect impact on the wellbeing and welfare of the public (including their moral and social welfare). The public have an interest in science, in terms of its expectation of net social benefits, and invests in science both financially and through the trust placed in scientists to contribute to the delivery of these benefits. But more profoundly than this, the public have an underlying public interest in the overall moral and ethical texture of the society in which they live. How technologies like genome editing are taken up and regulated both reflects and influences the broader moral values on which common social life is based and the social meaning of the practices in question.” (21)

And, quoting from Sheila Jasanoff’s article “Technology as a site and object of politics”:

“…technology, once seen as the preserve of dispassionate engineers committed to the unambiguous betterment of life, now has become a feverishly contested space in which human societies are waging bitter political battles over competing visions of the good and the authority to define it. In the process, the virtually automatic coupling of technology with progress, a legacy of the Enlightenment, has come undone. Uncertainty prevails, both about who governs technology and for whose benefit. No matter which way one looks, the frontiers of technology are seen to be at one and the same time, frontiers of politics.” (21)

4. On normality, moral norms and rights

Should we judge what constitutes an acceptable or unacceptable biological intervention using a concept of what is “normal?” What would that mean and who would decide? What lessons must we heed from 20th century eugenics programs about desires to direct humanity?

“While nature contains many prodigies, the normal can serve to orientate moral action (for example, in terms of whether that action tends to support what is regarded as normal functioning or produce divergence from it). What counts as normal is therefore a legitimate question but often one that is highly contested with regard to the extent to which norms are related to natural states or socially constructed, particularly in relation to issues of disability, medical intervention and enhancement. Disability justice and rights scholars have made a range of moral arguments against selective technologies, from individual rights based arguments such as the right to life of people with disabilities, to arguments for the social and emotional value (e.g. vulnerability to contingency) of biological difference, to the value to humankind of conserving disability cultures, and the importance of the visibility of disability in establishing social attitudes, behaviour, and structures.” (28)

“A particular concern that has been raised is that genome editing combined with social liberalism may facilitate the ‘consumerisation’ of human biology, and the spread of ‘consumer’ or ‘liberal’ eugenics, driven by the choices of parents rather than by state policy, but with possibly similar, socially divisive results. Objections here concern the practice as well as the consequences: that the biological conditions of human existence should not be the subject of choice since they allegedly interfere with identity of the person in morally significant ways.” (52)

5. On social justice and a just society

The advantages and opportunities of science and technology in general, and of genome editing in particular, may not be fairly distributed among different groups, different nations, or across generations. Developments cannot therefore be seen outside of the context of social, intergenerational and global justice. 

“Such concerns require us to attend to the need to ensure that measures (such as the introduction of a new biotechnology) that affect welfare do so without discriminating unfairly among people. Although people may be equal in dignity and the enjoyment of rights, they are not equally situated with regard to the benefits and harms of biomedicine and biotechnology. Certain people may be disproportionately affected, may find themselves (perhaps involuntarily) in circumstances that render them particularly vulnerable, or be excluded from access to decision making or to benefits that are available to others. As a result, they may experience unfair discrimination and systematic disadvantage. It is argued by many that dignity and rights discourse is, in fact, insufficient to ground socially just action and that a specifically social justice perspective is called for: they consider it to be essential to put in place means for tracking social justice outcomes over time, and social justice goals in regulation of genome editing technologies.” (29-30)

6. On public policy

Public policy initiatives around genome editing are high-stakes, representing a collective vision of a desirable future, and determining those actions deemed unacceptable to the public interest. Public policy is both reflective of and impactful upon the society in which it functions, and in the world at large.

“As well as forestalling or redressing unjust treatment of individuals, public policy measures both reflect and affect the kind of society in which they are implemented, including the relationship between public and private, how and to what extent different groups and members participate in social life, how different priorities, preferences and values are resolved or tolerated, how equal or unequal in power, status and wealth its members are, and how open or closed the society may be. The features of any society are complex, interdependent and dynamic, but public policy measures often imply and express consistent common values and may be articulated around a collective vision of the desirable future state that they are expected to contribute to bringing about. These, in turn, influence the behaviours, institutions and culture of the society, for example whether it is welcoming or hostile to difference in terms of ethnicity, belief, appearance or ability.” (30)

7. On looking forward

Genome editing is a new development that has garnered enormous excitement. It is important to discuss the impacts of this disruptive new technology, but it will also be useful to avoid inevitability arguments, sky-high expectations, and to remember that it is just one element of a number of larger converging technologies. Future discussions would benefit from beginning with real human challenges or problems, rather than with a technology for its own sake.

“It should be remembered that most prospective technologies fail, and that some lead to undesirable consequences, a fact often obscured by ‘whig’ histories that reconstruct the history of successful technologies and their beneficial social consequences. Scientific discovery and technological innovation is important but not inevitable. Most important among the factors shaping technological development is human agency. It is human agency, in terms of decisions that are made about directions of research, funding and investment, the setting of legal limits and regulatory principles, the design of institutions and programmes, and the desire for or acceptance of different possible states of affairs, that will determine whether, and which, prospective technologies emerge and, ultimately, their historical significance.” (112)

“We are convinced that it makes little sense to treat the questions raised by genome editing as if they belonged to a single field (a hypothetical discipline of ‘genome editing studies’). Rather, they should be addressed as part of different technology convergences (e.g. with ART, with gene drives, with agricultural technologies, etc.), which also includes political technologies (regulation, legislation, etc.). But, more than that, we conclude that it is not the scale at which questions are posed but also their orientation that is important. Beginning with questions about what can be achieved at the genome level risks reducing all questions to ‘ELSI’ questions (questions about the ethical, legal and social implications of genome editing, as if that were the only or most obvious pathway available to address a complex set of real world challenges) and leaving questions about the appropriateness of genome technologies in any given case unaddressed. This is why the next, normative, phase of our work should begin with problems or challenges (and the potential diverse framings of those challenges), rather than technologies, and adopt a comparative methodology.” (115)

Previously on Biopolitical Times:

Image via Nuffield Council on Bioethics

3-Person IVF Breaking News: Where Are the Advocates for the Public Interest?

Posted by Leah Lowthorp on October 7th, 2016

Turquoise microscopic image of human egg being injected with sperm with long needle in vitro
The unapproved technique involves injecting sperm into an engineered two-person egg via intracytoplasmic sperm injection or ICSI (pictured).

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The first baby born as a result of the “3-person IVF” technique known as maternal spindle transfer (MST) was reported by New Scientist on September 27. To avoid US regulation, a team led by Dr. John Zhang of New Hope Fertility Center performed the unapproved and controversial procedure in Mexico. Now five months old, the child appears healthy but may encounter serious problems later in life.

Media coverage of this event in the United States and United Kingdom has been overwhelmingly celebratory, downplaying the serious health risks involved for the child and future generations, as well as Zhang’s flagrant disregard of established US regulatory policies (see New Scientist, New York Times, BBC, and The Telegraph). Zhang’s widely cited self-justification – “To save lives is the ethical thing to do” – has not been examined, despite the clear conclusion in the recent Institute of Medicine report that this technique “does not address a medical need,” let alone save lives, as it “would not treat an existing person for a disease, illness, or condition.”

Outside the US and UK, media coverage has been more tempered. While less celebratory, the German press has been surprisingly uncritical, despite emphasizing the fact that the procedure is illegal in Germany. The Portuguese language press has tended to syndicate translations of the English language press, although the Observador published a thoughtful piece raising questions about potential “Lego-babies.” The French language press has tended more towards the critical side, often including a section devoted to the health and/or ethical risks associated with the procedure. An article by Grégory Rozières at Le Huffington Post (France) warned, “This can be seen as the first step on a dangerous path…The risk of eugenic abuses is evident.” 

A number of news stories did include comments from public interest advocates, scientists, and policy experts voicing a range of concerns. Nature News quoted biologist David Clancy saying, “They just went ahead and did it. The number of issues that are still unresolved — it’s just staggering.” For other examples, see coverage at NPR, NBC News, Forbes, and BBC.

Several statements and articles explored the concerns in more depth. The Center for Genetics and Society released a press statement emphasizing the unsafe nature of the procedure, its unknown health consequences for the child and future generations, and the dangerous precedent set by renegade science, urging scientists and policy makers to “condemn rogue experimentation that takes advantage of families’ misplaced trust in people who wear white coats.” CGS executive director Marcy Darnovsky, PhD, stated,

No researcher or doctor has the right to flout agreed-upon rules and make up their own. This is an irresponsible and unethical act, and sets a dangerous precedent.

Paul Knoepfler, Professor in the Department of Cell Biology and Human Anatomy at UC Davis, expressed his deep concern about the ethics and safety of the procedure on his blog, emphasizing the need to recognize it for what it is, namely a “living human experiment” that has produced “a genetically modified human being.”

David King, PhD, director of the UK watchdog group Human Genetics Alert, issued a press statement condemning the news, stating,

This is entrepreneurial reproductive technology at its most unethical and irresponsible.  It is outrageous that they simply ignored the cautious approach of US regulators and went to Mexico, because they think they know better. Since when is a simplistic “to save lives is the ethical thing to do” a balanced medical ethics approach, especially when no lives were being saved? These scientists have used an experimental technique that many scientists still think is unsafe, in order to create a world first. When are the world's governments going to stop rogue scientists crossing crucial ethical lines?

Finally, in an invited article in the Deccan Chronicle, Biopolitical Times contributor Pete Shanks wrote:

What we now know for certain is that national regulations without international cooperation may be almost useless in today’s interconnected world. Meanwhile, gene-editing technology is advancing rapidly…. Among the most worrying possibilities is the creation of children with genetic modifications that could change forever what it means to be human. “Designer babies”, for short.

What if we come to a consensus about what should not be allowed… and then some renegade scientists, convinced that they know best, just go ahead and do it?

Previously on Biopolitical Times:

Image via Pixabay

CRISPR Embryos at Karolinska: Controversies Demand Oversight

Posted by Elliot Hosman on October 7th, 2016

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Rumors have been circulating since 2014 about various research teams around the world applying the genetic engineering tool CRISPR-Cas9 in human embryos. Surprisingly, only two experiments have been officially reported in scientific journals—both of them in nonviable embryos incapable of being used for reproduction, and both out of Guangzhou, China.

CRISPR in viable human embryos

On September 22, NPR’s Rob Stein reported an exclusive look inside the Karolinska Institute in Sweden at ongoing but previously undisclosed work using CRISPR in viable human embryos. Stein had traveled to Stockholm to interview researcher Fredrik Lanner and his colleagues about their program of injecting CRISPR into viable human embryos to “knock out” genes potentially linked to early development. NPR quoted CGS executive director Marcy Darnovsky who cautioned:

It's a step toward attempts to produce genetically modified human beings. This would be reason for grave concern. … If we're going to be producing genetically modified babies, we are all too likely to find ourselves in a world where those babies are perceived to be biologically superior. And then we're in a world of genetic haves and have-nots...

The next day, Hank Greely, director of the Center for Law and the Biosciences at Stanford University, told Eric Niiler in Seeker that there is “good valid medical use” for basic scientific research using CRISPR in embryos, but followed that with a warning:

Still, Greely acknowledges that some scientists or the public might say that the Swedish experiment could be an ethical "slippery slope" toward a gene-edited human. “Even if you don't intend to, it makes it easier for someone else to do it,” Greely said.

Rogue actors: “Bioethics, get out of the way”

While many scientists, scholars, legal experts, and public interest advocates oppose using human gene editing for reproductive purposes, others question why anyone would dare stand in the way. There are longer and shorter answers. Our knowledge of both CRISPR and genetics/genomics is poor—not  just on its own terms, but also in relation to other spheres of knowledge, particularly the ways in which they each interact with evolution, environments, public health, and social justice. For the foreseeable future, it would be reckless for a scientist to implant CRISPR-injected embryos for pregnancy not only because of serious safety concerns, but also in terms of democratic governance—especially given the select echelons to which most of the debate is currently restricted, and the range of social and political threats that genome editing poses to the human species.

In Seeker, legal scholar Rosario Isasi of the University of Miami voiced concern about edited human embryos being misused to produce genetically modified humans.

What are the oversight and controls to prevent this technology from being misused and go to a stage that, for now, the scientific community has agreed is a no-go?

In the italics (added) above, Isasi refers to the concluding statement from the International Summit on Human Gene Editing in D.C. in December 2015, in which the organizing committee argued:

It would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved…and (ii) there is broad societal consensus about the appropriateness of the proposed application.…any clinical use should proceed only under appropriate regulatory oversight.

Ensuring that researchers work within the bounds of existing national and international prohibitions against heritable genetic modifications in early human cells can be difficult when: (1) commercial and reputational incentives interfere, and (2) rogue scientists exploit basic research for socially and scientifically unsafe ends. Isasi noted in Seeker that the Karolinska Institute has been the venue of an ongoing controversy involving Paolo Macchiarini, a stem cell researcher whose implants of artificial trachea into people led to deaths between 2012 and 2014. Isasi asked:

How did they supervise that [artificial trachea] research, which makes me wonder, what mechanisms were in place to oversee this (gene-editing) proposal [?]

Concerns about end runs or misbehavior by individual scientists have recently grown. On September 27, the news heard ‘round the world was that a fertility doctor based in New York City went to Mexico to use scientifically controversial mitochondrial manipulation techniques to produce a child from an embryo engineered from the DNA of three people. New Hope Fertility Clinic’s John Zhang will take the stage and present the methods used to produce this “three-parent baby” at the upcoming conference of the American Society for Reproductive Medicine, the trade organization for fertility practitioners. The scientific portion of the annual meeting this year is aptly titled: "Scaling New Heights in Reproductive Medicine". It will be instructive to see whether Zhang is met with applause for his “disruptive” and “innovative” foray, or whether his colleagues will criticize the ways he short-circuited public policy and democratic discussions of emerging biotechnology regulations.

Clear boundaries - for some

In an interview with Paul Knoepfler, Lanner noted the existing Swedish policy against using modified embryos for pregnancy:

Swedish law is clear that genome editing is only allowed within the first 14 day[s] as long as the embryo is not transferred back for a continued pregnancy. This means that heritable genome editing for clinical purposes would not be allowed in Sweden. The clear legislation has been key in us moving ahead with these plans…. I’m actually pretty skeptical that the technology will be used for genome editing in the early embryo anytime soon.

The situation in China is different. While that country has regulations that would technically ban gene-edited embryos being used for pregnancy, it is unclear whether these regulations are enforced. On September 24, news emerged out of China that a CRISPR testing facility for genetically modified animals was under scrutiny for “faking inspection records and using students instead of certified technicians to conduct tests.” The testing center was established by the Chinese Academy of Agricultural Science, whose website lists partners including the Gates Foundation and UC Davis. It is a subsidiary of the Chinese Academy of Science which co-sponsored last December’s International Summit on Human Gene Editing with the U.S. National Academies and the UK’s Royal Society. Chief researcher Huang Dafang noted:

The incident has exposed management problems of some similar institutes, and serves as a warning…

Where does that leave the U.S.?

Many across the spectrum of opinion have noted the alarming speed with which CRISPR is being applied in research labs, including to human embryos, outside public scrutiny. Absent consistent laws or guidelines, many are concerned that rogue researchers may conclude that it is “safe enough” to implant edited embryos for pregnancy.

Given the competitive pressures in the world of science, the commercial incentives to be “first to market,” and the forum-shopping inherent to today’s biomedical enterprise, the “three-person IVF” child born in Mexico is a cautionary tale. Someone, somewhere could soon decide to try for a CRISPR baby. We should aim to protect future children from being born stripped of their privacy and guaranteed a life of medical display and tracking that was justified on their behalf to service goals like parental genetic connection.

We need a federal ban on any private or publically funded research aimed at clinical tests of human germline interventions and specifically against the use of gene-edited human germ cells in assisted reproduction. We also need an international conversation on how to pressure the biomedical sector in a range of political contexts to stay away from the human germline.

Previously on Biopolitical Times:

Composite image via Pixabay (lungs), Pixabay (baby silhouette), and Flickr/Lisa Camper (DNA)

Collaborative Science on Historically Burdened Concepts: Intelligence, Genetics, Race & Socio-economic Status

Posted by Daphne Martschenko, Biopolitical Times guest contributor on October 6th, 2016

Image via Wikimedia: "Lithograph of a North American skull from Samuel Morton's Crania Americana, 1839. Morton believed that intelligence was correlated with brain size and varied between racial groups".

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Charged Words

Intelligence is a highly charged word with ties to racist, classist, and eugenic narratives. In the United States, it has been used historically to assert and establish racial and class hierarchies, especially those between Blacks and Whites, and has long been linked to notions of biological difference.

In the early twentieth century, these notions were frequently explicit. As one example among many, Princeton psychologist Carl Campbell Brigham, creator of the SAT and member of the Advisory Council of the American Eugenics Society, wrote in 1922:

According to all evidence available…American intelligence is declining, and will proceed with an accelerating rate as the racial admixture becomes more and more extensive…There is no reason why legal steps should not be taken which would insure a continuously progressive upward evolution… The steps that should be taken to preserve or increase our present intellectual capacity must of course be dictated by science. (Brigham, 1922: 210)

Even in the years following World War Two, when overt claims of racial differences in intelligence were often muted, Nobel Laureate (in physics) William Shockley could openly argue:

I sincerely and thoughtfully believe that attempts to demonstrate that American Negro shortcomings are preponderantly hereditary is the action most likely to reduce Negro agony in the future… I propose a serious scientific effort to establish by how much the distribution of hereditary potential for intelligence of our black citizens falls below whites…If those Negroes with the fewest Caucasian genes are in fact the most prolific and also the least intelligent, then genetic enslavement will be the destiny of their next generation. (Shockley, 1971: 244)

In June 2000, when the completion of a preliminary sequence of the human genome was announced at the White House, President Bill Clinton famously said,

One of the great truths to emerge from this triumphant expedition inside the human genome is that in genetic terms, all human beings, regardless of race, are more than 99.9 percent the same. (GenomeTV, 2012)

But this did not end debate about race, genes, and intelligence. In fact, many observers have noted that the years following this announcement saw an uptick in claims that race is a biologically meaningful system of classification. In 2005, Francis Collins himself suggested that “we now need to study how genetic variation and disease risk are correlated with self-identified race” (Krimsky, 2011: 25).

Among those who study genetics and intelligence today, the discourse about race is couched in more subtle and humanitarian terms than it was in the twentieth century. Take for example G is for Genes, published in 2013 by behavioral psychologist Kathryn Asbury and behavioral geneticist Robert Plomin. The book advocates for “genetically sensitive” schools that use genetic information to maximize a child’s abilities through a system of personalized learning. In a chapter titled “Mind the Gap: Social Status and School Quality,” the authors discuss the impacts of low-income status, poor parenting, and teacher quality on a child’s success in the classroom. Race is remarkably absent from the picture.

Of course, conscious and unconscious assumptions about links between race and cognitive ability haven’t simply disappeared. Although race is not valid as a biological system of categorization (Cooper et al, 2003), it remains an important causal social factor. Any research that has a history of marginalizing certain groups needs to address race explicitly—both as an inherited colonial system of classification and as a form of social inequality.

Recognizing the detrimental impact of race on an individual’s life circumstances is important for creating meaningful and effective improvements and change. Talking about race as a social factor that shapes an individual’s everyday experiences is a way of challenging vast and recurring misapprehensions that locate race in notions of the biological. Failing to talk about it makes that challenge far less likely to succeed.

Heated Debate

Both in the social sciences and hard sciences, discomfort, confusion, and even denial often accompany conversations about intelligence. Each side habitually questions the rigor, benefit, and legitimacy of the other’s work. My own research as a PhD candidate sits between these fields, where the tensions between the two are inescapably clear.

My work focuses on four terms with burdened histories: intelligence, genetics, race, and socio-economic status. I examine how genetics research into intelligence and educational attainment affects the United States education system, where documented racial and socioeconomic disparities prevail and where teacher perceptions of student ability are known to affect student performance and referrals for gifted education programs (Elhoweris et al, 2005; Gillborn et al, 2012; Grissom, 2016; Slate et al, 1990).

On the one hand this means that I’m reading Genome-Wide Association Studies on educational attainment or intelligence, and engaging with geneticists who produce a form of scientific knowledge (Davies et al, 2011; Plomin et al, 2013; Rietveld et al, 2013; Selzam et al, 2016). On the other hand, I’m working with teachers in the classroom who are trying to make sense of why some bodies are less visible in gifted education programs than others (though gaining access in schools has been remarkably difficult, highlighting the charged and controversial nature of this project).

This is terrain on which it should be possible to connect the social sciences to hard sciences. But it is a landscape fraught with competing and underlying political debate. Two of the key questions: Are hard scientists socially responsible for how their work is interpreted and disseminated? Are social scientists truly informed about the science behind the work they often critique?

As an anthropologist, I am aware of the murky origins of my field as a whole—its expansion to legitimize Western colonialism, its use of scientific language and eugenics to validate social hierarchy as naturally occurring and biologically based. Anthropology, like other disciplines, has mobilized the concept of intelligence to maintain racialized matrices of power and hierarchies of inequality.

Scientists, on the other hand, often see their work as separate from social structures and narratives, rather than embedded in them. But insisting on the inherent objectivity of science is dangerous. In the case of genetics research on intelligence, its social impact on the US education system is potentially vast. Those who choose to research the biological basis for intelligence or educational attainment have a special responsibility to recognize this, and to understand its historical and foreseeable pitfalls. Collaborating with social scientists can help to make social implications more clear. While socially neutral research might not exist, socially responsible research certainly should.

Social scientists also have a responsibility. They can understand the methods and techniques of scientific research. And they can engage with geneticists in an open and inquiring manner. Intelligence researchers see legitimate benefits for individuals and society in their work. The social sciences can understand what the argued benefits are and why they are deemed valuable. Having a background in basic genetics and understanding the methodological practices at work in the field can strengthen critiques of the risky assumptions built into the methods and techniques of genetics research or highlight weaknesses in findings.

Scholars working in the hard sciences have faulted the media for misinterpretation, oversimplification, or sensationalism of their work (Asbury and Plomin, 2013: 96). Those in both social and hard sciences have noted that misleading hype often emerges in university press releases associated with the research (Evans, 2016: 11-13).  Understanding the conditions and constraints of research, and what published academic journal findings can actually demonstrate, might test whether this is, in fact, the case and keep researchers and public media in check.

Prospects for Reconciliation

So how do we collaborate across the social and hard sciences? And how do we as researchers make our ways through our work detached from personal lived experiences, appearances, and backgrounds that might inform how we look at another discipline? How might we try and set apart our work from the history that precedes it? Is it too dangerous to even try? Would doing so perpetuate systems that marginalize or make peripheral certain groups? I know my experiences as an ethnic minority and my work in the education system with underrepresented groups certainly inform my approach to research; denying this would ignore potential biases I carry.

Whatever collaboration might look like, finding a common language for discussion is paramount. Part of the disconnect between the soft and hard sciences stems from different academic vocabularies and expressions, making one field at times seem like a foreign language to the other. I think, for instance, that hard scientists might have trouble reading this piece, filled as it is with an anthropologist’s lexicon.  Creating a shared language centered on the pursuit of knowledge could be one good starting point, since both sides already seem invested in this area in their own way. Shared language that acknowledges the social consequences and historical context of knowledge production would also be enormously beneficial. Together, these sets of common concepts and vocabulary might help bridge the existing divide between the social and hard scientists.

Intelligence. Genetics. Race. Socio-economic status. Using these four words in the same sentence has closed doors for me as a researcher. Each is difficult to talk about on its own—and they’re almost explosive when joined together. Despite this, I strongly believe in combining these concepts through a full range of biological and social science methodologies—and in the value of picking up some diplomacy skills along the way.

Image via Wikimedia

Works Cited

Asbury, K., & Plomin, R. (2013). G is for genes : the impact of genetics on education and achievement, xii, 197 pages.

Brigham, C. C. (1922). A study of American intelligence. Princeton: Princeton university Press.

Cooper, R. S., Kaufman J. S., & Ward, R. (2003). Race and Genomics. New England Journal of Medicine, 348(12), 1166-1170.

Davies, G., Tenesa, A., Payton, A., Yang, J., Harris, S. E., Liewald, D.(2011).
Genome-wide association studies establish that human intelligence is highly heritable and polygenic. Molecular Psychiatry, 16(10), 996–1005.

Elhoweris, H., Mutua, K., Alsheikh, N., & Holloway, P. (2005). Effect of Children’s Ethnicity on Teachers’ Referral and Recommendation Decisions in Gifted and Talented Programs. Remedial and Special Education, 26(1), 25–31.

Evans, J. P. (2016). (Mis)understanding Science: The Problem with Scientific Breakthroughs. Hastings Center Report, 46(5), 11–13.

GenomeTV. (2012). Human Genome Announcement at the White House (2000). Retrieved from

Gillborn, D., Rollock, N., Vincent, C., & Ball, S. J. (2012). “You got a pass, so what more do you want?”: race, class and gender intersections in the educational experiences of the Black middle class. Race Ethnicity and Education, 15(1), 121–139.

Grissom, J. A., & Redding, C. (2016). Discretion and Disproportionality: Explaining the Underrepresentation of High-Achieving Students of Color in Gifted Programs. AERA Open, 2(1).

Krimsky, S., Sloan, K., & Council for Responsible Genetics (Eds.). (2011). Race and the genetic revolution: science, myth, and culture. New York: Columbia University Press.

Plomin, R., Haworth, C. M. A., Meaburn, E. L., Price, T. S., & Davis, O. S. P. (2013).
Common DNA Markers Can Account for More Than Half of the Genetic Influence on Cognitive Abilities. Psychological Science, 24(4), 562–568.

Rietveld, C. A., Medland, S. E., Derringer, J., Yang, J., Esko, T., Martin, N. W., Koellinger, P. D. (2013). GWAS of 126,559 Individuals Identifies Genetic Variants Associated with Educational Attainment. Science, 340(6139), 1467–1471.

Selzam, S., Krapohl, E., von Stumm, S., O’Reilly, P. F., Rimfeld, K., Kovas, Y., Plomin, R. (2016). Predicting educational achievement from DNA. Molecular Psychiatry.

Shockley, W. (1971). Negro IQ Deficit: Failure of a “Malicious Coincidence” Model Warrants New Research Proposals. Review of Educational Research, 41(3), 227–248.

Slate, J. R., Jones, C. H., & Charlesworth, J. R. (1990).Relationship of Conceptions of Intelligence to Preferred Teaching Behaviors. Action in Teacher Education, 12(1), 25–30.

Don’t Miss This: The Story of CRISPR Told in a Comic

Posted by Kayla Tolentino on October 6th, 2016

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The billion-dollar patent battle over CRISPR/Cas-9 “gene editing” technology is layered with blockbuster scientific papers, media storms, superstar researchers, and legal drama, which are all the right elements to make up a thrilling graphic novel. Illustrator Andy Warner helps to break down the complexities of the still unraveling CRISPR story through a recent comic strip, “Bad Blood: Who gets credit for the technology to cut-and-paste the human genome?”

Two opposing hands tug on DNA strands as if in competition. Text reads: "One of the biggest discoveries in biotech has the potential to radically alter our lives... and nobody knows who owns it."

A baby's eye pupils reflect DNA strands, as if looking into future. Text reads: "This system could be theoretically used to edit the genome of any organism, from wheat to mosquitoes... to human."

“Bad Blood” animates the key players in the ongoing legal fight between the Broad Institute and UC Berkeley, focusing on the increasingly recognizable trio of CRISPR co-discoverers Jennifer Doudna, Emmanuelle Charpentier, and Feng Zhang. The strip also illustrates journalists Antonio Regalado (MIT Tech Review) and Sharon Begley (currently STAT) who have been closely following the patent case and technical developments, and cites their thoughts on the ambiguities of credit for CRISPR and its potential social conseqeunces. 

Strikingly, after explaining the nitty-gritties of the science and patent law underlying gene editing technologies, Warner leaves readers with a thought-provoking parallel: the historic development of the nuclear bomb, and the anguishing dilemma it posed for the scientists involved with the effort. His portrayal of Albert Einstein invokes the volatile political climate during which the atomic bomb was developed, and suggests the current need to question the social and political context of CRISPR and how this will shape the potential outcomes of its uses.

Albert Einstein contemplates. Text reads: "In the spring of 1939, Albert Einstein realized that every step required for the creation of an unfathomable powerful weapon had been individually comlpeted."A cloud of nuclear wastes is illustrated with red colors. Text reads: "All that was required was sequence. If you strung these reactions together in order, you obtained an atomic bomb."

We are in a critical moment to make decisions that would safeguard future generations. And we are in a critical moment for artists, cultural groups, and various non-scientific communities to actively come together to interpret the present debates about gene editing technologies, creatively examine their unknowns, and engage in conversations about how to shape our future. 

In the last panel of “Bad Blood,” Warner recognizes the urgency of an ongoing discussion to discuss the potential impacts of gene editing on our humanity:

Text reads: "It is fitting then, that the responsibility for ushering in this brave new world is as undecided as the ethical and existential questions it raises." Bordering the text are strands of DNA. A hand is snipping parts of it, and a glue bottle is featured at the top left corner of the border.

For more information on CRISPR, you can visit CGS’ resources:

Previously on Biopolitical Times:

Images via Andy Warner/The Nib

Presidential Candidates on Science

Posted by Pete Shanks on September 16th, 2016 was launched in 2007 with a goal of promoting a Presidential debate entirely on scientific topics. That hasn't happened yet, but the organization, which includes a broad selection of establishment figures and is co-organized by the National Academies, AAAS, and the Council on Competitiveness, is still trying.

Meanwhile, they set a perhaps more realistic goal of agreeing on 20 science-related questions and getting written answers from the candidates. The answers from Hillary Clinton, Donald Trump and Jill Stein are now online. Libertarian Gary Johnson has not yet responded.

Here’s what you get from the candidates for each question (illustrated with extracts from responses to the opioid problem):

  • From Clinton, three or four paragraphs that read as though they were drafted by a competent policy analyst and edited, or at least approved, by the candidate.
    • Sample:  "We must work with medical doctors and nurses across the country to treat this issue on the ground, from how patients are accessing these medications to how we are supporting them in recovery."

  • From Trump, one paragraph that might have been extemporized by himself and then translated into a form of English.
    • Sample: "As this is a national problem that costs America billions of dollars in productivity, we should apply the resources necessary to mitigate this problem."

  • From Stein, short paragraphs (often several) that frequently make a lot of utopian sense.
    • Sample: "We will end the 'war on drugs' and redirect funds presently budgeted for the 'war on drugs' toward expanded research, education, counseling and treatment."

The Center for Genetics and Society’s core concerns about human biotechnologies are not explicitly covered. There are no references in either the questions or the answers to germline or other gene editing, or to genomics, stem cells, eugenics or precision medicine, to name but a few. Privacy is mentioned only in the context of the Internet in general.

Press reactions are listed on-site. Science had an anodyne but reasonably accurate summary. Lawrence M. Krauss in the New Yorker took a wry approach. Trump’s contributions were dissected at length by Martin Longman at Washington Monthly, who calls them variously “straight unresponsive pablum,” “almost unbelievable,” showing “no clue” and, on nuclear power, “positively Palinesque.” (Read the whole thing!) Michael Schulman at The Cubit blog (part of Religion Dispatches) has an entertaining summary that accurately concludes: asked questions about forces that will affect the basic well-being and survival of the United States’ citizenry. In theory, that’s the stuff of democracy. Not one of them, though, felt like something that will even remotely sway the election.

At almost the same time, Neal Lane and colleagues at Rice University issued a report arguing strongly that the White House Office of Science and Technology Policy (OSTP) and the position of science adviser should be retained by the next president, who should, as Science notes, "lay out priorities for science and innovation within the first 100 days of taking office.” The report is not specific on issues, but very strong on process.

On the lighter side, there are reports that Trump intends to nominate Peter Thiel, the notorious billionaire transhumanist, to the Supreme Court. Everyone involved denies this on the record, but the rumor is said to derive from sources close to Mr. Thiel. Someone allegedly close to the candidate confirms (on background) that there has been discussion but cautions:

Trump’s offers often fail to materialize in real life.

Previously on Biopolitical Times:

Will Genetic Engineering Really Change Everything Forever? [Video Review]

Posted by Elliot Hosman on September 8th, 2016

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Given the hype storm surrounding CRISPR and its potential use to create “designer babies,” it’s not surprising that many have begun to pontificate about this species-altering moment.

On August 10 a video was uploaded to YouTube with the following description:

Designer babies, the end of diseases, genetically modified humans that never age. Outrageous things that used to be science fiction are suddenly becoming reality. …

Two days later, the 16-minute animation had over two million views. It’s now the top video that comes up when you search “CRISPR” – the handle for a new “genome editing” technology that has been featured in headlines and on front pages around the world.

Genetic Engineering Will Change Everything Forever – CRISPR

One set of CRISPR questions that poses hugely significant threats to future generations goes something like this:

Can we engineer human germ cells and embryos to re-wire genetic risk factors?

And if we think it’s safe enough, should we try to create genetically modified babies?

To address these questions, the video raises some helpful points. It notes the likelihood of market pressures and consumer incentives and how they might impact what sort of children and what sort of modifications become popular (”Buy two enhancements, get the third free!”).


It also illustrates the massive iceberg of unknowns facing those who are interested in pursuing genetic upgrades in the IVF clinic.
Yet the video is restricted in its ability to fully countenance the future of designer babies by its cheery optimism, by its unsupported claims that a new biological era of “intelligent design” is just inevitable, and by its assumption that people will naturally warm up to the idea as time goes on.
One of the video’s sanguine assumptions is that any social downsides are confined to scenarios of evil dictators and mad scientists. While North Korea’s current situation makes it easy to construe our own social and political context as reasonable by comparison, there is no shortage of social justice concerns that transcend crude state-sponsored violence.

The video also indulges in some anti-aging hype—a key cornerstone for much of the Silicon Valley collective's future-making projects, and a generator of headline gems like this recent one:

Peter Thiel Is Interested in Harvesting the Blood of the Young.

Kurgesagt (“In a Nutshell”), the Munich-based company that produced the video, has some 2.8 million subscribers. Its previous videos animate a range of concerns, from increasing state surveillance, to the Syrian refugee crisis, to the failed “war on drugs.” In addition to producing a video per month, Kurgesagt works with a host of international clients, including the Bill & Melinda Gates Foundation (on data and disease), the Charles Koch Institute (on policing), and The United Nations Industrial Development Organization (on private/public partnerships).


The company’s visuals bring to mind the TED Talk that entrepreneur Juan Enriquez gave in November 2015 entitled “We can reprogram life. How to do it wisely.” Enriquez's slides  used emoji to describe the coming era of “intelligent design” in which humans “re-program” the “lifecode” of future generations. For all the policy wonks in the house, Enriquez has a super thorough plan for containing this GMO explosion:

We should take about a quarter of the Earth and only let Darwin run the show there. It doesn't have to be contiguous, doesn't have to all be tied together. It should be part in the oceans, part on land. But we should not run every evolutionary decision on this planet. We want to have our evolutionary system running. We want to have Darwin's evolutionary system running. And it's just really important to have these two things running in parallel and not overwhelm evolution.

How forward-thinking.


Like Enriquez, Kurgesagt’s CRISPR video, for all of its unbound future visions, adopts an exceedingly narrow vision of democratic progress and governance. “The only thing we know for sure,” it asserts, “is that things will change irreversibly.”

By this logic, technology’s impending arranged marriage to biology is inevitable, and we might as well sit back and watch the Silicon Valley “cradle of innovation” unburden us from our human imperfections—one human birthing experiment at a time.

But before we give up on the current reproductive order, it seems only fair that we first admit our troubling assumptions about what it means to be human:

  • Departures from the optimum—and certainly most disease and disability—simply equate to abject suffering without individual or societal value, and should be de-selected, prevented, secluded, avoided, exterminated.

  • Some genes are just “bad”—or at least “inconvenient” in our society—and not worth bringing into the world. Some genes are just “good” and worth increasing in the population.

  • Each of us has a moral duty to cleanse our children’s genome before birth to maintain a superior human race—I mean, for the state’s interest in public health.

These assumptions are in fact the rationales of eugenics past. Do we really want to marry them to the angel-winged free market of Big Biotech

Let’s be clear about what’s at stake. Let’s interrogate the assumptions that tell us our children must be bred from the finest stock available. Let’s challenge ourselves to forego conceiving of our children as value-enhanced property in a biopolitical marketplace. Let’s fight back against the politics and social pressures that tell us our bodies are the sole source of our value. Let’s ignore folks who say that we are internally deficient, that inequality is natural, and that we are each personally responsible when systems of power and oppression cut off our ability to thrive. Let’s allow all of us to be a little more human – imperfections, genetic variants, and all.

Previously on Biopolitical Times:

Images via YouTube.

Scandals Waiting to Happen: Institutional Conflicts of Interest at California Stem Cell Agency

Posted by Pete Shanks on September 8th, 2016

Alan Trounson is pictured giving a talk.

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David Jensen, who writes the essential California Stem Cell Report blog, published a detailed front-page article in the Sacramento Bee on September 2 with the eye-catching headline:

Stem cell company paid $443,500 to former head of state agency that funds research

As has previously been reported, Alan Trounson joined the board of StemCells Inc. in 2014, about a week after he resigned from a six-year stint as President of the California Institute for Regenerative Medicine (CIRM) to return to Australia. CIRM, which is funded by California taxpayers, had previously allotted some $40 million of grants to the company, based just across the Bay from Stanford.

As Jensen recounts, some of those grants had raised questions; one was made despite having been twice rejected by the grant committee. In addition, Irving Weissman, the Stanford University-based co-founder of the company, has received research grants amounting to $30.5 million from the agency. Weissman notoriously appeared in 2004 television ads promoting the establishment of CIRM, while wearing a white coat and identifying himself as a doctor (which he also is), but not as a stem cell entrepreneur. Weissman’s academic institution, Stanford University, has received over a quarter of a billion dollars from CIRM, including over $40 million for a new building.

The new information that Jensen turned up in SEC filings was how much StemCells Inc. paid Trounson after he joined its board: $59,500 in cash over a year and a half (far more than any other board member) and nominally $384,000 in stock options. (The stock has since tanked completely.)

Did Trounson or StemCells Inc. do anything illegal? Quite likely not. Was this transaction appropriate? Absolutely not! It’s scandalous, but it’s the kind of scandal that was built into CIRM from its very inception. Nature, in September 2004, during the run-up to the state election that established CIRM, opened an article this way:

Opponents of California's $3-billion plan to fund embryonic stem-cell research say that the proposal would give researchers carte blanche to rewrite well-established ethical guidelines to suit their needs. They say the research institute planned under the initiative will be exempt from legislative supervision and, if established, will be able to make its own rules about conflicts of interest and informed consent.

Among those opponents was the Center for Genetics and Society, whose extensive pre-election analysis is archived here. In January 2006, CGS examined CIRM’s first year and published a detailed “report card” [pdf]. The overall grade we gave CIRM was C–, and on several issues, including minimizing conflict of interest, we handed out a D.

Jesse Reynolds, then Director of Project on Biotechnology Accountability for CGS, deserves particular credit for drawing attention to the conflicts of interest embedded in the structure of the stem cell agency. He attended numerous public meetings of CIRM, testified for investigations of the agency before the California legislature and the state’s “Little Hoover Commission,” wrote many op-eds, and helped to push for reforms.

A few journalists, activists and academics have also been documenting the problems with CIRM from the start. Jensen has been indefatigable (and quite balanced in his approach). Los Angeles Times columnist Michael Hiltzik keeps pounding away at conflicts of interest in particular; see columns from 201420122009, and 2004Consumer Watchdog's John Simpson has always been particularly strong on issues of governance. Ruha Benjamin’s 2013 book, People’s Science: Bodies and Rights on the Stem Cell Frontier, is an excellent investigation of the issues, as is Good Science: The Ethical Choreography of Stem Cell Research by Charis Thompson.

CIRM was also scrutinized by the Institute of Medicine in 2012. Its report affirmed the existence and significance of the conflicts of interest and structural flaws that CGS and other public interest voices had identified even before the agency was approved by the 2004 ballot measure on which backers spent some $35 million. CGS’s invited testimony to the Institute of Medicine, and its press release welcoming the IOM’s report, provide details.

CIRM is now slowly running out of the $3 billion of public funds allocated to it in 2004, and is expected to wind up in 2020. It has provided an object lesson in how not to set up and run an independent public-funded agency. These latest revelations should end any speculation about extending its charter.

Previously on Biopolitical Times:

Image via Flickr/Monash University Gippsland Campus

Victory: Eggs-for-Research Bill Dies in California Legislature

Posted by Emily Galpern, Biopolitical Times guest contributor on September 8th, 2016

A pink picture of a cellular mass is shown, a magnification of human egg while still developing in an ovary.

The Center for Genetics and Society and allies are celebrating the demise of AB 2531, a bill that would have allowed payments to women who provide eggs for research, effectively expanding the commercial market for human eggs from the fertility sector to the research context.

The bill, which was sponsored by the American Society for Reproductive Medicine, died in the State Legislature last week, never making it to the Governor’s desk. Assemblymember Autumn Burke anticipated a veto from Governor Brown and decided not to bring it up for a vote in the Assembly when it was sent back for concurrence, after passing the Senate on August 29 with amendments that seemed to be a tepid response to opponents’ objections.

CGS and allied women’s health, reproductive justice and public interest organizations opposed the bill because of dramatically insufficient information about the health effects of egg provision; the impossibility of true informed consent given the lack of data; the likelihood that low-income women, women of color, and immigrant women would most likely be affected; and the bill’s conflict with national recommendations for federal policy and with state law. For a full explanation of these concerns, see the opposition floor alert and CGS’ letter to the Senate Health Committee.

Organizations opposing AB 2531 included the Alliance for Humane Biotechnology, Black Women for Wellness, Black Women’s Health Imperative, Breast Cancer Action, Center for Genetics and Society, Friends of the Earth, Forward Together, National Women’s Health Network, Our Bodies Ourselves, Pro-Choice Alliance for Responsible Research, and We Are Egg Donors.

The bill was covered by veteran journalist David Jensen in the Capitol Weekly (Senate eyes human egg business), and was criticized in a number of op-eds and columns, including one by former Senator Deborah Ortiz, author of a 2006 law that assured certain protections for egg providers:

AB 2531 was nearly identical to another Assembly bill from 2013, which passed the legislature but was vetoed by Governor Brown (see CGS’ commentary on those 2013 events, as well as California Controversy: Let's Not Expand the Market in Women's Eggs and Eggs for Cash: Pitting Choice Against Risk).

We hope legislators have come to understand the complexity of this issue and, instead of bringing payment and undue incentive to the table, begin to call for long-term studies to provide the information women need to make truly informed decisions about their bodies and their health.

Emily Galpern works with the Center for Genetics and Society as a consultant.

Previously on Biopolitical Times:

Image via Flickr/Ed Uthman

Remembering Ruth Hubbard

Posted by Marcy Darnovsky on September 8th, 2016

The yellow cover of Ruth Hubbard's book, The Politics of Female Biology, is shown with purple font.

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Ruth Hubbard — prominent biologist, feminist scholar, multi-faceted social justice advocate, and critic of what she termed “the gene myth” — died on September 1 at the age of 92. Her scholarly and public interest efforts to track and shape the politics of human genetics were an important inspiration to many working on these matters today, including those of us who helped establish the Center for Genetics and Society.

In 1974, Ruth became the first woman to be awarded tenure in the Harvard University biology department. In 1983, she was a founding member of the Council for Responsible Genetics. She also served on the boards of directors of the Indigenous Peoples Council on Biocolonialism and the Massachusetts chapter of the American Civil Liberties Union.

Her books include The Politics of Women’s Biology (1990), Exploding the Gene Myth: How Genetic Information is Produced and Manipulated by Scientists, Physicians, Employers, Insurance Companies, Educators, and Law Enforcers (with Elijah Wald, 1993), and Profitable Promises:  Essays on Women, Science, and Health (2002).

Ruth took on a range of political and social challenges related to the politics of science, genetic determinism, race, and gender. Among these was human germline modification, which she strongly opposed. In 1999, she co-authored Human germline gene modification: a dissent with Stuart Newman and Paul Billings in The Lancet.

In 1993, she wrote in Exploding the Gene Myth:

The cover of the book Exploding the Gene Myth is pictured.

Clearly, the eugenic implications of [human germline modification] are enormous. It brings us into a Brave New World in which scientists, or other self-appointed arbiters of human excellence, would be able to decide which are “bad” genes and when to replace them with “good” ones….We need to pay attention to the experiments that will be proposed for germ-line genetic manipulations, and to oppose the rationales that will be put forward to advance their implementation, wherever and whenever they are discussed.

The Boston Globe’s obituary for Ruth provides details about her long and influential life and career, as does an obituary written by her family that can be found here.

Previously on Biopolitical Times:

5 Reasons Why We Need People with Disabilities in the CRISPR Debates

Posted by Emily Beitiks, Biopolitical Times guest contributor on September 8th, 2016

A metaphorical graphic to explain the CRISPR-Cas9 gene editing complex is shown: Two wrenches with the words

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This article was cross-posted on Disability Remix, the blog of the Paul K. Longmore Institute on Disability at San Francisco State University.

Maybe you haven’t heard of CRISPR-Cas9. To be honest, if I hadn’t previously worked at the Center for Genetics and Society, I probably wouldn’t have heard of it either. It’s a new genetic technology that brings modification of the human germline closer in reach than ever before.

Driven by the promise of allowing parents to avoid passing on incurable genetic diseases to their offspring, the use of CRISPR to engineer human embryos presents serious risks with particularly strong implications for people with disabilities—in the present and future. It’s been getting plenty of press. And yet, as someone who tries to stay up to date constantly with what’s trending in the disability social media scene, it has seemed to me that CRISPR has been more or less absent.

Why aren’t people in the disability community talking more about this?

Why should people with disabilities have to keep spending their time justifying their existence rather than just enjoying it at present?

An event poster for Future Past in 2013 is shown, with purple clouds, and a DNA helix forms the base of a signpost with two directions: future and past.I recall a conference I organized with the Longmore Institute in 2013, “Future Past: Disability, Eugenics, and Brave New Worlds.” Disability studies scholar and activist Marsha Saxton began her panel by sharing a memory of talking with a genetics counselor while contemplating getting pregnant. The counselor exclaimed, “Gee, if I’d have known Spina Bifadas turned out as well as you, I would not have recommended selective abortion as much as I’ve done!”

Similarly, a conversation comes to mind that I had with another disability activist, who previously focused on the neo-eugenic uses of genetic technologies but left because she was burnt out. As a person with a disability, she didn’t want to continue spending her life’s work validating her own existence, and moved into the arts instead to celebrate the beauty that disability brings.

Despite the disability rights movement’s progress, both of these stories help illustrate why people with disabilities might not want to waste their time thinking about these issues. Indeed it suggests that my own lack of understanding of why people with disabilities aren’t more interested in following this comes from a place of privilege as a nondisabled ally. It seems that for many, engaging in the debate is just too hurtful. Why should people with disabilities have to keep spending their time justifying their existence rather than just enjoying it at present?

Yet when it comes to CRISPR for human reproduction, disability is at the center of it all. Whether or not CRISPR takes hold in the fertility clinic, the scientific and philosophical debate is constantly centered on disability. So here are five reasons why CRISPR and disability are dangerously intertwined, exemplifying why we need the perspectives of people with disabilities weighing in on this debate, as unappealing as diving in may be:  

  1. Modern-day eugenics. For me, it’s pretty much that simple… and that scary. Advocates of using CRISPR for heritable genetic modification argue that we can distinguish to ensure this is only used for deselecting genetic diseases (“germline therapy”), rather than using the technology to select for more desired traits (“enhancement”). But even this binary presumes we can draw clean lines to eliminate diseases that don’t also suggest preventing disabilities. It brings up questions of what we should and shouldn’t value in future generations. Knowing that these choices are being made in a deeply ableist culture—where people like Marsha Saxton would likely not have been born because of fear of the “spina bifidas”—illustrates how hard it would be to draw lines about what genetic diseases “we” agree to engineer out of the gene pool and which are allowed to stay. 

  2. We are moving backwards. Even as opponents of CRISPR germline modification make their case, it often hinges on the idea that we don’t need CRISPR because we already have preimplantation genetic diagnosis (PGD) to allow parents to have children free from genetic abnormalities. However, disability advocates still contest PGD as socially harmful genetic selection and disability prevention. The Center for Genetics and Society’s Executive Director Marcy Darnovsky recently shared with me that when she points out this tension to the press, they rarely if ever include it.

  3. It’s selling disability as tragic. This isn’t new. It’s how preimplantation genetic diagnosis was sold. It’s how stem cell therapy was sold. Before we even develop the technology, we develop the story: people with disabilities are living a sad, tragic existence, and only through progress in the genetic sciences can we spare their suffering in future people. This tragedy gets retold and retold, creating urgency for the technology in question: Forget the vibrant disability community. Forget the changes in technology, art, and culture that people with disabilities bring to our world from the insights of living with a disability. We don’t have time to worry about ethics or risks! Selling the need for the cutting edge technology comes on the backs of people with disabilities, so science policy and debates become one more place where the tired trope of disability as “the worst” thrives.

  4. Nondisabled people won’t get it unless people with disabilities are part of the debate. Nondisabled proponents are arguing we need to use CRISPR to prevent disabilities. Nondisabled opponents suggest we should be wary of CRISPR for its threat to disability justice. Both sides are talking about disability, but the conversation would carry more weight if disability activists were involved.

    This is why the work of disability activist and writer Harriet McBryde Johnson was so powerful. In a series of conversations with philosopher Peter Singer, one of the most outspoken advocates of preventing children with disabilities from being born, McBryde Johnson put a face to his theoretical exercises and argued that they had life or death consequences for people like her. (Still image via Vimeo)

    Harriet McBryde Johnson is pictured, smiling, in an interview from the It's Our Story project.When I share my interests in these sorts of debates, I often get this wave of enthusiasm from other nondisabled people who seem to find it fun to sit around and discuss how much better the world would be if we could prevent or cure all disabilities. They want to talk it out through thought experiments and philosophical exercises. I mean no disrespect to those who think that way. After all, I’m married to someone with a philosophy degree, and some philosophers with disabilities have made important contributions to the way disability is theorized in ethical debates (e.g. Adrienne Asch and Anita Silvers). However, I think the debate needs more perspectives and personal stories coming from people with disabilities who help us to attach faces and lives to the debate and to remind us what a loss it would be to live in a world with less disability.

    (At the 2015 National Academies' International Summit on Human Gene Editing, the conversation did not include any featured speaker open about being a person with a disability. There were efforts to invite one or two, and Ruha Benjamin did give a wonderful presentation which you can view here, but the omission was startling.)

  5. It impacts the fight for disability equity today.  When cures and the end of disability are always cast as “just around the corner,” it continues to make it harder to fight for what we need today. We continue to invest millions of dollars on anything that might help us eliminate disability. Meanwhile people with disabilities struggle to implement things to make our society more accessible right now,  as these social changes are always framed as “too costly.” This doesn’t mean that we need to be entirely anti-cure and certainly not anti-research, but again, we need people with disabilities to play a central role in this debate. A diversity of voices speaking to their experiences with disability can teach us that we don’t need CRISPR to “solve” the disability = tragedy equation. Social changes to the built environment and cultural changes to discriminatory attitudes are a safer bet with more widely shared impacts.

A overhead view of a spiral staircase made of white marble with a gold banister, circling into a distant horizon, is reminiscent of a DNA helix and the staircase in the 1997 film, GATTACA.

2017 will mark the 20th anniversary of GATTACA’s release, a film which brought to the big screen issues of genetic discrimination resulting from the effort to control human reproduction (for a great disability take on it, read here). The “not too distant future” imagined in the film grows closer with CRISPR.  I wish I could just turn away from CRISPR to hope it’ll pass over—I far prefer spending my time on our disability film festival or promoting disability history. Yet disability culture and arts are more related to CRISPR than one might think. They provide a powerful illustration of how disability enriches our world. It just might be worth making time for the CRISPR debates (even though the emotional labor of doing so is huge), to help ensure a long-term future for disability as a creative and generative force.

Emily Beitiks is Associate Director of Paul K. Longmore Institute on Disability at San Francisco State University, and a former staffer at CGS. Beitiks earned her Ph.D in American Studies from the University of Minnesota with the dissertation "Building the Normal Body: Disability and the Techno-Makeover". 

Previously on Biopolitical Times:

Image via Wikimedia

To Err is Biotechnological: Reflections on Pew’s Human Enhancement Survey

Posted by Gina Maranto, Biopolitical Times guest contributor on August 9th, 2016

Deep brain stimulation, image via Wikimedia.

Untitled Document

Permit me a brief digression before I comment on the latest Pew Research Center survey of Americans’ attitudes toward biomedical technologies meant to “enhance” human performance.

I am married to a bioengineered man.  Almost three years ago, after having been steadily eroded by Parkinson’s disease for over a decade, my husband Mark Derr braved deep brain stimulation (DBS) surgery.  His incredible surgical team at Johns Hopkins implanted electrodes into his brain and a battery-driven stimulus device in his upper left pectoral, and the results seemed, at the time, nothing short of miraculous.  With a mere incremental upping of the voltage during an initial adjustment session, the DBS instantaneously stilled Mark’s tremulous hand and foot, giving him relief that the standard drugs had only intermittently provided.

Much as DBS has improved his quality of life, Mark is far from cured.  DBS cannot address the muscle stiffness, balance problems, and neurological pain he experiences daily.  And the instrument requires constant attention.  Mark’s days consist of frequent monitoring of his device; his weeks, of periodic adjustments of the voltage; his months, of consultation with his medical minders in Baltimore, where he travels every five months or so for “tweaking.”  His latest technician there told him, “You are your own experiment.” 

Based on direct experience, then, I would advise that heady promises regarding biotechnology should be viewed with a high degree of skepticism. DBS, for example, may eventually get better at addressing Parkinson’s symptoms, but cannot reverse the neuronal damage that lies at the base of the disease.  Many other biotechnological interventions also carry with them an almost guaranteed set of deficits, inadequacies, inconveniences, and risks that are conveniently ignored in the valedictory narratives woven around them. 

More profoundly, Mark both is and is not the Mark he was before DBS, and questions of how identity or even soul are altered by such technologies are only rarely addressed. (For excellent examples where they are, check out Françoise Baylis’s, “'I Am Who I Am’: On the Perceived Threats to Personal Identity from Deep Brain Stimulation” and Sherry Turkle’s edited volume, The Inner History of Devices.)

In some ways, the Pew survey, which looked at attitudes toward three hypothetical “enhancements” (although one, which would involve genetic enhancement of future children, is presented as a preventative medical measure), suggests that Americans get that biotech interventions raise profound social and ethical questions.  In the chart below, more respondents said they were concerned rather than enthused about fiddling with babies’ genomes, following in the footsteps of Johnny Mnemonic, or engaging in blood doping squared.  Not only did most of those surveyed expect that the cons would outweigh the pros of such interventions, a majority believed such interventions “could exacerbate the divide between the haves and have-nots in society…[and that] inequality would increase because only the wealthy could afford these enhancements.”

[Figure via Pew Research Center]

But Pew itself seems oddly disposed to undercut its own findings in the large accompanying piece probing “expert” opinion on enhancement in general. David Masci, in “Human Enhancement: The Scientific and Ethical Dimensions of Striving for Perfection,” seems to take the side of the pro-enhancement champions, giving ample play to the “sky’s the limit” point of view of self-avowed transhumanists and giving the final world to a futurist who says, “We’ll probably start by taking a human version of nirvana and creating it in some sort of virtual reality,” and then “we’ll transition to realms of bliss that we can’t conceive of at this time because we’re incapable of conceiving it.”   Masci also strives to normalize enhancement, starting his piece with the claim that, “Human enhancement is at least as old as civilization.”

This claim, often advanced in pro-enhancement camps, suggests that education and exercise are equivalent to chips in the brain or performance enhancement through genetic alterations that would increase, say, fast twitch muscles.  Call it argument by sleight of hand or by failure to make proper category distinctions.  If we really want an accurate analogy, we should think about phase changes: water becomes colder and colder, and then becomes ice.  A quantitative change leads to a qualitative change.  Step by step, biotechnologists alter us; at a certain point, a qualitative change ensues.  We cannot perfect the human; we can only push genes and protoplasm past a certain point—and no one quite knows where it lies, but many have agreed that the germline is certainly one clear and present possibility—and we will have crafted a new entity. But to what purpose is questionable.

Masci writes

Instead of leaving a person’s physical well-being to the vagaries of nature, supporters of these technologies contend, science will allow us to take control of our species’ development, making ourselves and future generations stronger, smarter, healthier and happier.

To this I say hooey and hooey again.  Even the most exquisitely engineered of artifacts—take the Large Hadron Collider for example—are prone to error and screw ups.  Surprise, chance, and unpredictability are hard wired into our universe.  Whether breakdowns come from passing birds or wayward weasels, breakdowns will come.  Even when our biomedical and bioengineering prowess achieves its best, there will always be downsides.


Gina Maranto is a fellow at the Center for Genetics and Society. She is Professor and Director of Ecosystem Science and Policy and Coordinator of the Environmental Science and Policy program at the University of Miami's Leonard and Jayne Abess Center. Her articles, opinion pieces, and reviews have appeared in Discover, The Atlantic Monthly, Scientific American, The New York Times, and other publications. She is the author of Quest for Perfection: The Drive to Breed Better Human Beings.


Previously on Biopolitical Times:

Image via Wikimedia

Questions about Deaths in Cancer Trials using Gene-Altered Cells

Posted by Katherine Drabiak on August 5th, 2016

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In the past month, the media has reported seven patient deaths of subjects enrolled in separate gene therapy clinical trials being conducted by Juno Therapeutics and by Ziopharm Oncology, Inc., both aimed at immunotherapy-based cancer treatments that have sparked widespread hope. Despite these deaths, the trials continue to move forward.

Media coverage of trials related to gene therapy has portrayed the clinical research rollercoaster.  Just this past week, The New York Times ran an unusually lengthy and high-profile series of articles in the Sunday paper about immunotherapy treatments for cancer, some involving genetic modification of immune cells. The articles describe the promising aspects of engineering one’s own immune system to fight cancer, including dramatic stories of tumors “melting away” and promises of complete remission.  

Yet commentary on the ethical implications of these events has been scant, and these events raise a number of concerns about what bioethicists call “therapeutic misconception” – vulnerable patients seeking enrollment in a clinical trial with the mistaken belief that the gene therapy is approved by the FDA to be safe and effective. The clinical trial deaths also highlight lingering questions about transparent reporting of adverse events to the FDA and appropriately navigating financial conflicts of interest.  Instead, numerous articles have focused on how these deaths impact the bottom line: corporate stock prices

The excitement has been building for some time. In June 2015, MIT Technology Review described Juno’s experimental T-cell immunotherapy for leukemia as “Biotech’s Coming Cancer Cure” and profiled the “miracle” recovery of 20-year old leukemia patient Milton Wright III. Wright signed up for the clinical trial because “they hyped it up, like it was going to be amazing” and MIT Technology Review has characterized Juno’s immunotherapy trials as “remarkable.”

Some scientists are hopeful for a breakthrough, particularly for patients whose cancer has returned after multiple rounds of traditional chemotherapy. For vulnerable patients seeking a “miracle cure,” such characterizations blur the distinction between approved therapy and clinical research that may or may not produce a viable therapy. As a disclaimer, I have not seen any of the informed consent documents from Juno or Ziopharm. But whatever these documents say, media descriptions of a “coming cancer cure” make it challenging to fully convey the risks to sick people with few other options who are considering enrolling in clinical trials as a last-ditch treatment effort. This is precisely the kind of situation that the term “therapeutic misconception” addresses.  

We must cautiously tread when describing Phase I and Phase II clinical trials to patients who are simultaneously acting as research subjects, and take care not to inflate our words when we discuss this research in the media. Despite the misleading name, these early gene therapy trials are not approved therapies, but experiments to assess safety, dosing tolerability, and effectiveness. The goal for this stage of research is not to provide a treatment for this specific person, but rather to contribute to generalized knowledge. It focuses on asking: Will this method of gene therapy work? Is it safe? Are there adverse risks so severe or frequent which constitute an unacceptable level of risk? 

It is not clear whether the patients recognize the uncertainty of benefit, especially when measured against the magnitude of risk. Gene therapy poses a distinct, and an arguably riskier, profile of possible adverse effects compared to drugs alone because it can permanently alter the recipient’s cells and holds the potential for severe latent adverse effects such as cancer, immunologic, neurologic, and autoimmune complications. 

When unexpected serious adverse reactions do occur that are related to the trial, the sponsor must report these to the FDA. Several months ago in May 2016, Juno reported one death to the FDA of a subject who was enrolled in one of its CAR-T protocols for leukemia, asserting: “It is not clear what caused the death, and a change at this time is not warranted.” In July, Juno reported two more deaths, this time stating that they resulted from compounding factors (a chemotherapy drug Fludarabine used in conjunction with the CAR-T protocol). Juno subsequently updated its statement, disclosing there have been four total deaths from its CAR-T protocols. 

In response, the FDA temporarily (and very briefly) suspended the clinical trial, causing a fleeting plummet in Juno’s stock prices. Juno quickly submitted a modified protocol that removed Fludarabine, updated the trial brochure, and amended the patient consent form to the FDA. The FDA deemed these modifications acceptable and expediently lifted the hold within days, despite the alarming disclosure. Juno’s trial – and stock prices  – were back in business.  Articles (here and here) characterized these deaths and the corresponding swift response as a “bump in the road,” myopically questioning how it would impact the clinical trial progression and corporate financial outlook. Minimizing patient deaths that may have resulted from the gene therapy rather than their underlying illness is dehumanizing and ethically inappropriate, even if we reason that these patients were near the end of life.     

One biotech analyst questioned FDA’s decision to quickly lift the clinical trial hold, observing, “They are trying to referee a game while the rules are still being written. And it appears to be causing some deaths that should have been avoided.”

Ziopharm made similar headlines in the past few months relating to its Phase I clinical trials designed for glioblastoma patients. Ziopharm partnered with the synthetic biology company Intrexon, and has been studying a gene therapy technique using a genetically engineered virus that is directly injected into the subject’s tumor. According to Ziopharm, the third subject died 15 days after beginning the trial of an intracranial hemorrhage. Prior to this report, two other enrolled subjects also died, albeit months after the initiation of one of the trials. According to a press release, Ziopharm maintains the intracranial hemorrhage death “is an isolated case” and the other patient deaths were unrelated, and attributed those outcomes to pre-existing illness, stating, “these patients are all, unfortunately, medically fragile.”

The problem with reporting adverse events, including deaths, to the FDA resides in a substantial loophole that awards discretion to the investigator to decide whether the adverse event is serious and whether it reasonably resulted from the gene therapy. Although the investigator theoretically stands in the best position to sort through the noise of the confounding variables of underlying illness or other drugs the subject may be taking, this nonetheless creates a troublesome reliance upon the corporation whose stock price and profitability are tenuously tied to clinical trial performance. This creates an undeniably powerful motivation to shift the blame of any adverse outcomes.

As Professor Osagie K. Obasogie has noted, profit motives remain entrenched in medical research, which can further complicate relationships where industry and medical care become intertwined. The arrangement between Ziopharm and MD Anderson Cancer Center exemplifies such enmeshment: Ziopharm and Intrexon executed a deal with MD Anderson to provide $100 million in stock, and recently appointed MD Anderson physician Dr. Laurence Cooper as Ziopharm’s newly minted CEO.  Similarly, Science’s recent profile of competitor Dr. Carl June’s work at the University of Pennsylvania also flagged the potential conflict of interest arising from its partnership with Novartis to develop gene therapies for which June would hold a financial stake arising from related patents.

Despite assertions that these relationships will be managed according to institutional conflict of interest policies, such heavy financial ties heighten the stakes and necessarily raise concerns about independent judgment and transparency. The call to uphold ethical tenets of research is nothing new, particularly when there is a frantic competition to bring an FDA-approved product to market. Back in 2007, Obasogie raised similar concerns after a patient death in a gene therapy trial for arthritis: “Time is money; in the rush to get products to market, patient safety can inadvertently take a backseat.”

These vulnerable patients have a stake, too. We must ask the right questions to see whether they appreciate the risks they decide to undertake. We must stop blindly accepting these dismissals of deaths and assurances that conflicts of interests are mitigated, especially when there is so much riding on clinical trials’ success.

Katherine Drabiak, JD is an Assistant Professor at USF Health in the College of the Public Health.  You can follow her updates here:


Previously on Biopolitical Times:

Image via Pixabay

The Case Against Public Investment in Reproductive Genetic Modification

Posted by Jessica Cussins, Biopolitical Times guest contributor on August 3rd, 2016

Untitled Document Philosopher Tina Rulli argues that three-person IVF is not a “life-saving therapy” or even a medical treatment at all. Rulli explains why the technology does not meet a plausible social value standard that would justify public research investment, and why other germline modification techniques may not either.

UC Davis Assistant Professor of Philosophy Tina Rulli published a report titled "What is the Value of Three-Parent IVF?" in the July-August 2016 Hastings Center Report.

If you have seen any of the countless descriptions of three-parent or three-person IVF, also called mitochondrial replacement, as a “life-saving treatment,” you might find the question in the title confusing. How could any life-saving treatment not be of value?

As Rulli explains, the claim that this technology would save lives is “inaccurate and exaggerated.” Three-person IVF would not cure, treat, or save anyone. At best, it would allow women affected by a particular kind of mitochondrial disease to have an unaffected child who is mostly genetically related to her.  

The experimental procedure works by genetically engineering an embryo to combine the intending mother’s nuclear DNA with another woman’s mitochondrial DNA. The choice a woman would make is not “do I save my child?” but “do I want to have a child in this way?” Rulli makes a strong argument that these are not morally equivalent, and that it is irresponsible to act as though they are.

How one thinks about this distinction between creating an unaffected genetically related child and saving lives may have implications well beyond three-person IVF. As Rulli points out, the creating-saving distinction probably holds for any form of germline genetic modification:  

The argument here might provide a template for objections to other germline modifications or gene therapies that are valuable solely or primarily because they may enable prospective parents to have healthy genetically related children who would not otherwise exist.

For example, it would probably mean that the experiment carried out in April using CRISPR to introduce an HIV-resistant mutation into the DNA of embryos could also not be called a life-saving treatment, even if it worked well (it didn’t) and even if it was going to be used to generate a person with altered risk factors (it wasn’t).

Rulli further undermines the medical relevance of three-person IVF by pointing out that it isn’t the most effective way to reduce the transmission of mitochondrial disease. Only a small subset of mitochondrial disease could even hypothetically be addressed by this technology, since most cases involve mutations in nuclear DNA (instead of or in addition to mutations in mitochondrial DNA). And the procedure would only be accessible to women with far more financial resources than most have.

The alternative to three-person IVF – using an entire egg (rather than an egg that has had its nucleus removed) provided by another woman – would completely eliminate the risk of transmitting mitochondrial disease. In other words, the real value of the experimental procedure is not about health at all, but about the personal preference to have a genetic connection to one’s child. Rulli refers to this as “medicalization of a social preference” that works by “preserving the dominance of the bionormative family schema.”

Based on these points, Rulli asserts that three-person IVF lacks the social value that proponents have claimed for it, and that would be a necessary precondition of ethical clinical research, both in order to use limited health resources responsibly and to avoid human exploitation. She therefore concludes, despite the Institute of Medicine’s report endorsing the potential of “clinical trials,” that any public research investment in three-person IVF would be unethical.

Rulli reaches this conclusion even without addressing the multiple safety and efficacy concerns that have cropped up regarding three-person IVF. She takes it for granted that the technology will do what it says it will do. But she does note:

If the concerns about the safety of three-parent IVF for children and future generations are legitimate, then these considerations are not over-ridden by proponents’ claims about the great, life-saving potential of this technology. We know those claims to be fictional.

Throughout the push for legalization of these three-person IVF techniques, some advocates have painted any concern raised as anti-science or anti-technology. Rulli takes pains to point out that she is neither. Her argument is not against the technology per se, but whether to invest public resources in its development when the opportunity cost of that research includes, among other things, diminishing resources for investigating treatments for people suffering from mitochondrial diseases today.

Given the firestorm of attention to CRISPR, and the relative ease of genetically modifying an embryo versus an adult, we may well see arguments about germline gene editing as a “life-saving treatment.” Proponents are already pointing to three-person IVF as a pioneer technology that is paving the way for other forms of germline modification, so it is critical to set the record straight. Rulli’s report will be a useful framework to have on hand.

Previously on Biopolitical Times:

Image via Pixabay

Editorial Precision? Snapshot of CRISPR germline in the news

Posted by Hasmik Djoulakian on August 1st, 2016

Two colorful balls representing genes are in focus while the rest in the background are out of focus.

It’s been less than a year and a half since researchers at Sun Yat-sen University reported their first-of-its-kind experiment using CRISPR/Cas-9 to genetically modify nonviable human embryos. Since then, controversy about the prospect of using CRISPR for human reproduction – to alter the traits passed down to future generations – has been covered in hundreds of news articles, editorials, and commentaries. But how well has this media spotlight illuminated the key points of the debate?

Nearly every article that discusses CRISPR uses the term “gene editing,” and many say explicitly that it is a “precise” tool just like a “cut-and-paste” word processing program. A recent paper co-authored by CGS fellow Lisa Ikemoto notes that metaphors used to inform public policy addressing emerging biotechnologies should encompass: (1) the ethical complexity of the technology, (2) an accurate description of how it works, and (3) the known and unknown consequences of various applications.  Does the “gene editing” metaphor give us any of that in contemplating the idea of genetically modified babies?

Along with many others, the Center for Genetics and Society is deeply concerned about using CRISPR to modify the human germline, for both safety and societal reasons. First, as nearly all agree, it would be way too risky; among other problems, it could result in off-target effects that would be passed down to future generations. Second, it’s not medically necessary – there are much better and safer ways for people at risk of transmitting inherited diseases to ensure their children are unaffected. Beyond the technical risks of CRISPR are the likely social consequences of allowing human germline interventions, including its use to “enhance” the children of the already affluent, thus reinforcing existing inequalities and creating opportunities for new ones.

Curious about the extent to which these concerns were being fairly represented in the media, we decided to take a closer look. We selected 40 news articles and commentaries covering the potential uses of CRISPR in humans over the last year and a half in three media outlets: The Washington Post, The Guardian, and The New York Times. We then examined each article to see how it handled five specific points that we see as critical to a full understanding of the global, political, and technical aspects of human germline gene editing:

  • The first was whether the article notes the difference between somatic gene editing – that is, using CRISPR as a gene therapy to treat affected patients – and germline gene editing – modifying the genes in human embryos or reproductive cells.
  • Second, we asked whether the article mentions social and political concerns as well as technical and safety questions.
  • The third point we looked for was some acknowledgement that many countries have already established legal prohibitions on human germline modification.
  • Fourth, we determined whether the article takes stock of available alternatives to germline gene editing, such as embryo screening (pre-implantation genetic diagnosis or PGD, used with IVF).
  • Finally, we asked whether the article accurately represents the potential scope and type of illnesses that germline editing would theoretically be used to address.

Initial Observations

This project is a preliminary one, our sample was small, and our results should be seen as tentative. With those caveats in mind, here’s what we found.

Perhaps most surprising and unsettling is that very few articles (only 6 out of 40) mention PGD as an alternative to germline editing that, in nearly every case, would allow people to prevent the transmission of inherited conditions to a fully genetically related child. This omission could mislead readers into believing that germline editing is needed and desired by large numbers of people with genetic conditions, which it is not.

Similarly, only 7 of the 40 articles clearly specify that CRISPR technology would be technically relevant for diseases that have clear genetic determinants, but not for health conditions that are significantly determined either by social and environmental factors, or by so many genetic interactions and trade-offs that choosing which to “edit” could be a fool’s errand.

On the other hand, the majority of articles do distinguish in some way between somatic and germline modification, discuss social and political concerns along the lines of “ethics” and “unequal access,” and touch on other countries’ policies regarding human germline modification. Of the 40 articles in our sample, 28, 31, and 26, respectively, make these points.

It seems reasonable that readers should be able to rely on newspapers like The Washington Post, The Guardian, and The New York Times to make all of the key distinctions and provide key information about recent developments in biotechnology. Proposals to use powerful new technologies to create genetically modified human beings are highly controversial, and we will be ill-equipped to address them with only patchwork understandings of their significance and consequences. 

A spreadsheet showing the 40 articles in our sample, and our coding on each of the five points examined can be found here.

Previously on Biopolitical Times:

Image via Flickr/Tom Woodward

The Direct-to-Consumer Stem Cell Industry in the US

Posted by Pete Shanks on July 15th, 2016

Image via Figure 1 of the paper by Turner and Knoepfler (see text).

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Stem-cell clinics can be found around the world: Mexico, South Korea, the Philippines, China and many other countries. Several have been exposed as scams, and others are suspect, while several high-profile patients (not all) have claimed to have been cured, or at least helped, by them. Two competing storylines have become standard. One is that desperate Americans go abroad for treatments because they were conned; the other is that the FDA is over-cautious and withholding life-saving treatments.

Both narratives assume that few, if any, of these clinics are in the US. That may have been true some years ago: 60 Minutes ran an exposé in 2010 that eventually led to arrests, and another in 2012. Introducing the second one, Scott Pelley made it clear that these were meant as examples, that their team had found “hundreds of credible-looking websites offering stem-cell cures at overseas clinics.”

It seems fair to suggest that up till now many Americans have assumed that the FDA was keeping us safe. That is now in serious question.

Leigh Turner and Paul Knoepfler recently published an important paper in Cell Stem Cell on stem cell clinics in the US. Turner is a University of Minnesota bioethicist and expert on medical tourism; Knoepfler is a stem cell professor at UC Davis who also runs a very well-regarded blog about stem cell research.

They identified 351 businesses, operating 570 clinics, all over the country (see map above, which is a reduced version of Figure 1 in their article). Some of these clinics may be offering services that do not require FDA approval, but in many cases, Knoepfler explained on his blog,

... there is a strong likelihood that FDA pre-approval would be needed because of issues such as non-homologous use and/or more than minimal manipulation. Such a large industry with unclear regulatory oversight and pre-approval is a big concern overall.

At almost the same time, a horrifying story broke about someone who had traveled to Mexico, China and Argentina for stem cell treatment to help him recover from a stroke. Eventually he developed painful symptoms, which led to surgery that revealed a huge mass of rapidly growing cells in his spine, which were not cancerous, but were "predominantly composed of non host cells,” according to a letter to the New England Journal of Medicine:

Thus, although the lesion may be a considered a neoplasm (i.e., a “new growth”), it could not be assigned to any category of previously described human neoplasm on the basis of the data we gathered.

Stem cell treatments are by no means the only ones that can have unexpected and tragic outcomes, as recent headlines attest. Juno Therapeutics' small clinical trial of an immunotherapy approach to leukemia was abruptly halted last week after it announced that three subjects had died. (Juno later ackowledged a fourth death that occurred last year in a trial of a similar immunotherapy.) Fewer than 20 patients had been enrolled, and “only a minority” of them had the treatment that at first seemed responsible.

The protocol involved taking some of a patient’s own immune cells, performing gene editing on them to target cancerous growths, and then replacing the the rest of the immune cells with the genetically engineered ones. The clinical trial was being conducted under FDA regulations, and the FDA immediately stepped in.

To widespread amazement, it took only two days (the company had expected at least a month) before the FDA agreed that the problem involved a drug interaction and the trial could continue without using the incompatible chemotherapy drug. It’s unusual for the agency to move so fast, but — assuming they were right — it shows that bureaucracy can adapt.

Nevertheless, there are efforts to weaken the system of oversight. Senator Mark Kirk (R, Illinois) has introduced the REGROW Act (Reliable and Effective Growth for Regenerative Health Options that Improve Wellness), which is meant to speed up FDA approval for stem cell treatments. Knoepfler, who called a previous version of the bill “an attack on science-based stem cell trial oversight" remains skeptical:

it over-reaches so much that it would almost certainly do harm to patients and maybe to the stem cell field as a whole.

The Alliance for Regenerative Medicine also opposed the Act, at least in its original form. However, the California Institute of Regenerative Medicine (CIRM) has been campaigning for the FDA to loosen its regulations, even claiming that “patients are dying” because we are “so careful about safety.” CIRM President Randal Mills co-wrote an opinion piece for Fox News with former Senate Majority Leader Bill Frist demanding the the FDA make the approval of “cell therapies” (the word “stem” is not mentioned) easier.

Nature disagrees, in an editorial that references the Turner and Knoepfler article:

FDA should stand firm on stem-cell treatments [headline]
US regulators must regain the upper hand in the approval system. [short]

The pull quote accompanying the editorial is harsh but fair:

"The assumption that these treatments work is at the heart of the problem.”

Previously on Biopolitical Times:

Image via Figure 1 of the paper by Turner and Knoepfler (see above).

Puffing Cryonics in New Scientist?

Posted by Pete Shanks on July 13th, 2016

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New Scientist is a British-based popular science magazine. It’s been around for 60 years, which is long enough to stumble and recover a few times. For instance, in 2009 it published a cover story with the startling headline “Darwin Was Wrong.” (Not so, even if his concept of the “tree of life” was simplistic.) The story is mostly behind a paywall but still on-site; the cover image can be found elsewhere.

To be fair, New Scientist has also published informed and incisive commentary by experts such as Donna Dickenson and our own Marcy Darnovsky. The magazine has also been, at least on occasion, sensitive to questions of ethics, as in this 2014 editorial on “three-parent babies.”

But they just stumbled again. The July 2 issue featured on the cover “The Resurrection Project.” The articles included:

Ark of the immortals: The future-proof plan to freeze out death
A visual tour of the weird world of the cryogenically frozen
I want to put your death on ice so that you can live again

The perpendicular pronoun in the third title refers to Max More, the transhumanist who currently runs the Alcor Life Extension Foundation. We last mentioned More and Alcor in March, when we referred you to Corey Pein’s excellent article in The Baffler. Pein describes the folks behind Alcor as “technophilic necromancers” and digs deep into the risible history of More’s Extropy Institute and “proactionary principle.” As science (and business) goes, cryonics is on the quackery side of reality.

It would not surprise me to learn that, behind the paywall (I’m not paying) there was criticism of cryonics. But the topic was on the cover, not to mention featured in at least three email blasts, two of which used the term immortals. How should we understand those choices by a publication that calls itself a science magazine? As the writer of the aforementioned Darwin article admitted in response to complaints registered then:

Well, the cover is designed to sell the magazine. If we run very straight, sober covers, we sell fewer mags, we get fewer clicks and nobody blogs about us, so fewer people read what we produce.

What they think of us, the readers, is hard to tell. But here are the subject lines of the four most recent email blasts, as of this writing:

Self-promotion comes naturally to narcissists (July 10)
Your ultimate guide to reality’s true strangeness (July 9)
How to be a successful narcissist (July 8)
Embrace your inner narcissist (July 7)

And here is a worrying piece from the archives, 23 October 1999, to be precise. (So long ago, it took the Techno-Eugenics Email List, a distant ancestor of this blog, months to note it!) It’s a New Scientist Editorial titled “The Last Taboo,” in response to reports that scientists had, in principle, invented artificial chromosomes. The speculation around them was that they could be used to introduce heritable changes, in mice and theoretically in people. The technology was not then ready for use, by any means, but the editorial concludes:

For all these reasons, it would be a mistake to expect the taboo on human genetic engineering to last forever. Some day someone will want to try it. The invention of artificial chromosomes doesn’t make that desirable—only people can make that judgment. But it does add to the forces that are now beginning to make it seem inevitable.

As for taboos, they are simply a bad excuse for not thinking.

Apparently, sales are a good excuse for not thinking. Or perhaps the editors just suffered a brain freeze.

Previously on Biopolitical Times:

Image via New Scientist

Two Decades After Dolly

Posted by Pete Shanks on July 12th, 2016

Dolly’s remains are on display sat the National Museum of Scotland. (Even in death, an object of the human gaze.)

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Ten years ago last week, on what would have been the tenth birthday of the first cloned mammal, the soon-to-be-world-famous sheep, CGS published a 16-page Report [pdf] titled A Decade After Dolly.

This is how it opened:

It’s been nearly a decade since the birth of Dolly the cloned sheep in the summer of 1996—followed by the announcement of her existence in February 1997—put the prospect of cloning human beings clearly before us.

Since then, a near consensus has emerged: Cloning human beings is a very bad idea, and should be prohibited. In the past ten years, more than forty countries have adopted prohibitions against human reproductive cloning. But the United States has not.

The past decade has seen the development of techniques that could produce not only cloned children, but also a “designer baby” world of genetically modified humans. Again, unlike many other countries, the US has not put in place binding regulations to prevent this

Mutatis mutandis, it holds up pretty well as a summary. Gene editing and cellular reprogramming have emerged as collaborators with cloning. Concerns about genetically modified humans have therefore become even more realistic and pressing.

On this the twentieth year, Nature published perhaps the most interesting anniversary article, which told the story of Dolly’s conception, birth, life and death entirely in the words of the people who were actually there (plus a few closing comments from other experts). Scientific American had a multi-part feature, covering science, ethics and endangered species (also picked up by GEN). Stat had a piece by Sharon Begley that focused on human cloning, or the lack of it. And Pravda declared that pet cloning is the most profitable business in South Korea.

The last word should go to Ian Wilmut, who led the team that made and reared the first cloned mammal, quoted in Nature:

It would be wrong to say my name's known all the way around the world — but Dolly's is.

Previously on Biopolitical Times:

Image license for non-commercial use.

Frozen Eggs and Heated Debates

Posted by Angel Petropanagos, Biopolitical Times guest contributor on July 12th, 2016

A close-up shows ice crystals growing atop a darkened shape.

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Public debates about social egg freezing overemphasize the rights and responsibilities of individual women who delay childbearing and also misrepresent their reasons for doing so. These debates largely ignore the broader social and institutional structures and norms that shape and constrain the reproductive choices of men and women. Egg freezing is mistakenly framed as a solution to the risk of infertility that accompanies delayed childbearing.

* * *

Social egg freezing is becoming more widespread as a result of increased media coverage, clever marketing strategies, employer benefits from companies including Apple and Facebook, and government funding in Japan. 

I’ve been thinking and writing about the ethical issues surrounding social egg freezing and delayed motherhood (and fatherhood) for several years. And the public debates on these topics haven’t really changed.

Proponents of social egg freezing argue that this technology can promote women’s reproductive autonomy by affording them the option of delaying genetic reproduction and parenthood in order to pursue higher education or advance their career— an option that is generally available to men on the assumption that childcare is women’s work (so there will be a woman somewhere to care for his children while he pursues his education or advances his career).

Critics of social egg freezing raise concerns about the health risks to individual women and any resulting offspring. They also worry about the fact that most women who freeze their eggs likely will never use them for reproduction. This points to a service that is characterized by unnecessary physical risks to women and needless expenditures by them, and results in a surplus of stored biological material. Further, critics worry about “false hope” that can result from the use of a technology that is not guaranteed. Some feminists worry that social egg freezing detracts attention from broader social changes, such as improved parental leave, subsidised or universal daycare, and flexible work schedules that can make it easier for women (and men) to choose to have children at a younger age.

A few weeks ago I participated in a panel discussion about social egg freezing and delayed motherhood hosted by the Progress Educational Trust in Edinburgh, Scotland. The discussion included mention of all of the ethical considerations listed above. We also discussed the role of the media in promoting social egg freezing and spreading misleading information, as well as the importance of language for framing this technology. Despite these discussions, I was disheartened to see that much of the public discussion and the media coverage of this event focused on mistaken assumptions about the women who might use this technology. Media coverage also framed reproductive health education within a pronatalist mandate, that is, as targeting girls and young women to educate them about age-related infertility in order to prevent them from “the risk of missing motherhood.”

First, many people mistakenly assume that women delay childbearing because they are “picky” and waiting for “Mr. Right.” The reasons for delayed coupling that facilitates childbearing are complex. For example, women who have graduate degrees and demanding careers may have relocated several times, which can make it difficult to find a partner. The financial and time demands of work can leave some women without enough resources or energy to have kids at a younger age. Many women may be on second or third marriages and childbearing didn’t work out. Or, they may have children and want additional children with their new partner.

A second problem is the heteronormativity that permeates discussions of social egg freezing. Not all women who delay childbearing or contemplate social egg freezing are looking for Mr. Right. Some women may be looking for Ms. Right, while others may be choosing to parent alone, within polyamorous relationships, queer kinships or committed friendship communities. Discussions about social egg freezing should not assume or reinforce heteronormative nuclear family structures for raising children.

Third, people often assume that delayed motherhood is all about individual women’s choices. Indeed, public discussions typically fail to adequately address the role that men play in reproductive decision-making. Men also make choices around delayed parenthood, and for women who want to have children with men, this matters.

Fourth, women’s and men’s reproductive decisions are embedded within social contexts that help to shape their reproductive desires and values. For example, there is a pervasive social pressure to have genetically related children and “real” womanhood is often equated with motherhood. These pressures occur alongside social education and employment structures that make actually raising children really difficult, especially for people who lack adequate financial or social supports.

Finally, not all women want children. Discussions about social egg freezing assume that women without children, particularly those with advanced degrees or careers, have chosen to delay childbearing in order to achieve education and employment goals. Seldom do public discussions recognize that remaining childfree is a valuable option for some women. Widespread social pressure to freeze one’s eggs undermines the validity of this option.

Advancing public discussions of the ethics surrounding social egg freezing requires that we move beyond analyses of individual women’s choices. Social egg freezing is the result of social and systemic structural problems that influence decision-making. As such, addressing the concerns surrounding delayed motherhood (or parenthood more generally, for that matter) requires widespread social change.  

Angel Petropanagos is a Research Associate at Novel Tech Ethics at Dalhousie University and a Visiting Scholar at the Joint Centre for Bioethics at the University of Toronto. @APetropanagos

This blog is cross-posted at Impact Ethics.

Previously on Biopolitical Times:

Image via Pixabay

The "Outing" of Sperm Donor 9623

Posted by Hasmik Djoulakian on July 1st, 2016

Graffiti drawing of three large sperm on gray concrete.

Sperm banks continue to expand their search and selection criteria to include clinically ambiguous and frankly irrelevant donor information (favorite pets, astrological sign, hobbies). Yet their failures to verify the self-reported personal and medical histories of donors have recently prompted a set of legal complaints aimed at combating fertility clinic negligence in the unregulated assisted reproduction industry in the U.S.

Several families, including Angela Collins and Beth Hanson from Canada, have recently brought a lawsuit against one Georgia-based clinic, Xytex, and one particular donor. The legal questions are themselves significant, but the case also raises important considerations around disability, class, and genetic determinism.

Xytex, along with its distributor in Ontario, informed Collins and Hanson that Sperm Donor 9623 had an IQ of 160 and was pursuing a PhD in neuroscience, and had no history of physical or mental illness apart from his father’s colorblindness. The clinic did not verify this information, but relied on what Sperm Donor 9623 had reported. The parents, now raising their young son, were understandably shocked upon learning that his donor had in fact spent time in jail and received multiple diagnoses of mental illness.

Parents’ anger, and their concern about their families’ future, should of course be recognized and respected.  But so should the complicated set of issues that this case raises. How do we assess it while resisting genetic determinism, challenging biological explanations for class-based inequalities, and critiquing a purely medical understanding of disability? How do we negotiate the differences between human variation and costly, painful, mental illness? How should we come to terms, legally, politically, and emotionally, with the responsibility – or negligence – of commercial players in the realm of human reproduction?  None of the answers are obvious.

The couples who used Sperm Donor 9623 may never have realized that he had been diagnosed with schizophrenia and other mental illnesses if Xytex had not accidentally and negligently revealed his identity in an email exchange. Three of the many families who used his sperm are now seeking to set up a fund for their children’s preventative health care and future medical costs. In addition to its part in a legal strategy, the argument for this fund brings into focus the various roadblocks that people with mental illness face accessing employment, education, and mental health services.

In most articles discussing the case, the "perfect" sperm donor that families thought they were selecting (high IQ, graduate degree, etc.) is rhetorically pit against the donor’s "actual" identity: a "mentally ill convicted felon" (1, 2, and 3). Press releases, news coverage, and lawsuits indulge in assumptions about genetic determinism and overstate the chance that the children will take on the behavioral characteristics of their sperm donor.  Though such reductive sound bites are common in media representations, they do not emerge in a vacuum and their harm extends beyond this one case. The assumptions that permeate media and legal discourse about Sperm Donor 9623 hinge in part on widespread misunderstandings of disability, poverty, and genetics. Much of the language swirling around this case creates false dichotomies between health, intelligence, and success versus illness, criminality, and failure. We all live in far greater nuance than that, whether or not we currently live with a disability, including schizophrenia.

Aside from focusing on his schizophrenia, many articles also mention the sperm donor’s felony charge, implicitly suggesting there is a link between genes and criminality (and mental illness and criminality). This is an incorrect and politically troubling connection. But it is not without its supporters. For more than a decade, Kent Kiehl, a psychologist and neuroscientist who also studies schizophrenia, has been visiting high-security prisons in the U.S., scanning the brains of more than 4,000 inmates with a mobile MRI unit, and building a database to look for genetic links to violence. Kiehl claims that psychopaths and violent people "have different brains," which are "at least 50 percent caused by genetics" and supports research aimed at studying the MAO-A gene (which has been problematically nicknamed the "warrior gene"). A more recent study on MAO-A chose as its sample the brains of 328 male children. These studies and others like them assume a lot at the outset, including that incarcerated people (and males) are inherently more violent than others, and that this is genetically pre-determined.

Many news articles about Sperm Donor 9623 also mention that he had dropped out of college, implying there are "genetic links to educational attainment." While some researchers recently touted a study that identified 74 genetic variants that influence how many years of school people finish, a closer look reveals an important caveat: those 74 genes "explain slightly less than one-half of 1 percent of the differences between people’s education levels." Given the other aspects of Sperm Donor 9623’s identity, there’s a missing discussion in the press about whether he had the necessary mental health or financial support to finish his education.

The links between genes and the likelihood of developing schizophrenia are difficult to quantify or clinically predict. Many gene clusters have been identified that may contribute to the diagnosis, and it is also believed that environmental conditions can trigger schizophrenia. The complicated state of the field has been muddled in media coverage of this lawsuit, as in one CNN article claiming that certain gene clusters cause schizophrenia 70% to 100% of the time. Critics point out that research findings are often overhyped, despite the currently enormous gap between the huge amounts of genetic information that are generated and the relatively miniscule amounts of clinically reliable advice based on it.

Being predestined at birth for dropping out of school and committing crimes is logic that sounds familiar to historians. In the U.S. alone, tens of thousands of people have been sterilized and excluded from "respectable" society through state and institutional eugenics programs because they were considered predisposed to criminality, "feeble-mindedness," and all-around substandard genetic material. Fear of disability – physical or cognitive "deviance" from what those with power have historically decided is "normal" – is wrapped up in mistrust of people who are poor or have criminal records. At the core, this anxiety continuously answers its own question: Who should be allowed to reproduce?

Nothing about this case is objective, self-evident, or easily teased apart, but the history of eugenics informs the pressures faced by families in this high-tech fertility moment. People now encounter an expanded range of options, expectations, and ways of thinking about families and reproduction. Parents understandably want the best for their children. It would be difficult, if not impossible, to not feel frightened at the prospect of a child developing schizophrenia, especially when everything around us says our functioning needs to be "normal" and when social supports are so lacking. And many would recoil in fear from a gamete donor who had dropped out of college or had prior convictions, without stopping to consider the eugenic assumptions embedded in that reaction.

The ableist and classist underpinnings behind the drive for particular kinds of gamete donors sit on a landscape defined by expectations and mechanisms of consumer-based, free market products and purchases. If assisted reproduction becomes a transaction, it can become difficult to resist treating the resulting children as commodities. The parents in the Xytex lawsuit clearly don’t believe their children are "incorrect" or "undesirable," but it is difficult to procure damages for breaching informed consent and covering potential future medical costs without arguing that the sperm donor was absolutely "incorrect" and "undesirable."

Previously on Biopolitical Times:

Image via Flickr/Grace Hebert

Updates: The California Legislature and the Market in Human Eggs

Posted by Marcy Darnovsky on June 30th, 2016

A fertility industry-sponsored bill that would expand the market in human eggs is barreling through the California legislature, in spite of opposition from women’s health, reproductive justice, and public interest organizations. AB 2531 would overturn a California law that lets researchers reimburse women for their expenses incurred in providing eggs, but disallows payments beyond that. The 2006 statute that AB 2531 would eviscerate was authored by former state Senator Deborah Ortiz, known for championing both women’s health and stem cell research, and approved almost unanimously by both the Assembly and Senate.

In an April blog post, Will California Expand the Market for Women’s Eggs?, we summarized the reasons for opposing AB 2531 (see also this CGS letter) and reported that it had been unanimously approved by the Assembly Health Committee. In early June, the Senate Health Committee posted its analysis of the bill, including a summary of the arguments for and against it, and a list of its supporters and opponents.

The Committee passed the bill by a vote of 8-1 at a June 15 hearing. Testimony by CGS’s Elliot Hosman against it can be viewed here (starting at 52:35), or read at the end of this post.

The bill will go next to the Senate Appropriations Committee when the legislature returns from recess in early August, and then to a vote by the full Senate. Assuming it passes, it will then be sent to Governor Brown. The Governor vetoed an almost identical bill in 2013 with the following message:

Not everything in life is for sale nor should it be.

This bill would legalize the payment of money in exchange for a woman submitting to invasive procedures to stimulate, extract and harvest her eggs for scientific research.

The questions raised here are not simple; they touch matters that are both personal and philosophical.

In medical procedures of this kind, genuinely informed consent is difficult because the long-term risks are not adequately known. Putting thousands of dollars on the table only compounds the problem.

Six years ago the Legislature, by near unanimity, enacted the prohibition that this bill now seeks to reverse. After careful review of the materials which both supporters and opponents submitted, I do not find sufficient reason to change course.

I am returning this bill without my signature.

David Jensen of the California Stem Cell Report covered AB 2531 for the Capitol Weekly (Senate eyes human egg business), and Diane Tober discussed it at Undark (The Politics of Women’s Eggs). The notoriously under-studied risks of egg harvesting were also featured in a recent Washington Post article, Do women who donate their eggs run a health risk?

As those of us who support the existing limits on the egg market in California have pointed out repeatedly, without adequate health and safety information about egg harvesting, women can't give truly informed consent to undergo it in exchange for cash. And despite the claim of AB 2531 proponents, egg providers are very different from research subjects: Unlike clinical studies in which researchers follow the health outcomes of participants, egg retrieval supplies researchers with biological materials for other experiments, but without any study of its effects on those who provide them.

Elliot Hosman's testimony explains these and related points.

Testimony in opposition to AB 2531 by Elliot Hosman, June 15, 2016

Good morning, and thank you. I am Elliot Hosman, Senior Program Associate at the Center for Genetics and Society, a public interest organization based in Berkeley. We have long been concerned with the lack of adequate research on the health risks of egg retrieval. Our concerns are broadly shared by many others, including national and California women’s health and reproductive justice organizations you see opposing this bill, and including scholars and health professionals, and women who have themselves undergone egg retrieval.

The research that could identify the extent and frequency of health risks associated with egg retrieval has simply not been done. It’s been called upon to be done for decades, but it has not been done. Thus the information women would need to give informed consent does not currently exist. Unfortunately, this bill increases payments without providing mechanisms to bring about the conditions for substantive informed consent that women deserve.

The intent to treat egg providers as "human research subjects" may sound like a good idea, but in fact egg providers are not "research subjects" as we usually understand that term. They provide the cells that are used in research, not for their benefit, but no research is performed to ascertain the effects of egg retrieval on their own health outcomes.

While some Institutional Review Boards may review egg retrieval procedures, they are not required to do so. For example, if the eggs are anonymized, many reviewers may deem they are no longer required to evaluate retrieval protocols or informed consent forms, and eggs are often anonymized, so this is often case.

Even when IRBs do review, they typically do not provide adequate safeguards:

  • They don’t require tracking short term outcomes, so we don’t have good data on how many egg providers are injured or hospitalized due to ovarian hyperstimulation syndrome from the drugs they’re on.
  • They don’t require tracking long term outcomes so we have almost no data on the stimulation drug regimen’s impacts on their fertility, their short-term or long-term cancer risks, or other problems they may face.
  • They seldom require follow up health care for egg providers. At best they cover treatment of short term injuries that can be directly and causally linked, but don’t cover any longer term harms.  
  • They don’t review the treatment outcomes of clinics or researchers to determine if any are using inappropriate protocols that harm egg providers.
We all support promising research that might provide broad benefits, and we all want to make sure that women’s health is not compromised in the process.

Unfortunately, this bill does not accomplish that, and we respectfully urge you to vote against it.

Previously on Biopolitical Times:

The Disappointing NAS Gene Drive Report

Posted by Pete Shanks on June 30th, 2016

On June 8, the National Academies of Sciences, Engineering, and Medicine issued a report about gene drives, titled:

Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values

The headline of the associated press release summed it up succinctly:

Gene-Drive Modified Organisms Are Not Ready to Be Released Into Environment; New Report Calls for More Research and Robust Assessment

Francis Collins, director of the National Institutes of Health, commended the authors for a "thoughtful and comprehensive review of the unprecedented potential and challenge of gene drive technologies." That’s true enough. It is a valuable resource for a much-needed public debate — but it is sadly incomplete, and occasionally misleading. 

The report’s skepticism about "reversal drives" is welcome (see Recommendation 5-5, p. 99) but inadequate. If gene drive technology goes wrong, is the solution really to be more gene drive? Indeed, Kevin Esvelt, one of the pioneers of (and an advocate for) gene drive told The New York Times that the report failed to adequately flag its central risk. 

"They assume you can safely run a contained field trial," he said. "But anytime you release an organism with a gene drive system into the wild you must assume there is a significant chance that it will spread — globally — and factor that in."

The report makes repeatedly admits that field research is most likely to occur in "low- and middle-income countries" (p. 6 etc), recognizes "that many countries lack the capacity to develop a comprehensive regulatory scheme for gene drives from scratch" (p. 8), and the like. These should be warning flags. If technology really can help underdeveloped nations, the impetus should come from them. And the U.S. is not a party to the multilateral Convention on Biological Diversity (CBD) and its protocols, which aims to promote fair and equitable sharing of benefits arising from genetic resources. U.S. institutions are developing technology that, if applied, will mostly be used elsewhere. Centuries of exploitation do not suggest that wealthy foreigners are the best judges of humanitarian needs. 

(Or perhaps we should invite Cuban doctors to set up clinics in Appalachia?)

The report also appears to downplay the possibility of "weaponizing" gene drive technology. The worst case — a deliberately belligerent release of modified pathogens — would surely rank with nuclear destruction as a prospect to be avoided; and mere mistakes could be as bad. There is a reason the ETC Group titled its comment [pdf] on the report:

Stop the Gene Bomb!

Jim Thomas of the ETC Group wrote an excellent article about the report for the Guardian, calling for the CBD to agree on an international moratorium on release of gene drives. Friends of the Earth asked sardonically, "Permanently changing a species: What could go wrong?" and called for a moratorium. Ron Bailey of Reason initially wrote an apparently knee-jerk response ("Go slow and let more people suffer and die") which misunderstood Esvelt’s position; he then appended a much more interesting Correction acknowledging that "How to regulate an open access commons is always a perplexing problem." Michael Specter in The New Yorker called the National Academies’ effort "a worthy, if somewhat tepid, report," and Stanford’s Hank Greely agreed, in a valuable blog post that made "Eight Quick Points."

Finally, the report sometimes reads as though its goal was not so much "aligning research with public values" as "aligning public values with research." It’s striking that the "stakeholders" mentioned do not appear to include any of the civil-society groups widely known to have raised concerns about this issue. "Stakeholders" are described (Figure 7-1, p. 122) as "people with direct professional or personal interests in gene drives." May I raise my hand? I work with the Center for Genetics and Society; other public interest organizations that have been involved with gene drive deliberations include ETC GroupFriends of the Earth, and International Center for Technology Assessment.

Unfortunately, the initial flurry of reactions seems to have died down. Gene drive could be a major disruptive technology. It could affect not only our environment — the "out there" — but our food and even our selves. This report deserves to provoke a massive, global debate. A long pause for reflection is the least that is needed. Or T. S. Eliot may have finally been proved correct:

This is the way the world ends
Not with a bang but a whimper.

Previously on Biopolitical Times:

On the 14-Day Rule and Other Limits

Posted by Pete Shanks on June 29th, 2016

What is the speed limit where you live? In California, it varies but the maximum is 112.654 kph. In France, the speed limit can run as high as 80.778 mph (actually a couple of yards more). 

You don’t see those numbers on road signs, because the California vernacular uses the mile, which is officially defined as 1,609.344 meters, while France uses the kilometer. A meter, of course, is the length of the path travelled by light in vacuum during a time interval of 1/(299,792,458) of a second. It’s obvious when you think about it.

In both jurisdictions, the concept of a speed limit is the same, and the idea is generally justified by public safety, and perhaps fuel conservation, neighborhood nuisances and so on. It’s a common-sense restriction that gives all drivers guidance, and that is meant especially for those lacking in common sense.

The limit is not defined by the maximum speed of a vehicle.

Biology also has its widely accepted rules, which are sometimes given the force of law and sometimes mostly a matter of custom and ethics. Many of these were agreed at a time when there was no immediate prospect of successfully breaking them: a firm line, legally codified in dozens of countries, against human germline intervention, for instance, or the internationally accepted norm of a 14-day limit on human embryo experiments. They give researchers a clear guideline within to work, and they give the public confidence that rogue scientists will not go overboard.

Until very recently, no one had come close to growing a human embryo in a dish for 14 days. In May, however, two different groups of scientists (12) published experiments demonstrating that they could indeed do that. Simultaneously, three scholars — all experts in bioethics theory and/or practice — published a piece in Nature titled:

Embryology policy: Revisit the 14-day rule

They were just raising the question, they insisted in response to the obvious retort: Why revisit if you don’t want to change the rule? "Revisit need not mean revise," tweeted one author. Some other bioethicists, including Jonathan Moreno, agree that:

What’s really more important than whether it’s permissible to move those goalposts is how we make that decision.

That sounds incredibly reasonable. But why now? Just because the rule has suddenly become inconvenient? If that is the case, does it suggest that some bioethicists see their mission as working to legitimate whatever research desires scientists may have? That is, to convince the public of what they ought to think is good for them?

And if the pragmatic and useful 14-day agreement is broken, what then? Hank Greely spelled out a basic complaint:

"I don’t know where you stop. I do know that I would feel very concerned about a 20-week fetus being used as an experimental object, because it’s too damn close to being a baby," he said. "And people should not be treated as objects."

Greely expanded on this in his own blog post. Françoise Baylis wrote a nuanced analysis. By coincidence, the International Society for Stem Cell Research (ISSCR) issued its latest guidelines for stem-cell research [pdf] a few days later: they stick firmly to the 14-day rule.

There will undoubtedly continue to be pressure to change the norms that have guided research in many related fields over the next few years. Human-animal chimeras are up for discussion, so of course are human germline interventions, and gene drives in other species. Many knowledgeable people, including scientific participants, regard the prospects as extremely scary. 

Admittedly, in some cases, adjusting existing rules may seem sensible; the 55 mph speed limit was widely ignored and eventually repealed. But that change had nothing to do with the technical abilities of car manufacturers.

The top speed of a production car has been over 110 mph since 1947, and over 150 mph since 1959. It’s now over 250 mph, and I’d like to see that Bugatti trying to weave its way up the Pacific Coast Highway. Probably couldn’t get out of second gear.

Previously on Biopolitical Times:

Hateful politics infiltrate human genome editing debate in France

Posted by Elliot Hosman on June 29th, 2016

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A recent campaign calling for a ban on “transgenic” human embryos was launched by one of France’s most prominent organizations fighting for “science”-backed “one-man-one-woman” families, and the exclusion of all other forms.


“Stop GMO Baby: Yes to therapeutic progress, no to transgenic embryos” (image via Alliance VITA).

Since March 24, more than 15,500 people in France have signed a petition started by Alliance VITA declaring (translated from French*):

“I ask my country to engage with all urgency to obtain an international moratorium – that is to say an immediate stop – on the genetic modification of human embryos, especially via the technique CRISPR-cas9.”

*all French materials and quotations presented in English in this post have been translated using Google and my college-level French. Suggested revisions to translations are welcome and will be noted. Alliance VITA offers some materials on its website in English.

In that time, volunteers have canvassed cities around France, handing out brochures explaining the breakthrough CRISPR genome editing technology, and tweeting pictures of their advocacy using Flickr and the hashtags: #StopBébéOGM, #ProtectHumanity, and #CRISPR-Cas9.

Alliance VITA’s opposition to using human gene editing for reproduction is widely shared, including by my organization, the Center for Genetics and Society. But a closer look at the Stop GMO Baby campaign in France reveals a troubling and at times explicitly hateful politics infiltrating the human genome editing debate. A polarization of the conversation about heritable human genetic modification along “right to life” and “natural family” fault lines threatens to derail public conversations about responsible regulation of science and medicine that serves the public interest.

Paul also recently flagged Alliance VITA’s Stop GMO Baby campaign, cautioning:

“I’m concerned that these campaigns that specifically target CRISPR could have negative effects on the freedom of us scientists to do responsible CRISPR research in the lab. … at least some of the motivation seems to be related to a “right-to-life” perspective. “

I share this concern, and we’re not alone. In a February article titled Gene editing: The next frontier in America’s abortion wars, the “last scientist in Congress” U.S. Representative Bill Foster (D-IL) told Politico’s Sarah Karlin that he’d been warned by scientists that “‘this issue will get all tied up over the abortion debate,’ interfering with the creation of ‘good policy decisions.’”

The Stop GMO Baby Campaign

Alliance VITA’s campaign materials on CRISPR take as their central point that CRISPR-Cas9 is an ethically neutral and promising technology that could help gene therapy, but that any use in human embryos or gametes is a red line no researcher in the world should cross. In their other words: “GM babies? No!” Here are some examples of their slogans and statements:

  • Campaign slogan: “CRISPR-Cas9: Yes to Therapeutic Progress, No to Transgenic Embryo!” (March 24, 2016) [Brochure PDF]
  • On February 16, 2016, Alliance VITA Research Director Blanche Streb stated on Catholic television: “The technique poses no ethical problems on its own, it’s the application that does.” (YouTube)
  • Alliance VITA General Delegate-CEO Tugdual Derville commenting on Kathy Niakan’s application to the HFEA in January 2016:

“Although this technique might be promising for genetic therapy, Tugdual Derville reminds us that when applied to the human embryo: “the danger is to cause the emergence of custom-made babies, with pre-selected genetic criteria, heritable modifications, with unknown consequences for future generations. The human genome is part of our most precious “heritage of humanity.” Its integrity must absolutely be preserved for future generations.”

In March, Alliance VITA released a study they conducted finding that 76% of French people support gene therapy, but oppose using CRISPR to genetically modify embryos in vitro. Some of their data conform to a number of other recent studies. But the slipperiness of public opinion polls that Pete Shanks describes in a recent survey of public opinion of human heritable genetic modification is on point here, as the framing of questions may lead to an overstatement of the sanctity of the embryo for the people who polled their opposition.

On April 7, France’s National Assembly Parliamentary Office for Scientific and Technological Assessment (l’OPECST) held a hearing on issues raised by CRISPR (program, in French). Alliance VITA Research Director Blanche Streb testified, advocated for an international ban on embryo experiments, and noted that her organization was also concerned by “3 person IVF” mitochondrial replacement technologies in the UK. While Alliance VITA’s media statements and materials mention threats posed by eugenics and transhumanism, their stance is clearly that all experiments on embryos should cease. They appeal to UNESCO’s “genome as commons” as authority, interpreting its call for a collective responsibility to future generations as including the sanctity of the embryo.

La Manif for whom?

Pictured L to R: Xavier Bongibault (celebrated by some as a “gay voice against gay marriage”), Frigide Barjot (former celebrity face of La Manif pour tous), and Tugdual Derville (CEO of Alliance VITA) (image via Flickr/Serge klk).

* * *

Alliance VITA was a leader of the first-ever rallies of a French movement called “La Manif pour tous” (the Strike for all), a coalition of anti-abortion, anti-LGBT organizations (many professing the Catholic faith) that organized a very visible campaign to oppose the fight for “marriage for all” in France from 2012 to 2014.

For a United States audience, visible opposition to gay and lesbian couples getting married is not novel, although public opinion polls show increasing acceptance. But many the world over were taken aback by the size of the crowds marching in Paris in early 2013 holding blue, pink, and white signs that read “One man, one woman, we don’t lie to children!” The number of marchers, which was hotly debated, was between 150,000 and 1 million.

Despite the jaw-dropping scale of these protests, President François Hollande signed a parliamentary law establishing the rights of gay and lesbian couples to marry and adopt in May 2013. The following year in August 2014, the French government expanded abortion access so women no longer have to argue “distress” to access a procedure, and agreed to pay for the procedures, at least most of the time.

These recent events could sound like a bell twice tolled for those seeking to narrow French and international discourse on and regulation of what counts as “family” and “life.” But Alliance VITA has rebounded from these two developments by capitalizing on the grassroots power amassed with La Manif pour tous, focusing on other issues related to death and conception (e.g. surrogacy, embryo selection) and launching the new “citizen’s campaign” against CRISPR experiments. Two recent research reports on CRISPR research using nonviable human zygotes have catalyzed the debate about certain cellular masses of particular interest to this movement: “des embryons.”

* * *

Crowds march in Paris in 2013 to oppose extending marriage and adoption to LGBT couples (image via Wikimedia).

* * *

Flying Colors Wave

Frigide Barjot, a devout Catholic, noted in 2012 that the three colors of La Manif pour tous’ protests represented blue for men, pink for women, and white for LGBT people who were included to show that “they were loved by protestors, who were not homophobic but rather wanted to protect the very idea of ‘family’ and ‘civilization.’” Barjot’s outsider status compared to the movement’s leadership of traditional Catholic and far right political groups led to her replacement in 2013.

Left. La Manif pour tous protest in Strasbourg on February 2, 2013 (image via Wikimedia).
Right. La Manif pour tous protest in 2013 (image via Flickr/Arslan).

In contrast, the new CRISPR-related campaign takes on the cautionary yellow of GMO campaigns across Europe (stock photo search). France, along with Germany, is one of the most stalwart opponents of GMO foods in Western Europe, creating a huge constituency to draw upon for Stop GMO Baby.

Left.“GMO, I don’t want any.” Greenpeace protestors march in Montpellier in May 2015 (image via Flickr/Pete).
"92 groups mobilized in defense to inform the public of the issues posed by CRISPR-Cas9.” (image via Twitter).

* * *

The Science Cited by Alliance VITA

In its 2012 coverage of Alliance VITA and its prominent role in the La Manif pour tous protests, VICE noted with some irony the peculiar sight of “secular opposition to gay marriage”:

“The French Republic was founded on the ideas of equality and a French concept called laïcité—the complete absence of religion in governmental affairs. This means political discourse in France must be entirely free of religious rhetoric…battling civil rights, not with religious ideals, but with science, sociology, and cold, reductive rationality.”

In other words, Alliance Vita needed to invoke science to support a campaign premised on denying gay and lesbian marriage and adoption rights. So the group used a widely cited – and widely discreditedNew Family Structures Study by American sociologist Mark Regnerus on the “differences” seen in children raised by same-sex couples. The study is riddled with methodological problems, and was denounced by the American Sociological Association and 200 scientists and doctors in a 2012 open letter. But Alliance VITA’s “scientific” evidence for the superiority of traditional families goes beyond the debunked significance of Regnerus’s interviews.

Tugdual Derville, CEO and General Delegate of Alliance VITA, led the group’s March 24 press conference, and coordinates media statements with Research Director Blanche Streb. Derville is currently on tour for his newly published book Human Ecology. In various French media venues, he attacks what he refers to as “gender theory feminism,” and argues for biologically determined and distinct gender roles for men and women in family creation, education, and society. It’s what he calls the “sexus,” the natural “family ecosystem” which depends on a “Father-Mother” distinction to prevent the “self-made man.” Derville equates transhumanists with animal rights’ activists, eugenicists with feminists, and the “radical cult of youth” with the “disconnected gerontocracy.” It’s all an indistinguishable bunch of individualistic nonsense to him. “In settling their accounts with their own personal stories, their advocates endanger us all,” he states in a recent interview.

* * *

The Time of Man: for a human ecology revolution
(image via
Tugdual Derville’s website).

Some French critics of Human Ecology have accused Derville of “green-washing” his traditional ideological fare. Associate professor of French studies at MIT Bruno Perrau has studied and written about La Manif pour tous for years, and commented on the recent campaign via email:

“[T]alking about ecology allows religious arguments to appear in the public debate in a more acceptable way (that is to say as secular arguments). My sense is that there’s no thorough investment on environmental issue (it is mostly used strategically).”

University of Chicago law professor Mary Anne Case, a U.S. expert on the Catholic Church’s rhetoric, doesn’t see contradictions in the environmental packaging of Alliance Vita’s various campaigns:

“Human ecology” is a favorite framework of Benedict XVI, who used it to warn of the potentially devastating effects of what he called the “ideology of gender.”

Case points to Pope Francis’ recent encyclical on the environment (welcomed for its critique of inequality, capitalism, and human-caused global warming), which also talks disapprovingly of embryo research:

“[I]t is troubling that, when some ecological movements defend the integrity of the environment, rightly demanding that certain limits be imposed on scientific research, they sometimes fail to apply those same principles to human life. There is a tendency to justify transgressing all boundaries when experimentation is carried out on living human embryos. We forget that the inalienable worth of a human being transcends his or her degree of development.” Laudato si’, par. 136.

Case noted in an email, “Seen from within the mindset of those Catholic writers invoking the need to safeguard human ecology in their campaigns against a whole host of sexual rights and law reform efforts, religious and secular motivations openly go hand in hand in the same direction.”

The “secular science v. religious ideology” binary can get in the way of acknowledging that people across the religious and political spectrum have voiced concern about the prospect of using a new generation of genome editing tools to produce altered embryos for the purpose of human reproduction. But the Pope’s and Derville’s framing, in which environmental advocacy somehow mandates accommodating the idea that human embryos should be accorded the status of human lives, doesn’t sit well with me either; it reminds me of a “zero-sum” game, when we need to be in a “grow the pie” mindset given our volatile political climate.

* * *

Laudato Si’: On the Care of Our Common Home (image via

Dangerous Political Territory

Many voices from France have joined in international mourning for the 49 slain and 53 injured victims of the massacre at queer dance club Pulse’s Latin Night in #Orlando on June 12, 2016. In the multi-dimensional public investigation that has followed, a number of tweets using the hashtag #Manifpourtous called out Alliance VITA and its allies for their role in inciting homophobic violence around the world. On June 26, Pope Benedict called on Christians to apologize to gay people and other marginalized groups.

Back in 2012 Alliance VITA and the La Manif pour tous coalition happily cited the Regnerus study, but they weren’t the only ones citing the flawed sociological research promoting homophobic laws. Among others leveraging the “science” to wage their defense of the “natural family” was nearly every American organization opposed to LGBT rights, including the controversial National Organization for Marriage.

One of Alliance VITA’s biggest admirers is Brian Brown, National Organization for Marriage’s president. Brown spent time with La Manif pour tous campaigners in France and this year was elected as President of the World Congress of Families. WCF is an almost 20-year-old effort to organize international spaces for conservative organizers and lawmakers from around the world to collaborate on an anti-LGBT, anti-abortion, “natural family” agenda to support legislation in multiple jurisdictions. (I recommend this historical overview by the Southern Poverty Law Center.)

Supporting bans on marriage equality is tame in comparison to WCF’s other ongoing efforts. The Southern Poverty Law Center tracks the organization as part of its Hatewatch program because of its support of discriminatory legislation, including “gay propaganda” bills in Russia (where regulations recently banned transgender people from driving), “kill the gays” bills in various African countries, and for its ideologically narrow view of “healthy families” used to justify government interference into people’s sex and family lives. WCF is also currently opposing “UN entities’” efforts to expand the UN’s definition of family to include same-sex couples.

“Uniting Leaders Worldwide in Defense of Family, Faith, and Freedom”, World Congress of Families 2016 (images via Eventbrite 1, 2).

The WCF’s 10th international convening in May 2016 was held in Tblisi, Georgia, where it bestowed honors on former president George W. Bush. He declined to appear, but sent a letter saying,

“I commend your efforts to recognize the importance of families in building nations. Your work improves many lives and makes the world better.”

The event drew far right politicians from around the world, including WCF representative to France Fabrice Sorlin, and granddaughter of French National Front party founder and youngest French MP in history, Marion Maréchal-Le Pen.

The founding family of the far right National Front party in France, pictured L to R: Marine Le Pen, her father Jean-Marie Le Pen (grey suit), and her niece Marion Maréchal-Le Pen (images via Wikimedia).

Marion and her aunt, Marine Le Pen, have been the “new face” packaging for the far-right party’s xenophobic campaign slogans such as “France for the French.” Before the Brexit referendum on June 23, 2016 when the UK voted to leave the European Union, Marine Le Pen supported a British “Leave” vote to spark a “chain reaction of decomposition” of the EU.

In addition to a shared support for a British-Exit, Le Pen’s bid in the French regional elections last year was eerily Trump-like. She beat former presidents Nickolas Sarkozy and François Hollande in the first round of the regional parliamentary race in December 2015, but lost in the second. (For many, the rise of Trump in U.S. politics echoes the rise of the extreme right in the British and European contexts; others argue that the Trump phenomenon is distinctly American in nature.)

As the world wrestles to reconcile global warming, unprecedented inequality, refugee crises, and mass shootings, and now the potential for a new era in European politics, how do we confront the political extremism bubbling up in reaction as we engage in sensitive policy debates that shape the world we will leave to future generations?

Ongoing political and religious controversies over abortion and embryo research may fuel partisan ways of thinking and reactionary policies that fail to serve the public interest in this arena. As increasing awareness about CRISPR takes shape, it will be important to be clear about the many “non-embryo” reasons to be critical of some emerging human biotechnologies. We cannot let the far-right capture the conversation about the social and ethical issues surrounding heritable human genetic modification technologies.

The development of new genetic techniques such as CRISPR-Cas9 demands a reflective debate on the sort of future world we want to build, the meaning of being human, and how far we’ll go to engineer individuals to fit the society we currently have. My hope is that this debate can spark discussions about deep structural social changes that we already know are needed to improve the lives of communities around the world.

* * *

This article was cross-posted on The Niche, UC Davis stem cell researcher Paul Knoepfler's blog.

CORRECTION: July 14, 2016

This article was cross-posted on The Niche, where a reader commented: "Great piece, thanks. Just a correction regarding the Dec. 2015 election in France: this was not presidential election (which will happen in 2017) but elections to regional parliaments. The far-right party of Mrs LePen indeed registered a political victory by leading the first round in many regions, but the party’s candidates including Mrs LePen lost in all regions during the second round of elections." The blog has been edited to reflect that Marine Le Pen beat Nicolas Sarkozy and Françoise Hollande in the first round of France's regional elections, not a presidential election. See more.

Previously on Biopolitical Times:

UK Researchers Now Say Three-Person Embryo Technique Doesn't Work; Propose New Method

Posted by Jessica Cussins, Biopolitical Times guest contributor on June 8th, 2016

Douglass Turnbull and Mary Herbert, Wellcome Trust Centre for Mitochondrial Research,
Newcastle University.

Untitled Document

In February 2015, the UK decided to create a controversial exception to its law against any form of human germline modification to allow the creation of “three-person embryos” to prevent the transmission of some mitochondrial disease. Then and now, unresolved scientific concerns remained, and many people have been waiting to see whether the science will indeed come through.

Adding to anxiety to see these data is the enormous global attention on a different technology proposed for human genetic modification: the gene editing technique CRISPR, and current controversy over varied attempts to try it on human embryos.

However, there is only one central place where the mitochondrial research is being carried out in the UK – the Wellcome Trust Centre for Mitochondrial Research at Newcastle University. But despite opening its doors in 2012 and encouraging excitement about the importance of  this research, none of the specific research requested by the Human Fertilisation and Embryology Authority (HFEA) had been published until now.

Today, that changed. Well-known Newcastle researchers including Mary Herbert and Douglass Turnbull have just published an update to their six-year-old Nature paper, which originally described how their preferred form of mitochondrial replacement – pronuclear transfer (PNT) – “has the potential to prevent the transmission of mtDNA disease in humans.”

Shockingly, their new paper reports that the proof-of-concept studies upon which everyone had been basing their enthusiasm “were not well tolerated by normally fertilized zygotes.”

In other words, the scientific basis for the controversial UK law and HFEA policy change turns out to have been unfounded. It did not work.

The researchers were able to develop an alternative method however, which may still justify the technique as a potential method to reduce the transmission of mitochondrial disease from mother to child. Their new paper (behind a paywall) is optimistically titled, “Towards clinical application of pronuclear transfer to prevent mitochondrial DNA disease.”

Initial media coverage has run with this alternative ePNT and downplayed the additional concerns raised by the new research

Three-person babies IVF technique ‘safe’ [BBC]
UK scientists find new 3-parent IVF technique safe in lab tests [Reuters]
‘Three-parent baby’ success could see trials in two years [New Scientist]

This overly positive characterization is perhaps understandable given the small but eager group of patients who wish to use this technology to decrease the chances of passing on mitochondrial disease to their offspring.

Yet as of this writing, only The Telegraph is giving weight to the range of unknowns still at play:

'Three parent baby' technique could still pass on mutated DNA, study shows

A more cynical headline for this news may be:

Scientists effectively distract press and public from the dangers inherent to the controversial technique they promised wasn’t unsafe by introducing a new technique promised not to be unsafe.

The new paper describes the alternative method as early PNT or ePNT because the researchers found it works better to transplant the pronuclei from one embryo into another immediately after meiosis rather than right before the first mitotic division. In 79% of the resulting embryos, less than 2% of the unhealthy mitochondria of the first embryo had transferred over to the new embryo, which might be enough to help a child avoid symptoms of mitochondrial disease. On the other hand, it might not. In decidedly less confident language than has often been used up to this point, the researchers conclude, “PNT has the potential to reduce the risk of mtDNA disease, but it may not guarantee prevention.”

Part of the reason for this caution is because of a Cell Stem Cell paper published just days earlier by US researchers including Dieter Egli called “Genetic Drift Can Compromise Mitochondrial Replacement by Nuclear Transfer in Human Oocytes.” This paper highlights their findings that even small amounts of carryover mitochondria can cause “genetic drift,” which can “lead to the restoration of the original donor mitochondrial genotype” and undercut any positive outcome from the technique. They suggest “although vertical inheritance of mtDNA is not required, it is critical to ensure inheritance of a single maternal mtDNA lineage.”

This paper led to Nature saying “Three-person embryos may fail to vanquish mutant mitochondria,” and stem cell scientist Paul Knoepfler declaring, “The data in it also in my view strongly make the case for now there should be no human clinical efforts using 3-person IVF for the foreseeable future.” Knoepfler also contributed a helpful headline to the coverage today: New Herbert lab Nature paper reinforces mitochondrial replacement Achilles heel.

As in 2010 when Turnbull and Herbert first published research using PNT in nonviable embryos, the conclusions from these recent data is still "we're working on it" not "this is safe." Such data support previous warnings from scientists, and the fact that we are still unsure about the extent of the role of mitochondria in the overall functioning of our bodies.

So, what’s the moral of the story? Perhaps that humility is the best path forward if we are ever to seriously contemplate bringing new lives into the world this way. And maybe also that policymakers should not be so easily won over by over-zealous promises of science not yet confirmed.

Previously on Biopolitical Times:

Composite image via Wellcome Trust

Unheard Publics in the Human Genome Editing Policy Debate

Posted by Elliot Hosman on June 8th, 2016

Untitled Document

Though the CRISPR-Cas9 genome editing platform is only some four years old, universities and industry are racing forward with a range of research projects, including in human embryos. Given the speed of uptake, and the recent approval of non-clinical experiments with embryos in a number of countries, many are wary of this kind of CRISPR research because it could so easily pave the path to high-tech fertility clinics vending eugenic upgrades.

A vast diversity of publics, communities, and stakeholders are deeply concerned about this prospect of heritable human genetic modification. Yet, a recent comment in JAMA Forum by Eli Adashi seeks to funnel this textured landscape of opinion into a tale of two cities in an international biomedical arms race in which the American research establishment is falling behind.

Adashi frames this battle royale as "Divergent US vs UK Human Embryo Research Policies" in light of the HFEA's decision to license Kathy Niakan's CRISPR research with viable human embryos. (Her research program has yet to begin. It recently received a second round of ethical approval to use surplus embryos from IVF clinics, but those may take months to secure.)

On one side, Dr. Adashi places a mostly British cohort of pioneers, including two groups of research charities and stem cell researchers that have separately gone on record advocating for clinical research into genetically modifying embryos for human reproduction, once certain thresholds are met. He writes:

Many UK scientists quoted in the lay and professional media welcomed the HFEA decision. Professor Sir Robert Lechler, MB, ChB, PhD, President of the UK Academy of Medical Sciences, offered that “studies such as [that proposed by Dr Niakan], that focus on asking basic questions about human-embryo development, are needed to help answer the many scientific and ethical questions remaining in this field.” Similar sentiments were echoed by other UK-based groups, including the Hinxton Group, an international consortium on stem cells, ethics, and law, the Wellcome Trust, an independent global charitable foundation dedicated to improving health, and the Medical Research Council, a leading funder of medical research. Some prominent US scientists also spoke approvingly of such work going forward.

On the other side, he places two lone voices termed “bioethics groups,” CGS included, whose concerns are vaguely glossed:

In contrast, some bioethics groups on both sides of the Atlantic criticized the HFEA’s action. Marcy Darnovsky, PhD, executive director of the Center for Genetics and Society, in Berkeley, California, warned that genome editing poses “dire safety and societal risks.” Calum MacKellar, PhD, of the Scottish Council on Human Bioethics, in Edinburgh, said that “allowing the gene editing of embryos opens the road to genetically modifying all the descendants of a person as well as full blown eugenics which was condemned by all civilised societies after the Second World War.”

A good number of bioethicists have spoken up in the human gene editing debate to voice concerns around informed consent of future generations, the sharing of risks and benefits, and the distributional justice problem of inequitable access to genetically enhanced reproduction. CGS' concerns with heritable genetic modification include those and others: they extend far beyond problems inherent to the individual doctor-patient relationship. As a public interest organization advocating for human biotechnology to serve the common good, we are deeply concerned about the social justice implications of moving forward with the human re-engineering project of germline gene editing under the mislabeled auspices of medicine and science.

What's on the international policy table is the potential creation of genetically modified humans. The substantive issues at hand strike at deeply held values across nations and cultures, including commitments to social justice, human rights, and the public interest. Yet many aspects of the futures that CRISPR would enable, and of the context of unprecedented health and wealth inequalities in which it would be deployed, are not being discussed democratically.

Who is most vulnerable of being “edited out” of future generations, and why aren’t their voices at the policy table? Groups and voices dangerously under-represented or missing in these conversations include those under consideration for editing: disability rights and justice, racial justice, reproductive rights and justice, public health, global health, environmental justice, religion and spirituality, LGBTQI rights and justice, and indigenous rights and justice. How would the unquantifiable lives and interests that these voices represent be affected by the fantasies and projects of a technology-enabled-and-optimistic few?

Recent public opinion studies show that a majority supports the development of accessible gene therapies for consenting patients. By contrast, the polled public is overwhelmingly opposed to genetically modifying human embryos for reproduction.

The history of eugenics and its goal to competitively optimize human reproduction is a century-old, and deeply fraught, enterprise. Without a federal law banning human germline modification, the United States is vulnerable to private interests moving forward uninhibited. This could usher in a new form of high-tech eugenics that would exacerbate existing inequalities, and create new forms of discrimination. We cannot proceed with germline interventions for human reproduction without imperiling the existence of a just and sustainable world for future generations.

Previously on Biopolitical Times:

Image via Free Stock

On Cyborgs and Gene Editing: Lessons from Orphan Black

Posted by Jessica Cussins on June 1st, 2016

Untitled Document

The latest season of Orphan Black takes a cue from Donna Haraway’s “A Cyborg Manifesto” to probe the boundaries of identity, humanity, and perfection, as it reminds us that mainstream genetic and reproductive technologies are closer to the show’s more radical technologies than we might think.

In “A Cyborg Manifesto,” originally published in 1985, Donna Haraway describes a cyborg as “a cybernetic organism, a hybrid of machine and organism, a creature of social reality as well as a creature of fiction.”

The clones of the BBC America television show Orphan Black seem to fit that definition well – they all possess snippets of synthetic DNA entwined in their genome, and often exist in an at least partially fictitious reality designed to better control their actions. However, the latest season explores the possibilities and meanings of cyborg-ness in greater depth. Fittingly, each episode is named with a quote from Haraway’s work: “The Collapse of Nature,” “Transgressive Border Crossing,” “The Stigmata of Progress,” “From Instinct to Rational Control,” “Human Raw Material,” and “The Scandal of Altruism.” And as Orphan Black engages with what it means to be a cyborg, this fourth season also situates itself in the ongoing conversation on new human genetic and reproductive technologies in the real world, including genome editing.


Neolution is the name of the show’s pro-eugenic movement, whose goal is to take control of human evolution. In the first episode of the season, a character reads from the book on Neolution: “The individual can only begin the journey to the extraordinary by casting off the genetically mandated human shell.” Sarah retorts that Cosima calls this stuff “sound bite science.”

The season reveals one of Neolution’s experimental genetic technologies: a synthetic worm-like organism implanted into people’s cheeks to act as an ongoing gene therapy delivery system. We find out that Sarah has had one implanted against her will and knowledge. But just as some transhumanists in real life choose to implant a range of devices in their bodies for numerous reasons, some Neolutionists in the show have opted for the “cheek worm” in order to produce a desired alteration to their body.

Whereas previous episodes have established a clear distinction between the clones as non-consenting research subjects and the Neolutionists as willing bio-hackers, the line between coercion and choice over one’s bodily autonomy is increasingly blurred in this season. In a particularly memorable moment, Cosima holds the decaying head of former Neolution leader Dr. Aldous Leaky to investigate his still-thriving “cheek worm” and asks, “Who’s the science now, bitch?”

In another heart-chilling scene, one of the clones agrees to withhold potential treatment from a child diagnosed with a genetic disorder who was made from her own cells, declaring the data learned from the disease’s progression to be more valuable for humanity than saving the child.

A more broadly relevant way in which the distinction between coercion and choice is tested comes in the form of a cutting-edge fertility program called BrightBorn. By this point of the show we know that Neolution’s leaders have extensive influence over the cloning programs; now we learn that cloning is only one mechanism of reproductive control in which they are interested. An acquaintance of suburbanite Alison has finally gotten pregnant thanks to BrightBorn Technologies, without having any idea that there may be a link between the company and more nefarious ends. Although BrightBorn keeps itself out of the public eye and does not publish its scientific findings, it is notably available to anyone willing to pay. BrightBorn is run by Neolutionists, but is marketed to all. In language reminiscent of the fertility clinic scene in GATTACA, the BrightBorn ad declares:

We can provide you with a healthy and thriving newborn, but why stop there? All of our children are born stronger and healthier. At BrightBorn Technologies we’re making the world a better place, one baby at a time.

Cosima points out:

Mainstream reproductive technology: it’s like a whole new side to Neolution.”

After sneaking into Brightborn’s facilities, Cosima not only finds a variety of experimental technologies ranging from embryo screening and selection to illegal germline modification techniques, but also what seem to be well-paid surrogate mothers under continuous surveillance while carrying the trial embryos. It is apparent that not all of the experiments go as planned, as Cosima witnesses the birth of a severely deformed baby in the limited time she is there. Afterwards, Cosima (italics) discusses what she saw with none other than the woman who created her:

“These are human beings that you’re tinkering with. Trial and error without consent.”

“These carriers are very well compensated.”

“And does that justify the baby that I saw? Look at me, I’m sick. I never gave permission for any of this.”

“No one gives permission to be born. I created you as a beautiful baseline to unlock the mysteries of the human genome.”

In a later conversation with the leader of BrightBorn who is competing for control of Neolution, Cosima learns that some people find cloning to be a crude mechanism for evolutionary control compared to gene editing:

“We don’t need your baseline. We can fix people now.”

“You can’t perfect the human genome. You can’t know what perfect is.”

“I do know. I was born sick.”

“I’m sick too. That doesn’t justify this.”

Season Four of Orphan Black also introduces the role of commercial genetic ancestry testing companies within the overarching project of understanding genetic identity, as Felix finds a “real [genetically related] sister” using an online DNA service. This poses a strange juxtaposition with the non-traditional clone “sestras,” as well as with Sarah, who was raised by a foster parent with Felix and who resents the implication that she is somehow less related than this “real sister” whom Felix has only just met.

Orphan Black has always been good at pushing the boundaries of what family and sexuality look like. The show has also made a move that destabilizes binary biological sex. Given Haraway’s claim that “the cyborg is a creature in a post-gender world,” it is fitting that we learn that the original DNA for both the female and male lines of clones came from a single chimeric woman.

Interestingly, even as everyone is enormously concerned with the well-being of “the original” in order to access her valuable DNA, she keeps secret the fact that she has leukemia. Perhaps she sees this as a way of reclaiming her death for her own, a kind of bodily autonomy she has been denied in her life.  Sadly, she is murdered in episode six, and so she is unable to have even that. But her desire to go untreated for her cancer is an interesting reminder that we often make different decisions when it comes to our own body than when it comes to the bodies of others.

This latest season of Orphan Black encourages us to question whether the kinds of technologies and ideologies presented in the show are less radical than they seem, and are in fact already with us in more innocuous forms today. Now that we have effectively donned smartphones as additional appendages and live in a world mediated by algorithms, to what degree are we all already cyborgs? And with the increasing normalization of assisted reproductive technologies to select and possibly even modify embryos, how far are we really from Neolutionism?

The quest towards perfection is a powerful narrative – in the show as in real life. But as the characters in Orphan Black prove repeatedly, biology and identity are marvelously complex and never compliant with even a single notion of perfection. And thank goodness for that. The show would be a lot less compelling if the clones really were all the same. 

Previously on Biopolitical Times:

See also:

Image via BBC

Forgotten Stories of the Eugenic Age #5: Creating Super-People

Posted by Natalie Oveyssi on May 23rd, 2016

The Birth of Venus by Sandro Botticelli, 1480s

Untitled Document

[Forgotten Stories of the Eugenic Age is a blog series exploring the lesser-known ways that eugenics affected and engaged American lives during the first half of the twentieth century.]

"Can science produce a superman?" science writer Waldemar Kaempffert wondered in the New York Times in 1928. "What kind of a superman do we want? And who shall dictate his specifications?"

In the early twentieth century, new genetic discoveries prompted supporters of eugenics to ponder the potential creation and characteristics of a superior human race. Many believed that encouraging the eugenically “fit” to mate and isolating or sterilizing the eugenically “unfit” would yield over time a superior population. They argued that breeding a better race represented the next step in human evolution. After all, careful husbandry had improved crops and livestock. Surely the production of "human thoroughbreds" could not be much different.

"Scientific" Creation
With new scientific knowledge and technologies, eugenists believed that they at last had the tools to create improved people. They were particularly interested in developing technologies for assisted reproduction, including the human application of animal husbandry techniques like artificial insemination. Dr. Julian Huxley, grandson of champion of the theory of evolution T. H. Huxley, predicted that such techniques would allow eugenically fit men and women to marry whomever they chose, but—regardless of their partners' fertility—have children with third parties who had been specially selected for their genetic qualities. (Those who might object to this cold calculation were merely exhibiting "outworn sentimentalism," said Huxley.)

Exhibiting similar thinking, Dr. George L. Streeter and Dr. Charles Davenport released a bulletin through the Carnegie Institute of Washington in 1933 discussing the eugenic implications of the quality of gametes. They wrote, "Every poultryman knows that in a setting of eggs not every egg will hatch a perfect chicken. Some eggs do not hatch at all; others produce defectives that soon succumb; from still others come chicks of inferior quality." Both in pigs and in people, as many as 25% of ova are "not good enough to hatch." According to the authors, the identification of gametes that would produce not only viable embryos but superior people could only be a worthwhile endeavor.

To detect superior gametes, scientists would need to examine genes more closely. Kaempffert wrote that marriage and childbearing between eugenically fit people was insufficient to breed a superhuman race. Successful eugenics would require a more "scientific" mode of thinking: Scientists needed to determine how to manipulate the genes that would be passed on to successive generations. "Unless we can control the interaction of the genes it is practically impossible to produce a race of supermen," Kaempffert wrote.

British scientist J. B. S. Haldane stated that with more knowledge about human genes, we could examine a newborn baby and say, for example:

He has got iso-agglutinin B and tyrosinase inhibitor J from his father, so it's twenty to one that he will get the main gene that determined his father's mathematical powers; but he's got Q4 from his mother . . . so it looks as if her father's inability to keep away from alcohol would crop up in him again; you must look out for that.

If we can understand the correspondence between genes and discrete characteristics, eugenists argued, we can largely determine the life trajectory of each human being. With such knowledge, we can facilitate the birth of the best individuals and eventually mold the human race into a finer shape.

Eugenic Health Certificates and Registries
Accordingly, selecting healthy eugenic partners for better raw materials became paramount for building super-people. In order to help fit members of the public find eugenic mates, many eugenists supported physician-issued eugenic health certificates and a eugenics registry office.

Continuing the comparison with livestock, Dr. J. H. Kellogg argued that since pedigree registries existed for horses, cattle, cats, and dogs, why not for people? "If a lady wishes to establish the standing of her pet poodle," he said, "she can do so by appealing to an official record and the puny canine may lift its head above its fellows as a born aristocrat, but nowhere on earth, as far as I know, is there to be found a registry of human thoroughbreds.” In an address before the second National Conference on Race Betterment in 1915, Kellogg argued that the world needed a "real aristocracy made up of Apollos and Venuses and their fortunate progeny." Without a eugenic registry, how could laypeople judge superiority and inferiority? How would we identify the human aristocracy?

The development of the eugenic aristocracy relied on classification schemes. One commenter, a Mr. Field of New Zealand, suggested the grouping of individuals into "three or four grades" based on their family health history. Field mused:

The “a” or top grade certificate given to a thoroughly sound and well developed person would be something worth having; a “b” would be tolerable; a “c” would conjure up visions of doctor's bills and physic for a family of future weaklings; and a “d”—well a “d” would be a pity.

Similarly, W. M. Hays, the Assistant Secretary of Agriculture, in an address before the American Breeders' Association, proposed a numerical classification of all people in the world. These numbers would "join genealogies into one numerical system, so that all relationships would be traced." Each person would be given a number that could be averaged with those of his or her family members to determine the family's quality. Hays acknowledged that this system would "somewhat divide people into classes," but stressed that "the classification would be beneficent, because it would be based on racial efficiency." Eugenists contended that a hierarchy based on "racial efficiency" would certainly possess greater validity than our current materialistic model. The Very Rev. William R. Inge predicted in 1931 that by the year 3000, individuals classified as "A-1" via mandatory mental and physical health examinations "will be as much sought after [for marriage] as wealth and titles are now."

Privacy of Genetic Information
Eugenists sought to assuage concerns about the exposure of personal genetic information, but their assurances may not have satisfied. Mr. Field promised readers that under his proposal, a eugenic examination would be "perfectly private and confidential" and "the person receiving it could then do as he or she thought fit with it." Nonetheless, he added that if a prospective bride or groom refused to present her or his certificate to the other party, the latter should be able to break an engagement without fear of a "breach of promise" reprisal in court. Furthermore, a copy of each person's certificate would be interred in government archives. Field proposed that officials could eventually use these records to determine the ancestry of all individuals committed to institutions.

Charles Davenport, the director of Cold Spring Harbor Laboratory and the Eugenics Record Office, argued that eugenics had been unnecessarily hindered by anxieties over revealing unfavorable family secrets. Davenport claimed that this fear was unwarranted because the careful collection of records would both improve the race and benefit the individual. For example, teachers could be given information on the “family and racial characteristics of each of their pupils" so that they could instruct their students differently. Also, state eugenic boards could "scientifically" regulate marriages and childbearing. If couples who were denied permission to have a child did so anyway, "the penalty shall be sterilization of the male." In spite of eugenists’ insistence that genetic privacy would be maintained—or would not be necessary—their proposals made it clear that exposing individuals’ genetic information was essential for achieving their desired goals.

While some supporters of eugenics stressed that the enhancement of the human race required not merely better breeding but also environmental and educational adjustments, others were skeptical. Men such as Leonard Darwin, son of Charles Darwin, and Henry Fairfield Osborn, the president of the International Eugenics Congress, argued that education and environment could not, in the words of the latter, "offset the handicap of ancestry." Plant specialist Luther Burbank added that environmental improvements could "bring individuals up to their best possibilities" but the practice of eugenic selection was "10,000 times more important and effective." Los Angeles Times science writer Ransome Sutton even wrote in 1933:

Education and environment may enable an honest-minded person to overcome inborn tendencies to a limited extent, but at heart no one can ever be much better than the two sets of chromosomes which come together when individual life begins.

Because many eugenists believed that genes dictated human potentiality and that social problems largely resulted from individual moral failings, the solution to social problems lay in improving genes. Reforming society was a palliative, not a cure.

American Exceptionalism
Despite the common conviction that the United States teetered on the precipice of utter mental and moral depravity, eugenists still believed that America was particularly well positioned to breed the great race of super-people.

Prof. Scott Nearing of the University of Pennsylvania's Wharton School, known in his later life as a left-wing economist, educator, writer, and political activist, was among those who believed that America had the "most potent opportunity the world has ever known . . . for the creation of a race of Supermen and Superwomen"—a contention perhaps incompatible with his other views that pajamas should be accepted evening attire, and that all women are leeches who need men's "sufferance and generosity" to survive. A New York Times article summarized Nearing's view that the United States could best produce a stronger race due to its “national resources, the stock of the dominant races, the possibilities of leisure, the emancipation of women, the abandonment of war, the knowledge of race-making and of social adjustment, and the widespread educational machinery." That half of the population consisted of parasites presumably would not hinder this outcome.

Appearance and Characteristics
Eugenists held varying views about the possible physical appearance and characteristics of super-people, as well as the implications of a super-race for society. Nearly all believed that super-people would be healthier, taller, more muscular, and more physically attractive. Some thought that super-people would have lower child mortality and life spans extending as much as 100 years. Many also expected that super-people would possess greater intelligence and social skills. While some eugenists predicted that a number of geniuses and great leaders would emerge from this superior stock, others thought that the race would experience a more general uplifting, with no increase in the rate of human stand-outs. Due to the prevailing belief that social problems originate from poor heredity, eugenists commonly thought that a superior race would produce social and moral improvements like fewer incidents of crime, violence, "violent eroticism," "extreme indolence," and divorce.

Several eugenists described at length the traits of a super-people and the outcome for a super-society. For example, Scott Nearing argued that the six core traits of a superman would be "physical normality, mental capacity, aggressiveness, concentration, sympathy, and vision." Dr. Ales Hrdlicka, curator of the division of physical anthropology at the National Museum in Washington, had perhaps the most precise projection. He believed that super-people would enjoy larger and more organized brains, greater height, longer legs, shorter arms, deeper-set eyes, thinner skulls, more prominent but narrower noses, smaller mouths, larger chins, smaller and fewer teeth, a tendency toward baldness, unaffected beards, thinner bodies, shorter intestines, narrower hands and feet, and diminishing fifth toes. Even so, man would be more handsome. But he would pay for these developments with greater mental disorders and physical impairments, until eugenics once again righted these defects.

Many eugenists maintained that these "improvements" wouldn't impact all races, classes, and genders equally. Unsurprisingly, their visions of the super-future corresponded to and reinforced the prevalent prejudices of the day. Hrdlicka predicted a "widening of the breach between the more civilized and backward people" and between "the front and the back ranks." He said, "There will always be masters and servants, the pioneers of progress and the drags." French scientist and professor Daniel Berthelot contended that as humans became more "advanced," human skin "evolved" into lighter shades. One day, super-people would have skin so white, it would reflect ultraviolet rays.

Naturally, men more than women would power the super-race. According to Prof. L. Bolk, the director of the Department of Anatomy at the University of Amsterdam, the development of the human skull had gradually slowed down, which had allowed the human brain to form over a longer period of time. Since boys mature more slowly than girls, their brains must develop more slowly, so men must be the superior sex. This trend would continue and intensify in the super-race; it would take men a long time to grow up, but they would be a formidable force when they did.

Even though supermen would, of course, eclipse superwomen, male scholars did not withhold their predictions for future women’s physical appearance. Dr. Richard Root Smith attested that “the imperfect or defective type of woman is . . . very slight, thin-chested, and nervous.” In contrast, superwomen would be “compact in build, deep-chested, with steady nerves and fleshy enough for the anatomical angles to be nicely rounded out.” Dr. A. J. Read, a professor of hygiene, told a race-betterment conference audience:

The ideal woman of the eugenic age will be taller than the average woman of today. She will be plump and well rounded, but not fat. Her complexion will be ruddy or brown, not pale, because the pale skin is a badge of disease rather than health.

Perhaps unusually for an Anglican priest, the Very Rev. William R. Inge predicted that clothes for both sexes would become more “scanty” such that “beauty [could] be recognized in the body and limbs as well as in the face.” It appeared that the perfect women of tomorrow would embody the ideal of the imperfect men of today.

Not everyone who supported eugenics in whole or in part believed that the creation of a super-race was possible or even desirable. Despite J. B. S. Haldane’s tendency toward biological determinism, he rejected the possibility of perfect people because he believed that society relied upon human diversity. In a 1932 interview with the New York Times, Haldane stated that in the ideal community, all people would be able to contribute their unique talents and would be afforded the opportunity to develop and thrive as individuals. Instead of altering people to fit an arbitrary notion of perfection, “the community should be fitted to the people of which it is composed rather than the misfits [fitted] to the community.” That certain people are considered “misfits” in our society, he said, does not mean that they wouldn’t be “happy members” if society were different.

Other individuals grappled with the outcome of achieving eugenic perfection. If we could indeed, through the proper breeding of the correct gametes of the right individuals, create nearly god-like people with greater concentration, thinner skulls, fewer teeth, whiter skin, rounder angles, and diminishing fifth toes, what then? What would happen to society after we had managed to—in the words of Scott Nearing—"model the plastic, living clay of humankind into nobler, finer, more spiritual forms"?

Not all observers were sanguine. Humor magazine Life offered this uncharacteristically serious picture in 1914:

The Eugenists dream of a race of Supermen and Superwomen. Let us dream of them, too. Imagine such a race suddenly created in the United States. Thirty millions of Superpeople—each one having the strength of Jack Johnson, the mental efficiency of Edison, the moral greatness of Lincoln. Meanwhile the economic scheme remains unchanged—a small class of Superpeople owns all the land and machinery, while the other Superpeople compete with each other for jobs. What about the Superpeople who don’t get jobs? Supermen in the breadline, Supermen piling into the Bowery Mission to get out of the wind and rain, Superwomen on the streets selling their bodies for bread, Supermen on the street-corners in the Supercold of a winter evening waiting for some Supermillionaire to give them the price of a night’s lodging. It is a pretty scene, and it provokes reflection.

This Life piece captured the fundamental objection to the attempted creation of genetic super-people: that eugenists were seeking answers to social problems inside human bodies instead of through social reforms. Eugenists believed that perfecting the human genetic code would create a healthier, more intelligent, more moral, and more perfect race of man, which would naturally improve the society in which it lived. However, opponents argued that even if we could collectively conceptualize health, intelligence, morality, and perfection and then operationalize these concepts in our genes, our success in this regard would have little bearing on problems that result from the societies we build, not the cells in our bodies. Moreover, encouraging unequal treatment and opportunity on the basis of a hierarchy that we claim is inscribed in human bodies is not a way to produce a more moral and just society. Creating a better world is more complicated than we hope.

During his interview with the New York Times, Haldane turned to passing scientist Dr. F. E. A. Crew of the Institute of Animal Genetics in Edinburgh and asked him, “What is the perfect man?”

Crew replied, “There isn’t any. Define us a heaven and we will tell you what an angel is.”

1. “Americans of the Future to Be the ‘Super Race.’” San Francisco Chronicle, Mar. 31, 1912.
2. “Brain Power Is Stationary.” Los Angeles Times, Jan. 1, 1915.
3. “Calls Thin Woman an Imperfect Type.” New York Times, Jan. 9, 1914.
4. “Case for Eugenics: Results Achieved Through the Use of Artificial Insemination.” New York Times, May 14, 1944.
5. Darwin, Leonard. “Babes of the Future: Major Leonard Darwin Tells True Purposes of Eugenics.” New York Times, Dec. 21, 1912.
6. “Eugenics As Basis of New Aristocracy.” New York Times, Aug. 8, 1915.
7. “Eugenists Dread Tainted Aliens.” New York Times, Sep. 25, 1921.
8. “Eugenics Is Urged to Lengthen Life.” New York Times, May 15, 1937.
9. “Eugenic Women to Be Tall and Dark.” Sacramento Union, Aug. 6, 1915.
10. “Hope of Better Brains for All.” New York Times, Sep. 27, 1912.
11. Hrdlicka, Ales. “Man’s Future in the Light of His Dim Past.” New York Times, Apr. 28, 1929.
12. “Human Race Improvement: Collecting Data for Plan of Practical Eugenics.” Los Angeles Times, May 12, 1912.
13. “Huxley Sees Life Prolonged in Future.” New York Times, Oct. 29, 1926.
14. Inge, Very Rev. William R. “Eugenics Will Aid Physical Beauty and Clothes Will Be More Sensible.” Los Angeles Times, Dec. 4, 1931.
15. Kaempffert, Waldemar. “The Superman: Eugenics Sifted.” New York Times, May 27, 1928.
16.  “Life’s Traits to Aid Eugenics.” Los Angeles Times, Nov. 30, 1914.
17. Laurence, William L. “Huxley Envisages the Eugenic Race.” New York Times, Sep. 6, 1937.
18. Laurence, William L. “Not a ‘Perfect Man’ in Haldane’s Utopia.” New York Times, Aug. 29, 1932.
19. P. H. D., in the Masses. “Eugenics and Economics.” Life, Apr. 2, 1914.
20. “Race of Super-Men.” Los Angeles Times, Feb. 12, 1914.
21. “Says Glands Cause Gloom and Crime.” New York Times, Oct. 2, 1921.
22. “Says Man Will Grow for Ages to Come.” New York Times, Apr. 20, 1929.
23. “Scientists Agree With Dr. Depew That Men Ought to Live to Be 100 By Observing Rules of Health.” Washington Post, Nov. 26, 1916.
24. “Scientists See Eugenics Aid in Doing Away With Crime.” New York Times, Jul. 29, 1923.
25. “Social Problems Have Proven Basis of Heredity.” New York Times, Jan. 12, 1913.
26. “Superman a Being of Nervous Force.” New York Times, Jan. 11, 1914.
27. “Supermen to Be Propagated Artificially, Says Biologist.” Los Angeles Times, Sep. 6, 1937.
28. “The Superrace: A Plea for the Evolution of That Rather Strange Production.” New York Times, Jun. 16, 1912.
29. Sutton, Ransome. “Some Born Great and Others ‘Out of Luck.’” Los Angeles Times, Jun. 25, 1933.
30. “To Breed Fine Race: W. [M]. Hays Would Begin By Classifying All People.” Washington Post, Dec. 30, 1911.
31. “Will Breed Men Like Fine Cattle.” San Francisco Chronicle, Oct. 20, 1912.

Previously on Biopolitical Times:

 Image via Wikimedia Commons

An Even Stranger Presidential Candidate

Posted by Pete Shanks on May 5th, 2016

Poster for the Istvan campaign

Some years ago, in deepest Asia, an American was reportedly kidnapped and hypnotized into doing his captors' bidding any time the Queen of Diamonds was played. Oh, wait, that was the Manchurian Candidate (1, 2, 3). We're talking about the Transhumanist Candidate. Let’s start again.

If you pay attention to the lamestream media, as a former VP candidate called our mighty organs, you may think that the pool of those running for President has or soon will have tightened from 23 (six D’s, don’t forget Lessig, and seventeen R’s) to two. You would be wrong.

In fact, it has shrunk from 1,711 to something like ten. According to Ballotpedia, four Democrats other than Hillary Clinton (or Bernie Sanders) will be on more than 5% of presidential ballots, along with two repeat offenders (Libertarian Gary Johnson and Green Jill Stein) and possibly Jesse “The Body" Ventura. Add in He Trump, and that makes nine. But wait, there’s more!

Zoltan Istvan is running.

The Federal Election Commission, stick-in-the-muds that they are, insist on calling him Zoltan Istvan Gyurko. He calls himself an American-Hungarian but this Magyar site seems to say, according to Google Translate, that he is a Hungarian-born American. That could cause a bit of difficulty, though certain other candidates seem to have evaded or redefined the “native-born” requirement. [ETA: He was born in Los Angeles, after his parents escaped from Hungary.]

Also, the FEC lists his party affiliation as “Other.” But Zoltan is actually running on behalf of the Transhumanist Party. The two other officers are Zoltan’s wife Dr. Lisa Memmel (who is an ob-gyn) and a big fan currently writing a “guide book” to Istvan’s transhumanist philosophy. The advisors include Aubrey de Grey and Gabriel (son of Martine) Rothblatt, as well as one of the Alcor Directors, and other low-wattage luminaries.

The short version of his platform is:

The Transhumanist Party and Zoltan Istvan's US Presidential campaign is politically-centric. It aims to support voters with future-inspired policies that will enrich America and the world. We believe science and technology can solve most of the world's problems.

Among the specifics are:

  • Lay groundwork for rights for other future advanced sapient beings like conscious robots and cyborgs.
  • Create stronger government awareness and policies to protect against existential risk (including artificial intelligence, plagues, asteroids, climate change, and nuclear warfare and disaster) [but not including protection of humans qua humans]
  • Implement policy for the phasing out of all individual taxes based on robots taking most jobs in the next 25 years. Advocate for a flat tax until we reach that point.
  • Develop international consortium to create a "Transhumanist Olympics”
  • Encourage private industry to develop and support usage of a cranial trauma alert chip that notifies emergency crews of extreme trauma (this will significantly reduce domestic violence, crime, and tragedy in America)
  • Work to use science and technology to be able to eliminate all disabilities in humans who have them.

But the big deal is downplayed in the official list, which does however refer to this statement of intent, which explains, right up front, as the first “primary goal” of his political agenda:

1) Attempt to do everything possible to make it so this country’s amazing scientists and technologists have resources to overcome human death and aging within 15–20 years—a goal an increasing number of leading scientists think is reachable.

(Presumably that’s why Aubrey de Grey is on board.)

Zoltan wrote a book a couple of years ago, and he seems to be having quite a lot of fun with this “campaign.” He raised $27, 250 on Indiegogo to create an Immortality Bus. (He accepts no financial contributions, on principle.) That's a "mobile 40-foot coffin" that he drove around the country "to ignite the next great civil rights debate in America and around the world." He did it, too, and even got some press.

He regularly publishes at Huffington Post (they’ll put almost anything up), and published pieces in the San Francisco Chronicle in both 2002 and 2003, in Outside in 2004, and in the Daily Caller in 2010 on the marijuana business. Slightly more substantial is his old work for National Geographic’s various outlets; he really was in deepest Asia.

He’s done a very respectable job boosting his profile among the notoriously small circle of transhumanists, but not without making enemies there. Notably, James Hughes can’t stand him. They had a “salty” debate in April, which was written up in Motherboard, with many lovely quotes, the best of which they kept for last:

Extra Sick Burn:
Hughes on Zoltan’s novel, The Transhumanist Wager: “It’s like Ayn Rand wrote Atlas Shrugged and then ran for office as a Democrat… At least in Atlas Shrugged the rich people buggered off and left everybody alone.”

But what will happen when the aliens turn over the triggering card? Now we know: The whole Presidential run was a feint. He’s really going for the Vice-Presidential slot:

Istvan said in an email Tuesday evening that he recently flew across the country to be interviewed by one of the remaining major party candidates to fill the slot of vice president on a ticket.

Right. There may be room in the White House for a food taster.

Previously on Biopolitical Times:

Public Opposes Human Germline “Enhancement” by Overwhelming Majority

Posted by Pete Shanks on May 5th, 2016

The public is firmly — overwhelmingly — opposed to using gene editing for heritable “enhancement” purposes. Many people, if pressed, will support the concept of heritable “cures” that for the foreseeable future, at least, are not practical and rarely needed, if at all. It is not clear, however, how many of the public (and perhaps the pollsters) have an adequate grasp of the issues involved in heritable human genetic modification (HGM).

CGS has for a decade been collecting polling data going back to 1986: over 50 polls, some of them international, on HGM and/or human cloning are summarized here. Assessing that data, however, has always been tricky.

Polls tend to show that public sentiment about human biotechnologies is strongly ambivalent. Most people value their potential to alleviate suffering, yet are apprehensive about the social consequences of some applications. Public opinion on HGM is particularly difficult to assess because of the ambiguity of some of the questions and the terminology used. Opposition decreases with increased emphasis on cures, and increases with emphasis on non-medical or “enhancement” uses, such as  improving intelligence.

Interpreting the data is now of much more than academic interest. Many scientists and policymakers have begun looking for a “broad societal consensus” to guide decision-making about the limits that should be put in place for human genetic applications.

Prompted by this, Robert Blendon, Mary Gorski and John Benson published a survey article, "The Public and the Gene-Editing Revolution" in the New England Journal of Medicine on April 14th. It analyzes, and links, 17 U.S. polls over the last three decades. (Several of them were not previously in the CGS collection, but they are in line with the several dozen that were.) The article concludes:

Most of the public favors gene therapy for clinical use in patients with serious diseases. The majority do not support gene editing in human embryos or germline cells, but the level of opposition varies depending on its goals. Of course, public opinion could change over time as discussions of these issues continue to evolve and as more is learned about the implications and safety of gene-editing technologies.

It’s possible to draw quite a different conclusion. The opposition to using enhancement technologies in HGM has been quite consistent for decades. Moreover, the “medical” arguments in favor are much weaker than the questions asked by pollsters generally imply. Inevitably, hypothetical questions assume success, which in this case is by no means guaranteed, or even likely. How different might the responses be if those being polled fully understood the risks involved, the slim likelihood of success in the foreseeable future, and the availability of alternatives?

Eric Lander, one of the most distinguished current geneticists, addressed these points in his presentation last December at the National Academies of Science gene editing summit (15-minute video here, strongly recommended), and elsewhere. For instance, he wrote in NEJM last June:

… Some observers might propose reshaping the human gene pool by endowing all children with many naturally occurring “protective” variants. However, genetic variants that decrease risk for some diseases can increase risk for others. (For example, the CCR5 mutations that protect against HIV also elevate the risk for West Nile virus, and multiple genes have variants with opposing effects on risk for type 1 diabetes and Crohn's disease.) … It has been only about a decade since we first read the human genome. We should exercise great caution before we begin to rewrite it.

More bluntly, he told the Washington Post in April that we don’t understand the genome well enough to be confident that the changes we make will be salutary in the long run:

"We’re crummy at it," he said. "We are terrible predictors of the consequences of the changes we make."

The most recent poll included in the NEJM survey was conducted in January 2016 [pdf] by STAT and the Harvard T.H. Chan School of Public Health. Sharon Begley, for STAT, wrote an analysis that opens:

Most Americans oppose using powerful new technology to alter the genes of unborn babies, according to a new poll — even to prevent serious inherited diseases.

They expressed the strongest disapproval for editing genes to create “designer babies” with enhanced intelligence or looks.

The poll showed significant support for gene therapy, skepticism about genetic testing (shared by doctors) and the usual, solid opposition to enhancement:

Do you think that changing the genes of unborn babies to improve their intelligence or physical characteristics should be legal?

Yes: 11%, No: 83%, Don't know: 6%

(A Global Social Media Survey published on May 5th shows somewhat more support [27%] for editing embryos to change "any non-disease characteristic," but the authors recommend great caution in interpreting results that may not be representative.)

Moreover, the STAT survey revealed this remarkable finding:

Do you think the federal government should fund scientific research on changing the genes of unborn babies that aims to improve their characteristics such as intelligence or physical traits such as athletic ability or appearance?

Yes: 14%, No: 82%, Don't know: 4%

These are, or should be, devastating numbers to anyone who thinks that the public supports human heritable genetic modification.

Previously on Biopolitical Times:

Hacking CRISPR: Patents, Gene Therapy & Embryos

Posted by Elliot Hosman on May 5th, 2016

Untitled Document

Bruiseless bananas, vegan cats, pig-to-human transplants, and super-muscular dogs: can you tell the real CRISPR projects from fake ones? It’s getting harder these days, as the latest generation of “gene editing” tools are not only (relatively) quicker, cheaper, and easier than any previous genetic engineering method, but have become “probably the fastest-spreading technology in the history of biology.” As it spreads, researchers the world over are discovering new hacks, complexities, and limitations for CRISPR. Here’s a round-up of recent developments in this booming arena.  

Trending globally: gene editing experiments with human embryos

On April 8, news broke that the second paper documenting CRISPR experiments in human embryos had been published. Researchers at Guangzhou Medical University sought to enhance nonviable embryos leftover from IVF with a naturally occurring mutation that confers HIV resistance: CCR5Δ32.

(Image via Wikimedia: Guangzhou Circle)

The experiments were largely unsuccessful: only 4 of 26 embryos wound up with a copy of the desired mutation, and none had the two copies that would be needed to resist the virus. Mosaicism was also a problem. A year prior in April 2015, the first research using CRISPR in tripronuclear human zygotes was reported by a team at Sun Yat-sen University in the obscure journal Protein & Cell, after Nature and Science turned it down. This second paper was reported in “an obscure reproductive journal” published by the American Society of Reproductive Medicine (the same body that releases non-enforceable guidelines into the void of any regulation over assisted reproductive technologies in the United States).

The research team acknowledged the controversial nature of their work amid ongoing debates:

We advocate preventing any application of genome editing on the human germline until after a rigorous and thorough evaluation and discussion are undertaken by the global research and ethics communities.…Despite the significant scientific and ethical issues involved, however, we believe that it is necessary to keep developing and improving the technologies for precise genetic modifications in humans.

Many found the latest CRISPR human embryos experiment to be ethically problematic in design and implication:

“Introducing CCR5Δ32 and trying repair, even in non-viable embryos, is just playing with human embryos.” – Tetsuya Ishii, bioethicist at Hokkaido University in Sapporo, Japan, Nature News

“The paper does not in my opinion strengthen the case that CRISPR’ing of human embryos with reproductive intent is ever something that could work well enough to be done clinically.” – Paul Knoepfler, associate professor of Cell Biology and Humanity at UC Davis School of Medicine, The Niche

“If you were serious about not wanting to go down this path where wealthy people are having children who have been genetically modified to have capacities that aren’t available to the children of poor parents, then the time to try and stop it is now.” – Robert Sparrow, associate professor at the Monash University Centre for Human Bioethics in Melbourne, South China Morning Post

A number of scientists commenting on the new publication distinguished its clear objective of refining human germline engineering for reproduction from the basic research goals of other ongoing CRISPR embryo experiments, including the HFEA’s February 2016 approval for Kathy Niakan’s embryo development research at the Francis Crick Institute in London. George Daley, stem-cell biologist at Children’s Hospital Boston in Massachusetts, categorized the new CRISPR embryo research as a “proof of principle for what would need to be done to generate an individual with resistance to HIV,” meaning “the science is going forward before there’s been the general consensus after deliberation that such an approach is medically warranted.”

“At least in the scientific community, I sense more support for basic-research applications," argued Fredrik Lanner, assistant professor at the Karolinska Institute near Stockholm, who was approved in June 2015 to use CRISPR in embryos to study early human development. In addition to UK and Sweden, a government bioethics panel in Japan on April 22 approved basic research using CRISPR in embryos, but denounced moving forward with clinical germline research.  

New tools and research for hacking the CRISPR patent war

Even as CRISPR investments, biomaterials, and research licenses proliferate internationally, the ongoing patent fight between prominent American universities has had a major impact on the landscape. Jacob Sherkow, associate professor of law at New York Law School, argues in Nature that “pursuit of profit poisons collaboration” and the “CRISPR-Cas9 patent battle demonstrates how overzealous efforts to commercialize technology can damage science” by pitting schools against one another and “erod[ing] scientific collaboration.”

Shobita Parthasarathy, associate professor of Public Policy and Women's Studies at University of Michigan, puts forth two important lessons. First, she argues that “patent systems no longer fit the realities of how science works, and patents give their owners significant control over the fate and shape of technologies.” She also notes that licensing decisions by CRISPR patent holders may subjugate democratic deliberation over “what kinds of research will take place in embryos … [and] what kinds of human genetic engineering might become commercially available.”

Meanwhile, researchers are publishing tweaks and upgrades to CRISPR-Cas9 on a near-weekly basis, causing observers to wonder if the patent fight will soon become a moot point—a “historical footnote.”

Recent CRISPR breakthroughs, setbacks, and related research include:

Gene Editing à “Base Editing”

On April 20, researchers reported they had engineered CRISPR to perform edits not just to a genetic sequence but to individual letters of DNA, changing “C” to “U” (“U” is usually found in RNA and is read as “T” in DNA).

(Image via Pixabay)

The lead author of the new "base editing" research, Harvard biochemist David Liu, is a co-founder and scientific advisor at Editas Medicine, the first CRISPR company to go public. Excitement surrounding the new hack led many to speak freely about the limitations of CRISPR, including Harvard biologist George Church who observed “what often passes as ‘genome editing’ would more appropriately be called ‘genome vandalism’” because, as STAT’s Sharon Begley writes, the “molecular machete” triggers the “cell’s DNA-repair machinery to make all sorts of unwanted changes.” While this new base editor method is being described as “pinpoint precision” and the “most clever CRISPR gadget” thus far, it’s unclear to many researchers what its usefulness or application will be moving forward.

Attempts to wipe out HIV with the CRISPR gene editor only made it stronger” [Source]

A number of researchers have been excited about the potential of CRISPR to deliver a long-sought cure for HIV—in living patients. Using an older gene editing method known as Zinc Finger Nucleases to snip out the CCR5 gene linked to HIV resistance, Sangamo Biosciences (Richmond, CA) is one of a group of biotech companies investigating HIV somatic gene therapies. On April 7, researchers working with CRISPR published some sobering data which showed that using gene editing to disable the HIV virus backfired, as the virus developed mutations near the sites of cuts which blocked RNA-guided CRISPR from making more cuts needed to disable the virus. A number of researchers still have hope for CRISPR providing a one-and-done fix. Some aim to use CRISPR to “carpet-bomb HIV” at multiple sites at once. Others are skeptical about the practicality of CRISPR-ing HIV, given the virus’ renowned resistance, the number of T cells that need to be successfully modified, and the existence of pre-exposure and post-exposure antiretroviral drugs that are being used to manage the disease with increasing success.


A week later on April 27, researchers laboring under the weight of compelling acronyms reported a new CRISPR method dubbed “CORRECT” (COnsecutive Re-guide or Re-Cas steps to Erase CRISPR/Cas-blocked Targets). Given the messiness of the CRISPR-Cas9 system, the research seeks to enable two new capabilities: stopping Cas9 from cutting again and again, and editing one but not both copies of a target gene. Scientists reacting to the news noted with caution that the CORRECT hack requires inserting three to twenty times the number of molecules into cells as does traditional CRISPR. (Others have previously noted delivery challenges with CRISPR due to the comparatively large size of the Cas9 protein.)


In a new profile, Nature News describes CRISPR co-discoverer Emmanuelle Charpentier as a “quiet revolutionary” who is looking “not to be defined by CRISPR, which is just one of five themes in her lab.” Charpentier’s latest CRISPR research suggests that an associated protein smaller than Cas9 known as “Cp1f1” can cleave RNA in addition to DNA, and “can do the jobs of both tracrRNA and the Cas9 protein.” The CRISPR-Cp1f1 method was first reported by Charpentier’s patent adversary Feng Zhang in September 2015.

Buffer “Superhero” Genes

Headlines recently proclaimed:

The story was that researchers had worked through almost 600,000 human DNA sequences—the majority from 23andMe users—and found 13 profiles whose medical records showed a lack of symptoms despite the fact they carried a genetic mutation linked to one of eight Mendelian diseases. The researchers have no way of contacting the individuals to confirm their “superhero” status, but the study has excited some researchers about the potential gold to be found at the end of the precision medicine rainbow: a deus ex machina buffer gene to fight monogenic disease. As several observers noted, these “lucky 13” could also lead to dashed hopes at the human margins of sequencing errors.

The genetic unicorns study conjures a handful of philosophical questions relevant to the future of gene editing: What are the biological mysteries that determine phenotype beyond genetics? What are the implications of widespread embryo screening for genetic conditions when false positives are rampant and embryo mosaicism is  poorly understood? What unknown unknowns in the realm of genetic mysteries might forestall the precise genetic modification of future human beings? What known social and political realities caution against gene editing future generations regardless of technical safety?

Resisting genetic determinism, embracing scientific modesty & democratic futures

Creative and potentially exciting, recent CRISPR and related research papers speak to the vast ocean of biological uncertainties that face those venturing into the genome with the intention of divining the cut-and-paste malleability of the human condition. On the eve of a major annual meeting on gene therapy in D.C. on May 4-7, Jocelyn Kaiser writing for Science culled a long list of additional obstacles for researchers to overcome in an article titled “The gene editor CRISPR won’t fully fix sick people anytime soon. Here’s why.”

What harm can a bit of enthusiasm do? For starters, unchecked techno-optimism frustrates the scientific enterprise. It also thwarts the funding of basic public health measures whose impact would be felt more broadly, beyond the upper echelons of biomedical access.

Several recent articles have explored these and related concerns. Columbia law professor Patricia Williams cautions against “a rat race to the patent office, a lunge to own all parts of the genome… A race against time. A race to market. A race to better babies.” As piecemeal gene editing innovations move forward, their value may be difficult to discern over the blaring refrains of the industry hype machine.

Jonathan Latham recently pointed to the “gospel of precision” floating the sails of the CRISPR moonshot and argued for historically minded caution:

The hubris is alarming; but the more subtle element of the propaganda campaign is the biggest and most dangerous improbability of them all: that CRISPR and related technologies are “genome editing”…That is, they are capable of creating precise, accurate and specific alterations to DNA …

Why is this discussion of precision important? Because for the last seventy years all chemical and biological technologies, from genetic engineering to pesticides, have been built on a myth of precision and specificity. They have all been adopted under the pretense that they would function without side effects or unexpected complications. Yet the extraordinary disasters and repercussions of DDT, leaded paint, agent orange, atrazine, C8, asbestos, chlordane, PCBs, and so on, when all is said and done, have been stories of the steady unraveling of a founding myth of precision and specificity.…

[W]e are once again being preached the gospel of precision. But no matter how you look at it, precision is a fable and should be treated as such.

As with many “disruptive” technologies in biotechnology, CRISPR pipedreams are rapidly assembled, dismantled, reassembled; moonshots are breathlessly announced, then fail to rise, then quietly recalibrate.  A world cleansed of genetic disease is repeatedly cast as the carrot to be dangled before an American public starved for more basic health investments. Will the CRISPR revolution bring vegan cats? Who decides what the future of (synthetic) biology looks like?

Previously on Biopolitical Times:

Image via Pixabay

10th Anniversary Baby Markets Congress

Posted by Elliot Hosman on April 7th, 2016

Baby Markets: Money and the New Politics of Creating Families (Cambridge University Press 2010, 1st ed., ed. Michele Goodwin)

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“We can only assess the justice of baby markets by stripping away the veneer of ‘freedom,’” said Dorothy Roberts at the Baby Markets International Congress, which met April 1-3 in Southern California. The meeting celebrated the 10th anniversary of the Baby Markets Roundtables series founded by Michele Goodwin, Chancellor’s Professor at UC Irvine Law School, author of Baby Markets (2010), and founder of the Center for Biotechnology and Global Health Policy.

For three days, panelists and participants engaged with assisted reproductive technologies (ARTs), reproductive justice, contractual parentage and procreation relationships, genetic testing and selection of embryos, gestational and transnational surrogacy, in vitro fertilization, abortion laws, constitutional rights to procreation and assisted reproduction, LGBT access to adoption and ARTs, selective reduction, and fertility professional negligence.

@DorothyERoberts "baby markets aren't free" keynote address at #BabyMarkets2016 @UCILaw @UCIrvine @Penn

The keynote address by Dorothy Roberts, professor of law and sociology at the University of Pennsylvania and CGS advisory board member, painted a rich picture of the complex systems of oppression that backdrop free trade reproduction. Roberts highlighted the wide-ranging reproductive injustices of abortion bans, neoliberal public healthcare disinvestment in the United States, dependency courts and disruptions of families of color, and centuries of ongoing racism that make it impossible for baby markets to be “liberating” for women of color.

Roberts also reflected on the “new eugenics” that pressures parents to make “the right genetic decisions,” leading to the widespread use of pre-implantation genetic diagnosis to select against disability, and the support of a few enthusiasts to attempt next-generation genetic engineering with CRISPR-Cas9 to “edit” the traits of future children. Roberts concluded that debates on the ethics of commercial assisted reproduction must center the people hurt most by market logics: people of color, disabled persons, transgender and intersex persons, and people acting as surrogates. “We can’t solve social problems with better technology,” she said. 

Marcy Darnovsky
, executive director of CGS, and Radhika Rao, professor of law at UC Hastings, separately introduced emerging technologies in reproduction that heighten a number of ongoing concerns about eugenics, informed consent, and elite access to what Roberts earlier referred as a “reproductive caste system” of “built” children. These new technologies include egg freezing, uterine transplants, gametogenesis (stem cell-derived artificial gametes), and CRISPR-Cas9 germline gene editing.

The ART Working Group’s Reproductive Justice panel

The ART Working Group, a collaborative effort between CGS and the Pro-Choice Alliance for Responsible Research (PCARR) that grew out of The Tarrytown Meetings, organized a panel introduced by CGS consultant Emily Galpern that focused on reproductive justice insights into assisted reproduction. UC Davis Professor of Law and CGS fellow Lisa Ikemoto discussed her research on egg providers and the “repro-stratification” of eggs based primarily on race. She noted that “currently we use ARTs to reproduce the nuclear family,” instead of collaborative reproduction marked by reciprocity and kinship.

PCARR co-founder Susan Berke Fogel gave an overview of reproductive justice, focusing on the centrality of women of color in the movement, and the shift away from the reproductive rights conversation about “choice” and privacy toward a holistic understanding of “justice” that looks at oppression and intersectionality, and that doesn’t privilege reproductive rights over other rights. 

Daisy Deomampo
, assistant professor of anthropology at Fordham University, presented research looking at surrogacy and the treatment of intended parents and gestational surrogates in India as a site of racialization that isn’t just “reflective” of oppressive racial hierarchies in the world, but which produces race. She noted that reproductive justice seeks to change structural inequalities, instead of liberating individuals from experiencing them.

Regina Tamés Noriega
from the Grupo de Información en Reproducción Elegida (GIRE) in Mexico discussed the recent expansion of transnational surrogacy in Tabasco and Cancún. She described policymakers’ sudden focus on regulating surrogacy despite their lack of interest in regulating other forms of assisted reproduction, potentially because it represents a way to control women’s bodies.

Reproductive Justice Film Festival

The 10th Baby Markets Congress also included a Reproductive Justice Film Festival. Three documentary films were screened during the weekend: 

Misconception (forthcoming), dir. Civia Tamarkin, showcases the “collateral damage” and “friendly fire” of the abortion wars, and the political indoctrination of youth into the anti-abortion movement.

Young Lakota (2012), dirs. Rose Rosenblatt and Marion Lipschutz, follows three youth living on the Pine Ridge reservation of the Oglala Sioux tribe who experience political awakenings around the issue of abortion.

Beautiful Sin (2014), dir. Gabriela Quirós, documents the political battle around embryo personhood and assisted reproduction in Costa Rica. A ban on IVF that passed in 2000  was finally lifted by a presidential decree ruled valid by the Inter-American Court on Human Rights in February 2016.

Thank you!

We learned so much from the fascinating papers, discussions, and research presented by the scholars, policy-makers, civil society advocates, journalists, and activists in attendance. Thanks to Michele Goodwin and all the participants!

About the Baby Markets Organizer and Sponsors

Michele Bratcher Goodwin
’s research engages law’s interaction with the body across multiple spheres, encompassing organ transplantation, reproduction, tissue harvesting, sex and marriage trafficking, and international surrogacy, among other topics. Goodwin recently edited The Global Body Market: Altruism’s Limits, published in 2013.

The International Congress was supported by generous contributions from the University of California, Irvine Medical Humanities Initiative, School of Law, and donors: Greg Rose and Pat Wilson, and co-sponsorsCenter on Globalization, Law, and Society (GLAS)Department of Criminology, Law and SocietyDepartment of Gender and Sexuality StudiesProgram in Public HealthReproductive Justice Initiative; and School of Social Ecology.

Previously on Biopolitical Times:

Canadian Eugenics Survivor and Activist Leilani Muir Dies at Age 71

Posted by Natalie Oveyssi on April 7th, 2016

Leilani (O'Malley) Muir, a survivor of the Sexual Sterilization Act of Alberta, Canada, passed away on the weekend of March 12 at the age of 71.

Following an abusive childhood, Muir’s mother committed her to Alberta's Provincial Training School for Mental Defectives at the age of eleven, falsely claiming that she had cognitive disabilities. The Sexual Sterilization Act of Alberta allowed the province to sterilize any ward of a mental health institution whom its Eugenics Board considered "mentally defective" and at risk of transmitting “defective genes” to future children.

Under this act, nearly 3,000 residents of Alberta were sterilized between 1928 and 1972, when the law was finally repealed.

When she was fourteen years old, Muir was brought before the Provincial Eugenics Board and briefly questioned. After this session, the board recommended sterilization, citing as the reason "Danger of the transmission to the progeny of Mental Deficiency or Disability, also incapable of Intelligent parenthood."

Told doctors would be removing her appendix, Muir was sterilized without her knowledge. She only learned what had happened to her many years later when she and her husband were unable to conceive a child.

She grew determined to achieve justice for herself and others impacted by forced sterilization. In 1996, Leilani Muir became the first individual to sue the Alberta government for wrongful sterilization. She won her case, Muir v. The Queen in Right of Alberta, in a judgment that stated:

The circumstances of Ms. Muir's sterilization were so high-handed and so contemptuous of the statutory authority to effect sterilization, and were taken in an atmosphere that so little respected Ms. Muir's human dignity that the community's, and the court's, sense of decency is offended.
Muir's case served as a precedent for many more lawsuits against the Alberta government on behalf of hundreds of survivors of eugenic sterilization. All told, the government paid more than $80 million to over 800 survivors.

In the years following the court decision, Muir became an advocate for other sterilization survivors and for the rights of people with disabilities. She continued her quest to educate the public about the history of eugenics in Canada. Muir wrote a book about her life called A Whisper Past, gave talks around the country, appeared in several documentaries and television programs, and even ran for a seat on the Alberta legislature in 2000 as a New Democratic Party candidate. Muir was recently featured in the 2015 documentary Surviving Eugenics which documents the survivor narratives of Alberta’s provincial schools.

Muir said of her experiences:
When I was born, God made me a whole person. When they sterilized me, they made me half a person. You never get over that hurt. . . . I don't want this to ever happen again to other children. My philosophy is that history repeats, but as long as I keep talking about it, it will not happen again.

Leilani Muir will be remembered for her courage to speak out, her strength to fight, and her determination to seek a more just world.

More information:

1. About Leilani, Leilani Muir: My Story Will Inspire You.

2. Dambrofsky, Gwen. Alberta woman who successfully sued province for wrongful sterilization dies, Global News, March 16, 2016.

3. Eugenics, Canada's Human Rights History.

4. Muir, Leilani. A Whisper Past: Childless After Eugenic Sterilization in Alberta. Victoria, BC, Canada: Friesen Press, 2014.

5. Muir v. The Queen in Right of Alberta. 132 D.L.R (4th) 695. Court File No. 8903 20759 Edmonton. Alberta Court of Queen's Bench. Veit, J. January 25, 1996.

Previously on Biopolitical Times:

Will California Expand the Market for Women’s Eggs?

Posted by Marcy Darnovsky on April 7th, 2016

Currently, California – like many countries – allows women who provide eggs for research to be reimbursed for travel, lost wages, child care, and other expenses connected to the egg retrieval process, but not to be paid beyond that.

A bill sponsored by the American Society for Reproductive Medicine, the fertility industry organization, would overturn that policy, and allow researchers to pay thousands of dollars beyond reimbursement for women’s eggs.

Despite opposition from women’s health and public interest organizations, including the Center for Genetics and Society, AB 2531 sailed through the state’s Assembly Health Committee on April 5 with a 17-0 vote. It now goes to the Assembly floor, and after than to the state Senate.

What’s wrong with expanding the market for women’s eggs? After all, women are allowed to sell their eggs for other people’s fertility treatments. Here are key reasons it’s important to hold the line:

  • The health risks of egg harvesting are significant, but they’re woefully under-studied. A well-known and fairly common short-term problem is ovarian hyper-stimulation syndrome (OHSS), but no one is sure how many women get the serious – sometimes life-threatening – version of it. Data on long-term outcomes, including follow-up studies on reports of cancers and infertility in egg providers, are notoriously inadequate.
  • It is impossible for women to give truly informed consent if adequate health and safety information can’t be provided.
  • Offering large sums of money encourages women in need to gamble with their health. It’s what bioethicists call "undue inducement."
  • Women who provide eggs are not research subjects, despite the inaccuracy in AB 2531. In clinical studies, researchers follow the health outcomes of participants. In egg retrieval procedures, researchers are interested in acquiring eggs for raw material for their studies, not in effects on women who provide them.
AB 2531 would overturn an existing California law, authored in 2006 by then-state Senator Deborah Ortiz, a well-known champion of women’s health and medical research. It would also conflict with guidelines from the National Academy of Sciences, and with the rules of the California stem cell agency. All these policies state that women who undergo egg retrieval for research can be compensated for their expenses, but not paid beyond that.

This isn’t the first time the fertility industry has sponsored legislation to expand the market for eggs. An almost identical bill was vetoed by Governor Brown in 2013. His veto message said in part,
"Not everything in life is for sale, nor should it be....The long-term risks are not adequately known. Putting thousands of dollars on the table only compounds the problem."
Letters of opposition to AB 2531 were sent by these organizations and individuals:
Previously on Biopolitical Times:

Ma Na Sapna – A Mother’s Dream

Posted by Gabriele Werner-Felmayer & Carmel Shalev, Biopolitical Times guest contributors on March 23rd, 2016

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Valerie Gudenus was inspired to make her award-winning film on surrogacy in India, Ma Na Sapna – A Mother’s Dream(2013), by American sociologist Arlie Russell Hochschild’s work on the outsourcing of emotional services (The Outsourced Self: What Happens When We Pay Others to Live Our Lives for Us, 2012). As Gudenus says in an interview, she wanted to make a film about “how different worlds and different areas are connected through certain dependencies.” Following one month of research in India on her own, she and her team went there to shoot the film in the world’s largest surrogacy clinic: the Akanksha clinic, in Anand, Gujarat run by Dr. Nayna Patel. Indeed, the film shows surrogacy as an “amazing example of worlds being connected in a very interesting way” (Gudenus).

The clinic had already taken center stage in Zippi Brand Frank’s documentary Google Baby (2009), and it was key to sociologist Amrita Pande’s in-depth ethnographic work Wombs in Labor (2014) on transnational commercial surrogacy in India. Despite this existing coverage, Gudenus brings a new and sensitive view of the surrogate mothers who are otherwise largely invisible – whether in the public perception or to the customers from abroad whose babies they carry – and allows them to speak for themselves.

Over a period of three months, Gudenus and her team spent every day with the women either at the Akanksha clinic or in the home for surrogates which it runs in a secluded by-road. The film opens with Madhu, a surrogacy "scout" who recruits women to become surrogates. Heena donated eggs four times to pay grocery bills, and she wants to buy a small hut for her daughter.  She is one of six women the film follows. They live in the home with 70 others, many divorced or widowed, in close quarters that at one dramatic moment brings about a verbally violent fight.

Sometimes Dr. Patel (pictured above, far left) comes to visit. The distance between her and the women is tangible. She is the professional doctor, a powerful business woman who reigns benevolently over her domain and insists the surrogates learn to sign their names before they leave. The women call her "our mother goddess" and bow in reverence and gratitude to touch her feet. They are in service, living in confinement far from their own children, lying on their backs most of the time, subject to strict quality control with regimens of nutrition and invasive medical procedures, including hormonal injections throughout the pregnancy and 100% rates of cesarean delivery.

At some moments, it becomes evident that not everything is as the women expected. Bikhi (pictured below), for example, is carrying a triplet pregnancy. Three months into the pregnancy she is shocked and heartbroken to learn that the doctors want her to undergo embryo reduction. If she had known about the reductions, she says, she would not have come here. “That a child will be killed in my own womb is really shocking.” To her relief, ultrasound shows that two of the fetuses are conjoined twins already dead.[1]

Gudenus and cinematographer Gabriela Betschart created a gentle and respectful intimacy with the women whose stories they follow, without being intrusive. The film captures the atmosphere of a woman’s cosmos that seems quasi-intrauterine yet situated within a technologized environment of breeding. The sound track brings in the noises of machines beeping in the neonatal intensive care unit, and the clacking of plastic breast milk pumps in the wards where the women recover after giving birth.

Papiha (pictured below) is a central character. We see her first at an ultrasound test toward the end of her pregnancy. The camera focuses on her rather than on the screen. She is carrying twins and is told that they both weigh more than 2 kilograms. Her face shows she is proud and happy. Later she gives birth to twins, half drugged with partial anesthesia. Someone asks her: "What will you do with the money?" She answers, "I'll buy a house." Then she is left alone in the delivery room, sprawled on the surgical bed like a bundle of rags. "Her" couple will arrive only 3 weeks later, with the reason for the delay  unclear. Perhaps they are advised to wait, to make sure the babies survive and are healthy. Perhaps they were busy with their lives.

After five days she is pumping milk, which her husband takes to the infants. He wants a rickshaw, and that's what they get. Madhu says there are no houses available for the money the women earn, not any more, even in a slum.

After ten days, Papiha goes to have a look at the babies and hold them for the first time. One of them stops crying when she picks her up. A few days later she is taking care of them in her room, and she names them. When it appears they are not gaining weight she starts breastfeeding. But she says, "it's better not to think I'm their mother" because it would make her sad. When Papiha's couple finally arrive, the situation is awkward. They seem not to know what to say or how to thank her. She changes their nappies for the last time, obviously in inner conflict. The intended mother (pictured below, right) tells her "don't cry, come on, smile, visit us tomorrow at the hotel" but it is obvious that this is good bye.

Parul also stays for three weeks to give milk and is not happy when she departs. She says she gained money but lost the respect of her neighbors and friends. Her son stopped talking to her. The job is "bad:" it's seen as selling children even though it's legal with stamped papers.

“How can you make a film about somebody else’s feelings?” asks Valerie Gudenus in the interview. Well, you obviously can, if you are able to look and listen as carefully and sensitively to the stories of others as she did. Understanding and showing that there is a mother's dream for a better life is the way in which Ma Na Sapna gives so-called ‘surrogates’ a face, a voice and a touching human story.


[1] The condition is rare with only a few case reports and seems to be connected to in vitro manipulations causing trauma of the zona pellucida. Usually, the pregnancy of the unaffected fetus goes on without further complications. See Hirata T. et al. Conjoined twins in a triplet pregnancy after intracytoplasmic sperm injection and blastocyst transfer: case report and review of the literature. Fertil Steril 2009;91:933.e9–e12, doi:10.1016/j.fertnstert.2008.07.1730


Gabriele Werner-Felmayer is Associate Professor of Medical Biochemistry at Medical University Innsbruck working at the intersection between basic biomedical research and bioethics, and chairs the bioethics network Ethucation [Austrian unit of the International Network, UNESCO Chair in Bioethics (Haifa)].

Carmel Shalev is the founding chair of the Department for Reproduction and Society at the International Center for Health, Law and Ethics, Haifa University, and a member of Israel's National Bioethics Council.

Images via Ma Na Sapna and Akanksha Clinic

Dinosaurs are Extinct, but Normalization is Alive and Well

Posted by Emily Beitiks, Biopolitical Times guest contributor on March 22nd, 2016

My son hugs a stuffed dino. (Kachine Blackwell, used with permission.)

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This article was cross-posted on Disability Remix, the blog of the Paul K. Longmore Institute on Disability at San Francisco State University.

Lately, I’ve been learning a lot about dinosaurs. Or, I should say, my three-year-old son has been learning a lot about dinosaurs, and I have been caught in the crossfire. My mind is often churning to relate any new information I take in to my own passion of disability studies. I didn’t expect to find a link to dinosaurs… but I did.

Dinosaur science has advanced remarkably since my childhood. (Did you know, for example, that scientists now believe many dinosaurs had feathers?!)

But while our notions of what dinosaurs could have been is constantly evolving, we still cling to certain tenets of what I like to call “dinosaur normalization.” (I haven’t lexis-nexis’d it, but I think you just witnessed the birth of a completely original school of academic thought!)

Dinosaur normalization is the idea of prescribing what dinosaurs would have been like based on our own narrow worldview.

For a quick example of dinosaur normalization, when scientists first discovered the Iguanodon (see right), they assumed he had a rhino-like horn on his nose. After further skeleton discoveries, it turns out the Iguanodon actually has two horn-like thumbs, something we’ve never seen before.

But you don’t have to be an obscure dinosaur like the Iguanadon (that only three-year-olds and their parents are likely aware of) to be a victim of dinosaur normalization.

Here’s a children’s song about the stegosaurus:

My name is stegosaurus,
I’m a funny looking dinosaur….
My front two legs are very short.
My back two legs are long.
My body’s big, my head is very small
I’m put together wrong!

You know… a little judgmental. Plus, if the stegosaurus is “put together wrong,” isn’t that kinda our bad since we literally put them back together?

But even the almighty T-Rex is not spared from the hammer of normalization. There’s a general fascination with the T-rex’s tiny arms, each with two small claws. Many books ask: why did such a ferocious beast have such puny, useless arms? One fictional children’s film that I watched recently spent a solid 30 seconds joking at the t-rex’s expense.

When the newest movie in the Jurassic Park franchise was released, I was itching to see it for it promised a genetically modified dinosaur. I don’t condone genetic modification, but I thought this premise was brilliant, as it would allow the filmmakers to take all the scariest parts of dinosaurs and jam them together (which, inevitably, makes a really strong argument against genetic modification). Much to my surprise (and many other disappointed fans), the resulting dinosaur mostly just looked like a t-rex with longer arms and a full hand of claws. Sure, it had a few other hidden tricks but if you freeze-frame the film, that’s it. It’s as if there were a bunch of dino-fans who were sitting around saying, “I’m not afraid of the t-rex because its got those tiny arms. But if you had a t-rex with proportionate arms, well, now that’d be scary!”

There’s so much we are still learning about the t-rex. Scientists are now hypothesizing that the tyrannosaurus rex might not have made the ferocious roar we think of from the movies, but something more like a loud bullfrog croak. There’s also a lot of uncertainty about how fast the t-rex runs. Just yesterday even, an article announced the discovery of a pregnant t-rex, which is providing new data on egg-laying. So why aren’t we culturally more open to exploring what purpose the t-rex’s tiny arms might have served?  The paleontologists are, but the children’s books and films don’t seem to be.

The disability rights movement pushes us to rethink our assumptions about how the body is supposed to look and what the body is capable of. Many disabled performance artists celebrate how their bodies are “put together wrong” to show us what the anomalous body can do once you embrace creativity and challenge bodily assumptions (see, for example, the many examples in Sins Invalid’s film An Unashamed Claim to Beauty). While the disability movement is pushing us away from normal, our dinosaur education for our kids lags behind.

Everything about dinosaurs is so totally not normal. When I stop and think about dinosaurs, the t-rex’s tiny arms and the stegosaurus’s small head seem so completely uninteresting compared to how bizarre it is that there were dinosaurs like this once living in North America:

Or knowing that this dinosaur-relative once swam in our oceans…yikes!

That our normalizing tendencies have extended to a species from over 65 million years ago shows us just how far our counter-efforts to take down normalcy must also go.

I’m going to encourage my kid not to think twice about the t-rex’s small arms. That’s just how they look, and from what we know about the t-rex (his FAVORITE dinosaur), they were pretty bad-ass, small arms or not.

*Believe it or not, this is actually the second blog by someone at the Longmore Institute with a connection to dinosaurs. Read the other, about Pixar’s access features in The Good Dinosaur, here.


Emily Beitiks is Associate Director of Paul K. Longmore Institute on Disability at San Francisco State University, and a former staffer at CGS. Beitiks earned her Ph.D in American Studies from the University of Minnesota with the dissertation "Building the Normal Body: Disability and the Techno-Makeover". 

Images via Wikimedia, Creative Commons.

Whose Body, Whose Property, What Choice?

Posted by Alison Irvine & Katayoun Chamany, Biopolitical Times guest contributors on March 21st, 2016

Katayoun Chamany, left & Alison Irvine, right (via Twitter)

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"I've done this because of my poverty. Otherwise I would never have taken this step."

The words of Aasia Khan, an Indian woman acting as a surrogate for an American couple in the documentary Made in India, echoed through the sound system at The New School’s panel entitled “Whose Body, What Choice: Egg Provision, Gestational Surrogacy, and Extending Parenthood”. In addition to viewing clips from Vaishali Sinha and Rebecca Haimowitz’s award-winning documentary, panelists spanning health psychology, queer studies, law, media studies, and life science came together to discuss how emerging reproductive technologies support new forms of family making, invoke bodies in labor and care, and provide bioresources for a burgeoning stem cell industry.

Psychologist Lisa Rubin, queer studies scholar Laura Mamo, and filmmaker Vaishali Sinha described the ways that Assisted Reproductive Technology (ART) has become a common practice in Western countries, yet increasingly more dependent on bodies abroad. As more individuals view ART as a “natural” part of their personal reproductive journey, many assume that the techniques involved in ovarian hyperstimulation, in vitro fertilization (IVF), and surrogacy are FDA-approved and safe. But few are aware of the necessary labor involved and the potential inequities that can arise with increased use of ART.

As a result of shifting legislation, there is both limited access to and varied payment for bodies, cells, and tissues used in the reproductive and stem cell contexts, with little regard to the labor and potential health outcomes of all involved. As one attendee commented, she was unaware of the details involved in the egg retrieval surgical procedure which requires puncturing hyperstimulated ovaries—a separate puncture for each egg removed.  Additionally, the ripple effects of the stress of living with economic constraints can influence the health of the egg provider or surrogate, and the health of the potential child through DNA reprogramming events.

Using visual narratives from the newly launched Stem Cells Across the Curriculum project, biologist Katayoun Chamany, showcased how ART can involve multiple bodies, including those of the egg provider, the potential surrogate, the embryo, and the future child. Some children are conceived though a combination of IVF and Preimplantation Genetic Diagnosis (PGD), a genetic screening technique that can exclude embryos with gene variants associated with disease risk, but improve the probability of an immunological match to a sibling living with disease. Stem cells can be obtained from the cord blood, peripheral blood, or bone marrow of the “savior sibling” to support the treatment of the sibling living with disease. The labor involved in hormone stimulation of the mother’s ovaries and the retrieval of stem cells from the sibling, create new forms of kinship and responsibility in families that have the means to engage in such practices.  

During her presentation, law scholar Lisa Ikemoto touched on the issues of labor, property, and informed consent. Participation in surrogacy, tissue and egg donation, and clinical trials is not commonly thought of as “labor” as it is defined in The Labor Theory of Value. When it comes to regulating ART practices, this perception influences how compensation for surrogacy and egg donation is determined. Providing a history of property law and practice, Ikemoto, illustrated how bodies and cells used in the service of ART may be considered property secured through “purchase” or “labor of invention.”  In the past, informed consent was designed to give research participants the autonomy to consider the risks and benefits associated with a research study as part of their decision making about whether to agree or refuse to participate. As Ikemoto illustrated using three case studies, it seems that informed consent now serves the purpose of a contract in which the cell or tissue provider gives up all property rights.

As Ikemoto detailed, the landscape in the U.S. is complicated and inconsistent from state to state and case by case. Thus, other countries have emerged as leaders in commercialized gestational surrogacy supporting contract pregnancies and creating a multibillion-dollar-a-year industry. In this context, IVF is used to create embryos that are then transferred to the uterus of the person willing to serve as the gestational surrogate and undergo caesarean section to deliver the child to the intended parents.

In the U.S., acquiring the services of a gestational surrogate can cost upwards of $100,000.  Some states, including New Jersey, Michigan, and Washington, ban contract surrogacy, while New York and Washington D.C. currently have pending legislation that would regulate and legalize the practice. The varied patchwork of laws combined with the steep cost has pushed some prospective parents to seek out surrogates from other countries, including India, in a process known as “transnational surrogacy” or “reproductive tourism.”  India legalized contract surrogacy in 2002 for heterosexual couples, and costs are listed at under $30,000 with surrogates reportedly being paid anywhere from $800-$8,000 at the discretion of the surrogacy clinic.

During the dialogue moderated by Lisa Rubin, the panelists discussed the consequences of a new law enacted this year put forth by the Indian Council of Medical Research (ICMR), a government-appointed body. The law bans surrogacy services to foreigners and is driven by a desire to “safeguard the rights of the surrogate mothers.” A similar ban is already in place in Thailand. However, as Sinha pointed out, there has been concern that these bans will push surrogacy to the black market, increasing the danger to surrogates. Instead of outlawing transnational surrogacy, many women’s rights advocates in India have come out in support of more regulation of the surrogacy industry, as depicted in Amrita Pande’s ethnographic work Wombs in Labor: Transnational Surrogacy (mentioned in Ikemoto’s presentation). Many of these advocates believe the process of putting regulatory measures into place encourages discourse around the subject, and keeps surrogacy out in the open and off the black market.  

Laura Mamo extended the conversation regarding rights, protections, and benefits by asking “From what towns, communities, and countries will the bio-materials be fulfill the American Dream?”  The conversation then turned to who is most likely to benefit, as it is clear that most of the economic gain benefits some stakeholders, such as surrogacy clinics and medical professionals, and not others, such as the surrogates. This disparity calls into question society’s ability to put the emotional, mental, and physical well being of surrogates in front of a profitable industry and the desire to create genetically related families. Shamina Shafiq, head of the nonprofit Progressive Organization for Women’s Empowerment and Rehabilitation, states that the main beneficiary of surrogacy should be the surrogates, not the medical fraternity. Even if regulations were put in place to ensure that providers are the main beneficiaries of their labor, would it be enough to shift the balance of power and prevent surrogates and egg providers from being exploited?

In addition to fair payment, appropriate guidelines, and regulation, the panelists also discussed procedural justice issues associated with ARTs.  That India and some states in the U.S. restrict access to ARTs to those who are married or in heterosexual couplings exemplifies the ways in which family making is not accessible to all. Not surprisingly, a new market catering to homosexual couples and singletons has emerged, with Mexico serving as one site of such services.

The panelists also raised questions around the recruitment practices for egg “donors” that seek individuals with high SAT scores and other desirable characteristics and juxtaposed this practice to those used for egg provision in stem cell research. In June 2009, New York became the first state to allow taxpayer-funded researchers to compensate those who provide eggs to scientific research, stating that the compensation was socially just. Similar to the varied regulations for surrogacy, compensation rates for egg donors for reproductive purposes fluctuates by state. Thus, the Ethics Committee for the Empire State Stem Cell Board used the caps put forth by the The Ethics Committee of the American Society for Reproductive Medicine (ASRM) at no more than $10,000 per egg retrieval cycle. Though the matching amounts for egg provision across the reproductive and stem cell research sectors can be described as equitable, the payment scales have come under question. Some feel that the pay exploits those with low economic means and further widens the gender equity gap in employment opportunities, and others feel that they should be able to negotiate a fair rate, and have sued the ASRM for price fixing based on the Sherman Act.  

Documentaries such as Eggsploitation by Jennifer Lahl, filmmaker and founder of The Center for Bioethics and Culture Network, highlight the potential short-term and long-term health risks and overall lack of knowledge around the process of egg retrieval. The process of retrieving oocytes consists of a series of self-administered daily hormone injections to suppress the donor’s cycle, stimulate the ovaries, and trigger ovulation. Using human chorionic gonadotropin (hCG) injections is associated with many health risks, such as Ovarian Hyperstimulation Syndrome (OHSS), which could result in ovarian torsion, blood clots, fluid accumulation in abdomen and chest, kidney failure, and in rare cases, death.

Given these risks, those lobbying for the 2013 “Bonilla Bill” in California argued that without compensation, they couldn’t retrieve the oocytes that will one day contribute to the research that will benefit women’s health. Ultimately, though the bill was passed by the congressional legislature, it was vetoed by the governor who claimed that "Not everything in life is for sale, nor should it be." However, a new act was proposed in February 2016 by California Assembly Member Autumn Burke for compensation to those providing eggs for medical research on the basis that they are acting as any other human subject participating in research. However, as Chamany pointed out, given that there are no long-term data on the health outcomes of young fertile oocyte providers, bills such as this one proposed in California, and the existing order in New York, should incorporate long-term monitoring of the health of these oocyte providers if the rationale is based on encouraging research participation in clinical trials

More recently, advances in egg freezing may shift these health and economic concerns from third-party egg providers to those seeking pregnancy later in life. As Ikemoto highlighted in her presentation, earlier this year the United States military agreed to cover the costs of sperm and egg freezing for their personnel, following the trend set by Apple and Facebook in 2014. This type of policy highlights how social policy frames family making as an essential human activity, such that if an opportunity is available, one should take advantage by any means. The discussion on this panel cast a critical eye on such generalized views and presses us as we move forward to consider the trade offs of any such policy in terms of who benefits and who carries the burden or risk.

Alison Irvine is Community Manager at Genspace and a performance artist & writer based New York City. @alisonirvine1

Katayoun Chamany is Associate Professor of Biology at Eugene Lang College for Liberal Arts at The New School. @KatayounChams

Previously on Biopolitical Times:

Composite image via Twitter

Correction: The first iteration of this blog post paraphrased Aasia Khan's quote from Made in India as "I would not have done this if it weren't for the money."

Uterus Transplants: Identifying Stakeholders & Objections

Posted by Elliot Hosman on March 10th, 2016

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On February 25, the Cleveland Clinic announced that the first “womb” transplant had been successfully completed in the US, using a uterus from a deceased donor. The 26-year old recipient, identified as Lindsey, joined a press conference on March 7 in a wheelchair and expressed her gratitude. On March 9, the clinic released a second media statement:  Lindsey’s uterus transplant had been removed due to a “sudden complication.” As NPR noted, the clinical trial will continue—nine women with uterine factor infertility still await the procedure in Cleveland. Their motivation to continue with the grueling, risk-laden procedure may be similar to Lindsey’s:

“I crave that experience,” she said. “I want the morning sickness, the backaches, the feet swelling. I want to feel the baby move. That is something I’ve wanted for as long as I can remember.”

The future of reproduction has never appeared so technologically complex. Amid ongoing policy debates about gene-editing embryos, and the potential spread of “3-person IVF” from the UK to the US, we’ve also seen a rapid increase of clinical trials for a revolutionary surgical procedure: womb transplants—i.e. temporary uterus transplantation into “genetic females” born without uteruses (but with working ovaries) for the purpose of enabling pregnancy for one or two genetically related IVF offspring.

An early effort at uterus transplantation was conducted in Germany in 1931 on Lili Elbe, who is historically identified as both transgender and intersex, and who died shortly thereafter. (Her story is told in The Danish Girl.) Unsuccessful attempts were also made in Saudi Arabia in 2000, and in Turkey in 2011.

Headlines since 2014 exhibit building momentum and clinical uptake:

Uterus Transplants Enter U.S.

Setbacks for clinical patients like Lindsey are to be expected, as successes have been few and recent. The procedure’s clinical viability (and eligibility guidelines) began in Sweden—where nine transplants, seven that were ultimately successful, have taken place resulting in five babies since 2014.

For more than a decade, a research team led by Dr. Mats Brännström, professor of gynecology and obstetrics at the University of Gothenburg, conducted surgeries on animals ranging from rodents to non-human primates (including some 80 baboons) to establish a threshold of perceived safety for the transplantation of donor uteruses into humans. According to a New York Times report, Dr. Andreas G. Tzakis, director of solid organ transplant surgery at the Cleveland Clinic, spent a lot of time with this Swedish team, “practicing in miniature swine and baboons and observing all nine of the human transplants in the operating room.”

Notably, the Swedish researchers are the only ones to have established and documented their protocol working in animal models. They have shaped not only the technical specifics of the procedure, but also protocols and assumptions about who is considered an acceptable clinical subject. So far the majority of people targeted for the procedure have been diagnosed with Mayer-Rokitansky-Küster-Hauser syndrome in which infants are born with an intersex phenotype, including underdeveloped or absent uteruses and vaginas. It’s also important to note that all gestational surrogacy is banned in Sweden, both commercial and “altruistic”—so people set on having genetically related children may be more willing to turn to risky surgeries instead.

Media have quoted the Swedish team expressing the underlying values and assumptions that drove their research, including:

“Dr Brännström said that the nine women who had received womb transplants had already been deeply affected by the experience. ‘Some of them say that it’s fantastic just to have a period. They say: ‘Now I feel like a real woman, a normal woman, for the first time.’” (2014)

“‘We are not going to call it a complete success until this results in children. That's the best proof.’” (Michael Olausson, 2012)

In light of the birth of a handful of premature babies via uterine transplant and ongoing safety and ethical concerns, Brännström is focusing on improvements including efforts to grow a womb in the lab,  a “bioengineered uterus.” He describes this process as “taking one from a deceased donor, stripping it of its DNA and using cells from the recipient to line the structure.” According to news reports, he has “started preliminary tests in animals and estimated it would be another five years before the technique can be tried on humans.” This may impact a key concern with the transplant: maternal and fetal exposure to powerful immunosuppressants.

Bioethics and Biopolitics: Making Policy in the Lab?

As these clinical trials migrate from Sweden to clinics around the world, ethical concerns have been mounting. A lonely set of formal ethical guidelines, “The Montreal Criteria,” was published in 2012, and slightly revised in 2013. There was immediate pushback to the criteria; one concern: the guidelines are narrowly applicable, myopically reflecting the context of wealthy countries with well-developed biomedical sectors.

In the 1970s, only 1 out of 10 women in the United States made it to menopause without giving birth to a child. Fast-forward to 2010 and that number had doubled according to Pew Research Center, roughly 1 in 5, or 20% of women end their “child-bearing years” child-free. (More recently, Pew found childlessness is actually decreasing among highly educated women.)  Which is to say that even in these modern times of single ladies, egg freezing parties, and the increasing legal acceptance of LGBT relationships—and interdependent upon factors such as income, ethnicity, and education—some 80% of women will become pregnant and give birth in their lifetime.

With this in mind it’s important to start asking a wide range of questions about the assumptions and values that underlie current  excitement about the potential of uterus transplants:

  • Is uterus transplantation a medical procedure? A cosmetic surgery? Neither?
  • Why are clinical subjects only allowed to participate in a trial if they have working ovaries, given that fallopian tubes are never connected to the transplant itself?
  • Why is genetic relationship so important if the main draw is to experience a pregnancy?
  • Why should the procedure be limited solely to “genetic females” when the majority of clinical subjects are on the intersex spectrum of sexual difference? Should men and transgender women have access given the congruent technological advances of gender-affirming surgeries?
  • What influence and relevance does the long-standing and recent history of medically unnecessary and coercive surgeries on intersex children and adults have in this context?
  • How do we ensure long-term clinical follow up for women and children who participate in this brave new world of gestational place-making?
  • What are the health impacts for all parties involved that would caution against using either living or deceased donors?

What else would you add to a growing list of ethical, social, or political objections?



Mats Brännström et al., Livebirth After Uterus Transplantation, THE LANCET 1, 8 (2014) [Sweden], available at

Ariel Lefkowitz et al., The Montreal Criteria for the Ethical Feasibility of Uterine Transplantation, 25 TRANSPLANT INT’L 439-47, at 444 (2012), available at

Ariel Lefkowitz et al., Ethical Considerations in the Era of the Uterine Transplant: An Update of the Montreal Criteria for the Ethical Feasibility of Uterine Transplantation, 100.4 TRANSPLANT INT’L 924-26 (2013), vailable at

Wafa Mohammed Khalil Fageeh, et al., Transplantation of the Human Uterus, 76 INT. J. GYNECOLOGY AND OBSTETRICS 245–51 (2002) [Saudi Arabia], available at

Zubia Mumtaz & Adrienne Levay, Ethics Criteria for Uterine Transplants: Relevance for Low Income, Pronatalistic Societies?, J.CLINICAL RESEARCH AND BIOETHICS S1:004 (2012), available at

Omer Ozkan, et al., Preliminary Results of the First Human Uterus Transplantation from a Multiorgan Donor, 99 FERTILITY AND STERILITY 2:470-476 (2013) [Turkey], available at

Previously on Biopolitical Times:

Images via Flickr/Tom Simpson; Wikimedia: Mats Brännström; and Pixabay

CRISPR Eugenics in The X Files

Posted by Elliot Hosman on March 10th, 2016

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CRISPR-Cas9 “gene editing” has been a source of hype, hope, and caution for the past several years, and its presence in labs, patent fights, policy discussions, and headlines has grown exponentially.

But in the finale of The X Files’ comeback season, it is aliens who first harness genome editing. “CRISPR patent belongs to aliens,” Sara Reardon comically claims in the Nature books and arts blog A View From the Bridge. As she notes,

it is human genome editing that forms the season’s backbone: a concept that is far more scientifically plausible today than it was in 2001 [around when The X Files went off-air] — or even 2012 [when CRISPR-Cas9 was developed as a genome editing platform].

In The X Files, the aliens use gene editing in the service of population control campaigns on other planets. In the real world, the range of potential CRISPR applications triggering social and ethical controversy includes

  1. human “germline” gene editing, i.e. creating modifications that will be passed down to future generations by engineering germ cells (gametes or embryos) prior to initiating a pregnancy — what the media sometimes call “designer babies” and
  2. climate change gene editing, i.e. attempting to alleviate the effects of anthropogenic global warming by modifying plants and animals, including drought-tolerant corn and soybeans and heat-tolerant cows.

Both of these brave-new-world applications come into play in the finale’s dystopian plot.

The Science of The X Files

The science in The X Files finale is discussed rather breathlessly, so for those who might have missed it:

In an earlier era of Roswell crash-landings and secretive extraterrestrial research, scientists discover that aliens had developed a “Spartan Virus” to “manage” overpopulation. At some point in the last century, motivated parties on earth co-opt this viral population-control method by creating a germline gene therapy to slip into mandatory smallpox vaccinations.

In real life, routine smallpox vaccination ended in the United States in 1972; in The X Files finale, regardless, the Spartan Virus continued to infiltrate the population for decades because everyone who was vaccinated passed on the CRISPR complex to future generations.  Fast-forward to 2016, and a prominent villain from earlier seasons has decided it’s time to activate the Spartan Virus in order to CRISPR-edit out a gene to turn off people’s immune systems. (The reference is to the adenosine deaminase (ADA) gene, which is associated with “bubble boy syndrome.”)

How does the villain activate this CRISPR mechanism? With chem trails of aluminum nanoparticles! The only way to survive? An elite cabal has exclusive access to a secret germline technique using alien DNA (literally) that disables CRISPR from editing out the ADA gene, thereby preserving immunity.

Some of the described or implied science here is pretty far-fetched, but some not so much. The time-delay germline engineering described in The X Files finale, for example, bears at least some similarity to the CRISPR complex recently reported [PDF] by the Stanley Qi Lab at Stanford University. In that study, a “dead Cas9” protein is used to regulate gene expression through activation or interference. This seems to suggest that it may be possible to design platforms like these, capable of being designed to hang out in the genome until sometime later (in The X Files’ case, decades), when they could be activated and begin to carry out programmed edits or regulatory activity.

The science of how CRISPR is delivered into living children and adults to affect their germ cells is not made clear in the finale. This is an important point to clarify regarding the state of the science, as many in the ongoing policy debate, including the Center for Genetics and Society, draw a clear line between gene therapy that would affect the body of just one patient (somatic), and interventions into gametes or early embryos (germline).

Familiar Political Themes

What about the politics embedded in The X Files finale?

Since the days of Thomas Malthus, alarms about overpopulation have often been accompanied by xenophobia, elitist attempts to control reproduction, and racialized crackdowns on borders and migration. In The X Files finale, the plot situates itself among the fears of anti-vaxxers and conspiracy theorists, but concerns over anthropogenic climate take center stage. The villain’s purported goal in undermining human immunity is to “to kill everyone but the chosen.” He cites “40-percent loss of bird life, the decimation of the ‘megafauna.’” He applauds the aliens for divining this efficient method of population control for their own planets, an eerie tribute to the American eugenicists who embraced forced sterilization for ”defectives” and better breeding among the “chosen.”

In the finale, CRISPR is controlled and distributed by those in power: the villain holds captive the antidote to immunity breakdown, and doles it out (in exchange for “favors”) to those he deems worthy to survive. In our twenty-first century reality of global inequality, both human and nonhuman applications of CRISPR involve a lot of private investment and patentable content. Will nonfictional biotechnological advantage become the province of the wealthy? Will it exacerbate existing disparities in living and health conditions between the wealthy few and the majority of humanity living in poverty?

In The X Files, CRISPR was portrayed as a magical techno-fix to global climate change and overpopulation; in real life, some are similarly hyping it for disease prevention. The New York Times recently discussed the vast biotech menagerie of Randall “RJ” Kirk, whose Intrexon empire includes the gene-edited-pests company Oxitec, which is currently releasing 250,000 GM mosquitoes per day in Brazil in attempts to combat the spread of a virus linked to birth defects. And the FDA is “greatly expediting” Oxitec’s application to begin testing out their GM mosquitoes in the Florida Keys. What makes Kirk eyebrow-raising, among various eccentricities cited in the article, is his portfolio of controversial, financially struggling, but nonetheless bio-revolutionary firms, and his willingness to take unilateral leaps forward into the biotech unknown. Whether chasing techno-enthusiastic solutionism or the risk-laden profit margins of spread-thin solvency, Kirk symbolizes many of the concerns raised by the undemocratic development of biotechnology.

Science, Storytelling, and Public Debate about Emerging Technologies

The X Files director Chris Carter recently called on long-time science consultant and University of Maryland virologist Anne Simon to brainstorm a technology that could help tie together the series’ ongoing plot lines. A number of reporters have asked Simon whether she feels that the plot’s reliance on CRISPR could escalate public fears about the (real-world) game-changing technology. Some of Simon’s responses have been dismissive:

[I]f you think that people are going to avoid vaccinating their kids because of imaginary aliens doing things on a TV show, that is just ridiculous. There isn't any hope to begin with for anyone that dumb.

Others seem overly optimistic:

Simon wants it made clear that in the real world, CRISPR and other genetic engineering techniques are tools for good, not evil. ‘The X-Files’ may be spooky, but it’s just a TV show. “The whole idea of trying to get something into everyone’s cells – that’s not a viable system,” she told GeekWire. “We keep trying to say these are aliens doing this. … It’s aliens, OK? Aliens can do anything.”

And sometimes she waxes thoughtful:

Simon doubts that the episode will fuel fears of CRISPR. “It’s just a tool,” she says. In fact, when director Chris Carter asked her to create a world-destroying technology, she took care to avoid stoking real fears. GMOs and common vaccines were right out. She settled on the smallpox vaccine because it hasn’t been routinely given since 1972. And relegating vaccination conspiracies to the same level as aliens and chemtrails might even be helpful.

Simon does hope that the entrance of CRISPR into popular culture will stimulate discussion of its many applications and ethical ramifications, primarily those involving editing humans. “I think we have to be careful about modifying the human germline because we don’t know what we’re doing,” she says. The public, not just those who wield the technology, should be crucial players in making such decisions.

As Simon indicates, CRISPR’s potential use on the human germline – the third rail of genetic technologies – threatens to escalate public distrust in science. A concluding statement issued by the organizing committee of the three-day international summit on human gene editing in D.C. last December stated that it would be “irresponsible to proceed” with germline gene editing in the absence of “broad societal consensus.”

In 1998, the National Academies founded The Science & Entertainment Exchange, which has consulted over a thousand times on films and television shows. As this project indicates and as many observers recognize, popular narratives that engage with emerging bio-engineering technologies can shape public sentiment and facilitate broad debate about the multi-generational and societal impacts of research and experimentation.

The X Files is the first television show to feature CRISPR gene editing, the alternate futures it enables, and the social and political questions it raises. Let’s hope the writers now working on 12 new episodes of the British hit show Black Mirror are taking note.

Previously on Biopolitical Times:  

Images via Wikimedia: Roswell, Smallpox, Malthus, Rabbits

Cryonics Taken Apart

Posted by Pete Shanks on March 10th, 2016

Screenshot from promotional video.

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Corey Pein has written another excellent piece in The Baffler, this time focusing mainly on Alcor, the cryonics company he describes as "technophilic necromancers." His starting point is actually a very unfortunate New York Times article.

Pein's "Everybody Freeze" begins:

Narratives are made by the artful omission of facts. Never was this maxim more evident than in a gullible feature story that landed on the front page of the New York Times last fall, about a young woman's last-ditch bid for life extension as she succumbed to the ravages of brain cancer. A sober look at the case would have revealed it to be but the latest botched mortuary procedure conducted by a gang of creepy scam artists. Instead, through the good graces of the Times, this grim tale was spun into an inspirational saga of one person's courageous quest for a second chance at life, aided by medical visionaries on the verge of miraculous technological breakthroughs.

(Incidentally, the Times also gave Alcor publicity back in 2005, though in a less hagiographic article.)

Pein details the gruesome facts of the case, with splendidly straight-faced humor: "a crack team of quacks shaved her head and drilled a number of sizable holes into her skull." He then delves deep into the history of Alcor and indeed the origins of modern transhumanism.

Of particular interest to those of us who have been following transhumanism and the like for a while is that Alcor's head nowadays is Max More, the quondam Max O'Connor, who reinvented himself and devised the Extropy Institute in the late 80s. He also coined the "proactionary principle" and for a while there was quite the philosopher of transhumanism. The Extropy Institute declared victory and shut down in 2006, but More evidently landed on his feet, apparently back where he started: in 1986, he co-founded "Britain's first cryonics organization, now defunct."

The Baffler piece is nearly 7000 words long. You'll laugh, you'll cry, you'll despair of humanity and then you'll realize that a human made this too. Read the whole thing, and check out this video, which is mentioned but not linked in the article. For extra credit, see Pein's equally astonishing article last year on the Singularity Institute.

Previously on Biopolitical Times:

Image via YouTube

My Genes, Myself?

Posted by Jessica Cussins, Biopolitical Times guest contributor on March 8th, 2016

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We have become accustomed to ascribing individualistic agency to our genes. We speak of gene x doing thing y. However, our biology is not a collection of independent actors, but a highly interdependent ecosystem. And every now and then a story comes along that reminds us just how foolish we are to forget that.

In what is being called the first of its kind in the UK, the birth of a pair of genetically identical twins provides a striking case in point. Despite having split from the same embryo, one of the girls has brown eyes and darker skin, while the other girl has blue eyes and fairer skin. Other couples have defied the odds with the birth of two sets of twins with different skin and eye colors, but the notion of identical twins looking markedly different is much more unusual.

Studies have shown that identical twins growing up in the same household with largely the same opportunities and experiences can still develop quite different personalities and skills. This has largely been attributed to the growth of new neurons in the brain. But the rest of our bodies are also far from static.

Massive studies of identical twins have discovered that hundreds of genes can end up contributing to just 1% of the heritability of a disease or trait; moreover, epigenetics – the expression of genes – can profoundly alter phenotypic outcomes. 

Such visual divergence of identical twins is very rare, but even rare findings have important consequences. As I tweeted last week, the finding “sure throws a wrench in that whole genetic determinism thing…!” And as Dorothy Roberts (Professor of Law and Sociology at the University of Pennsylvania as well as an Advisory Board member of the Center for Genetics and Society) responded, this case particularly complicates the notion of biological race:

Recognizing the multiplicities of our bodies and identities matters. For one thing, we can refute those who try to justify inequality on the basis of (purported) genetic differences, and make the critical point that, for example: Genes Don't Cause Racial – Health Disparities, Society Does. And that, “There is no inherent reason why children from low-income families cannot succeed as much as those from affluent homes.”

None of this is to deny the role of genetics, which is obviously a necessary and critical component to us all. However, as long as the myths of “individualistic” genes and genetic determinism continue to circulate wildly, it seems worthwhile to take the opportunity to remember that DNA is neither static nor prescriptive. Just as every locust is a genetic grasshopper facing a phase change brought on by hard times, so too are humans radically impacted by their environments. No amount of physical tinkering will ever erase the also necessary and infinitely messier importance of the outside world.

Previously on Biopolitical Times:

Image via Pixabay

Bridging Borders: Transnational Surrogacy, Queer Kinship & Reproductive Justice

Posted by Elliot Hosman on February 25th, 2016

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On the heels of the U.S. Supreme Court’s 2015 marriage equality decision, some argued that “family equality” was the next LGBT movement priority, which was described in part as increased access to surrogacy for gay men. Media scrutiny of commercial surrogacy can tend to be myopically focused on the gay couples using it, which is unfair given the high rates of heterosexual couples who also enter into surrogacy agreements both domestically and abroad. Yet the need for a diverse discussion of LGBTQ families and communities’ needs in a post-Marriage moment persists, as does the problem of excluding the voices of women who engage in the physically risky acts of gestational surrogacy and egg donation—particularly when they work for wealthier couples traveling to their country because of decreased costs.

On February 19, a symposium was held at UC Berkeley* entitled “Making Families: Transnational Surrogacy, Queer Kinship & Reproductive Justice”. A key goal of the symposium was linking up these three areas of practice and study to address the social justice implications of the growing, unregulated tool shed of reproductive biomedicine.


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Scientists Make Mice Glum

Posted by Pete Shanks on February 25th, 2016

Lab mice are probably not the happiest of creatures. Food is not much of a problem (unless they are in one of those starvation-diet experiments) but roaming is discouraged, the environment is not that cozy and I imagine they don’t get given the wifi password. Even so, most of them don’t have to put up with researchers deliberately making them depressed.

All in a good cause, naturally, from the human point of view. Researchers, mostly at UCSF, identified a variant form of the PER3 gene in humans, which is involved with the circadian clock. The variant also seems to be linked to a tendency to sleep and wake very early (Familial Advanced Sleep Phase, or FASP) — and also with seasonal affective disorder (SAD). SAD is a relatively common kind of depression related somehow to changes in the length of the day, especially in the fall.

There is a long, long way to go before anyone can even think about using this linkage in therapeutic approaches, but it could be an important clue as to how sleep and mood disorders may be linked.

Bring on the mice. The scientists made transgenic mice with the human gene variant. And controlled the lighting to match the changing seasons. Bingo:

The model mice slept and behaved normally when their days and nights were of equal length, but developed depression-like symptoms as nights became longer than days.

You can’t do talk therapy with mice, but basically when they are feeling under the weather they don’t wriggle as much and they give up quick when something disturbing happens, like someone with a white coat picking them up.

The variant gene produces a less stable protein, and affects the performance of related circadian-linked genes. The authors note that this provides "a mechanistic explanation for the circadian trait.” This clearly could be a significant finding, eventually, but in the meantime, the poor old mice get bummed out.

They’re not the only ones. The researchers made mutant fruit flies too:

Although we were not able to test mood in fruit flies, we did uncover a sleep trait similar to that seen in humans in flies carrying the human variants.

Fruit flies are, or course, classic research subjects, and this is real science, but the observational work seems ... challenging. Imagine someone trying to test an alleged “criminality gene” in insects? Would they bite harder, perhaps? Or more often? Or both?

Previously on Biopolitical Times:

Image via Wikimedia

Cross-Border Reproduction: An "Ethic of Care" and an Unregulated Market

Posted by Marcy Darnovsky on February 23rd, 2016

Brocher Foundation

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Concerns about cross-border fertility arrangements – especially human rights violations of women serving as surrogate mothers or providing eggs – brought 23 participants (including myself) from 14 countries  to a three-and-a-half-day workshop at the Brocher Foundation near Geneva, Switzerland in January.

The event was called Inter-country medically assisted reproduction: Conceiving a human rights ethic of care, and its aim was “to explore and conceptualize ethical principles for a human rights-based regime of governance that might offer an alternative to the unregulated market.” It was co-organized by Carmel Shalev of the Department for Reproduction and Society at Haifa University’s Center for Health, Law and Ethics, and Gabriele Werner-Felmayer of the Division of Biological Chemistry at Medical University Innsbruck and its bioethics network Ethucation.

In addition to intensive discussion, we were treated to a screening of an award-winning documentary about surrogacy in India, Ma Na Sapna (A Mother’s Dream), which to my knowledge has not been widely screened in North America. Austrian director Valerie Gudenus was present, and answered a flurry of questions about the film and the several months she spent with a camera crew at the Akanksha Infertility Clinic.

Workshop sessions were devoted to exploring the meaning of an “ethic of care,” and how it would apply to surrogacy, third-party gamete providers, and embryo selection. Not surprisingly, a range of views surfaced among the gathered public interest and women’s health advocates, bioethicists, biologists, physicians, anthropologists, legal scholars, and others. But there was enough shared perspective for a series of recommendations to emerge, and a report explaining the background and reasoning for them is planned.

Many of the troubling aspects of the cross-border fertility industry that we discussed have become somewhat familiar. One concern that is still overlooked in some media accounts, but that was emphasized in these discussions, is the invisibility of the women who assist infertile couples and individuals in having a child. Another, even less commonly considered, is the rights and well-being of children born as a result of arrangements involving women working as surrogates or to provide their eggs. 

We also discussed the contribution that a “human rights ethic of care” might make to the practice of inter-country assisted reproduction. Even in jurisdictions with significant public policy, and especially in those where regulation and oversight is absent or inadequate, there is still no satisfactory standard of care that takes into account the vulnerabilities and interests of everyone involved in such arrangements for bringing a child into the world. As one participant put it, “Reproduction takes place in response to people's desire or need for child, and it is only appropriate that if people want to start a caring relationship, their efforts should be founded on an ethic of care.”

Two other topics that are less commonly included in conversations about cross-border reproductive care also emerged. One concerned the unique status of First Nations / indigenous peoples. Participants stressed that these groups may hold wider concepts of community ownership, rights, and responsibilities with regard to genetic materials than others, and that their views should be considered in consultations about best practices, regulations, and guidelines for the applications of assisted reproductive technologies.

The session on embryo selection that I chaired together with Australian scholar Andrea Whittaker prompted a discussion of the connections among assisted reproduction, genetic selection, and new germline gene editing techniques including CRISPR-Cas9. There was wide agreement among the participants that pre-implantation genetic diagnosis should be used only for serious medical conditions, wide concern about the cross-border reproductive market for non-medical sex selection, and a strong view that these genetic screening/selection technologies could negatively affect social values of equality, solidarity and diversity.

There was also wide concern about new genetic modification techniques posing the potential for an international market in genetic traits and for genetic stratification. Participants cited the principle of intergenerational responsibility – mandating that the interests of future generations are represented in considerations of these technologies – and encouraged international dialogue that includes civil society groups and community participation.

Image via Flickr

Previously on Biopolitical Times:

Race, Genetics, Society

Posted by Elliot Hosman on February 11th, 2016

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CGS Advisory Board member Dorothy Roberts on race and intelligence in genetic research

Important research that casts doubt on many uses of racial categories in genetic research is discussed in a recent article co-authored by CGS Advisory Board member Dorothy Roberts and published in Science.

Taking race out of human genetics, Michael Yudell, Dorothy Roberts, Rob DeSalle & Sarah Tishkoff, Science (Feb. 5, 2016), Illustration by Davide Bonazzi.

The perspective piece begins by citing to scientists and historians who undermined the scientific validity of the concept of biological race—including W. E. B. DuBois some 100 years ago.  While the Human Genome Project found that humanity was 99.9% genetically the same, the authors note an uptick since 2000 in the use of race in genetics research as a data stratification factor. To avoid confusion, they helpfully define two separate but often conflated concepts: ancestry (“a very personal understanding of one’s genomic heritage” based on individual lineage) and race (“a pattern-based concept” used to “draw conclusions about hierarchical organizations of humans”).

They put forth two recommendations:

  1. “Scientific journals and professional societies should encourage use of terms like ancestry and population to describe human groupings in genetic studies … Historical racial categories that are treated as natural and infused with notions of superiority and inferiority have no place in biology.”
  2. “The U.S. National Academies of Sciences, Engineering, and Medicine should convene a panel of experts… to recommend ways for research into human biological diversity to move past the use of race as a tool for classification in both laboratory and clinical research.”

In an interview on NPR, Dorothy Roberts noted:

As a social scientist, looking at biologists treating these groupings as if they were determined by innate genetic distinctions, I'm dumbfounded. There's so much evidence that they're invented social categories … It in many cases leads researchers down the wrong path and leads to harmful results for patients. … It's not only that there's scientific evidence that humans aren't divided into discrete biological categories we'd call races. But there's also evidence of the harm these biological meanings of race have caused for centuries.

Dorothy Roberts breaks down the widespread use of race to make false biological predictions in her new TedMed Talk, where she highlights problematic ongoing diagnostic practices, including some developed during the American era of—and in justification of—slavery.

In related news, Dorothy Roberts was cited in the National Geographic story, Are There Genes for Intelligence—And Is It Racist to Ask? regarding her work as a Fellow at The Hastings Center and their recent Report on the ethics of genetic intelligence research. Journalist Robin Marantz Henig paraphrases Roberts as saying that

any research that bolsters the hereditary concept of intelligence could actually hurt the disadvantaged, since it almost inevitably would be used to support ‘racist, classist, gendered notions of intelligence.’ The bottom line, to Roberts, is that studying the genetics of intelligence ‘cannot possibly be socially neutral—and in fact will intensify social inequities.’

For more on this and related points, see Roberts’ Can Research on the Genetics of Intelligence Be “Socially Neutral”? in The Hastings Center Report.

ACLS Public Fellow: CGS Project Director on Race, Genetics & Society

As we announced back in January, recent PhDs can apply to the American Council of Learned Societies (ACLS) Public Fellows Competition for a shot at joining CGS for a two-year position as Project Director on Race, Genetics & Society. We are eagerly looking forward to bringing a new colleague on board to grow our organizational work and capacity on the social justice implications of leveraging race in genetics research. You can find more information about the application process on the ACLS website, and learn more details about the position via this PDF. The application deadline is March 24, 2016.

CGS Resources on Race & Genetics

As a part of our communications program, we collect news and commentary on racial justice issues in human genetic and reproductive technologies. Here’s a sampling of some recent resources that you can find on the CGS website.

Recently in the news: 


Over the years, our staffers and fellows have produced a range of commentary on the intersection of race and genetic research. Key reports include Playing the Gene Card? : A Report on Race and Human Biotechnology by CGS Senior Fellow Osagie K. Obasogie, and a joint report we published with the Center for American Progress Geneticizing Disease: Implications for Racial Health Disparities[PDF] by Jamie D. Brooks and Meredith L. King.

Recent episodes of our online conversation series Talking Biopolitics have also delved into  issues of race in genetics, including:

Previously on Biopolitical Times:

Images courtesy of Elliot Hosman/CGS and ACLS

CGS Website Reboot: Seeking Your Feedback

Posted by Jonathan Chernoguz on February 11th, 2016

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This year the Center for Genetics and Society will be overhauling our website, and we’d value your suggestions as we embark on what we expect to be a major improvement.  

The new website will be implemented on an open-source platform, with a streamlined user interface and inviting design. Please take a few minutes to fill out this quick 10-question survey about your experience with the current CGS website and your suggestions about the new one.  

Your feedback is very important to us and we greatly appreciate your responses.

California’s Stem Cell Agency Considers “Editing” Human Embryos

Posted by Marcy Darnovsky on February 9th, 2016

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A committee of California’s state stem cell agency met on February 4 to consider whether it should fund genetic editing of human embryos, and if so, whether such experiments require any change of its rules or regulations.

Back in 2004, 59% of Californians voted to allocate $3 billion of public money to establish the California Institute for Regenerative Medicine (CIRM), persuaded by promises that stem cell-based cures were imminent, and by frustration about the Bush administration’s restrictions on federal funding of techniques that destroyed human embryos. Now, as CIRM considers whether to underwrite research involving the genetic modification of human embryos, decisions at the federal level are again playing a role. National Institutes of Health director Francis Collins said in April 2015 that it won’t fund such research because “altering the human germline in embryos for clinical purposes….has been viewed almost universally as a line that should not be crossed.”

CIRM’s mandate to support research that can’t be federally funded was mentioned several times during the February 4 Standards Working Group meeting. According to CIRM staffer Geoff Lomax, current agency regulations allow research using human embryos, but prohibit their reproductive use. Much of the discussion at the meeting focused on identifying questions that new gene editing techniques raise about the conduct of such research. The resulting list of issues includes whether the research should be funded at all, and if so, how the use of modified embryos to initiate a pregnancy could be prevented. New considerations about informed consent from people donating gametes and embryos for research were also raised. As a next step, a subcommittee will examine the identified issues and draft recommendations that the Standards Working Group will consider and then pass on to CIRM’s governing board.

The meeting was live-streamed, but the audio quality was so poor that remote participation was quite challenging. David Jensen’s California Stem Cell Report coverage of the meeting here and here includes the complete list of identified questions as provided by CIRM. An account by Kevin McCormack, CIRM's Senior Director of Public Communications and Patient Advocate Outreach, can be found here. And writing at Stat, Charles Piller put CIRM’s deliberations in a broader policy context.

Having attended the meeting, three points stand out for me as takeaways:

  • On the final panel of the day, Charis Thompson raised key issues about CIRM’s ethical and social responsibilities. Her invited presentation included reminders that CIRM is mandated to serve not only patients with unmet medical needs, but also the taxpayers and voters of California; that disability justice experts as well as patient advocates should be consulted about gene editing directions; that CIRM should ensure that the work it funds does not exacerbate health disparities; and that if evidence of health disparities or eugenic trends emerges, “real consequences” must ensue.  She concluded by saying that “It is not `anti-science’ to note that historically, slopes are indeed slippery,” and that “California deserves – and can have – both the best science and the best ethics.”
  • Jeff Sheehy, a member of both the Standards Working Group and CIRM’s governing board, is quite concerned about the following prospect: CIRM might decide to fund research involving the genetic modification of human embryos but then have little recourse if grantees used other funds to initiate a pregnancy. “Where does our reach start and end?,” he asked. “Does it start at the purpose of the proposed research? Do we just say you can’t implant?” Sheehy suggested that if CIRM approves any grants for research that would produce modified human embryos, it include as a contractual requirement that those embryos cannot be used to initiate a pregnancy, whatever the funding source for that final (and trivial) step.  
  • Finally, an unsettling (if unsurprising) note about David Baltimore, who has played an influential role in the current controversy about germline gene editing and who chaired the organizing committee for last December’s International Summit. In previous comments about human gene editing, Baltimore has talked about responsible science; at the CIRM meeting, he came out explicitly in support of human germline modification. In his invited presentation, he said – as if this were a matter of scientific fact – that the desire for biologically related children is genetically hard-wired. He acknowledged that people at risk of transmitting genetic disease can already almost always have unaffected children in a variety of ways, and that therefore germline gene editing would at best benefit very few. But, he continued, "there are circumstances where it is the only opportunity for doing what a patient wants....To me, that’s sufficient reason to bring it to clinical use."

Composite image via CIRM and National Academies.

Previously on Biopolitical Times:

Israeli Parents, Indian Surrogates, a Nepali Earthquake, and "Cheap White Eggs"

Posted by Diane Beeson, Biopolitical Times guest contributor on February 8th, 2016

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The typical media story about transnational commercial surrogacy presents the process as a creative solution for people who could not otherwise do so to become parents.  The experience of the women whose bodies are used to nourish and develop these babies, and who give birth to them, remains a back-story. But in a recent Radiolab episode, a chance encounter and a momentous earthquake coincide to reveal rarely examined layers of complexity in this oft-told fairy tale.

Two Israeli men, Tal and Amir—legally excluded only by virtue of their sexual orientation from hiring an Israeli woman to bear children for them in their own country—discover that they can do so through an agency that hires Indian and Nepali women. Of course they have to obtain eggs from women with more desirable physical attributes. They soon learn that “cheap white eggs” can be obtained from the Ukraine.

All of this is managed successfully. That is to say, they now have three children, each of whom has the genes of one of them as well as the genes of an unknown, tall, young, Ukrainian woman. And they have three more embryos in a freezer in Nepal.  So why, looking back on the experience, did they say: “We feel like suckers”?

The men claim, as do many commissioning parents, that they did not want to be part of an exploitative process. Yet they seem to have given little thought to the provider of those “cheap white eggs”—only that their child’s genetic mother’s height and physical appearance fit their specifications. They pay somewhat more attention to the birthmother. They were told that the amount of money that she would receive would change her life. It would enable her to buy a house or send her children to a university. They concluded “if it’s a life changer, it’s not exploitative.” Issue resolved.

While Amir and Tal were in Nepal to pick up their third newborn they had a chance encounter with another “surrogate” away from the watchful eye of the intermediaries. They concluded from what she told them that the women were receiving only a fraction of the amount that commissioning parents were led to believe. They explained they would have made more inquiries, but the next day a major earthquake struck Nepal killing 7000-10,000 and injuring many thousands more.

Amir and Tal’s newborns were among the 24 babies TV cameras showed being evacuated to Israel. The babies were saved, but the fate of their birth mothers – and of other women who were still pregnant under contract – is unclear. The earthquake revealed a pipeline of scores of babies moving from Nepal to Israel, and led the Nepali government to ban commercial surrogacy.

Efforts to follow up specifically on the fate of Tal and Amir’s surrogates were suspended when they were told that these inquiries jeopardized the lives of the women.  To the credit of Radiolab, they sought out a Nepali journalist in an effort to learn more about other women who participate in such arrangements. They found that these women sometimes receive as little as $1000, and often well less than half the $12,000 the Israeli men had been led to believe their surrogates would receive. They learned that the contract language, which reads “Payment for surrogacy services,” apparently includes many other recipients: middlemen, and middlemen who have middlemen. Furthermore, the women, who are given a variety of potentially harmful drugs prior to implantation, are paid only a small amount each month of the pregnancy, with the bulk of the agreed upon amount paid only once the birth is completed. In the event of miscarriage – a not-infrequent occurrence – she receives nothing more.

Notwithstanding the poverty and inequality that drive women to agree to “rent their wombs” and to trade on their skin color to sell their eggs, the Radiolab reporters expressed admiration for “the inventiveness of people.” One of them dubbed it a “kind of symbiotic benefit” explaining, “Okay, it’s not the crazy amount of money we thought it was," but  . . . “they chose to do this . . . in some ways they are in charge of deciding how they want their life to be.”

Writing about the Radiolab story under the title From IVF to Designer Babies, Technology Is Not Colorblind, Princess Ojiaku points out:

There are wider issues at work here — issues of class, financial power, transnationalism, and racial hierarchies — but they go mostly undiscussed in the service of presenting how wonderful it is that this technology is available for those that can afford it.

In this case, securing “cheap eggs” from an economically depressed white country and placing the resulting fetus into the body of a woman of color— who has chosen to rent out her womb for an acceptable price—mitigates the high cost of producing a white, biological child. It’s clear here that the couple’s desire isn’t simply for a biological child, but for a white biological child—something that’s a little eerie in practice when a woman of color bears a white baby simply because it’s cheaper.

This is one of the many questions about transnational commercial surrogacy that this episode manages not to really address. Among the others:

  • Why is so little attention given by journalist, policy makers and others to the social conditions that give rise to transnational commercial surrogacy?
  • Why is so little attention given by journalists, policy makers and intended parents to the consequences of commercial surrogacy for the women involved?
  • Why aren’t investigative reporters looking into the practices of the “middlemen who have middlemen” and all the others profiting from these commercial surrogacy arrangements?
  • What about the providers of those “cheap white eggs?”  What do they understand about the risks this process poses to their health and fertility?
  • What kind of follow-up medical care is provided to women whose bodies are mined for eggs and women who serve as surrogates?
  • How will infants, often born weeks early as Tal’s twins were, and separated from their birth mothers so abruptly, only to be placed in the hands of an intended parent “terrified to touch them,” fare physically and emotionally?
  • Why should the desire for a genetic connection to one’s child be respected in adults who are willing to deprive their child of the possibility of knowing their genetic and gestational mothers?
  • Does the moral acceptability of this process depend on the amount of money paid to a woman for going through it, as Tal and Amir concluded?
  • Once we accept turning human reproduction into a business with clear eugenic dimensions, as Tal and Amir described in choosing their egg provider, where do we draw the line on future genetic manipulations?


Diane Beeson is a fellow at the Center for Genetics and Society. She is Professor Emerita of Sociology, California State University, East Bay. Over the past three decades, she has conducted research and published in leading sociology and medical journals on prenatal diagnosis, genetic testing, and social challenges of new reproductive technologies, most recently, on issues related to third-party reproduction. Beeson is co-founder and Associate Director of the Alliance for Humane Biotechnology, a network of scholars, students and activists working for a biotechnology that places the health and welfare of people and the natural environment above financial interests. She received her PhD from the University of California, San Francisco, where she specialized in medical sociology.

Composite image via Radiolab and Pixabay

A Monkey Circles in a Cage

Posted by Elliot Hosman, Biopolitical Times on January 29th, 2016

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Monkeys with Autism?

“…first ever nonhuman primates to show autism-like symptoms in the lab.”

On January 25, news broke widely in the press on research published in Nature by a team in Shanghai, who spent six years creating two generations of macaque monkeys engineered to have duplications of the MECP2 gene in their brains—a gene that researchers have associated with Rett Syndrome, a condition on the severe end of the human autism spectrum.

Trans-cranial Magnetic StimulationThe researchers listed a battery of behavioral tests which they claimed as evidence that the transgenic monkeys were now genetically predisposed to autism-associated behaviors. In a press briefing organized by Nature, Zilong Qiu, a leader of research at the Institute of Neuroscience at the Chinese Academy of Sciences, stated plans to leverage their research into human clinical trials down the line, with the aim of developing somatic gene therapies or non-invasive interventions like trans-cranial magnetic stimulation [Wiki] to correct autism in humans. Qiu stated the researchers are currently trying to identify the brain circuitry responsible for what they believe is the monkeys' changed, autism-like behavior; after that, they plan to use CRISPR-Cas9 gene editing to manipulate the MECP2 duplications in the transgenic monkeys they created.

With “autism,” “transgenic,” and “monkey” in the headlines, it’s not surprising that a flurry of media coverage might flatten the social and ethical implications of what’s at stake with using animals models to study stigmatized human behavioral conditions. One article was promoted on Twitter asFirst Monkeys with Autism are Sickly Loners Who Pace Their Cages.” Comments on that article included: “I have a child with autism and even I find what you are doing to these monkies [sic] repulsive. This is a sad commentary on science and our society.” …“I have a daughter with autism, and I find this to be very disturbing!!!” … “I'm autistic, but I don't need to be cured, thank you very much.”

The Limits of Animal Models in Studying Human Behavior

While unvalidated claims that vaccines cause autism are ongoing, scientists have been motivated for some time to clarify genetic bases for autism spectrum disorders. Some estimate that hundreds of genes are involved, many assert that environmental factors may also be at play, and many others assert that the majority of “disorders” classified as autism (and targeted by market-driven drug trials) are just points on the spectrum of human neurodiversity that we ought to be de-stigmatize and de-medicalize.

Most articles on the transgenic monkeys cited scientists who agree that cheaper, quicker mouse models have severe limitations in studying human behavior. Yet a number of reporters, or the scientists they quoted, pushed back on the claims of the study. David Cyranoski in Nature quoted stem cell and autism researcher Alysson Muotri, who stated that symptoms in mice and monkey animal models for autism are often “less severe than ‘what we actually observe in human patients… It remains to be seen if the model can actually generate novel insights into the human condition.’” James Cusack, research director at Autistica, told Ian Sample in the Guardian that “people with autism vary in a number of ways, and autism itself is linked to a number of other conditions. With this in mind, developing a single animal model of autism may be difficult to achieve.” A number of reporters also cited MECP2 pioneer Dr. Huda Zoghbi’s critiques of the study, including: (1) the monkeys did not exhibit behaviors associated with MECP2 duplication in humans like seizures and severe cognitive problems; (2) the monkeys’ circling behavior in their cages is a symptom not exhibited in human children with MECP2 duplications (perhaps the cage is relevant); and (3) the monkeys only carried MECP2 duplications in their neurons, not throughout the brain as in humans with Rett Syndrome.

The Ethics of Biomedical Research on Animals

Virginia Hughes in BuzzFeed discusses the pulse of clinical research moving from mice toward sentient non-human primates, linking to the recent debut of transgenic monkeys with a 2008 US study on the genetics of Huntington’s disease. The first transgenic monkeys made with CRISPR-Cas9 were reported by researchers in China in 2014. Hughes notes that research with non-human primates is “ethically fraught”; indeed the ethical pushback to genetic experimentation on monkeys and other animals is wide-ranging in recent news:

In just the last few months, this evidence shows a growing swath of concerns regarding animal research ethics that the biomedical sector will encounter as it moves forward with monetizing CRISPR gene editing and placing clinical applications in the research and development pipeline.

Previously on Biopolitical Times:

Image via Flickr/Vince O'Sullivan

Who's Looking to Profit from Human Germline Changes?

Posted by Pete Shanks on January 28th, 2016

Intrexon logo

The National Academies summit on human germline gene editing has dominated discussion over the last few months, with talk about international agreements and a voluntary moratorium or formal ban. But perhaps those of us concerned about the prospect have been looking in the wrong direction. Consider this scenario:

A multi-billionaire becomes fascinated by synthetic biology. He starts with a fairly small company, and decides to turn it into a big one without using venture capital. His goal is to make it "the Google of the life sciences." Among the acquisitions and partnerships he makes are:

  • a company developing personalized cell and gene therapies using iPS cells
  • an animal cloning company (both the agricultural and pet markets)
  • a biopharmaceutical company focused on cancer immunotherapies
  • a drug development and delivery company
  • a company that makes genetically modified fish (even before selling them was legal)
  • a company that makes sterile mosquitoes in order to effect permanent germline changes
  • a company that makes genetically modified apples
  • a company pushing hard into multiple IVF markets around the world, with
    • products not currently legal in the U.S., and
    • research into human egg precursors with the explicit intention of producing hundreds of eggs and possibly embryos — and the ambition of editing them

In short, lots of private money, deep connections with the pharmaceutical industry, a major focus on synthetic biology, a willingness to jump borders for legal convenience, a deep interest in reproductive technologies, and the clear intention to work on "enhancing" embryos.

That could turn into a nightmare. But it's real, and it's happening now.

The billionaire is Randal Kirk, the main company Intrexon, which cannily snagged the URL The iPS company is Fibrocell; the cloning one is Viagen (part of Trans Ova Genetics); the (disappointing so far) biopharmaceutical is Ziopharm; the drug company is Halozyme; the fish are AquAdvantage salmon made by AquaBounty; Oxitec makes the sterile mosquitoes; the Arctic® Apple was developed by Okanagan; and the IVF company is the extremely controversial OvaScience.

Kirk, a lawyer by training, made his first fortune ($65 million) with a medical supplies company; his first big one with New River Pharmaceuticals (he cleared $1.2 billion); his second with Clinical Data (roughly $600 million); and his third when he took Intrexon public in 2013 (his shares have been valued at $1.5 billion). He avoids outside venture capital, and held onto over 60% of Intrexon; the success of its IPO may have been largely because of his existing reputation.

Clearly Kirk bought Intrexon as a way into synthetic biology. Its founder, molecular geneticist Thomas Reed, positioned what was originally called Genomatix as a gene-tools or DNA-parts venture, but Kirk had much broader ambitions (yes, the Google quote was his, though he said it before Google became the Google of the life sciences). In a 2011 profile, Forbes also reported Kirk's prediction that:

in a decade it [Intrexon] could become "the largest, most significant company" in its burgeoning field.

He could be right.

Of course, he also might not. Indeed, Viagen was a spin-off from Genetic Savings and Clone (GSC), a pet cloning company that was set up by the billionaire John Sperling. GSC was finally abandoned, partly for technical and ethical reasons and above all because it was not commercially viable.

Intrexon and OvaScience

Last April, MIT Technology Review noted that OvaScience intended to "correct [harmful genetic] mutations before we generate your child," and Motley Fool pointed out the potential synergies between OvaScience and Intrexon, focused on a joint venture called OvaXon, described on the Intrexon website thus:

The joint venture looks to create new applications for improving human and animal health. Under the joint venture, OvaScience's EggPC platform will be combined with Intrexon's genome engineering capabilities with the goal of offering an innovative approach for the prevention of inherited diseases in humans, such as mitochondrial and other genetic disorders.

The technology behind OvaScience is scientifically controversial, ultimately based on the disputed discovery of "egg precursor cells" that "have the potential to develop into mature eggs, thereby replenishing a woman’s egg supply." Its main product at present is Augment, which "uses the energy-producing mitochondria from your own egg precursor (EggPC℠) cells … to supplement the existing mitochondria in your eggs" and thus supposedly improve fertility.

One of the founders of OvaScience told a stock analyst last spring that using CRISPR in germline engineering was not on the current agenda ("they have enough headaches at this point") but they do admit to being aware of the potential to use it that way.

The FDA will not allow Augment to be sold in the U.S. without clinical trials. However, it is sold in Canada, where the first baby was born after that treatment in May, 2015; and also in Japan, Turkey and Dubai. A British IVF clinic is applying for permission to use the procedure "in a pilot trial involving about 20 women."

Permission may not be granted in the UK — Robin Lovell-Badge, for one, is extremely skeptical — but the attempt illustrates the difficulty of establishing, let alone enforcing, international standards. The company is trying to pressure the FDA by creating consumer demand here with promotional stories from abroad.

Intrexon and its subsidiaries have other experience with transnational evasion techniques: AquaBounty was an American company, founded in Maynard, MA, and incorporated in Delaware, that set up in Canada to create eggs that would be grown in Panama. It nearly went bust until Kirk bought in.

Kirk is arguably "Biotech's Best Investor." He's clearly a technophile and definitely thinks that synthetic biology is the future — he's called his partner Reed "the Henry Ford of DNA" — but he does not seem to be primarily an ideologue; he wants to make another boatload of money.

So what's to stop Kirk and his companies and allies, or people like them, from developing a germline "enhancement" technology that they could introduce in, say, Dubai and promote everywhere else?

[This post was edited on January 30th to include Oxitec, previously omitted by mistake.]

Previously on Biopolitical Times:

Genetic Issues at the London Sperm Bank

Posted by George Estreich, Biopolitical Times guest contributor on January 22nd, 2016

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On December 29th, 2015, the Guardian reported that the London Sperm Bank is being investigated for discriminating against people with disabilities. The bank had turned away a man with dyslexia; it had published a 2010 pamphlet with a long list of disqualifying “neurological diseases,” including dyslexia, autism, ADHD, and other conditions.

Vanessa Smith—described as a “quality manager at the JD Healthcare Group,” the bank’s parent organization—defended the bank. Backpedaling without budging an inch, she said that the pamphlet had been withdrawn and policies would be reviewed. Still, little seems likely to change. According to Smith, “We are looking for someone who is medically clear of infectious diseases and genetic issues that may possibly be passed on to any resulting child.” She also claimed, “We definitely don’t work in eugenics.” She may mean something like, “In the popular mind, ‘eugenics’ is associated with Nazis, an association we wish to avoid.” But to shape future children, based on a policy that describes human variation as disease, is by definition eugenic. The bank’s currency is genes, and it wants good ones.

Smith’s grouping of “infectious diseases” with “genetic issues” is significant. Both are disqualifiers: in the view of the London Sperm Bank, they make the sperm unsuitable to produce a future human being. In the Guardian article, people with dyslexia were quoted, questioning the Bank’s criteria. My interest is less in the specific items on the list, or in the need for one—of course a prospective mother would prefer to have a child free of, say, hepatitis-C—than in the neutral, euphemistic vagueness of the phrase genetic issues, and the way it tends to pathologize human variation. (When I think of our rapidly increasing, fine-grained knowledge of human genetic variation, and the pressures that turn said variations into Issues, I imagine the pans of a giant balance. On one side is the gigantic and growing pile of genomic data, and on the other side is an equally gigantic but correspondingly undifferentiated idea, a blobby sense of abnormality stuffed into a neutral-sounding word, like issues. Even as we generate specificity, we generate vagueness, ideas and words capacious enough to suggest all that is different from an undefined norm, and therefore undesirable.)

Specifics imply caring. To lump together a vast array of conditions as “genetic issues” suggests an unconcern about the radical differences between said conditions, and a lack of interest in exploring the question. (Of course, the ability to predict and select makes precisely those explorations necessary.) Conversely, the pamphlet is obsessively specific about Different Brains, even to the point of redundancy: forbidden are ADD and ADHD, autism and Asperger’s (yes, a special Not Welcome Mat is spread out for you, high-functioning Different Person), and both “mental retardation” and Down syndrome. Since men with Down syndrome are thought to be sterile, the prohibition seems—well, let’s just say it’s on the cautious side.

Disease and disability are different but overlapping categories. There is no tidy division between them. But the (evolving) criteria of the London Sperm Bank pathologize pretty much everything not nailed down. Autism is not a disease. Neither is dyslexia. Neither are unambiguously genetic, in the way that Tay-Sachs or Down syndrome is. Cerebral palsy can occur without genetic influence at all. But since these conditions may have a significant genetic component, they’re on the list. This is the one-drop rule for the new millennium: any hint of a disorder that may or may not be genetic is, in this scenario, sufficient to disqualify its bearer. The London Sperm Bank’s approach to human difference can be thought of in terms of Russian nesting dolls: inside Difference is Medicalization, which opens to reveal Geneticization.

We are always thinking/not thinking about disability, it is always just beneath the surface of our days and discussions, and I am interested in the places where our ideas break into the open. Discussions of future humans provide one place: they are virtual arenas of the normal and abnormal, where our assumptions bubble up to the surface. Because we seem to be discussing only the prospect of dyslexia or mental illness, and not specific people with those conditions, no actual person appears to be directly harmed. We are only discussing an A vs. B scenario, one where A (a future human without dyslexia) appears clearly preferable, the better choice. All other things being equal, that is.

This is flawed for several reasons, the first being that all things are never equal; the second being that we are talking about present people with dyslexia when we imply dyslexia is serious enough to disqualify a future person; and the third being that actual people with different brains are being discriminated against in the present: in the minor way of not being allowed to donate to a specific sperm bank, and in the major way of being publicly described as lesser humans, as unwelcome.

George Estreich received his M.F.A. in poetry from Cornell University. His first book, a collection of poems entitled Textbook Illustrations of the Human Body, won the Gorsline Prize from Cloudbank Books. His memoir about raising a daughter with Down syndrome, The Shape of the Eye, was published in SMU Press’ Medical Humanities Series. Praised by Abraham Verghese as “a poignant, beautifully written, and intensely moving memoir,” The Shape of the Eye was awarded the 2012 Oregon Book Award in Creative Nonfiction. Estreich lives in Oregon with his family.

Previously on Biopolitical Times:

Image via Pixabay

Why Is Editas Going Public?

Posted by Pete Shanks on January 14th, 2016

Editas logo

Editas, the gene-editing company founded by several of the scientists who developed CRISPR technology, announced on January 4th that it had filed preliminary paperwork for a public offering of stock. The filing with the Securities and Exchange Commission is extremely long, but lacks certain vital details, For instance, some clearly unanswered questions are:

  • How much cash does Editas hope to raise? There is a placeholder number of $100 million, but that is very likely to change dramatically.
  • When will this take place? "As soon as practicable after this Registration Statement is declared effective."
  • Will anyone be cashing in? "A significant portion of our total outstanding shares is restricted from immediate resale but may be sold into the market in the near future."

The Economist response seems acute:

As difficult sales pitches go, this one is hard to beat. This biotech company has burned through $75m in the past few years and has not yet started clinical work on a drug candidate. It says it will be many years, "if ever", before it has something ready to commercialise. If this were not enough, not only is there a thorny patent thicket to manage but the firm must fight and win a case seeking to overturn its own intellectual-property claims on the ground that it was not the first to invent them.

The prospectus does include some new information, including the gossipy history that the company was originally incorporated as Gengine. (Gene-engine? Could we have been spared the whole "editing" metaphor? Probably not.) There is certainly more detail about its product plans and, if you can read the tables correctly, current shareholders, the largest of which, per Xconomy's summary, are all venture capital funds:

16.6%   Flagship Ventures
15.6%   Third Rock Ventures
15.6%   Polaris Venture Partners
  9%      Bng0 (a Bill Gates-affiliated fund)
  5.7%   Viking Global
  5.7%   Fidelity
  5.7%   Deerfield
  4.8%   CEO Katrine Bosley

The prospectus confirms that Editas hopes to begin clinical trials on a therapy for Leber congenital amaurosis in 2017. That disease, which affects 2–3 per 100,000 newborns, is listed by NIH as being associated with at least 14 genes. Mutations in CEP290 (the Editas target, also known as LCA10) account for 15–22% of cases.

Being able to claim that the blind shall see is of course a great selling point, but even if the proposed treatment works, no price has been set for it. (Spark Therapeutics, which may be a competitor, has in the pipeline at least one gene therapy product for LCA blindness that seems likely to cost $500,000 per eye.)  Presumably this is more of a proof of concept for Editas than a big moneymaker.

Editas is not the only gene-editing firm considering raising money on the stock market. Intellia, one of the companies founded by Jennifer Doudna, co-author of the first published paper on the technology, has been rumored to be "IPO-ready." CRISPR Therapeutics, founded by Doudna's co-author Emmanuelle Charpentier, is at least considering one, according to CEO Rodger Novak, who noted wryly that

Coming late to this party is not very smart.

Meanwhile, the patent wars are coming to a head. In headline terms, that's a fight between Feng Zhang of Editas on one side, and Doudna (and Charpentier) on the other. Doudna was also a co-founder of Editas, along with Zhang, George Church and others, but withdrew when the patent dispute arose. The Patent Office has officially declared an "interference" and Doudna seems to be a slight favorite at present. (UC Berkeley is favored over the Broad Institute and MIT.) Both sides have stated that the technology will be freely available to researchers, but commercial licenses could be very, very lucrative. When this all ends is unclear.

The business of business is, of course, business, and far be it for those not expert in such matters to criticize decisions about going public. But Editas is said to have at least two years' cash on hand, and the current investors might even snap up the shares on offer.

So why now? Is this all about striking while the publicity is hot?

Previously on Biopolitical Times:

Coming Up at CGS in 2016

Posted by Jonathan Chernoguz on January 14th, 2016

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As 2016 gets underway, we’re noticing how deeply last year’s events are shaping the start of this new year. You can catch up with developments in inheritable genetic modification, genetic testing & biobanks, stem cells, synthetic biology and surrogacy in our Biopolitical News of 2015 blog post. We also compiled our favorite commentaries in Top Biopolitical Times blog posts of 2015.

Online conversations

In 2015 our Talking Biopolitics webinar series featured online interviews with

To watch any of these conversations, check out our YouTube page.

We’re looking forward to kicking off this year’s Talking Biopolitics on Tuesday, January 26 with Paul Knoepfler, author of the just-released GMO Sapiens: The Life-Changing Science of Designer Babies. Paul will discuss the book and its implications with historian of science Nathaniel Comfort. You can RSVP here, and check out the Facebook event for updates.

Film series

Coming up next in our Being Human in a Biotech Age film series at UC Berkeley is No Más Bebés. The film documents the coercive sterilization of Mexican immigrant women in 1960-70s Los Angeles, and the landmark lawsuit they brought against those responsible. The screening will take place on Tuesday, February 16th at 4 pm in 470 Stephens Hall. We are very fortunate that we’ll be joined in person by filmmakers Renee Tajima-Pena and Virginia Espino for a Q&A following the screening. You can learn more about the screening at the Facebook event.

On Tuesday, April 12, we’ll be screening DNA Dreams. This documentary explores the inner workings of Shenzhen BGI (formerly Beijing Genomics Institute), which calls itself "The World’s Largest Genomics Organization,” and its animal cloning and cognitive genomics projects.

If you’re interested in other films with biopolitical themes, the earlier screenings in the Being Human series were FIXED: The Science/Fiction of Human Enhancement, Made in India, and Surviving Eugenics.

Job openings at CGS

The new year will also bring a new position to CGS. We have been selected as a host organization for the the American Council of Learned Societies Public Fellows Program, which allows us to seek a Project Director on Race, Genetics, and Society. The ACLS fellowship application process is open for recent PhDs in the humanities or humanistic social sciences. The fellowship competition will accept applications between January 14 and March 24; all applications must go through ACLS. The Project Director on Race, Genetics, and Society will plan, coordinate, and implement CGS’s programmatic work related to the impacts of genetic research, technologies, products, and services on social understandings of race and on racial justice, with the goal of tracking and contesting the re-emergence of race as biological rather than sociopolitical category.

Other positions will be posted soon. For more information, visit our Jobs and Internships page.

Image via Flickr/Dafne Cholet.

Previously on Biopolitical Times:

The Third Rail of the CRISPR Moonshot: Minding the Germline

Posted by Elliot Hosman, Biopolitical Times on January 13th, 2016

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As the 2015 news cycle ground down and rebooted for the new year, a wide swath of news publications—industry, research, scientific, and popular—declared CRISPR gene editing to be one of 2015’s biggest stories. In the new year, an ongoing CRISPR concern is how we can strengthen and brighten the line of policy and practice that cautions against creating genetically modified human babies.

Much of the news since the #GeneEditSummit in December has focused on a very different application of CRISPR: producing therapies for patients living with genetic conditions. Jaw-dropping investment news is issuing forth as multiple biotech firms team up with drug companies and venture capitalists to bring the CRISPR moonshot of gene-editing therapies into view.

While CRISPR coverage doesn’t always make it clear, many of the leading gene-editing companies have clearly stated that they’re aiming to treat genetic disease in one consenting patient at a time, not on a population level, and not in a fertility clinic for prospective parents seeking to tailor the genetic variants they pass on to their future children. Several key players in this lab-to-market push have spoken out forcefully:

Sangamo Biosciences (key figure(s): Edward Lanphier, CEO/president)

Early in 2015 as rumors were circulating that scientists were experimenting with the CRISPR/Cas9 technology on human embryos, some biotech figures stepped up proactively to make their concerns heard.  Edward Lanphier, CEO/president of Sangamo Biosciences (using older gene-editor Zinc Fingers to develop HIV/AIDS gene therapies), published an article in Nature with colleagues from the Alliance for Regenerative Medicine entitled “Don’t edit the human germline.” The article describes the use of CRISPR  gene editing in embryos to create edited humans as “dangerous and ethically unacceptable” and says “[w]e are concerned that a public outcry about such an ethical breach could hinder a promising area of therapeutic development, namely making genetic changes that cannot be inherited.” Recently, Sangamo announced that the FDA had approved its new hemophilia drug application for what could be the first in vivo clinical trial of a gene editing technology.

Intellia Therapeutics, Caribou Biosciences (Jennifer Doudna) and CRISPR Therapeutics (Emmanuelle Charpentier)

Intellia Therapeutics and CRISPR Therapeutics, two companies founded by CRISPR co-discoverers, released a statement [pdf] on the first day of the National Academies’ summit on human gene editing that said in part:

[G]ermline gene editing is outside of the scope of our companies’ research and development. We are dedicated to discovering and developing gene editing-based treatments for serious diseases using only non-germline somatic cells. This is the greatest area of patient need, where the benefits and risks are best understood, and where the ethical support is unambiguous. … [W]e are committed to … [r]efraining from directly modifying germline cells, including sperm, egg or embryonic tissue, or developing any clinical applications of germline gene editing.

Jennifer Doudna and Emmanuelle Charpentier have held this view for some time.

A few weeks after the Sangamo et al. Nature article, Doudna joined a cautious-yet-optimistic statement with other scientists that asked for a pause in CRISPR germline research in order to engage in broad public debate. In Doudna’s personal and professional capacity since “A prudent path forward for genomic engineering and germline genetic modification,” [pdf] she has expressed more extensive reservations. There’s the Hitler dream she recalled to Michael Specter in The New Yorker, and the article she published in Nature on the first day of the #GeneEditSummit that argued against editing the human germline because of “the unknown social consequences” and our limited knowledge of the “technology” and “the human genome.”

Emmanuelle Charpentier has gone further, telling BBC in September “Personally I don't think that it is acceptable to manipulate the human germline for the purposes of changing some genetic traits that will be transmitted over generations,” and telling New Scientist in December: “I hope that using the technology with the idea of changing human characteristics will not be pursued. …  Philosophically and sociologically speaking, I have lots of issues with this.”

In New Scientist, Charpentier also noted, “[T]here is money involved, whether I like it or not.” Indeed. A few weeks later news broke that Charpentier’s company CRISPR Therapeutics had penned a five-year $350 million joint venture with German drug firm Bayer to develop “new delivery technologies” to overcome a big gene therapy obstacle: getting CRISPR into the cells of targeted tissues. Doudna’s firms, meanwhile, are also teaming up with major investors. Caribou has formed “strategic alliance[s]” with two giants, chemical manufacturer DuPont to develop a variety of fields including industrial, agricultural, animal and antimicrobial applications of CRISPR, and drug developer Novartis which will be working with Caribou’s offshoot company Intellia to pursue human therapeutics, while also collaborating with Caribou in research.

Editas Medicine (Feng Zhang, CEO Katrine Bosley)

The first CRISPR company to file to go public still hasn’t made it clear where it stands on the germline controversy. Asked by Nature in May [pdf], Editas co-founder and CRISPR co-discoverer Feng Zhang noted, “[G]iven that many diseases might be treatable through somatic cell genome editing, it is unclear whether germ line editing is an appropriate solution.” In the same interview, Editas CEO Katrine Bosley stated,

The current question about CRISPR and germline engineering is far more complex [than mitochondrial replacement or 3 person IVF], and we don’t have a sense of the breadth of the implications, and we don’t understand the risks well. The technology’s progress now demands us to confront these questions, but that can’t be done quickly.

In recent coverage, Zhang is paraphrased as saying that “the importance of germline editing varies between groups of people, such as potential parents and policy-makers,” while noting that as a researcher, “we are not ready to use [CRISPR] for medical treatment, because there are issues with specificity and efficiency.” Yet neither Zhang nor Editas has voiced principled objections to allowing scientists, private companies, or others to engineer the genes we pass on to future generations. With money rolling in, they may not be worried about the fears of investors, but as a company racing to be the first to begin human clinical trials of a CRISPR gene therapy, they should probably be concerned about how the public will view their ambivalence on the germline question.

  * * *

Minding the Germline

Gene therapy companies know that there are numerous obstacles to overcome if they are to translate shiny and powerful new nano-engineering tools like CRISPR into accessible medical treatments down the line. Many remember Jesse Gelsinger, a teenager who died after a gene therapy trial gone wrong, and are aware that this tragedy cautions against the breakneck speed that the market dynamics of drug development engender. Researchers working in stem cell therapeutics—many of whom, like the scientists and biotech figures cited above, have called for a moratorium on germline applications of CRISPR—are also familiar with this tale.

Concerns about the safety and effectiveness of this new kind of gene therapy have been voiced by many, though hyperbole about Eradicating! All! Genetic! Disease! can still be found. Less widely acknowledged are questions about whether any treatments that are successfully developed will be affordable. In California, billions of dollars of taxpayer money have been invested into the California Institute for Regenerative Medicine (CIRM) in hopes of developing hugely hyped but so far nonexistent therapies; after ten years, two late-stage clinical trials are ongoing and may produce medically relevant results, but at sky-high prices.

While CRISPR is ubiquitous in some circles, it still hasn’t hit the public fan like stem cells did back in the 2004 presidential election. It is heartening to see biotech companies come out in very public ways against research and development aimed at engineering the human germline, but questions remain. Will this long-anticipated reboot of gene therapy deliver safe and effective treatments? Will the hundreds of millions of invested dollars—private money to be sure, but money chasing a scientific advance made in large part at public universities—lead to treatments that are accessible and affordable?

Previously on Biopolitical Times:

Image via Flickr/Richard Masoner

False Inevitabilities and Irrational Exuberance

Posted by Gina Maranto, Biopolitical Times guest contributor on January 8th, 2016

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Scans of media coverage carried out by CGS and others after the National Academies of Medicine and Sciences co-sponsored International Summit on Human Gene Editing in early December revealed that, for editors at least, it was a confusing event.  Some stories ran under headlines signaling that gene editing research had been given a green light [Science]; others said scientists were seeking a moratorium [The New York Times].

Since then, several disquieting themes have emerged online in mainstream media and science blogs. These include the phenomenal medical gains to be had from gene editing for somatic therapeutic interventions, with the attendant piquing of interest among venture capitalists in search of the next big profit-taking opportunity in biomedicine. 

There is also ongoing discussion of the desirability of “fixing” the human genome through reproductive genetic interventions.  Disturbingly, some commentators are touting the “inevitability” of human germline.  And a few powerful voices in science and bioethics seem to be at pains to prove that CRISPR-Cas9 modifications that aim to “improve” resulting offspring—eugenics by any other name—would be categorically different from any previous efforts of that sort because they would be driven by public demand rather than state mandate.

Take, for example, the December 22 Quartz piece whose headline trumpets that 2015 was “the year it became OK to genetically engineer babies.”  The article itself, by Akshat Rathi, makes less forceful claims about the “okayness” of designer babies, but does argue

[W]hen historians of science look back decades from now, they may well mark 2015 as the year genetically engineering humans became acceptable. That’s because, while the world was paying attention to the gene-editing summit, a more momentous decision had been made just a month earlier in the UK.

That decision was the British Parliament’s approval of regulations allowing so-called “three-person IVF” which produces heritable alterations in embryos, though via a technique that’s very different from gene editing.  Rathi goes on to predict:

Based on past progress, it is likely that genetic enhancements to humans will become a reality step by step. Just like mitochondrial replacement therapy, they will first appear for a very narrow purpose, such as curing single-gene disorders, and then, likely over many decades, we might reach the stage of creating those fabled designer babies.

Rathi is not alone in proclaiming the coming of the new age of genetic tinkering. For example, Michael Specter in The New Yorker, writes of CRISPR-Cas9, “Inevitably, the technology will also permit scientists to correct genetic flaws in human embryos.”

But is reproductive human germline editing inevitable?  Rathi offers an ostensibly well-founded prediction on past evidence, but errs in globalizing from the case of Britain.  Specter forecasts from a more gee-whiz angle.

Such decontextualized and ahistorical rhetoric does no one a service.  At this date in the world’s history, it is fatuous to contend that all technologies must be used because they are developed.  Technology indeed has an internal momentum, as individuals and industries seek to refine existing techniques and products.  But even path dependence—the tendency for newer innovations to build upon older ones—is not a given.  The history of invention is littered with cases in which old forms are abandoned completely (think CDs and VHS) or technologies are simply not deployed.

And Britain cannot be taken as a norm of any sort with regard to genetic policy.  Since the 18th century, the British have been fascinated by animal and agricultural breeding.  In the 19th century, Galtonian eugenics sprang from a particular cultural ground, combining longstanding classist, racist, imperialist, and liberal capitalist notions with biology to yield scientistic social policies—policies that were different not in kind but in degree from previous approaches to controlling the lower classes.

Despite the claim by many that after WWII British recoiled from eugenics, we know that is not true.  IVF developers Patrick Steptoe and Robert Edwards both voiced eugenic aims for their IVF research, and in the past ten years or so, a vocal and influential group of neo-eugenicist philosophers and biologists there have pushed a eugenics agenda and acted as boosters for germline interventions. 

One such advocate, Julian Savulescu of Oxford University, has even argued that to “save” humanity, we should pursue the elimination of “genes” for “aggression” and other “negative” traits.  Savulescu goes one step further by maintaining that would-be parents are morally obligated to make these kinds of interventions on embryos.

But when we look beyond Britain, the landscape appears quite different.  Modification of human embryos by whatever technique has been seen as problematic enough to have been prohibited in over 40 countries  and such interventions are anathema to many people, including scientists, in countries that do not yet have specific policies in place.  Rather than focus on inevitability, better to ask how, when, and by whom germline editing might be used.  Given the breadth of opposition, where would the drive come from for the wholesale policy changes that would need to happen to make germline editing a widespread reality?

So-called “patient demand” could be a factor.  As historian of science Daniel Kevles pointed out at the gene editing summit, eugenics was never limited to state interventions, but embraced widely by individuals.  In Politico recently, Kevles wrote,

What could happen now is likely to be far more bottom-up than the top-down, state-directed racial programs of the past—individuals and families choosing to edit their genes, whether to prevent illness or improve capacity or looks, and finding themselves encouraged to do so by what was absent in the era of eugenics: the biotechnology industry.

During and after the summit, reporters advanced the patient demand argument, seizing especially on the tearful plea during a comment session by Sarah Gray, from the American Association of Tissue Banks, who had lost a baby to anencephaly (a condition whose unclear genetic basis would make it ill-suited for gene editing), “If you have the skills and the knowledge to fix these diseases, then frickin’ do it.”

But is all patient demand really what it seems?  As Boston University sociologist Ruha Benjamin noted—referencing scientists’ campaign in 2004 for $3 billion in public funding for stem cell research in California—it is possible to leverage a “pro-cures” bias and to mobilize patients and their families to fight on behalf of scientists’ agenda.  At the gene editing summit, Benjamin suggested that patients could again be co-opted by scientists eager to move forward with both therapeutic and germline applications of CRISPR-Cas9.

The campaign in Britain over three-party embryos also prominently featured narratives of women afflicted with mitochondrial disease and their traumas and travails.  Such tales pull at the heartstrings and deflect attention from broader ethical considerations and, in some cases, facts.  As David King, who runs the watchdog group Human Genetics Watch, remarked when the UK’s fertility agency, the Human Fertilisation and Embryology Authority (HFEA), approved mtDNA work,

The decision is very disappointing, but comes as no surprise, since the HFEA can never say no to scientists.  These experiments are scientifically useless and morally very problematic. The research lobby has distorted the scientific facts in order to defuse criticism.

Although it has been described as exceedingly thorough—with several reviews by an expert panel, solicitation of views on ethical issues, surveys and calls for comment from the public, and debates in the House of Parliament—the HFEA process has also been deemed problematic by civil society groups in Britain and elsewhere.  And as CGS consultant Pete Shanks and CGS staffer Jessica Cussins found, the HFEA’s claim of “broad public support” for approving the techniques is misleading at best.

The gene editing summit, while billed as a “global discussion,” was also found wanting.  CGS’s Marcy Darnovsky and others in attendance (see, for example, presentations by Catherine Bliss and Ruha Benjamin) enumerated the many groups left out.  If the NAS is genuinely committed to “ongoing discussion,” as it has said it is, it should develop a robust framework for how and when those discussions will occur and implement measures for true inclusivity.  As David Corn of the Innovative Genomics Initiative at University of California has written, “We need to keep talking about gene editing. And by ‘we’, that means everyone, even across national boundaries. And everyone in all walks of life needs to be involved in the conversation.”


Gina Maranto is a fellow at the Center for Genetics and Society. She is Professor and Director of Ecosystem Science and Policy and Coordinator of the Environmental Science and Policy program at the University of Miami's Leonard and Jayne Abess Center. Her articles, opinion pieces, and reviews have appeared in Discover, The Atlantic Monthly, Scientific American, The New York Times, and other publications. She is the author of Quest for Perfection: The Drive to Breed Better Human Beings.

Previously on Biopolitical Times:

Composite image via Flickr/John Ward, Flickr/Rob Pearce, Flickr/Gennie Stafford

Biopolitical News of 2015

Posted by Elliot Hosman, Pete Shanks & Marcy Darnovsky, Biopolitical Times on December 22nd, 2015

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For controversy and consequence, no story in 2015 came close to the rapidly developing CRISPR-Cas9 “gene editing” tools, and the prospect of their use to modify the human germline. The 2015 wave of news about gene editing swelled to pervade many of our concerns, from inheritable genetic modification to assisted reproduction, from disability and racial justice to synthetic biology, from the legacy of eugenics to the general culture of biotech.

Of course, CRISPR wasn’t the only news of the year. The UK approved a form of inheritable genetic modification based on nuclear genome transfer techniques, based in part on a public consultation process that was represented as demonstrating broad support, but that actually did not. Biobanks and DNA databases grew ever larger, raising both hopes and concerns. Research on all kinds of stem cells continued, with a combination of advances, scandals, and major financial concerns. Products made using synthetic biology techniques began reaching the market. Cross-border surrogacy dominated the news about assisted reproduction.

The Center for Genetics and Society continues to work to raise public awareness, inform policy debates, and include a wide range of public interest perspectives in the regulatory and governance decisions that shape the way human assisted reproduction and biotechnologies develop. Here is a breakdown of highlights roughly grouped by topic:


In 2015, CGS’s core organizational concern about human heritable genetic modification moved from the realm of scientific fiction to a thinkable clinical prospect.

In February, the UK Parliament carved out an exception to its law prohibiting human germline modification, allowing the HFEA to begin licensing clinics to create children via “3-person IVF,” also known as mitochondrial manipulation or nuclear genome transfer. In the US, the FDA has asked the Institute of Medicine (now the National Academy of Medicine) to produce a consensus study about these controversial techniques; Marcy Darnovsky spoke at the committee’s first public meeting. A related technique, the unvalidated fertility “booster” AUGMENT, which adds mitochondria from ovarian stem cells into eggs during IVF, made its way into the fertility markets in Canada and Japan but not in the US; the FDA considers the cell transfer protocol an “experimental new drug.”

The gene editing tool known as CRISPR/Cas9 proliferated into thousands of labs and research papers. In April, researchers used CRISPR in non-viable human embryos, sparking an international debate as the prospect of genetically modified babies came into view. The NIH, the White House, and UNESCO [pdf], along with prominent scientists and biotech industry figures, voiced their opposition to the technology moving into use for human reproduction. CGS attended the three-day #GeneEditSummit co-organized by the U.S. National Academies; Marcy Darnovsky spoke on a panel about “societal implications.”

CRISPR-produced super-dogs, micro-pigs, more pigs, and hornless cows made headlines. A related technique called gene drive became a pressing concern, as scientists held out the promise of ending malaria by using germline editing to eliminate particular genes in wild mosquito populations.

The development of artificial gametes inched along this year, with press releases and news coverage emphasizing how the technology could create biokids for LGBTQ couples—despite the host of risky unknowns associated with creating eggs and sperms in a lab. Human cloning was back in the news, as the notorious stem cell researcher Hwang Woo Suk re-emerged from the shadows of past fraud and embezzlement to sign up with animal cloning giant Boyalife, whose CEO told reporters they have the technology to create human clones.


In a rush to monetize the genome, the direct-to-consumer genetic testing market saw regulatory, scientific, and ethical pushback throughout 2015. On the other hand, the FDA cleared 23andMe to offer a limited range of carrier tests, leading to big investment bucks for a company already scaling up. also began talks with the FDA about selling health data. The FDA cracked down on a range of blood and genetic medical tests that were avoiding oversight via an old exception for laboratory-developed tests, due to inaccuracies that have promoted unnecessary surgeries, put tens of thousands of people on unneeded drugs, and raised medical costs. 

President Obama’s Precision Medicine Initiative progressed towards its goal of sequencing a million American genomes starting in 2016, as California launched its own, despite concerns that the underpinnings of the projects remain dubious. Biobanks generally soared in size and scope, as national, international, law enforcement, for-profit, and for-research DNA storage proliferated around the world. Meanwhile reports of secret law enforcement requests that personal genomics companies hand over customer data circulated widely.

The supposedly exact science of DNA forensics was repeatedly called into question, as observers noted the tendency of criminal DNA databases to become feedback loops to incarcerate and re-incarcerate the same oppressed communities. DNA testing also reared its head in the Syrian refugee crisis and immigration, where genetic evidence is used in family reunification cases to promote a narrow definition of family.

In clinical care, preliminary results from seemingly successful gene therapy trials were offset by the likelihood that costs alone could forestall clinical utility. The fast-expanding availability of early non-invasive prenatal genetic testing led Ohio’s state legislature to consider an anti-choice bill that would ban abortions for fetuses with Down syndrome; disability rights and others who support reproductive rights questioned the assumption that women should be encouraged to terminate pregnancies after diagnoses of Down syndrome and other genetic variants; and clinicians and genetic counselors questioned the accuracy of the tests, especially when they reach beyond chromosomal aneuploidies or are used in routine rather than high-risk pregnancies.


Research on all kinds of stem cells continued, with a combination of advances, scandals, and major financial concerns. At least 200 clinical trials are under way, most of which seem to be safe and some are possibly, though not certainly, effective. Unfortunately, the number of unregulated clinics peddling unproven treatments continues to climb, to an estimated 100–200 inside the US, and many more in Mexico, the Philippines (which is cracking down on them) and elsewhere. The FDA, as Paul Knoepfler emphasizes, is not doing enough.

As treatments approach the clinic, the question of cost has become prominent. One stem cell-based drug that has been approved in Canada is likely to be priced at over $200,000. That could be a big blow to the efforts of the California Institute for Regenerative Medicine (CIRM) to reinvent itself by pushing hard for therapies, partly in hopes of extending its existence beyond 2020 when the money runs out.


This was the year that synthetic biology went so mainstream that it almost disappeared in plain sight: Much of the work referenced above on gene editing and gene drive is a form of synthetic biology, and many of the current regulatory issues are also affected by it. Indeed, the recent report that CGS and Friends of the Earth produced on Extreme Genetic Engineering and the Human Future began in 2014 as an introduction to synthetic biology, because back then most people didn’t know gene editing was so far along in development.

Now, products made using synthetic biology techniques are reaching the market [pdf], unlabeled and essentially unregulated. About a billion dollars has been invested in the last three years, and the Defense Advanced Research Projects Agency (DARPA) has been ramping up its spending on synthetic biology as a “strategic investment.” On a different scale, and perhaps worrying for different reasons, biohackers are getting into the concept of doing synthetic biology at home. And puff pieces now call biologists “the next rock star designers,” who inhabit (apparently without irony) a “brave new world.” No wonder they are so utopian in their thinking, not to mention undemocratic.


Cross-border surrogacy agreements continued to dominate the news about assisted reproduction. Nepal banned commercial surrogacy, following the lead of Thailand and India, and Mexico (vote in progress) may also limit surrogacy arrangements to heterosexual families living in the country who can demonstrate maternal infertility. Other repro-tourism zones are emerging; in Cambodia, the government is planning on curbing unregulated fertility practices.

Stories continued to emerge of unwanted babies left behind, exploitative baby farms, intended parents stuck in Mexico and Thailand while governments decide parentage, women dying while serving as surrogates, and surrogates in Nepal left in a post-earthquake danger zone while their gestational children were evacuated. Posing as a surrogacy client, a journalist had dinner with a broker who brought along a baby and offered it to sell it to her on the spot.

Uterine transplants were presented in the UK and American media as a would-be ethical alternative to surrogacy, although the risky transplant protocol comes with its own host of social and ethical concerns. Clinical trials have migrated from Sweden—where the first baby gestated in a transplanted uterus was born in 2014—to London and Cleveland where new transplants are expected to begin in 2016.

In 2015, CGS published Global Surrogacy Practices, a report based on the international symposium we co-organized in The Hague, and co-authored What’s In a Name? Variations in terminology of third-party reproduction. We organized a screening of the surrogacy documentary Made in India, followed by Q&A with the filmmakers, as part of our film series Being Human in a Biotech Age.

Previously on Biopolitical Times:

Image via Wikimedia

Top Biopolitical Times Posts of 2015

Posted by Elliot Hosman, Pete Shanks & Marcy Darnovsky, Biopolitical Times on December 20th, 2015

In 2015, CGS staffers and guest contributors posted 80 blogs at Biopolitical Times. Some were syndicated on our guest blog at Psychology Today, Genetic Crossroads.

Fourteen of our favorite posts plus a series by CGS staffers are shown below in chronological order. Scroll down for posts by our wonderful guest contributors.


Contributors and Fellows

A number of remarkable guest bloggers on Biopolitical Times contributed their commentary on a wide variety of issues during 2015. Not much for choosing favorites among our friends, we do want to extend our appreciation for their time and perspectives. In alphabetical order:

George Annas on inheritable genetic modification: The Moral Imperative for Psychologists

Naomi Cahn on donor gametes:The Rights of Donor-Conceived Offspring

Katayoun Chamany on precision medicine: New Rules Proposed to Address Privacy and Trust in the Precision Medicine Initiative

Nathaniel Comfort on inheritable genetic modification: Putting Ourselves in Harm's Way: Thoughts on Pinker and the Role of Bioethics

Colleen Cordes on synthetic biology: DIY Bio-Engineering: Disrupting Democracy

Gwen D’Arcangelis on biosecurity: U.S. Bioweapons Research: Are Anthrax Lab Accidents All We Have to Fear?

Sayantani DasGupta on donor gametes: Why Facebook’s Egg Donor Ads Freak Me Out (And Should Freak You Out Too)