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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