Old Songs, New Tests, and Expensive Children
Posted by George Estreich, Biopolitical Times guest contributor on February 20th, 2014
|The “distressed baby” Tim Armstrong blamed for benefit cuts. Photo by Deanna Fei|
On Thursday, February 6th, Tim Armstrong, the CEO of AOL, justified a restructuring of the company’s 401(K) matching plan by citing the sick children of employees. Two sick children, to be exact. At an internal town hall meeting, Armstrong claimed, "We had two AOL-ers that had distressed babies . . . that we paid a million dollars each to make sure those babies were OK in general.” Unsurprisingly, the backlash was substantial. Tone-Deaf CEO is a tune we all know, and Armstrong’s improvisation on the theme, like others in the genre, was both memorable and inelegant. The complex discordance of Caring (“OK in general”), Slashing (the benefit cut), and personal wealth (Armstrong’s salary last year: twelve million dollars)—not to mention the blaming-the-infants thing—was answered by a disapproving choir, tweeting and talking and commenting, more or less in unison. Armstrong has since apologized and restored the matching plan to its previous form.
Rising above the other voices was a personal essay published in Slate, and written by Deanna Fei, the mother of one of the babies in question. Fei’s daughter was born months premature, weighing less than two pounds, and her narrative exposes the euphemism “distressed” for what it is:
We were too terrified to name her, to know her, to love her. In my lowest moments—when she suffered a brain hemorrhage, when her right lung collapsed, when she stopped breathing altogether one morning—I found myself wishing that I could simply mourn her loss and go home to take care of my strapping, exuberant, fat-cheeked son.
Since Armstrong’s announcement effectively compromised Fei’s privacy, she essentially had two options. She could remain silent, thereby accepting Armstrong’s characterization of her daughter as a “cost,” or she could out herself, then speak for her child. She chose the latter, replying to his numbers with a story. In doing so, she makes clear that numbers are not enough, that cost and value are not the same.
Posted in Bioethics
, Biotech & Pharma
, Civil Society
, Genetic Selection
, Human Rights
, Personal genomics
, Public Opinion
, Reproductive Justice, Health & Rights
, Sequencing & Genomics
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Hwang's Patented Fraud and
Posted by Pete Shanks on February 19th, 2014
New Questions about STAP Cells
|Early detective work on|
one of Hwang's fakes
Jaws dropped around the globe last week when the U.S. Patent Office awarded Patent No. 8,647,872 to Hwang Woo-Suk and 15 Korean co-workers. The patent concerns a "human embryonic stem cell line prepared by nuclear transfer of a human somatic cell into an enucleated human oocyte." The astonishing part is that the whole world knows he faked it. More precisely, he faked some of the data in the papers originally published in Science in February, 2004 and May, 2005, both of which were formally retracted in January, 2006.
Hwang's motto at the time appeared to be "fake it til you make it," and he never withdrew the patent application. (He also committed numerous other ethical and financial crimes.) Indeed, he still claims that he succeeded in cloning human blastocysts and deriving embryonic stem cells.
By a strange coincidence, there are now swirling rumors about the STAP stem cells that drew attention earlier this month. The RIKEN research institute at which Haruko Obokata is based has launched an investigation into possible irregularities, following revelations of partially duplicated images, unearthed by anonymous bloggers.
That is exactly how Hwang's fraud was first discovered. Anonymous Korean scientists examined the images in his published work and noted anomalies on blogs. One is pictured, showing that a supposedly clonal stem cell was pictured in the same culture dish as one obtained from a fertilized egg. Soon, other bloggers picked apart the DNA analysis that purportedly proved the match with specific patients. Finally, Seoul National University (SNU) conducted a rigorous analysis that definitively established the frauds.
The STAP work is brand new, and at least some of the controversy may be normal post-publication review. Obakata and colleagues have admitted to "mistakes" with the images, but blamed late edits and her "extremely heavy workload." Still, other researchers do seem to be having difficulty duplicating the experiments, and informed opinion seems to be moving away from accepting the published results.
But what on earth is going on with the award of a patent for faked work? Jeanne Loring, the leading ESC specialist who has been deeply involved in challenging the stem cell patents held by the Wisconsin Alumni Research Foundation (WARF), explains:
My challenge of the WARF patents made me learn a great deal about patents and patent law, and trust me, the principles you cherish as scientists simply don't apply for patents.
The fact is that Hwang’s patent could impede further work on SCNT hESCs.
The patent owners may demand a licensing fee for use of any SCNT hESCs
and collect royalties on any commercial application of SCNT hESCs. This
is not out of the realm of possibility: those are the terms that WARF
imposed on blastocyst-derived hESCs, but at least those were real.
New Scientist (which is actually cited in the Hwang Patent) noted in 2006 that Hwang could still get his patent in some jurisdictions, or at least establish permanent prior disclosure. Indeed, Canada actually awarded Hwang a patent in 2011, though the general view, even in Korea, was that no other country would. Besides, if the method doesn't work, what's the point? That's part of the reason that SNU, which fired Hwang, dropped their efforts to patent the technology; they do not seem to have commented on the latest news.
But Hwang's incentive is much greater. As is his wont nowadays, he leaves the talking to others, in this case Prof. Hyun Sang-hwan at Chungbuk National University, described as "one of Hwang's closest aides." He told the Korea Herald:
"The patent is important because it officially confirms that the NT-1 is a human embryonic stem."
(Well, not really, but it certainly sounds good.) Getting to the heart of the matter, Hyun told the Korea Times:
"The USPTO acknowledged the technological edge of Hwang's team, which means something in consideration of the global scientific leadership of the U.S. Against this backdrop, I sincerely hope the government will allow Hwang to restart work on cloned human embryos. It's a pity that a scientist with very advanced technology cannot work on them."
Reasonable people can certainly disagree.
Previously on Biopolitical Times:
Letter Signed by Hundreds Sent to the FDA: Preserve the global consensus against human germline modification
Posted by Jessica Cussins on February 19th, 2014
A sign-on letter prepared by the Center for Genetics and Society and the International Center for Technology Assessment, a project of the Center for Food Safety, has been sent to the U.S. Food and Drug Administration (FDA) in anticipation of the agency’s discussion of a technique that would constitute a form of human germline modification.
The letter will be transmitted to members of the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee, which on February 25-26 will hold a public meeting to discuss “oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility.”
In just ten days, this letter garnered 255 signatures from 42 U.S. states and thirteen countries. From the Edmond J. Safra Center for Ethics at Harvard, to the Pro-Choice Alliance for Responsible Research, to Nurses for Life, to Friends of the Earth Nigeria, the respondents come from a broad array of affiliations and interests. The number and diversity of the signers speaks to the widespread public concern about experimental efforts to genetically alter humans.
N.B. We will continue to update the list of signatories (with a demarcation of who signed after the letter was sent to the FDA), so please consider showing your support for this effort and adding your name here.
Additionally, the FDA has released its background materials for next week’s meeting, which include a 35-page briefing document that discusses the scientific, technologic, and clinical issues related to “mitochondrial manipulation technologies.” The document is fascinating for many reasons.
It acknowledges that “ethical and social policy issues related to genetic modification of eggs and embryos… have the potential to affect regulatory decisions” but it puts these issues “outside the scope of this meeting.” Perhaps this bias was a foregone conclusion given the venue and the fact that none of the FDA committee members are social scientists, bioethicists, policy experts, women's health advocates, or children's advocates. However, even the document itself can’t fully disengage the clinical issues from the ethical ones, noting, for example, what would be needed to “ensure ethical conduct of long-term follow-up.”
The document notes, over and over, the difficulty of making a sound judgment about these technologies, given “the complexity of the science, the novelty of mitochondrial manipulation technologies, and the absence of a specific regulatory application.” It acknowledges that “the full spectrum of risks… has yet to be identified,” but does offer five categories of safety concerns for both the women involved and the potential resulting children, which include damage caused to the egg or embryo from the manipulations, nuclear-mitochondrial incompatibility, epigenetic modification of nuclear DNA, and the impact of the chemicals and drugs used at various points throughout the procedure.
The document also discusses the limited studies that have been carried out to date, noting, “Because most of these studies were not done with models of mitochondrial disease or infertility, it is not clear whether these data provide any support for the potential effectiveness if these methods in humans, for either prevention of transmission of mitochondrial diseases or treatment of female infertility.”
Given the many risks of these techniques, and the current paucity of data about them, it is hard to imagine that the FDA will eagerly usher in the world’s first human clinical trials of inheritable genetic modification. But, we will have to wait until next week to see what comes of this long-anticipated meeting. Live webcasts of the meetings will be available for both February 25 and 26.
Previously on Biopolitical Times:
Posted in Assisted Reproduction
, Biopolitics, Parties & Pundits
, Biotech & Pharma
, Egg Retrieval
, Global Governance
, Inheritable Genetic Modification
, Jessica Cussins's Blog Posts
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, US Federal
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Bodies and Babies Commodified: A Review of Breeders
Posted by Gina Maranto, Biopolitical Times guest contributor on February 17th, 2014
We can now add to the growing list of disquieting films about the global reproductive industry and its ramifications the documentary Breeders: A Subclass of Women?, produced by the Center for Bioethics and Culture.
Listen to the stories of the women in this documentary—Heather, Gail, Tanya, and Cindy, all white and American—and you will be struck at turns by their compassion, naïveté, and befuddled disempowerment. Heather, 20 years old with two children of her own under age 3, wants to help another family experience the same joy she has felt. Gail initially only wants to provide eggs for her brother and his same sex partner, but becomes convinced to serve as a surrogate. Tanya, who has found her previous pregnancies easy, intended to serve as a surrogate only for a gay couple, because she believed it would be easier to separate from the baby that way. Cindy proceeded under the assumption that she was going to bear babies with a friend of hers and help raise them, but not within the confines of a “normal” relationship.
Breeders serves as a necessary corrective to the rosy PR the surrogacy industry puts out. If you haven’t had occasion to land on surrogacy websites lately, suffice it to say that they frame the act of bearing children for other people for pay in entirely positive terms, deploying everything from sports analogies (become a part of “Team Baby”) to invocations of creating a “miracle.” Jennifer Lahl, founder of the socially conservative Center for Bioethics and Culture, which also produced Eggsploitation and Anonymous Father’s Day, about egg and sperm donation, and Matthew Eppinette, who with Lahl wrote, produced, and directed Breeders, provide a look at the realities behind the hype.
Spoiler alert: These are heartbreaking tales. Nothing turned out as planned. As Breeders unfolds, good turns to bad turns to worse.
The women in Breeders entered into surrogacy with various motives. Each, in telling her story, downplays the fiscal motive (although Lahl, who appears on screen, underscores the monetary driver, noting that many military wives and women from lower income brackets have been drafted into surrogacy). Each describes what happened as they encountered major physical and emotional problems with their pregnancies—we see and hear their distress—and as their relationship with the commissioning couples turned sour, yielding schisms and legal interventions. As Lahl remarks, “When money and contracts get involved in the creation of a child, what often happens when things go wrong is that the law has to step in.”
Breeders turns to O. Carter Snead, a law professor and the William P. and Hazel B. White Director of the Center for Ethics and Culture at the University of Notre Dame (and an outspoken opponent of abortion rights), for an overarching perspective on the legal issues involved in surrogacy. Snead notes that while surrogacy is not technically baby selling, the practice in many states circumvents the frameworks that have been put in place for adoption, which are meant to protect the best interests of children. “We don’t have a lot of good empirical evidence on the question of what are the harms, short-term and long-term, with respect to children or anyone who’s involved in this process,” he says. “And it seems to me if you’re confronted with the possibility of real, serious harms, the prudent thing to do for the legislature would be to try to pause for a moment, impose a moratorium, and conduct very serious and searching inquiry into what the harms are.”
Lahl and Eppinette explore the potential emotional harms to children born via surrogacy arrangements by interviewing psychotherapist Nancy Verrier, author of Primal Wound (1993). Verrier argues that pre- and perinatal bonding between mother and infant is disrupted by surrogacy. As a result, such children may be left questioning their identity within the family or suffering other long-term psychological impacts.
Breeders has a bias: The filmmakers chose only to include narratives of women whose experiences had been so negative in sum as to leave viewers shaken by a sense of sorrow and injustice. Even those entirely opposed to surrogacy must grant that not all such arrangements go so badly awry. The film does include segments with Darren Spedale, founder of Family by Design, which works in the “modern family space” and helps people form “parenting partnerships,” and with Joe Taravella, a clinical psychologist, both of whom talk about the benefits that surrogacy brings to couples straight and gay, and to single parents, and emphasize that it suits the modern redefinition of parenting. Says Taravella, “A family is love. And long gone are the days when we have a mom and a dad and two children.” Collin Smikle and Marlane Angle, the medical and IVF lab directors of Laurel Fertility Care in San Francisco also tell us how stressful building families outside normal channels is, and Angle admonishes us that it’s not anyone’s place to stand in judgment.
But the overwhelming message is that surrogacy poses grave social risks.
Lahl and others in her organization oppose abortion, though they keep that issue out of their films about assisted reproduction. And Lahl has worked with prochoice advocates who are also deeply disturbed by aspects of the fertility industry, including commercial surrogacy. In Breeders, Kathleen Sloan and MonaLisa Wallace, both on the board of directors of the National Organization for Women (NOW), emphasize that it is part of the ongoing trend whereby reproductive medicine commodifies women’s bodies. Sloan sees the fertility industry as having “huge profit generating capacity and [a] need for constant inputs, be that women providing their eggs or providing their bodies.” Wallace sees the surrogacy business as attempting to hide the fact that they treat women as mere means to an end: “Calling a mother a gestational carrier is a euphemistic way of dehumanizing her and taking away the relationship [with the child] by removing the word ‘mother.’” What results are “industrial human farms.”
In a film full of haunting moments, perhaps the most jarring comes when we hear from Jessica, who at age 26 found her birth mother. She says, “As much as I do believe that surrogacy can come from a compassionate place, as a product of surrogacy, it’s hard not to be aware that there is a price tag. There is an awareness that in essence you were bought by the family you grew up with. You are a product at the end of the day.”
Gina Maranto 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. She is the author of Quest for Perfection: The Drive to Breed Better Human Beings (1996).
Previously on Biopolitical Times: