Genetic Issues at the London Sperm Bank
Posted by George Estreich, Biopolitical Times guest contributor on January 22nd, 2016
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 Backpedaling without budging an inch, she said that the pamphlet had been withdrawn and policies would be reviewed.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, 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
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?
on Biopolitical Times:
Coming Up at CGS in 2016
Posted by Jonathan Chernoguz on January 14th, 2016
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.
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.
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
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