Posted by Diane Beeson, Biopolitical Times guest contributor on February 8th, 2016
The typical media story about transnational commercial surrogacy presents the process as a creative solution for people who could not otherwise do so to become parents. The experience of the women whose bodies are used to nourish and develop these babies, and who give birth to them, remains a back-story. But in a recent Radiolab episode, a chance encounter and a momentous earthquake coincide to reveal rarely examined layers of complexity in this oft-told fairy tale.
Two Israeli men, Tal and Amir—legally excluded only by virtue of their sexual orientation from hiring an Israeli woman to bear children for them in their own country—discover that they can do so through an agency that hires Indian and Nepali women. Of course they have to obtain eggs from women with more desirable physical attributes. They soon learn that “cheap white eggs” can be obtained from the Ukraine.
All of this is managed successfully. That is to say, they now have three children, each of whom has the genes of one of them as well as the genes of an unknown, tall, young, Ukrainian woman. And they have three more embryos in a freezer in Nepal. So why, looking back on the experience, did they say: “We feel like suckers”?
The men claim, as do many commissioning parents, that they did not want to be part of an exploitative process. Yet they seem to have given little thought to the provider of those “cheap white eggs”—only that their child’s genetic mother’s height and physical appearance fit their specifications. They pay somewhat more attention to the birthmother. They were told that the amount of money that she would receive would change her life. It would enable her to buy a house or send her children to a university. They concluded “if it’s a life changer, it’s not exploitative.” Issue resolved.
While Amir and Tal were in Nepal to pick up their third newborn they had a chance encounter with another “surrogate” away from the watchful eye of the intermediaries. They concluded from what she told them that the women were receiving only a fraction of the amount that commissioning parents were led to believe. They explained they would have made more inquiries, but the next day a major earthquake struck Nepal killing 7000-10,000 and injuring many thousands more.
Amir and Tal’s newborns were among the 24 babies TV cameras showed being evacuated to Israel. The babies were saved, but the fate of their birth mothers – and of other women who were still pregnant under contract – is unclear. The earthquake revealed a pipeline of scores of babies moving from Nepal to Israel, and led the Nepali government to ban commercial surrogacy.
Efforts to follow up specifically on the fate of Tal and Amir’s surrogates were suspended when they were told that these inquiries jeopardized the lives of the women. To the credit of Radiolab, they sought out a Nepali journalist in an effort to learn more about other women who participate in such arrangements. They found that these women sometimes receive as little as $1000, and often well less than half the $12,000 the Israeli men had been led to believe their surrogates would receive. They learned that the contract language, which reads “Payment for surrogacy services,” apparently includes many other recipients: middlemen, and middlemen who have middlemen. Furthermore, the women, who are given a variety of potentially harmful drugs prior to implantation, are paid only a small amount each month of the pregnancy, with the bulk of the agreed upon amount paid only once the birth is completed. In the event of miscarriage – a not-infrequent occurrence – she receives nothing more.
Notwithstanding the poverty and inequality that drive women to agree to “rent their wombs” and to trade on their skin color to sell their eggs, the Radiolab reporters expressed admiration for “the inventiveness of people.” One of them dubbed it a “kind of symbiotic benefit” explaining, “Okay, it’s not the crazy amount of money we thought it was," but . . . “they chose to do this . . . in some ways they are in charge of deciding how they want their life to be.”
There are wider issues at work here — issues of class, financial power, transnationalism, and racial hierarchies — but they go mostly undiscussed in the service of presenting how wonderful it is that this technology is available for those that can afford it.
In this case, securing “cheap eggs” from an economically depressed white country and placing the resulting fetus into the body of a woman of color— who has chosen to rent out her womb for an acceptable price—mitigates the high cost of producing a white, biological child. It’s clear here that the couple’s desire isn’t simply for a biological child, but for a white biological child—something that’s a little eerie in practice when a woman of color bears a white baby simply because it’s cheaper.
This is one of the many questions about transnational commercial surrogacy that this episode manages not to really address. Among the others:
Why is so little attention given by journalist, policy makers and others to the social conditions that give rise to transnational commercial surrogacy?
Why is so little attention given by journalists, policy makers and intended parents to the consequences of commercial surrogacy for the women involved?
Why aren’t investigative reporters looking into the practices of the “middlemen who have middlemen” and all the others profiting from these commercial surrogacy arrangements?
What about the providers of those “cheap white eggs?” What do they understand about the risks this process poses to their health and fertility?
What kind of follow-up medical care is provided to women whose bodies are mined for eggs and women who serve as surrogates?
How will infants, often born weeks early as Tal’s twins were, and separated from their birth mothers so abruptly, only to be placed in the hands of an intended parent “terrified to touch them,” fare physically and emotionally?
Why should the desire for a genetic connection to one’s child be respected in adults who are willing to deprive their child of the possibility of knowing their genetic and gestational mothers?
Does the moral acceptability of this process depend on the amount of money paid to a woman for going through it, as Tal and Amir concluded?
Once we accept turning human reproduction into a business with clear eugenic dimensions, as Tal and Amir described in choosing their egg provider, where do we draw the line on future genetic manipulations?
Diane Beeson is a fellow at the Center for Genetics and Society. She is Professor Emerita of Sociology, California State University, East Bay. Over the past three decades, she has conducted research and published in leading sociology and medical journals on prenatal diagnosis, genetic testing, and social challenges of new reproductive technologies, most recently, on issues related to third-party reproduction. Beeson is co-founder and Associate Director of the Alliance for Humane Biotechnology, a network of scholars, students and activists working for a biotechnology that places the health and welfare of people and the natural environment above financial interests. She received her PhD from the University of California, San Francisco, where she specialized in medical sociology.
On January 25, news broke widely in the press on research published in Nature by a team in Shanghai, who spent six years creating two generations of macaque monkeys engineered to have duplications of the MECP2 gene in their brains—a gene that researchers have associated with Rett Syndrome, a condition on the severe end of the human autism spectrum.
The researchers listed a battery of behavioral tests which they claimed as evidence that the transgenic monkeys were now genetically predisposed to autism-associated behaviors. In a press briefing organized by Nature, Zilong Qiu, a leader of research at the Institute of Neuroscience at the Chinese Academy of Sciences, stated plans to leverage their research into human clinical trials down the line, with the aim of developing somatic gene therapies or non-invasive interventions like trans-cranial magnetic stimulation [Wiki] to correct autism in humans. Qiu stated the researchers are currently trying to identify the brain circuitry responsible for what they believe is the monkeys' changed, autism-like behavior; after that, they plan to use CRISPR-Cas9 gene editing to manipulate the MECP2 duplications in the transgenic monkeys they created.
With “autism,” “transgenic,” and “monkey” in the headlines, it’s not surprising that a flurry of media coverage might flatten the social and ethical implications of what’s at stake with using animals models to study stigmatized human behavioral conditions. One article was promoted on Twitter as “First Monkeys with Autism are Sickly Loners Who Pace Their Cages.” Comments on that article included: “I have a child with autism and even I find what you are doing to these monkies [sic] repulsive. This is a sad commentary on science and our society.” …“I have a daughter with autism, and I find this to be very disturbing!!!” … “I'm autistic, but I don't need to be cured, thank you very much.”
The Limits of Animal Models in Studying Human Behavior
While unvalidated claims that vaccines cause autism are ongoing, scientists have been motivated for some time to clarify genetic bases for autism spectrum disorders. Some estimate that hundreds of genes are involved, many assert that environmental factors may also be at play, and many others assert that the majority of “disorders” classified as autism (and targeted by market-driven drug trials) are just points on the spectrum of human neurodiversity that we ought to be de-stigmatize and de-medicalize.
Most articles on the transgenic monkeys cited scientists who agree that cheaper, quicker mouse models have severe limitations in studying human behavior. Yet a number of reporters, or the scientists they quoted, pushed back on the claims of the study. David Cyranoski in Nature quoted stem cell and autism researcher Alysson Muotri, who stated that symptoms in mice and monkey animal models for autism are often “less severe than ‘what we actually observe in human patients… It remains to be seen if the model can actually generate novel insights into the human condition.’” James Cusack, research director at Autistica, told Ian Sample in the Guardian that “people with autism vary in a number of ways, and autism itself is linked to a number of other conditions. With this in mind, developing a single animal model of autism may be difficult to achieve.” A number of reporters also cited MECP2 pioneer Dr. Huda Zoghbi’s critiques of the study, including: (1) the monkeys did not exhibit behaviors associated with MECP2 duplication in humans like seizures and severe cognitive problems; (2) the monkeys’ circling behavior in their cages is a symptom not exhibited in human children with MECP2 duplications (perhaps the cage is relevant); and (3) the monkeys only carried MECP2 duplications in their neurons, not throughout the brain as in humans with Rett Syndrome.
The Ethics of Biomedical Research on Animals
Virginia Hughes in BuzzFeed discusses the pulse of clinical research moving from mice toward sentient non-human primates, linking to the recent debut of transgenic monkeys with a 2008 US study on the genetics of Huntington’s disease. The first transgenic monkeys made with CRISPR-Cas9 were reported by researchers in China in 2014. Hughes notes that research with non-human primates is “ethically fraught”; indeed the ethical pushback to genetic experimentation on monkeys and other animals is wide-ranging in recent news:
During the #GeneEditSummit in D.C. on the ethics of CRISPR-Cas9 human genome editing, livetweets reacted to the disturbing videos shown by Weizhi Ji from the Kunming Institute of Zoology depicting gene-edited monkeys undergoing various tests to document changes in behavior (December 2015) (video here, t12:37 for noise test, t13:33 for heat test; slides document previous experiments with monkeys and MECP2).
In BuzzFeed, Hughes links to the extensive and compelling reporting done by Peter Aldhous on the use in the US of thousands of monkeys, many of whom were killed, in testing experimental drugs for biosafety research in the “war on terror” (July 2015).
Researchers are using CRISPR to edit the horns off of cows pre-birth to make them more convenient for Big Ag (December 2015), amid “a flurry of research looking at how to make cattle easier to maintain, transport and turned into food” despite “concerns among some farmers and animal-rights activists.”
Animal cloning factories are in the news, including in China, with a range of customers, including sentimental individuals with dead pets, military and police forces, and big agriculture; and with the stated organizational goal of migrating into human cloning experiments. Then there’s the “Google”—err—Monsanto “of life sciences” being erected by technoenthustiastic but venture capital-allergic billionaire Randal Kirk, which Pete Shanks outlines in detail in Who Will Pay for Human Germline Changes?
In just the last few months, this evidence shows a growing swath of concerns regarding animal research ethics that the biomedical sector will encounter as it moves forward with monetizing CRISPR gene editing and placing clinical applications in the research and development pipeline.
The National Academies summit on human germline gene editing has dominated discussion over the last few months, with talk about international agreements and a voluntary moratorium or formal ban. But perhaps those of us concerned about the prospect have been looking in the wrong direction. Consider this scenario:
A multi-billionaire becomes fascinated by synthetic biology. He starts with a fairly small company, and decides to turn it into a big one without using venture capital. His goal is to make it "the Google of the life sciences." Among the acquisitions and partnerships he makes are:
a company developing personalized cell and gene therapies using iPS cells
an animal cloning company (both the agricultural and pet markets)
a biopharmaceutical company focused on cancer immunotherapies
a drug development and delivery company
a company that makes genetically modified fish (even before selling them was legal)
a company that makes sterile mosquitoes in order to effect permanent germline changes
a company that makes genetically modified apples
a company pushing hard into multiple IVF markets around the world, with
products not currently legal in the U.S., and
research into human egg precursors with the explicit intention of producing hundreds of eggs and possibly embryos — and the ambition of editing them
In short, lots of private money, deep connections with the pharmaceutical industry, a major focus on synthetic biology, a willingness to jump borders for legal convenience, a deep interest in reproductive technologies, and the clear intention to work on "enhancing" embryos.
That could turn into a nightmare. But it's real, and it's happening now.
Kirk, a lawyer by training, made his first fortune ($65 million) with a medical supplies company; his first big one with New River Pharmaceuticals (he cleared $1.2 billion); his second with Clinical Data (roughly $600 million); and his third when he took Intrexon public in 2013 (his shares have been valued at $1.5 billion). He avoids outside venture capital, and held onto over 60% of Intrexon; the success of its IPO may have been largely because of his existing reputation.
Clearly Kirk bought Intrexon as a way into synthetic biology. Its founder, molecular geneticist Thomas Reed, positioned what was originally called Genomatix as a gene-tools or DNA-parts venture, but Kirk had much broader ambitions (yes, the Google quote was his, though he said it before Google became the Google of the life sciences). In a 2011 profile, Forbes also reported Kirk's prediction that:
in a decade it [Intrexon] could become "the largest, most significant company" in its burgeoning field.
He could be right.
Of course, he also might not. Indeed, Viagen was a spin-off from Genetic Savings and Clone (GSC), a pet cloning company that was set up by the billionaire John Sperling. GSC was finally abandoned, partly for technical and ethical reasons and above all because it was not commercially viable.
Intrexon and OvaScience
Last April, MIT Technology Review noted that OvaScience intended to "correct [harmful genetic] mutations before we generate your child," and Motley Foolpointed out the potential synergies between OvaScience and Intrexon, focused on a joint venture called OvaXon, described on the Intrexon website thus:
The joint venture looks to create new applications for improving human and animal health. Under the joint venture, OvaScience's EggPC platform will be combined with Intrexon's genome engineering capabilities with the goal of offering an innovative approach for the prevention of inherited diseases in humans, such as mitochondrial and other genetic disorders.
The technology behind OvaScience is scientifically controversial, ultimately based on the disputed discovery of "egg precursor cells" that "have the potential to develop into mature eggs, thereby replenishing a woman’s egg supply." Its main product at present is Augment, which "uses the energy-producing mitochondria from your own egg precursor (EggPC℠) cells … to supplement the existing mitochondria in your eggs" and thus supposedly improve fertility.
One of the founders of OvaScience told a stock analyst last spring that
using CRISPR in germline engineering was not on the current agenda
("they have enough headaches at this point") but they do admit to being
aware of the potential to use it that way.
The FDA will not allow Augment to be sold in the U.S. without clinical trials. However, it is sold in Canada, where the first baby was born after that treatment in May, 2015; and also in Japan, Turkey and Dubai. A British IVF clinic is applying for permission to use the procedure "in a pilot trial involving about 20 women."
Permission may not be granted in the UK — Robin Lovell-Badge, for one, is extremely skeptical — but the attempt illustrates the difficulty of establishing, let alone enforcing, international standards.
The company is trying to pressure the FDA by creating consumer demand here with promotional stories from abroad.
Intrexon and its subsidiaries have other experience with transnational evasion techniques: AquaBounty was an American company, founded in Maynard, MA, and incorporated in Delaware, that set up in Canada to create eggs that would be grown in Panama.
It nearly went bust until Kirk bought in.
Kirk is arguably "Biotech's Best Investor."
He's clearly a technophile and definitely thinks that synthetic biology is the future — he's called his partner Reed "the Henry Ford of DNA" — but he does not seem to be primarily an ideologue; he wants to make another boatload of money.
So what's to stop Kirk and his companies and allies, or people like them, from developing a germline "enhancement" technology that they could introduce in, say, Dubai and promote everywhere else?
[This post was edited on January 30th to include Oxitec, previously omitted by mistake.]
Posted by George Estreich, Biopolitical Times guest contributor on January 22nd, 2016
On December 29th, 2015, the Guardianreported that the London Sperm Bank is being investigated for discriminating against people with disabilities. The bank had turned away a man with dyslexia; it had published a 2010 pamphlet with a long list of disqualifying “neurological diseases,” including dyslexia, autism, ADHD, and other conditions.
Vanessa Smith—described as a “quality manager at the JD Healthcare Group,” the bank’s parent organization—defended the bank. Backpedaling without budging an inch, she said that the pamphlet had been withdrawn and policies would be reviewed. Still, little seems likely to change. According to Smith, “We are looking for someone who is medically clear of infectious diseases and genetic issues that may possibly be passed on to any resulting child.” She also claimed, “We definitely don’t work in eugenics.” She may mean something like, “In the popular mind, ‘eugenics’ is associated with Nazis, an association we wish to avoid.” But to shape future children, based on a policy that describes human variation as disease, is by definition eugenic. The bank’s currency is genes, and it wants good ones.
Smith’s grouping of “infectious diseases” with “genetic issues” is significant. Both are disqualifiers: in the view of the London Sperm Bank, they make the sperm unsuitable to produce a future human being. In the Guardian article, people with dyslexia were quoted, questioning the Bank’s criteria. My interest is less in the specific items on the list, or in the need for one—of course a prospective mother would prefer to have a child free of, say, hepatitis-C—than in the neutral, euphemistic vagueness of the phrase genetic issues, and the way it tends to pathologize human variation. (When I think of our rapidly increasing, fine-grained knowledge of human genetic variation, and the pressures that turn said variations into Issues, I imagine the pans of a giant balance. On one side is the gigantic and growing pile of genomic data, and on the other side is an equally gigantic but correspondingly undifferentiated idea, a blobby sense of abnormality stuffed into a neutral-sounding word, like issues. Even as we generate specificity, we generate vagueness, ideas and words capacious enough to suggest all that is different from an undefined norm, and therefore undesirable.)
Specifics imply caring. To lump together a vast array of conditions as “genetic issues” suggests an unconcern about the radical differences between said conditions, and a lack of interest in exploring the question. (Of course, the ability to predict and select makes precisely those explorations necessary.) Conversely, the pamphlet is obsessively specific about Different Brains, even to the point of redundancy: forbidden are ADD and ADHD, autism and Asperger’s (yes, a special Not Welcome Mat is spread out for you, high-functioning Different Person), and both “mental retardation” and Down syndrome. Since men with Down syndrome are thought to be sterile, the prohibition seems—well, let’s just say it’s on the cautious side.
Disease and disability are different but overlapping categories. There is no tidy division between them. But the (evolving) criteria of the London Sperm Bank pathologize pretty much everything not nailed down. Autism is not a disease. Neither is dyslexia. Neither are unambiguously genetic, in the way that Tay-Sachs or Down syndrome is. Cerebral palsy can occur without genetic influence at all. But since these conditions may have a significant genetic component, they’re on the list. This is the one-drop rule for the new millennium: any hint of a disorder that may or may not be genetic is, in this scenario, sufficient to disqualify its bearer. The London Sperm Bank’s approach to human difference can be thought of in terms of Russian nesting dolls: inside Difference is Medicalization, which opens to reveal Geneticization.
We are always thinking/not thinking about disability, it is always just beneath the surface of our days and discussions, and I am interested in the places where our ideas break into the open. Discussions of future humans provide one place: they are virtual arenas of the normal and abnormal, where our assumptions bubble up to the surface. Because we seem to be discussing only the prospect of dyslexia or mental illness, and not specific people with those conditions, no actual person appears to be directly harmed. We are only discussing an A vs. B scenario, one where A (a future human without dyslexia) appears clearly preferable, the better choice. All other things being equal, that is.
This is flawed for several reasons, the first being that all things are never equal; the second being that we are talking about present people with dyslexia when we imply dyslexia is serious enough to disqualify a future person; and the third being that actual people with different brains are being discriminated against in the present: in the minor way of not being allowed to donate to a specific sperm bank, and in the major way of being publicly described as lesser humans, as unwelcome.
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.
Editas, the gene-editing company founded by several of the scientists who developed CRISPR technology, announced on January 4th that it had filed preliminary paperwork for a public offering of stock. The filing with the Securities and Exchange Commission is extremely long, but lacks certain vital details, For instance, some clearly unanswered questions are:
How much cash does Editas hope to raise? There is a placeholder number of $100 million, but that is very likely to change dramatically.
When will this take place? "As soon as practicable after this Registration Statement is declared effective."
Will anyone be cashing in? "A significant portion of our total outstanding shares is restricted from immediate resale but may be sold into the market in the near future."
As difficult sales pitches go, this one is hard to beat. This biotech company has burned through $75m in the past few years and has not yet started clinical work on a drug candidate. It says it will be many years, "if ever", before it has something ready to commercialise. If this were not enough, not only is there a thorny patent thicket to manage but the firm must fight and win a case seeking to overturn its own intellectual-property claims on the ground that it was not the first to invent them.
The prospectus does include some new information, including the gossipy history that the company was originally incorporated as Gengine. (Gene-engine? Could we have been spared the whole "editing" metaphor? Probably not.) There is certainly more detail about its product plans and, if you can read the tables correctly, current shareholders, the largest of which, per Xconomy's summary, are all venture capital funds:
16.6% Flagship Ventures
15.6% Third Rock Ventures
15.6% Polaris Venture Partners
9% Bng0 (a Bill Gates-affiliated fund)
5.7% Viking Global
4.8% CEO Katrine Bosley
The prospectus confirms that Editas hopes to begin clinical trials on a therapy for Leber congenital amaurosis in 2017. That disease, which affects 2–3 per 100,000 newborns, is listed by NIH as being associated with at least 14 genes. Mutations in CEP290 (the Editas target, also known as LCA10) account for 15–22% of cases.
Being able to claim that the blind shall see is of course a great selling point, but even if the proposed treatment works, no price has been set for it. (Spark Therapeutics, which may be a competitor, has in the pipeline at least one gene therapy product for LCA blindness that seems likely to cost $500,000 per eye.) Presumably this is more of a proof of concept for Editas than a big moneymaker.
Editas is not the only gene-editing firm considering raising money on the stock market. Intellia, one of the companies founded by Jennifer Doudna, co-author of the first published paper on the technology, has been rumored to be "IPO-ready." CRISPR Therapeutics, founded by Doudna's co-author Emmanuelle Charpentier, is at least considering one, according to CEO Rodger Novak, who noted wryly that
Coming late to this party is not very smart.
Meanwhile, the patent wars are coming to a head. In headline terms, that's a fight between Feng Zhang of Editas on one side, and Doudna (and Charpentier) on the other. Doudna was also a co-founder of Editas, along with Zhang, George Church and others, but withdrew when the patent dispute arose. The Patent Office has officially declared an "interference" and Doudna seems to be a slight favorite at present. (UC Berkeley is favored over the Broad Institute and MIT.) Both sides have stated that the technology will be freely available to researchers, but commercial licenses could be very, very lucrative. When this all ends is unclear.
The business of business is, of course, business, and far be it for those not expert in such matters to criticize decisions about going public. But Editas is said to have at least two years' cash on hand, and the current investors might even snap up the shares on offer.
So why now? Is this all about striking while the publicity is hot?
Coming up next in our Being Human in a Biotech Age film series at UC Berkeley is No Más Bebés. The film documents the coercive sterilization of Mexican immigrant women in 1960-70s Los Angeles, and the landmark lawsuit they brought against those responsible. The screening will take place on Tuesday, February 16th at 4 pm in 470 Stephens Hall. We are very fortunate that we’ll be joined in person by filmmakers Renee Tajima-Pena and Virginia Espino for a Q&A following the screening. You can learn more about the screening at the Facebook event.
On Tuesday, April 12, we’ll be screening DNA Dreams. This documentary explores the inner workings of Shenzhen BGI (formerly Beijing Genomics Institute), which calls itself "The World’s Largest Genomics Organization,” and its animal cloning and cognitive genomics projects.
The new year will also bring a new position to CGS. We have been selected as a host organization for the the American Council of Learned Societies Public Fellows Program, which allows us to seek a Project Director on Race, Genetics, and Society. The ACLS fellowship application process is open for recent PhDs in the humanities or humanistic social sciences. The fellowship competition will accept applications between January 14 and March 24; all applications must go through ACLS. The Project Director on Race, Genetics, and Society will plan, coordinate, and implement CGS’s programmatic work related to the impacts of genetic research, technologies, products, and services on social understandings of race and on racial justice, with the goal of tracking and contesting the re-emergence of race as biological rather than sociopolitical category.
Posted by Elliot Hosman, Biopolitical Times on January 13th, 2016
As the 2015 news cycle ground down and rebooted for the new year, a wide swath of news publications—industry, research, scientific, and popular—declared CRISPR gene editing to be one of 2015’s biggest stories. In the new year, an ongoing CRISPR concern is how we can strengthen and brighten the line of policy and practice that cautions against creating genetically modified human babies.
Much of the news since the #GeneEditSummit in December has focused on a very different application of CRISPR: producing therapies for patients living with genetic conditions. Jaw-dropping investment news is issuing forth as multiple biotech firms team up with drug companies and venture capitalists to bring the CRISPR moonshot of gene-editing therapies into view.
While CRISPR coverage doesn’t always make it clear, many of the leading gene-editing companies have clearly stated that they’re aiming to treat genetic disease in one consenting patient at a time, not on a population level, and not in a fertility clinic for prospective parents seeking to tailor the genetic variants they pass on to their future children. Several key players in this lab-to-market push have spoken out forcefully:
Early in 2015 as rumors were circulating that scientists were experimenting with the CRISPR/Cas9 technology on human embryos, some biotech figures stepped up proactively to make their concerns heard. Edward Lanphier, CEO/president of Sangamo Biosciences (using older gene-editor Zinc Fingers to develop HIV/AIDS gene therapies), published an article in Nature with colleagues from the Alliance for Regenerative Medicine entitled “Don’t edit the human germline.” The article describes the use of CRISPR gene editing in embryos to create edited humans as “dangerous and ethically unacceptable” and says “[w]e are concerned that a public outcry about such an ethical breach could hinder a promising area of therapeutic development, namely making genetic changes that cannot be inherited.” Recently, Sangamo announced that the FDA had approved its new hemophilia drug application for what could be the first in vivo clinical trial of a gene editing technology.
[G]ermline gene editing is outside of the scope of our companies’ research and development. We are dedicated to discovering and developing gene editing-based treatments for serious diseases using only non-germline somatic cells. This is the greatest area of patient need, where the benefits and risks are best understood, and where the ethical support is unambiguous. … [W]e are committed to … [r]efraining from directly modifying germline cells, including sperm, egg or embryonic tissue, or developing any clinical applications of germline gene editing.
Jennifer Doudna and Emmanuelle Charpentier have held this view for some time.
A few weeks after the Sangamo et al. Nature article, Doudna joined a cautious-yet-optimistic statement with other scientists that asked for a pause in CRISPR germline research in order to engage in broad public debate. In Doudna’s personal and professional capacity since “A prudent path forward for genomic engineering and germline genetic modification,” [pdf] she has expressed more extensive reservations. There’s the Hitler dream she recalled to Michael Specter in The New Yorker, and the article she published in Nature on the first day of the #GeneEditSummit that argued against editing the human germline because of “the unknown social consequences” and our limited knowledge of the “technology” and “the human genome.”
Emmanuelle Charpentier has gone further, telling BBC in September “Personally I don't think that it is acceptable to manipulate the human germline for the purposes of changing some genetic traits that will be transmitted over generations,” and telling New Scientist in December: “I hope that using the technology with the idea of changing human characteristics will not be pursued. … Philosophically and sociologically speaking, I have lots of issues with this.”
The first CRISPR company to file to go public still hasn’t made it clear where it stands on the germline controversy. Asked by Nature in May [pdf], Editas co-founder and CRISPR co-discoverer Feng Zhang noted, “[G]iven that many diseases might be treatable through somatic cell genome editing, it is unclear whether germ line editing is an appropriate solution.” In the same interview, Editas CEO Katrine Bosley stated,
The current question about CRISPR and germline engineering is far more complex [than mitochondrial replacement or 3 person IVF], and we don’t have a sense of the breadth of the implications, and we don’t understand the risks well. The technology’s progress now demands us to confront these questions, but that can’t be done quickly.
In recent coverage, Zhang is paraphrased as saying that “the importance of germline editing varies between groups of people, such as potential parents and policy-makers,” while noting that as a researcher, “we are not ready to use [CRISPR] for medical treatment, because there are issues with specificity and efficiency.” Yet neither Zhang nor Editas has voiced principled objections to allowing scientists, private companies, or others to engineer the genes we pass on to future generations. With money rolling in, they may not be worried about the fears of investors, but as a company racing to be the first to begin human clinical trials of a CRISPR gene therapy, they should probably be concerned about how the public will view their ambivalence on the germline question.
* * *
Minding the Germline
Gene therapy companies know that there are numerous obstacles to overcome if they are to translate shiny and powerful new nano-engineering tools like CRISPR into accessible medical treatments down the line. Many remember Jesse Gelsinger, a teenager who died after a gene therapy trial gone wrong, and are aware that this tragedy cautions against the breakneck speed that the market dynamics of drug development engender. Researchers working in stem cell therapeutics—many of whom, like the scientists and biotech figures cited above, have called for a moratorium on germline applications of CRISPR—are also familiar with this tale.
Concerns about the safety and effectiveness of this new kind of gene therapy have been voiced by many, though hyperbole about Eradicating! All! Genetic! Disease! can still be found. Less widely acknowledged are questions about whether any treatments that are successfully developed will be affordable. In California, billions of dollars of taxpayer money have been invested into the California Institute for Regenerative Medicine (CIRM) in hopes of developing hugely hyped but so far nonexistent therapies; after ten years, two late-stage clinical trials are ongoing and may produce medically relevant results, but at sky-high prices.
While CRISPR is ubiquitous in some circles, it still hasn’t hit the public fan like stem cells did back in the 2004 presidential election. It is heartening to see biotech companies come out in very public ways against research and development aimed at engineering the human germline, but questions remain. Will this long-anticipated reboot of gene therapy deliver safe and effective treatments? Will the hundreds of millions of invested dollars—private money to be sure, but money chasing a scientific advance made in large part at public universities—lead to treatments that are accessible and affordable?
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.”
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.
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:
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 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.
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.
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.
Precision Medicine in Context Pete Shanks
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.
Incurious about Ethics? Marcy Darnovsky
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?
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:
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.
Posted by Elliot Hosman, Biopolitical Times on December 10th, 2015
In 1975, scientists engaged in an invitation-only conference meant to encourage self-regulation of a new genetic engineering technology that many thought posed significant threats to the living world: recombinant DNA. This meeting met in Monterey, CA at a resort called Asilomar, a name that would ring on for decades as a purported model for scientists wrestling with the social implications of the breakthrough technologies they develop.
In the past few years, a new suite of synthetic biology tools known as “gene editors” (ZFNs, TALENs, and CRISPR/Cas9) has made possible the widespread and unforeseen consequences of genetically engineering flora, fauna, and ourselves, and “Asilomar” once again became a rallying cry. Yet many[Nature Editorial Board] prominent[Ben Hurlbut] voices[Sheila Jasanoff, Kris Saha & Hurlbut] have pushed back on this metaphorical monolith, noting the 1975 meeting’s extremely insular nature, its structural bias wherein defining risk was left to scientists alone, and its rapidly diminishing usefulness as a model in the modern global context of science and human society.
Cognizant of these critiques—yet tied to the “mythic” Asilomar as one of its principal organizers—David Baltimore, chair of the organizing committee for the International Summit on Gene Editing, opened the meeting (somewhat less insular, still mostly invitation-based) with the following remarks:
… a lot has changed since 1975. Science has become an increasingly global enterprise … The public also has become more engaged in debates about science and scientific progress, and the new modes of rapid communication have provided novel platforms for these discussions. At Asilomar, the press participated with the understanding that nothing would be written about what was said until the meeting is concluded. Today, individuals will blog, tweet, and retweet messages about our discussions from within this very room and in real time. Thus our conversations will be widely disseminated, giving rise to real time commentary. [Webcast, Day 1, Part 1, t: ~1:05:00]
Indeed, the organizers of the meeting initiated the Twitter hashtag #GeneEditSummit, and a number of the reporters present at the D.C. meeting participated by replicating scientists’ talking points from the stage.
Center for Genetics and Society also livetweeted the three days of the conference, trying to highlight the critical concerns of a range of stakeholders, from Broad Institute Director Eric Lander:
.@ruha9 there is an unspoken litmus test that patient advocates be cheerleaders for the science to be at the policy table. #GeneEditSummit — Genetics and Society (@C_G_S) December 3, 2015
Benjamin spoke on Day 3, as part of a panel called “Interrogating Equity.” Its presence on the agenda represented a welcome departure from many past meetings organized by scientists, but few of the scientists in attendance seemed to engage with the concerns it raised. During the “comments from the floor” period, CGS consultant Pete Shanks asked whether scientists in the room believed that analyses of the social and political implications of gene editing were just “rubbish”—and if so, could they please come to the microphone to say that so a civil dialogue between opposing views could materialize? The panel’s moderator Françoise Baylis responded in part by illustrating the contours of the debate that she had discovered over the meetings’ three days:
For the first time at this meeting I’ve tried to follow what was happening on Twitter and to try to learn to contribute. I’m sure I’ve made mistakes along the way because I didn’t understand the technology, but I honestly had the experience of participating in two separate conferences, which I thought was interesting. That on the one hand there were conversations happening there, around issues to do with race, around issues to do with disability, that weren’t happening in the room and on the floor, so I think that’s an interesting idea to interrogate, why that is, and I think that may speak to structural issues where people feel capable or empowered to speak in some contexts that they’re more familiar with and used to… . [Webcast, Day 3, Part 1, t: Pete Shanks Q @ 1:40:05; Françoise Baylis A @ 1:43:58]
One of the many questions moving forward from this #GeneEditSummit is: what exactly did tweeting and retweeting accomplish for the sake of democratic deliberation of society-altering technologies? Did it impact the shape of the debate? Did it strengthen the showing of the public in the consideration of how to proceed? If the majority of the voices engaging on the widely disseminated Twitter platform were reporters and members of the scientific and academic research communities, what does this bode for engaging with the “wide range of perspectives” that was called for, among numerous others, by CGS’s Marcy Darnovsky before and at the meeting, UC Berkeley Professor Charis Thompson during the meeting, and the Summit’s organizing committee at the close of the meeting [see Pt. 4]?
Posted by Elliot Hosman, Biopolitical Times on December 10th, 2015
Paul Knoepfler is a stem cell and genetics researcher at UC Davis who works with CRISPR on in vitro research in stem cells and cancer. He writes and blogs widely about developing issues in genetics and genomics, and has been particularly prescient about the emerging human genetic modification controversy. Paul will be interviewed by Nathaniel Comfort early next year (stay tuned for the exact date) in our online interview series Talking Biopolitics about his forthcoming book GMO Sapiens:The Life-Changing Science of Designing Babies [Amazon, World Scientific].
On December 7, Paul engaged with online forum community Reddit’s celebrated feature Ask Me Anything (AMA) and fielded hundreds of pressing questions about the promise and peril of CRISPR-Cas9 “gene editing” embryos and gametes for reproduction. Some of the questions posted by Redditors online related to the current technical capacity of precise genetic engineering: What is currently possible with “gene editing” tools? What genetic conditions could be targeted? How soon until I can have a baby unicorn child? The short answer to all of them, echoed by Broad Institute director Eric Lander at the #GeneEditSummit, is: We are still learning the genetics behind complex traits, and at this point the science has not caught up to our imaginations. But it is the range of non-technical questions related to this radical technology that have many, including Paul, working to involve the public in this crucial debate.
In setting the stage for the dialogue, Paul posited a range of questions on the societal implications of precise DNA engineering in the global laboratory, including:
[A]re we ready to make genetically modified people (what I call GMO sapiens as a mashup of Homo sapiens and GMO)?
Is it OK to do this for trying to prevent genetic diseases? What about for human enhancement via designer babies? Could we draw the line between the two? …
Are past works of art like Brave New World and GATTACA now appropriate to discuss as human genetic modification appears to be marching toward reality? Or is that just going to scare people?
What about eugenics turbo-charged by new technology?
How do we find the right balance in discussion of this revolutionary issue so that we do not freak people out, but at the same time we have a real discussion that doesn’t sugar coat things or dodge real potential issues? (formatting added)
Here is a small selection of questions and answers from the AMA that strike at the variety of concerns raised by genetically modifying human cells for reproduction.
[frankstandard] Q: “I've been interested in CRISPR since hearing about it on Radio Lab a few months back, so it was exciting to see you here! My question: Dr Stephen Hawking recently highlighted that we don't really have to fear robots in the future, but rather Capitalism and the societal structures that will create greater inequality, stating, ‘If machines produce everything we need, the outcome will depend on how things are distributed. Everyone can enjoy a life of luxurious leisure if the machine-produced wealth is shared, or most people can end up miserably poor if the machine-owners successfully lobby against wealth redistribution. So far, the trend seems to be toward the second option, with technology driving ever-increasing inequality.’ Can you please comment on this related to CRISPR and the potential for it to create more inequality due the current structure of society?”
[PaulKnoepfler] A: “This kind of concern is legit and it applies to any kind of technological advancement. A disruptive, powerful technology like CRISPR has already got the attention of investors to the tune of potentially $1-$2billion USD. They are going to want a return on their investment. Human modification, whether for disease prevention or enhancement, is unlikely any time soon after (or if) it is proven safe and effective to reach a diverse group of patients of different socioeconomic classes. There are risks for active class strife as well through eugenics too. These are issues we should be actively discussing, but too often they aren't on the table.”
[reddevilit] Q: “Can this be used to "cure" certain genetic syndromes like the Costello syndrome, by enabling/disabling specific protein or gene?”
[PaulKnoepfler] A: “That is the hope, but rather than using the word "cure" which implies a pre-existing person/patient, I think the more accurate word to use is "prevent". If you make a designer baby with a corrected mutation then there was no disease to start with to cure. Just something that was prevented.”
[CybernewtonDS] Q: “…Given how expensive medical treatments in the US are mostly inaccessible to working-class individuals, what social safeguards will we have in place to ensure little Timmy and dear Sally are free from Huntington's, Tay-Sachs, and Down Syndrome? The greatest fear here is not that the wealthy will have smarter and healthier offspring, but that those without the means to afford any corrective procedures will bear the brunt of bills and burdens of untreated genetic disorders.
[PaulKnoepfler] A: “Socioeconomic issues are relevant and important here. As with any expensive medical produce (thinking for the moment only about non-enhancement uses for human genetic modification) there could well be disparities and issues of access.”
[wiizbiiz] Q: “Dr Knoepfler, I'm a person with hemophilia deeply involved in education and activism within the bleeding disorders community. The entire community has been watching the field of genetic engineering very carefully, and lots of people are very excited about the incredible innovations that CRISPR makes possible. At the same time, however, the hemophilia community has an incredibly troubled history when it comes to medical innovation and securing access to safe and affordable treatments. During the 70s and 80s thousands of hemophiliacs died of HIV and Hep C contracted from tainted blood products while the factor companies and FDA failed to warn us, and today those very same companies who create our meds in the 80s have used every trick in the book to ensure that factor prices remain exorbitantly high. In view of this history, my question for you is a personal one and not necessarily a professional one. What are your biggest concerns about CRISPR's application, and do you think that the world economy is structured in such a way that it's ready for CRISPR? If not, why and what needs to be done?"
[PaulKnoepfler] A: “Hi, Thanks for sharing your story and that of your community. I really admire those who work on education and are patient activists. Commercial interests is a big issue with CRISPR that wasn't discussed much at all at last week's National Academy Summit that I attended. Some have patent applications and companies focused on CRISPR. Clearly investors view CRISPR as a potential big source of profit. How will the money side of things influence the evolution of this technology? I don't know for sure, but there is likely to be a strong influence. How will the FDA handle CRISPR? I'm not sure, but it is unlikely to be able to do much in advance. We need to view this very cautiously and avoid hyping the potential clinical applications. I was disappointed that the Summit failed to recommend a moratorium on clinical use because I think there are quite some risks here both to individuals and to society. There's real potential too. We need a balanced, democratic discussion on all of this that includes the public. So far that hasn't happened. The main driving force for me to write my new book was to educate people and spark discussion because there are huge issues here.”
[Jayrobinson92] Q: “Hello! Thanks for doing this AMA. I'm really glad you mentioned the movie GATTACA, that was the first thing I thought of when I started reading this post. When watching that movie I honestly felt like I was looking at the future. What is your opinion? Do you think we're potentially headed to a future where genetic predisposition can dictate the paths of our lives?”
[PaulKnoepfler] A: “Hi Jay, I do think GATTACA is relevant here. Many scientists get upset with the movie is mentioned in this context because they think it scares people, but at the same time this kind of technology is now here today so what's the point in pretending it isn't? My sense is that the makers of GATTACA were very good at predicting the future in some ways. It remains unclear if human genetic selection and modification will permanently change our species and our world, but today it seems far more possible at least relatively speaking than just 3 years ago. At the same time I agree with one of the commenters below that an important message of the movie is that genetics is not destiny. I make that point in my book too. There's a catchy notion floating around out there --genetic determinism --that argues the opposite. It says genetics is more powerful than anything else. I don't think it's everything, but it is powerful. One of my concerns about human genetic modification that was a focus of my TED talk is that it could become driven by pop culture and even by governments with bad consequences. Eugenics is a real possibility. To those who say, "don't mention GATTACA or Brave New World" in the discussion of human gene editing, I say go watch the movie and read the book again, and then ask yourself if they really don't belong in the discussion.”
Posted by Gina Maranto, Biopolitical Times guest contributor on December 9th, 2015
Review of Genes and the Bioimaginary: Science, Spectacle, Culture, by Deborah Lynn Steinberg. Ashgate, 2014. 191 pp. [Ashgate; Amazon]
Decades before the advent of molecular biology, genes occupied a central role in “the bioimaginary.” From the early 1900s on, although they could not fully define it, biologists, eugenicists, physicians alike increasingly placed the gene at the center of the enterprise to explain bodies and behaviors. After the elucidation of the double helix, researchers conceived the project of explicating the structure and function of genes and DNA as the grail of modern science (especially handy as nuclear physics proved so problematic an exercise). Public and private institutions devoted to genes proliferated, such that one study in 2013 estimated the genetics and genomic industry had a trillion-dollar impact on the U.S. economy.
To challenge the collective assumptions, values, and narratives of those—from academics to entrepreneurs—who labor in that increasingly ubiquitous and powerful industry, is to undertake a huge task. Indeed, the genetic realm of the bioimaginary has expanded so far beyond science that it has infiltrated the social sciences, humanities, and arts, not to mention pop culture—everyone from Nigerian Christian gospel singer T# to highbrow dance schools deploy the DNA trope even when its relevance is unclear.
In Genes and the Bioimaginary, Deborah Lynn Steinberg, professor of Gender, Culture and Media Studies at the University of Warwick, UK, has carried out a masterful, far-ranging analysis of how the gene has come to dominate Western discourses of identity, justice, psychology, and medicine, and the ways in which projections about how genes shape our agency, wellbeing, and social worth have seduced us into placing more belief into the power of genetic science than is warranted and have thus granted it a good deal of sway in our lives.
Steinberg brings to bear multiple social scientific, philosophical, and rhetorical tools to deconstruct the language, metaphor, imagery, narratives, and spectacle of the genetic bioimaginary. She examines an array of scientific and popular texts, from Introducing Genetics, a 2011 illustrated primer by Steve Jones and Borin Van Loon that is rife with racist, sexist, and imperialist jokiness; to the wildly successful CSItelevision franchise (with series set in Las Vegas, Miami, New York); to the infamous 1996 CIBA Foundation Symposium, “Genetics of Criminal and Antisocial Behavior” [paywall]; to Nancy Kress’s feminist sci-fi Beggars trilogy.
Women, criminals, gays, Jews, and people of color are, in these texts, the embodiment of genetic “error.” Women in particular, as maternal “carriers”—both of faulty genes and embryos—are again and again a focus of “anxieties about sexual morality and familial and reproductive ‘fitness’” and a locus of risk in need of medical and social “correction,” domination, and intervention. Geneticists, Steinberg finds, often figure forth as allegorical heroes on a quest with noble purpose, which sometimes takes the form of crafting a “safe” eugenics—one chosen by individuals rather than imposed by states. In the future, all traits will be testable, goes the story, and available to all.
In such a narrative “a significant contradiction emerges,” writes Steinberg:
On the one hand, a drift to inequality is seen as inherent in genetic screening. At the same time, genetic science is held to herald substantive potentials for democratisation. The extraordinary number of sweeping ‘ifs’ that must be satisfied in order that genetics does not [emphasis hers] reinforce inequalities, indeed, in order to make a world safe for genetics, is a testament to the tragic absurdity of such wishful thinking. (p. 49)
Steinberg’s chapter including the 1996 CIBA Foundation meeting that purported to explain crime and antisocial behavior as rooted in genetics is especially elucidating. She points to the multiple methodological and conceptual problems inherent in work that attributes such behaviors to genes—most pointedly, that different cultures define crime differently and that even the same culture may categorize the same act differently at different times—and shows how racial and class stereotypes run through the report of the CIBA meeting:
[F]or example, none of the studies refer to white-collar crimes, or to large-scale violent crimes committed by the affluent or extremely powerful. It is interesting in this context, that while many authors note that genetic research has a danger of contributing to negative social labeling and discrimination, none go on to consider how genetic research can be constructed either to avoid or to mitigate against such adverse consequences. (p. 97)
Throughout, Steinberg demonstrates how “the biological facts of genes are often attached to the most cloudy of concepts as if there were a one-to-one correspondence” (p. 164). Although the scientific descriptions of the functions of genes at the level of the organism over time is fraught with “instabilities” and “illogics,” not to mention uncertainties, these aspects go largely unmentioned in the ongoing collaboration of science and culture that is the bioimaginary. In this process, while genetic fact may become obscured, genetic reality does not, as the power we believe genes have—whether they do or not—drives individual and collective decisions that have major ethical and economic impacts.
Steinberg’s prose does not always make for easy slogging—it is densely theoretical and intensely scholarly in its approach—yet Genes and the Bioimaginary is essential reading for anyone who wants to understand the ways in which contemporary genetics has covertly and overtly revived old notions of racial science and eugenics; participated in media spectacle to “sediment” its ideas “into popular idiom and wider cultural commonsense”; promulgated and commercialized “utopian tropes” about the perfectibility of organisms; and promoted the “deep [phantasmic] investment in the notion that we can know what is unknown and by that knowledge, control that which appears to be uncontrollable” (p. 162).
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.
Posted by Jessica Cussins, Biopolitical Times on December 9th, 2015
Generally the stock of research hospitals, laboratory developed tests (LDTs) were traditionally considered relatively benign and straightforward, tending not to require premarket review in the U.S. by the F.D.A. However, with the advent of genetic testing and private biotech company research, LDTs are now being used to diagnose common and serious diseases such as heart disease and cancer—highlighting the need for regulatory oversight to manage the diagnostic consequences of unvalidated testing. Over the last year, the F.D.A has been working towards new guidance of LDTs while seeking comments from the public. On November 16, the administration released a report of 20 case studies depicting the negative public health impact caused by LDTs that don’t perform as promised.
Robert Pear covered the issue for The New York Times, remarking that “Inaccurate and unreliable medical tests are prompting abortions, promoting unnecessary surgeries, putting tens of thousands of people on unneeded drugs and raising medical costs.” These are non-trivial findings. Beyond the personal harm caused by these mistakes, the costs are impressive. For example, an inaccurate genetic biomarker test for autism that was given to 2,027 children had an estimated social cost of $66.1 million, far outweighing the profits provided to the company.
In addition to these immediate individual and social harms, there is also a looming existential threat to the healthcare and research communities. These tests are in the limelight largely because they form the backbone of “precision medicine,” an effort to which the current Administration is now committed. The promise of precision medicine rests in knowledge: if we can test and sequence and analyze, then we will know; and if we know, then we may be able to conquer. But if we can’t trust the data, the logic falls apart. Without reliable signals, all we have is noise, and there is nothing precise about that.
Among the cases described in the report are an ovarian cancer test marketing an accuracy rate of 94% that was in fact just .8%, a cancer biomarker test offering suggested treatments that have never been validated as a result of a test that has never been validated, and an RNA-based test for breast cancer patients that failed in a recent trial to positively diagnose a single individual correctly. The errors in these tests can lead to unnecessary treatment as well as the withholding of potentially life-saving treatment.
The test that perhaps fared the worst was noninvasive prenatal cell-free DNA testing (NIPT). This is a blood test given to a pregnant woman to provide genetic information about her fetus. These tests were described as yielding “both many false-positive and false-negative results.” The report mentions one woman who got an abortion after screening positive for Patau syndrome who then found out from post-abortion testing that she had actually been carrying a healthy pregnancy all along.
Although these findings are striking, it is worth remembering that all medical tests have an error rate. Particularly when a disease is rare, a positive result is often no reason for concern. However, these findings make it clear that the current regulatory framework is insufficient. Every one of the tests described in the report was carried out at a CLIA-certified lab (Clinical Laboratory Improvement Amendments). CLIA certification on its own says nothing about the safety, effectiveness, labeling, or marketing of the tests themselves. CLIA also does not require adverse event reporting, allow removal of unsafe devices from the market, or require informed consent for patients participating in clinical studies of their tests. The F.D.A. is right to target false labeling and flawed trial designs, and to call for greater accuracy and accountability. In light of outlandish claims, high costs, and evidence of harm, failing to provide oversight of the tests themselves by way of the “LDT” designation is merely outdated and irresponsible.
The F.D.A. seeks to play the challenging dual role of enabling innovation while protecting American consumers and patients. But importantly, the administration recognizes that providing more oversight of LDTs at this stage is crucial to the advancement of both ends. The success of “precision medicine” may well depend on it.
Posted by Elliot Hosman, Biopolitical Times on November 19th, 2015
The 1986 Franklin Spelling Ace, a previous generation of spellcheck. Flickr/Nate Bolt
News about genetic engineering continues to emerge at a dizzying pace. In recent weeks, a handful of reports suggest that the suite of new “gene editing” tools may have so-called “proofreaders” and “undo” protocols that increase technical safety. At the same time, a growing consensus seems to be emerging that looks beyond immediate technical safety to the long-term and social implications of modifying the genes of human embryos for the purpose of “enhanced” reproduction.
Is CRISPR safer?
A November 13 story in The Scientist, headlined Cas9 Proofreads Gene Edits, canvassed two recent research publications (in Nature and Science) co-authored by CRISPR co-discoverer Jennifer Doudna. The take-home message was that the Cas9 protein – the molecule charged with making cuts to DNA in the CRISPR/Cas9 gene editing complex – may have certain built-in mechanisms that work against off-target cuts. The headline’s metaphorical imagination conformed to the headline used by UC Berkeley in its related November 12 press release: CRISPR-Cas9 gene editing: check three times, cut once.
The same day, VICE Motherboard reported on work done by researchers at UMass Medical School (published in Molecular Therapy) that “used a ’non-cutting’ version of the protein Cas9” to research the genetics of muscular dystrophy. In contrasting the UMass team’s research with the typical function of CRISPR/Cas9 complexes, VICE’s Melissa Cronin wrote descriptively,
Usually, CRISPR is a cutting machine, hacking away at pathogenic genes. But sending a weed-whacker into a delicate genome to cut away hundreds of spots is risky, and could result in mistakes.
On November 16, Nature News described research by a team including George Church and Kevin Esvelt on gene drive – a technology that can amplify specified genes in populations by altering inheritance probabilities – with the headline: Safety upgrade found for gene-editing technique. A few days earlier, Sharon Begley had reported in STAT on increasing concerns with gene drives with the headline Why FBI and the Pentagon are afraid of gene drives. The “undo button” proposed by Church, et al.’s research, or what Scientific American referred to perhaps appropriately as a “kill switch” [paywall], was, it seems, more of the unforeseeable same. The so-called upgrade was “sending a second gene drive out to undo the effects of the first.”
Is there an emerging consensus against CRISPR-ing future people?
These recent headlines may “calm some fears about the technology.” But even if the promised safeguards function as advertised, they wouldn’t necessarily prevent gene editing tools from effecting unforeseeable and irreversible changes to human genomes or ecological systems – not to mention the fabric of our society. Gang Bao, professor and bioengineering researcher at Rice University who studies the genetics of sickle cell disease, recently noted:
In the germline, off-target effects might persist for generations and could lead to long-term changes in the genome. Until we know the full consequences of gene editing, it would be a huge mistake to use it to modify the germline.
Jennifer Doudna has long been cautious of the potential for CRISPR technology to go awry. Just days prior to her most recent publication, she was quoted by Michael Specter in The New Yorker story The Gene Hackers on its potential to “do more harm than good”:
I lie in bed almost every night and ask myself that question,” she said. “When I’m ninety, will I look back and be glad about what we have accomplished with this technology? Or will I wish I’d never discovered how it works? … I have never said this in public, but it will show you where my psyche is,” she said. “I had a dream recently, and in my dream”—she mentioned the name of a leading scientific researcher—“had come to see me and said, ‘I have somebody very powerful with me who I want you to meet, and I want you to explain to him how this technology functions.’ So I said, Sure, who is it? It was Adolf Hitler. I was really horrified, but I went into a room and there was Hitler. He had a pig face and I could only see him from behind and he was taking notes and he said, ‘I want to understand the uses and implications of this amazing technology.’ I woke up in a cold sweat. And that dream has haunted me from that day. Because suppose somebody like Hitler had access to this—we can only imagine the kind of horrible uses he could put it to.
Many voice concern that eugenics in the modern age could be as pernicious as the twentieth-century variety, even if it is submerged in the shiny casing of individual consumer decisions. Nathaniel Comfort’s historical essay Better Babies (Aeon, November 17) argues,
Scientific medicine rescued eugenics, turning human perfection from a social programme [of who to mate with and who to sterilize] into a biotechnical problem. … CRISPR must be seen as the latest step in this history of promises: the promise of ending genetic disease, of designer babies, of the self-direction of human evolution.
[P]reimplantation genetic diagnosis already offers a practical and much less ethically challenging option for most couples seeking to avoid the birth of a child with a serious genetic disorder. … Do we want to accept the scenario that only those with financial resources get to ‘improve’ the genomes of their children?
Collins concluded that there was a “profound paucity of compelling cases” where germline editing could overcome a balance that “leans overwhelmingly against human germline engineering.”
Changes to germ line cells will affect all subsequent generations. Ethically, it offers possible benefits to — but imposes risks on — people who were never involved in the original decision. And whatever happens, good or bad, will reverberate down the generations. ... germ line engineering is, in my opinion, the least likely gene editing application in the near term — potentially forever. Established methods could, a lot more simply, avoid some grievous or fatal genetic defects. You could adopt a child or use donor sperm and eggs. Or you could use in vitro fertilization and pre-implantation genetic diagnosis for embryo selection to avoid bringing a child into the world who will suffer with a serious disease.
All these recent comments suggest that even as researchers rush to proclaim they’re solving CRISPR’s technical limitations, its long-term consequences and social implications can’t be ignored.
Posted by Elliot Hosman, Biopolitical Times on November 19th, 2015
The Center for Genetics and Society and many others have long argued that it’s important to draw a sharp policy line between heritable genetic modification and genetic alterations aimed at treating an existing patient – gene therapy. That does not, however, mean that gene therapy is problem-free. With the CRISPR boom of the last three years, a number of biotech companies have been planning human clinical trials for a range of gene therapy applications, which raise important questionsof their own.
What’s happening now is also a rat race, to beat out others in the charge to the patent office; a lunge to own all parts of the genome, to close down the public commons in the bioterritory of the genome. Hence, much of this has a temporal urgency to its framing that exploits our anxiety about mortality itself. Hurry up or you’ll die of a really ugly disease. And do it so that ‘we’ win the race, for everything is a race, a race against time, a race to file patents, a race to market, to better babies … there is never enough glory or gain, there is always the moving goalpost. And this is a cause for worry in the framing of a broad spectrum of technologies.
Amid the excitement about the new generation of genetic engineering tools and protocols that Williams evokes, and the fast-paced reporting on research developments and scientists’ speculations, important distinctions are too often being muddied and serious concerns are too often overlooked.
Three recent developments in the gene therapy world, for example, were sometimes reported in ways that not only conflated somatic and germline applications, but also failed to distinguish in vivo treatments (inserting specifically programmed CRISPR complexes inside the body, in which case precision is paramount) from ex vivo approaches (editing cells in a lab, and then inserting the successfully edited cells into a patient’s body). On the other hand, the developments did lead reporters to raise concerns about the huge costs associated with the field of gene therapy, and the many obstacles still left to overcome.
Baby Layla and Cellectis
The first was widespread commentary starting November 5 on a press release from Great Ormond Street Hospital in London and biotech company Cellectis in France about an infant named Layla who had received gene-edited cells that had rid her body of otherwise unresponsive leukemia. The genetic repair method used for this somatic gene therapy was a lesser-known molecular nuclease known as TALENs. It involved not an ex vivo or in vivo engineering of the infant’s cells (that is, “personalized medicine” based on the patient’s DNA), but edited donor immune cells that were already on hand when the prospect of Layla’s experimental clinical case emerged.
Layla’s doctors were excited but circumspect in the press release, with one saying:
We have only used this treatment on one very strong little girl, and we have to be cautious about claiming that this will be a suitable treatment option for all children.
Three months may seem way too soon to report even startling results on a single cancer patient. ‘Cancer-free’ is usually evoked only 5 years after successful treatment, and I wouldn’t even use it then…The timing of the announcement may be important when we look back on the birth of gene and genome editing.
Lewis speculated that given the hype surrounding CRISPR, Layla’s story (even though it involves gene therapy enabled by a different gene editing tool) may have “its greatest impact” on the upcoming “International Summit on Human Gene Editing to be held in Washington D.C. December 1-3” which concerns germline modification. She added that following the news release, “Cellectis’s stock rose, 11% after the news broke and another 3% the next day.”
Editas Medicine CRISPR human clinical trials in 2017?
A second gene editing development that broke on the same day was Editas Medicine CEO Katrine Bosley’s announcement at a tech conference that the biotech company would begin human clinical trials of CRISPR somatic gene therapy by 2017 to treat a form of the rare genetic blindness, Leber’s congential amaurosis (LCA)—what could amount to the first use of CRISPR for human medical treatment. The UK Telegraph misleadingly reported Editas’ plans with the headline First genetically modified humans could exist within two years. While gene therapy technically produces “genetically modified humans,” the term is typically used to refer to (hypothetical) humans created after the genetic modification of embryos or gametes. The confusion can’t be blamed on the headline writer, since the article also overbroadly states that CRISPR (regardless of application) is “controversial because it fundamentally changes a person’s genetic code which can then be passed down to offspring.” Contrary to the Telegraph’s reporting, however, Editas’ proposed CRISPR gene therapy trial would not target the genes that are passed on to future generations.
In addition, the article and its headline also mislead by implying that the Editas clinical trial would be the first instance of gene therapy. This suggestion erases a wrought history of gene therapy trials in the last decades that were largely unsuccessful, and that harmed or killed patients, most notably Jesse Gelsinger in 1999.
A third development, reported a few days later (November 11) in The Washington Post, described a different gene therapy for LCA blindness. This clinical trial, sponsored by Spark Therapeutics, partially restored the vision of Allison Corona, who began experimental clinical treatment three years ago. Reporters Carolyn Y. Johnson and Brady Dennis did a good job both of putting this story in the context of previous gene therapy clinical trials gone wrong, and of confronting a clearly controversial aspect of the current approaches: “soaring drug prices.” The estimated cost of Spark’s LCA gene therapy? $500,000 per eye. The reporters also cited a 2014 study in Nature Biotechnology that “found that a gene therapy could conceivably be priced as a one-time payment of $4 million to $6 million.”
In reporting on Editas’s plans (and helpfully distinguishing them from what Spark is doing), MIT Technology Review writer Antonio Regalado also noted that “the eventual cost of such a treatment could be extraordinarily high, given the small number of people who would need it.” Of the roughly 3,000 people in the United States with LCA, Editas’s gene therapy is targeting a gene impacting some 20%, or 600 people.
Gene therapy's troubled comeback
As clinical trials using the latest genetic engineering tools for gene therapy are announced, there will be many questions to consider. Among them: How should we distinguish the safety and technical risks associated with in vivo and ex vivo applications? Will CRISPR or other molecular nucleases remain in a clinical patient, continuing to snip DNA and causing potentially dangerous off-target effects for years to come? How will we as a society resolve the huge six- and seven-figure costs associated with a medical treatment that stands to benefit so few in a world plagued by health disparities? And how can we make sure patients are protected if biotech companies rush their gene editing products to market, whether to influence international summits, to boost their stock prices, or just to overshadow a competitor’s recent press?
Posted by Katayoun Chamany, Biopolitical Times guest contributor on November 19th, 2015
With the launch of the US Precision Medicine Initiative (PMI), patient autonomy within the practice of informed consent is being revisited. The PMI is designed to amass the data of a million volunteers in an effort to advance research and support public health. Alongside this national effort, proposed revisions to the “Common Rule” that regulates research with human subjects in the US are open for public comment through December 7, and are summarized in a Perspective published in the New England Journal of Medicine on October 28, 2015 by NIH director Francis Collins and NIH senior advisor Kathy Hudson.
In general, the process known as “informed consent” is designed to give research participants the autonomy to consider the risks and benefits associated with a research study as part of their decision making about whether to agree or refuse to participate. Early on in biomedical and genomics research, the risks and benefits presented as part of the process were confined to health side effects and therapeutic outcomes. More recently, with the advent of advances in biotechnology, supercomputing, and the construction of large-scale data sets, risk and benefit have taken on new meaning.
In a country that is struggling to address national healthcare within the context of racial and economic inequities, analyses of risk and benefit must expand beyond traditional definitions. This is especially true as biomedical research has become increasingly dependent on human bodies, cells, tissues, and DNA. Today, healthy volunteers in clinical trials can gain financial benefit in the form of payment or compensation; contributors of genetic information must consider privacy and discrimination risk associated with release of genetic information; and patients must be aware of profits made from research on biospecimens collected as part of diagnosis or therapy.
Though standards of ethical conduct are mandated in the US by Institutional Review Boards as required by the National Research Act of 1974 and the Belmont Report (the “Common Rule”), these guidelines are in need of updating and revision given the unusual nature of cells as propagating entities or “biologics.” Professional working groups and ethics advisory councils, such as the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Office of Management and Budget Working Group to Revise the Common Rule, the National Academy of Sciences, and the American College of Genetics and Genomics have issued statements regarding ethical conduct for research with human subjects and biospecimens, and healthcare provider responsibility to inform patients of incidental genomic findings and downstream profit making.
A good example of some of the changes underfoot is the establishment of the HeLa Genome Access Working Group in 2013. This group was put in place to acknowledge the important contributions made to tissue culture and cell research using a cervical biopsy specimen taken from Henrietta Lacks during her clinical treatment in 1951. That the Lacks family members, two of whom are members of the working group, now have a say in how the HeLa genome is used in research does much to acknowledge the history behind the establishment of this cell line and the downstream profits made from it in the creation of cell culture reagents, diagnostics, vaccines, and drugs.
However, I would argue, as others have, that this kind of personalized gatekeeping cannot be put in place for each individual biospecimen collected in the future. Once a cell is removed from a human tissue or blood sample, its establishment into a cell line makes it a portable entity that can move across time and space in labs spanning a wide array of investigation. Requiring consent for secondary research with stored biospecimens would mean that researchers would have to locate donors and participate in the informed consent process for each new research study that was not foreseen when the sample was collected. This proposal, alongside another to place de-identified samples within the scope of the Common Rule, may present formidable challenges for those researchers with limited funding and infrastructure. Thus, rather than broaden research participation and research scope, these proposals may bias research directions towards those that are seen to have large financial payoffs and that include the participation of a privileged class that has not endured the injustices of past biomedical studies.
Certainly additional oversight is needed to avoid medical injustices inflicted upon the marginalized or uninformed, as described in the Nature editorial titled “Justice for All” and the Presidential Commission for the Study of Bioethical Issues 2011 Report “Ethically Impossible,” which details the egregious practices of the US Public Health Service in the Guatemala and Tuskegee studies of sexually transmitted diseases from 1932-1972. In addition to reparations and apologies, a more proactive and interdisciplinary approach to conducting biomedical research using large data sets is underway.
In January, with the launch of the PMI, the National Institutes of Health convened a Workshop to Explore the Ethical, Legal, and Social Implications (ELSI) of Citizen Science. Many attendees struggled with the term “citizen science,” wondering if the language was appropriate when discussing population-based biomedical research. Citizen science often conjures up images of people sampling trees and water to address environmental concerns like climate change and pollution. But speakers, including Elizabeth Yeampierre of UPROSE, showcased the ways in which building relationships between communities and researchers is a form of citizen science. She highlighted the importance of being mindful of health and environmental injustice that has its origins in colonization, oppression, and slavery. Others highlighted the importance of involving communities and patients in research study planning, such that research goals are in line with the needs of these communities, as is being done in the National Patient Powered Research Networks (PCOR).
Though these are important points, they appear to be more relevant to hypothesis-driven studies or epidemiological ones that have a specific disease focus. In the context of the PMI, there is no hypothesis. Instead, a large dataset amassed from existing and prospective studies would be mined to observe patterns and design future research studies that could influence policies regarding environmental toxin disposal, but also the development of lucrative drugs and products.
During the Citizen Science Workshop, participants expressed interest in learning how communities can be involved in regulating how, when, and where biospecimens can be used in research. Many of the issues raised are reflected in the proposed revisions of the Common Rule and associated comments. The workshop also informed the development of the Privacy and Trust Principles associated with the PMI, issued earlier this month. These principles are designed to acknowledge the complexity associated with the collection, manipulation, and dissemination of publicly donated biospecimens and lifestyle information, and to build a community of trust in the safeguarding of property and privacy.
What is somewhat disheartening is the lack of conversation around incentivizing contributions and participation from communities in an effort to honor this work, or what some have come to describe as biolabor. With respect to compensation for participation in research, there are a range of responses. Some believe that incentives or financial compensation can address the need for bioresources to assemble large data sets to advance scientific and biomedical research. These approaches, they argue, would specifically address the lack of diversity in samples by including those that have not traditionally been involved in such research. Others see biobanking as a civic duty to support a public good, not unlike other requirements in society, such as taxation, catalytic converter requirements for cars, and anti-smoking laws. Those that challenge this latter stance argue that each individual should be able to act autonomously, and that the choice to participate in research should be protected and recognized. This is precisely why the US uses an opt-in approach to organ donation upon one’s death, which is counter to other countries such as Wales which, on December 1 through the Organ Donation Wales Program, will move to an opt-out plan for organ donation upon death.
There also appears to be a level of “bodily exceptionalism” at play in public contributions, such that contributions involving internal resources (blood, DNA, cells) appear to warrant a different level of oversight and regulation than contributions that involve external resources such as money (taxation) or demographic information (census). Thus, some would argue that it is bodily integrity, not autonomy that is important. The range of responses to these positions, proposals, and practices is varied, reflecting the plurality of opinion even within groups that traditionally hold uniform voice.
Perhaps one of the most surprising proposed changes is that the Common Rule would no longer be limited to federally funded research. Rather, researchers operating in the private sector, or funded by state monies, would also need to comply. Because biologics can be traded, exchanged, shared, and sold, they often move in and out of the public and private sectors, making ethical oversight at the current time difficult to apply. If all research involving biospecimens was regulated under the same Common Rule, consistency would be achieved and donors and volunteers would have a clearer understanding that tissues collected during clinical diagnosis or treatment, or those donated for academic research, may down the road be used in research studies to develop drugs, diagnostics, and vaccines.
Another important proposed rule change applies to social science researchers. These researchers often complain that the Common Rule is not appropriately designed for their work and creates unnecessary hurdles. Thus, the proposed change exempts most of these studies. In this instance, the broad-strokes approach to solving a research challenge may cause more problems in the long run.
This is particularly true as the PMI intends to collect lifestyle and social information alongside genomic data. Similarly, private genomics companies like 23andMe and research studies using Apple’ ResearchKit will be collecting data that can be used in both biomedical and social science research, and will be most useful when these data are used together to address epigenetic influences on health. That biological data falls under the Common Rule, while environmental (built, social, and natural) data does not, seems counterintuitive to the goals of these interdisciplinary projects.
Katayoun Chamany is Associate Professor of Biology and the founder of the Interdisciplinary Science program of Eugene Lang College for Liberal Arts at The New School and a Science Education for New Civic Engagements and Responsibilities (SENCER) Leadership Fellow.
Maris isn’t simply trying (successfully) to make headlines, he’s looking to drive a consumer genomics market by convincing people to hand over their genetic material for research. He isn’t alone on this front. 23andMe and Ancestry.com have also engaged in grand, seductive promises: Learn your carrier status! Meet your long-lost relatives! Learn how “African” your DNA is, based on “ancestry informative markers!”
This kind of hype downplays the limits and obstacles to providing reliable genetic information and using it to generate beneficial health impacts. It completely obscures the extent to which research as a system—corporate, academic, governmental, what have you—has been co-opted by private gains and has proceeded with little-to-no accountability to the public good and health. And it elides the real drivers of the genomics business model: mass data collection and brokering data access.
Another recent news story bridges what have been largely segregated conversations about personal genomics and DNA forensics. Brendan Koerner reports in WIRED about a 36-year-old filmmaker in New Orleans who learned to his surprise that he was a suspect in a 1996 murder. Idaho police had run a “familial search” with DNA found at the crime scene, which bore similarities to DNA his father had submitted to his Mississippi church’s genealogy project, later bought up by Ancestry.com. Police got a warrant to compel Ancestry.com to de-anonymize the father’s DNA, and the company complied, leading police to the filmmaker’s door in December 2014. The filmmaker was cleared after 33 days, but the implications of law enforcement collaborating with personal genomics companies in cold cases came as a chilly reminder of the current climate of mass surveillance—genetic and otherwise.
In the week after the story broke, several reporters investigated whether other personal genomics companies were collaborating with law enforcement. Amid fanfare regarding the FDA decision allowing them to partially resume selling health-related tests, 23andMe responded by publishing a “Transparency Report” on its website stating that it had received and denied five requests from law enforcement since 2006.
Yet the lessons of surveillance in other contexts caution against unchecked reliance on the goodwill of big data companies to protect their users’ privacy. Indeed, with secret courts sealing law enforcement’s requests to access other data points on civilians, how transparent are “transparency reports” anyway?
“What are you worried about? Your genome isn’t really secret.”
In the same Bloomberg Business article, Bill Maris asks us why we would want to withhold our data from an exponentially growing corporate database. The answer is: We’ve been here before.
In a post-WikiLeaks world where #privacy is trending, many of us are still formulating and learning the impact of corporate and government surveillance over daily life. Now we have to grapple with the realization that server farms aren’t just for phone records: DNA, the code of life, can also be analyzed, synthesized, and applied in innumerable contexts for a range of political and corporate ends.
Science recently reported on the growing number of biobanks around the world that contain over a million samples, and as sequencing and data storage costs fall, the numbers of samples and banks could continue to balloon. We already know that DNA databases have led to devastating impacts on people’s lives in the context of criminal justice and immigration decisions, most notably in poor communities, communities of color, and among immigrant families. The scaling up of consumer genomics widens the net of genetic surveillance into more privileged populations. Whether provided voluntarily (to purchase ancestral information, or contribute to medical research) or forcibly (via the criminal justice or immigration systems) our DNA, once collected, could make us all more vulnerable.
The Gmail Metaphor for Genomics
In the last few years, as 23andMe has scaled its empire, commentary has repeatedly compared the genetic data collection of personal genomics companies to the case of Google (yes, 23andMe CEO Anne Wojcicki was until recently married to Google founder Sergei Brin). In 2013, Charles Seife, writing in Scientific American, argued:
“[A]s the FDA frets about the accuracy of 23andMe’s tests, it is missing their true function, and consequently the agency has no clue about the real dangers they pose. The [23andMe] Personal Genome Service isn’t primarily intended to be a medical device. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.” [emphasis added]
I've long been of the mind that, just as the traditional business model of newspapers is to get revenue not from readers but from advertisers, personal genomics companies see the potential profit not from the consumers themselves but from the compiled databases – likely in the form of selling access to them.
However, 23andMe spokesperson Angela Calman-Wonson claimed just the opposite in an interview in Nature about the recent FDA decision, stating that consumer testing “is always going to be at the core of our business model.” Reporter Erika Check Hayden apparently didn’t find this convincing, and followed the quote with the statement:
As it grows larger, 23andMe's customer database becomes more valuable for research and drug development by the company and its partners, such as California-based biotechnology firm Genentech.
In his 2013 article, Seife expands his comparison of 23andMe to Google by reflecting on the search engine’s early history:
When it first launched, Google billed itself as a faithful servant of the consumer, a company devoted only to building the best tool to help us satisfy our cravings for information on the web. And Google’s search engine did just that. But as we now know, the fundamental purpose of the company wasn’t to help us search, but to hoard information. Every search query entered into its computers is stored indefinitely. Joined with information gleaned from cookies that Google plants in our browsers, along with personally identifiable data that dribbles from our computer hardware and from our networks, and with the amazing volumes of information that we always seem willing to share with perfect strangers—even corporate ones—that data store has become Google’s real asset. By parceling out that information to help advertisers target you, with or without your consent, Google makes more than $10 billion every quarter.
Even if our genomes aren’t stolen, can we trust the corporate keepers, or will they inappropriately spill the beans on our medical conditions? Remember the story about Target sending pregnancy-related coupons to a teenager’s house?
23andMe is positioning itself as an advocate for “democratizing healthcare,” luring consumers to buy information related to their health and family in exchange for handing over a bundle of data that are potentially more precious and valuable than search queries and cookies combined. For better or for worse, genetic data can be used for a range of powerful ends, including linking someone to a crime (that they may or may not have committed), selling to third parties for advertising purposes, or developing expensive drugs putatively precise enough to target particular genetic variables.
We need to think broadly about the connections between mass surveillance, biological discrimination, criminal justice, DNA as irrefutable evidence of family or of crime, immigration procedures. And we need to consider whether concepts like “privacy,” “informed consent,” and “notice” are robust enough to preserve human dignity in the face of Big Data’s latest project: mass genetic surveillance.
Critics of efforts to "improve" our species via heritable genetic modification are sometimes reluctant to call this "eugenics," for fear that enhancement enthusiasts will derail the conversation by invoking Godwin's law.
The argument against using eugenics as a frame of reference for new human biotechnologies is generally that the 20th-century variety was defined by state action (not entirely true), whereas human betterment enabled by 21st-century science will be a different thing entirely.
So it’s almost refreshing to read, in a respectable, albeit conservative, daily newspaper:
Eugenics need not be a dirty word — instead, it could be lifesaving technology
The article in question, by Madhumita Murgia who writes for Wired as well as the Daily Telegraph, was prompted by the fact that today the UK law comes into force that allows the use of nuclear replacement technology in attempts to avoid the births of children with mitochondrial (mtDNA) disease.
Murgia argues that
Eugenics is a dirty word, most commonly associated with racist profiling, or Nazi experiments. But the time has come to rethink our attitude. It can also be understood as manipulating the genome in order to solve human health crises.
At least she admits that mtDNA interventions do affect the germline, and are in practice eugenic. But there is a lot wrong with the piece. For instance:
Murgia ignores the fact the UK law allows clinical use of these biologically extreme techniques, without clinical trials or mandated follow-up.
She perpetuates the (at least partlydiscredited) claim that mitochondria have no influence on traits.
She repeats the misleading statement that germline interventions “could potentially save lives” without acknowledging the distinction between embryos (that may become people who never develop a particular condition) and patients (who have one).
And she cites, as a reason for hope, golden rice, which Michael Pollan called “a purely rhetorical technology” in 2001 — an assessment that remains accurate today.
The article gets even worse when she turns to the notoriously failed experiments that prompted this year’s very public concerns about the gene editing of embryos. She supports them thus:
A new type of gene editing technique, known as CRISPR-Cas 9, was already used in human embryos by Chinese researchers to modify the gene responsible for beta-thalassaemia, a potentially fatal blood disorder.
This experiment, while decried as unethical and dangerous, was in fact a crucial lesson in revealing the problems with the CRISPR technique, and enhanced the scientific community’s understanding of how gene editing works in practice.
So for the sake of those who need it the most, we must be brave enough push the frontiers of present-day human knowledge into territories unknown.
Robert Pollack warned about eugenics in his letter to Science in May [pdf]. Nathaniel Comfort warned about eugenics at length in The Nation in August. They were not scaremongering, they were helping to bring a debate we need to have out of the shadows and into the limelight. Perhaps inadvertently, so is Madhumita Murgia.
It may be time to return to first principles and explain how eugenics was not merely misapplied, but wrong.
The Black Stork movie poster, 1917. Image by Martin Pernick
[Forgotten Stories of the Eugenic Age is a blog series exploring the lesser-known ways that eugenics affected and engaged American lives during the first half of the twentieth century.]
[Parts 1and 2 tell the story of Dr. Harry Haiselden’s refusal of life-saving surgery for a baby with disabilities, whom he believed would be a burden on society, and the ensuing controversy.]
While public debate about the Baby Bollinger case subsided, Harry Haiselden continued to work as a physician. He diversified his eugenic medical practices to include sterilizations, and claimed to have personally sterilized nearly 400 patients in Chicago by late 1915.
In addition to sterilizations, Haiselden was called to consult on cases throughout the country to decide whether “defective” infants should receive operations or be allowed to die. Sometimes Haiselden decreed that a baby’s health issues could be corrected satisfactorily through surgery, especially if the baby appeared to be of “bright” intellect. At other times, as Haiselden told news reporters, if he found a child to be a “hopeless idiot,” he would “unhesitatingly advise that it be permitted to die.”
In July 1917, Haiselden once again approached newspapers, this time to report his recommendation that another three children be permitted to die. He explained that Baby Meter, who had already died at one day old by the time stories went to print, had been missing part of her upper skull case and had what appeared to be a small, malformed brain. “When I saw the baby, I knew it had lived too long already,” he said. He concluded that allowing the child to survive would be a crime against the race; letting the child die would be a “favor.” As in the Baby Bollinger case, Haiselden claimed that fifteen other doctors had agreed with his assessment, although again he provided no names.
Baby Mattys was five months old, paralyzed, and had an “incurably affected” head. Haiselden estimated that surgery could prolong the child’s life by a year or two, but said that the parents had agreed to let the child die now. Neither the Baby Meter nor the Baby Mattys case garnered much attention in the press. The third baby for whom Haiselden had recommended death did not receive any news coverage at all.
However, another case that emerged in November 1917 revived controversy, almost exactly two years after Baby Bollinger’s brief life and death.
Two-and-a-half-year-old Paul Hodzima had a microcephalous head and severe breathing difficulties due to a tracheal obstruction. Haiselden prescribed the child drugs that he said would both ease his pain and cause him to lose his appetite so he would starve to death. He asserted that his actions had an altruistic purpose in addition to “saving” the race from another defective child. The drugs would permit the baby’s exhausted, distressed mother to focus her attentions on her other child, who “is normal in every way.”
Perhaps for the first time, Haiselden himself used the word “euthanasia” to describe his work. He said of his decision in the Hodzima case, “Euthanasia or painless killing by God-given drugs relieves the old pain and takes away the horror of death," which arrives within a week to a month. He extolled the benefits of morphine in treating “lives of no value and bodies in constant pain” that, by existing, “check the vitality of others.”
Chicago coroner Peter Hoffman, who had expressed ambivalence in the Bollinger case two years prior, seemed to find this case more distasteful. He warned Haiselden that he would present him to a grand jury and ask for an indictment if the drugs caused the baby's death. Ever seeking the spotlight, Haiselden replied that he would welcome such an action because it would give him the opportunity to “enlighten the public on many things.” Even so, he thought that his critics should “devote their attention to the scores of automobile murders, the abortions, the daily street murders, and similar unchecked crimes against persons who have every right to live,” unlike Paul Hodzima, who had no such right.
Other doctors spoke out against Haiselden's actions. They argued that Hodzima’s pain could be alleviated without condemning him to death. They protested that a physician did not have the right to directly cause death, even if they agreed that it was morally acceptable to “passively” let death occur as an act of nature or divinity. Though some commentators, like W. D. Brooke of Oakland, expressed “outspoken and unqualified approval” of Haiselden’s actions in the Hodzima case on the grounds that a defective individual is incapable of “attaining the social position of her naturally-formed sisters and brothers,” these views surfaced more rarely. To most critics, allowing a baby—especially one they perceived as never really human, never truly alive—to “fade away” was one thing. Poisoning a toddler was another.
The clear demarcations that Haiselden supporters saw between allowing “nature” to take a baby's life and committing murder were evidently not so obvious to others. Shortly after the Baby Bollinger case, Mrs. James F. Darcey of St. Louis told newspapers that she had written a letter to Dr. Haiselden about her six-year-old son who had been labeled defective and currently lived in a city sanatorium. She wrote, “I worry so over him. I would be glad if he were to die. Now, is there any way that he could die, or do you think that there is any cure for such children?” Mrs. Darcey added, “I wouldn’t want to kill him, of course, but I would rather have him dead than in his present condition.”
Other parents seemed unable to distinguish between the “incurable” and “curable” defectiveness Haiselden traveled the nation diagnosing. On July 28, 1917, shortly after Haiselden’s announcement about the determined fates of the three “defective” babies, a father urged surgeons at the Jewish Maternity Hospital in New York not to operate on his newborn son, who had unspecified health problems. Physicians overrode the father’s wishes, believing that the baby had an excellent chance at a complete recovery. Yet according to the baby’s doctors, the father, a supporter of Dr. Haiselden, apparently “could not grasp that this case was different” than the others.
With clamor over the Hodzima case, a police officer went to the child’s home and confiscated the drug his mother had been administering. Haiselden then had the child removed to the hospital. Nothing more is known about the fate of Baby Hodzima, and it appears that despite Coroner Hoffman's threats, Haiselden was never formally charged with a crime.
After Baby Bollinger’s death, biologist Dr. Harold N. Moyer noted in the New York Times, “The public will be educated by this discussion. Those questions must sooner or later come to the attention of the masses.” But the discussion did not persist very long. While the Hodzima case provided a little kindling to temporarily reignite the opposition, after the initial uproar of the Baby Bollinger case waned, Dr. Haiselden’s actions no longer seemed shocking. Just two months after newspapers ceased publishing about the Hodzima case, the New York Times succinctly reported, “Another ‘Haiselden baby,’ so-called, has been permitted to die.” Baby Emma Stanke was two months old and quadriplegic. Inventing yet another questionable boundary, Haiselden remarked that doctors gave the baby “ordinary, human care,” but not “the full benefit of scientific care.” Little else was said of Baby Emma Stanke. There was no public outcry this time.
When Dr. Haiselden died in 1919 of a cerebral hemorrhage while vacationing in Havana, news articles offered little mention of his eugenic preferences or the lives he had allowed “nature” to snuff out. Haiselden once said, “They will criticize me, but I shall have friends too. And some day they will wonder how there could be any criticism.” It seems that in fact a third path was taken: The press apparently forgot that anyone had ever criticized Harry Haiselden.
After Haiselden’s passing, his friend and brother-in-law Dr. Clarendon Rutherford commented, “Every great man is misunderstood, but Dr. Haiselden was maligned. . . . He refused to prostitute his art by prolonging the lives of babies who were born idiots and morons. He was twenty-five years ahead of his time.” Rutherford’s prediction was disturbingly accurate: Child euthanasia became an official program in Nazi Germany in 1939.
The eugenic judgments of Harry Haiselden, other medical and legal professionals, and members of the public relied on moral codes predicated on the imposition of boundaries. Commentators drew boundaries to separate human beings based on determinations of fitness and unfitness, normality and abnormality, and humanity and sub-humanity. Important to these placements were additional boundaries: health and sickness, intelligence and idiocy, and burden and benefit.
With these boundaries set, observers then made additional demarcations to distinguish who had a right to live and who didn't; who was curable and who wasn't; and which conditions or states of being were tolerable, which weren't, and to which gradations.
Then, these boundaries pervaded the medical realm to differentiate “ordinary, human care” from “the full benefit of scientific care” and to determine which actions were acceptable for physicians: intervening to save a life, allowing “nature” to end one, or prescribing drugs to hasten that end. These boundaries also determined what the public should know or discuss. And they facilitated the final determinations—those between inaction, involuntary euthanasia, and murder, and between innocence and guilt.
All the boundaries were blurry. There were many exceptions and no consensus. But their establishment unquestionably engendered the systematic devaluation and dehumanization of people with disabilities. Quite simply, Dr. Harry Haiselden decided not to try to save the lives of several babies with disabilities because he did not believe that those babies should live, and many people supported him. Did the supposed degree of passivity or activity in effecting the outcome of death matter? To borrow the eloquent phrasing of the Los Angeles Times in 1915, Baby John Bollinger “died of inertia,” and inertia is a choice.
Classical eugenics fell into disfavor after the atrocities of the Holocaust. It became less socially acceptable to (openly) refer to persons with disabilities as drains on the vitality of humanity, or to deny them life-saving medical care. But until then, Haiselden’s career contributed to the development of an ethos in which it was normal and unobjectionable for the Chicago Daily Tribune on April 15, 1916, to write of Dr. Haiselden’s latest patient, “Eliza Johnson, the five year old girl who ‘would be better off dead’ because her mental growth stopped when she was but a few months old, is ‘better off.’”
1. “17 Doctors Favor Letting Baby Die.” Washington Post, Nov. 16, 1917.
2. Bonsfield, Dr. M. O. “Haiselden Speaks at Appomattox Club.” Chicago Defender, Dec. 4, 1915.
3. Brooke, W. D. “Unqualified Approval of Dr. Haiselden’s Conduct.” San Francisco Chronicle, Nov. 23, 1917.
4. “Condemns Death Drugging Plan.” Washington Post, Nov. 13, 1917.
5. “Defective Baby Dorothy Cleveland Should Live, Rules Dr. Haiselden.” Washington Post, Mar. 5, 1916.
6. “Doctors Agree Deformed Babe Is Better Dead.” San Francisco Chronicle, Nov. 16, 1917.
7. “Dr. Haiselden Dead in Cuba.” New York Times, Jun. 20, 1919
8. “Dr. Haiselden of ‘Baby Fame’ Dies in Cuba.” Chicago Daily Tribune, Jun. 19, 1919.
9. “Dr. Haiselden to Let Deformed Baby Die.” Chicago Daily Tribune, Jan. 22, 1918.
10. “Evanston Girl Dies Under Knife of Dr. Haiselden.” Chicago Daily Tribune, Apr. 15, 1916.
11. “Haiselden Died Suddenly, Trip Pleasure Jaunt.” Chicago Daily Tribune, Jun. 20, 1919.
12. “Haiselden to Sterilize Youth.” Chicago Daily Tribune, Dec. 19, 1915.
13. “Lets Afflicted Baby Die: Dr. Haiselden of Chicago Again Refuses to Save a Life-Cripple.” New York Times, Jan. 28, 1918.
14. “Meter Baby Dies; Nature Is Kind, Says Haiselden.” Chicago Daily Tribune, Jul. 25, 1917.
15. “Mother Asks Knife to Check Insanity Threat.” Chicago Examiner, Nov. 19, 1915.
16. “Mother of Defective Boy Wishes Him Dead in Letter to Physician.” Washington Post, Dec. 5, 1915.
17. “Mrs. Bollinger Is Dead: Grieved for Deformed Baby Whose Life Was Forfeited.” New York Times, Jul. 29, 1917.
18. “Operation for Boy Would Block Taint.” Chicago Examiner, Nov. 18, 1915.
19. “Opinion Divided on Killing Babies Deformed or Imbecile, as Chicago Doctor Says He Is Doing in Mercy.” Washington Post, Nov. 18, 1917.
20. “Physician Assists Patients to Die.” Los Angeles Times, Nov. 12, 1917.
21. “Physician Lets Second Defective Child Die, Rather Than Operate.” Washington Post, Jul. 25, 1917.
22. “Physician Who Sentenced Babe Defies Coroner.” San Francisco Chronicle, Nov. 14, 1917.
23. “Question Doctor’s Power Over Life and Death.” Los Angeles Times, Nov. 20, 1915.
24. “Save Abnormal Baby.” Washington Post, Jul. 29, 1917.
25. “Surgeon Lets Baby, Born to Idiocy, Die.” New York Times, Jul. 25, 1917.
26. “Threatens Arrest if the Baby Dies.” Washington Post, Nov. 14, 1917.
27. United States Holocaust Memorial Museum. “Euthanasia Program.” Holocaust Encyclopedia. Last updated Aug. 18, 2015. http://www.ushmm.org/wlc/en/article.php?ModuleId=10005200.
28. “Will Rule on Life or Death for Baby.” Washington Post, Dec. 26, 1917.
The conversation about how to regulate powerful new genome editing tools is heating up as the National Academies’ December “international summit” draws closer.
A Natureeditorial on October 14 argues (echoing the conclusions others have drawn [1, 2] as the CRISPR hype has mounted) that valorizing the 1975 Asilomar meeting as a model for modern scientific policy debate is ill-advised:
“When controversy comes calling, rather than asking for an Asilomar conference — which, after all, was closed to the public — scientists should reach outwards.... The world has moved on since then; science must as well.”
Nature continues, “[S]cientists who wish to self-regulate ignore public outcry at their peril” and “the most polarized US government in history… can turn any new technology into a political weapon.” While the editors recognize that ‘[d]iscussions should extend beyond researchers and ethicists,” their qualified recommendation – that this means “includ[ing] or at least broadcast[ing] to, the broader public”– is a bit worrisome. (emphasis added)
Unfortunately, Nature then goes on to malign one of the common entry points for public engagement with biotechnological controversies: “[D]iscussions should avoid unhelpful references to the genetically modified humans in the 1997 film Gattaca.” By cordoning off cultural references, this move in effect erects boundaries to public participation and restricts the debate to scientific authorities and terms.
These views are especially troubling because media coverage of the CRISPR controversy in the past few weeks has focused on anything-but-ELSI news, as evidenced by other recent stories.
Nobel Prizes and Consolation Deals
After a flurry of media speculation, Jennifer Doudna and Emmanuelle Charpentier were passed over this year for a Nobel Prize. But on October 8, the day after the Nobel announcement, Doudna’s nascent CRISPR company Caribou Biosciences inked a deal with DuPont giving the Big Ag biotech company exclusive rights to Berkeley’s pending CRISPR patents on plants—if those patents are granted. With DuPont’s $11 billion annual business in GM seeds and crop chemicals, the deal is a serious consolation prize after the missed laurels.
A thought experiment on CRISPR’s profit potential has emerged, in the form of teeny weeny CRISPR pigs, available soon as designer pets. They were created by the Chinese company BGI to serve in human drug trials, their efficient size being optimal for reducing the dosage required for expensive new drugs. BGI is seeking to develop its capacity to serve customers specifically customized piglets in the future.
Commenting on different research with pigs, Jennifer Doudna expressed her surprise in Science that cells even survived an experiment led by George Church in which his team hacked up pig genomes in 62 locations to cut out copies of the “PERV” (porcine endogenous retrovirus) gene that might impede pig-to-human organ transplantation by taking advantage of “an apparently rare phenomenon called gene conversion”—a DNA-cutting “snowball effect.” Church’s response was cautious; he pointed out the difference between what his team has done and targeting numerous unique genes in the same cell, and noted that he is not confident the method is “generalizable”:
It doesn’t mean that we can now change 62 different genes easily.
When I reported on such transplants for a feature in 2012, some immunologists mentioned to me that PERVs were a somewhat hypothetical concern. ... My sense is that the PERV-less pigs are remarkable less as a source of organs and more as testament to the power of CRISPR.
VICE Media’s Motherboard helped to extend the metaphor of genome editing, covering developments in CRISPR gene drives to produce a so-called “undo button.” The article highlighted bioethicist Art Caplan’s advice that:
Regulations should require the development of methods to halt the effects of edited insects or animals should they prove harmful to other organisms, the environment, or humans.
But while cmd+Z patents may be on the horizon, most observers agree that the off-target effects of CRISPR remain a significant obstacle. Unfortunately, some researchers and media commentators seem to be relying on an as-yet unseen deus ex machina to resolve all of the potential consequences of a technology whose effects are far from completely understood.
Ethical, Legal, Social Implications?
And so the sine wave of CRISPR hype, speculative applications, and Twitter-shattering developments has continued these past weeks. The policy debate about how to regulate genome editing also continues, though it often seems to be monopolized by the same few voices.
The Associated Press made a pass at discussing ethics on October 9 under the headline Gene editing: Research spurs debate over promise vs. ethics. The story quoted scientists heavily invested in CRISPR research, in varying degrees of cautious stances. "We need to try to get the balance right," Jennifer Doudna told AP, while George Daley remarked “this isn't a conversation on a cloud,” emphasizing the drive to “move this forward” from families who seek treatment for rare genetic diseases. But in the National Academies’ October 5 “public information session,” Daley emphasized the need to draw the line between “permissible and nonpermissible applications” for CRISPR, clarifying that he was not implying that George Church’s list of protective alleles for germline enhancement would qualify as “permissible.”
Canvassing the social concerns at issue, UNESCO updated its report on the human genome, recommending a moratorium on editing the human germline and that somatic CRISPR interventions be used “only for preventive, diagnostic or therapeutic reasons.” Kings College bioethicists Silvia Camporesi and Lara Marks responded quickly and bizarrely, calling the UNESCO suggestion “undemocratic” and a rehash of “old arguments.” In fact, UNESCO’s concerns — justice, access, the human genome as commons, and the potential for a renewed form of eugenics — deserve the global public’s full attention as we weigh the benefits and risks, known and unforeseeable, of germline intervention into human DNA amid the commercial and political dynamics of rapidly advancing biotechnology.
We have yet to see any real plans for a publically inclusive democratic debate (not like that one) that fully engages the host of social and ethical issues that genome editing manifests.
The direct-to-consumer (DTC) genetic testing business hit a major speed bump when the Food and Drug Administration (FDA) stopped 23andMe in its tracks two years ago. The FDA asserted control over the sale of DTC tests, saying that it required proof of their analytical or clinical validity.
At the time, this was controversial, with libertarians particularly up in arms about "bureaucrats" and "ridiculous bans." Others pointed out that the FDA was doing its job. Matthew Herper in Forbes (or his editor) came up with the headline:
23andStupid: Is 23andMe Self-Destructing?
We now have a definitive answer: No. From the same author, same publication, already online, and in print on November 2:
23andMe Wins A Second Life: New Business Plan Scores $115 Million From Investors
The latest investment, from several venture capital outfits, values the company at $1.1 billion.
A company spokesperson told The Verge that they "will return health reports to consumers by the end of this year." Back in February, the FDA did give the company clearance to sell a test for one specific gene correlated to a rare genetic disease, and CEO Anne Wojcicki is spinning that hard:
Now Wojcicki says she hopes the FDA will allow 23andMe to market some health-related tests again soon. "There's a huge value in actually being the only one who's gone through the FDA process and can sell directly to consumers," she says. Some of them, she hints, may have higher margins than the $99 test.
23andMe has for a long time had the concept of leasing the content of their database for research as an important part of their business plan, and announced a deal with Genentech back in January. A week later, the company announced a similar deal with Pfizer. They have also poached a couple of Genentech executives, and launched their own research unit.
But there are other players diving into the business.
Ancestry.com is in the "very early stages of a conversation with the FDA" about DTC tests for risk of disease. They claim to have a larger DNA database than 23andMe (both have over a million samples), and clearly want to leverage that into sales for research purposes: They announced a deal with Calico Life Sciences in July to "work together to unravel the role that genetics play in how long a person lives." (Calico is a Google company; 23andMe was founded with Google money but Wojcicki's divorce from Sergei Brin may have distanced the companies.)
Also in July, the company announced AncestryHealth (beta here), which seems to be heading in the same direction but via family history rather than genetic analysis. In 2010, family history was called "the gold standard in personal disease risk assessment," and it is by no means clear that genomics has yet caught up.
There may be much more competition in the works, as well as a proliferation of third-party tools. Both Apple and Google have indicated interest in offering data-storage, and possibly analysis, services for genetic information. And a major force in genome sequencing is jumping in.
Illumina, which sees the sequencing market heading a long way upwards of $20 billion, is expanding. In 2013, it committed $450 million to acquire Verinata, which specializes in prenatal tests, and now it wants a piece of the DTC action. They have a cute name for a company with a cute idea: Helix (to launch in 2016) will be "an enormous app store for genetic information." (Hat-tip to Antonio Regalado, who has broken several important stories in MIT Technology Review.)
The idea is that Helix will partner with other companies, which will generate apps on their platform, and then save the data and sell it again for a different app. That is, to paraphrase Regalado, you buy the "speed gene" app (ACTN3, but don't count on it), send in spit, and they lose money on the first one by doing more analysis than they let on. Helix gets some cut of the app sales, and holds on to the data:
"We are betting on the consumer coming back and asking for more, and then you don't have to sequence a second time," says [Illumina CEO] Flatley.
Indeed, along with two venture capital firms, they are betting some $100 million.
Worth noting in this context are a couple of non-profits. DNA.LAND, which launched last week, has neatly grabbed a very slick URL. The founders are academics from the New York Genome Center and Columbia University, who hope to pool data from (at first) customers of 23andMe, Ancestry.com and FamilyTreeDNA. It's free to the customers, who are expected to download their data from the site of origin and then upload it.
The site launched on October 10, and six days later, they have 5758 genomes. That may be a better start than Genes for Good, which is based at the University of Michigan. That launched in April, as a Facebook app, and by one report now has 7200 "research participants."
Linking the silos is scientifically interesting, but it's a little
hard to see the appeal to clients unless, of course, they get massive
The potential for misleading customers, for breaches of privacy (yeah, sure, everything will be as secure as possible), and generally for promoting genism and the market for high-tech medicine aimed at the affluent, is enormous. The FDA did us a major service in 2013 in slowing this juggernaut. Let's hope they hold firm.
The 2015 US Surrogacy Conference was held in San Francisco on September 26. Attendees were greeted by a series of representatives from surrogacy agencies (based in the US, Mexico, and India) who sought to assure them that although surrogacy can be a trying process “not for the faint of heart,” it is often a tremendously rewarding “journey.” Psychologists, lawyers, and physicians similarly celebrated the quest for children via third-party reproduction.
The audience at various panels ranged from about 15 people (mainly for presentations pertaining to international surrogacy) up to 50 for popular presentations such as The Psychology of Surrogacy and Pre-Genetic Testing & Embryo Transfer Decisions. A substantial portion consisted of male couples, and they were the target demographic for most presenters. Both at booths describing services and during presentations, images of happy babies, pregnant bellies, and glowing families were unavoidable. Happy families are, after all, the “happy ending” that surrogacy is designed to attain.
I came to the event not because I was considering hiring a surrogate, but because of a range of questions about commercial surrogacy that I haven’t seen widely considered. Who is served by the “happy ending” that’s so widely advertised, besides parents who want families? The assumption is that babies born from surrogacy arrangements will have loving parents, who expended time, effort, and money on their creation. What about babies who may never know the truth of their origin, or who may experience consequent health risks that are currently unknown and consistently understudied? Surrogates who say they experience great joy after seeing the family they helped to create certainly seem to benefit. But others claim they are taken advantage of and subjected to needless health risks.
These questions were largely sidelined at the US Surrogacy Conference: they linger below the surface-level concerns of family creation. Granted, physicians did stress the health risks of multiple births for surrogate mothers, and agency representatives did try to emphasize the important of building a relationship with one’s surrogate. But those warnings were overpowered by the happy-family imagery, by the reassurance that surrogates are thoroughly screened and selectively chosen, and by instructions on how to choose the right agency for you or construct a comprehensive legal contract. In other words, the ideas and jargon presented at the conference toggled between a narrative of wholesome, joyful family creation on one hand and caution on the other. The “happy family” rhetoric constitutes the surface narrative offered by surrogacy agencies, while the caution reflects the (often submerged) complexity of surrogacy. Which narrative is more accurate?
If surrogacy is indeed an ethically complicated commercial transaction entailing significant risk, then cost is a concern, regulation is needed, and agencies and surveillance are necessary to manage the process. If surrogacy is merely an alternative family-building method free of substantial concern, then cost is not an issue, and third-party reproduction (and PGD, sex selection, and monetarily valuing certain traits over others) can be mediated by personal decisions alone rather than by formal regulation. Critics of surrogacy and third-party reproduction often assert that yes, there is a market, and it needs regulation, while most speakers at the conference ignore the market even though, paradoxically,they themselves constitute key players. What should we make of this?
Debora Spar famously posited that we ignore the “baby business” because we are reluctant to consider babies and commerce in the same breath. In addition, I venture to guess that most representatives of surrogacy agencies would like us to forget that their activities are embedded in that business. Thus, money—a key component of any financial market—becomes an important concern.
Several speakers addressed the price of surrogacy and admitted that it is indeed “a costly adventure.” Among the costs: $4500–5000 for pre-implantation genetic screening, $1000 for blood tests at 10 weeks of gestation, $32,000 for an egg from an Indian donor, $45,000 for an egg from a Caucasian donor, and $20,000 for lawyer’s fees (all US dollars).
In the United States alone, the fertility industry is estimated to generate over $3 billion in revenue each year. But overall the price tags were muted by industry representatives who wanted to showcase their compassionate expert services, not advertise dollar signs that hint at the commodification of bodies and babies. Cost is obviously an issue for many people, including those who came to the 2015 US Surrogacy Conference. But to find such information, attendees would have to mine their brochures.
Further, if caution is necessary due to the risks of surrogacy, there is an accompanying need for regulation. Currently, registered clinics only voluntarily follow Society for Assisted Reproductive Technology guidelines. If they fail to do so, there are no repercussions. There are no federal laws in the United States that specify how much or little egg donors can be paid or that prohibit discrimination against non-heteronormative couples. The United States, in fact, is widely considered the “Wild West” of the global fertility market. This leaves agencies like those represented at the conference to self-regulate; and however altruistic the principals of these businesses (indeed, many have children via some type of third-party reproduction themselves), the bottom line is omnipresent.
Brokers and agencies at once deny the existence of a market in favor of a more family-oriented ethos and embody the existence of the market themselves. Conference speakers routinely warned that agencies are absolutely necessary to navigate the many bureaucratic hoops that define the surrogacy process. Sam Everingham cautioned that if intended parents don’t do their “due diligence” and create trust in the process, they will “get burned.” Steve Snyder claimed that “the cases that go awry are cases that are not well-monitored.”
In other words, if you wish to create your family and avoid risks, hire an agency. Thus, agencies position themselves as shields against an otherwise harsh marketplace that they themselves create and uphold. This apparent contradiction must force us to seriously question the ramifications of the existing baby market.
If, on the other hand, surrogacy is simply an alternative “family-building” mechanism free of substantial ethical risks, several opposite conclusions follow. Third-party reproduction then becomes not about money—cost isn’t an issue!—but about family creation, which is priceless. Dr. Kim Berman of Growing Generations said that surrogacy is a “relationship, not a business transaction.” Victoria Ferrara of The Ferrara Law Group reminded the audience that “we don’t want to think about this as buying a baby.”
She’s right: we don’t. So instead of a business transaction or baby selling, third-party reproduction becomes a “journey” in which surrogates (whom one participant dubbed altruistic “angels”) give families the “ultimate gift”: a child (genetically-related, of course). Money is sidelined in favor of more profound concerns.
In addition to “journey” and “gift-giving” rhetoric, libertarian ideals about individual choice were a pronounced theme. From the idea of personal “choice” family-building flows unfettered personal “choice” in a variety of more particular decisions. You can choose to have pre-implantation genetic screenings, and choose whether or not to terminate the pregnancy based on the results. This is about your family, nothing more. You can choose to practice sex selection—or, as those at the conference would say, “family balancing.” You will not singlehandedly reinforce society’s devaluation of female-bodied people. You can choose to pay a premium for a Caucasian egg donor rather than an Indian one. You are not personally upholding systemic racism.
Indeed, slides presented at the conference routinely mentioned sex selection, screening for Down syndrome, and paying more for certain traits in “high demand” without even hinting that such practices might be problematic. In fact, the nonchalance with which they were referenced can only indicate that the speakers were confident their audience wouldn’t object. These practices are now a part of the myriad options open to the rational individual consumer, appropriate choices in the free market surrogacy agencies would like to pretend doesn’t exist.
On the surface, then, surrogacy is a journey that simply fulfills parents’ desires for children. But the interplay I witnessed between the “happy family” rhetoric and the many doses of caution reflect the complications bubbling beneath.
One of Dr. Harry Haiselden's refrains when defending his behavior in the Baby Bollinger case was that doctors everywhere routinely decided to let hopeless defectives die; he only wanted to illuminate the practice for the public. Yet, the doctor seemed to desire the spotlight not only for eugenic medicine but also for himself.
After the Baby Bollinger case entered the news, Haiselden was invited to speak at social clubs, improvement societies, and professional organizations. On November 29, 1915, not two weeks after the baby's death, he gave a speech about the case and "defective" children generally in between the second and third acts of a controversial race improvement play called “The Unborn.” In early December, he addressed the Chicago Physicians, Dentists, and Pharmacists Association, where he reaffirmed his actions in the Bollinger case and expressed his commitment to sterilization of the unfit, including all those who had been confined to an institution for the "feebleminded" for more than one year.
In an acknowledgement of Dr. Haiselden’s rising celebrity and a demonstration of the cultural reach of the Baby Bollinger case, the January 10, 1916, edition of the Los Angeles Times “Pen Points” column, consisting of a series of pithy observations by the staff, included the following: “Dr. Haiselden has been summoned to New York to study a ‘defective’ case and to be the guest of honor at the opening of a play. It looks as if in allowing the Bollinger baby case to become public the doctor was foolish like a fox”—meaning, not very foolish at all.
Haiselden's growing visibility intensified public discourse over the Baby Bollinger case. Biologists, doctors, eugenists, clergymen, lawyers, and lay persons wrote letters to the editor in droves, and newspapers began to solicit and publish compilations of these letters in long features under titles like “Was the Doctor Right?” and “Does Humanity Demand the Saving of Defective Babies?”
Letters in Support
Those who wrote in support of the doctor raised several common arguments. One major contention was that in deciding not to operate, Haiselden was merely acting as an objective agent of science. It was authoritative, factual science that decreed the baby should not live, and one cannot question the dictates of science. Others maintained that the autonomy of a doctor in caring for a patient is inviolable. No other person has the right to interfere in a doctor’s work.
Many more commentators took a direct eugenic approach: Haiselden did the right thing in limiting the number of parasitic “degenerates” who would pollute the national stock and drain public resources. All such babies should be put to death upon birth. After all (in a disturbingly distorted echo of Dr. John Dill Robertson's testimony before the coroner's jury), weak babies in ancient Sparta were unsentimentally exposed to the elements to die.
Some earnestly argued that if we can approve of sterilization of feebleminded individuals, then surely we can approve of the elimination of unfit babies. The well-known eugenist Irving Fisher wrote that the idea is only shocking because it is new. In time, he said, we will grow accustomed to such extreme preventive action. In a letter to the editor, Charles Davenport, the famous head of the Eugenics Record Office, described death as “one of Nature’s greatest racial blessings.”* A few supporters recalled neighbors or acquaintances with disabilities that they believed were prime candidates to receive this “blessing.”
With similar conclusions but a softer approach, some letter writers argued it would be a mercy to let babies with disabilities die rather than to allow them to experience a lifetime of “pain, shame, humiliation, and distress.” If we can be kind enough to put down injured or abnormal animals, they said, then certainly we can muster the same kindness for defective human babies.
Still others doubted that Baby Bollinger could have claimed the labels of "human" or "alive." As biologist Raymond Pearl wrote, "[T]his infant could never develop into anything even approaching a normal human being.” The editor of the London Lancet, one of the world's most prestigious medical journals, said, "I do not consider that the child ever really lived.”
A number of individuals tried to pinpoint the general conditions under which Haiselden’s measures would be acceptable. They distinguished between physically and mentally “defective” children. The former might still contribute something to society and should be permitted to live, but the latter are a useless drain, they said. An additional demarcation was that Dr. Haiselden hadn’t actually killed the baby; he had merely permitted nature to take its inevitable course. Since not operating was not a deliberate action but the absence of an action, he could not be blamed for "nature fulfill[ing] its own destiny." Death or life would be nature's decision. (They did not acknowledge that there is never more than one possible outcome for a baby left without basic care over the course of several days.)
Another common approach for supporters was to dodge the issue of the rightness of Haiselden’s actions. They expressed a lack of comfort with the idea that a single man, even if a doctor, could make the decision to withhold life from another individual, even though they agreed with the results. Some expressed disapproval of Dr. Haiselden for “making such a public ado about the matter.” Several opined that the treatment of the baby and babies like him was hardly worth discussing. Instead, the public should turn its attention to things that matter, like war or abortion.
An additional category of responses in affirmation were purportedly—though judging by their contents, rather doubtfully—sent from children with disabilities who with wide-eyed innocence lamented their unfortunate lives. Haiselden reported that he had received a letter from a young girl that read:
Just a line from a little crippled girl, thanking you for not letting that baby live. . . We can’t play like other children. We are in every one’s road but mother’s and her poor heart aches with ours. We are just a curiosity for people to gaze at. Tell Mrs. Bollinger she is a grand, good mother, and her baby is an angel in a beautiful place—heaven. Why do people want to keep me and that little baby out of heaven? I remain your little invalid, ready to go to heaven at any time.
The most sympathetic writers were mothers and fathers who loved their children with severe disabilities, but who struggled to take care of them and didn’t know where to turn for assistance. They felt that it might have been better for their children to have died at birth than to condemn them to abuse in asylums, or to spend their own lives in fear of what would happen to their children when they died. (Interestingly, Dr. Haiselden himself frequently spoke out against the terrible conditions in asylums and institutions for the care of persons with disabilities.)
But the most striking letters by far were written by other doctors who had the power to practice Haiselden's ideals. Dr. William Rausch, Jr. of Albany, New York wrote that in the cases of babies with severe inherited disability, he believed it was “humane to cut off their future suffering by one means or another, preferably ‘forgetting’ to tie the cord” so they would hemorrhage. Dr. David Monash of Northwestern University Medical School admitted to having done just that in a few cases. Dr. Charles Sumner Bacon of the University of Illinois took issue with Rausch’s recommendation, countering that he found that particular method of infanticide to be “unreliable.” He wrote, “The usual methods of killing a new-born are by smothering, strangulating, or dividing.”
Letters in Opposition
Letters in opposition to Haiselden’s actions also followed common themes, though newspapers published them less frequently. Although we do not know the exact proportion of viewpoints expressed in the letters submitted to the media, the Independent estimated that they had received four times as many letters supporting Haiselden than condemning him.
Many opponents argued that only God could give or take away life, so Haiselden was assuming a power to which he had no right. (Haiselden’s supporters tended to respond that God wouldn't mind too much.) Others referenced a different higher power—the courts—as the only earthly decider over life and death. They cited the fifth amendment of the Constitution: No one can be deprived of life, liberty, and property without due process of law. Certainly, a single doctor neither elected nor appointed had the authority to order life or death. Said noted social worker Jane Addams, “Under no circumstances has any human being the right to pass judgment of death for unfitness on any other human being. Only one thing will justify such presumption: the course of the law in punishing a murderer.”
Others focused on the duty of a doctor to treat the sick and prolong life, not end it. By not doing everything in his power to save the baby, Haiselden was violating the dictates of his profession. One letter said that doctors who are “eugenist-enthusiasts” should be forced to declare their beliefs and let patients decide whether to patron their services. Few would want to leave their health in the hands of a doctor who might believe they would be better off dead.
Some heralded great “defectives” of the past who had contributed much to society, naming Helen Keller, John Milton, Lord Byron, Robert Louis Stevenson, Fyodor Dostoevsky, Napoleon, Emperor Wilhelm, and ancient Greek orator Demosthenes as examples. These individuals overcame their challenges and developed “greater capacities in other respects.” Wrote P. Smith, “Who knows but what this babe—deformed and malformed as it is said to have been—might have possessed some gift that would have added a little mite to the world’s spiritual or intellectual heritage?” (For her part, Helen Keller submitted a letter to the New Republic in support of Haiselden, writing, “The toleration of such anomalies [as Baby Bollinger] tends to lessen the sacredness in which normal life is held.”)
A few letter-writers stated that they taught, treated, or worked with people with disabilities and found them equally deserving of life, rights, and benefits as individuals who did not have disabilities. Others said that regardless of the severity of an initial diagnosis, with treatment, patients might do better than was initially anticipated. In addition, new treatments and therapies were constantly being discovered that might help once-hopeless cases.
Many were concerned that the doctor’s actions would set a bad precedent for future cases. Though the Bollinger case may have appeared straightforward to some, where would we draw the line between fit and unfit, normal and subnormal? The possibility for abuse was enormous.
Doctors critical of Haiselden wrote that they had been trained to treat patients, relieve suffering, and extend life. They were not equipped to judge the worthiness of an infant’s continued existence, and had no desire to become executioners. Wrote Dr. James J. Walsh:
The physician has assumed the exercise of a power that is not his. Doctors have the care of life, not death. Physicians are educated to care for the health of their patients, but so far at least as I know we have no courses in our medical colleges as yet which teach how to judge when a patient’s life may be of no service to the community so as to let him or her die properly. Some of us physicians may thank God that we are not yet the licensed executioners of the unfit for the community, and some of us know how fallacious our judgments are even with regard to the few things we know.
The Black Stork
While public discussion eventually waned, Haiselden remained determined to share his beliefs with a broader audience. He co-wrote and starred as himself in a 1917 propaganda movie derived from the Bollinger case called The Black Stork. The Sheriott Pictures Corporation, which produced the film, frantically objected to the “propaganda” label, preferring the interpretation that the film was a "living document" intended to teach "moral cleanliness." Despite its stated aims, the moral authorities challenged the film because its subject matter was seen as risqué and threatened to revoke the license of any theater that showed it.
In the film, a mother gives birth to a baby that the doctor (played by Haiselden) labels as physically, mentally, and morally defective. The doctor suggests to the mother that she allow her baby to die, but the mother is unsure. She falls asleep and dreams about what would happen if the baby lived. The baby grows up to be a violent criminal who returns to the hospital and murders the doctor for allowing him to live a miserable life. The mother awakens and tells the doctor that she agrees to allow the child to pass away. The doctor looks on as the child’s soul leaves its body and enters the arms of an awaiting Jesus Christ.
The film was not well received. Variety reported, “Not in many moons has a feature film received such a panning in the Chicago dailies as was given ‘The Black Stork.’”
Chicago Daily Tribune movie critic Mae Tinée wrote of the “nauseating display”:
The production has not even the saving grace of being a good picture. It is amateurishly acted. . . and the photography is bad. It has no elements to attract either the thinking or the sensation seekers and is as pleasant to look at as a running store. Itself a hopeless defective, it should have been mercifully throttled at birth.
The Billboard said of the film in its review:
The Black Stork is a sickening excuse to drag before the camera all of the deteriorated humanity which the defective hospitals could pour into five reels. It is a gagging nauseating exposition of the results of uncurbed licentiousness, in a story told with a smear of science as a prop. It is not a sex-lure film; it is a mere cataloguing of the pitiable mess of human dregs which is left, crawling, crippled and criminal, after the fire has burned out.
While the film was widely mocked, Haiselden's ideas continued to have serious consequences. Only a couple of months after the film opened in theaters, the doctor contacted the media once more to announce that he planned to let another three “defective” babies die.
[To be concluded with Part 3.]
*It is worth noting that “race” in this context does not refer to the
racial categories as we consider them today, but to the “human race” or
even the “American race.”
A video clip of The Black Stork:
1. “The Black Stork.” Billboard, 29.7: 61. Feb. 17, 1917.
2. “Black Stork Feature.” Billboard, 29.16: 56, Apr. 21, 1917.
3. “Black Stork Panned.” Variety, 46.6: 28, Apr. 6, 1917.
4. “Crippled Girl Writes, Upholding Dr. Haiselden in Bollinger Case.” Washington Post, Nov. 23, 1915.
5. “Defeats Cardinal Farley: Injunction Permits Production of an Objectionable Play.” New York Times, Nov. 30, 1915.
6. “Defective Babe Dies as Decreed.” New York Times, Nov. 18, 1915.
7. “Does Humanity Demand the Saving of Defective Babies?” Chicago Daily Tribune, Nov. 17, 1915.
8. “Dr. Haiselden Praised by Bent and Crippled.” Chicago Daily Tribune, Nov. 22, 1915.
9. Keller, Helen. “Physicians’ Juries for Defective Babies,” New Republic, Dec. 18, 1915. Accessed via the Disability History Museum. http://www.disabilitymuseum.org/dhm/lib/detail.html?id=3209.
10. “Judge Scully Assails Dr. Harry J. Haiselden.” Chicago Daily Tribune, Jul. 28, 1916.
11. “Many Defectives Included Among World’s Greatest Men and Women.” Washington Post, Nov. 18, 1915.
12. “Most Doctors Let a Defective Live.” New York Times, Nov. 21, 1915.
13. “Moving Pictures: Comm. Bell Bans Three.” Variety, 48.6: 16, Apr. 20, 1917.
14. “Pen Points.” Los Angeles Times, Jan. 10, 1916.
15. “Right and Wrong in the Case of the Baby Who Was Allowed to Die.” Current Opinion, Vol. L, No. 1, Jan. 1916.
16. “Surgeon Lets Little Child Die When Knife Could Have Saved It.” Washington Post, Nov. 18, 1915.
17. Tinée, Mae. “It Is Cheap, Sickening, Unnecessary: ‘The Black Stork.’” Chicago Daily Tribune, Apr. 2, 1917.
18. “Was the Doctor Right?: Some Independent Opinions.” Independent . . . Devoted to the Consideration of Politics, Social and Economic Tendencies, 85.350: 23, Jan. 3, 1916.
Another week, a fresh slew of CRISPR gene editing news and developments.
On September 24 Thomson Reuters predicted that Jennifer Doudna and Emmanuelle Charpentier would earn a Nobel Prize in chemistry for their widely celebrated 2012 research on the gene editing complex, CRISPR and associated protein Cas9. We could know as early as October 7 whether the Nobel committee will cut the wait time between publishing and laurels for a chemistry award from its 20-year average since 1985 to just three years.
The same day that the annual Nobel predictions hit the wire, Doudna, Charpentier, and a number of other researchers were gathered at Cold Spring Harbor Laboratory (CSHL) in New York for the first day of a conference called Genome Engineering: The CRISPR/Cas Revolution. That evening, Charpentier co-chaired a session with Feng Zhang, a co-discoverer of CRISPR’s gene editing capabilities and currently a rival of Charpentier’s and Doudna’s in a patent fight about the discovery. When Zhang took the stage after Charpentier, he pivoted away from CRISPR-Cas9 and, in the words of one participant, “blew us all out of the water.”
Zhang’s talk described a new CRISPR discovery that would be published the next day in Cell: an alternative CRISPR-associated protein called Cpf1. According to a Broad Institute press release,
“Zhang and his collaborators searched through hundreds of CRISPR systems in different types of bacteria, searching for enzymes with useful properties that could be engineered for use in human cells.”
The statement goes on to quote Broad Director Eric Lander asserting that the “Cpf1 system represents a new generation of genome editing technology…with the potential for even simpler and more precise genome engineering.”
Nature’s and Science’s headlines echoed this assessment, celebrating the discovery as an improvement on Cas9 and a sharper pair of molecular scissors, respectively.
But coverage in MIT Technology Review included some additional views. Science writer Antonio Regalado quotes University of Minnesota researcher Dan Boytas, who notes that the “greatest value may be more in terms of the patent landscape than a scientific advancement,” and George Church, who describes a coming “niche market for a collection of different proteins so that cuts can be placed anywhere in the genome.” Regalado also reports that researchers outside the Cpf1 research team “said the new system was likely to fill a limited role in what is a growing toolbox of DNA-editing techniques.”
Writing in Wired—a publication not averse to CRISPR hype—Sarah Zhang reinforced the idea that Cpf1 is not a Cas9 “rival so much as a complementary tool,” not so much an improvement as a method with slightly different capabilities. Wired quotes Feng Zhang’s research colleague John van der Oost: “We have the feeling it’s just the tip of the iceberg.” Doudna herself, in an October 1 interview on the Nobel Prize rumors, said that the research “underscores the wonderful diversity of these CRISPR systems” but that it was “unclear” whether Cpf1 will be “useful for genome editing.”
So for some, Cpf1 signals CRISPR 2.0, a “better way to edit the genome” or an “outsnip” of CRISPR/Cas9 potentially undercutting Doudna and Charpentier’s predicted grasp on a #NobelPrize. A different take is that we are still in the earliest stages of understanding the scientific, let alone the social, legal, and ethical, implications of CRISPR genome editing.
Officially co-hosting will be the Chinese Academy of Sciences and the UK Royal Society. No other European organization is included as a partner, despite (or perhaps because of) the region’s explicit policies on human germline modification as set forth by the Council of Europe’s Convention on Human Rights and Biomedicine, which proscribes it.
A German scientist is, however, a member of the planning committee. The UK and China each have two representatives on the committee.
The explicit goal of the "international summit" is "to discuss the scientific, medical, ethical, and governance issues associated with human gene-editing research." Though the meeting is only ten weeks away, the details of the agenda and the invited speakers have not been announced. CGS’s Marcy Darnovsky has been invited to speak, and has accepted.
It is perhaps interesting that the word "medical" has been added to the list of issues since the original announcement. It's not inappropriate, but the addition would seem to skew the discussion in the direction of implementation. Also, what will be the scope of the "ethical issues" discussed? Worryingly, a recent Institute of Medicine committee considering a related technique seemed to limit them to narrowly defined research ethics, and not to consider broader social issues.
Naturally, people with varying views are staking out positions and trying to persuade others. George Church is campaigning in New Scientist; and others on all sides of the issue are, quite rightly, putting their views forward.
On September 1, the Wellcome Trust, Medical Research Council, and three other leading British research organizations put out a statement supporting preclinical use of gene editing in human embryos and affirming
that there may be future potential to apply genome editing in a clinical context using human germ cells or embryos, though this is prohibited by law in the UK and unlikely to be permissible in other European jurisdictions at present.
Then the Hinxton Group, an international consortium of stem cell researchers, essentially agreed. Its statement stressed [pdf] that
Policymakers should refrain from constraining scientific inquiry unless there is substantial justification for doing so that reaches beyond disagreements based solely on divergent moral convictions.
Critics called this increasing the pressure for genetically modified embryos. It certainly seems close to "get out of the way."
So far, so normal in the politics of science. But the next step was
unusual: Kathy Niakan, a researcher at the Francis Crick Institute in London, applied to the UK
authorities for a license to edit the genes of human embryos.
not sure the case has been made that you need to go and study human
embryos right now. It does seem to me that before you make the case that
you want to try this in human embryos, you ought to explain why you
don't need to do more animal work with this brand-new technology.
going to be true for quite a while yet. So with the discussion of germline gene editing just getting underway, why the rush?
Robin Lovell-Badge, one of the two British representatives on the National Academies' summit organizing committee, seems to have been involved in all three of these efforts. He's Naikan's boss, and advocate in the press; he's on the steering committee of the group that drafted the Hinxton statement; and his connections with the Wellcome Trust are long-standing and deep. Certainly all three initiatives match his opinion, expressed in April, that:
I disagree with such a moratorium [on embryo editing], which is in any case unlikely to be
effective. I am fully supportive of research being carried out on early
human embryos in vitro…The arguments become even more contentious when
dealing with 'enhancement'. However, while we work towards using the
methods to make disease-resistant crops and animals, should we deny this
possibility for humans?
He is of course entitled to express that opinion, as he surely will in December. But does it begin to look as though there is
an effort to put a thumb on the scale?
The recent Ohio bill that would ban abortion based on a fetal diagnosis of Down syndrome has triggered widespread comment. In a state where 23 of 33 senators, 65 of 99 representatives, and the governor oppose abortion rights, and half of abortion clinics have closed in the past four years, it is likely to pass.
The bill also raises longstanding tensions between perspectives based in disability rights versus reproductive rights. As Sujatha Jesudason and Julia Epstein explain:
The disability rights movement is concerned about the number of pregnancies terminated solely because an expectant mother receives a diagnosis of a potential fetal disability. And the reproductive rights movement worries that any line of questioning concerning a woman’s prerogative to terminate her pregnancy will inevitably lead to undermining her decision-making autonomy.
Here, we examine how a selection of news articles and commentaries address – or ignore – this tension.
News coverage in The Economist is explicit on the point, arguing that “the bill scrambles some familiar positions.”
Abortion advocates are almost uniformly proponents of robust state funding for social services, including for the disabled. The anti-abortion lobby is generally staunchly conservative and opposed to anything that looks like a new entitlement. If the law goes through, as seems likely, women will be required by the state to give birth to their disabled child, but will not be able to count on much help from the state to raise it.
An article in The New York Times also mentions strains between advocates of disability rights and abortion rights, and notes in passing that the bill has the effect of “driv[ing] a wedge” between them. But the article mainly focuses on the fact that “some parents of children with Down syndrome [who] are strong proponents” of the bill, giving no indication that many disability rights advocates support abortion rights, and that many reproductive rights advocates are sympathetic to the disability rights perspective.
Several op-eds and commentaries explore these matters with far greater nuance and sensitivity. In a New York Times op-ed, Mark Lawrence Schrad presents his and his wife’s decision to have a daughter with Down syndrome as just that: a choice, despite medical and societal assumptions that they would opt to terminate the pregnancy. “[W]hen it comes to abortion and special needs,” he writes, “there is no easy answer – and the idea that these deeply personal ethical and social decisions could simply be legislated away is ridiculous.” Like The Economist piece, Schrad highlights the hypocrisy of abortion rights opponents who would both force women to have children for whom they may be unprepared and slash state support for those same families. Personal experience has driven Schrad to value reproductive choice, but he that believes for any choice to be meaningful, the necessary support systems must first be in place.
Writing in Bioethics Forum, philosophy and bioethics professor Bonnie Steinbeck stresses that the Ohio bill is unconstitutional and unenforceable, much like the authors above, but she also grapples with disability rights advocates’ concerns “that the choice of abortion in such cases is often based on ignorance about the kind of life the child could lead and discriminatory attitudes toward people with disabilities.” In addition, she notes, these attitudes may extend to people already living with disabilities, or even to the belief that because abortion is an option there is no need for the state to provide resources for people with Down syndrome and other disabilities. Steinbeck concludes with a call for Ohio legislators to direct their attention to “ensuring that all people with disabilities, Down syndrome or otherwise, get the resources and services they need.”
Judith Levine’s “Disability and the Politics of Abortion” in Seven Days explores more deeply the “tension between the ideals of the two movements” and the “ambivalence in the hearts of any of the people who hold those ideals.” As she points out, “many people straddle the two communities — pro-choice feminists who also fight for respect and rights for the disabled, and disability-rights activists who believe in unqualified reproductive freedom.” Levine quotes the late disability scholar Adrienne Asch, who was simultaneously fully committed to the right to choose abortion for any reason, and profoundly troubled by termination of pregnancies with particular children. “My moral opposition to prenatal testing and selective abortion flows from the conviction that life with disability is worth living,” Asch wrote. In a phone conversation, disability rights scholar and advocate Martha Saxton explained to Levine the “bind” that feminists with disabilities encounter: constant confrontation with their own mortality, when they wonder – in a “ridiculous hypothetical” – whether their mother would have chosen to abort them had testing been available. Saxton remains politically pro-choice and personally conflicted. "The challenge for reproductive-rights activists,” she said, “is not to identify with the fetus but to identify with women and with disabled people who are alive now — to fight for people living under this oppression, this idea that we would be better off being dead."
Levine notes that anti-choice activists have long portrayed the fetus as the ultimate innocent victim, and that adding disability to the imagery only completes this picture of perfect vulnerability. Their objective, she says, is not good policy, but “to gain strategic – and emotional – advantage. By portraying themselves as friends of the disabled unborn, they're vying for the sympathies of the already born disabled.” Levine argues that rather than allowing legislation to save fetuses with disabilities at the expense of their mother’s freedom, we should develop policies and technologies that make lives in all bodies – no matter what their abilities – worthwhile.
In January of this year, before the Ohio bill had been introduced, a similar legislative initiative in Indiana prompted David Perry, the father of a son with Down syndrome, to write a commentary in RH Reality Check entitled “Anti-Choice Legislators Try to Force Wedge between Reproductive, Disability Rights Activists.” Perry takes issue with the “faux advocacy for disability right” in which anti-choicers and the “disability hierarchies” they invoke one-dimensionally label children with Down syndrome as “cute” “blessings” and “angels.” He supports what he calls the pro-information movement, which seeks to equip potential parents with accurate information free of bias. He furthermore advocates for an intersectional approach to movement-building that would connect disability and reproductive rights activists. Perry endorses a coalition that acknowledges “a woman’s right to choose is inviolate” but warns that “before that choice, let’s make sure that it’s based on reality, not fear-mongering or misinformation.”
The tension between reproductive rights and disability rights activists stoked by Ohio legislators is not new. One effort to address it was a series of cross-movement roundtable discussions sponsored by Generations Ahead, a public interest organization in existence from 2007 to 2012 that grew out of a Center for Genetics and Society program. Bridging the Divide, a report on the roundtable series, articulated a series of shared principles and values that, it concluded:
suggest a need to reframe the issues—a framing away from the right not to have children to a right to have children, and a framing away from creating a self-sufficient, productive individual to re-shaping society to provide for the needs of all people, regardless of gender, race, ability, sexual orientation, citizenship status and class. In pivoting away from more narrow agendas and principles to broader, more inclusive values, new political opportunities and new alliances are possible.
These recommendations have not yet been fully embraced by reproductive rights and disability rights advocates. But the legislators in Ohio would do well to remember the call for basic human dignity that inspires both the movements they seek to divide.
[Forgotten Stories of the Eugenic Age is a blog series exploring the lesser-known ways that eugenics affected and engaged American lives during the first half of the twentieth century.]
In November 1915, Chicago physician Harry Haiselden decided to let newborn John Bollinger die.
Baby Bollinger, as he was called in the many press reports of the time, was born paralyzed on the left side of his body, missing his left ear altogether and the ear drum of his right ear. His right cheek was connected to his shoulder, and he had a curved spine and closure of the intestinal tract. His only chance of survival was immediate surgery.
Obstetrician Climena Serviss called in the hospital’s chief surgeon, Dr. Haiselden, to consult. A firm believer in the doctrine of eugenics, he examined Baby Bollinger and arrived at the conclusion that even if surgery was successful, the child would grow up to be a mental and moral “defective” who would burden his family and society and taint the human race. Indeed, Haiselden believed that it would be morally wrong to allow the baby to live. As he later recounted, he wondered, “Would his mind be clear? Would his soul be normally alive? That I do not know, but the chances are against it.” Haiselden informed the baby’s parents that, in his estimation, the child would be better off dead. In due course, Mr. and Mrs. Bollinger came to agree.
Having made this decision, Haiselden contacted a reporter to share the story, believing that shedding light on such practices would make the case for the betterment of society through eugenics. Journalists from other newspapers latched onto the story, reporting it as one of the first cannon shots of the eugenic movement.
Haiselden was not the first prominent figure to voice the belief that certain children’s lives should not be preserved. In 1912, D. H. H. Goddard—respected eugenist, author of The Kallikak Family: A Study in the Heredity of Feeble-Mindedness, and coiner of the term “moron”—argued, ironically at a Philadelphia “baby saving show,” for the extermination of children with intellectual and physical disabilities who are “calculated to grow up to increase the race of thieves and paupers.” But Haiselden's decision in the case of Baby Bollinger pushed this concept from the hypothetical realm into reality.
As newspapers printed the story, a firestorm erupted. While the baby lay in the hospital dying of starvation, calls poured in, with some people begging Haiselden to reconsider, and others urging him to remain steadfast in the course he had chosen. Threats to kidnap the child and take him elsewhere for care led the hospital to station a guard at his bedside.
When the baby finally died on November 18 at five days old, the controversy intensified. Members of the public thirsted to hear Haiselden's reasons for refusing to operate so they could decide whether to praise his ideals or excoriate his callousness. Some took to the papers to demand that the state open an inquest to formally settle the matters of whether Baby Bollinger would have lived with operation, whether the baby was truly mental or morally “damaged,” and whether a doctor had the right to determine “defectiveness” in an infant, and, once done, decide if that baby should live or die. They wanted, too, to pass their own judgments on Baby Bollinger’s fitness to live.
Coroner Peter Hoffman had initially believed that an inquest was unlikely, since “the case is not different from many others” and “the physician knows the cause of death,” but the extensive public attention prompted police to open an official investigation. Hoffman's office was asked to perform an autopsy, and a coroner's jury was to determine whether Haiselden would be charged with any crime.
Six prominent Chicago-area physicians were selected for the jury and held a hearing in which they called witnesses and peppered Haiselden with questions about the baby's health and his reasons for inaction. Haiselden explained his choices in a signed statement issued before the Coroner’s jury took up its inquiry:
I say again that it is our duty to defend ourselves and the future generations against the mentally defective we allow to grow and suffer among us, and add to our burden and our problem. . . . So let us be sensible. Let us approve of the sterilization of the insane and the defective, and of the children of habitual drunkards, when both father and mother are so. Let us reproduce ourselves in 100 per cent fashion, so that by weeding out of our undesirables we decrease their burden and ours and lay the foundation for a normal race, which would result four generations from now. Let us venerate a standard with soul and sense, instead of desecrating it with crumbling tradition and mindless sentimentality.
At the hearing, Haiselden testified that he had consulted with fifteen other physicians over the fate of Baby Bollinger, fourteen of whom had agreed with his decision. However, when pressed to give names, he could only provide two: Dr. Climena Serviss, who had initially called him for consultation, and Chicago Health Commissioner Dr. John Dill Robertson, who had publicly denounced Haiselden's actions and who testified against him at the hearing.
Haiselden further stated that he had told these fifteen physicians that if any wished to operate, he would not prevent them from doing so. They all declined his offer, he said, until one asked for permission about two hours before the baby died. Haiselden denied the request on the grounds that it was “against [his] ethics to operate on a dying person.”
Haiselden’s testimony included a series of contradictory statements. “I did not believe the life prospects of the child were good.” “He might have lived for a number of years." "A dangerous surgical operation would have gained nothing for the child.” “Without [an operation], the baby could not live.” “I did not wish to operate lest, if it should die on the table, I should be accused of killing the baby.”
He argued that the parents had been fully informed about their baby's health problems and had not been pressured to accept his decision. He recounted telling the father that, in his professional estimation, the baby would be disturbingly deformed, mentally and morally defective, a burden to himself and society, and doomed to a life of pain and suffering. The mother had never seen the child, and the parents had not been informed that Dr. Robertson supported an operation. Mr. and Mrs. Bollinger had agreed to allow the doctor to treat their baby as he thought best.
He protested in his defense that it was common practice among Chicago doctors—and indeed doctors everywhere—to allow “hopelessly defective” babies to die. In fact, he said, at least one baby a day in Chicago is secretly left to die, a statement that no one at the hearing contradicted. He concluded, “If I am to be jailed, I am ready to take my medicine. My conscience is clear.”
John Dill Robertson was Haiselden's strongest critic at the hearing. He testified that he had examined the baby, and had expected his problems to be worse than they were. Robertson thought that if the infant had received a timely operation, he would have had a chance of survival. He expressed concern about the dangerous precedent of not working to the fullest extent to save a life, and of relegating to a single doctor judgment over worthiness to live. “If our civilization has reached a stage where the life or death of infants is to be determined on the grounds of fitness,” he said, “then, like the ancient Spartans, we should establish a legal tribunal to pass upon the babies that are to live and those that are to be exposed to death.”
After the autopsy and hearing, the jury declared in a statement, “We find no evidence from the physical defects in the child that it would have become mentally or morally defective. Several of the physical defects might have been improved by plastic operations.” The jury also expressed the belief that a “prompt operation would have prolonged and perhaps saved the life of the child.”
The jury agreed that “morally and ethically, a surgeon is fully within his rights in refusing to perform any operation which his conscience will not sanction.” However, it hinted that it was uncomfortable with the idea of any one doctor making a decision to withhold a potentially lifesaving operation. It recommended that at least two doctors be consulted in such matters. In its strongest criticism of Haiselden, the jury concluded, “We believe that the physician’s highest duty is to relieve suffering and to save or prolong life.”
This was indeed the strongest formal censure Haiselden would receive; the coroner’s jury decided not to charge him.
Even after the verdict, the state of Illinois considered indicting Haiselden for criminal carelessness due to a faulty diagnosis in the Baby Bollinger case. In December, the Illinois Board of Health pursued an inquiry and examined the testimony from the inquest, but chose not to pursue further action. Haiselden had been the consulting and not the attending physician in the Bollinger case, they reasoned, and so could not be held responsible for the baby’s death.
Professional organizations issued a range of responses to the Baby Bollinger case. Before the child's death, the Medico-Legal Society of New York passed a resolution commending Haiselden for allowing the baby to die, thus “not only saving the child misery, but saving society the responsibility of caring for it.”
On the other hand, after long deliberation, the Chicago Medical Society expelled Haiselden on March 14, 1916. Even so, the society sidestepped addressing the morality of Haiselden's actions, and explained that their decision was based not on the doctor’s actions in the Bollinger case, but for “seeking newspaper notoriety and gaining financially” from it. As Independent magazine later observed, Haiselden’s offense, then, “at the worst is not a question of ethics at all, but merely a violation of trade union rules.”
Other organizations deliberately ignored the case. The New York Academy of Medicine held its regular meeting on the evening of December 2, two weeks after the baby’s death. Earlier that same day, another baby had died due to similar inaction from her doctors, whom some maintained had been emboldened by Haiselden’s precedent. However, the president of the organization said that it would be against the association’s rules to discuss the two cases at the meeting.
In spite of his expulsion from the Chicago Medical Society, Haiselden continued to practice at the German-American Hospital where Baby Bollinger had been born and died, and the case continued to bring him his notoriety and financial benefits in the following months and years. In fact, debate raged long after the legal and professional consequences were put to rest. And the public was soon to receive more fodder, as Haiselden’s eugenic legacy was not yet complete.
1. “Baby a Day Allowed to Die.” Washington Post, Nov. 21, 1915.
2. “Bollinger Baby Inquiry: Illinois Authorities May Prosecute Doctor Who Refused to Operate.” New York Times, Dec. 10, 1915.
3. “Chicago Medical Society Drops Dr. H. J. Haiselden.” Chicago Daily Tribune, Mar. 15, 1916.
4. “Clear Baby’s Doctor: Six Physicians on Coroner’s Jury Make Report.” Washington Post, Nov. 20, 1915.
5. “Clears Dr. Haiselden: Health Board Drops Charges in Baby Bollinger Case.” New York Times, Feb. 7, 1916.
6. “Death for Weak Babies Is Opposed by Medical Men of the Capital.” Washington Post, Jun. 3, 1912.
7. “Defective Babe Dies as Decreed.” New York Times, Nov. 18, 1915.
8. “Dispute Doctor Who Let Baby Die.” New York Times, Nov. 20, 1915.
9. “Dr. Haiselden Called Before Medical Body.” Chicago Daily Tribune, Dec. 14, 1915
10. “Dr. Haiselden Expelled: Bollinger Baby’s Doctor Dropped by Chicago Medical Society.” Washington Post, Mar. 15, 1916
11. “Dr. Haiselden Is Expelled.” New York Times, Mar. 15, 1916.
12. “Dr. Haiselden to Face State Board Inquiry.” Chicago Daily Tribune, Nov. 24, 1915.
13. “Hurrah for Dr. Holt: Dr. Haiselden Endorses Action of New York Specialist.” New York Times, Nov. 25, 1915.
14. “Jury Clears, Yet Condemns, Dr. Haiselden” Chicago Daily Tribune, Nov. 20, 1915.
15. “Jury of Surgeons Studies Babe’s Case.” New York Times, Nov. 19, 1915.
16. “Justify Doctor’s Act: Chicago Officials Hold Autopsy Over Bollinger Baby.” Washington Post, Nov. 19, 1915.
17. “May Prosecute Doctor: Movement in Chicago to Accuse Haiselden Because of Baby’s Death.” Washington Post, Nov. 24, 1915.
18. “Medico-Legal Society of New York Commends Dr. Haiselden’s Stand.” Washington Post, Nov. 18, 1915.
19. “Might Kill Baby to Use the Knife.” New York Times, Nov. 26, 1915.
20. “New-Born Cripple to Be Left to Die.” New York Times, Nov. 25, 1915.
21. “Physician Is Sustained in Baby’s Death.” San Francisco Chronicle, Nov. 20, 1915.
22. “Roberts Baby Dies Without Operation.” New York Times, Dec. 3, 1915.
23. “State Opens Inquiry: Illinois Officials Takes Up Bollinger Baby’s Case.” New York Times, Nov. 25, 1915.
24. “Surgeon Lets Little Child Die When Knife Could Have Saved It.” Washington Post, Nov. 18, 1915.
25. “Won’t Let Malformed Baby Die Despite the Wish of Its Parents.” Washington Post, Nov. 25, 1915.
Posted by Lisa C. Ikemoto, Biopolitical Times guest contributor on September 10th, 2015
Researchers borrowed a tool from the bacterial immune system toolkit, and developed a genetic modification technique called CRISPR/cas9. CRISPR’s rapid uptake by biologists in nearly every field demonstrates the technology’s utility and potential. Its use for deliberate species modification, and human germline modification in particular, has spurred vociferous debate.
The debate has three buttons – Stop, Pause, and Fast Forward. Or so it seems.
Steven Pinker grabbed headlines and staked out the Fast Forward position with his Boston Globe op-ed. His central point – that taking dignity, social justice, health and safety into account will cost millions of lives – expresses technological optimism at its extreme. His central pitch, “get out of the way,” targets those who would Pause or Stop CRISPR’s use to address those concerns. “Get out the way” functions like recent accusations of “scientific authoritarianism.”
Big Tobacco called researchers and public health experts “Nicotine Nazis,” in its campaign to fight tobacco regulation. More recently, opponents of environmental protection measures have accused climate scientists who support such measures of scientific authoritarianism. Here, Pinker’s “Get out of the way” in effect charges those who support moratoria or regulation of CRISPR with being human, rather than scientific.
There is nothing inherently wrong with technological optimism. Nor is technological optimism incompatible with principled caution. A 2012 study by Hochschild, Crabill & Sen shows that a majority of the 4,300 Americans they surveyed holds coherent views that pair technological optimism and support for regulation of genomic science. Hyper-optimism paired with scientific authoritarianism, on the other hand, makes any other position seem oppositional, and creates both a false sense of polarization and a false divide between science and human values.
Most are also narrowly tailored, subjecting only human germline modification to scrutiny. The combination of the Fast Forwards’ efforts to characterize moratoria as extreme, and the Pause and Stop supporters’ sole focus on modifying the human germline, effectively edits out other pressing issues that genetic modification techniques like CRISPR raise.
Jasanoff, Hurlbut and Saha have pointed out that the 1973 moratorium on recombinant DNA research and the subsequent meeting as Asilomar bracketed off “three serious concerns: environmental release of engineered organisms; biosecurity; and ethical and social aspects of human genetic engineering.” The proposed moratoria may have the same effect.
Social stratification by wealth, race, and disability patterns technology use; technology does not by its very existence erase stratification. That fact alone should temper our optimism. Yet the Fast Forwards tend to overlook history and social reality in projecting the effects of new technology.
Only a few observers, including Hank Greely, have raised concerns about the environmental consequences of using CRISPR and a technique known as “gene drive” to re-engineer organisms. Some scientists have also pointed to risk that releasing modified mosquitoes may have unintended consequences, as have importation of nonindigenous plants and animals.
The CRISPR debate is just getting started. The issue of genetic modification is not new. Nor is human germline modification a stand-alone issue. While I support a moratorium and rigorous discussion, we need more than an ad hoc response. It is time to develop a participatory governance approach to the many issues that technologies like CRISPR raise.
Lisa C. Ikemoto is a fellow at the Center for Genetics and Society. She is Professor at the University of California, Davis School of Law. She teaches bioethics, health care law, public health law, reproductive rights, law & policy, and marital property. Her research areas include reproductive and genetic technology uses, health care disparities, and public health law. Her recent work addresses reproductive tourism, the ways in which human gamete use links the fertility and biotechnology industries, and the privatizing effects of informed consent. She will interview George Annas in the upcoming installment of the Center for Genetics and Society's Talking Biopolitics series.
Posted by Gina Maranto, Biopolitical Times guest contributor on September 9th, 2015
Like so many medical terms, “precision medicine” is a combination of both wishful thinking and obfuscation. In this case, it also carries a somewhat unsettling suggestion: if medicine has not up until now been precise, then what has it been?
Precision medicine started being touted in the specialized journals in the late aughts as part of a “new era” being ushered in by coordinated and integrated care, fiscal transparency, and patient-centered practice. It was one of a suite of approaches that promised to bring costs down while improving outcomes. The idea was that by looking at drugs and other therapies according to how they succeeded (or didn’t) in people sharing particular gene variations and similar physical traits, physicians could make more intelligent choices patient-by-patient, selecting the treatment with a greater chance of working.
Big Pharma saw promise in the approach and made strategic partnerships (Pfizer and Medco Health Solutions in 2011, for example, and Novartis and Genoptix that same year); startups and researchers rushed to secure patents; while medical groups such as the American Society of Clinical Oncology devoted sessions at their annual conferences to precision medicine’s potential benefits now that speedier gene sequencing was bringing costs down sufficiently to make it possible to contemplate tailor-making cancer drugs.
At the same time, some in the burgeoning field saw major structural hurdles. For example, most work on biomarkers—the substances or physical signs that a disease is present or a drug is working—is done in university and government research labs, and it takes time for any given biomarker to be proven accurate, as well as to be adopted by physicians in the clinic. Finding biomarkers that not only show whether a drug is present but whether it is affecting the target cells to reduce disease presented a further challenge.
Soon enough, though, proponents were touting precision medicine in scientific meetings as “revolutionizing oncology,” and medical programs launched courses in whole genome sequencing. Dean Dennis Charney of Mt. Sinai School of Medicine gave the rationale for their decision to start offering an elective course “Practical Analysis of Your Personal Genome” in 2012, "For precision medicine to become a routine in the medical clinic, we need to train the next great generation of physicians to harness sequencing-driven medical genetics."
Genome sequencing, though, wasn’t enough, argued some. That same year, Peter Taylor, director of the Victorian Life Sciences Computational Institute at the University of Melbourne, wrote in The Australian,
Medicine today is as much about statistical literacy as it is about bedside manner or learning about anatomy. As the world heads towards the field of personalised, or, as I prefer to put it, precision, medicine where treatments are designed for individual patients based on their genetics, cancer type and family history, the next generation of doctors need to know about statistics, errors and measurements so they can understand how the almost daily announcements of breakthroughs, recalls of medicines and clinical trial results impact on their patients.
In addition to advocating a renaming of the field by replacing the previously used word “personalized” with “precision,” and championing the value of statistics for future physicians, Taylor delivered a zinging backhand indictment of the med school status quo: “These tools they will be using will be produced by mathematicians and bio-statisticians, not just the anatomists of old.”
Precision medicine made the leap out of medical circles and into the mainstream around this time. Google Trends shows the term emerging onto the interwebs in March 2012 with 11 news headlines and then blipping along at about the same level until February 2015, when it leaps to a new plateau of about 100 in the wake of President Obama’s announcement of a $215 million precision medicine initiative in his State of the Union address.
Critics offered a raft of objections to the announcement. Even those in favor of increased use of genetic testing predicted it would be years before there were enough sufficiently trained physicians and genetic counselors to ensure that patients received accurate readings; until then, the complexities of genomics would likely result in an unsettlingly large number of faulty diagnoses. Others said it would just bring about more problems related to genetic privacy.
Writing in The New York Times, Mayo Clinic physician Michael Joyner leveled a much more sweeping critique of the entire precision medicine effort, one that can’t be answered better privacy protections or more doctors with training in genetics. Joyner argued that Obama's plan, which he dubbed "moonshot medicine" is unlikely to prevent disease and a misdirection of effort. He cites the “unexpected findings” emerging from the Human Genome Project, including the growing scientific consensus that genetic variants don't account for most common complex diseases, and the “missing heritability” problem. His advice:
We would be better off directing more resources to understanding what it takes to solve messy problems about how humans behave as individuals and in groups. Ultimately, we almost certainly have more control over how much we exercise, eat, drink and smoke than we do over our genomes.
As a colleague said to me recently, precision medicine is also a non-starter when it comes to social justice: in the U.S., dollars could be better spent on providing primary and preventive care to more people who, even with the Affordable Care Act still cannot access medical treatment on a regular basis.
But the hype, with its hopeful but unlikely message, is so much easier to sell than the not-terribly encouraging reality. And in research and medical circles, the funding being directed at gene-based health care is a powerful lubricant of enthusiasm. So the megaphones will likely be blaring the precision medicine tune for some time to come.
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.
Posted by George Annas, Biopolitical Times guest contributor on September 9th, 2015
Steven Pinker was one of the first to have his genome sequenced, and he wrote a long essay about the experience in the New York Times magazine in 2009. He sensibly concluded that your genome could tell you some things, but that there were more direct ways to find out about yourself. In his words: “If you really want to know yourself, consider the suggestion of François La Rochefoucauld: ‘Our enemies’ opinion of us comes closer to the truth than our own.” Pinker seems to have gained a whole new group of “enemies” with his recentBoston Globe op-ed calling on ethicists to leave scientists alone to pursue their research with new gene editing technologies. But it’s at least possible, if not entirely plausible, that Pinker actually agrees with his critics that genetic editing requires regulatory and bioethics oversight, and that he believes that such regulation needs more, not less, attention.
Pinker understands the power of language to shape beliefs. In his 2009 book How the Mind Works, he noted that “in everyday life” we will need language (and humor) to “undermine the pretensions of countless blowhards, blusterers, bullies, gasbags, goody-goodies, holier-than-thous, hotshots, know-it-alls, and prima donnas.” I’ll let him decide which one he most closely represents when he “claims authority on a pretext of beneficence and competence” (a strategy he says he despises in How the MindWorks).
In his recent op-ed, Pinker is, of course, beneficent, promising that science will slay premature death and disability. His promise, however, comes at a high price: we must ignore human dignity and social justice.
But if morals are not to matter to scientists, why should they matter to bioethicists? How can Pinker suggest as a matter of importance that bioethics should “get out of the way” of research because this is (or should be) “the primary moral goal” of today’s bioethics? Maybe this is because he has always mistrusted morality as being too dependent on philosophy (rather than science?). As he argued in How the Mind Works,
Maybe philosophical problems are hard… because the mind of Homo sapiens lacks the cognitive equipment to solve them. We are organisms, not angels, and our minds are organs, not pipelines to the truth.
The argument seems to be, if psychologists think that the human mind cannot solve a problem, humans should not waste their time trying to deal with it.
The ability to ignore human dignity was on display when Pinker’s own profession of psychology, through the American Psychology Association (APA), decided post-9/11 that it was “ethical” for psychologists to ignore human rights, and to participate in torture at Guantanamo Bay and at the CIA’s black sites. Of course they thought they were being beneficent and saving lives. As the playwright Arthur Miller observed, “to perceive somehow our own complicity with evil is a horror not to be borne.” Only this summer did the APA unequivocally denounce its pro-torture “ethics” and adopt a human rights framework for the profession. Psychiatrists’ organizations, in contrast, consistently refused to permit their members to join in the torture, even in the ticking-time-bomb scenario where thousands of lives could theoretically be saved.
It is worth asking whether this is because psychiatrists are physicians with a “do no harm” moral tradition; whereas psychologists, who are non-physicians, have no such tradition. Similarly, most genetic researchers are not physicians, and there is no equivalent of the Hippocratic “do no harm” morality in science.
Since Pinker knows all this, it is worth at least considering his essay as a cry for help from bioethics to aid in the rehabilitation of his own profession, and to prevent the perversion of science in general. This is not as far-fetched as it seems since Pinker praises bioethics for setting up safeguards “for the safety and informed consent of patients and research subjects.” He has to be able to see this contradiction which can be resolved only with more, not less, attention to ethics.
So here’s the real question Pinker raises: should there be a scientific exception to our laws against committing crimes against humanity? This is (or should be) an easy question regarding genocide, murder, torture, or slavery. But mostly what is at stake in the new gene editing techniques is what I have called a “type 2” crime against humanity: altering humans in such a way as to either irrevocably transform the species itself or to put the human species at risk of extinction (e.g. through a novel pathogen, a risk at the core of “gain of function”—ferret flu type—research).
Put another way, if researchers really, really want to do good, should society simply let them decide among themselves whether the risks to humanity are acceptable? Can we (morally?) say to our scientists, if you can give us all an extra decade of disease-free life (plausible) by killing all the members of a tribe that lives in a remote jungle of Brazil in some necessary experiment (implausible to be sure), you have our blessings? To answer this question in the affirmative—it seems to me—means we have already given up the ethical values that make our species worth preserving. I think the (new) American Psychology Association would agree, and perhaps Steven Pinker would too.
PLOS Biology, a peer-reviewed open-access journal, recently asked “eight leaders” for their predictions about the next ten years in genetics and genomics. Many responses acknowledge that this task may be impossible; nonetheless, the answers do not waver: “All are optimistic and predict enormous positive impact.”
Is this insider enthusiasm warranted? Should the rest of us be so optimistic?
One thing we can count on is uncertainty – both in the biological systems and with regard to the power of emerging technologies. Contributors Laura F. Landweber of Princeton University and Ian Dunham of European Molecular Biology Laboratory and Wellcome Trust Genome Campus each underscore how much more we have to learn of vast and complex “genome architectures.” They highlight how new findings from more sophisticated whole genome sequencing and data mining are “eroding traditional notions of a gene,” moving us ever further from the “classical reductionist examples from early molecular biology and the idea that molecule X ‘does’ function Y.”
Aside from such concessions of uncertainty, the overall tenor of the commentaries is near-utopian.
None of the contributors mention even widely acknowledged challenges of the genetic future such as data overload, let alone the potential for much more difficult social and legal problems such as new modes of surveillance or lawsuits due to “gene editing” gone wrong.
Meanwhile, examples of the boons of genetic advances range from the practical to the conceptual. Routine genetic sequencing of tumors to provide more precise cancer treatment is mentioned. There is also a prediction that we will soon have precise, personal “miniaturized genomic monitoring” devices capable of reading our bodies for signs of sickness and disease, causing the whole of healthcare to shift from primarily reactive to primarily proactive.
In addition to revolutionary new products on the personalized healthcare market, predictions meander briefly into social implications, maintaining an oddly optimistic gaze. Bartha Knoppers, director of the Centre of Genomics and Policy at McGill University, suggests that genetic information could move us away from today’s contentious human classifications such as gender and ability towards “destigmatized” “subpopulations of risk or resistance” revealed by genomic profiles. It’s an interesting idea, but the trend so far has moved us in the opposite direction: toward genetic information being used to underscore the “biological reality” of human difference.
It seems quite likely that we will have to continue struggling to avoid reifying social categories like gender, race, and ability. In addition, we may have to fight discrimination at newly imagined sites of difference – say for example, against carriers of a particular gene mutation who can suddenly no longer purchase life, disability, or even health insurance.
Unwittingly straining against Knoppers’ colorblind destigmatization prediction, BGI-Shenzen director Huanming Yang predicts that we will sequence “most, if not all, of the species identified on earth” as well as “most, if not all, ethnic groups.” He asserts that this knowledge will help treat diseases and restrict the births of those deemed genetically “abnormal,” and that we will manage to simultaneously honor individual privacy, intellectual property rights, and free access to genome sequencing data because “the future is brilliant and is now.”
But whose future is this?
Missing from these short exploratory essays is discussion of the forces that will be shaping this biotechnological future. There is no mention of societal mechanisms such as regulation or democratic participation. Nor is there any mention of the impact of money, global collaborations among biotech giants, or competing national agendas. This notable absence of actors supports the insidious storyline that biotechnology is an unguided force leading inevitably to human progress; a kind of cellular manifestation of destiny, unstoppable and un-shapeable in its trajectory.
In this view, biotechnology itself is protagonist: an unrelenting [bio]power that asserts itself on all forms of life. The people, the structures, and the money that do in fact guide the specific research goals and ultimate direction of biotechnology are made invisible.
The question posed by PLOS – “But how will society view such developments?” –positions us as passive observers and receivers of exciting advances coming our way. Importantly, the phrasing of the question suggests that while society may view developments in a negative way, the developments themselves could not actually be negative. In other words, it asserts the judgment that people could only feasibly be concerned about the future of biotechnology if they misunderstand. After all, the “leaders” are all in agreement: Utopia is around the (research funding) bend.
It is only this telling of the biotechnological future that makes it possible for one to consider the most ethical option for bioethicists and concerned bystanders to “get out of the way.”
To meaningfully consider the future requires imagination, but the story of biotechnology as heroic protagonist is a fairytale. We must make visible the monetary, social, and political forces determining the direction of genetics and genomics. If we fail to enrich the stories we tell with the context of our times, we risk becoming a footnote to our own future.
Jessica Cussins is a consultant and former Project Associate at the Center for Genetics and Society, currently earning a Master's in Public Policy from the Harvard Kennedy School. She is a regular blogger at Biopolitical Times, Psychology Today, and the Huffington Post.
Posted by Stuart Newman, Biopolitical Times guest contributor on September 4th, 2015
Some scientists like to think of themselves as modern counterparts of Prometheus, the Greek god who brought the creative power of fire to humankind. Privately they may express surprise that an activity – research – in which they take so much satisfaction can (at least potentially) attract public or private funds. But the fact that this occurs, and is indeed routine, only confirms their self-image as foremost among society's heroes. Much rarer is for scientists to question why this money flows to their enterprise, or how science and technology has helped those governmental and commercial institutions with such resources to dispense increase their leverage over everyone else.
There are other academics, frequently in quasi-scientific fields, who take it on themselves to publicly congratulate scientists for all the good that they do. How dare anyone presuming to speak on behalf of the public even suggest putting precautionary or ethical obstacles in the way of scientific research and its commercial implementation, they ask. “Get out of the way,” barks Steven Pinker, a Harvard psychologist, in a recent Boston Globe op-ed piece.
While addressing himself to professional bioethicists (a notoriously meek lot when it comes to recommendations that would alter the course of technological developments in any meaningful way), Pinker’s broader target is a purported pro-disease and pro-death lobby which he claims to be concerned about such things as “warehouses of zombies to supply people with spare organs.” Pinker’s disingenuous rhetoric notwithstanding, after mammalian cloning was shown to be feasible in the late 1990s, there was in fact active discussion of producing genetically replicate humans (usually conceived as lacking a conscious brain) to provide replacement organs.
Pinker decries “perverse analogies with…Nazi atrocities,” assuring his readers that “we already have ample safeguards for the safety and informed consent of patients and research subjects.” He might have benefited from looking into the origins, at the Nazi war crime trials, of the Nuremberg Code, the basis of these “ample safeguards,” and the opposition to them while they were being drafted by the American Medical Association, using professionalist arguments much like his own. He might also have considered the evidence that the Code is routinely ignored.
Pinker mocks those skeptical of using the new CRISPR/Cas gene modification methods for “editing genomes” (presumably including those of humans, since his op-ed concerns human health). He supports his call to leave to the experts all decisions as to when, or if, to genetically engineer humans by invoking increased lifespan and decline of disease in prosperous countries – as if these were attributable to biotechnology rather than improved nutrition and sanitation. Genuine advances in medicine due to molecular biology, such as treatments for heart disease and therapies for certain cancers, were arrived at by trial-and-error on volunteers chosen among desperately ill existing people with few alternatives. They were not intended as techniques for irreversible experimental refashioning of prospective people, as germline modification would be.
Non-specialists may not have the nuanced technical understanding of the CRISPR/Cas system that Pinker seems to believe qualifies one to make these decisions (though apparently technical expertise is not needed in order to cheer the scientists on). Anyone who follows the news, however, can read about the brewing industrial battles over patents for “gene drive” technologies that would permit a company’s preferred genes to displace natural variants, or those of competitors. They might also acquire an alternative perspective on the moral and social compass of some experts by following the stories of computer scientists aiding the government in the collection of massive amounts of personal data on ordinary citizens, or the design and participation in CIA torture programs by Pinker’s fellow members of the American Psychological Association.
Clearly not all experts or genetics researchers are inclined to take the low road by participating in such ethically unacceptable activities. The sad reality, however, is that the grip on technology by commercial and governmental centers of power ensures that scientists, whether Manhattan Project researchers (some of whom hoped that the Atomic bomb be used in a demonstration, not on population centers) or well-intentioned developers of antibiotics who have seen their efforts to alleviate disease turn into their opposite, do not control the fruits of their research, notwithstanding the optimism of certain aficionados of science.
Stuart A. Newman is professor of cell biology and anatomy at New York Medical College, where he directs a research program in developmental biology. He has contributed to several scientific fields, including the theory of biochemical networks and cell pattern formation, protein folding and assembly, and mechanisms of morphological evolution. He also writes on the social and cultural dimensions of biology and biotechnology, and was a co-founder of the Council for Responsible Genetics, Cambridge, MA. He is co-editor (with Gerd B. Müller) of Origination of Organismal Form: Beyond the Gene in Developmental and Evolutionary Biology and co-author (with Gabor Forgacs) of Biological Physics of the Developing Embryo.
Posted by George Estreich, Biopolitical Times guest contributor on September 4th, 2015
Steven Pinker’s recent piece extolling the benefits of CRISPR-centered biomedical research, and decrying the bioethicists who are supposedly in the way, has been widely dissected and debunked. Many objected to Pinker’s inflammatory tone, but that tone was part of a larger rhetorical strategy, one which should be of interest to those of us concerned about cutting-edge biotech and human futures.
As a tenured academic dismissing an entire academic field, Pinker resembles a politician who, in a bid for status within a system, pretends to be outside it. It’s a maverick’s pose: say things shocking enough to go viral, but not shocking enough to disqualify. Like other faux outsiders, Pinker takes a simple approach: sketch a simple, moral narrative, with an obvious problem and an obvious solution; populate it with good guys (researchers who heal) and bad (bioethicists who obstruct); and inject a crude emotional appeal (do you really want your loved ones to die early?). The Internet, duly infected and feverish, keeps you in the news, and the outrage only confirms your outsider status.
In Pinker’s narrative, disability (not distinguished from suffering or disease) is the problem, and biotechnology is the solution. If disability were purely physical, this approach might hold. But if, as scholars in disability studies generally assert, disability is produced by impairment in context, then a technological fix is by definition insufficient; and if disability is not equivalent to suffering, then the get-out-of-the-way approach may not be warranted. Before we charge ahead with fixing something, we need to ask what counts as broken. This does not mean we should not aggressively pursue treatments, or cures, for pancreatic cancer. It does mean that the details matter, and that lumping in cancer, Down syndrome, deafness, and bipolar disorder (for example) into a disability-adjusted global burden of disease, as Pinker does, may not square with the actual experience of human beings.
Pinker’s op-ed presents an extreme case of a pattern familiar from other debates: a frightening or primarily negative view of disability is paired with an overly optimistic view of technology. If disability is scary, then the technology—even, or especially, when it seems extreme—looks more appealing. This pattern is also visible in arguments about “mitochondrial transfer” and advertising for prenatal tests for Down syndrome: unintended consequences are dismissed and great benefits are promised. As a corollary, questions about new technologies are dismissed as emotional—even as an emotional appeal is made for their promises.
These distortions do not serve good policy outcomes. Science is part of society, and in a genuine democracy we would not rush ahead, cowed by promises of cures: we would deliberate. We would distinguish between science and salesmanship, between promising research and patent hopes. We would approach powerful technologies in the spirit of the best science—that is, with a radical uncertainty about their (intentional and unintentional) results, with an acknowledgment that we do not actually know which cures will come, or when, or how, and with an understanding that science is, to paraphrase Jonathan Marks, only one way of knowing things. We would ask whether an ethos that paints disability with such a broad brush can hope to truly serve a democracy where disability is a part of life. And in discussions of emerging technological promises, people with disabilities would serve not as object lessons in suffering, but as participants, as voices to be heard.
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.
Grandiose visions of gene-editing tool CRISPR’s ability to change! revolutionize! transform! the world recently reached a zenith of absurdity in a WIRED cover story titled The Genesis Engine. The article triggered the Twitter hashtag #CRISPRfacts, which for days was devoted to poking fun at the overly optimistic tenor of CRISPR’s press. But the financial world is viewing CRISPR dreams as no laughing matter.
On August 10, Editas Medicine announced that Bill Gates, Google Ventures, Deerfield Management, and other investors have funded CRISPR to the tune of $120 million. In what seems to be a case of self-fulfilling prophecy, the biotech financial press declared that money changes everything, or as one headline put it, “CRISPR: Editas’ $120M proves it isn’t a bunch of hype.”
The $120 million investment takes place amid a CRISPR patent fight between two Editas co-founders: Feng Zhang (Broad Institute) and CRISPR’s celebrated innovator Jennifer Doudna (UC Berkeley) who has since left Editas. It’s the largest round of financing yet for CRISPR, though as Xconomy noted, it’s only a fraction of the private biotech financing record set by Moderna Therapeutics earlier in 2015, when it raised $450 million for messenger RNA drug development.
So there’s a lot going on behind the scenes. Bill Gates and Google, of course, have their hands deep in other pies of sexy research funding including Gates’ backing of Wi-Fi activated birth control (speculated to arrive in 2018) or Calico’s “longevity research.”
One of the striking points of the recent funding announcement is the first condition Editas is targeting, a rare form of genetic blindness called leber congenital amaurosis (LCA) that affects roughly 1,000 people in the United States – well under the 200,000-person number that qualifies as an “orphan disease.” Those 1,000 people may be seeking medical help, and it’s certainly possible that a CRISPR treatment for LCA will turn out to be a step toward treating other diseases. But it’s an important point to consider.
A recent article by Ronald Bayer and Sandro Galea in the New England Journal of Medicine, "Public Health in the Era of Precision Medicine," acknowledges that precision medicine may ultimately make “critical contributions to a narrow set of conditions that are primarily genetically determined.” Yet, they argue, “the challenge we face to improve population health does not involve the frontiers of science and molecular biology. It entails development of the vision and willingness to address certain persistent social realities.”
In that spirit, we may want to ask whether, in this time of unprecedented social and economic inequality, investors and governments are getting hyped into funding marginally relevant treatments for rare conditions rather than allocating adequate funds to tackle problems that systemically impact health status in America: lack of nutrition, lack of housing, lack of basic healthcare access.
We may also reasonably inquire whether $120 million will buy CRISPR researchers and the media a pass on considering the serious ethical, social, and political concerns that CRISPR poses.
Maggie was diagnosed with Stage IV Invasive Ductal Carcinoma, a breast cancer, at the age of 32. Her risk factors were minimal: she was young, healthy, had never had children, and had no family history of cancer. But Maggie had undergone egg retrieval ten times in as many years because, she said, she wanted “to help people.” She now believes that these procedures caused her cancer.
At the time, Maggie was excited to have her eggs “chosen” by an infertile couple. But over the course of the decade, she gradually became “uncomfortable” with the fertility industry. One turning point came when a nurse urged Maggie to demand more money for her eggs, because of “what you’re going through and how many times he [the fertility doctor] has used you and everything he’s gotten from you.” When a second fertility clinic recruited her because of her previous successful egg retrievals, she felt it was a bit odd. She became more suspicious when a fertility clinic discovered a lump in her breast, but then declared it to merely a cyst. Months later, a doctor unaffiliated with the fertility industry diagnosed her Stage IV breast cancer. Looking back, she notes that one of the fertility clinics also excised precancerous cells from her cervix, but didn’t mention the association between hormone treatments and cancer.
Like many other women who provide eggs for other people’s fertility treatments, Maggie didn’t know that long-term studies of the effects of egg extraction are lacking, and that therefore caution should prevail. We do know, however, that short-term risks include ovarian hyperstimulation syndrome (OHSS), with symptoms including abdominal pain, vomiting, and shortness of breath . Other risks include infection, damage to ovaries, infertility, and of course breast, ovarian, or endometrial cancers. Studies about the incidence of these problems have found widely varying rates.
In addition to the disturbing inadequacy of research about egg retrieval, there is also a dearth of regulation of the fertility industry. That fertility clinics performed ten egg retrieval procedures in Maggie’s case is an example of the consequences. While the fertility industry’s own professional organizations – the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technologies (SART) – recommend no more than six cycles of hormonal treatment for IVF and/or egg retrieval, Maggie nonetheless underwent ten.
Is Maggie’s experience an outlier? How many other egg providers have stories similar to hers? How many contract cancer, and how do those rates compare to women who haven’t had their eggs harvested? Until we have better research, tracking, and regulation of egg provision and the fertility industry as a whole, these important questions will remain dangerously unanswered.
Posted by Nathaniel Comfort, Biopolitical Times guest contributor on August 12th, 2015
"Get out of the way." So said the European colonists as they pushed indigenous Africans, Americans, Aborigines, and Maoris off their own lands to make way for Christianity, urbanization, Western medicine, industry, capitalism, railroads, and global warming. And so says Dr. Pinker on behalf of biomedicine, stating what, in his view, should be the "primary moral goal" for bioethics.
"Biomedical research," he writes, "promises vast increases in life, health, and flourishing." To him, ethics is but a horsefly dogging the progress of the potent, muscular thoroughbred of biomedicine—an annoying obstacle bogging down life-saving research in "red tape, moratoria, or threats of prosecution based on nebulous but sweeping principles such as 'dignity,' 'sacredness,' or 'social justice.'" If he and other scientific cheerleaders had their way, not only regulation of medical research but even serious discussion weighing potential harms and benefits would vanish, so that the researchers could get on with their task of saving the world.
Pinker's Panglossian paean notwithstanding, biomedicine, like industrialization, has a mixed legacy. Industrialization has brought improvements in public health and quality of life, reduction of death and suffering, and profound creativity and culture. But it has also led to the destruction of cultures and ecosystems, pollution, and climate change. Further, it has increased some forms of suffering—through, for example, sweatshops, child labor, and occupational disease and injury. Industrialists, too, like to cry "Get out of the way!" to regulators who think beyond the short term.
In support of his argument Pinker invokes nebulous but sweeping principles such as health, flourishing, suffering, disability, harm, and effective treatment—all terms with real but complex meanings that shift with time, context, and geography. A few decades ago, biomedicine considered homosexuality a mental disorder demanding treatment; today such a view is a barbarism. Until the 1970s, deafness was considered a severe disability demanding segregation and rehabilitation; today, the Deaf community has a vibrant and distinctive culture and genetic counselors sometimes help deaf couples increase their chances of having a deaf child.
And of course, the mother of all examples—the root of modern bioethics—is the Nuremberg trials, in which distinguished German physicians were charged with war crimes for carrying out unfettered human experimentation. With all ethical principles pushed out of the way, Nazi doctors were free to subject their "patients" to atrocities, often carefully controlled and carried out according to established principles of the scientific method—but against all norms of humanity.
But one need not Godwin the discussion to find examples of the value of regulation and ethical discussion of biomedical research. When ethicists got in the way, the decades-long Tuskegee study of untreated syphilis was finally halted, in 1972. When the historian Susan Reverby got in the way in 2010, she unearthed evidence of the deliberate infection of Guatemalans with syphilis and gonorrhea in the 1940s. When regulators got in the way in 2000, retroviral gene therapy experiments were temporarily halted, reining in the biomedical cowboys and doubtless saving the lives of patients like Jesse Gelsinger, the teenager who died mysteriously in a routine gene therapy experiment. When ethical discussion got in the way, William Halsted's radical mastectomy procedure for breast cancer—a life-saving, state-of-the-art technique in the early 1900s—was scaled back, preserving much more of the patient's tissue without sacrificing survivorship. When ethical discussion got in the way, the use of sentient animals such as chimpanzees and dogs in vivisection experiments was reduced or eliminated.
There's no denying that biomedicine has brought about many benefits to society. Even if its contributions were limited to antibiotics and anaesthesia, it would be a heroic, potent, and noble discipline. But with great power comes the potential for abuse. Biomedicine's promise for reducing suffering and improving our lives can only be maximized if research takes place in a context of reflection, deliberation, and regulation. Thinking these complex issues through takes time, and impatient researchers may become frustrated at times. Fidget away, Dr. Pinker.
Humanistic debate can help identify potential harm in research practice: critical ethicists and historians deliberately get in harm’s way to spare harm to others. The more powerful biomedicine becomes, the more we need critical discourse to keep its technical advances in humane perspective.
Dorothy Rice Peirce in 1916. Source: Wikimedia Commons
[Forgotten Stories of the Eugenic Age is a blog series exploring the lesser-known ways that eugenics affected and engaged American lives during the first half of the twentieth century.]
The previous installment of this series reviewed the early twentieth-century idea that eugenics could be a tool for selecting a good spouse and building a happy marriage. The optimistic eugenists promoting this approach might not have expected that eugenics could also play a role in the demise of romantic relationships.
Though divorce was difficult and stigmatized in the early 1900s, about 10 to 15 percent of American marriages were legally ended between 1910 and 1925. Judges typically only granted divorces for abandonment, adultery, or abuse. Perhaps because marriages were so often permanent, a woman could sue a man for damages if he ended an engagement to marry. (The reverse was rarely true, since it was considered a woman’s prerogative to change her mind.) Eugenics featured in several “breach of promise” cases because it was a convenient and seemingly moral reason for a man to “cry off.”
In the most high-profile and dramatic of these cases, covered by the Washington Post in 1916, Sigma Ahlgren sued Ward Hall Ream for $10,000 for ending their engagement. Ream had reneged on his promise to marry Ahlgren when her doctor, Lucetta Morden, diagnosed her with tuberculosis, a disease many believed was inheritable. Although Ream affirmed that Ahlgren was a “respectable young woman,” he claimed she didn’t meet his “ideal of a mother.” Ahlgren denied that she was tubercular and argued that she had since obtained two physicians’ certificates indicating that she was “a magnificent specimen of womanhood.” She further declared that she would be willing to “‘prove it in open court,’ if the judge wants her to.” (The Washington Post article notes sardonically, “The judge doesn’t.”)
Ahlgren offered an alternative reason for Dr. Morden’s diagnosis: a nasty love triangle. She accused Morden, Ream’s longtime family friend, of being a “catty” rival for his affections. Morden denied that she harbored romantic feelings for Ream, only admitting to a “friendly interest.” The court hearing eventually fell into disorder, with Ahlgren and Morden sniping at each other about their age and physical appearance.
In a similar breach of promise case, Rose Markewsky brought a $25,000 suit against Charles F. Drucker after he broke off their engagement. Drucker alleged that he ended their engagement when he discovered that Markewsky's brother had tuberculosis. Markewsky refuted this accusation, adding that her brother “is a stronger man than Mr. Drucker.” She continued, “I might have been entitled to break the engagement from a eugenic standpoint, but certainly Drucker was not. I can play better golf and tennis than he can today. I was never ill a day in my life.”
In yet another case, David Arthur Greenhouse of New Jersey ended his engagement with Bertha Schechtel when she told him that she was infertile. Schechtel sued for breach of promise, but the judge found for Greenhouse, declaring that a man had a right to children, children had a right to "a heritage of mental and physical health," and matrimony "concerns the entire human race." The judge said, "A man or a woman is justified in withdrawing from a marriage contract if he finds that his, or her, prospective life partner has a sufficiently serious physical or mental defect.”
If publicly labeling one’s former romantic partner as biologically inadequate appears cruel, perhaps even more striking than the breach of promise cases are the dissolution of eugenic marriages. In 1914, the Washington Post highlighted the story Josephine and Joseph Sanger of Cleveland, each of whom hurried to beat the other to the local courthouse to file for an annulment of their eugenic marriage. In their suits, each alleged that the other had “misrepresented [his or her] physical condition.” Said Mrs. Sanger, “He told me he was a marriageable, healthy man. I found out he wasn’t.”
Yet another eugenic marriage unraveled after only one month. Both Mr. and Mrs. Perron had obtained eugenic health certificates and both had “declared that their mating was in strict accord with scientific principles.” But after only a few weeks of marriage, the groom told police that he had been assaulted by a man whom he had encountered alone with his wife. In her defense, the bride complained that all of the eugenic praise had inflated her husband's ego.
Though all these stories about the termination of eugenic marriages made news, the public was particularly shocked by the divorce of Waldo and Dorothy Rice Peirce.* Waldo was a former Harvard football star, World War I ambulance driver, and rising painter. Dorothy was a millionaire heiress and famous aviatrix who had trained women war pilots. While there is no evidence that Waldo and Dorothy regarded their marriage as a “eugenic” one, many others saw it that way. Waldo and Dorothy seemed like the perfect couple, and in accordance with eugenic principles and eugenists’ promises, their marriage ought to have been a happy one. Nonetheless, the New York Times reported in 1917 that Dorothy filed for divorce from Waldo on grounds of non-support and cruel and abusive treatment.
Newspaper stories grappled with the question of how a relationship between two such perfect—even eugenic—individuals could fail. The December 9, 1917, issue of the San Francisco Chronicle included a full page spread on Dorothy and Waldo’s divorce with photographs of the unhappy couple, entitled “The Sad and Very Imperfect Romance of a Perfect Man and Perfect Woman.” The article stated that when Dorothy and Waldo married in 1912, the public saw it as “the test of a new biological theory—the mating of two perfect persons.” It continued:
The young couple were hailed as the progenitors of a new race: exponents of the theory that only the perfect man and the perfect woman should be allowed to marry. Scientists, surgeons and medical men, educators and ministers, legislators and sociological theorists, witnessed the marriage with great expectancy, hoping it would prove and that the children that should come of it would prove the contention that eugenic principles and not the impulses of the heart should be the foundation of every marriage license.
But now, the perfect man and the perfect woman “declare that perfection, like familiarity, breeds contempt.”
The article attributed to Dorothy the claim that her husband was violent because of his pride in his physical perfection and to Waldo the accusation that Dorothy's bohemian eugenic upbringing, fashioned by her mother to mold her into the "perfect woman," had skewed her marital expectations. Although Waldo had passed the eugenic tests upon which Dorothy's mother had insisted, their marriage had not lasted. How could perfection have gone so wrong?
From our twenty-first century vantage, perhaps a better question is why the public was so surprised, and how twentieth-century Americans so easily accepted eugenic claims about perfection. It seems fairly obvious that expectations of flawlessness are rarely met by fallible people in a complicated world. And a close look at the intricate social effects of historical eugenics reveals that just as the label of "defective" can do harm—in the cases of individuals sterilized and institutionalized, or, more simply, in promises broken—so can the label of "perfection." Treating individuals not as complex human beings with intrinsic worth but as gradations on some arbitrary "quality" scale not only hurts those who do not rate highly, but places unrealistic expectations on those who do. The greater the external pressures for perfection, the more profound the sorrow, disappointment, and shame when we inevitably fall short. This pain is even more acute when the pressures emanate from those who have promised to love us.
After Dorothy Peirce's marriage ended, her "heartbroken" mother said, "I had hoped my daughter would be honored in all future histories of the world as the creator of the perfect race. I am sorry she could not become more than a mere wife—and an unhappy one at that.”
For her part, Dorothy pledged, "I want no more perfect men. My next husband will have been examined most carefully before we approach the altar, not for perfection, but for signs of the faults that will make him human.”
*Some sources incorrectly spell their surname as "Pierce."
1. “Aviatrix Seeks Divorce.” New York Times, Oct. 16, 1917.
2. “Eugenics and Law in Charge to Jury.” New York Times, Dec. 18, 1914.
3. “Eugenics Breach of Promise Suit Due to ‘Catty’ Rival, Declares Girl.” Washington Post, Feb. 27, 1916.
4. “Eugenic Bride Packs Up Her Belongings.” Boston Daily Globe, Jul. 29, 1913.
5. “Failure in Eugenics." Washington Post, Aug. 24, 1913.
6. “Girl Says Eugenics Broke Troth, Sues Man.” St. Louis Post-Dispatch, Aug. 29, 1913.
7. “History in the Making: First Eugenic Marriage Is Failure.” San Francisco Chronicle, Aug. 17, 1913.
8. “Jilted by Eugenic Wooer.” Washington Post, Feb. 26, 1916.
9. Jones, Audra M. “Historical Divorce Rate Statistics.” Accessed August 5, 2015. http://divorce.lovetoknow.com/Historical_Divorce_Rate_Statistics.
10. “The Sad and Very Imperfect Romance of a Perfect Man and Perfect Woman.” San Francisco Chronicle, Dec. 9, 1917.
Posted by George Estreich, Biopolitical Times guest contributor on August 3rd, 2015
[This essay has many spoilers.]
Ex Machina, the new film directed by Alex Garland, begins with a young coder in front of a screen (Caleb Smith, played by Domnhall Gleeson). He receives an email: he's won a corporate lottery. He texts a friend: I won. Instant congratulations follow, online and in the casual, open-floor plan office, where co-workers applaud. He looks happy and dazed. In short order, he's being chauffeured by helicopter over the National Park-sized estate of the corporation’s founder, whom Caleb will get to meet, in a week-long, coder’s dream vacation.
The office scene is as loaded as it is brief. In it, we see Caleb as if from a webcam. Colored light flickers at the edges of his face and in his eyes; a grid appears against his face’s contours. The camera’s perspective suggests that he’s being surveilled--as it turns out, he is—but also, more disturbingly, that he is himself synthetic, that coder and hardware share more than proximity. He almost flickers from within. The same effect recurs later in the movie, when Caleb—thoroughly disoriented by the events soon to come—slices his arm open to see if he is human, smears blood on a bathroom mirror, then punches the mirror with his fist. It’s a seconds-long drama of identity, embodiment, and surveillance, and just as in the opening scene, we see him as if through the mirror, which conceals a camera.
In both scenes, the camera angle implicates the audience. Seeing Caleb voyeuristically, on a screen, we assume the point of view of an unseen watcher. The movie is a black mirror, a screen and a window at once, showing us our world as it shows us ourselves. It’s set in the present, not the future; and its true subject, despite its dazzling special effects, is less the technology to come than the technology around us now.
Other tweets included graphics which poked fun at CRISPR content:
For those of us with deep social and political concerns about CRISPR –
especially about proposals to use it to create genetically modified
human beings, which the WIRED article discusses – the Twitter
wave was double-edged. It was great to see the hype bubble pierced,
but a little worrisome that few of the tweets acknowledged any problem
with CRISPR beyond the hype. Here are some of our efforts in that
direction from our twitter, @C_G_S:
The fun finally petered out a couple days later, after more than 1,500 tweets and memes. However, the challenges posed by germline gene editing, of course, remain.
Notwithstanding its overwrought headline and cover, the WIRED article provides a decent overview of the CRISPR controversy. Sure, it fails to mention some key policy aspects of the situation, like the widespread international agreement that editing the human germline should be legally off-limits – and already is in more than 40 nations.
But its bottom-line message about CRISPR and the human germline seems appropriate both in fact and in tone – and it’s nothing to joke about:
"Engineered humans are a ways off—but nobody thinks they’re science fiction anymore."
At first glance, the embryo-screening technique known as preimplantation genetic diagnosis (PGD) and the confederate flag seem to have little in common. But as a twelve-year old article by bioethicist and disability studies pioneer Adrienne Asch reminded me, both carry symbolic power as indicators of societal hierarchies and perceived human value.
PGD is used with in vitro fertilization to test eight-cell embryos for “serious” diseases like cystic fibrosis, Down syndrome, and Tay-Sachs disease before transferring them into a patient’s uterus. It’s also used to create “savior siblings” and to produce children of the sex that parents prefer. And one fertility clinic briefly offered it to control for cosmetic traits like skin complexion, hair color, and eye color.
The confederate flag – a lightning rod of debate following a Supreme Court ruling and the Charleston massacre – is viewed by some as a symbol of Southern pride and heritage and by others (a view with which I agree) as a symbol of a racist oppression, a relic that demonstrates that a cruel and painful history is alive and well.
The ongoing debate about both PGD and the confederate flag often positions intent as the sole arbiter of meaning. In other words, if I raise the confederate flag because I strongly believe in states’ rights, does the flag still serve as a symbol of racism? (This argument of course ignores the fact that the history of states’ rights is so deeply marred by racism that the two cannot be disentangled.) Or, if I opt not to implant an embryo because PGD reveals a high likelihood that the fetus would develop Down syndrome, can I simultaneously claim to believe that people with disabilities are entitled to lives as full and equal members of society? Do egalitarian beliefs about race or (dis)ability mitigate the flag or testing’s symbolic power?
But these questions, which frame the controversy as one about individual choice and intent, miss the mark. People and their decisions do not exist in a vacuum. The “Stars and Bars” cannot be removed from its history as the emblem for a region that fought to uphold a slave society, and which was later resurrected to signal opposition to civil rights. Similarly, prenatal testing in its various forms is a technology that identifies disability and disease – with an inherently blurred line between them – so that a pregnancy can be terminated.
Intent and expectations are thus embroiled in a racist and ableist context. In Asch’s words:
The flying Confederate flag tells people historically victimized by racist discrimination that racism and the history of racism is and was acceptable; enumerating a set of testable genetic diseases tells people who currently have those conditions that it would be better if prospective parents went to considerable lengths to prevent the births of children with those conditions.
In other words, the complex, symbolic, historically-constructed meanings of the confederate flag and prenatal testing cannot be removed from the practice.
First-person accounts from Panama Jackson, a Black writer who has lived in Alabama and Georgia, and Marsha Saxton, a disability studies scholar, are telling. Jackson recalls that his high school friends would wear t-shirts emblazoned with the flag without meaning to offend him; they would politely carry on small talk and yet the flag:
Was there as a constant reminder that you’ve come only so far … there’s no way to get around that its use has now and will always be tied to white supremacists insistence on reminding Black folks to stay in line.
Jackson elaborated that the flag serves as a reminder that “progress comes with stipulations,” and that it displays – in t-shirt, bumper sticker, or belt buckle form – how much progress remains to be achieved.
In a similar way, the rights of people with disabilities have no doubt expanded since the start of the disabilities rights movement, but there’s a long way to go. Saxton notes that genetic testing reinforces the medical model of disability, which unequivocally views disabilities as conditions to be avoided at all costs. Saxton and other disability rights advocates point out, however, that the impairments the medical model finds strictly in biology are at least in part products of a society that stigmatizes physical differences and often resists accommodating them.
Prenatal and pre-implantation testing has become more and more routinized, and increasingly framed as the responsible and logical choice for parents wishing to give their future child(ren) the best possible chances in life. Saxton explains that “these technologies make us [people with disabilities] feel devalued as human beings.” What is more, genetic testing relays the message that “it is better not to exist than to have a disability … your family and the world would be better off without you alive.” With that being said, while abortion ought to be an individual decision that remains protected, it is impossible to separate that decision from a larger social context in which, as Saxton contends, people with disabilities are devalued.
Both the confederate flag and genetic testing, implicitly (or arguably not-so-implicitly) devalue the existence of certain populations who by no coincidence have experienced vast historical marginalization. That is, these are problems about systems of oppression. The #BlackLivesMatter movement reminds us that “black lives exist in at state of precariousness.” Racism, and anti-Black racism in particular, is not sewn only into a flag but into our culture, laws, history, geography, language, and criminal justice system.
Likewise, society’s devaluation of people with disabilities can be located in all of those same places, which might well be thought of as repositories for social norms and expectations. Again, this demonstrates why straightforward concepts like “choice” and “intent” are insufficient to capture the full extent of what is at stake in these debates.
Nathaniel Comfort – author of The Science of Human Perfectionand recent guest on Talking Biopolitics with fellow eugenics historian Alexandra Minna Stern – writes about enthusiasts who advocate using new genetic engineering techniques to attempt to alter the traits passed on to future generations, a practice called human germline modification. Some public personae embrace the term “liberal eugenics” and argue that a “free-market environment with real individual choice” is the best way to protect us from repeating past eugenic abuses. But, as Comfort warns, “liberal eugenics is really neoliberal eugenics.” And the invisible hand of the market isn’t pulling back on the reins of technological progress anytime soon.
In countries outside the U.S. with a more honest memory of state-controlled human betterment projects, there is no beating around the bush of what’s at stake. In addition to the history of public outcry that Comfort recounts, there has been an international consensus for decades that engineering the human germline is off-limits. More than 40 nations have passed legislation to ban it outright—including nearly all nations with developed biotech sectors except for the United States. The United Nations has declared the human genome the “heritage of humanity” which ought to be protected and transmitted to future generations—without markups and edits. And UNESCO’s International Bioethics Committee has stated that justice demands we do not interfere with the biology of future humans based on the “particular conceptions of ‘good’ and ‘bad’ human traits” of our time.
The debate about CRISPR gene editing is currently dominated by discussion of whether it would be “safe” to edit human embryos, a fixation that serves to downplay the historical, social, and political contexts that Comfort so richly describes. While CRISPR and related techniques can also be used as “gene therapy” to help people who are sick, the argument that gene-editing human embryos is a necessary medical treatment is tenuous: Couples concerned about passing on serious genetic diseases can use pre-implantation genetic diagnosis to screen embryos—and although this technology also raises eugenic concerns, it does not pose the same biological and societal threats as does the genetic manipulation of the human germline.
When he moves from history to current politics, Comfort explores the ways in which the issue of human germline gene editing can scramble political allegiances, precisely because of the larger motivators—private interests and social inequality—that a system wed to neoliberal individualism is failing to address. In an age where personal choice can easily obscure the impact of our self-interested decisions on others, developments in human biotechnology present many ways to stumble. Comfort concludes:
In short, neoliberal eugenics is the same old eugenics we’ve always known. When it comes to controlling our evolution, individualism and choice point toward the same outcomes as authoritarian collectivism: a genetically stratified society resistant to social change—one that places the blame for society’s ills on individuals rather than corporations or the government.
I’ll be excited to watch the workaday applications of techniques like CRISPR unfold, in medicine and, especially, basic science. But sexy debates over whether reproductive biotechnology will permit us to control our genetic evolution merely divert us from the cultural evolution that we must undertake in order to see meaningful improvement in human lives.
[Forgotten Stories of the Eugenic Age is a blog series exploring the lesser-known ways that eugenics affected and engaged American lives during the first half of the twentieth century.]
For American women in the early twentieth century, marriage was a dangerous affair.
Upon her marriage, a woman’s civic and social identity became subsumed in her husband’s. A wife was expected to be subservient in the home and in the marital bed. If a husband became abusive, indifferent, or otherwise lackluster, she had little recourse. Divorces were rare, difficult to obtain, and stigmatized.
Even if a woman could obtain a divorce on grounds of cruelty or adultery, separation was often impractical. Few women worked after marriage and even fewer after having children, leaving most financially dependent on their husbands. To make matters worse, judges in divorce cases typically awarded custody of children to their fathers. Sexually transmitted diseases were rampant, alcoholism was epidemic, and even discussion of these serious matters—especially in regards to their impact on women—was considered uncouth. For all these reasons, a woman’s choice of spouse was likely to be one of the most important determinants of her lifelong happiness.
But broad social changes were afoot. The middle-class “True Woman” of the Victorian Era—passive, pious, frail, and domestic—was facing challenges from the Progressive Era “New Woman”—passionate, opinionated, independent, and well-educated. The New Woman studied in university, worked before marriage and occasionally after, and didn’t hesitate to tackle some of the more difficult and uncomfortable marital and reproductive matters of the time.
In this context, the field of eugenics emerged as a lens through which white middle-class women could more deeply examine these issues and solve the “marriage problem.” As a 1909 Current Literature article declared, “Marriage is, essentially, a science.” And indeed, eugenists advised women to learn all they could about the scientific basis of marriage, and then put the facts into practice in life’s laboratory. If women carefully studied eugenics, they could determine with the greatest accuracy which man to marry to ensure a happy future.
Eugenists argued that the negative traits men could display after marriage, such as alcoholism, promiscuity, feeble-mindedness, and cruelty, all had a hereditary basis. Furthermore, claimed Dr. Woods Hutchinson, Clinical Professor of Medicine at New York Polyclinic, these traits were not limited to "the communities of chicken thieves [and] feudists who fight and inbreed among themselves and live like animals," but could also be found "on the roof of society, among the idle and mentally weak." Since any man regardless of class status or outward appearance could have hereditary defects invisible to the untrained eye, middle-class women hoping for a happy marriage had to be vigilant to protect themselves.
Here, eugenists combined an insistence on the hereditary nature of most undesirable traits with a healthy scorn for the traditional practice of shielding middle-class women from some uncomfortable truths about sex and married life. Dr. Anna Blount, one of the most well-known women eugenists, warned that eugenically inferior men were more likely to contract devastating venereal diseases—euphemistically called “red light diseases” or “social diseases”—that they would then pass on to their wives and subsequent children. Even "modern novelists," Blount wrote, are unable to convey the misery of "the blooming bride transformed in a few short months to the querulous invalid, or returning from the surgical operation at the hospital with the best of life and hope gone." Blount further cautioned that cruelty and the propensity for wife desertion were hereditary. Women needed to educate themselves about eugenics to safeguard against marriage to such men.
Dr. Norman Barnesby counseled that alcoholism was either a symptom or a cause of natural inferiority. Women may idealize marring an alcoholic man to reform him, but these innately hopeless causes would produce a "wrecked life and a dreary home." With statements like these, eugenists warned women that despite their hopes that the men they marry will abandon their damaging habits, love cannot eliminate inborn qualities.
Along with developing awareness of eugenic principles, eugenists emphasized that women could undertake special eugenic training to help identify signs of insidious degeneracy in prospective marriage partners. Professor Dean Inge of Cambridge University and the Eugenics Education Society claimed that without eugenic knowledge, women might find themselves drawn simply to a man's "fine and strong physique," despite lack of adequate information about his health. But the development of a "scientific eye" could help them avoid these womanly pitfalls.
Virginia Hinkins, who taught eugenics at Indiana University's YWCA, provided some concrete love-interest examination tools. When gazing deeply into a lover's eyes, she advised, women should not look for the "yearning, burning, soulful fires, which rage in the erotic litany of love," but for symptoms of eye disease. She continued, "His heart, to beat true, must pump seventy-two to the minute, and his sighs should rest under suspicion as indicating a liverish and morbid disposition." Eugenists also pressed for local and state governments to adopt laws requiring men and women hoping to marry to first present a eugenic health certificate signed by a physician indicating that they were fit to wed.
If these suggestions appear to strike a blow to romance, eugenists certainly didn't think so. Dr. Elizabeth Hamilton-Muncie asserted that eugenists wanted love to be essential for marriage but also desired that couples love "with their eyes open and brains active." Learning about eugenics would enable women to pursue romantic relationships with a healthy dose of common sense, contributing to a more informed, and thus purer, love. Notable British eugenist and sexologist Havelock Ellis wrote that marriage between two young healthy “wholesome wooers” in love was more likely to benefit the race than a money marriage between a young woman and a sick, elderly man. Love marriages were often eugenic by nature compared with marriages for money, social status, or simple convenience because love required people to find worthy characteristics in one another.
Some newspapers bolstered this connection between eugenics, love, and marriage with profiles of “eugenic” weddings. These weddings typically occurred between wealthy, well-educated, and socially prominent men and women who were vocal about their support for eugenics and their conviction that their marriage conformed to eugenic ideals. Along with the usual details about the bride’s family, the groom’s occupation, and the honeymoon destination, these flattering profiles frequently described the couple’s physical qualifications and eugenic credentials.
One such eugenic wedding occurred between Leo B. de Lano—quite the renaissance man as an "athlete, aquatic hero, temperance advocate, hat salesman, USC graduate, adventurer, and extremist”—and Betty Wehrle, "about as pretty a girl as ever posed for an artist." A Los Angeles Times article noted that de Lano was 5 feet 10 inches tall and 175 pounds, Wehrle was 5 feet 4 inches tall and 110 pounds, and both were “perfect blondes” who were “practically perfect physically,” as evidenced by the eugenic health exams to which they had submitted before agreeing to wed.
The previously cited Virginia Hinkins, who herself had a eugenic wedding, said that eugenic marriages were born out of “a normal desire to know the standing of a life partner, the only human insurance we can get for permanent love and happy married life." At a time when women’s life options significantly diminished after marriage, some middle-class women turned to eugenics in fervent hope that this “science” could assist them in making the best possible marital choice. In a way, focusing on scientific selection of a spouse was a way to avoid addressing the serious issues women faced once they were married. Eugenics provided assurance that women could identify a good husband, and that happiness would naturally follow.
Yet women’s interest in eugenics during this period also indicates their concerted effort to grapple with the difficulties and dissatisfactions of marriage and to claim greater control over their lives. It is poignant that in the early twentieth century, marrying eugenically appeared more attainable than social reforms to expand married women’s economic and legal options and to reduce the stigma of domestic abuse.
1. Barnesby, Norma. "Eugenics and the Child." Forum (Mar. 1913): 341.
2. Blount, Anna. "Effect of Divorce on the Next Generation." San Francisco Chronicle, Jan. 28, 1917.
3. Blount, Anna. "What Marriage Health Test Bill Means If It Becomes Law." San Francisco Chronicle, Mar. 18, 1917.
4. Dicker, Rory. A History of U.S. Feminisms. Berkeley, CA: Seal Press, 2008.
5. Ellis, Havelock. "Why First Love Is Always Wrong." Chicago Daily Tribune, Nov. 24, 1912.
6. "Eugenic Wedding to Begin the New Year." Los Angeles Times, Jan. 01, 1914.
7. "The Future of Love-Making in the Light of Science." Current Literature OL. XLI, (Jul. 1906): 97.
8. "Marriage As the Youngest of the Sciences." Current Literature OL. XLVI., (May 1909): 561.
9. "Real Eugenic Marriage." Los Angeles Times, Dec. 31, 1913.
10. Schneider, Dorothy and Carl J. Schneider. American Women in the Progressive Era, 1900–1920. New York: Facts on File, 1993.
11. "'Science First' in This Wooing." Chicago Daily Tribune, Oct. 25, 1915.
12. "Science in Marriage: Knowledge of Eugenics Would Prevent Unwise Unions." Washington Post, Mar. 20, 1910.
13. "Won't Banish Cupid: Dr. Elizabeth Muncie Defends the Purpose of Eugenics." Washington Post, Jul. 07, 1914.
14. "Would Check Birth of All Defectives." New York Times, Sep. 21, 1912.
On June 26, the U.S. Supreme Court ruled in a widely celebrated decision that all 50 states must issue marriage licenses to couples regardless of their sexual orientation, likely ending an era of patchwork marriage rights for same-sex couples in the United States.
In a same-day op-ed for the Los Angeles Times, Douglas NeJaime, law professor and faculty director of the Williams Institute at UCLA, argues that “equality for gay families” has not been delivered with marriage. To ensure family dignity for gays and lesbians, says NeJaime, the next step is removing legal barriers to surrogacy. By failing to embrace commercial surrogacy, NeJaime continues, states will be effectively limiting the definition of family to heterosexual couples who can bear their own children.
For many decades leading up to present day, a number of discriminatory state laws have specifically excluded LGBTQ people from adoption and parental rights. This history is heart-breaking. Lesbian, gay, and transgender parents have been deemed “unfit” for being “antisocial,” “mentally ill,” and lacking in the moral fiber of “traditional family values” required to raise an upstanding citizen. These parents have fought for the dignity of their families, in schools, hospitals, social gatherings, churches, and too often, in unsympathetic courtrooms. With the victory of marriage equality, there are pressing issues for LGBTQ rights that extend way beyond weddings—as NeJaime suggests. Yet looking to the same principles of justice and equality that the marriage decision represents, we should proceed with caution and not move to an uncritical acceptance of the commercial surrogacy industry in this moment of hope and change.
Assistive reproductive technologies (ART) have helped many couples facing fertility barriers to start families. As NeJaime explains, lesbian couples can make use of commercially available sperm, in vitro fertilization, and fertility treatments for the partner who carries the child, while gay couples can turn to commercially available eggs and gestational surrogates. Yet the ART industry is highly unregulated, with a throng of unresolved issues including the safety of women and children, informed consent, privacy versus access to information, economic access, and marketing standards.
Additional problems surface when we turn our attention to those who provide wombs or gametes— especially eggs—in assisted reproduction, and to the children who result from these arrangements. Too often in commercial surrogacy, the desires of intended parents overshadow the health, rights, and well-being of those other people: the woman who provides her eggs, the woman who gestates and delivers the baby, and even the longed-for baby.
Women who sell their eggs to clinics, often for use as anonymous “donors,” are required to undergo drug treatments to increase ovulation that can have serious impacts on their health. Women who work as surrogates, especially in countries other than the US, often enter into contracts where the intended parents pay for both the attorney and the healthcare providers—raising concerns about compromises to the surrogate’s health and rights. A growing number of children conceived with third-party gametes and gestated by surrogates are realizing that they want to know about and perhaps to meet the people who contributed to their birth.
These and other unanswered questions hover around commercial surrogacy. And we already know that some of these ongoing practices are clearly harmful to women who bear children for others. Shouldn’t affronts to their human dignity be among those for which we fight? As we celebrate marriage equality and acceptance, we must also ensure that the voices of everyone participating in the creation of non-traditional families are heard, and that their rights are recognized and protected.
The debate about heritable human genetic modification continues, with opinions ranging from enthusiasm to dismay, and strong arguments for political as well as scientific involvement. Among the notable contributions in the last few weeks are the following.
Jacob Corn, Scientific Director of the Innovative Genomics Initiative (IGI), which is “dedicated to the enhancement and proliferation of genome editing research and technology in both the academic and commercial research communities” in the San Francisco Bay Area wrote a blog post (July 6) that stated categorically:
At this time, the IGI Lab will not do research on human germline editing for several reasons, including: 1. The IGI Lab is focusing on diseases for which somatic (non-heritable) editing would be a transformative advance. … 2. Cas9 technology is currently too nascent for me to consider germline editing wise. …
Corn was an organizer of the Napa meeting that led to the call in Science for a moratorium. CRISPR pioneer Jennifer Doudna is IGI’s Executive Director. Critics may point to the phrase “at this time” as a wiggle or loophole, but he is specifying a moratorium even on research, not just applications. We may not see any stronger statements from major researchers in the field ahead of the National Academies meeting, which Corn says is slated for October.
Daniel Sarewitz, co-director and co-founder of the Consortium for Science, Policy, and Outcomes at Arizona State University, made the important point in Nature (June 23) that weighing up the benefits and risks of gene editing and artificial intelligence is a political endeavour, not an academic one: "Science can’t solve it.”
Also in Nature (June 24), science and technology studies scholar Charis Thompson deplored the simplistically gendered nature of much of the discussion and urged a balanced approach aiming for “better science and better ethics.”
Republican members of the U.S. House of Representatives have started to weigh in, via the appropriations process. That could be a worrying sign of political polarization. But on the Democratic side, Rep. Bill Foster, who describes himself (accurately) as “the last scientist with a Ph.D. remaining in Congress,” has also expressed serious concern. Writing in The Hill, he issued a warning about the implications of fundamentally changing the course of human evolution:
We are on the verge of a technological breakthrough that could change the future of humankind; we must not blindly charge ahead. Now is the time to engage in serious and thoughtful discussion about what this means for the future of the human race.
Another commentary, by Craig Holdrege at the Nature Institute, discussed (June 22) “unforeseen effects” and unintended consequences, and strongly endorsed MIT and Whitehead Institute geneticist Rudolph Jaenisch’s view that “it is unacceptable to mutate normal embryos. For me, that means there is no application [of this technique in human embryos].”
By contrast, Henry Miller of the Hoover Institution at Stanford, a right-wing think tank, has no doubts, publishing a letter in Science (June 19) under the provocative title:
Germline gene therapy: We're ready
In passing, Miller accuses Baltimore et al.—the authors of the call for a moratorium in Science—of “apparent nostalgia” for Asilomar, which he regards as a failure because it “exaggerated the potential risks of recombinant DNA technology,” among other things.
There were also some relatively unhelpful pieces in the press. Newsweek published one (June 30) that conflated the upcoming Institute of Medicine report on “3-person IVF” with gene editing, and contained the confused line: “Embryo editing could allow a mother to replace faulty genes with genes from a different woman.”
An article in The New York Times (June 29) suggested that germline intervention was entirely unproblematic unless used “to change such traits as eye color or intelligence”; implied that only Chinese scientists were working on applying gene-editing technology in this way; and seemed to hint that Chinese researchers have weaker ethical constraints and standards than Americans do.
Much better was the Natureeditorial (July 1) noting that
the culture wars … are a reality that all must face — and that is a good thing. … As public awareness of the technology increases, that ethical discussion will rightly be taken out of [academic] hands alone and planted firmly in those of broader society.
Finally, Pew Research released (July 1) the results of a science-related public opinion poll conducted in August 2014. The public was split over “changing a baby's genetic characteristics to reduce the risk of serious diseases,” with 50% saying that was “taking medical advances too far,” while 46% considered it appropriate. (Young male liberals tended to be in favor, and the respondents were not informed about already existing medical alternatives to germline manipulation.) However, 83% thought that “changing a baby's genetic characteristics to make the baby more intelligent” was going too far.
A bipartisan bill introduced in the Senate on June 25 would give a financial break to people in North Carolina and Virginia who were sterilized under those state’s official eugenics programs, and who are now hoping to receive compensatory payments that have been established by their state legislatures. 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.
Senate Bill 1698 would exclude payments from current or future state eugenics compensation programs from consideration in determining eligibility for Federal benefits including Medicaid, Supplemental Nutritional Assistance Program, Supplemental Security Income, and Social Security Disability Insurance. It was introduced by Senator Thom Tillis (R-NC), who was joined by Senators Mark Warner (D-VA), Tim Kaine (D-VA), Tom Carper (D-DE), and Richard Burr (R-NC). On July 8, Congressman Patrick McHenry (R, NC-10) and Congressman G. K. Butterfield (D, NC-01) introduced companion bill H.R. 2949, the “Treatment of Certain Payments in Eugenics Compensation Act,” in the House of Representatives.
Between 1907 and 1977, 33 states passed laws authorizing eugenic sterilization of various categories of people (including “criminals,” the “mentally ill,” and the “feeble minded”). Populations most often targeted by the eugenics programs were unmarried women, African-Americans, and poor children.
Only two states have issued plans for reparation through monetary compensation. North Carolina became the first to enact legislation to compensate living victims of forced sterilization laws in 2013, setting aside a $10 million compensation fund. Following North Carolina’s example, Virginia passed similar legislation in 2015. While North Carolina identified 220 living sterilization survivors; Virginia has identified only twelve so far. Virginia will award $25,000 to each involuntarily sterilized person who was alive as of February 1, 2015.
Unfortunately, many North Carolinians and Virginians who were sterilized against their will do not qualify for reparations, and thus would receive no benefits from the newly introduced federal legislation. The states’ current compensation laws say that to be eligible for compensation, the sterilization operation must have occurred under the state's Eugenics Board. However, judges, local health officials, and social service workers were also permitting and arranging sterilizations, as in the case of Debra Blackmon.
In a short video about the bill, Senator Tillis encourages “other states to follow North Carolina’s lead, as Virginia has recently done, to right this wrong in our nation’s history.”
Fitter Family contest medal, awarded by the American Eugenics Society, 1920s.
Source: Center for Genetics and Society
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Forgotten Stories of the Eugenic Age is a blog series exploring the lesser-known ways that eugenics affected and engaged American lives during the first half of the twentieth century.
Eugenics became a popular ideology in the United States beginning in the second decade of the twentieth century. Concerned with producing a stronger and fitter population through the careful and often coercive control of reproductive behavior, eugenics captured the attention of a citizenry eager to use science to solve its social problems.
Many scholars divide the early eugenics movement into two branches: “positive” and “negative” eugenics. Positive eugenics was the encouragement of reproduction for those believed to be of superior hereditary stock, in contrast to “negative” eugenics, the discouragement or prevention of reproduction for those deemed hereditarily “unfit.” Many eugenists, as eugenic advocates were known, believed that the goals of positive eugenics could be achieved voluntarily through education campaigns, while negative eugenic aims would require more coercive means for attainment, such as mass sterilization and immigration quotas.
Baby health contests at agricultural and state fairs perhaps most vividly exemplify popular campaigns for positive eugenics. Judges at these contests examined infant contestants according to a set of criteria for physical health and intelligence that included factors such as shape of the head, width between the eyes, condition of tonsils, strength of spine, and ability to walk or crawl. They quite tellingly employed scorecards derived from those used to judge livestock. First begun in 1908 at the Louisiana State Fair, baby health contests spread to forty states within just a few years.
However, somewhere along the eugenic line, "Better Baby" contests, as they were known, morphed into "Fitter Family" contests that examined not only the baby but the whole family. Scholars have attributed this change to a shift in focus from the health and development of the child towards a more comprehensive look at hereditary history, in keeping with the principles of eugenics. But how exactly did this change transpire?
Mary T. Watts, co-founder of the Better Baby contests, revealed the impetus for the transformation in an address at the Thirty-third Annual Meeting of the International Association of Fairs and Expositions in 1923.
As Watts recounted, shortly after she began the Better Baby contests in her home state of Iowa, she received a letter in the mail from none other than Charles B. Davenport, a titan of the eugenics field. Davenport wielded significant influence as the director of the Biological Laboratory at Cold Spring Harbor, the Eugenics Record Office, and the Carnegie Institute of Washington’s Station for Experimental Evolution.
On a one-cent postcard, Davenport had written only, “You should give 50 per cent to heredity before you begin to score a baby.” Overwhelmed by answering inquiries from intended Better Baby organizers across the United States and Canada, Watts placed the letter aside and forgot about it.
The following year, she received yet another terse postcard from Davenport with the single ominous sentence, “A prize winner at two may be an epileptic at ten.” Watts, who had since become aware of Davenport’s authority in eugenics, understandably found the postcard “so startling it could not be ignored.”
Watts shared Davenport’s letter with her Better Baby co-founder, Dr. Florence Sherbon, who noted that many prize-winning babies likely had alcoholic fathers, diseased mothers, or insane relatives. Perhaps Davenport was on the right track; rather than examining babies alone, in order to truly test for eugenic ideals, judges must look to a baby’s family as well. How else could they tell if a baby was “better”?
Watts and Sherbon decided that they wanted to insert family and heredity tests into the contests, but were concerned that doing so would eliminate their popular appeal. It took the pair six years to develop a satisfactory approach. They presented their plan for Fitter Family contests to a group of experts who offered a mixed response.
The experts universally approved of the reasoning behind the new plan, but felt that Fitter Families would not be able to replicate the smashing success of Better Babies. Watts recalled that the experts said, “You can bring the baby to the fair because he cannot help himself, but you will never get the fathers and mothers to a fair for physical and mental examinations.” The experts were especially concerned that adults would not submit to the Wassermann test for syphilis, presumably because some would not want their spouses to discover the results.
Nonetheless, the experts assisted in making a scorecard to judge not only the babies’ physical and mental qualifications, but also those of their parents and siblings. All were shocked when twenty families entered the first Fitter Family contest at the Kansas Free Fair in 1920. The Fitter Family contest organizers continued their newfound relationship with Davenport well into the 1920s, as Sherbon and Watts sought his advice on their family history forms and contest procedures.
Critics of the Fitter Family plan had said that “we could never hope to interest educated, self-respecting families in physical examinations for adults at a fair ground.” But, Watts stated proudly in her 1923 address, the Fitter Family contests were thriving. And the organizers and contestants—as well as the eugenic cause—could thank Charles Davenport, whose postcards had provided the spark that lit the fire.
1. Lovett, Laura L. “‘Fitter Families for Future Firesides’: Florence Sherbon and Popular Eugenics.” The Public Historian 29, no. 3 (Summer 2007): 69–85. JSTOR.
2. Selden, Steven. “Transforming Better Babies Into Fitter Families: Archival Resources and the History of the American Eugenics Movement, 1908–1930.” Proceedings of the American Philosophical Society 149, no. 2 (June 2005): 199. EBSCO host.
3. Watts, Mary. "Fitter Families for Future Firesides." Billboard 35, no. 50 (Dec. 15, 1923): 230–231. ProQuest.
Changes are in the works here at the Center for Genetics and Society, both on our staff and our Advisory Board.
On the staff side, Jessica Cussins will be leaving her position at CGS at the end of the month, and starting a Master’s program in public policy this fall at the Harvard Kennedy School. Jessica started at CGS in 2012 as a summer staff associate, and quickly grew to be a key and deeply valued member of our team. As readers of Biopolitical Times know well, she is an insightful analyst and compelling writer about all things biopolitical. We’ve also benefited greatly from her research and policy analysis skills (is there anyone who knows more than Jessica about the unfortunate push for approval of “three-person IVF” in the UK?). We’ll greatly miss Jessica’s day-to-day presence in the office, but are very glad that she plans to stay connected, doing some writing and researching for CGS in a consulting role. And we’re thrilled about the exciting new adventures that await her.
CGS’s Advisory Board plays a vital and much appreciated role in our organizational strategizing, development and culture. We recently welcomed a wonderful new member, Alexandra Minna Stern. Alex is a historian of science and medicine and Professor in the Departments of Obstetrics and Gynecology, American Culture, and History at the University of Michigan. Her research and public scholarship has focused on the history of eugenics and the uses and misuses of genetics in the United States and Latin America. She is the author most recently, of Telling Genes: The Story of Genetic Counseling in America (Johns Hopkins University Press, 2012), and the award-wining Eugenic Nation: Faults and Frontiers of Better Breeding in Modern America (University of California Press, 2005). A new edition of Eugenic Nation will be published in December 2015; the publisher describes it as “radically new and relevant,” connecting “the eugenic past to the genomic present with attention to the ethical and social implications of emerging genetic technologies.”
Back in the office, we’re fortunate to be joined this summer by two terrific staff associates, Jonathan Chernogouz and Natalie Oveyssi. Jonathan is with us full time until he begins his junior year at UC Berkeley majoring in political economy and minoring in public policy. He has been working at CGS part time since he was a sophomore, and has been interested in the history of eugenics since learning about the movement in high school. Natalie, who will be working part time, graduated summa cum laude from UC Berkeley in spring 2015 with a B.A. in Sociology. She served for two years as editor-in-chief of UC Berkeley's undergraduate humanities and social science research journal, and was awarded highest honors for her thesis on women's empowerment and the early twentieth-century American eugenics movement.
We expect to have more news to share shortly about new staff. Stay tuned!
Discussion of germline genetic modification continues, most recently in the House of Representatives Research and Technology Subcommittee, Committee on Science, Space, and Technology. The Subcommittee's June 16 hearing gives this post its title. Video is available, as are pdfs of the four witness statements.
Victor J. Dzau, President of the Institute of Medicine (soon to be the National Academy of Medicine) outlined the plans for the Academies Initiative. There will be two parts to this:
a global summit to examine recent scientific developments in human gene editing and the range of associated ethical and governance issues
a concurrent expert committee to conduct a comprehensive study on human gene-editing research
The exact date of the global summit, which will be held in "late fall," has not yet been announced, and the study, which may take a year, does not yet have a final "statement of task." The day before the hearing the advisory group for the initiative was announced. The 14 members include six of the 18 signatories of the March paper in Science that called for a moratorium (including David Baltimore, Paul Berg and Jennifer Doudna; notable omissions include George Church and Hank Greely) but none of the 5 authors of the stronger Nature paper. All but two members are American, the exceptions being Robin Lovell-Badge (UK) and Xu Zhihong (China).
The other witnesses at the Subcommittee hearing were Doudna, who gave a brief overview [pdf] of gene editing and its possible applications; Elizabeth McNally, who notably included [pdf] the perspective of families who might want to apply such technologies; and Jeffrey Kahn, whose presentation [pdf] included a useful overview of US regulatory mechanisms but seemed to overlook previous international agreements that might serve as models.
The meeting was well attended and the subcommittee members seemed engaged in the topic, if somewhat unclear how best to proceed.
Away from Capitol Hill, there have been some other noteworthy developments:
Eric Lander wrote a thoughtful perspective in the New England Journal of Medicine, concluding that (except possibly for a few severe monogenic diseases) for the foreseeable future germline editing should be banned.
Margaret Somerville in the Toronto Globe and Mail raised questions of eugenics and a society of the "gene rich" and "gene poor," and expressed strong disagreement with Steven Pinker.
The Lancet editorially endorsed the Academies initiatives.
CIRM, the California Stem Cell agency, will hold a "public workshop" on November 3 in the Los Angeles area, to see if these "red hot" developments might require a change in their policies.
Meanwhile, research continues. CRISPR has been used experimentally on the hepatitis B virus, and also applied to zebrafish. Agriculturalists are actively discussing genome editing in animals, to make them resistant to disease and other threats from climate change.
Nature News published a good overview of "CRISPR, the disruptor." Next Big Future has a useful comparison of the costs and benefits of using CRISPR rather than Zinc Fingers or TALENs. Finally, Reuters published a thought-provoking report, inspired by the (failed) attempt to modify human embryos, titled:
Doug Turnbull, Director of the Wellcome Trust Centre for Mitochondrial Research. Photograph: Christopher Thomond for the Guardian
How does one go about regulating the world’s first cross-generational biological experiment in human germline modification? The regulating body in charge isn’t exactly sure. They’re seeking input via an online survey by July 1, 2015.
The technique in question, called mitochondrial replacement or three-person IVF, would combine genetic material from three different people into a single embryo, causing permanent changes to the human germline, in the hopes of allowing a woman to have a child who resembles her in all but her mitochondrial disorder.
The UK actually has a law against genetically modifying human embryos for reproductive purposes, but a tireless push from a small group of the UK science elite over many years ultimately swayed Members of Parliament in both the House of Commons and the House of Lords to allow a limited exception to be made for only this technique, and for only the prevention of serious mitochondrial disorders.
Now, the Human Fertilisation and Embryology Authority (HFEA) faces the daunting task of having to determine a system to regulate these techniques within fertility clinics before the regulations come into force October 29, 2015.They are currently seeking views from experts.
But if you look at either the “lay summary” or the “background document” they have prepared, you would not necessarily understand why anyone cared so much about these technologies in the first place. Nowhere in either of these documents does it actually explain that these technologies result in human germline modification – something people just might care about since it is banned by every country that has ever considered it, as well as the Council of Europe’s Convention on Human Rights and Biomedicine.
Because of this omission, they have a hard time getting to the heart of the matter – how does one regulate a cross-generational biological experiment?
Instead, their online survey seeks input on more discrete questions. For example, they ask how they should license a clinic to undertake the techniques. This feels somewhat disingenuous since in their lay summary they admit that only one research team in the UK is likely to be in a position to offer this at the moment (surely, the Wellcome Trust Centre for Mitochondrial Research at Newcastle University.)
They also ask how each patient should be determined to be at “particular risk” of passing mitochondrial disease to a child – a requirement of the regulations. However, they say that the presence of “a mutation” in a woman’s mitochondrial DNA (mtDNA) is enough to satisfy this requirement. Now, maybe I’m missing something. But I’m pretty sure that a substantial number of women alive today have mtDNA mutations, and in
the vast majority of cases these DNA changes do not cause disease. More precise language would reflect the fact that risk is caused much more specifically by a “known disease-causing
mutation in one of the 37 mitochondrial genes.” And that typically, problems only occur once a certain mutation threshold has been passed – say, if there are mutations in more than 20% of your mtDNA.
As for follow-up studies, which “many experts have recommended,” the HFEA is deferring to the clinics. They plan to encourage clinics to ask their patients to take part in studies of the clinics’ design, but will not require the patient or resulting child to take part. However, if a clinic becomes aware that a child has been born with any disease or genetic abnormality, the clinic will be required by law to report this as an “adverse incident.” Of course, in utero genetic testing could find many of these issues before the child is born, in which case the public would be unlikely to be made aware. Moreover, the genetic changes made to that child will be passed onto future generations, but there have been no recommendations for how to monitor any long-term, cross-generational issues that may arise.
For more information on the current regulatory process by the HFEA, see here. Fill out the online survey by July 1, and if you’re in the UK, consider attending their public workshop being held June 23. But be warned: they “are not asking you to comment on the wider ethical and scientific issues involved, nor the statutory framework.”
Previously on Biopolitical Times:
The documentary No Más Bebés, Spanish for “no more babies,” portrays the stories of Mexican-American mothers who were coercively sterilized at LAC+USC during those years. Directed by Academy Award nominee Renee Tajima-Peña and produced by UCLA historian Virginia Espino, the film premieres at a sold-out screening on Sunday, June 14 in the LA Muse section of the Los Angeles Film Festival. An additional screening has been added to the film festival on Tuesday, June 16 due to popular demand.
The film explains that women were asked by their obstetricians to sign consent forms for emergency caesarean sections while in the late stages of active labor. Most did not speak English; many do not recall being offered these forms. None knew that they were agreeing to tubal ligation procedures while giving birth.
As the film depicts, these women sued their doctors in the landmark Madrigal v. Quilligan case after they discovered they had been sterilized. It juxtaposes rare archival footage of the trial and the emerging Chicano rights movement with recent interviews of the women who were subjected to the unwanted procedure.
Madrigal v. Quilligan was a federal class action lawsuit involving the sterilization of ten Latina women without informed consent. Initially, the lawsuit named Dr. Edward James Quilligan, head of the Women’s Hospital at LAC+USC when the sterilizations were taking place; the LAC+USC Medical Center; the Department of Health, Education, and Welfare; and the U.S. Government. The defense argued successfully that charges against Dr. Quilligan and others holding positions of power within LAC+USC should be dropped, leaving as defendants the ten doctors who performed sterilization procedures on the plaintiffs. This in effect transformed the case into a set of personal grievances, rather than a case against institutional biases.
While the lawsuit led to better informed consent for patients, requiring that hospital forms are translated to multiple languages so that patients can understand the procedures completely, the judge ultimately sided with the county hospital, ruling in favor of the doctors. He argued that it was not objectionable if a physician thought that a tubal ligation could improve a perceived overpopulation problem.
The documentary interviews a wide range of the key figures in the case: the lead plaintiff, Dolores Madrigal; defendant Dr. Edward James Quilligan; five other women sterilized without their consent; and Antonia Hernandez, the lawyer who represented them in the trial. It also includes Dr. Bernard Rosenfeld, who suspected that Mexican immigrants were being sterilized by tubal ligation without their consent and helped expose the malpractice at the hospital. Rosenfeld is now a nationally known specialist in tubal ligation reversal surgery.
No Más Bebés draws on the growing body of research into the history of sterilizations in California by scholars such as Elena Gutiérrez and Alexandra Minna Stern. Unfortunately, this history is not that far behind us. In 2003, California Governor Gray Davis issued an apology acknowledging that “between 1909 and 1964, an estimated 20,000 Californians were sterilized” under California law in state-run institutions. However, the apology does not address the sterilizations that took place at LAC+USC during the 1960s and well into the 1970s.
Even more recently, evidence emerged of unauthorized sterilizations in California prisons due to persistent efforts by Justice Now and an extensive investigation by Corey Johnson of the Center for Investigative Reporting. Those revelations prompted a state audit and a 2013 bill, authored by State Senator Hannah-Beth Jackson, which prohibits coercive sterilization for the purpose of birth control for people incarcerated in California prisons.
No Más Bebés will alert many more people to these sadly under-recognized chapters of California’s past, while educating its viewers about the coerced sterilizations at LAC+USC and honoring the women who were its victims by sharing their stories.
Posted by Gwen D’Arcangelis, Biopolitical Times guest contributor on June 10th, 2015
In the latest laboratory incident involving potential bioterror pathogens, the U.S. Army’s Dugway Proving Grounds laboratory in Utah accidentally shipped live anthrax to labs in nine states across the U.S. and one in South Korea. News of the mishap has sparked renewed concern about the ability of the U.S. government to adequately safeguard the public from lethal pathogens being studied by the military.
Pentagon assurances that they have secured all the samples and that there is no known risk to the general public do not entirely allay concerns. Mishaps involving loss or release of bacteria, viruses, and toxins reported by U.S. laboratories to the Centers for Disease Control number more than 200 incidents per year. Some of them have harmed researchers and surrounding communities.
Many observers, including scientists and government officials, rightly focus on the inadequacies of lab safety culture. The Dugway anthrax debacle, for example, was the result of lab personnel not properly verifying that the anthrax had been inactivated before shipping it.
However, focusing too much on lab accidents and mishaps obscures the more fundamental issue of why the U.S. is producing these pathogens in the first place.
Research into pathogens like anthrax that are potential biological weapons, known as biodefense, is a multi-billion dollar enterprise. It is limited by the 1972 Biological and Toxins Weapons Convention to scientific, therapeutic, and defensive purposes. This binding international treatyoutlaws any research for offensive military ends. Yet, herein lies the dilemma: Biodefense research includes not only the development of exclusively defensive measures such as vaccines against biological weapons, but also producing bioweapons in order to test the efficacy of countermeasures. (The Dugway anthrax was, in fact, produced and shipped to labs to test their new detection kits.)
Biodefense research is, effectively, part of the U.S.’s already substantial arms arsenal. As such, it augments U.S. military power, enabling the U.S. to act with virtual impunity in forcefully securing its strategic and economic interests globally. Since 2001, federal funding of biodefense research, driven by the post 9-11 political climate, increased dramatically, tripling between 2001 and 2002. These high levels of funding have been maintained through the present day.
It is time for the U.S. to reverse its buildup of biological arms in the name of biodefense and to engage, instead, in disarmament. The U.S. should also, as with other international disarmament agendas, renounce its exceptionalist orientation in favor of even-handed scrutiny of its own programs, to the same degree that it applies to weapons control by other countries.
Much of the funding currently being directed at biodefense could be better allocated to research for medical purposes, or better yet improvement of public health infrastructure. Such a shift—away from biological weapons production and the inevitable accidents that accompany it—will go a much longer way towards improving public health and safety.
Gwen D’Arcangelis is an assistant professor of Interdisciplinary General Education at California State Polytechnic University, Pomona. She is an activist scholar whose work explores the social dimensions of bioscience and biotechnology, in particular their intersections with gender, race, and imperialism. D’Arcangelis is author of the forthcoming article “Defending White Scientific Masculinity: the FBI, the Media and Profiling Tactics during the Post-9/11 Anthrax Investigation” (2015 in International Feminist Journal of Politics). D’Arcangelis also engages in community-based research and work in environmental justice.
BEINGS 2015, or “Biotech and the Ethical Imagination: A Global Summit,” billed itself as “a gathering of global thought leaders to reach consensus on the direction of biotechnology for the 21st century.” The event, held May 17–19 in Atlanta, took place against the backdrop of the simmering controversy about the use of new gene editing tools to alter the human germline, and the prospect of human germline modification was a frequent and hot topic.
Both my observations as a “delegate” attending BEINGS 2015 and commentary about it (including this post at The Guardian by Charis Thompson, Ruha Benjamin Jessica Cussins and myself, and this coverage in BuzzFeed) unsurprisingly indicate that “consensus” is not in the cards. This is especially true because lead organizer Paul Wolpe set out to include participants representing the full spectrum of views, and succeeded in that goal.
By design, “faculty” and “delegates” addressed a broad range of biotech topics, and a months-long document-drafting process that is now underway will reflect that full range. More about the conference can be found on Twitter at #beings2015, and the organizers have promised that video will soon be posted. This post focuses mostly on comments and exchanges at BEINGS 2105 about human germline modification.
The far end of techno-enthusiastic perspectives, both on human germline modification specifically and on biotech in general, was represented by Harvard experimental psychologist and popular science writer Steven Pinker. In his opening remarks, Pinker counseled bioethicists to "stay out of the way of progress." In his closing comments, he cast “vague fears” as standing in the way of saving millions of lives. In between, he epitomized the “bad boy scientism” that too frequently characterizes the biotech field.
Pinker provided an undiluted dose of the trope that feminist scholar Charis Thompson calls the “pro-curial frame.” In that framework, “cures and treatments for disease” – promises of which are often wildly exaggerated – are pitted against “risks and ethics,” often described as fuzzy and hypothetical. Pinker, for example, told Buzzfeed that “biomedical research has the potential to save a vast number of lives and prevent staggering amounts of human suffering” and that “[g]etting in the way of progress in biomedical research means more people will be sick and die.” From the stage of BEINGS 2015, he proclaimed, “Ethics is quite simple: life is better than death, and health is better than disease. That’s it.”
In this view, any concerns about any aspect of biotechnology other than immediate harms to identifiable individuals are illegitimate. One participant summarized Pinker’s perspective with this tweet: “We need to resist bowing at the altar of amorphous existential risks without identifiable harms.” And without specifying his target, Pinker himself tweeted, “Sadly, some still use woolly dignity/sacredness arguments against curing disease & preventing death.”
Another tired trope that surfaced over and over at BEINGS 2015 was a starkly disdainful tone about “the public.” Dan Gincel, Executive Director of the Maryland Stem Cell Research Fund, talked about “a lot of public alarmism that as scientists we can discount.” Dismissals of “the public” were sometimes tempered by the view that “the public” simply needs to be educated (by scientists). As an article about BEINGS 2015 in BioWorld that gave most of its play to the biotech-cheerleading camp put it, “Much of the fear surrounding science – of any kind – can be attributed to lack of clear communication with the public.”
This view of the public, known in science and technology studies as the “deficit model,” was clearly applied to concerns about the creation of genetically modified human beings. Harvard geneticist and synthetic biologist George Church, for example, remarked that concerns about human germline modification and reproductive cloning “come up like a reflex not passing through the cerebral cortex.” Several speakers opined that the major problem regarding human germline modification is “the public’s perception” of it. Pinker went on at some length about why there’s no need to be concerned about genetic engineering of future human beings. According to BioWorld, he “scoffed at the idea of gene-editing tech ever being used to allow wealthy people to build genetically enhanced children.”
While it’s true that, as Pinker put it, “There is no gene that gives you 10 IQ points,” researchers continue to search for the combinations of genes associated with “intelligence,” and gene variants said to confer particular kinds of athletic prowess have been identified. It’s easy to imagine, as germline modification advocate and Princeton molecular geneticist Lee Silver did years ago in the pages of Time, that fertility clinics of the future will advertise the “once-in-a-lifetime” opportunity to procure genetic upgrades for “your child-to-be.”
After arguing that concerns about human germline enhancement are silly, Pinker went on to ridicule the notion that modifying the germline would represent anything new. In fact, he said, human germline modification has “no coherent meaning.” As BioWorld reported,
"I'm not sure what it means to pass on the germline to future generations," because mutations are constantly being introduced, he said. "Each of us is changing the genome, whether we like it or not, when we have children."
BioWorld did not report Pinker’s following comment that “the women who decided to sleep with me or not sleep with me were making decisions about altering the human germline.”
The litany of comments trivializing public concerns about biotech developments is unfortunately nothing new. But there's a novel twist on this trope that was in evidence at BEINGS 2015, and that's also cropped up in other recent conversations about human germline modification. It holds that people have been brainwashed to worry by anti-science depictions in literature, on television and in films. During a recent hour-long NPR program titled Re-Engineering Human Embryos, for example, host Tom Ashbrook played a clip from the 1997 film GATTACA; later that day, Carl Zimmer blogged, “I’d like an international ban on invoking GATTACA in these discussions.”
As the BioWorld account of BEINGS 2015 put this view, the public has been “conditioned by a pop culture filled with dystopian fiction – not to mention many a Hollywood blockbuster – that has instilled a common wariness for the unintended outcomes that can accompany scientific progress.” Genetics Policy Institute Executive Director Bernie Siegel came to the microphone to say that “the public is hysterically afraid of biotechnology based on what they see on TV" and that “the public thinks scientists are creating the zombie apocalypse.” Pinker warned bioethicists to “stay away from science fiction dystopias,” a category in which he included GATTACA and Mary Shelley’s Frankenstein, as well as the myths of Prometheus and Pandora.
These efforts to police the boundaries of conversation about human germline modification were in keeping with other similar moves at BEINGS 2015. In response to a comment about the experiences of physicists who helped develop the nuclear bomb and were appalled when it was dropped without warning in Japan, Pinker said, “We have absolutely nothing to learn from the Manhattan Project.” At another point, libertarian Ron Bailey declared that “the precautionary principle is an evil influence on bioethics.” In sum, these techno-enthusiasts are now arguing that as we think about the human future, we should rule out considering what we might learn from works of literature and film, as well as those aspects of myth, policy and history they don’t like.
One final cameo from BEINGS 2015 illustrates the antipathy to public oversight of biotechnology, as well as a gender dynamic that often creeps into discussions about its social implications. Dan Gincel opened his presentation on the second day of the conference with a slide of a bright red Ferrari and announced, “Now that’s innovation.” Biotech researchers, he said, are doing their best to move forward as fast as possible, and efforts to establish regulations are the brakes. That was an opening I couldn’t resist. Here’s a rough rendition of what I said in response:
What kind of person gets to climb behind the wheel of a car like that, and who is being taken on a wild ride? In a world in which we’re trying to keep fossil fuels in the ground to avoid a civilizational climate crisis, a world of galloping inequality, should we be encouraging and celebrating a car that costs a quarter of a million dollars?
Yes, we want to keep moving forward, but carefully and following the rules of the road. And even a Ferrari has a steering wheel. A lot of us are saying that we need a way to get many more hands on the wheel – citizens’ hands. A Ferrari also has a rear-view mirror, and looking in it once in a while should help inform where we’re going. A Ferrari has brakes; we should certainly apply those as needed. In fact, sometimes we need to slam on the brakes. That’s the case with human germline modification. There’s no need to go there, and it would take us down a very dangerous road.
Beth Shapiro is a distinguished molecular biologist who has specialized in ancient DNA. She has worked on the dodo [pdf] and the late-Pleistocene steppe bison [pdf], been anointed as a "Young Innovator" by The Smithsonian, and won a MacArthur grant. Alas, she seems to have fallen into dubious company.
As she has recounted several times, she became frustrated by the press because every time she returned from a field trip hunting for mammoth DNA, someone asked her about cloning the mammoth. So she looked into it, and decided it was (a) impossible and (b) foolish. She has said that many times, at least twice in my hearing. So what on earth is she doing publishing a book entitled How to Clone a Mammoth? She told Nature:
"I probably should have called the book How One Might Go About Cloning a Mammoth (Should It Become Technically Possible, And If It Were, In Fact, a Good Idea, Which It's Probably Not). But that was a much less compelling title."
Well, she has a point. It does make the book something of a bait-and-switch, though, as some have complained and she has admitted more than once. But there is a good reason that Stewart Brand is still very much on her side, and it's not just that she has let his protégé have lab space to work on reviving the passenger pigeon.
Shapiro is conceptualizing a much more subtle, and potentially dangerous, concept than merely putting a mammoth in a zoo.
I argue that … the birth of an animal that is capable, thanks to resurrected mammoth DNA, of living where a mammoth once lived and acting, within that environment, like a mammoth would have acted — is a successful de-extinction, even if the genome of this animal is decidedly more elephant-like.
She is hoping to see what are admittedly novel creatures — for instance, "cold-tolerant Asian elephants" — not just fill ecological niches but change entire ecologies, for instance to "lower the temperature of the soil and slow the release of greenhouse gases trapped within it." In her view:
De-extinction is a markedly different approach to planning for and coping with future environmental change than any other strategy that we, as a society, have devised. It will reframe our possibilities.
That is precisely why environmentalists should be wary of these technologies. As a species, we are busily making irreversible changes to the world in which we live. We already know for certain that we have made and probably will continue to make big mistakes. At the very least, plans to deliberately re-engineer ecosystems should be subjected to broad public consultation and strict regulatory oversight. And we should be asking ourselves whether we really want to turn the entire world into Anthropocene Park.
The Scope of Eugenics, held at the Banff Centre from May 22-25, focused on eugenics as both a historical practice and an ideological motivation. In addition to many presentations about the history of eugenics in North America, the conference sought to connect these historical examples to what participants called “Newgenics.”
Newgenics is a term used to describe current and emerging medical, political and social practices aimed at “improving” humankind, and at eliminating disability and difference. These goals are often accomplished through gentler means than those historically used in the service of negative eugenics. But Newgenic practices include coercive sterilization as well as, prenatal testing, educational standards, and institutionalization. Human germline modification, now being discussed as a real prospect, would also fall in this category. Newgenics retains the same eliminative logic of twentieth-century eugenics, though often in more subtle and differently problematic ways.
In attendance were Judy Lytton, Leilani O’Malley (Muir), and Glenn Sinclair, whose stories are featured in the upcoming documentary Surviving Eugenics, which provides a unique insiders' view of life in institutions for the "feeble-minded" during the mid-twentieth century, and raises broad questions about disability, human variation, and contemporary social policies. The film’s protagonists are people who were themselves sterilized at the Provincial Training School for Mental Defectives in Red Deer, Alberta, and their testimonies added a uniquely personal experience to the discussions of emerging Newgenic issues.
Members of The Living Archives Project spoke as well. Nicola Fairbrother, who interviewed the survivors, discussed the importance of taking personal testimony from people whose voices are typically silenced and devalued. Fairbrother’s work amplifies these voices and stories, both in the documentary and in the “Our Stories Told” section of the online Eugenics Archives. Living Archives member Justin Houle spoke about his work creating “Newgenics: The Game,” which aims to reach a younger demographic on the Archive’s webpage.
Both The Scope of Eugenics conference and the Eugenics Archives reflect the collaborative work of scholars, sterilization survivors, students, and university and community partners in challenging eugenics in a balanced and informative way. You can explore the online Archives’ ten tools, including personal narratives, the Newgenics game, timelines, and other visual representations, to learn more about the history of eugenics and to connect that legacy to our realities today.
A new rumor is spreading that Apple may be leveraging its ubiquity to encourage iPhone owners to participate in DNA testing, perhaps to bulk up the medical data-collecting capabilities of its ResearchKit.
According to Antonio Regalado at MIT Technology Review, Apple will work with academic partners to collect and test the DNA, and may provide add-ons such as the ability to widely share genetic information directly from an iPhone with a single swipe.
This wouldn’t be the first time genetic researchers have tapped into social networks to recruit participants. University of Michigan’s Genes for Good project is using a Facebook app to encourage 20,000 volunteers to share information about their genes, health, habits, and moods to help the researchers uncover new connections between genetic variants, health, and disease.
While Apple’s ResearchKit has been growing in popularity, it has also encountered serious problems – from user bias to inaccurate reporting – all of which can lead to misleading data and ultimately to wasted research funds and increased medical costs. Adding genetic information to the mix may only compound these problems. Our genomes contain so much data that distinguishing between signal and noise is a huge problem. And then there is the point made succinctly in a recent article about “Big Data” in The New York TimesSunday Review: “The things we can measure are never exactly what we care about.”
It is also unclear whether people will rush to share this most personal kind of data. It’s one thing to take action on social networks following DNA testing – say, to join a Facebook group to discuss a shared gene variant – but enabling widespread sharing of the genetic data itself may ultimately benefit biotech companies at your or your family’s expense.
A recent news story published in The New Orleans Advocate, and later covered by theElectronic Frontier Foundation, highlights the potential for genetic data shared for a particular purpose with a private company to later be used for familial genetic surveillance in the name of law enforcement.
Ancestry.com, which owns a trove of genetic data called the Sorenson Database, allowed Idaho police investigators to search through 100,000 DNA samples in their attempt to shed new light on a 20-year-old murder case.
The investigators found a DNA sample from a man that matched on 34 out of 35 alleles of DNA from the crime scene, indicating a close familial relationship. They then used the database’s genealogical information to track down all of the man’s family members. Subsequent Google and Facebook searches led them directly to his son, who turned out to be a filmmaker known for his depiction of gruesome murder scenes.
As it turned out, he wasn’t the murderer, and was able to establish that. But he got lucky. Given the proliferating use of trace DNA in forensics, the acceptable margin of error for genetic “matches” is a problem. If the original crime scene had only provided trace DNA, the evidence stacked against this guy may very well have ended in a conviction.
If widespread sharing of our genetic data is soon enabled by Apple, it may be smart to swipe left.
One failed experiment can crystallize a discussion. On April 18, a paper describing an attempt to use CRISPR gene-editing technology to modify a human embryo was published in Protein & Cell, an obscure Chinese journal. On April 22, Nature, which had rejected the paper on ethical grounds, published a news article about the publication, which was the first many people had heard of it. And then pretty much everyone in the biotech/bioethics world had something to say.
The pump had been primed by recent commentaries in Nature and Science that called, with significantly different emphasis, for a moratorium on human germline interventions. An earlier widely circulated article in MIT Technology Review had suggested such experiments were soon to be published.
Creating genetically modified humans has long been seen as dangerously unacceptable, and is prohibited by law in dozens of countries. Until the recent advent of new gene-editing tools, scientists had also refrained from human germline experiments.
The Center for Genetics and Society’s reasons for supporting these prohibitions are described in these press releases (1, 2) and this backgrounder. In short, CGS supports the prospect of somatic gene therapy, which if successful would help consenting patients by treating disease but would not affect their descendants; and opposes inheritable genetic modification (or germline intervention) for multiple reasons, including dire safety risks, ethical considerations and social consequences.
Most responses to the prospects of GM humans can be roughly grouped into a few categories, each of which covers a spectrum of views: opposition, either permanent or conditional; calls for dialog, with varying implications; and support, even enthusiasm. Views also vary on whether, when and under what conditions it would be appropriate or acceptable to modify the genes of human embryos for research purposes.
The lines are frequently blurry, and not everyone is convinced of the good faith of those with whom they disagree. Moreover, the discussion has so far largely been confined to professionals working in the field — researchers and bioethicists. The controversy has now reached the national and international media, and anecdotally there is growing public awareness. But we’re nowhere near the broad participation that the high stakes of this conversation demand.
What follows is by no means complete, but an attempt to lay out the current parameters of the evolving discussion. Links are included below, including to some of the most useful summaries, and readers are encouraged to follow them for further clarification.
Don’t Do It
Edward Lanphier of Sangamo BioSciences and the Alliance for Regenerative Medicine, with four co-authors, laid down an early marker on March 12, with an op-ed in Nature succinctly titled:
Don’t edit the human germ line
They opposed not only creating and bringing to term genetically modified humans but also "research involving genetic modification of human germ cells.” That is an important distinction, and controversial even among those who firmly oppose using heritable genetic modification for reproductive purposes. Those who support germline modification argue for continuing research to establish safety (if possible, which is by no means certain). Those who oppose such applications are concerned that such research "could be exploited for non-therapeutic modifications,” as Lanphier et al. wrote.
They called for a moratorium — the term “ban” is evidently considered impolitic, although many countries and international organizations have in fact banned germline intervention. Many prominent figures agreed with all or part of their approach. Broad Institute Director Eric Lander asserted that there is "no therapeutic application he could think of that would justify gene editing in human germline cells” and said:
"The call for a moratorium isn't based on a probability calculation that someone will do it. We need to truly ban this from a moral standpoint. We should forbid this for at least a while — not by law, but by agreement."
Francis Collins formally reiterated NIH policy against funding "any use of gene-editing technologies in human embryos." The Society for Developmental Biology agreed [pdf]. The International Society for Stem Cell Research called for a moratorium on clinical applications, but not research.
Everyone says they support wide-ranging discussion of the prospect of genetically modified humans. Just how wide-ranging is a point of contention, with some scientists apparently insisting on technical expertise as a precondition for decision making, or preferring that scientists keep the conversation close and proceed with voluntary agreements or self-regulation, or assuming that “public participation” means that they will educate the public to let them do what they want. Bioethicists and other experts naturally disagree, as do public interest advocates and everyone committed to democratic participation.
A week after the Nature article by Lanphier et al., Science published one by Nobel laureate David Baltimore and 17 others titled:
A prudent path forward for genomic engineering and germline gene modification
This may not be quite the cynical, enabling position it seems to be at first: it likely represents a compromise among widely varying views. The Science commentary arose from a meeting organized by CRISPR expert Jennifer Doudna, who has previously expressed ethical doubts about the practice and its possible “dark side." But the co-authors also include Harvard expert George Church, who has frequently been enthusiastic about human germline interventions.
Another co-author was Stanford law professor Hank Greely, who thinks that the fuss has been overstated, because the technology will not be practical in humans "for a long time, if ever.” Nobel laureate Craig Mello seems to agree, saying "It’s not something that’s going to be easy, cost-effective or safe, given existing technology,” (Mello’s position has, however, also been characterized as, if it’s safe, go for it.) British expert Robin Lovell Badge, otherwise a strong supporter of refining techniques to create genetically modified humans, agrees that "a lot of the fuss about the possibility of germline gene editing is misplaced,” not least because PGD can be used to avoid many heritable conditions.
Transhumanists, including James Hughes and Zoltan Istvan, and libertarians such as Ron Bailey who have long argued in support of human germline interventions have predictably chimed in to affirm their positions. So have some philosophers associated with this view, including Julian Savulescu et al. in Nature [behind paywall and on a blog]. One of the co-authors, Chris Gyngell, wrote an op-ed in The Guardian titled “The case for genetically engineered babies,” in which he fails to mention that what he proposes is explicitly illegal in the UK, where he lives. He bases his argument on the prevention of inherited diseases, without acknowledging that this can be accomplished through already-existing embryo screening techniques. He also includes this remarkable sentence:
Genes fashionable in one generation may prove to be harmful in the next.
Many mostly rather passive supporters were quoted in this selection by the Science Media Centre, including Dusko Ilic, Ewan Birney, Darren Griffin (who mentioned a possible “moral imperative to make sure that we do it”) and Anna Smajdor, who cited the recent UK decision to allow nuclear transfer to avoid mitochondrial disease.
More worrying is the appearance of at least notional support from some self-described environmentalists, such as Amelia Urry in Grist, though that piece seems somewhat muddled on the basic distinction between somatic gene editing and germline interventions.
Press coverage has been extensive. The following are some of the articles that include comments from scientists and others:
The folks promoting DIY synbio — Counter Culture Labs, in Berkeley, for instance — are actually discouraging people from practicing science. Science is a quest to understand the nature of reality, with an appreciation with each new insight of how much more remains to be comprehended. It's a serious quest, because the stakes of misunderstanding reality are so high. But the goal in synbio is not about understanding reality, or one's own ignorance. It's about trying to fundamentally change reality, based on one's own narrow perspective and fantasies.
Rejecting reality is really at the root of synbio. Some synbio engineers go so far as to strive to rid our species of aging and death, which are essential aspects of being alive. Yes, there's an eagerness for more knowledge — but only the tidbits about the extremely narrow slice of reality that synbio engineers think they need to know to force an organism to do whatever they desire to force it to do. The word "hacking" captures the inherent violence of this mindset.
That's not good science; it's bad engineering. And the same kind of thinking about the natural world that got us into the current ecological mess. So Counter Culture and their ilk promote "citizen genetic engineers," or "citizen bioengineers." But not "citizen scientists."
How democratic is the idea of "citizen bioengineers"? Not at all. It's a kind of anarchy. (No wonder the movement has attracted anarchists.) But this is a weird anarchy that insists upon conformity. It confers power only on those who are willing to conform to the vision pushed by very powerful commercial forces that the natural world, including human beings, must be and will be redesigned.
In fact, the DIY synbio movement unwittingly supports the profoundly anti-democratic nature of the entire synbio enterprise. The DIY branch, by intent or not, is a valuable ally for companies like Dow AgroSciences, whose bioengineers have helped spread the idea that synbio revolutionizes who can "do" biology. (See here and here.)
The DIY buzz that synbio is exciting, fun, and empowers each person to tinker with life suggests that everyone has the right to play the game pretty much the way they want. That serves powerful corporate and academic interests because it means no one has much right to participate in decisions about common, enforceable rules. Won't that make just about anything that the synbio industry and patent-heavy universities want to commercialize acceptable too? That neatly negates the whole possibility of democratically decided limits or prohibitions on designing or using these unprecedented technologies. In short, it nixes democracy.
And, no, voluntary codes of ethics designed by the hackers themselves won't cut it. Participatory democracy is government of, by, and for the people. It's about all citizens' shared power to govern synbio, whether we fantasize about engineering life or not.
Ethically speaking, the redesigns of the natural world — including the human body — visualized by many synthetic bioengineers are so dramatic and potentially irreversible that a good case can be made that they should require some kind of global consensus. And ethically speaking, a good case could also be made that it would need to be a consensus not just of us humans who happen to be alive right now, but a consensus that included other species and future generations.
Is that an impossibly high bar? Yes. But the living world is not the property of a relatively small elite of academic, corporate and DIY bioengineers, venture capitalists, and self-interested stockholders. The synbio enterprise, from this perspective, is inherently anti-democratic and elitist.
And many of us who are aware of what's going on in synbio are appalled because we love the natural world as it is. We not only don't want to re-design it ourselves, we absolutely resist the proposition that a small elite has the right to rush forward and try to redesign it for the rest of us.
So racing ahead despite the fact that billions of your fellow global citizens are either unaware of your agenda or opposed to it is the opposite of promoting democracy. It serves only the powerful players — the for-profits, universities, and government agencies — that have the most invested in winning that race and the least enthusiasm for letting genuine democracy interfere.
Colleen Cordes, writing here in her personal capacity, is director of outreach and development for The Nature Institute. She is a former co-chair of the Loka Institute, which advocates for greater public participation in decisions about the design and use of technologies, anad former executive director of Psychologists for Social Responsibility. She reported on issues of science and technology policy for more than a decade for The Chronicle of Higher Education.
Three white chicken eggs with smiley faces drawn on them peer out at me from a Facebook ad. (Notably, a Facebook ad forwarded to a listserv by a young woman in college, not one that popped up in my own middle-aged Facebook feed.) One of the smiling eggs exclaims, “Donate Me and Help Make a Family!”
Fifteen or twenty years ago, this ad would have made little sense. Donate a chicken egg to create a family? But in today’s brave new reproductive world, where in-vitro fertilization, commercial surrogacy, and sperm and egg donation are no longer obscure medical secrets but commonplace knowledge, it’s fairly obvious to most people viewing this ad that it is targeted at young women, encouraging them to “donate” their ova.
I put the word “donate” in quotes above because unlike kidneys, ova are not usually “donated” in this country. While it is illegal to offer economic compensation to people for other sorts of organ donation (due, rightfully, to the bioethical concern that this will create a market for human organs, and impoverished people will be unequally coerced into selling their body parts), getting paid for giving up your ova (and sperm) is perfectly legal in the U.S.
But why is it particularly worrisome that ads for ova donation have made it onto personalized Facebook feeds?
The Commodification of Women’s Bodies: Economic Coercion
Back when the only egg donation ads I saw were in the hallways of the Ivy League medical school in which I teach, I was equally concerned. Whether on digital or brick-and-mortar walls, ova donation ads make clear that women’s bodies and body parts are commodities to be bought and sold. Which of course begs the deeply troubling question — are women’s bodies things to be owned and traded on the open market?
Whatever a young woman’s opinion on bodily “ownership,” the economic inducement is so significant ($5,000–10,000, with higher fees going to donors with Ivy League educations, high IQs and preferred ethnic and racial features) that a young woman does not need to be in dire financial straits to feel tempted by the quick and supposedly easy money of egg donation. From medical bills to house payments to college and graduate school debts, young women use egg donation payments in myriad ways. And besides, you get to help someone, right?
Yet, the altruistic rhetoric of “helping create families” and “women helping women” only serves to distract us from the fact that ova donation is ultimately a booming business, and as such, it is about the money, honey. (Without the economic compensation, would many young women do it?) As of 2007, the assisted reproductive technology industry in the U.S. was a $6.5 billion for-profit industry, and growing. Fertility clinics and other middlemen are clearly invested in keeping this lucrative business going.
Lack of Transparency About Health Risks, and the Lack of Research
Unlike sperm donation, which has few to no health risks and indeed usually involves free porn, ova donation is a risky business. As a complex medical procedure involving hormones, injections, blood draws, anesthesia, and a surgical procedure to extract a body part, many things can go wrong with ova donation. The risks of egg donation include bleeding, pain, stroke, kidney disease, ovarian cysts, torsion, infertility, and even death. The Center for Bioethics and Culture argues,
OHSS (ovarian hyperstimulation syndrome) is caused by the process of superovulation and is well-documented in the medical literature as a risk associated with women who take fertility drugs to stimulate ovulation. It is also documented in the literature that young women are more at risk for OHSS.
These risks are not, however, freely shared with the young women donating their ova. Indeed, there is very little research being conducted, little data being gathered about the long-term health effects of ova donation — if donating ova earlier in life affects later-in-life fertility, cancer rates, or other diseases. And that, as the award-winning documentary film Eggsploitationsuggests, is the fertility industry’s “dirty little secret.”
Racist Elitism: A New Eugenics
“Make another woman’s dreams come true!” cried the advertisement I used to see (and systematically take down) on the walls of the medical school where I teach. The ad infuriated me not only due to how it signaled a commodification of women’s bodies, but also in its obviously racist, and elitist, implications. “Ivy League Donors Wanted,” read the subheading. The photograph in the advertisement was of a young, smiling blonde woman, clearly indicating that this was the kind of Ivy League–educated woman who was desired. In the words of an article from The Journal of Health Care Law,
Wealthy couples, who utilize egg brokers or high-profile advertisements, do not seek general traits. These couples are seeking a “perfect gene pool” for their commodity — notice the highly sought-after donor is a woman who has blonde hair, blue eyes, received a 1400 on her SAT, attends an Ivy League school, and who preferably has some additional talents such as music, sports, or theatre.
These perspectives make women with such highly desirable traits prized reproductive commodities, and clearly sends the broader social message to all women that we are only valued for our abilities to produce genetically favorable offspring. Interestingly, a more recent study indicates that this racially motivated preference may be changing, as couples using egg donors choose “brains” over perceived “beauty.” (Although I would argue it’s just a shift in what is seen as genetically “valuable.”) In the words of Robin Marantz Henig, writing at NPR’s health blog,
But as the practice [of using donated eggs] becomes more widespread, a recent study finds, women are no longer trying to hide the fact that their babies come from donor eggs by working hard to find donors who are physically or genetically similar to them. Instead, the researchers say, recipients tend to look for other qualities, such as intelligence and athletic ability, that they hope to pass on to their children.
Whether it’s shopping for blonde hair or brainiacs, the eugenic implications are still the same. These sorts of genetic preferences in choosing an egg donor are still part and parcel of the social pressure on people to produce “perfect” children genetically related to at least one parent. They are still part and parcel of a mentality which, for lack of a better word, is ultimately about “designer babies.”
The Surveillance Society: Facebook Algorithms See All
With all of these disturbing aspects of the ova donation industry in mind, the commodification of bodies, the eugenic tendencies, and the ill-explained or known health risks, the additional digital twist of the personalized Facebook ova ad is particularly disturbing. Like Big Brother or some dystopian fascist corporation from Blade Runner or Minority Report, Facebook algorithms see all — our age, gender, height, weight, ethnicity, and education — and make conclusions about the genetic desirability of our reproductive parts, our possible willingness or need to donate ova for compensation. As early as 2009, Jennifer Lahl, the president of the Center for Bioethics and Culture, was demanding that Facebook take down egg donor ads targeting young women. One blogger posted a critique of multiple aspects of the practice in 2011 called “Facebook Thinks I’m an Asian Egg Donor.”
Where to begin?? Let’s start with the copy:
“Asian Egg Donors Earn $8K”
I get that they’re trying to customize this ad somewhat to my ethnicity by putting “Asian” on there. But does this mean if I were of another race, that I would earn more or less? Does my ethnicity equate my monetary potential in this market of egg donors?
I’m assuming this company went about facebook [sic] targeting the same way a lot of us do — select from Facebook’s menu of options and then add some keywords. They probably entered some common Chinese/Japanese/whatever they think is “Asian names — and I guess my last name (which is a pretty popular Asian name) fit into the category they are targeting. However, I wonder if they considered the fact that I may be adopted, or that I may be half-Asian, or I married an Asian guy. But I guess this sort of crass targeting fits into their overall way of thinking …
Amongst the weight loss, cellulite reduction, online dating, and hair removal advertisements featured in the margins of my Facebook account, there have been an increasing amount of advertisements requesting college-age egg donors. With an alluring compensation of $100,000, I couldn’t help but click on the ad. The ad took me directly to a site called “Elite Donors: Creating Happy Families,” a site that recruits egg donors for infertile couples for the purpose of In Vitro Fertilization into the female client or surrogate. The site was plastered with photos of smiling babies and mothers, all with blonde hair, blue eyes, and perfect white teeth.
Intrigued to determine whether or not I have “elite” status, I searched their criteria for an eligible donor. The standards were as follows:
Height 5’9″ or taller: You may apply if you are shorter, but it helps to have family members who are 5’9″ or taller.
Caucasian: Check back in the future if you are a different heritage.
Very Attractive: Modeling experience is a plus, but not required.
Must be 18–28 years old.
Proven Intelligence: We are looking for a donor who has graduated from a top 100 four-year college.
Athletic Ability: Looking for a donor who has a history of participating in athletics or dance. Playing or performing at a college or professional level is ideal.
No Genetic Medical Issues: This criterion is absolute.
The writer goes on to wonder if with her history of braces, her less-than-4.0 grade point average, and her non-modeling / normal woman weight, her ability to earn might go down and down. She concludes, “I guess if these are the standards by which one measures women, we’re not worth a whole lot, are we? Be more than what someone is willing to pay for you: Protest egg donation advertisements on Facebook today.”
In the end, I agree with the writer above. It’s creepy enough that Facebook knows whether I am in the market for a new dentist or dining room table. It freaks me out infuriates me that the digital giant is also now in the business of luring young women into selling their body parts for profit. But as I wrote about recently in regard to Facebook offering to pay for female employees who want to freeze their ova, the corporate giant clearly thinks that women’s reproductive parts and wholes are part and parcel of their global purview. Facebook’s ova donation ads don’t signal a brave new world, just old exploitations packaged in slick, sophisticated, and frighteningly targeted digital packaging.
Sayantani DasGupta is an assistant clinical professor of pediatrics and a core faculty member of the Program in Narrative Medicine at Columbia University. She also teaches in the graduate program in Health Advocacy at Sarah Lawrence College, and is a prose faculty member in the summer writing conference Writing the Medical Experience at Sarah Lawrence College. Dr. DasGupta is co-author of The Demon Slayers and Other Stories: Bengali Folktales (1995), author of Her Own Medicine: A Woman's Journey from Student to Doctor (1999), and co-editor of Stories of Illness and Healing: Women Write Their Bodies (2007).
Heart disease is the single biggest contributor to the racial mortality gap in the US, which, in case you didn’t know, is still really bad. Many hoped that advances in genetics would help explain and ultimately close that gap.
So Jay Kaufman, Professor in Epidemiology & Biostatistics at McGill, recently led a study to systematically review six years’ worth of genomic research to see if there is any evidence that genetic differences explain this major racial-health disparity.
What he found is incredibly important. He found, effectively, nothing.
Silverstein reminds us that an explicit goal of the Human Genome Project was to close health disparities, and that we’ve invested more than $1 billion in the field every year since. But given the results of efforts to understand racial health disparities by looking at our DNA, it might be argued that pretty much anything else would have done better.
You’d think that educated people knew this, right? That race is a social construct with the same scientific legitimacy as “grouping raccoons, tigers, and okapis on the basis that they are all stripey?” Some researchers seem to acknowledge this, and recommend
studying “ancestry” rather than “race.”
But Silverstein points out that “ancestry” tends to be merely a proxy for race, masquerading with “a phony moustache and glasses.” Moreover, the lack of precision in the use and definition of “ancestry” has rendered it nearly meaningless scientifically.
The bigger take-away, he argues, is that no matter how you cut it up, biological difference simply isn’t a major driving force behind health disparities. Social inequality, racism, and injustice are. Given what we know now about the ineffectiveness of this research, he suggests that “[looking] for the cause of racial disparity in genetics isn’t only scientifically flawed. It is morally flawed as well.”
For more on how biotechnological advances have worked to re-construct social categories of race as biological phenomena, the following is a list of some essential reading:
“Outsourcing Embryos” is the name of a new fifteen-minute documentary from Vice for HBO in which correspondent Gianna Toboni travels to India to delve into the industry of commercial surrogacy. What she uncovers is eye-opening, even for those who have been following the surge of cross-border “womb-renting” for years.
India’s medical tourism industry is now worth $2.3 billion, with $500 million of that solely from the legalization of commercial surrogacy. Couples travel to India from all over the world to take advantage of prices that are a sixth of the cost in the US - about $30-60,000 from a reputable clinic. But, as Toboni explains, the problem with commercialization is that “businesses start under-cutting one another and next thing you know, we’re bidding for the cheapest baby.”
To find out how low the prices could go, Toboni went undercover and found a man working from a back alley who offered a guaranteed delivery for just $12,000.
At the other end of the spectrum is Dr. Nayna Patel, who is surely the most well-known fertility specialist in India. She is currently building what will be the largest surrogacy clinic in the world, an “all inclusive facility” that will eliminate the need for a hospital entirely.
Patel schedules all of the women working for her as surrogates to undergo C-sections, so she can perform deliveries back to back. After watching one herself, Toboni was visibly shaken. “We just saw a baby being born ten minutes ago and already we’re racing back upstairs to see the next baby being born. It’s like this turn-over is so quick here.”
According to Patel, surrogates carrying a foreign couple’s baby can make about $9,500 for one, or $12,000 for twins. Patel is adamant that surrogacy is highly beneficial to the woman who take part. And indeed, many women find it to be the best option available to them.
A woman named Vasanti told Toboni, “Nobody likes doing this. I didn’t have a home, so I thought I could build one by being a surrogate.”
Another surrogate, Nisha, told her “It does feel a little bad, but what can I do? I’m helpless. There are no alternatives.”
Toboni found non-profit organizations that purportedly “empower” women to find employment, but effectively work as surrogacy recruiters by explaining to women living in extreme poverty how the payment compares to the alternatives of housecleaning or menial labor. Other recruiters regularly comb through the slums.
Despite Patel’s insistence that she discourages this practice, a recruiter found in the Mahavir slum claimed to be working directly for her, and seemed to be skimming several thousands of dollars off the payments to women that had been quoted by Patel.
There is currently no law regulating surrogacy in India. Dr. Ranjana Kumari of the Centre for Social Research explains the position of her group,
We are not against surrogacy. We think if the child can be given to a childless couple, it’s a noble idea. But we are against commercialization. This commercialization is totally based on an exploitative system. The violation of rights of a poor woman.
Throughout their Centre’s extensive research, they did not find a single surrogate who had a copy of her contract, leaving them without any legal recourse if they are under-paid or encounter serious medical problems.
The documentary includes Michele Goodwin, Chancellor’s Professor of Law at UC Irvine, explaining that clinics are motivated to implant multiple embryos at a time to maximize their chances of delivering a "successful product.” As well as putting the surrogate mother and babies at additional health risks, this ends up leading to “extra” babies that the commissioning parents weren’t expecting. As the Baby Gammy controversy of last summer made clear, some unwanted babies simply get abandoned.
And this documentary uncovers an even darker side of the problem. While posing as potential clients over dinner with a surrogacy broker, two Vice correspondents are shown a baby and told, “you can take that baby now… Let’s just make the deal now.” Toboni explains their reaction,
We soon realized that this woman was actually trying to sell us the baby they had brought with them to the restaurant. This wasn’t renting someone’s womb. This was human trafficking.
This fifteen-minute documentary shows the complex reality of the unregulated world of commercial surrogacy, beyond the smiling photos of beautiful babies and appealing price tags. As Goodwin puts it: “It’s a baby farm.”
Posted by Gina Maranto, Biopolitical Times guest contributor on April 22nd, 2015
Egg harvesting is a medical procedure that has been used since the late 1970s in infertility clinics worldwide. The number of egg harvesting procedures has risen steeply in the last decade due to increased prevalence of in vitro fertilization (IVF) with so-called “donor eggs” rather than the birth mother’s own eggs, as well as to growing demand for human eggs from scientists investigating stem cells. Within the last two or three years, infertility specialists have also begun promoting egg harvesting and freezing as supposed means for otherwise healthy young women to ensure their future ability to have children.
Short-term risks of the type of egg harvesting that is accompanied by hormone treatment are well known. Yet despite the fact that hundreds of thousands of women have undergone egg harvesting, few long-term studies of potential risks have been done, and those have yielded contradictory results (e.g., Ness, 2002, Althius, et al., 2005; Brinton, et al., 2005).
The practice of soliciting young women’s participation in what has become a global market for eggs thus raises critical ethical issues concerning informed consent (Beeson and Lippmann, 2006). Our team at the University of Miami and CGS is surveying young women’s knowledge and attitudes toward egg harvesting and its risks. Such information will yield critical insights into how best to frame health information intended to enable women to make informed choices about this procedure.
If you’ve ever donated your eggs, or if you’re interested in taking a survey about egg donation and are a woman 18-40 with U.S. citizenship, we’d like to hear from you.
This survey will take less than 10 minutes to complete and will help us understand how much American women in this age group know about egg harvesting; how many women have had their eggs harvested and for what reasons; and how women understand and think about the long- and short-term risks of the procedure.
If you are willing to take the survey, the link is here.
This is an anonymous survey; your answers will not be connected to you in any way. We will not be connecting your name, although we will ask for some geographical information if you have had your eggs harvested or have donated eggs in the past.
After you complete the survey, you will also be given information for contacting the principal investigator, Gina Maranto, at the University of Miami in case you would like to participate in a followup interview (which is entirely optional).
Althuis, M.D., Moghissi, K.S., Westhoff, C.L. et al. 2005. Uterine cancer after use of clomiphene citrate to induce ovulation. American Journal of Epidemiology 161, 607–615.
Beeson, D. & Lippmann, A. 2006. Egg harvesting for stem cell research. Reproductive BioMedicine Online 13, 573-579.
Brinton, L.A., Kamran, S., Moghissi, M.D. et al. 2005. Ovulation induction and cancer risk. Fertility and Sterility 83, 261–274.
Ness, R.B., Cramer, D.W., Goodman, M.T. 2002. Infertility, fertility drugs, and ovarian cancer: a pooled analysis of case–control studies. American Journal of Epidemiology 155, 217–224.
Gina Maranto is Director of Ecosystem Science and Policy and coordinator of the Environmental Science and Policy program at the University of Miami's Leonard and Jayne Abess Center. She is also a Fellow at the Center for Genetics and Society. She is the author of Quest for Perfection: The Drive to Breed Better Human Beings (1996).
The April 14 Washington Post
prints an interesting article on regulation and the fertility industry.
It quotes both Marcy Darnovsky and me on the lack of oversight of
assisted reproductive technology in this country. Another issue that it
addresses is the rights of donor-conceived offspring to learn the identity of their egg and sperm donors. As I’ve written in numerous articles and books, it is a fundamentally important right for all donor-conceived offspring to learn the identity of their donors.
Other academics disagree with this position, believing it important to protect the identity of gamete donors for a variety of reasons. I disagree, and I think the law has a critical role to play in ensuring respect for the rights of donor-conceived people. Parents can make the legal choice never to find out the identity of their donor. By contrast, donor-conceived offspring have no such legal right in the United States: unless their parents opted into a known donor program, they are unable to learn the identity of their donors. While their parents’ choices affect them as children, donor-conceived children grow up, and many become curious about their origins. Yet the law’s tight focus on the parent-child relationship excludes legal questions relating to donor-conceived adults.
Donor conception has drawn on traditional adoption practices, including beliefs that a person did not need to know that she was adopted and did not need health or genetic information, but could be brought up as though she were the biological child of her parents. It is, by contrast, now well accepted in the adoption world that adopted individuals not only have the right to know they are adopted, but also that they may be interested in finding their birth parents. An increasing number of states now allow adopted individuals to obtain their original birth certificates; thirty-one states have set up mutual consent registries, and others have established search and consent and other procedures.
There is no such widespread recognition in the donor-conception arena, notwithstanding the increasing number of donor-conceived family members who are looking for one another. The Donor Sibling Registry has now matched more than 12,000 people, and the numbers are growing. (Full disclosure: I am a member of the DSR’s board.) The DSR is a mutual consent registry that works diligently to maintain the privacy of its members.
Yet the DSR can’t change the law. Instead, we need to do as so many other countries, including England, have done: End donor anonymity and give donor-conceived offspring the right to learn about their origins.
Naomi Cahn is the Harold H. Greene Professor of Law at The George Washington University Law School. She is the author of numerous law review articles and several books, including The New Kinship (2013), and Test Tube Families: Why the Fertility Market Needs Legal Regulation (2009); she has co-authored Finding Our Families: A First-of-Its-Kind Book for Donor-Conceived People and Their Families (2013)(with Wendy Kramer) and Marriage Markets: How Inequality is Remaking the American Family (2014)(with Professor June Carbone); and she has co-written casebooks in the fields of family law, trusts, and estates.
Three high-profile scientists’ statements published in quick succession last month called for various kinds of moratoria on research on and/or use of gene-editing techniques that would result in genetically modified humans. The statements were prompted by reports that human sperm, eggs or embryos have already been created using such techniques in China and the US, and that papers are forthcoming.
These calls from within the scientific community are important, and highlight scientists’ desires not to have their discoveries used for means they condemn. But even among this limited group of scientists, there isn’t a clear consensus about what an appropriate solution looks like. The statement in Nature argues that in vitro research should be part of a moratorium because there is unlikely to ever be a justifiable therapeutic application that warrants the associated risks, while the statement in Science calls for extensive in vitro research to explore possible clinical applications straight away.
Jennifer Doudna, lead author of the Science statement and one of the pioneers of the CRISPR/Cas9 system, gave a lecture at UC Berkeley yesterday in which she raved about how popular the technique has become in the past couple years. She expressed her desire to spread the technology even more widely, beginning with a campus workshop this summer to teach students how to use it themselves. It’s not clear, however, if Doudna’s vision for a free and open CRISPR future will pan out given the heated patent fights already stirring up.
In reality, scientists have the most to gain from the development of these technologies (whether for good or for ill), and for this reason alone are probably not the right people to be guiding international policy. Writing in The Guardian, science, technology and society policy scholars Sheila Jasanoff, J. Benjamin Hurlbut, and Krishanu Saha make a strong case that “Human genetic engineering demands more than a moratorium.” They argue that merely waiting until we have more technical knowledge misses the point:
The answer to how we should act does not lie in the technological details of CRISPR. It is our responsibility to decide, as parents and citizens, whether our current genetic preferences should be edited, for all time, into our children and our children’s children… Decisions such as whether or not to edit human genes should not be left to elite and invisible experts[.]
Patricia J. Williams, writing in The Nation, reminds us that so much more is at stake in the question of whether to genetically modify the human species than just the health of an individual resulting child.
As sociologist Nikolas Rose has observed, the very project of medicine seems to have shifted from a metric of health versus disease to one of ever-expanding perfectibility of the species itself… The post-War aversion to eugenics—the understanding that despite great variability from one human to another, no one life is worth more than another—has eroded.
Writing in The Hastings Center’s Bioethics Forum, Gregory E. Kaebnick reminds us of an important limitation of any gene editing technique at the moment:
[I]dentifying the correct genetic changes is the real issue, though, and CRISPR/Cas9 doesn’t even address this problem. In fact, no gene editing tool can solve the second problem, any more than a word processing tool can by itself solve the problem of how to write the next great American novel. To identify the “correct” genetic changes, we need to understand what the targeted gene does, but also how it interacts with other genes, and also how the genome interacts with environments. We’re not there.
And at Ivy Magazine, Jamie Metzl summarizes the dangers of human germline modification, including:
[P]lain hubris….When we tinker with systems we don’t fully understand, it is very likely we’ll make mistakes….A genetics arms race, especially if different societies have different ideas about the desirability of genetic selection and engineering….Start[ing] to see our children as consumer products.
Metzl invites readers to visit his website and read his novel Genesis Code, and notes that “This may be the most important issue of our lifetime, and yet it hasn’t entered into public consciousness."
These articles are welcome, and necessary, contributions to the public debate at a time when some “practical bioethicists” (all of whom have argued in favor of human germline enhancement) can see only “emotive panic” in the call for broad engagement with this consequential decision for the human future.
It is also nice to see stem cell biologist Paul Knoepfler take these transhumanist-leaning Oxford bioethicists to task for their “one-sided verbiage”:
So experimentally de novo creating designer babies with gene edits that the resulting genetically modified people could then pass along to future generations forever with unknown consequences is really not so different than say getting your vision corrected, stepping outside to smoke a cigarette, changing ones friends or allowing new generations to use the Internet?
I don’t think so.
Other scientists continue to be vocal critics, too. Eric Lander, founding director of the Broad Institute of MIT and Harvard, told C. Simone Fishburn of BioCentury that there is no therapeutic application he can think of that would justify gene editing in human germline cells.
Huntington's patients are heterozygous; 50% of the embryos are just fine, so you can use IVF. There's no case for using germline gene editing in Huntington's because we have a simple technology for people with the disease… We need to truly ban this from a moral standpoint.
Amazingly, despite such widespread disapproval for barreling ahead with this level of manipulation of future humans, it seems that commercial ventures have already been established to utilize precision gene editing techniques. OvaXon is a joint venture between OvaScience and Intrexon that promises to develop “new applications to prevent the transmission of inherited diseases by gene-correcting egg precursor cells for applications in human and animal health.”
A sentence from the article in The Guardian is worth repeating: “Knowing science does not teach us how to live well with its power.” The increasing collapse of barriers between scientific endeavor, commercial enterprise, and careerist aspiration mean that we can no longer casually defer to scientists as voices of objectivity. Moving forward, we desperately need to broaden the conversation about the desirable uses of this technology to include students and teachers, public health workers, reproductive and disability and racial justice advocates, concerned members of the public, and more. There is surely as much to learn and consider about the social and policy implications of germline modification proposals as about their technical details.
DARPA wants to change the world — again. The Defense Advanced Research Projects Agency, as it is rarely called, mostly focuses on national security and "game-changing military capabilities" but its range goes much wider. The agency boasts of its contributions to our high-tech society, including the Internet, GPS and even graphical interfaces. And now synthetic biology is becoming an important part of its agenda.
At the end of March, the agency released a 40-page report, Breakthrough Technologies for National Security [pdf]. As the press release summarizes, one of DARPA's four current main areas for "strategic investments" is:
Harness Biology as Technology: To leverage recent breakthroughs in neuroscience, immunology, genetics and related fields, DARPA in 2014 created its Biological Technologies Office, which has enabled a new level of momentum for the Agency's portfolio of innovative, bio-based programs. DARPA's work in this area includes programs to accelerate progress in synthetic biology, outpace the spread of infectious diseases and master new neurotechnologies.
The report is basically a PR document. Skeptics such as Ed Hammond point to unaddressed risks of field releases and the engineering of vaccines; bioethicist Jonathan Moreno is concerned that DARPA doesn't seem to take ethical advice seriously.
But there are those who are thrilled by the new vision: transhumanists. A well-reported article in February's H+ (humanity-plus) magazine is triumphantly titled:
Biology is Technology — DARPA is Back in the Game With A Big Vision and It Is H+
The piece summarizes the agency's ambition in this arena:
They're out to revolutionize the practice and products of bio-science and along the way they are re-defining what it will mean to be human.
DARPA is not the only federal agency ramping up biotechnology. The Department of Energy's Joint Genome Institute, which has been deeply involved in genome sequencing for years, is planning, according to GenomeWeb, to move "into functional genomics and synthetic biology."
Government agencies have long been involved in many kinds of high-tech research. International security expert Nafeez Ahmed may perhaps overstate his case, but the connections between the various defense and surveillance industries and Silicon Valley are real. This would be less surprising, and less unsettling, if it were not for the widely shared perception that the high-tech titans are now fundamentally disconnected from morality, as Eric Giannella details in "Morality and the Idea of Progress in Silicon Valley." In defense and high tech, it is fair to say that transparency has rarely been a priority. It is worrying to think that synthetic biology may be heading in the same direction.
We hear that, at the press conference promoting the new DARPA report, some journalists asked about the current controversies over human germline engineering, and were brushed off with a dismissive comment about "pressing on." This does not seem to have been published, so we cannot confirm it, but it's certainly plausible. DARPA Director Arati Prabhakar is quoted (or perhaps paraphrased) in The Atlantic as saying that "the agency constantly considers the political and scientific controversies surrounding biotechnology research, but that it isn't in the interests of DARPA or the nation to hold back because of controversy."
Clearly this recent DARPA focus on cutting-edge biotech is potentially quite disturbing. At best it means that secret, unaccountable biological research is continuing; at worst — if government-funded scientists are pursuing human germline modification behind closed lab doors — that we have a lot more to worry about than we thought.
An Institute of Medicine committee is in the midst of a 19-month study, undertaken at the FDA’s request, of the “ethical and social policy considerations” of germline-modifying techniques that cobble together gametes or embryos produced with eggs from two women. The committee held its first public meeting on March 31 and April 1, in the wake of statements of concern about human germline gene editing by several groups of prominent scientists.
Presumably because of the Center for Genetics and Society’s longstanding interest in the techniques and their serious implications, I was invited to speak on a panel about human germline modification. The materials I received in preparation for the meeting included questions about the social and ethical implications of modifying genes that are inherited by future generations, and about the historical context of the prohibitions against human germline modification that have been put in place by several international human rights treaties and dozens of countries (though not the US).
Another question was whether it would be “advisable” to draw policy lines between therapeutic and enhancement applications of genetic modification techniques, the implication being that this might be preferable to the current widespread agreement that encourages gene transfer to treat sick people, but puts off limits changes that would be passed on to children and subsequent generations. Several invited speakers addressed these questions from a cautionary perspective; see, for examples, here and here.
Unfortunately, most of the IOM committee members seemed remarkably incurious about these points. Few follow-up questions were asked about the societal implications of human germline modification, or about the social values and concerns that have prompted more than 40 countries to adopt laws against it. Committee members didn’t inquire, let alone probe, about the effects of violating this prevailing policy agreement, or about the commercial and social dynamics that might come into play if human germline modification were to be introduced into fertility clinics.
There was, however, a framework of value-laden assumptions that seemed to guide many committee members. In this framework, ethical considerations center on relationships between physicians and their patients, and between researchers and their human subjects (in this case, with parents acting as proxies for their future children). Thus the overwhelming majority of committee members’ comments and questions about ethics involved matters of informed consent, acceptable risk, and whether it was permissible for parents to be required or encouraged to permit medical follow-up of any children produced as a result of germline mitochondrial manipulation.
In short, “ethical considerations” were largely equated with “research ethics,” a critically important but ultimately narrow set of guidelines that is indifferent – and sometimes hostile – to broader social concerns. Within this research ethics framework, the plans and prerogatives of scientists are subject to limits only when there is clear evidence that they are likely to directly harm individuals.
Also central to many committee members’ thinking are those parental desires for genetically related children. For some, such desires trump even the fact that trying to fulfill them would put any resulting children at significant risk. From this perspective, the risks to a child born as a result of mitochondrial manipulation should be weighed against the burden of mitochondrial disease. Of course, this logic assumes both that people at risk of passing on mitochondrial disease have no alternatives, and that the desire for a child who is not just healthy but full genetically related is paramount.
In fact, there is a much less risky way for the overwhelming majority of women with mutated mitochondria to have healthy and genetically related children. But this was also curiously under-explored. Some speakers simply ignored the availability of pre-implantation genetic diagnosis (PGD), an embryo-screening technique that can identify “healthy” embryos for almost all affected women. Another speaker, a proponent of moving ahead with mitochondrial manipulations, went into some detail about the successful use of PGD in Europe for preventing the transmission of mitochondrial disease. But his remarks failed to prompt any reconsideration of the need for germline mitochondrial techniques.
One of the final invited speakers, University of Texas bioethicist John Robertson, is known for his theory of “procreative liberty,” which elevates the desire of some parents for a genetically related child to a right that should be constitutionally protected. Although risks to women and offspring can be taken into account, Robertson argued, any other concerns are “airy” and “moralistic.”
The FDA commissioned the IOM study because its own focus is supposed to be safety and efficacy, and because it recognized the salience and critical importance of broader concerns about mitochondrial manipulation techniques after they came up repeatedly at its February 2014 Advisory Committee meeting. Taken as a whole, the day-and-a-half conversation at the recent IOM meeting leaves a lot of room for a more thorough exploration of the “ethical and social policy considerations” of these germline-modifying techniques. The IOM committee plans another three meetings before it develops its report to the FDA. So there’s still time, if there’s interest and willingness.
Michael Hiltzik of the Los Angeles Times used newly published research by Kalina Kamenova and Timothy Caulfield [abstract] to write a scathing article largely focused on the California Institute for Regenerative Medicine (CIRM):
New study: Stem cell field is infected with hype
This conclusion is scarcely novel, but both the academic analysis and the polemical journalistic commentary are welcome. The researchers examined "the portrayal of translational stem cell research in major daily newspapers in Canada, the United States, and the United Kingdom between 2010 and 2013" and found that optimistic perspectives outnumbered pessimistic ones by more than five to one, with less than a third of the reports being neutral.
Kamenova and Caulfield conclude by essentially pinning the responsibility on scientists for "authoritative statements … regarding unrealistic timelines." Hiltzik, on the other hand, "wouldn't give journalists this much of a pass," noting their complicity in exaggerating promises of breakthroughs and cures.
In fact, there is plenty of criticism to spread around.
There are also long-term effects of stem-cell hype. Many people are still predisposed to believe hucksters — and why wouldn't they be? Weren't we promised cures a decade ago?
Blog comments reveal that some people now think that the pharmaceutical multinationals are in cahoots with the FDA to prevent treatments from becoming available. (The discussion at this post, in which Paul Knoepfler explains the need for regulation, is one of the better threads.) It is therefore hardly surprising that desperate patients are willing to travel to Mexico, or the Philippines, or the Bahamas, or elsewhere, and to spend thousands of dollars on what are almost certainly placebos at best.
The stem cell hucksters and frauds have become so blatant and widespread that a number of prominent figures and organizations in the field have begun working hard to counter them. This is a welcome development. But the researchers, biotech entrepreneurs, patient advocates and others who puffed the possibilities of stem cells, perhaps most egregiously in the Prop. 71 campaign that led to CIRM, never seem to admit responsibility for the fantasies they did so much to promote.
What may draw their attention is that increased funding for CIRM, as David Jensen notes, is looking unlikely:
The agency has undoubtedly made a major contribution to stem cell science. But the unfulfilled promises of the campaign hype gave its foes the kind of tools they need to battle any efforts to provide more state funding for the agency.
Meanwhile, governments around the world are also beginning to wrestle with the details of regulating stem cell clinics. It's about time.
In a March 5 expose in MIT Technology Review titled "Engineering the Perfect Baby," Antonio Regalado reported on just how close some scientists are to using the precision gene editing technique CRISPR to modify nuclear DNA within human gametes or embryos. A week later, an article in Nature alluded to rumors that this has already been done, and that papers reporting on it will be published shortly.
This startling news has prompted statements about human germline modification from three different groups of scientists so far: one published in Nature, one in Science, and one released by the International Society for Stem Cell Research. All discourage clinical applications and call for public dialogue and debate to acknowledge the profound societal, policy, ethical and safety implications raised by efforts to control the genes we pass on to future generations – a welcome sign from within the scientific community. But the statements offer a range of different paths forward.
A Center for Genetics and Society press statement released this morning supports the call for a moratorium on human germline gene editing. CGS opposes efforts to create genetically altered human beings, and has long advocated that the United States join the 40+ other countries that already prohibit this.
The proposal for the strongest moratorium came from scientists writing in Nature under the clear headline "Don’t edit the human germ line." Their commentary, posted on March 12, calls for "a voluntary moratorium in the scientific community" to discourage human germline modification and to raise public awareness of the critical difference between gene editing in somatic cells and in germ cells. The authors include scientists and executives associated with the gene-editing company Sangamo BioSciences and with the Alliance for Regenerative Medicine, an advocacy organization of stem cell companies and institutes, whose executive committee approved the statement.
The authors emphasize a key distinction between altering somatic (non-reproductive) and germline cells. While somatic gene therapies hold real medical promise for treating a range of diseases, the medical rationale for using germline alterations on gametes or embryos is unconvincing. As the authors of the Nature commentary put it, “Heritable human genetic modifications pose serious risks, and the therapeutic benefits are tenuous.”
(Unfortunately, the authors seem less concerned about “mitochondrial DNA transfer,” which is an example of a distinct, but nonetheless profound, form of germline alteration that poses an accompanying array of inherent challenges. Is there a justifiable reason to condemn every form of germline alteration but this one? Does this really qualify as a “truly compelling case” when safer alternatives exist?)
The second commentary, published today by Science, is authored by a group of prominent bioethicists and scientific figures. As suggested by its title, “A prudent path forward for genomic engineering and germline gene modification,” its tone is more permissive than that of the Nature statement, and in fact it encourages moving ahead with germline gene editing research. It does, however, “strongly discourage…any attempts at germline genome modification for clinical applications in humans, while societal, environmental, and ethical implications of such activity are discussed among scientific and governmental organizations.”
A statement from the International Society for Stem Cell Research, also released today, takes a similar line, calling for “a moratorium on attempts to apply nuclear genome editing of the human germ line in clinical practice.” It notes that
consensus is lacking on what, if any, therapeutic applications of germ line genome modification might be permissible. For example, some argue that the ability to eradicate disease justifies attempts at therapeutic editing of the human germ line, while others emphasize the difficulty of drawing clear distinctions between applications in human disease and attempts at human enhancement.
Science’s Gretchen Vogel sums up the broad calls for restraint here, noting that while these technical possibilities were mostly hypothetical at the infamous 1975 Asilomar conference, we now have to face their reality. Vogel quotes George Church asking: “What is the scenario that we’re actually worried about? That it won’t work well enough? Or that it will work too well?” The fact that both scenarios are deeply troubling marks human germline modification as one of the world’s most dangerous and consequential technologies.
Posted by Lisa C. Ikemoto, Biopolitical Times guest contributor on March 19th, 2015
This ad appeared as a “suggested post” on a law student’s Facebook News Feed page. Sponsored by A Perfect Match, a southern California company that “specializes in the recruitment of intelligent, college-aged egg donors,” it includes appealing taglines: “Gift of life,” “$10,000 or more,” “Change lives . . . earn money!”
The law student said the ad made her feel “like a hen.”
The fertility industry asserts that women gift their eggs for others’ use and receive payment for the time and effort of doing so. Thus, we call them “egg donors.” In fact, the egg donation process carefully calibrates the ratio of altruism and financial need that motivates women to provide eggs for other’s use.
Medical sociologist Jennifer Haylett’s work in fertility centers reveals that staff screen out applicants who place too much emphasis on financial motive. Rene Almeling’s research shows that fertility clinics nudge egg providers to construct altruistic explanations. And yet, what intended parents and agencies pay for are ascribed traits.
The ABCs of egg donation are SAT, IQ, and college ranking. High scores and enrollment at prestigious universities are central to the egg market. Certainly, other traits matter, as well. Youth, good health, race, ethnicity, religion, good looks, height, and athleticism are among the characteristics used to solicit, profile, and select women. Women not enrolled in college are sometimes chosen as third-party egg providers. But what agencies prize are college students.
Third-party eggs form the basis of a luxury market governed by the rules of supply and demand. For example, demand for eggs from Asian women exceeds supply. Thus, prices offered to Asian women for their eggs sometimes exceed the prices offered to women of other races. However, it is the elitist criteria – near-perfect SAT scores and a place at a top-ten university – that consistently command the higher prices.
Paying women to provide high IQ eggs resembles a mix of awarding scholarships and executing futures contracts. Universities, egg agencies, and intended parents offer “$10,000 or more” to applicants who meet the elite criteria. Like commodities traders, they are speculating. Agency ads invite speculation in high scores as predictors of future success. It is probably true that if and when conception with third-party eggs results in birth, parents care more about the happiness and well-being than the IQs of their children. But at the outset, so-called traits like test scores matter. They matter most because of the ways in which SAT, IQ and college ranking are used to sort and price women who want “to change lives and earn money.”
The “High IQ Eggs Wanted” ad omits any notice of health risks arising from ovarian stimulation and egg retrieval. California law requires that ads include specific notice language that includes the statement, “There may be risks associated with human egg donation.” The law exempts members of the American Society for Reproductive Medicine (ASRM) who certify compliance with ASRM guidelines. By its own admission, A Perfect Match, Inc. exceeds the ASRM guidelines that restrict payment to women to $5,000 to $10,000, and is therefore subject to the notice requirement.
The California law also requires disclosure to women, before any contract is signed, of “specific information on the known risks of egg donation.” Disclosure does not address risks arising from the conflict of interest that pervades egg retrieval from egg donors – most physicians who perform the procedure are paid to maximize the fertility chances of another.
However, disclosure is important. Known risks focus on short-term, physical risks. They range from mild to severe effects of the drugs used to suppress ovulation, stimulate production of multiple eggs, and then release the eggs simultaneously. Severe ovarian hyperstimulation syndrome (OHSS) may be the scariest risk. Researchers have identified risk factors for OHSS,and ironically, agencies select for two of these factors – youth and low body mass index. It is suspected that conflict of interest prompts use of a third factor – high doses of ovarian stimulation drugs to maximize egg production.
There are unknowns, as well, including long-term effects of the drug most often used for ovarian suppression. Apparently, that’s the acceptable cost of making the gift of life.
Lisa Ikemoto, J.D., LL.M., is Professor at the University of California, Davis School of Law, where she teaches bioethics, health care law, public health law, reproductive rights, law & policy, and marital property, and a Fellow at the Center for Genetics and Society.
Posted by Ricki Lewis, Biopolitical Times guest contributor on March 16th, 2015
I have been struggling with why the idea – and likely coming reality – of universal newborn genome sequencing disturbs me. It’s finally crystallized: the practice could create a genetic underclass.
On the day that genome sequencing of all newborns begins, a cohort of individuals about whom a tremendous amount of personal information exists will be instantly created. At the same time, the practice will establish a shrinking cohort of most of the rest of us who do not know our genome information.
A century from now, possibly everyone will have access to her or his genome data. But until then, how can we prepare to handle the avalanche of information of what I’d call, if I were a science fiction writer, “generation Alpha?”
My idea of the Alphas is inspired by the 1992 dystopian novel The Children of Men, by P.D. James. In 1994, all human sperm suddenly die, and 1995 becomes Year Omega. After that, populations plummet in the face of global infertility, with the last remaining people, the Omegas, struggling towards inevitable extinction.
What will happen in our world as the Alphas age? For now, mining sequenced genomes is experimental and seeks to end the “diagnostic odysseys” endured by patients, typically children with rare or one-of-a-kind diseases . But just as opening a magazine can reveal much more than the article one is looking for, a genome sequence provides hundreds of thousands of gene variants that might mean something about a person’s health. And so the American College of Medical Genetics and Genomics lists 56 “actionable” secondary (“incidental”) conditions, a minimal menu of conditions which doctors can prevent or treat. The list is always growing.
Thousands of newborns have already had their genomes sequenced, and the actual deciphering takes under a day – a lot better than the decade it took for the first human genomes. But our understanding of our genomes, of how genotype becomes phenotype, lags behind the ability to decipher the overlapping strings of A, C, T and G. The value of an “annotated” genome to “raw sequence” is like comparing the meaning of the novel To Kill a Mockingbird to the book cut up into a pile of tiny pieces. When it comes to genomes, meaning and context are everything.
The era of looking for what we already know, the “round up the usual suspects” approach to gene identification and disease diagnosis, will gradually end as more human genome sequences and their interpretations are stored in clouds. Our algorithms will ultimately identify all possible gene variants and all possible combinations of and interactions among them – and what they mean at the whole-body level, the phenotype.
My concern is not those “usual suspects,” the well-studied mutations known for decades to cause inherited illness: cystic fibrosis, sickle cell disease, Huntington disease. I fear the fuzzier genetic information. Genome-wide association studies, for example, identify suites of gene variants that signal a good chance that an illness will happen, but not with the power of a clinical diagnosis. The media often trumpet such findings with a false sense of certainty. (Note on terminology: “gene variant” is a broader, more politically correct term without the negative connotation of “mutation,” which classically means “change in a gene” from the most common form [“wild type”] in a particular population.)
What I fear most isn’t the use of genome information in predicting disease, but in identifying the harder-to-follow, multifactorial traits that are molded by genes and the environment: intelligence, personality, temperament and talents. Each gene contributes a small amount and to a differing degree to characteristics that aren’t as neatly predictable as the single-gene, Mendelian disorders like cystic fibrosis.
Will the idea of genetic determinism – that we are our genes – strengthen as the stockpile of genomic information swells through the population, beginning with the youngest? Will the practice become the ultimate example of paternalism, because newborns weren’t asked? As they age, can they choose not to know? Will that even be imaginable, as today it is difficult to envision a time without the Internet? Choosing not to know will be especially difficult if others have access to genome information. And who should those others be?
Annotated genome sequences could guide pediatricians in troubleshooting problems, providing a powerful new tool in preventive medicine. At the first birthday, a microbiome analysis might be added to identify children with tendencies towards certain conditions, or with underdeveloped immune systems due to too much cleanliness.
Beyond infancy, will availability of genome information fuel stratification as DNA information better predicts who is most likely to benefit from a scarce medical resource, and only the young have that information? Years from now, will I be denied a treatment unless I have my genome sequenced to show that I’m just as likely to benefit as a 20-year-old whose genome has been in the electronic medical record since birth?
In a few years, will posh preschools scan applicants’ genome information to select pupils? Will teachers use it to create compatible playgroups, or to identify bullies like the Tom Cruise film Minority Report punished future criminals? Will standardized test scores be compared to DNA data to deduce whether students are working up to their potential? Will employers look for genomic red flags, the way they stalk Facebook now for visual evidence of stupidity? I’ve already written about the fallacy of DNA-based dating.
I’m not sure where all this is heading, but it is coming. Newborn genome sequencing could happen within 5 to 10 years, experts have told me. At a conference April 8-10 at Children’s Mercy in Kansas City, several research groups already doing this work will address population-wide newborn genome sequencing. That’s a great start to what will certainly be an intriguing and important conversation.
Ricki Lewis is a science writer with a PhD in genetics. She is author of The Forever Fix: Gene Therapy and the Boy Who Saved It (St. Martin’s Press), the college textbook Human Genetics: Concepts and Applications (McGraw-Hill Education), and co-author of two human anatomy and physiology textbooks. She has also published a short human genetics book, an essay collection, a novel about stem cells, and more than 3,000 articles. She writes the DNA Science blog at Public Library of Science and contributes regularly to Medscape Medical News. Ricki is a genetic counselor at CareNet Medical Group in Schenectady, NY, and teaches “Genethics” online for the Alden March Bioethics Institute of Albany Medical College. She lives near Schenectady, New York with husband Larry and many felines.
98% of all babies born in the United States have a tiny prick of their blood screened for a few serious diseases within the first few days of their lives. This test has been hugely successful at catching and beginning early treatment for inherited diseases such as sickle cell anemia and severe combined immunodeficiency.
Pressure is now mounting on multiple fronts to take advantage of this wellspring of potential genetic information. In the past, some states, most notably Texas, have gotten in trouble for their willingness to give it up for uses with which many parents are uncomfortable.
Now, attention has turned to California. In an article in U-T San Diego, the Council for Responsible Genetics’ Jeremy Gruber points out that while 19 states store these samples for more than two years, only California and a few other states keep them permanently and rent them out to researchers for a fee.
While the state’s Department of Public Health asserts that the samples are anonymous, we’ve been learning over and over again that DNA is rarely truly anonymous.
For example, the UK Department of Health finally acknowledged in correspondence with The Guardian that the genomic information in the 100,000 Genome Project will not actually be anonymous, but “pseudonymised” – though they have continued use of the former term publicly because apparently “the term ‘pseudonymisation’ is not widely understood.”
In the US, each state is rapidly building its criminal DNA database, in some cases using DNA from people never convicted of a crime. In an article in The Sacramento Bee, Jeremy B. White reports on growing concern about outside pressure to find new ways to access genetic data, by whatever means necessary. Jennifer Lynch, a senior staff attorney at the Electronic Frontier Foundation (EFF), asked “are we going to get to the point where law enforcement says, ‘Well, we have this giant repository with the information of everyone born in California in the last 30 years, and that’s a huge treasure trove’?”
It’s not an entirely abstract concern. Earlier this month, the Supreme Court sided in favor of letting a conviction stand that had been made using DNA collected from an interrogation-room chair.
In a brief to the Court, the EFF warned that "allowing police the limitless ability to collect and search genetic material will usher in a future where DNA may be collected from any person at any time, entered into and checked against DNA databases, and used to conduct pervasive surveillance."
Even if newborn DNA is never explicitly shared with police enforcement, Assemblyman Mike Gatto, D-Los Angeles believes “it’s only a matter of time before there’s a high-profile hack.” Gatto has created a bill (AB 170) to help parents regain agency over the fate of these samples. The bill would enable parents to choose to have their babies’ sample destroyed immediately after its intended use.
But the bill wouldn’t necessarily do enough if parents aren’t properly informed. Gruber has found that the majority of people don’t see any written materials explaining what will happen with their newborn’s sample, and that in California, consent to long-term storage and third-party use is simply assumed unless parents take the initiative and put their dissent in writing. He points out that newborn screening and storage tend to be exempt from state genetic privacy laws, so improved transparency will be critical to preventing misuse.
Posted by Jaydee Hanson, Biopolitical Times guest contributor on March 5th, 2015
Lawmakers in Virginia have agreed to pay compensation to people who were forcibly sterilized between 1927 and the early 1970s. The decision makes Virginia the second state after North Carolina – out of more than 30 with eugenic programs during the twentieth century – to provide restitution to those sterilized by their state governments.
Virginia passed its Eugenical Sterilization Act in 1924. Almost immediately, the Virginia Colony for the Epileptic and Feebleminded selected a test case that would allow other sterilizations to proceed: Carrie Buck, a 17-year-old young woman committed to the Colony by her foster parents after she gave birth to an illegitimate child conceived when she was raped by one of their relatives.
Buck’s court-appointed attorney called no witnesses to challenge the charges made about her mental health, or to question the science behind the eugenic theory espoused by so-called expert witnesses. The Amherst County Circuit Court quickly affirmed the sterilization law, as did the Virginia Supreme Court of Appeals. The Buck v. Bell case then went before the United States Supreme Court, which upheld it by a vote of 8 to 1 on May 2, 1927. In his opinion, Chief Justice Oliver Wendell Holmes, Jr. agreed with the “expert” witnesses at Buck’s original trial, asserting in a now infamous comment that “three generations of imbeciles are enough.”
A few months later, Carrie Buck became the first person in Virginia to be sterilized under the new law. Over the next 50 years, another 8,000 persons were sterilized in six Virginia facilities. Two thirds were women, most of them poor or African American.
Some 63,000 people were subsequently sterilized in similar programs across the US, more than 20,000 in California alone. The Virginia state program is also considered to have provided a model for other nations, including Nazi Germany.
During the late 1800s and early 1900s, eugenics was widely considered “good science” and “good religion,” and many US organizations and educated elites were strong advocates of eugenic laws. Today, few of these organizations have acknowledged or repented for their past support. Most Protestant denominations participated in the religion committee of the American Eugenic Society, but to my knowledge, only the United Methodist Church has formally apologized.
Virginia’s eugenic sterilization law was revoked in 1979. It has taken 35 years for the state to decide to provide financial reparations for its victims, each of whom will receive $25,000. Sadly, many have died since 1979; it is estimated that fewer than 20 may still be alive, and the whereabouts of only 11 are known.
The compensation effort united liberals and conservatives in the state. The conservative Christian Law Institute was joined by the liberal United Methodist Church and by my organization, the International Center for Technology Assessment, in advocating for the payments. The compensation measure was sponsored by Delegate Ben Cline, a conservative Republican from Rockbridge County, and Patrick Hope, a liberal Democrat from Arlington County who happens to be my delegate.
The bill originally would have granted $50,000 to each person sterilized under Virginia’s program, the amount provided by North Carolina. But fiscal conservatives balked, and the sponsors agreed to the lower amount in order to get the bill passed now. In the past year, two more of those sterilized by the state’s program have died, so the $400,000 appropriated will likely be more than enough for all the surviving victims of this sad chapter in Virginia’s history.
A lengthy and consequential policy process in the UK has now come to an end. Despite what could turn out to be insurmountable legal and safety hurdles, on February 24 the United Kingdom legalized the use of nuclear genome transfer, also known as “3-person IVF” or “mitochondrial donation,” a suite of techniques that combine genetic material from two eggs or embryos causing inheritable alterations to the human germline.
After several hours of debate, the House of Lords gave overwhelming final approval to pass the regulations that had also been approved following 90 minutes of discussion in the House of Commons February 3. These regulations, which go into effect October 29, will enact a limited exception to the UK’s prohibition of the genetic modification of human gametes or embryos.
The understandable goal of these techniques is to prevent the maternal transmission of certain kinds of rare mitochondrial diseases. However, as CGS pointed out in a statement following the news, using experimental biotechnologies to bring a new person into the world is a very different prospect from using them to help someone alive today. Unlike a gene therapy that only impacts the single consenting individual, manipulations of gametes and embryos create permanent changes to the human germline that are passed on to future generations. This trans-generational experimentation is a dimension of the risk/benefit ratio that regulators have never dealt with explicitly before. And it’s a big part of why germline modification is prohibited in over 40 countries and by multiple human rights treaties.
It is not encouraging that this decision was made despite the fact that scientists from around the world warned that the techniques could well cause more problems than they solve, and that an early pioneer of their development, David L. Keefe, MD, abandoned them because he believes they are too dangerous for any resulting children. In a letter to the senior policy officer of the UK’s Human Fertilisation and Embryology Authority (HFEA), Keefe, chair of Obstetrics and Gynecology at NYU Langone Medical Center, explains that there is already a safer alternative available for women who want to have a healthy, genetically related child.
UK authorities have made assurances that more robust safety data is still coming and that no attempts will be made before that data is in. However, women were already being urged to give up their eggs to enable these techniques and “save as many lives as possible” weeks before the final vote even took place.
Amazingly, it seems that clinical trials of these techniques are actually illegal in the UK since the European Union Directive on clinical trials states "No gene therapy trials may be carried out which result in modifications to the subject's germ line genetic identity." This may be why discussion has centered on clinical use rather than clinical trials. But some UK lawyers, including international law expert Daniel Brennan, have argued that these regulations are nonetheless in violation, and legal challenges may be undertaken.
Has the desire to be at the forefront of biomedical innovation encouraged some of the people working on and promoting these techniques to overlook these challenging, if not insurmountable, legal and safety hurdles? It is unfortunate that this process came to feel like a petty political battle instead of a sober and honest assessment of a use of genetic technology long considered “contrary to human dignity” by the Universal Declaration on the Human Genome and Human Rights.
This move has now turned the UK into an international outlier, but it may not remain that way for long. Shoukhrat Mitalipov of Oregon Health and Science University is initiating a business arrangement in China with Boyalife (and infamous cloning fraudster Woo Suk Hwang) to commercialize these techniques for his company, Mitogenome Therapeutics. He intends to use germline modification techniques not only for the prevention of rare mitochondrial diseases, but for the treatment of age-related infertility. Regarding that “slippery slope” everyone insisted was ludicrous? As Pete Shanks pointed out, “We didn't have to wait a week.”
The US Institute of Medicine has a tough job ahead of it now. It has been charged by the FDA to consider the ethical and social policy issues raised by these techniques and to produce a consensus report that will undoubtedly influence the future of germline modification in the US. On March 31 and April 1, the committee will be holding a public workshop in DC – you can register for the workshop here.
Scientists at the University of Cambridge working with the Weizmann Institute have created primordial germ cells — cells that will go on to become egg and sperm — using human embryonic stem cells. Although this had already been done using rodent stem cells, the study, published today in the journal Cell, is the first time this has been achieved efficiently using human stem cells.
Two months later, Lois Rogers of the London Sunday Times caught on that these were artificial gametes, interviewed some of the scientists and published a piece titled
Cell breakthrough to bring two-dad babies
A senior co-author, Jacob Hanna of the Israeli Weizmann Institute, went so far as to suggest that the technique might lead to a baby "in just two years." (Other experts are not convinced; the phrase "total baloney" has been used.) And from there, the story hit Newsweek and a flurry of headlines.
Artificial gametes have been a source of discussion for so long that a recent survey in Human Reproduction turned up 2424 articles. Indeed, the UK HFEA has had a backgrounder on the subject for at least five years; the use of "in-vitro derived gametes" for reproduction is prohibited in the UK, and the creation of embryos for research would require a license.
The recent paper is an incremental step. The research is real, and the science is interesting, particularly (as the journal article title suggests) in the discovered difference between mouse and human development.
But it would be a very long way from this development to any kind of practical use.
There might eventually be some medical value derived from this work, but don't hold your breath. Moreover, as Paul Knoepfler notes, "there’s a 'dual use issue' here. This same kind of technology, if applied by some rogue scientists, could be used to clone human beings as well." Knoepfler goes on to remind us that the United States has no formal policy prohibiting human reproductive cloning, and that it's "probably well past time" for one to be put in place.
The techniques could also facilitate human germline genetic modification, also not regulated by law in the US. Both human reproductive cloning and germline modification are prohibited in dozens of other countries.
As long ago as 2008, Marcy Darnovsky wrote in the San Francisco Chronicle, when a rodent experiment made similar headlines:
Why are speculative and risky technologies being held out to lesbians and gay men as tantalizing prospects? Are reproductive methods that amount to dangerous experimentation on their children really a road to freedom for gay families? Or is the language of equality and empowerment being used to justify human experimentation that puts these children at great risk?
On Tuesday February 3, the UK House of Commons voted in favor of legalizing nuclear transfer so that a small number of women with a particular subset of mitochondrial disease could try to have unaffected and genetically related children. The British press headlined it the next day, and the rest of the world's media then caught on that this was a Very Big Deal. The Associated Press report noted that:
While this legislation was drafted specifically to grant permission only for certain specified techniques, critics fear it will encourage scientists to push for other experiments in the future.
No, no, said supporters on both sides of the pond. "This is not a slippery slope," UK Public Health Minister Jane Ellison insisted. Susan Solomon of the New York Stem Cell Foundation agreed. Bioethicist Arthur Caplan also discounted worries about the slippery slope. So did the MP Frank Dobson, in the Commons debate.
Really? We didn't have to wait a week.
On Sunday February 8, British newspapers reported that Shoukhrat Mitalipov of the Oregon Health and Science University (OHSU), who pioneered a variation of the techniques in question, had asked the FDA for permission to start clinical trials of it in order to treat age-related infertility. This concept is not new: It was part of the FDA discussions in February 2014, critiqued and dismissed, and discussed again last summer. Nor is it a surprise that Mitalipov applied, though this may be the first public announcement.
Here's the fun part (#1): Mitalipov told The Independent that "We hope [the UK vote] will help in the US, and hopefully the FDA will move faster." In response, said the UK Telegraph:
if the technology was made available to infertile women in America, there would be growing pressure for Britain to follow, experts said.
This is what's technically known as a Trans-Atlantic Cross-Ruff.
(The term was coined to describe the early career of the American actress Raquel Welch, who arrived in the UK with publicity claiming she was the newest Hollywood bombshell, made a movie in which she wore a fur bikini, and returned home as the newest Hollywood bombshell.)
And here's the fun part (#2): Bioethics Professor John Harris not only supports the idea (he supports pretty much everything techno) but insists that
"It could not be argued this is further down a slippery slope for the simple reason the slippery slope applies to the extension of the technique, not to the use of the same technique for another therapeutic purpose — and treating infertility is recognised as a therapeutic purpose."
Off-label use of human germline engineering? No problem!
But wait, there's more! Here's the real fun part (#3): Just two days later, on February 10th, Science Insider published this story about Mitalipov:
Stem cell pioneer joins forces with stem cell fraudster
Yes, that means the notorious Korean scientist, Hwang Woo-suk. The guy who claimed to do what Mitalipov actually did do — custom-make embryonic stem cells. The "fake it till you make it" guy who got caught fabricating data, embezzling public funds and abusing women to get at their eggs. The disgraced guy who has been trying hard to rehabilitate his reputation for a decade. The guy who does clone dogs and wants to clone a mammoth. The guy who desperately hopes to get his license to work with human cells back from the Korean authorities.
Mitalipov tried to walk the story back a bit the next day in Nature, insisting that he was "baffled by reports that he and Hwang would be collaborating on academic research." Hwang would be collaborating with the Chinese company Boyalife on animal husbandry, he said, while Mitalipov would collaborate with Boyalife on non-human primate work. And the $93 million investment mentioned in the Science article? News to him! "I was very surprised to see all those zeroes," says Mitalipov. "We've only had one small meeting."
That doesn't square with Hwang's version, which Science translated from an interview with the Korean Dong-A Ilbo:
Mitalipov's "strength is in primate stem cells. My specialty is in cell nuclear transplantation. So we've agreed that if we combine his strength with mine, we can create a breakthrough outcome in curing maternal line genetic disease, on which he is now focusing," the paper quotes Hwang as saying.
It's entirely possible that Hwang is — to use another technical term — bullshitting. But even so, what on earth was Mitalipov thinking? The kindest interpretation is that he is frustrated that he cannot immediately move into human clinical trials in the U.S. But why take up with a disgraced fraudster? Why let himself be photographed shaking hands with Hwang? The picture is dated January 13, and Mitalipov seems to have kept quiet about it, so presumably he suspected he might face criticism. So … what was he thinking?
Media reaction to these new wrinkles has so far been quite muted, especially compared to the hubbub that accompanied the UK vote. There is no evidence that Mitalipov's proposal is having an effect in Parliament (the House of Lords is yet to vote), and most people seem to have drawn a discreet curtain over the cloning connection. Stem-cell scientist and blogger Paul Knoepfler, on the other hand, called Mitalipov and Hwang "The Odd Couple of Cloning Research" and described the venture as "a major development." Which it may turn out to be.
Presumably, Mitalipov did not actually intend to provide an illustration of the slippery slope. But it's hard not to see it.
Posted by George Estreich, Biopolitical Times guest contributor on February 9th, 2015
De-extinction raises a host of questions: ethical, practical, philosophical. But for advocates, there’s a rhetorical question as well: How do you persuade a lay audience to support the project? That persuasion involves special challenges: one has to explain and normalize a complex technology, answer ethical objections, and make a radically new approach to nature seem emotionally “right.”
De-extinction has been much discussed in print, but the most complete case for the project is made at the website of Revive and Restore, a nonprofit dedicated to “genomic conservation”; their “overall goal,” in their words, is “enhancing biological diversity and ecological health worldwide.” Revive and Restore—the project of environmentalist, entrepreneur and Whole Earth Catalog founder Stewart Brand, and his wife, Ryan Phelan—touts, sponsors, and helps to coordinate several hoped-for restorations, including the heath hen, the passenger pigeon, and the woolly mammoth. In TED talks and other forums, Brand has been a passionate advocate of de-extinction.
Revive and Restore’s webpages are artful and complex: words, images, and video combine and reinforce each other, and appeals to reason and emotion are interwoven. The total effect of these strategies is to present de-extinction as an ideal route to an ideal outcome; in doing so, however, the persuasion tends to erase or minimize complexities, both technical and conceptual. To see how this works, let’s take a closer look, beginning with the smallest unit: the word chosen to describe the project.
Prefixes, nouns, and frames
The word “de-extinction”—neutral, scientific-sounding—frames the discussion in a powerful way. That power resides largely in the prefix.
1. The prefix assumes a central and debatable premise: that extinction can, in fact, be reversed. If this premise is accepted, then conceptual questions (would an engineered approximation count as a revival? is it right to revive an Ice Age creature on a rapidly warming planet?) become secondary to technical ones (what is the best way to bring species back?). To Brand’s credit, he has engaged with these questions publicly; but they are clearly secondary to the project of revival, which has already begun.
2. The prefix also frames the technology as positive, opposing it to “extinction,” just as the word revival links it to life. At the same time, the coinage gives the reader a foothold in the familiar, linking synthetic biology to the known. This tactic is used throughout the webpages, which is filled with words like revive, restore, rescue, conservation, comeback. Often these words are paired with a technical word (“genomic conservation,” “genetic rescue”). These phrases position science and technology as saviors, not threats.
As a result, a complex world of ideas and choices is divided into simple alternatives: extinction or de-extinction, loss or rescue. This is the beginning of persuading people to adopt one alternative, and not the other.
What’s next? Filling in the frame with a picture.
Images: filling in the frame
On a well-designed webpage, words and images work together. That’s true of the Revive and Restore home page,
where reproduced paintings show us images of the species to be
restored, including a composed still life of lost species, with the
passenger pigeon front and center; an image of a single pigeon, soaring
in the sky; and a picture of a woolly mammoth in fisheye perspective,
its majestic tusks dominating the foreground, the curvature of the
earth barely visible behind it. The mammoth is, in Brand’s terms,
“iconic.” These images are informative, in that they show us species
that are lost; but their true function is persuasive: they help the
viewer imagine an ideal outcome of the de-extinction experiment.
In context, however, a digital reproduction of a painting is more than a little ironic. Though the lush realism of the image evokes another century, a time when many extinct species were alive and abundant, the image functions differently in practice: digitally reproduced, distributed on the Internet, viewed on screens, the images are computer-dependent reproductions used to advocate for computer-dependent reproductions. (In the large composed still life, we can “mouse over” lost species to learn more.)
The emphasis on the visual is a function of the medium. But this medium privileges the beauty of individual members of species over other things harder to represent: less beautiful species that matter more in an ecosystem (like, say, bees); groups of animals (it’s ironic that we see a single pigeon, and not flocks); and ecosystems themselves. But the emphasis on the visual is also driven by the economics of restoration. To paraphrase a recent interview with Brand,mammoths are easier to fund than mice: “As architects say, form follows funding. The animals that will draw avid supporters who have avid amounts of money will probably be the first ones that get dealt with.”
An idealized process
Persuading the public to approve of new technologies entails explaining those technologies. That explanation, however, has a persuasive bent. We can see this tendency in a clever graphic on the Revive & Restore site: the “extinction continuum.”
This graphic gives form to the project’s central premise. Like the word de-extinction, the graphic implies that species can be restored in their original state, while linking that premise to the power of biotechnology (“How Biotechnology Can Help” is the caption). It’s also deftly constructed, and more complex than it first appears.
In the graphic, both living and lost creatures are recognizable silhouettes, as if to emphasize the uncertain status of threatened or theoretically revivable species: present yet absent, gone but not lost. Only one creature—the dinosaur, with “no DNA” available—appears as a skeleton. The other animals, whether extinct or still living, are rendered in shades of gray. That, and the ability to see all the creatures in a single image, makes it almost as if the extinct creatures are still present—thus making “revival” imaginable, as if the pigeon simply needed to follow the green arrow back to “recovering.”
And yet the arrows, though graphically parallel, are conceptually askew. One (the red) is factual. The other (green) is hypothetical. Therefore, the diagram blurs the distinction between fact and projection. It is fact that the passenger pigeon is extinct; whether it is “revivable” is hypothetical, and “reintroduction” and “recovering” extend the hypothesis. Fact and optimistic projection coexist in the same image.
That optimism reaches its zenith in one of Stewart Brand’s selling points for reviving the mammoth: ameliorating climate change. In a short essay reproduced on the Revive and Restore site, Brand writes, “[The mammoth’s] return to the north would bring back carbon-fixing grass and reduce greenhouse-gas-releasing tundra.” In this paradigm, the mammoth—an engineered creature—will itself become an agent of geoengineering. Created to live on the earth, it will also alter the earth in a beneficial way.
Apart from the optimism cascade required to believe that synthetic mammoths will help lower the Earth’s temperature, the scenario displays a fundamental tension in the de-extinction project: it is sold with the rhetoric of restoration and preservation, but driven by an ethic of engineering and control.
To sum up: de-extinction frames the issues with a deft use of naming, establishes a vivid picture in words and images of a desired outcome, establishes biotechnology as the sole route to that outcome, and portrays the technology itself in a positive light.
Similar patterns are visible in the persuasive tactics used for other technologies, including noninvasive prenatal testing and mitochondrial transfer. But the pitch for de-extinction has a distinguishing feature: what I call a “blockbuster aesthetic,” a belief in visual spectacle, technical impressiveness, the project’s sheer size—and perhaps even its expense—as proofs of value.
The “revival” of the woolly mammoth, and of the passenger pigeon, closely resembles a Hollywood movie: the revival and restoration of the Jurassic Park franchise, for example, or (as historian of science and medicine Anita Guerrini suggested to me) Avatar.
As with those movies, the relaunch of the species is closely associated with a larger-than-life, charismatic auteur. And as with those movies, the return of lost species is meant to awe and overwhelm. In Stewart Brand’s narrative, these effects have a moral purpose:
Such animals can also serve as icons, flagship species inspiring the protection of a whole region.
Conservationists are learning the benefits of building hope and building on hope. Species brought back from extinction will be beacons of hope.
The return of the marvelous marsupial wolf called the thylacine (or Tasmanian tiger), extinct since 1936, would ensure better protection for its old habitat.
The returned species, in other words, will be living persuasive tools. Images in the present will inspire action to “bring back” species; those species will then themselves inspire further action. What is hoped for, then, is a feedback loop of persuasion.
“The Long Now”
What troubles me most about the paradigm Brand promotes is the naïve idea of interpretation at its heart: the belief that the creature, once authored, will be understood, even decades from now, precisely as its creator intends. That naïveté is present in another, seemingly unrelated project of Brand’s Long Now Foundation: The 10,000 Year Clock.
This clock, a massive device composed of “marine grade 316 stainless steel, titanium and dry running ceramic ball bearings,” and currently being built inside a West Texas mountain, is meant to “creatively foster long-term thinking”: pilgrims, hiking miles to the clock, will witness it and presumably think about time in a different way. (They will also need to help wind it occasionally.) From the Long Now’s home page:
Such a clock, if sufficiently impressive and well-engineered, would embody deep time for people . . . . Ideally, it would do for thinking about time what the photographs of Earth from space have done for thinking about the environment. Such icons reframe the way people think.
Like a living mammoth, the clock’s sheer scale is meant to elicit a specific idea. The idea of “deep time,” expressed by the phrase “The Long Now,” is an interesting one—and, like the reversal of a tragic extinction, difficult to oppose in principle.
And yet I see a second meaning in the phrase “The Long Now.” The 10,000 Year Clock and the revival of lost species are meant to demonstrate taking the long view beyond our present moment. But it seems to me that they do precisely the opposite: they extend specific, local, cultural values associated with our time and place—and, even more specifically, with Silicon Valley—into the foreseeable future. In the uncritical belief in technological solutions, in the belief in size and spectacle, in the exalting of computing power that bridges both online persuasion and the engineering of new genomes, “The Long Now” may mean something other than its authors intend.
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.
Posted by George Estreich, Biopolitical Times guest contributor on February 5th, 2015
Editors' note: The US Food and Drug Administration is currently considering regulation oflaboratory developed tests (LDTs), which include noninvasive prenatal tests. The comment here was submitted to the FDA by George Estreich, as part of a comment period that closed on February 2. The FDA's materials on LDTs can be found here.
To the Food and Drug Administration:
I’m writing to urge the FDA to regulate the new, noninvasive prenatal tests, and I wish to focus particularly on health claims being made in the advertising for the tests. If prenatal testing is to be of greatest benefit both to individual women and to society at large, the information that accompanies that testing should be accurate, complete, useful, and most of all nondirective. The ads for NIPT do not meet these criteria. As a result, the advertising has a number of potential adverse consequences for consumers.
Beth Daley’s recent investigative report in the Boston Globe offers a disturbing look at the consequences of misinformation: as Daley notes, when both health professionals and patients believe that the test is “99% accurate,” as it is often advertised to be, both false positives and false negatives have serious consequences for prospective parents’ state of mind, and for the course of an intended pregnancy. Believing the test to be accurate, women have aborted healthy fetuses in the case of a false positive, or have carried fetuses with severe conditions to term.
These beliefs are mistaken, but they are completely understandable, given the expertly executed ads for the technology. Though the figure “99%” is ubiquitous in the ads, whether referring to sensitivity, specificity, or “accuracy,” the number of true interest to a consumer—the positive predictive value—is either in fine print, or difficult to find. As genetic counselor Katie Stoll has pointed out, the PPV—the chance that a positive is a true positive—ranges from around 50% accurate in the case of the most common conditions, to the single digits in the case of some of the microdeletion screenings now being offered. In some cases, the claim of accuracy is supported by the factually inaccurate claims that “fetal DNA” (or even “your baby’s DNA”) is tested directly. (It is placental DNA that is tested; the occasional mismatch between fetal and placental DNA likely accounts for false results.)
Misleading statistical claims are accompanied by powerful emotional appeals. The ads for NIPT are rife with images that provide emotional content, but no clinical information: beautiful pregnant women and chromosomally normal children. These images, along with risk-laden descriptions of the conditions to be avoided, establish an emotional, value-charged implicit argument for the test.
Indeed, even the name “noninvasive” is part of a coordinated marketing campaign. The companies contrast the test with amniocentesis and CVS, whose risks are repeatedly highlighted. And yet this approach may mislead. Since NIPS is not a diagnostic test, but a screening test, a positive result will require confirmation by invasive techniques. Therefore, it is troubling to see NIPS framed as an alternative. There’s a further danger too: in emphasizing the miscarriage risks of amnio and CVS, while presenting NIPS as accurate, the ads may discourage women from using the truly diagnostic test available to them.
In the ideal world, women would receive accurate, complete, and nondirective information to accompany a prenatal test. They would also have access to a genetic counselor or other expert health professional to help them interpret results. But the ads for NIPT are the opposite of this ideal: they are covert, using emotional appeals and misleading statistics; and they are, by definition, directive, in that their aim is to get consumers to opt for an expensive, proprietary test.
Because of the size of the market, the potential health consequences of this advertising are extensive. False results may lead to avoidable anxiety, and even to irreversible outcomes. In addition, the ads may undercut the relationship between healthcare provider and patient, requiring the provider to explain where the ads exaggerate. Regulating advertising for NIPS can therefore result in better outcomes for patients.
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.
In the State of the Union speech delivered on January 20, President Obama made the first announcement of what seems to be a major policy initiative:
I want the country that eliminated polio and mapped the human genome to lead a new era of medicine – one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable. So tonight, I'm launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthier. We can do this.
That's all he said about it in that speech, though one cystic fibrosis patient, William Elder, was invited to sit with the First Lady. (By the way, the cystic fibrosis reversal is not exactly news, and not as widely applicable as once hoped. Only 4% of those affected by cystic fibrosis benefit, as Elder does, from Kalydeco, a drug approved by the FDA in 2012, which incidentally costs some $300,000 a year.)
Some observers felt "a bit of déjà vu" – Jeremy Gruber found a rather similar statement in the 1998 State of the Union delivered by President Clinton. Indeed, then-Senator Obama proposed legislation to promote "genomics and personalized medicine" in both 2006 and, with Republican Senator Burr, 2007.
We soon learned that the historical connections go much further back. More than four decades, in fact, to Richard Nixon's 1971 State of the Union.
That connection was made clear at the end of January, when Obama, just before formally presenting his budget to Congress, officially launched the Precision Medicine Initiative at the White House with remarks in front of a distinguished invited audience. Among those present were patients (including Elder and Kareem Abdul-Jabbar), politicians, public officials and other researchers. Also in attendance were both biotech entrepreneur Craig Venter and National Institutes of Health head Francis Collins, who famously competed in the late 1990s race to "map" the first human genome.
The related fact sheet included the $215 million price tag that reached many headlines, though the President stuck mostly to generalities. Collins and Harold Varmus simultaneously released an article in the New England Journal of Medicine, which was much more specific:
The proposed initiative has two main components: a near-term focus on cancers and a longer-term aim to generate knowledge applicable to the whole range of health and disease. … Oncology is the clear choice for enhancing the near-term impact of precision medicine. … Although cancers are largely a consequence of accumulating genomic damage during life, inherited genetic variations contribute to cancer risk, sometimes profoundly.
An important part of the proposed approach is to "engage a million or more Americans to volunteer to contribute their health data." The idea is to encourage "strong partnerships with existing research cohorts, patient groups, and the private sector" while simultaneously "developing new approaches to patient participation and empowerment." The President stressed in his remarks that
we're going to make sure that protecting patient privacy is built into our efforts from day one.
He also lauded "patients' rights advocates" who will "help us design this initiative from the ground up, making sure that we harness new technologies and opportunities in a responsible way." In case any skeptics are not reassured by this, the fact sheet also refers to privacy experts and medical ethicists (apparently they get $5 million).
Policy proposals offered by a Democratic President to a Republican Congress are, to say the least, unlikely to be translated unchanged into legislation. But this one may sail through, suggests Politico, partly because it "doesn't cost a lot" (ouch, but the money is basically a rounding error in a $4 trillion budget). Also, some Republicans are already generally on board. It probably helps that a bipartisan group in the House of Representatives has announced a "21st Century Cures" discussion document [pdf], which bids to reform the way the FDA translates research into clinical application.
There are critics and caveats, as well as giddy boosters. David Altshuler (formerly of the Broad Institute, now of Vertex Pharmaceuticals) warned that any new medicines are 10–15 years away. Mayo Institute researcher Michael Joyner called it "'Moonshot' Medicine" in The New York Times and predicted that "precision medicine is unlikely to make most of us healthier." Hank Greely of Stanford told Vox that "It's been the hot thing coming for almost 20 years."
Is this initiative going to over-emphasize a gene-focused view of disease? Since the vast majority of common complex diseases are influenced by many genes, how much practical help will genetic sequences – even a million of them – turn out to be?
Might it lead, in practice, to racialized medicine? Like "personalized medicine" (the now discarded term for what's being proposed), precision medicine will likely be tailored not to individuals, but to groups. Will people be categorized on the basis of actual genetic information, or will researchers and physicians continue to use "race" as a biological proxy?
Will it detract from other public health approaches? It is discouraging that the hoopla over this announcement seems to have overshadowed a much larger, and likely more important, commitment to funding research on antibiotic resistance: that's penciled in for $1.2 billion but didn't receive the celebrity treatment.
Will the (welcome) nods to privacy concerns be adequately backed up in practice? Will those who turn over their DNA sequences be adequately informed of the breach-of-privacy possibilities and consequences?
And why this rebranding? "Personalized medicine" has been the most common term for the kind of individualized care being discussed here. "Precision" sounds, perhaps, more high-tech – but it turns the focus away from people and toward the technology. That might be the wrong direction.
Finally, we must not forget the history. President Nixon, in the 1971 State of the Union declared:
I will also ask for an appropriation of an extra $100 million [worth over $500 million today] to launch an intensive campaign to find a cure for cancer, and I will ask later for whatever additional funds can effectively be used. The time has come in America when the same kind of concentrated effort that split the atom and took man to the moon should be turned toward conquering this dread disease. Let us make a total national commitment to achieve this goal.
We have been "at war" with cancer for nearly half a century. There have been advances in both treatment and prevention, certainly, but we are nowhere near "conquering" the disease. Genomic analysis of tumors, for instance, may help in targeting interventions, and research funds are always welcome, but hype can lead to deadly disappointment. Let's not get too excited yet.
Two papers published simultaneously in Nature on January 21 describe a novel strategy for biocontainment (1, 2). Both teams, using different methods, engineered a strain of E. Coli to be dependent on a synthetic amino acid that does not exist in the wild; if the bug leaves the lab, it quickly dies.
George Church's Harvard lab produced one of the papers and previously nurtured the career of Yale's Farren Isaacs, lead author of the other; they had both worked on a related 2013 paper about "genomically recoded organisms" as well as the seminal