How to Watch the Biggest Science Story of 2017
Posted by Leah Lowthorp on January 19th, 2017
Less than three weeks into the new year, gene editing is already set to be one of the biggest stories of 2017.
CRISPR, the latest gene-editing tool, allows scientists to make changes to DNA faster, cheaper, and easier than ever before. There has been an explosion in the number of researchers using this technique over the past two years, and the coming year is sure to see more.
Media coverage of gene editing is also likely to be extensive. And if past experience is a guide, it will include lots of hype and ample confusion. In an effort to provide clarity, here are three key points to watch out for.
1) Germline gene editing and “3-person IVF” are not the same
The first 3-person in vitro fertilization (IVF) (aka “mitochondrial replacement”) birth was reported in September, where a baby with DNA from three people was delivered in Mexico by a New York-based fertility doctor seeking to avoid US regulation. Since then, there has been a tendency in the media to conflate the technique with gene editing.
On New Year’s Day, for example, NPR published a piece on 3-person IVF with the headline “Unexpected Risks Found in Editing Genes to Prevent Inherited Disorders.” After recognizing the error, NPR changed the headline to “Unexpected Risks Found in Replacing DNA to Prevent Inherited Disorders.”
While both germline gene editing and 3-person IVF are technically forms of human germline modification, or the genetic modification of human reproductive cells or embryos, they are completely different procedures.
Gene editing removes, inserts, and/or replaces nuclear DNA sequences in a living organism. Human germline gene editing means changing the nuclear DNA of a human egg, sperm, or embryo. The prospect of using genetic engineering for the purpose of controlling which traits are passed down to future generations has long raised major concerns worldwide. Foremost among these are that 1) this would have unalterable and largely unpredictable biological effects on resulting children and their future offspring; and 2) this would have disastrous social consequences if, as many believe, engineering genes thought of as “superior” exacerbated existing forms of inequality and discrimination.
By contrast, 3-person IVF refers to a range of techniques that don’t alter DNA sequences at all. Instead, they take apart and recombine fragments of reproductive cells in a process that is actually more similar to cloning than to gene editing. The primary goal of 3-person IVF is to prevent the transmission of a small subset (about 15% of cases) of mitochondrial disease, which can be passed from mother to child. In these cases, it is caused by mutations in a cell’s mitochondria, numerous organelles outside of the cell’s nucleus that have their own set of genes. 3-person IVF works not by transferring mitochondria, as the misnomer “mitochondrial replacement” implies, but by transferring the nucleus of an intending mother’s egg (or the nucleus of a fertilized embryo) into a mitochondria-rich donor egg that has had its nucleus removed. Inheriting nuclear DNA from the intending mother and father, and mitochondrial DNA from the egg provider, the child would thus be genetically related to three people. If that child were female, all future offspring would also inherit the changes.
As I’ve written before, 3-person IVF leads us down a slippery slope toward a wider acceptance of germline gene editing for reproduction. One way to avoid this risk is by recognizing that the two procedures are completely different.
2) There is a big difference between somatic and germline gene editing, and between germline gene editing for research and reproduction
Another common mistake in the media is treating somatic and germline gene editing as the same, and conflating the different uses of germline gene editing.
In Newsweek's recent cover story, “Gene Genie: Scientists Can Edit Your DNA to Cure What Ails You…Unless you Live in America,” Madhumita Murgia begins with the success story of Layla Richards, the first person cured of leukemia through “gene editing”. But Richards isn’t the main focus of the story. The bulk of the article focuses on gene editing in human embryos. For the casual reader, there is no distinction between the two cases. But that’s the problem.
Richards’ case refers to somatic gene editing, or gene therapy, which alters the genetic sequences of an individual’s non-reproductive cells in order to treat an existing medical condition. A major concern about using somatic gene editing to treat diseases is
ensuring the procedures are safe, effective, and accessible. Earlier
attempts at gene therapy, using older genetic engineering techniques,
were largely unsuccessful, and, in the well-known case of Jesse Gelsinger, caused a tragic and unnecessary death.
By contrast, germline gene editing refers to editing human reproductive cells or embryos. This poses unique ethical questions because, unlike somatic gene editing, germline changes would be inherited. Germline gene editing thus has to grapple with what these changes mean for a future generation.
A second often-overlooked distinction is the different ways germline gene editing is used: for research or for reproduction.
Germline gene editing for research will not result in a pregnancy; by contrast germline gene editing for reproduction has to account for the future generations that will be affected. Using a genetically altered human embryo to initiate a pregnancy, which would affect the genes of the resulting child and all future generations, is currently outlawed in more than 40 countries worldwide. Widespread international prohibitions on modifying the genes that are passed down through generations were put in place out of concerns about safety, human rights, and the potential for high-tech eugenics. CGS supports a prohibition on all forms of germline gene editing for reproduction.
The Newsweek article is one of a number of instances in which these distinctions have been blurred in the media. Making them clear is crucial to public understanding of the medical, policy, and social implications involved.
3) “Designer babies” remain a serious concern
Several recent articles emphasize that scientists do not yet understand enough about the human genome to begin creating so-called “designer babies,” or children whose genes have been changed to “enhance” them physically or behaviorally (see here, here and here). While this is true, it does not mean that there’s nothing to worry about, or that concern about inheritable genetic modification is a “sideshow” in the CRISPR debate, as Vox recently stated.
As Rob Stein at NPR notes, “The concern here is that if you [edit the DNA of human embryos] for medical research, what’s to stop other scientists to try to do it for other reasons, like, for example, to try to create designer babies that are taller or smarter or better athletes?”
Stein adds that “the concern is that this could open the door to someday creating genetic haves and have-nots.”
This has been a serious concern since inheritable genetic engineering was first imagined. With recent advances in gene editing, it’s true now more than ever. The fast-moving, commercially motivated nature of CRISPR technology means that a world where the affluent can afford genetic “enhancements” is an uncomfortably real possibility. Combined with reporting that most scientists think “editing embryos will probably be a clinical option one day,” broad societal debate about human gene editing and its implications for the future of humanity is urgently needed.
In a world where technologies such as CRISPR have the power to exacerbate social inequalities in unprecedented ways, it is essential that the public understand the nuances of this emerging technology in order to make informed decisions about what we do or do not want for our future. Gene editing for reproduction is a social and political matter, not just a scientific one, and there is simply too much at stake to move forward without broad inclusion of the wider public.
Previously on Biopolitical Times:
Image via Pixabay
CGS Board Member Leads Redress Call for California Survivors of Eugenic Sterilization
Posted by Marcy Darnovsky on January 16th, 2017
Scholars researching California’s twentieth-century legacy of eugenic sterilization, led by University of Michigan professor and Center for Genetics and Society Advisory Board member Alexandra Minna Stern, are urging state legislators to consider reparations for survivors of this abusive chapter in California’s history.
An estimated 20,000 people underwent compulsory sterilization in state institutions from 1909, when California passed its eugenics law, well into the 1950s. According to the study published in the American Journal of Public Health, based on painstaking analysis of historical records, the research team estimates that as many as 831 people sterilized under that law are alive today.
“The remaining survivors of California’s eugenic sterilization program deserve further societal acknowledgement and redress,” the researchers wrote.
And the researchers emphasize that “time is of the essence”: According to their estimates, the average age of the survivors is 87.9 years.
“We suggest that interested stakeholders, including public health advocates, legislators, reproductive justice and disability rights activists, and survivors willing to come forward, move quickly to ensure that California takes steps toward reparations and full accountability for this past institutional and reproductive injustice.”
Their efforts aren’t being ignored. The findings have drawn media attention from high-profile outlets including The Atlantic, the New York Times, NPR Weekend Edition, Scientific American, and the Los Angeles Times. Much of the coverage highlights the call for California officials to make serious efforts to identify the survivors and consider offering them monetary compensation. Such reparations programs have been established with bipartisan support in North Carolina and Virginia, which had similar eugenic sterilization programs.
Stern’s research on eugenics has spanned more than a decade. In 2005, she published Eugenic Nation: Faults and Frontiers of Better Breeding in Modern America examining eugenics in the American West. She has continued her work by investigating the race, gender, class, and disability status of California’s sterilization victims; documenting the disproportionate number of patients with Spanish surnames who were sterilized; and focusing on stories of efforts by families and patients themselves to challenge sterilization procedures.
Stern has also worked to bring public awareness to the stories and meanings of eugenics in California. She helped CGS and other organizations plan a 2012 symposium at UC Berkeley Law, Eugenics in California: A Legacy of the Past?, and at San Francisco State University’s Future Past: Disability, Eugenics, and Brave New Worlds event in 2013, and spoke at both.
Stern has also participated in several of CGS’s Talking Biopolitics conversations. In 2013, she and journalist Corey Johnson discussed an episode of sterilization abuse in California women’s prisons between 2006 and 2010 that Johnson had revealed while working with the Center for Investigative Reporting. She joined medical historian Nathaniel Comfort in 2015 to talk about the implications of the quest for “human perfection” in an age of rapidly advancing genetic technologies. And last year, Stern interviewed the producers and director of No Más Bebés, a documentary about immigrant women in Los Angeles who sued county doctors, the state of California, and the US government after they were coerced into sterilizations while giving birth during the 1960s and 70s.
The hundreds of eugenic sterilization survivors in California alone make plain the echoes of America’s eugenic past that still reverberate in the present. Coming to terms with this legacy will serve not just the individuals subjected to eugenic sterilization, but all of us who must confront its continuities today.
Previously on Biopolitical Times:
Image via University of California Press
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We Launched a New Website! Surrogacy360
Posted by Kiki Zeldes, Biopolitical Times guest contributor on December 14th, 2016
|Members of Women's Rehabilitation Center in Nepal lead community discussions on international surrogacy|
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 Surrogacy360.org, 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.
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Biopolitical News of 2016
Posted by Pete Shanks, Leah Lowthorp & Marcy Darnovsky on December 13th, 2016
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:
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
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.”
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.
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.
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
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
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