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Biopolitical News of 2014

Posted by Pete Shanks, Jessica Cussins & Marcy Darnovsky on December 18th, 2014


2014 has been another busy, and decidedly mixed, year in biopolitics.

Some technical advances suggest that gene therapies and genomics-based personalized medicine may be coming closer, while a few advocates seize on the same news to speculate about making irreversible, dangerous, and socially pernicious changes to the human genome.

The need for regulation of new human biotechnologies became both more obvious and more widely accepted this year, but simultaneously there were efforts (which may succeed in the UK) to shatter long-accepted norms by allowing a form of inheritable genetic modification based on nuclear genome transfer techniques.

Other biopolitical developments also abounded, from commercial surrogacy, egg freezing parties and early-pregnancy fetal gene tests, to police DNA databases and resurgent claims about race as biology. These and yet more new biotech products and practices bring us ever closer to unprecedented personal and societal dilemmas and decisions. 

The Center for Genetics and Society (CGS) continues to monitor all of these developments, and attempts to encourage their responsible usage 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 2014, roughly grouped by topic:

Surrogacy

A number of countries grappled with how to regulate surrogacy in 2014. Ireland published draft surrogacy legislation in February; Toronto saw a boom in surrogacy despite it being only semi-legal; India took further steps to determine how to regulate its huge surrogacy market.

International surrogacy arrangements came under increasing media scrutiny, including a three-part front-page series in The New York Times (1, 2, 3). And numerous surrogacy scandals surfaced. The high-profile surrogacy broker Planet Hospital was outed for scamming would-be parents who thought they were arranging contract pregnancies in Mexico. An Australian couple left their son (Baby Gammy) who has Down syndrome with his Thai surrogate mother, taking only his twin sister back home with them. The surrogate agreed to care for the child and was able to crowd-fund the costs of his needed medical treatment.

Shockingly, it was then discovered that the babies’ father has been convicted of 22 child sex offenses in Australia. Soon after, it was revealed that a 24-year-old Japanese businessman had fathered 14 babies with different Thai surrogates, and that a different Australian father of Thai surrogate twin girls was charged with sexually abusing them. These much-publicized outrages led Thailand’s Parliament to approve a bill banning all commercial surrogacy in the country.

The news about Baby Gammy prompted others around the world (San Francisco and England) to share similar experiences, and increased awareness about the need to consider the “best interests of the child” in international surrogacy arrangements. The European Court of Human Rights, meanwhile, ruled that France must officially recognize the legal parentage of children in two families who were conceived with their fathers’ sperm and third-party eggs, and carried and delivered by surrogates in California and in Minnesota.

The Center for Genetics and Society co-organized a three-day landmark international forum on international commercial surrogacy in the Netherlands to help inform the work of the Hague Convention on Private International Law, as its member states consider moving forward toward an international agreement on international surrogacy.

CGS and Our Bodies Ourselves were awarded a two-year grant by the MacArthur Foundation to investigate human rights and social justice concerns about cross-border surrogacy and commercial egg retrieval. 

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Women’s eggs

A 23-year-old Indian woman died after an egg harvesting procedure at an IVF clinic in Lajpat Nagar, which put the spotlight on the unregulated egg industry in India. In Canada, an investigative program learned that some clinics are helping couples circumvent the law to pay egg providers. In China, an underground market in women’s eggs is booming.

Meanwhile, egg-freezing parties became a thing, first in New York (inspiring some trenchant commentary) and now across California too.

Facebook and Apple announced a $20,000 benefit for their female employees toward elective egg freezing. The move triggered a backlash, with critiques pointing to the serious and under-studied health risks to women and children, and concerns about increased workplace pressures for women to postpone childbearing.

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Assisted Reproduction

Births from IVF hit a new high in 2014. But the year also saw increased awareness of failure rates. Following on last year’s Cracked Open: Liberty, Fertility, and the Pursuit of High-Tech Babies by Miriam Zoll, this year saw the publication of The Big Lie: Motherhood, Feminism, and the Reality of the Biological Clock, and articles about murky data from the fertility industry. A study of 300,000 births found that IVF babies have a slightly greater risk of complications and a study of donor egg pregnancies revealed that those carry higher complication rates. A review of many studies of IVF’s health impacts on women and children led some European researchers to suggest we should cut back on its use; multiple medical associations also pushed for elective single embryo transfers to reduce risks.

The trend towards openness in donor conception continued, with Australia ordering clinics to release anonymous sperm donor information so children can learn about their genetic origins. The American Society for Reproductive Medicine updated its guidelines for gamete donation in the light of the growing recognition that offspring may have a right to know their genetic parents.

A Calgary fertility clinic came under fire for refusing to treat a woman who wanted to use sperm that did not match her ethnic background because of its policy against creating “rainbow families.” In October, it was revealed that a white Ohio woman was suing her sperm bank, alleging that the company mistakenly gave her vials from an African-American donor. This news prompted discussion about the role of race in donor conception, and about the lack of regulation of sperm banks.

The first baby was born in Sweden following a womb-transplant.

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Prenatal / preimplantation genetic screening 

In February, a study found that “noninvasive prenatal testing” – a procedure that analyzes fetal DNA found in women’s blood very early in pregnancy – is more accurate in detecting Down syndrome and other chromosomal disorders than a blood test and ultrasound screening. But this week, the New England Center for Investigative Reporting published a report showing the tests to be much less accurate than companies have led women and doctors to believe.

As genetic testing of embryos and fetuses increased this year, questions about ethical issues were raised in The New York Times and CNN, and parents of kids with conditions “on the list” spoke out about the risk of dehumanization. Heavy marketing of the early prenatal gene tests continued as profits rose, with the addition of microdeletions to the conditions detected, and an attempt to use the new tests in all pregnancies rather than those with specific risks. An undercover assessment of five early prenatal gene test labs found a need for better quality control. A clinical trial found that when pregnant women are educated about their choices on prenatal genetic testing, the number of tests actually drops.

Meanwhile, the US grew as a destination for couples opting to use IVF and PGD purely to choose the sex of their child (with only minimal pushback). In the UK, sex-selective abortion was made illegal with bipartisan support. UN Women produced a report showing that in India, the sharply declining child sex ratio has reached emergency proportions. In the US, dozens of right-wing bans on sex-selective abortion were introduced in a number of states and in Congress, with seven states enacting bans; a report by abortion rights supporters identified six major inaccuracies in their claims and made it clear that they are meant to undermine abortion rights.

The first baby was born after having had his whole genome sequenced in utero. Proposals for whole-genome newborn testing gained steam (and funding), despite ethical dilemmas and privacy concerns.

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3-person IVF

The FDA public meeting to discuss 3-person IVF or nuclear genome transfer (which it termed “oocyte modification”) took place February 25-26. CGS sent the committee its own letter, as well as a sign-on letter with more than 250 signatures; CGS’s Marcy Darnovsky testified at the meeting and wrote a commentary on the issues for The New York Times. The FDA’s panel of experts discussed many safety and efficacy concerns, heard from members of the public about social and ethical matters, and concluded on a cautionary note, saying that it could take decades to confirm the safety of the experimental technique.

Nonetheless, the very next day the UK government issued proposed regulations (including numerous misrepresentations and concerning proposals) that would allow researchers to use the techniques in fertility clinics. The House of Commons debated the issue on September 1, and the Parliament’s Science and Technology Committee held an evidence hearing on October 22; 75% of submissions they received warned that more evidence is needed prior to offering these techniques.

Studies published in 2014 provided increasing evidence that mitochondria do impact a person’s phenotype and that the analogy between manipulating mitochondria in an egg or embryo and “changing a battery in a camera” is highly misleading, despite claims by proponents.

In August, the US fertility clinic that 15 years ago used a precursor of the controversial techniques now in question (which they termed “cytoplasmic transfer”) finally launched an investigation into the health of 17 children, now teenagers, who were born as a result.

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Eugenics and inheritable genetic modification

The prohibition against making heritable (germline) changes to human genes came under serious threat in 2014. Inheritable human genetic modification is still explicitly illegal in dozens of countries, and nowhere is it explicitly allowed (but see “3-person IVF,” above). However, its advocates were increasingly vocal this year, perhaps encouraged by experiments that altered the genetic makeup of monkey embryos.

The Chinese company BGI continued its quest for a “better baby,” partly documented in the movie DNA Dreams. Opinions about the ethics of such a move varied (1, 2, 3) and CGS’s Marcy Darnovsky debated them with Nita Farahany at The Aspen Institute in July. In September, Israeli historian Yuval Noah Harari made a compelling case that “body upgrades” for the rich would contribute to rising inequality.

Eugenics is not merely a threat, nor is its history entirely in the past. North Carolina finally compensated its victims of eugenic sterilizations, becoming the first US state to do so. In California, Gov. Jerry Brown signed SB 1135 into law, providing protection against the kind of sterilization abuses in California prisons that were revealed last year by the prison rights group Justice Now and an investigation by the Center for Investigative Reporting.

Meanwhile, Lee Silver launched a company called GenePeeks that uses the DNA of sperm donors and recipients to create "virtual babies" with desirable traits.

Lord Robert Winston warned us all that breakthroughs in IVF could prompt parents to demand particular traits for their babies. One father asked, “Will my disabled daughter have a place in this genetic wonderland?”

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Genetic testing

Almost all former direct-to-consumer genetic testing companies have closed up shop, and public trust in personalized medicine was threatened  this year by 23andMe’s failure to comply with FDA standards, as well as the difference between the company’s rhetoric of personal control and its actual business plan.

Its ancestry testing also came under criticism after stories emerged about revelations of previously unknown sibling relationships that wound up tearing families apart. However, 23andMe is now selling its tests (with health information) in Canada and the UK, and there are ways of accessing the data in the US if you really want to.

Additionally, the Federal Trade Commission charged GeneLink, which served 30,000 customers, for making claims not based on science and for failing to protect consumer information. Concrete evidence emerged about errors in test interpretation by a DTC company causing potential harm.

Efforts in the UK to link all medical records to whole-sequenced genomes provoked some pushback. Privacy concerns about DNA testing attracted attention, as did concerns about storage, access, security, difficult information, family secrets, and usage.

The long-awaited $1,000 genome was announced by Illumina in February with help from the US government, though that price tag ignored substantial hidden costs. Craig Venter formed another company, Human Longevity Inc., to exploit this technology, with the goal of sequencing half a million human genomes within five years.

Myriad Genetics continues to wage legal battles over its BRCA gene patents in the US; surprisingly, Australia chose to uphold Myriad’s patents in September. Meanwhile, it was discovered that mutations in a gene called PALB2 also greatly increase the risk of breast cancer. Breast cancer patient advocates warned that genetic testing of all women would not provide a solution to the breast cancer epidemic.

New studies suggest that doctors need to be more cautious when they release genetic information to patients, and the American College of Medical Genetics and Genomics now claims that patients should be allowed to “opt out” of learning how their DNA might increase their risk of disease.

Some people are avoiding genetic testing because of major omissions in protection offered by GINA — life, disability and long-term care insurance — that are especially important to people who may have serious inherited diseases. The Council for Responsible Genetics released a report on “Genetic Privacy and Non-Forensic Biobanks” outlining the need for regulatory reform.

Efforts to ease data sharing of genomic information ramped up around the world. Google set up a cloud to allow people to import, process, store and search DNA data, and joined forces with The Global Alliance; Kaiser Permanente now has a genetic database with information from over 210,000 of its members.

There is increasing evidence of the importance of epigenetics, although scholars warned in Nature that we should not allow this research to place undue blame on mothers.

Examples of genetic determinism abounded, from Uzbekistan testing children as young as ten years old to determine their athletic potential, to former New York Times reporter Nicholas Wade arguing in a new book that genetic variation between races could underlie global economic, political and social differences.

The book elicited considerable criticism from geneticists, social scientists and public interest advocates; CGS sponsored a Talking Biopolitics conversation assessing the reaction. There were also some scientific studies that countered this narrative: smart genes are proving elusive (despite the ardent search), and there doesn’t seem to be a “longevity gene” either. In most cases, it turns out that the role of DNA in our lives is more complex and subtle than we expected, and that scientific racism is just bad science.

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Synthetic biology

A major focus of technological enthusiasm was synthetic biology. Most public attention went to powerful new gene editing technologies, notably CRISPR, but scientists also produced synthetic chromosomes and artificial nucleotides.

One of the most potentially consequential technologies being seriously discussed is the “gene drive,” which involves altering genes and then deliberately spreading the new version through the entire population of a species. Unusually, scientists published a technical paper about it and simultaneously another about the need to regulate this technology, accompanied by an informative blog post.

Regulation of synthetic biology in general was much in the air. The United Nation’s Convention on Biological Diversity called for it, and an event  at Arizona State University raised the issue, but the discussion has barely started.

Other applications being discussed include synthetic food; modifying pigs to make organs for transplant into humans; the “de-extinction” of mammoths and other species (which provoked some notable objections); and even some absurd, misogynistic fantasies.

The US Department of Defense formalized its interest in synthetic biology, and money seems to be flowing in. Patent disputes are heading for the courts, companies are jockeying for position, and the future remains uncertain.

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DNA forensics

An FBI audit of a national DNA database found nearly 170 profiles that probably contain errors, and New York authorities turned up mistakes in their state's DNA database. Meanwhile, DNA contamination was shown once again to be a sizeable problem.

Privacy advocates warned that warrantless searches of a person’s DNA, especially for misdemeanor arrests, is a slippery slope. “DNA sweeps” were shown to be particularly troubling, as was the rise in familial DNA searches.

In March, a federal appeals court upheld California's law requiring people arrested for felonies — though not necessarily convicted or even charged — to submit samples of their DNA to police. But in December, an appeals court decided unanimously that the practice violates the state constitution.

However, the FBI is preparing to accelerate the collection of DNA profiles for the government's massive new biometric identification database, and is hoping to use a machine that can scan your DNA in just 90 minutes. Some argue that we are facing a backdoor move into total population surveillance by both governments and companies.

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Stem cells and gene therapy

The biggest story of the year turned out to be a bust: so-called STAP cells were presented in January as a paradigm changer — an easily obtainable alternative to embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs). By July, however, Nature had retracted the relevant papers and almost everyone has now given up on the process.

Two additional research teams produced ESCs by nuclear transfer or cloning (NT-ESCs) after the first success in 2013, reinforcing concerns about the risks to women who would provide the needed eggs and about inadequate laws against human reproductive cloning. To the researchers’ surprise, however, and despite initial reports, iPSCs turned out on analysis to be just as good as NT-ESCs, though studies will continue on both methods.

Stem cells are moving into clinical trials, mostly with adult stem cells but also the first iPSC-based trial. However, premature commercialization of the technology continues, and drew increasing criticism (1234); professional athletes are frequently lured to dubious clinics.

The California Institute for Regenerative Medicine (CIRM) survived a rocky year. A conflict-of-interest scandal involving its recently departed President, Alan Trounson, brought unwelcome publicity. The 10th anniversary of its founding prompted a look back that was compelled to note that no cures have reached the clinic, or even come close. But at year’s end the new management launched a new effort to produce treatments, in what could be CIRM’s last gasp before its public money runs out.

Even without the technical advances promised by synthetic biology (see above), the historically troubled field of gene therapy made significant progress in 2014. It was announced that eight of nine “bubble boys” had survived for up to 43 months (so far) after treatment. Advanced Cell Technology’s stem-cell therapy for eye disease seems to be at least safe and possibly effective; the company has just changed its name to Ocata Therapeutics, Inc.

The ESC-based spinal cord treatment program that Geron let go for business reasons has been revived. Asterias, a subsidiary of BioTime, took over the project and received a $14.3-million grant from CIRM to proceed. The company also says it is working on a potential ESC-based treatment for lung cancer.

In Germany, the first gene therapy drug has been announced, with a record price tag of €1.1 million ($1.4 million). But it won’t go on sale until 2015.

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Previously on Biopolitical Times:





Top Biopolitical Times Posts of 2014

Posted by Jessica Cussins & Pete Shanks on December 18th, 2014


Untitled Document

In 2014, CGS staffers and contributors posted 107 blogs in Biopolitical Times. These are 12 of our favorites, in chronological order:

Chinese Scientists, “Genius Genes,” and the Future of Genomics
Jessica Cussins
The New Yorker delves into the “biological data mill” that is BGI: the world’s largest, and arguably most controversial, genomics headquarters.

Hit-and-Miss Genetic Testing
Pete Shanks
In at least four experiments, identical DNA has been sent to different direct-to-consumer testing companies. In every case, significant anomalies appeared.

Human Longevity, Inc.
Pete Shanks
Craig Venter's new genomics company may face some stiff competition.

Nicholas Wade: Genes, Race and Anthropology
Pete Shanks
Is Nicholas Wade shocked and horrified that his new book, A Troublesome Inheritance: Genes, Race and Human History, is getting support from racists? Really, what did he expect?

Scientists, Stem Cells and Self-Delusion?
Pete Shanks
A very disquieting meta-analysis casts doubt on recent findings suggesting that bone marrow stem cells can help in treating heart disease.

Orphan Black: The Best Show You’ve Never Seen
Jessica Cussins
A BBC America television series about clones is seriously good.

A Paragraph in Slow Motion: Three-Person IVF in The New York Times
George Estreich
A close look at the rhetoric used to justify experimental technologies, and particularly at the way reasonable objections are dismissed.

Data Yearning to Become Expensive Information
Pete Shanks
Big players have big “big data and genetics” plans afoot. Here’s the news from Genomics England, 23andMe, Google and Craig Venter.

Dear Facebook, Please Don’t Tell Women to Lean In to Egg Freezing
Jessica Cussins
In the latest example of Silicon Valley’s challenges in dealing with non-virtual reality, Facebook and Apple are offering female employees a $20,000 benefit toward elective egg freezing, despite serious and under-studied health risks to women and children.

A Season of Surrogacy Scandals
Marcy Darnovsky
Recent stories about dubious practices or outright scandals in Australia, Thailand, China, Mexico and Los Angeles have underscored concerns about commercial and cross-border surrogacy arrangements.

What Good is a Scientific Meeting If You Dismiss the Science?
Jessica Cussins
The Science and Technology Committee of the UK Parliament held an evidence hearing to examine the science and proposed regulation of so-called “mitochondrial donation,” or “3-person IVF,” but huge swaths of evidence were dismissed.

The Vagina Bio-Hack That Wasn’t: How Two “Startup Bros” Twisted and Took Credit for a Young Woman’s Company
Jessica Cussins
When news broke that two male CEOs wanted to make women’s vaginas smell like peaches, there was a well-deserved backlash. Now, it turns out the project wasn’t even theirs, and they got it all wrong.

Previously on Biopolitical Times:





Prenatal Tests: Oversold and Misunderstood

Posted by George Estreich, Biopolitical Times guest contributor on December 16th, 2014


Lincoln Samuel tested positive for Edwards syndrome, but was born perfectly healthy

Untitled Document On Sunday of this week, the Boston Globe published an article that I've been waiting to see for months. It's Beth Daley's investigative report on noninvasive prenatal testing, and I'm hoping it will both create a larger public conversation, and shift the terms of the conversation so far.


As many of you know, NIPT is a new technology that promises to detect Down syndrome and other chromosomal conditions based on a maternal blood draw alone. These tests are sold as "99% accurate" something I believed for a long time, and that some health professionals seem to believe but as genetic counselor Katie Stoll has written, the actual test performance is nowhere near as good. NIPT is not diagnostic; it is a screening test, and a "positive" result only means that a diagnostic procedure, like amniocentesis or CVS, will be required to confirm fetal status. 

I believe that it is not enough to consider reproductive technologies in the abstract. They cannot be contemplated only in a statistical or bioethical vacuum: we need fact-based stories to perceive human consequences on the ground. Beth's article accomplishes this by focusing on the cost of false positives and false negatives in real people. She also delves into the facts about LDTs, or laboratory-developed tests, which are currently unregulated by the FDA. Because her article has already sparked pieces at The New York Times, NBC News, and elsewhere, I have hopes that a new conversation is beginning.

I very much hope that disability will be a part of that conversation. In an online chat that accompanied the article launch, the main conversation focused on the accuracy of marketing claims and the consequences for women. These are vital and relevant issues, but they aren't the only ones. We also need to question what we test for, and why – and the way "objective" tests project human values into the world. Ultimately, I think NIPT needs to be seen in the context of a rapidly increasing power to read and alter our genetic code.

One key part of Beth's report is that it shifts the ground of discussion. Though questions about NIPT often get subsumed under discussions of abortion an idea encouraged by the Globe's headline Beth's article makes clear that other questions, from corporate responsibility to loopholes in regulation to gaps in practitioner understanding, are also at issue. 

Untitled Docume

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:





DC Symposium: “The Future of Reproduction”

Posted by Marcy Darnovsky on December 4th, 2014


The week before Thanksgiving took me to Washington, DC to speak at The Future of Reproduction, a public symposium organized by Future Tense, a partnership of Slate, New America Foundation, and Arizona State University. You can view the event in full or individual panels here.

The afternoon was introduced by New America’s Liza Mundy. Three panels followed:

  • “Where Babies Will Come From” with Dieter Egli, senior researcher fellow, New York Stem Cell Foundation and Rebecca Sokol, President, American Society for Reproductive Medicine; moderated by Darshak Sanghavi
  • “Whose Business is Reproduction?” with Evan Snyder, stem cell biologist at Sanford-Burnham Medical Research Institute; Debora Spar, President, Barnard College and author of The Baby Business: How Money, Science and Politics Drive the Commerce of Conception; and Camille Hammond, CEO, Tinina Q Cade Foundation; moderated by Elizabeth Weingarten
  • “In the Gattaca-Family Way: How Far is Too Far?” with Marcy Darnovsky, Executive Director, Center for Genetics and Society; Charis Thompson, Chancellor's Professor and Chair, Gender and Women's Studies, University of California, Berkley; Jane Maienschein, Director, Center for Biology and Society, Arizona State University; moderated by Christine Rosen
3-person IVF” came up on each of the panels. Dieter Egli is one of the US researchers developing and promoting this risky experimental procedure; Evan Snyder chaired the February FDA hearing that concluded it’s currently too risky for clinical trials; and as Biopolitical Times readers know, the Center for Genetics and Society has been working against it on both safety and social grounds. (We were, however, on three different panels.)

Speakers addressed a range of other issues including the commercial dynamics of the fertility industry, the minimal regulation of assisted reproduction in the US, the history of eugenics, the invisibility of women in discussions of egg harvesting, prenatal and pre-implantation genetic testing, and the recent offer by Apple and Facebook to pay for freezing their employees’ eggs.

Summaries of the event can be found at Slate and The Daily Beast.




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