False Inevitabilities and Irrational Exuberance
Posted by Gina Maranto, Biopolitical Times guest contributor on January 8th, 2016
Scans of media coverage carried out by CGS and others after the National Academies of Medicine and Sciences co-sponsored International Summit on Human Gene Editing in early December revealed that, for editors at least, it was a confusing event. Some stories ran under headlines signaling that gene editing research had been given a green light [Science]; others said scientists were seeking a moratorium [The New York Times].
Since then, several disquieting themes have emerged online in mainstream media and science blogs. These include the phenomenal medical gains to be had from gene editing for somatic therapeutic interventions, with the attendant piquing of interest among venture capitalists in search of the next big profit-taking opportunity in biomedicine.
There is also ongoing discussion of the desirability of “fixing” the human genome through reproductive genetic interventions. Disturbingly, some commentators are touting the “inevitability” of human germline. And a few powerful voices in science and bioethics seem to be at pains to prove that CRISPR-Cas9 modifications that aim to “improve” resulting offspring—eugenics by any other name—would be categorically different from any previous efforts of that sort because they would be driven by public demand rather than state mandate.
Take, for example, the December 22 Quartz piece whose headline trumpets that 2015 was “the year it became OK to genetically engineer babies.” The article itself, by Akshat Rathi, makes less forceful claims about the “okayness” of designer babies, but does argue
[W]hen historians of science look back decades from now, they may well mark 2015 as the year genetically engineering humans became acceptable. That’s because, while the world was paying attention to the gene-editing summit, a more momentous decision had been made just a month earlier in the UK.
That decision was the British Parliament’s approval of regulations allowing so-called “three-person IVF” which produces heritable alterations in embryos, though via a technique that’s very different from gene editing. Rathi goes on to predict:
Based on past progress, it is likely that genetic enhancements to humans will become a reality step by step. Just like mitochondrial replacement therapy, they will first appear for a very narrow purpose, such as curing single-gene disorders, and then, likely over many decades, we might reach the stage of creating those fabled designer babies.
Rathi is not alone in proclaiming the coming of the new age of genetic tinkering. For example, Michael Specter in The New Yorker, writes of CRISPR-Cas9, “Inevitably, the technology will also permit scientists to correct genetic flaws in human embryos.”
But is reproductive human germline editing inevitable? Rathi offers an ostensibly well-founded prediction on past evidence, but errs in globalizing from the case of Britain. Specter forecasts from a more gee-whiz angle.
Such decontextualized and ahistorical rhetoric does no one a service. At this date in the world’s history, it is fatuous to contend that all technologies must be used because they are developed. Technology indeed has an internal momentum, as individuals and industries seek to refine existing techniques and products. But even path dependence—the tendency for newer innovations to build upon older ones—is not a given. The history of invention is littered with cases in which old forms are abandoned completely (think CDs and VHS) or technologies are simply not deployed.
And Britain cannot be taken as a norm of any sort with regard to genetic policy. Since the 18th century, the British have been fascinated by animal and agricultural breeding. In the 19th century, Galtonian eugenics sprang from a particular cultural ground, combining longstanding classist, racist, imperialist, and liberal capitalist notions with biology to yield scientistic social policies—policies that were different not in kind but in degree from previous approaches to controlling the lower classes.
Despite the claim by many that after WWII British recoiled from eugenics, we know that is not true. IVF developers Patrick Steptoe and Robert Edwards both voiced eugenic aims for their IVF research, and in the past ten years or so, a vocal and influential group of neo-eugenicist philosophers and biologists there have pushed a eugenics agenda and acted as boosters for germline interventions.
One such advocate, Julian Savulescu of Oxford University, has even argued that to “save” humanity, we should pursue the elimination of “genes” for “aggression” and other “negative” traits. Savulescu goes one step further by maintaining that would-be parents are morally obligated to make these kinds of interventions on embryos.
But when we look beyond Britain, the landscape appears quite different. Modification of human embryos by whatever technique has been seen as problematic enough to have been prohibited in over 40 countries and such interventions are anathema to many people, including scientists, in countries that do not yet have specific policies in place. Rather than focus on inevitability, better to ask how, when, and by whom germline editing might be used. Given the breadth of opposition, where would the drive come from for the wholesale policy changes that would need to happen to make germline editing a widespread reality?
So-called “patient demand” could be a factor. As historian of science Daniel Kevles pointed out at the gene editing summit, eugenics was never limited to state interventions, but embraced widely by individuals. In Politico recently, Kevles wrote,
What could happen now is likely to be far more bottom-up than the top-down, state-directed racial programs of the past—individuals and families choosing to edit their genes, whether to prevent illness or improve capacity or looks, and finding themselves encouraged to do so by what was absent in the era of eugenics: the biotechnology industry.
During and after the summit, reporters advanced the patient demand argument, seizing especially on the tearful plea during a comment session by Sarah Gray, from the American Association of Tissue Banks, who had lost a baby to anencephaly (a condition whose unclear genetic basis would make it ill-suited for gene editing), “If you have the skills and the knowledge to fix these diseases, then frickin’ do it.”
But is all patient demand really what it seems? As Boston University sociologist Ruha Benjamin noted—referencing scientists’ campaign in 2004 for $3 billion in public funding for stem cell research in California—it is possible to leverage a “pro-cures” bias and to mobilize patients and their families to fight on behalf of scientists’ agenda. At the gene editing summit, Benjamin suggested that patients could again be co-opted by scientists eager to move forward with both therapeutic and germline applications of CRISPR-Cas9.
The campaign in Britain over three-party embryos also prominently featured narratives of women afflicted with mitochondrial disease and their traumas and travails. Such tales pull at the heartstrings and deflect attention from broader ethical considerations and, in some cases, facts. As David King, who runs the watchdog group Human Genetics Watch, remarked when the UK’s fertility agency, the Human Fertilisation and Embryology Authority (HFEA), approved mtDNA work,
The decision is very disappointing, but comes as no surprise, since the HFEA can never say no to scientists. These experiments are scientifically useless and morally very problematic. The research lobby has distorted the scientific facts in order to defuse criticism.
Although it has been described as exceedingly thorough—with several reviews by an expert panel, solicitation of views on ethical issues, surveys and calls for comment from the public, and debates in the House of Parliament—the HFEA process has also been deemed problematic by civil society groups in Britain and elsewhere. And as CGS consultant Pete Shanks and CGS staffer Jessica Cussins found, the HFEA’s claim of “broad public support” for approving the techniques is misleading at best.
The gene editing summit, while billed as a “global discussion,” was also found wanting. CGS’s Marcy Darnovsky and others in attendance (see, for example, presentations by Catherine Bliss and Ruha Benjamin) enumerated the many groups left out. If the NAS is genuinely committed to “ongoing discussion,” as it has said it is, it should develop a robust framework for how and when those discussions will occur and implement measures for true inclusivity. As David Corn of the Innovative Genomics Initiative at University of California has written, “We need to keep talking about gene editing. And by ‘we’, that means everyone, even across national boundaries. And everyone in all walks of life needs to be involved in the conversation.”
Gina Maranto is a fellow at the Center for Genetics and Society. She is Professor and 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. Her articles, opinion pieces, and reviews have appeared in Discover, The Atlantic Monthly, Scientific American, The New York Times, and other publications. She is the author of Quest for Perfection: The Drive to Breed Better Human Beings.
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Composite image via Flickr/John Ward, Flickr/Rob Pearce, Flickr/Gennie Stafford
Biopolitical News of 2015
Posted by Elliot Hosman, Pete Shanks & Marcy Darnovsky, Biopolitical Times on December 22nd, 2015
For controversy and consequence, no story in 2015 came close to the rapidly developing CRISPR-Cas9 “gene editing” tools, and the prospect of their use to modify the human germline. The 2015 wave of news about gene editing swelled to pervade many of our concerns, from inheritable genetic modification to assisted reproduction, from disability and racial justice to synthetic biology, from the legacy of eugenics to the general culture of biotech.
Of course, CRISPR wasn’t the only news of the year. The UK approved a form of inheritable genetic modification based on nuclear genome transfer techniques, based in part on a public consultation process that was represented as demonstrating broad support, but that actually did not. Biobanks and DNA databases grew ever larger, raising both hopes and concerns. Research on all kinds of stem cells continued, with a combination of advances, scandals, and major financial concerns. Products made using synthetic biology techniques began reaching the market. Cross-border surrogacy dominated the news about assisted reproduction.
The Center for Genetics and Society continues to work to raise public awareness, inform policy debates, and include a wide range of public interest perspectives in the regulatory and governance decisions that shape the way human assisted reproduction and biotechnologies develop. Here is a breakdown of highlights roughly grouped by topic:
INHERITABLE GENETIC MODIFICATION
In 2015, CGS’s core organizational concern about human heritable genetic modification moved from the realm of scientific fiction to a thinkable clinical prospect.
In February, the UK Parliament carved out an exception to its law prohibiting human germline modification, allowing the HFEA to begin licensing clinics to create children via “3-person IVF,” also known as mitochondrial manipulation or nuclear genome transfer. In the US, the FDA has asked the Institute of Medicine (now the National Academy of Medicine) to produce a consensus study about these controversial techniques; Marcy Darnovsky spoke at the committee’s first public meeting. A related technique, the unvalidated fertility “booster” AUGMENT, which adds mitochondria from ovarian stem cells into eggs during IVF, made its way into the fertility markets in Canada and Japan but not in the US; the FDA considers the cell transfer protocol an “experimental new drug.”
The gene editing tool known as CRISPR/Cas9 proliferated into thousands of labs and research papers. In April, researchers used CRISPR in non-viable human embryos, sparking an international debate as the prospect of genetically modified babies came into view. The NIH, the White House, and UNESCO [pdf], along with prominent scientists and biotech industry figures, voiced their opposition to the technology moving into use for human reproduction. CGS attended the three-day #GeneEditSummit co-organized by the U.S. National Academies; Marcy Darnovsky spoke on a panel about “societal implications.”
CRISPR-produced super-dogs, micro-pigs, more pigs, and hornless cows made headlines. A related technique called gene drive became a pressing concern, as scientists held out the promise of ending malaria by using germline editing to eliminate particular genes in wild mosquito populations.
The development of artificial gametes inched along this year, with press releases and news coverage emphasizing how the technology could create biokids for LGBTQ couples—despite the host of risky unknowns associated with creating eggs and sperms in a lab. Human cloning was back in the news, as the notorious stem cell researcher Hwang Woo Suk re-emerged from the shadows of past fraud and embezzlement to sign up with animal cloning giant Boyalife, whose CEO told reporters they have the technology to create human clones.
GENETIC TESTING & BIOBANKS
In a rush to monetize the genome, the direct-to-consumer genetic testing market saw regulatory, scientific, and ethical pushback throughout 2015. On the other hand, the FDA cleared 23andMe to offer a limited range of carrier tests, leading to big investment bucks for a company already scaling up. Ancestry.com also began talks with the FDA about selling health data. The FDA cracked down on a range of blood and genetic medical tests that were avoiding oversight via an old exception for laboratory-developed tests, due to inaccuracies that have promoted unnecessary surgeries, put tens of thousands of people on unneeded drugs, and raised medical costs.
President Obama’s Precision Medicine Initiative progressed towards its goal of sequencing a million American genomes starting in 2016, as California launched its own, despite concerns that the underpinnings of the projects remain dubious. Biobanks generally soared in size and scope, as national, international, law enforcement, for-profit, and for-research DNA storage proliferated around the world. Meanwhile reports of secret law enforcement requests that personal genomics companies hand over customer data circulated widely.
The supposedly exact science of DNA forensics was repeatedly called into question, as observers noted the tendency of criminal DNA databases to become feedback loops to incarcerate and re-incarcerate the same oppressed communities. DNA testing also reared its head in the Syrian refugee crisis and immigration, where genetic evidence is used in family reunification cases to promote a narrow definition of family.
In clinical care, preliminary results from seemingly successful gene therapy trials were offset by the likelihood that costs alone could forestall clinical utility. The fast-expanding availability of early non-invasive prenatal genetic testing led Ohio’s state legislature to consider an anti-choice bill that would ban abortions for fetuses with Down syndrome; disability rights and others who support reproductive rights questioned the assumption that women should be encouraged to terminate pregnancies after diagnoses of Down syndrome and other genetic variants; and clinicians and genetic counselors questioned the accuracy of the tests, especially when they reach beyond chromosomal aneuploidies or are used in routine rather than high-risk pregnancies.
Research on all kinds of stem cells continued, with a combination of advances, scandals, and major financial concerns. At least 200 clinical trials are under way, most of which seem to be safe and some are possibly, though not certainly, effective. Unfortunately, the number of unregulated clinics peddling unproven treatments continues to climb, to an estimated 100–200 inside the US, and many more in Mexico, the Philippines (which is cracking down on them) and elsewhere. The FDA, as Paul Knoepfler emphasizes, is not doing enough.
As treatments approach the clinic, the question of cost has become prominent. One stem cell-based drug that has been approved in Canada is likely to be priced at over $200,000. That could be a big blow to the efforts of the California Institute for Regenerative Medicine (CIRM) to reinvent itself by pushing hard for therapies, partly in hopes of extending its existence beyond 2020 when the money runs out.
This was the year that synthetic biology went so mainstream that it almost disappeared in plain sight: Much of the work referenced above on gene editing and gene drive is a form of synthetic biology, and many of the current regulatory issues are also affected by it. Indeed, the recent report that CGS and Friends of the Earth produced on Extreme Genetic Engineering and the Human Future began in 2014 as an introduction to synthetic biology, because back then most people didn’t know gene editing was so far along in development.
Now, products made using synthetic biology techniques are reaching the market [pdf], unlabeled and essentially unregulated. About a billion dollars has been invested in the last three years, and the Defense Advanced Research Projects Agency (DARPA) has been ramping up its spending on synthetic biology as a “strategic investment.” On a different scale, and perhaps worrying for different reasons, biohackers are getting into the concept of doing synthetic biology at home. And puff pieces now call biologists “the next rock star designers,” who inhabit (apparently without irony) a “brave new world.” No wonder they are so utopian in their thinking, not to mention undemocratic.
Cross-border surrogacy agreements continued to dominate the news about assisted reproduction. Nepal banned commercial surrogacy, following the lead of Thailand and India, and Mexico (vote in progress) may also limit surrogacy arrangements to heterosexual families living in the country who can demonstrate maternal infertility. Other repro-tourism zones are emerging; in Cambodia, the government is planning on curbing unregulated fertility practices.
Stories continued to emerge of unwanted babies left behind, exploitative baby farms, intended parents stuck in Mexico and Thailand while governments decide parentage, women dying while serving as surrogates, and surrogates in Nepal left in a post-earthquake danger zone while their gestational children were evacuated. Posing as a surrogacy client, a journalist had dinner with a broker who brought along a baby and offered it to sell it to her on the spot.
Uterine transplants were presented in the UK and American media as a would-be ethical alternative to surrogacy, although the risky transplant protocol comes with its own host of social and ethical concerns. Clinical trials have migrated from Sweden—where the first baby gestated in a transplanted uterus was born in 2014—to London and Cleveland where new transplants are expected to begin in 2016.
In 2015, CGS published Global Surrogacy Practices, a report based on the international symposium we co-organized in The Hague, and co-authored What’s In a Name? Variations in terminology of third-party reproduction. We organized a screening of the surrogacy documentary Made in India, followed by Q&A with the filmmakers, as part of our film series Being Human in a Biotech Age.
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Top Biopolitical Times Posts of 2015
Posted by Elliot Hosman, Pete Shanks & Marcy Darnovsky, Biopolitical Times on December 20th, 2015
In 2015, CGS staffers and guest contributors posted 80 blogs at Biopolitical Times. Some were syndicated on our guest blog at Psychology Today, Genetic Crossroads.
Fourteen of our favorite posts plus a series by CGS staffers are shown below in chronological order. Scroll down for posts by our wonderful guest contributors. Staffers
Blog Series: Forgotten Stories of the Eugenic Age
Forgotten Stories of the Eugenic Age explores the lesser-known ways that eugenics affected and engaged American lives during the first half of the twentieth century.
Part I: How “Better Babies” Became “Fitter Families”
Part II: Eugenics, Love and the Marriage Program
Part III: Divorce, “Crying Off,” and the Perils of Eugenic Perfection
Part IV.1: The Short Life and Eugenic Death of Baby John Bollinger
Part IV.2: The Black Stork Rises: Dr. Haiselden’s Celebrity and Public Controversy
Part IV.3: The Blurry Boundaries of Eugenic Infanticide
- Key Questions About the Social and Ethical Implications of Nuclear Genome Transfer or “3-Person IVF” Techniques
As the U.S. Institute of Medicine (now National Academy of Medicine) launches an official assessment over the next year, here are eight questions to consider.
- Precision Medicine in Context
President Obama's proposal for a Precision Medicine Initiative – which echoes President Nixon's "War on Cancer" – should start a conversation
that includes lots of questions.
- Mitochondrial Mission Creep and the Cloning Connection
Shoukhrat Mitalipov wants to use nuclear genome transfer for age-related infertility. He has joined forces with the disgraced stem cell researcher Hwang Woo-suk.
- Babies from Two Bio-Dads?
Recent research on human germ cells has revived speculation about the possible uses of artificial gametes.
- Calling for “More than a Moratorium” on Human Germline Modification
A broader array of critical responses and policy suggestions follows recent reports that the gene-editing technique CRISPR has been used to genetically modify human sperm, eggs or embryos.
- Incurious about Ethics?
An Institute of Medicine committee is studying the “ethical and social policy” implications of germline mitochondrial manipulation. Why do most of its members seem uninterested in social or policy questions?
- Racial Health Disparities: It’s Inequality, Not Genes
A review of genomic research on racial health disparities in heart disease finds it has made “little or no contribution to our understanding.”
- The Blurred Lines of Genetic Data: Practicality, Pleasure and Policing
Amid a rumor that Apple may encourage iPhone owners to share their genetic data, shocking news from Ancestry.com and Idaho police is a reminder that we don’t always control what happens with our data, and won’t always like it.
- Tired Tropes and New Twists in the Debate about Human Germline Modification
Techno-enthusiasts now argue that as we think about the human future, we should rule out considering what we might learn from literature, film, myth, and history that they don’t like.
- First Federal Bill to Acknowledge US Eugenics Would Help Victims of State
If passed, it would be the first federal legislation to recognize the history of sterilization abuse that took place during the twentieth century in the name of eugenics.
- Surrogacy as an
Iceberg: 90 Percent Below Water
While agencies market surrogacy as a fulfilling “journey,” they also caution prospective consumers about ethical and financial pitfalls.
- Big Money Heading for Consumer Genomics
Investors are now betting hundreds of millions of dollars that the direct-to-consumer testing business will become profitable.
- Gene Therapy: Comeback? Cost-Prohibitive?
Recent CRISPR news sometimes confuses germline modification which should be put off limits and gene therapy, which presents its own set of social and ethical risks to resolve before rushing to market.
- Livetweeting #GeneEditSummit: Democratized Debate or Segregated Conversations?
Though #GeneEditSummit was trending on Twitter, inclusive public debate must be more robust than the live-tweeting of insular stakeholder meetings.
Contributors and Fellows
A number of remarkable guest bloggers on Biopolitical Times contributed their commentary on a wide variety of issues during 2015. Not much for choosing favorites among our friends, we do want to extend our appreciation for their time and perspectives. In alphabetical order:
George Annas on inheritable genetic modification: The Moral Imperative for Psychologists
Naomi Cahn on donor gametes:The Rights of Donor-Conceived Offspring
Katayoun Chamany on precision medicine:
New Rules Proposed to Address Privacy and Trust in the Precision Medicine Initiative
Nathaniel Comfort on inheritable genetic modification: Putting Ourselves in Harm's Way: Thoughts on Pinker and the Role of Bioethics
Colleen Cordes on synthetic biology: DIY Bio-Engineering: Disrupting Democracy
Gwen D’Arcangelis on biosecurity: U.S. Bioweapons Research: Are Anthrax Lab Accidents All We Have to Fear?
Sayantani DasGupta on donor gametes: Why Facebook’s Egg Donor Ads Freak Me Out (And Should Freak You Out Too)
George Estreich on genetic screening:
FDA Regulation and Early Prenatal Testing; de-extinction: Of Clocks and Mammoths: The Pitch for De-Extinction; new film releases: Ex Machina: Of Screens and People; and inheritable genetic modification: The Rhetorical Two-Step: Steven Pinker, CRISPR, and Disability
Jaydee Hanson on eugenics reparations:
Virginia Votes Compensation for Victims of its Eugenic Sterilization Program
CGS Fellow Lisa Ikemoto on CRISPR/Cas9: Fast Forward-Pause-Stop: The 3-Speed Human Germline Debate; and donor gametes: “High IQ Eggs Wanted” – ads appeal to ego and altruism, offer $10,000
Ricki Lewis on genome sequencing: Universal Newborn Genome Sequencing and Generation Alpha
CGS Fellow Gina Maranto reviewing Deborah Lynn Steinberg's Genes and the Bioimaginary: Genetic Facts, Genetic Reality, Genetic Imaginaries; on precision medicine: "Moonshot Medicine": Putative Precision vs. Messy Genomes; and egg retrieval: Seeking Your Input: Survey on Egg Retrieval
Stuart Newman on inheritable genetic modification: Pinker's Damn: A Naive Rejection of Controls Over Genetic Engineering
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Weak Arguments For Modifying the Human Germline
Posted by Pete Shanks on December 10th, 2015
At last week’s International Summit on Human Gene Editing, philosopher John Harris
made the case for heritable human genetic modification. According to
three reliable sources with previous experience of the Manchester-based
Harris, he did so in a significantly more understated manner than
One is compelled to conclude that in mid-season form, his act
lacks only a red nose and a dancing bear to qualify for an old-fashioned
circus (which the Summit was not). Straw men blazed under the withering scorn of his sarcastic ridicule (unlike Monty Python's Doug Piranha,
litotes seems not to be part of his arsenal). Some of his gags are so
old and trite that I remember them from my own childhood, and at least
one particularly sexist poke has been rolling around for 90-odd years. Talking points that should long have been left to rot in peace were exhumed and animated as if by Dr. Frankenstein himself.
OK, enough. A little comedy is fine, but it should be a seasoning, not the main dish.Video of his performance can be found here (Day 1, Part 3). (Deaf activists
pushed for captioning but there’s none on the archived version.) There
seems to be no official transcript, but I had access to an audio
recording. Much of the talk was included in two preprints he handed
out, and also in this peer-reviewed article and this Op-Ed. The italicized numbered headings are accurate paraphrases of Harris’ comments, and all quotations have been checked.
Attempting to Rebut the Objections
Harris began by listing, and attempting to counter, what he
understands to be three principal objections to human germline
interventions that are “very obvious and obviously fallacious and
dogmatic.” In brief, they are: these affect future generations; the
risks to future generations are unacceptable; and consent from future
generations cannot be obtained. On all three, his characterizations and
counter-arguments are, to put it politely, seriously flawed.