Stem-cell clinics can be found around the world: Mexico, South Korea, the Philippines, China and many other countries. Several have been exposed as scams, and others are suspect, while several high-profile patients (not all) have claimed to have been cured, or at least helped, by them. Two competing storylines have become standard. One is that desperate Americans go abroad for treatments because they were conned; the other is that the FDA is over-cautious and withholding life-saving treatments.
Both narratives assume that few, if any, of these clinics are in the US. That may have been true some years ago: 60 Minutes ran an exposé in 2010 that eventually led to arrests, and another in 2012. Introducing the second one, Scott Pelley made it clear that these were meant as examples, that their team had found “hundreds of credible-looking websites offering stem-cell cures at overseas clinics.”
It seems fair to suggest that up till now many Americans have assumed that the FDA was keeping us safe. That is now in serious question.
Leigh Turner and Paul Knoepfler recently published an important paper in Cell Stem Cell on stem cell clinics in the US. Turner is a University of Minnesota bioethicist and expert on medical tourism; Knoepfler is a stem cell professor at UC Davis who also runs a very well-regarded blog about stem cell research.
They identified 351 businesses, operating 570 clinics, all over the country (see map above, which is a reduced version of Figure 1 in their article). Some of these clinics may be offering services that do not require FDA approval, but in many cases, Knoepfler explained on his blog,
... there is a strong likelihood that FDA pre-approval would be needed because of issues such as non-homologous use and/or more than minimal manipulation. Such a large industry with unclear regulatory oversight and pre-approval is a big concern overall.
At almost the same time, a horrifying story broke about someone who had traveled to Mexico, China and Argentina for stem cell treatment to help him recover from a stroke. Eventually he developed painful symptoms, which led to surgery that revealed a huge mass of rapidly growing cells in his spine, which were not cancerous, but were "predominantly composed of non host cells,” according to a letter to the New England Journal of Medicine:
Thus, although the lesion may be a considered a neoplasm (i.e., a “new growth”), it could not be assigned to any category of previously described human neoplasm on the basis of the data we gathered.
Stem cell treatments are by no means the only ones that can have unexpected and tragic outcomes, as recent headlines attest. Juno Therapeutics' small clinical trial of an immunotherapy approach to leukemia was abruptly halted last week after it announced that three subjects had died. (Juno later ackowledged a fourth death that occurred last year in a trial of a similar immunotherapy.) Fewer than 20 patients had been enrolled, and “only a minority” of them had the treatment that at first seemed responsible.
The protocol involved taking some of a patient’s own immune cells, performing gene editing on them to target cancerous growths, and then replacing the the rest of the immune cells with the genetically engineered ones. The clinical trial was being conducted under FDA regulations, and the FDA immediately stepped in.
To widespread amazement, it took only two days (the company had expected at least a month) before the FDA agreed that the problem involved a drug interaction and the trial could continue without using the incompatible chemotherapy drug. It’s unusual for the agency to move so fast, but — assuming they were right — it shows that bureaucracy can adapt.
Nevertheless, there are efforts to weaken the system of oversight. Senator Mark Kirk (R, Illinois) has introduced the REGROW Act (Reliable and Effective Growth for Regenerative Health Options that Improve Wellness), which is meant to speed up FDA approval for stem cell treatments. Knoepfler, who called a previous version of the bill “an attack on science-based stem cell trial oversight" remains skeptical:
it over-reaches so much that it would almost certainly do harm to patients and maybe to the stem cell field as a whole.
The Alliance for Regenerative Medicine also opposed the Act, at least in its original form. However, the California Institute of Regenerative Medicine (CIRM) has been campaigning for the FDA to loosen its regulations, even claiming that “patients are dying” because we are “so careful about safety.” CIRM President Randal Mills co-wrote an opinion piece for Fox News with former Senate Majority Leader Bill Frist demanding the the FDA make the approval of “cell therapies” (the word “stem” is not mentioned) easier.
Nature disagrees, in an editorial that references the Turner and Knoepfler article:
FDA should stand firm on stem-cell treatments [headline]
US regulators must regain the upper hand in the approval system. [short]
The pull quote accompanying the editorial is harsh but fair:
"The assumption that these treatments work is at the heart of the problem.”
New Scientist is a British-based popular science magazine. It’s been around for 60 years, which is long enough to stumble and recover a few times. For instance, in 2009 it published a cover story with the startling headline “Darwin Was Wrong.” (Not so, even if his concept of the “tree of life” was simplistic.) The story is mostly behind a paywall but still on-site; the cover image can be found elsewhere.
To be fair, New Scientist has also published informed and incisive commentary by experts such as Donna Dickenson and our own Marcy Darnovsky. The magazine has also been, at least on occasion, sensitive to questions of ethics, as in this 2014 editorial on “three-parent babies.”
But they just stumbled again. The July 2 issue featured on the cover “The Resurrection Project.” The articles included:
The perpendicular pronoun in the third title refers to Max More, the transhumanist who currently runs the Alcor Life Extension Foundation. We last mentioned More and Alcor in March, when we referred you to Corey Pein’s excellent article in The Baffler. Pein describes the folks behind Alcor as “technophilic necromancers” and digs deep into the risible history of More’s Extropy Institute and “proactionary principle.” As science (and business) goes, cryonics is on the quackery side of reality.
It would not surprise me to learn that, behind the paywall (I’m not paying) there was criticism of cryonics. But the topic was on the cover, not to mention featured in at least three email blasts, two of which used the term immortals. How should we understand those choices by a publication that calls itself a science magazine? As the writer of the aforementioned Darwin article admitted in response to complaints registered then:
Well, the cover is designed to sell the magazine. If we run very straight, sober covers, we sell fewer mags, we get fewer clicks and nobody blogs about us, so fewer people read what we produce.
What they think of us, the readers, is hard to tell. But here are the subject lines of the four most recent email blasts, as of this writing:
Self-promotion comes naturally to narcissists (July 10)
Your ultimate guide to reality’s true strangeness (July 9)
How to be a successful narcissist (July 8)
Embrace your inner narcissist (July 7)
And here is a worrying piece from the archives, 23 October 1999, to be precise. (So long ago, it took the Techno-Eugenics Email List, a distant ancestor of this blog, months to note it!) It’s a New Scientist Editorial titled “The Last Taboo,” in response to reports that scientists had, in principle, invented artificial chromosomes. The speculation around them was that they could be used to introduce heritable changes, in mice and theoretically in people. The technology was not then ready for use, by any means, but the editorial concludes:
For all these reasons, it would be a mistake to expect the taboo on human genetic engineering to last forever. Some day someone will want to try it. The invention of artificial chromosomes doesn’t make that desirable—only people can make that judgment. But it does add to the forces that are now beginning to make it seem inevitable.
As for taboos, they are simply a bad excuse for not thinking.
Apparently, sales are a good excuse for not thinking. Or perhaps the editors just suffered a brain freeze.
Ten years ago last week, on what would have been the tenth birthday of the first cloned mammal, the soon-to-be-world-famous sheep, CGS published a 16-page Report [pdf] titled A Decade After Dolly.
This is how it opened:
It’s been nearly a decade since the birth of Dolly the cloned sheep in the summer of 1996—followed by the announcement of her existence in February 1997—put the prospect of cloning human beings clearly before us.
Since then, a near consensus has emerged: Cloning human beings is a very bad idea, and should be prohibited. In the past ten years, more than forty countries have adopted prohibitions against human reproductive cloning. But the United States has not.
The past decade has seen the development of techniques that could produce not only cloned children, but also a “designer baby” world of genetically modified humans. Again, unlike many other countries, the US has not put in place binding regulations to prevent this
Mutatis mutandis, it holds up pretty well as a summary. Gene editing and cellular reprogramming have emerged as collaborators with cloning. Concerns about genetically modified humans have therefore become even more realistic and pressing.
On this the twentieth year, Nature published perhaps the most interesting anniversary article, which told the story of Dolly’s conception, birth, life and death entirely in the words of the people who were actually there (plus a few closing comments from other experts). Scientific American had a multi-part feature, covering science, ethics and endangered species (also picked up by GEN). Stat had a piece by Sharon Begley that focused on human cloning, or the lack of it. And Pravda declared that pet cloning is the most profitable business in South Korea.
The last word should go to Ian Wilmut, who led the team that made and reared the first cloned mammal, quoted in Nature:
It would be wrong to say my name's known all the way around the world — but Dolly's is.
Posted by Angel Petropanagos, Biopolitical Times guest contributor on July 12th, 2016
Public debates about social egg freezing overemphasize the rights and responsibilities of individual women who delay childbearing and also misrepresent their reasons for doing so. These debates largely ignore the broader social and institutional structures and norms that shape and constrain the reproductive choices of men and women. Egg freezing is mistakenly framed as a solution to the risk of infertility that accompanies delayed childbearing.
Proponents of social egg freezing argue that this technology can promote women’s reproductive autonomy by affording them the option of delaying genetic reproduction and parenthood in order to pursue higher education or advance their career— an option that is generally available to men on the assumption that childcare is women’s work (so there will be a woman somewhere to care for his children while he pursues his education or advances his career).
Critics of social egg freezing raise concerns about the health risks to individual women and any resulting offspring. They also worry about the fact that most women who freeze their eggs likely will never use them for reproduction. This points to a service that is characterized by unnecessary physical risks to women and needless expenditures by them, and results in a surplus of stored biological material. Further, critics worry about “false hope” that can result from the use of a technology that is not guaranteed. Some feminists worry that social egg freezing detracts attention from broader social changes, such as improved parental leave, subsidised or universal daycare, and flexible work schedules that can make it easier for women (and men) to choose to have children at a younger age.
A few weeks ago I participated in a panel discussion about social egg freezing and delayed motherhood hosted by the Progress Educational Trust in Edinburgh, Scotland. The discussion included mention of all of the ethical considerations listed above. We also discussed the role of the media in promoting social egg freezing and spreading misleading information, as well as the importance of language for framing this technology. Despite these discussions, I was disheartened to see that much of the public discussion and the media coverage of this event focused on mistaken assumptions about the women who might use this technology. Media coverage also framed reproductive health education within a pronatalist mandate, that is, as targeting girls and young women to educate them about age-related infertility in order to prevent them from “the risk of missing motherhood.”
First, many people mistakenly assume that women delay childbearing because they are “picky” and waiting for “Mr. Right.” The reasons for delayed coupling that facilitates childbearing are complex. For example, women who have graduate degrees and demanding careers may have relocated several times, which can make it difficult to find a partner. The financial and time demands of work can leave some women without enough resources or energy to have kids at a younger age. Many women may be on second or third marriages and childbearing didn’t work out. Or, they may have children and want additional children with their new partner.
A second problem is the heteronormativity that permeates discussions of social egg freezing. Not all women who delay childbearing or contemplate social egg freezing are looking for Mr. Right. Some women may be looking for Ms. Right, while others may be choosing to parent alone, within polyamorous relationships, queer kinships or committed friendship communities. Discussions about social egg freezing should not assume or reinforce heteronormative nuclear family structures for raising children.
Third, people often assume that delayed motherhood is all about individual women’s choices. Indeed, public discussions typically fail to adequately address the role that men play in reproductive decision-making. Men also make choices around delayed parenthood, and for women who want to have children with men, this matters.
Fourth, women’s and men’s reproductive decisions are embedded within social contexts that help to shape their reproductive desires and values. For example, there is a pervasive social pressure to have genetically related children and “real” womanhood is often equated with motherhood. These pressures occur alongside social education and employment structures that make actually raising children really difficult, especially for people who lack adequate financial or social supports.
Finally, not all women want children. Discussions about social egg freezing assume that women without children, particularly those with advanced degrees or careers, have chosen to delay childbearing in order to achieve education and employment goals. Seldom do public discussions recognize that remaining childfree is a valuable option for some women. Widespread social pressure to freeze one’s eggs undermines the validity of this option.
Advancing public discussions of the ethics surrounding social egg freezing requires that we move beyond analyses of individual women’s choices. Social egg freezing is the result of social and systemic structural problems that influence decision-making. As such, addressing the concerns surrounding delayed motherhood (or parenthood more generally, for that matter) requires widespread social change.
Angel Petropanagos is a Research Associate at Novel Tech Ethics at Dalhousie University and a Visiting Scholar at the Joint Centre for Bioethics at the University of Toronto. @APetropanagos
Sperm banks continue to expand their search and selection criteria to include clinically ambiguous and frankly irrelevant donor information (favorite pets, astrological sign, hobbies). Yet their failures to verify the self-reported personal and medical histories of donors have recently prompted a set of legal complaints aimed at combating fertility clinic negligence in the unregulated assisted reproduction industry in the U.S.
Several families, including Angela Collins and Beth Hanson from Canada, have recently brought a lawsuit against one Georgia-based clinic, Xytex, and one particular donor. The legal questions are themselves significant, but the case also raises important considerations around disability, class, and genetic determinism.
Xytex, along with its distributor in Ontario, informed Collins and Hanson that Sperm Donor 9623 had an IQ of 160 and was pursuing a PhD in neuroscience, and had no history of physical or mental illness apart from his father’s colorblindness. The clinic did not verify this information, but relied on what Sperm Donor 9623 had reported. The parents, now raising their young son, were understandably shocked upon learning that his donor had in fact spent time in jail and received multiple diagnoses of mental illness.
Parents’ anger, and their concern about their families’ future, should of course be recognized and respected. But so should the complicated set of issues that this case raises. How do we assess it while resisting genetic determinism, challenging biological explanations for class-based inequalities, and critiquing a purely medical understanding of disability? How do we negotiate the differences between human variation and costly, painful, mental illness? How should we come to terms, legally, politically, and emotionally, with the responsibility – or negligence – of commercial players in the realm of human reproduction? None of the answers are obvious.
The couples who used Sperm Donor 9623 may never have realized that he had been diagnosed with schizophrenia and other mental illnesses if Xytex had not accidentally and negligently revealed his identity in an email exchange. Three of the many families who used his sperm are now seeking to set up a fund for their children’s preventative health care and future medical costs. In addition to its part in a legal strategy, the argument for this fund brings into focus the various roadblocks that people with mental illness face accessing employment, education, and mental health services.
In most articles discussing the case, the "perfect" sperm donor that families thought they were selecting (high IQ, graduate degree, etc.) is rhetorically pit against the donor’s "actual" identity: a "mentally ill convicted felon" (1, 2, and 3). Press releases, news coverage, and lawsuits indulge in assumptions about genetic determinism and overstate the chance that the children will take on the behavioral characteristics of their sperm donor. Though such reductive sound bites are common in media representations, they do not emerge in a vacuum and their harm extends beyond this one case. The assumptions that permeate media and legal discourse about Sperm Donor 9623 hinge in part on widespread misunderstandings of disability, poverty, and genetics. Much of the language swirling around this case creates false dichotomies between health, intelligence, and success versus illness, criminality, and failure. We all live in far greater nuance than that, whether or not we currently live with a disability, including schizophrenia.
Aside from focusing on his schizophrenia, many articles also mention the sperm donor’s felony charge, implicitly suggesting there is a link between genes and criminality (and mental illness and criminality). This is an incorrect and politically troubling connection. But it is not without its supporters. For more than a decade, Kent Kiehl, a psychologist and neuroscientist who also studies schizophrenia, has been visiting high-security prisons in the U.S., scanning the brains of more than 4,000 inmates with a mobile MRI unit, and building a database to look for genetic links to violence. Kiehl claims that psychopaths and violent people "have different brains," which are "at least 50 percent caused by genetics" and supports research aimed at studying the MAO-A gene (which has been problematically nicknamed the "warrior gene"). A more recent study on MAO-A chose as its sample the brains of 328 male children. These studies and others like them assume a lot at the outset, including that incarcerated people (and males) are inherently more violent than others, and that this is genetically pre-determined.
Many news articles about Sperm Donor 9623 also mention that he had dropped out of college, implying there are "genetic links to educational attainment." While some researchers recently touted a study that identified 74 genetic variants that influence how many years of school people finish, a closer look reveals an important caveat: those 74 genes "explain slightly less than one-half of 1 percent of the differences between people’s education levels." Given the other aspects of Sperm Donor 9623’s identity, there’s a missing discussion in the press about whether he had the necessary mental health or financial support to finish his education.
The links between genes and the likelihood of developing schizophrenia are difficult to quantify or clinically predict. Many gene clusters have been identified that may contribute to the diagnosis, and it is also believed that environmental conditions can trigger schizophrenia. The complicated state of the field has been muddled in media coverage of this lawsuit, as in one CNN article claiming that certain gene clusters cause schizophrenia 70% to 100% of the time. Critics point out that research findings are often overhyped, despite the currently enormous gap between the huge amounts of genetic information that are generated and the relatively miniscule amounts of clinically reliable advice based on it.
Being predestined at birth for dropping out of school and committing crimes is logic that sounds familiar to historians. In the U.S. alone, tens of thousands of people have been sterilized and excluded from "respectable" society through state and institutional eugenics programs because they were considered predisposed to criminality, "feeble-mindedness," and all-around substandard genetic material. Fear of disability – physical or cognitive "deviance" from what those with power have historically decided is "normal" – is wrapped up in mistrust of people who are poor or have criminal records. At the core, this anxiety continuously answers its own question: Who should be allowed to reproduce?
Nothing about this case is objective, self-evident, or easily teased apart, but the history of eugenics informs the pressures faced by families in this high-tech fertility moment. People now encounter an expanded range of options, expectations, and ways of thinking about families and reproduction. Parents understandably want the best for their children. It would be difficult, if not impossible, to not feel frightened at the prospect of a child developing schizophrenia, especially when everything around us says our functioning needs to be "normal" and when social supports are so lacking. And many would recoil in fear from a gamete donor who had dropped out of college or had prior convictions, without stopping to consider the eugenic assumptions embedded in that reaction.
The ableist and classist underpinnings behind the drive for particular kinds of gamete donors sit on a landscape defined by expectations and mechanisms of consumer-based, free market products and purchases. If assisted reproduction becomes a transaction, it can become difficult to resist treating the resulting children as commodities. The parents in the Xytex lawsuit clearly don’t believe their children are "incorrect" or "undesirable," but it is difficult to procure damages for breaching informed consent and covering potential future medical costs without arguing that the sperm donor was absolutely "incorrect" and "undesirable."
A fertility industry-sponsored bill that would expand the market in human eggs is barreling through the California legislature, in spite of opposition from women’s health, reproductive justice, and public interest organizations. AB 2531 would overturn a California law that lets researchers reimburse women for their expenses incurred in providing eggs, but disallows payments beyond that. The 2006 statute that AB 2531 would eviscerate was authored by former state Senator Deborah Ortiz, known for championing both women’s health and stem cell research, and approved almost unanimously by both the Assembly and Senate.
In an April blog post, Will California Expand the Market for Women’s Eggs?, we summarized the reasons for opposing AB 2531 (see also this CGS letter) and reported that it had been unanimously approved by the Assembly Health Committee. In early June, the Senate Health Committee posted its analysis of the bill, including a summary of the arguments for and against it, and a list of its supporters and opponents.
The Committee passed the bill by a vote of 8-1 at a June 15 hearing. Testimony by CGS’s Elliot Hosman against it can be viewed here (starting at 52:35), or read at the end of this post.
The bill will go next to the Senate Appropriations Committee when the legislature returns from recess in early August, and then to a vote by the full Senate. Assuming it passes, it will then be sent to Governor Brown. The Governor vetoed an almost identical bill in 2013 with the following message:
Not everything in life is for sale nor should it be.
This bill would legalize the payment of money in exchange for a woman submitting to invasive procedures to stimulate, extract and harvest her eggs for scientific research.
The questions raised here are not simple; they touch matters that are both personal and philosophical.
In medical procedures of this kind, genuinely informed consent is difficult because the long-term risks are not adequately known. Putting thousands of dollars on the table only compounds the problem.
Six years ago the Legislature, by near unanimity, enacted the prohibition that this bill now seeks to reverse. After careful review of the materials which both supporters and opponents submitted, I do not find sufficient reason to change course.
As those of us who support the existing limits on the egg market in California have pointed out repeatedly, without adequate health and safety information about egg harvesting, women can't give truly informed consent to undergo it in exchange for cash. And despite the claim of AB 2531 proponents, egg providers are very different from research subjects: Unlike clinical studies in which researchers follow the health outcomes of participants, egg retrieval supplies researchers with biological materials for other experiments, but without any study of its effects on those who provide them.
Elliot Hosman's testimony explains these and related points.
Testimony in opposition to AB 2531 by Elliot Hosman, June 15, 2016
Good morning, and thank you. I am Elliot Hosman, Senior Program Associate at the Center for Genetics and Society, a public interest organization based in Berkeley. We have long been concerned with the lack of adequate research on the health risks of egg retrieval. Our concerns are broadly shared by many others, including national and California women’s health and reproductive justice organizations you see opposing this bill, and including scholars and health professionals, and women who have themselves undergone egg retrieval.
The research that could identify the extent and frequency of health risks associated with egg retrieval has simply not been done. It’s been called upon to be done for decades, but it has not been done. Thus the information women would need to give informed consent does not currently exist. Unfortunately, this bill increases payments without providing mechanisms to bring about the conditions for substantive informed consent that women deserve.
The intent to treat egg providers as "human research subjects" may sound like a good idea, but in fact egg providers are not "research subjects" as we usually understand that term. They provide the cells that are used in research, not for their benefit, but no research is performed to ascertain the effects of egg retrieval on their own health outcomes.
While some Institutional Review Boards may review egg retrieval procedures, they are not required to do so. For example, if the eggs are anonymized, many reviewers may deem they are no longer required to evaluate retrieval protocols or informed consent forms, and eggs are often anonymized, so this is often case.
Even when IRBs do review, they typically do not provide adequate safeguards:
They don’t require tracking short term outcomes, so we don’t have good data on how many egg providers are injured or hospitalized due to ovarian hyperstimulation syndrome from the drugs they’re on.
They don’t require tracking long term outcomes so we have almost no data on the stimulation drug regimen’s impacts on their fertility, their short-term or long-term cancer risks, or other problems they may face.
They seldom require follow up health care for egg providers. At best they cover treatment of short term injuries that can be directly and causally linked, but don’t cover any longer term harms.
They don’t review the treatment outcomes of clinics or researchers to determine if any are using inappropriate protocols that harm egg providers.
We all support promising research that might provide broad benefits, and we all want to make sure that women’s health is not compromised in the process.
Unfortunately, this bill does not accomplish that, and we respectfully urge you to vote against it.
On June 8, the National Academies of Sciences,
Engineering, and Medicine issued a report about
gene drives, titled:
Gene Drives on the
Horizon: Advancing Science, Navigating Uncertainty, and Aligning
Research with Public Values
The headline of the associated press release summed it up succinctly:
Gene-Drive Modified Organisms
Are Not Ready to Be Released Into Environment; New Report Calls for More Research and Robust Assessment
Francis Collins, director of the National Institutes of Health, commended the authors for a "thoughtful and comprehensive review of the unprecedented potential and challenge of gene drive technologies." That’s true enough. It is a valuable
resource for a much-needed public debate — but it is sadly incomplete, and occasionally misleading.
The report’s skepticism about "reversal drives" is welcome (see Recommendation 5-5, p. 99) but inadequate. If gene drive technology goes wrong, is the solution really to be more gene drive? Indeed, Kevin Esvelt, one of the pioneers of (and an advocatefor) gene drive told The New York Times that
the report failed to adequately flag its central risk.
"They assume you can safely run a contained field
trial," he said. "But anytime you release an organism with a gene drive system into the wild you must assume there is a significant chance that it will spread — globally — and factor that in."
The report makes repeatedly admits that field research is most likely to occur in "low- and middle-income countries" (p. 6 etc), recognizes "that many countries lack the capacity to develop a comprehensive regulatory scheme for gene drives from scratch" (p. 8), and the like. These should be warning flags. If technology really can help underdeveloped nations, the impetus should come from them. And the U.S. is not a party to the multilateral Convention
on Biological Diversity (CBD) and its protocols, which aims to promote fair and equitable sharing of benefits arising from genetic resources. U.S. institutions are developing technology that, if applied, will mostly be used elsewhere. Centuries of exploitation do not suggest that
wealthy foreigners are the best judges of humanitarian needs.
(Or perhaps we should invite Cuban doctors to set up clinics in Appalachia?)
The report also appears to downplay the possibility of "weaponizing" gene drive technology. The worst case — a deliberately belligerent release of modified pathogens — would surely rank with nuclear destruction as a prospect to be avoided; and mere mistakes could be as bad. There is a reason the ETC Group titled its comment [pdf] on the report:
Stop the Gene Bomb!
Jim Thomas of the ETC Group wrote an excellent article about the report for the Guardian, calling for the CBD to agree on an international moratorium on release of gene drives. Friends of the Earth asked sardonically, "Permanently changing a species: What could go wrong?" and called for a moratorium. Ron Bailey of Reason initially wrote an apparently knee-jerk response ("Go slow and let more people suffer and die") which misunderstood Esvelt’s position; he then appended
a much more interesting Correction acknowledging that "How to regulate an open access commons is always a perplexing problem." Michael Specter in The New Yorker called the National Academies’ effort "a worthy, if somewhat tepid, report," and Stanford’s Hank Greely agreed, in a valuable blog post that made "Eight Quick Points."
Finally, the report sometimes reads as though its goal
was not so much "aligning research with public values" as "aligning public values with research." It’s striking that the "stakeholders" mentioned do not appear to include any of the civil-society groups widely
known to have raised concerns about this issue. "Stakeholders" are described (Figure 7-1, p. 122) as "people with direct professional or personal interests in gene drives." May I raise my hand? I work with
the Center for Genetics and Society; other public
interest organizations that have been involved with gene drive deliberations include ETC Group, Friends of the Earth, and International Center for Technology Assessment.
Unfortunately, the initial flurry of reactions seems to have died down. Gene drive could be a major disruptive technology. It could affect not only our environment — the "out there" — but our food and even our selves. This report deserves to provoke a massive, global debate. A long pause for reflection is the least that is needed. Or T. S. Eliot may have finally been proved correct:
This is the way the world ends Not with a bang but a whimper.
What is the speed limit where you live? In
California, it varies but the maximum is 112.654 kph. In France, the speed limit can run as high as 80.778 mph (actually a couple of yards more).
You don’t see those numbers on road signs, because the
California vernacular uses the mile, which is officially defined as 1,609.344 meters, while France uses the kilometer. A meter, of course, is the length of the path travelled by light in vacuum during a time interval of 1/(299,792,458) of a second. It’s obvious when you think about it.
In both jurisdictions, the concept of a speed limit is the same, and the idea is generally justified by public safety, and perhaps fuel conservation, neighborhood nuisances and so on. It’s a common-sense restriction that gives all drivers guidance, and that is meant especially for those lacking in common sense.
The limit is not defined by the maximum speed of a vehicle.
Biology also has its widely accepted rules, which are sometimes given the force of law and sometimes mostly a matter of custom and ethics. Many of these were agreed at a time when there was no immediate prospect of successfully breaking them: a firm line, legally codified in dozens of countries, against human germline intervention, for instance, or the internationally accepted norm of a 14-day limit on human embryo experiments.
They give researchers a clear guideline within to work, and they give the public confidence that rogue scientists will not go overboard.
Until very recently, no one had come close to growing a human embryo in a dish for 14 days. In May, however, two different groups of scientists (1, 2) published experiments demonstrating that they could indeed do that. Simultaneously, three scholars — all experts in bioethics theory and/or practice — published a piece in Nature titled:
Embryology policy: Revisit the
They were just raising the question, they insisted
in response to the obvious retort: Why revisit if you don’t want to change the rule? "Revisit need not mean revise," tweeted one author. Some other bioethicists, including Jonathan Moreno, agree that:
What’s really more important
than whether it’s permissible to move those goalposts is how we make that decision.
That sounds incredibly reasonable. But why now? Just because the rule has suddenly become inconvenient? If that is the case, does it suggest that some bioethicists see their mission as working to legitimate whatever research desires scientists may have? That is, to convince the public of what they ought to think is good for them?
And if the pragmatic and useful 14-day agreement is broken, what then? Hank Greely spelled out a basic complaint:
"I don’t know where you stop. I do know that I would feel very concerned about a 20-week fetus being used as an experimental object, because it’s too damn close to being a baby," he said. "And people should not be treated as objects."
Greely expanded on this in his own blog post. Françoise Baylis wrote a nuanced analysis. By coincidence, the International Society for Stem Cell Research (ISSCR) issued its latest guidelines for
stem-cell research [pdf] a few days later: they stick firmly to the 14-day rule.
There will undoubtedly continue to be pressure to change the norms that have guided research in many related fields over the next few years. Human-animal chimeras are up for discussion, so of course are human germline interventions, and gene drives in other species. Many knowledgeable people, including scientific participants, regard the prospects as extremely scary.
Admittedly, in some cases, adjusting existing rules may seem sensible; the 55 mph speed limit was widely ignored and eventually repealed. But that change had nothing to do with the technical abilities of car manufacturers.
The top speed of a production car has been over 110 mph since 1947, and over 150 mph since 1959. It’s now over 250 mph, and I’d like to see that Bugatti trying to weave its way up the Pacific Coast
Highway. Probably couldn’t get out of second gear.
A recent campaign calling for a ban on “transgenic” human embryos was launched by one of France’s most prominent organizations fighting for “science”-backed “one-man-one-woman” families, and the exclusion of all other forms.
“Stop GMO Baby: Yes to therapeutic progress, no to transgenic embryos” (image via Alliance VITA).
Since March 24, more than 15,500 people in France have signed a Change.org petition started by Alliance VITA declaring (translated from French*):
“I ask my country to engage with all urgency to obtain an international moratorium – that is to say an immediate stop – on the genetic modification of human embryos, especially via the technique CRISPR-cas9.”
*all French materials and quotations presented in English in this post have been translated using Google and my college-level French. Suggested revisions to translations are welcome and will be noted. Alliance VITA offers some materials on its website in English.
In that time, volunteers have canvassed cities around France, handing out brochures explaining the breakthrough CRISPR genome editing technology, and tweeting pictures of their advocacy using Flickr and the hashtags: #StopBébéOGM, #ProtectHumanity, and #CRISPR-Cas9.
Alliance VITA’s opposition to using human gene editing for reproduction is widely shared, including by my organization, the Center for Genetics and Society. But a closer look at the Stop GMO Baby campaign in France reveals a troubling and at times explicitly hateful politics infiltrating the human genome editing debate. A polarization of the conversation about heritable human genetic modification along “right to life” and “natural family” fault lines threatens to derail public conversations about responsible regulation of science and medicine that serves the public interest.
“I’m concerned that these campaigns that specifically target CRISPR could have negative effects on the freedom of us scientists to do responsible CRISPR research in the lab. … at least some of the motivation seems to be related to a “right-to-life” perspective. “
Alliance VITA’s campaign materials on CRISPR take as their central point that CRISPR-Cas9 is an ethically neutral and promising technology that could help gene therapy, but that any use in human embryos or gametes is a red line no researcher in the world should cross. In their other words: “GM babies? No!” Here are some examples of their slogans and statements:
Campaign slogan: “CRISPR-Cas9: Yes to Therapeutic Progress, No to Transgenic Embryo!” (March 24, 2016) [Brochure PDF]
On February 16, 2016, Alliance VITA Research Director Blanche Streb stated on Catholic television: “The technique poses no ethical problems on its own, it’s the application that does.” (YouTube)
Alliance VITA General Delegate-CEO Tugdual Derville commenting on Kathy Niakan’s application to the HFEA in January 2016:
“Although this technique might be promising for genetic therapy, Tugdual Derville reminds us that when applied to the human embryo: “the danger is to cause the emergence of custom-made babies, with pre-selected genetic criteria, heritable modifications, with unknown consequences for future generations. The human genome is part of our most precious “heritage of humanity.” Its integrity must absolutely be preserved for future generations.”
On April 7, France’s National Assembly Parliamentary Office for Scientific and Technological Assessment (l’OPECST) held a hearing on issues raised by CRISPR (program, in French). Alliance VITA Research Director Blanche Streb testified, advocated for an international ban on embryo experiments, and noted that her organization was also concerned by “3 person IVF” mitochondrial replacement technologies in the UK. While Alliance VITA’s media statements and materials mention threats posed by eugenics and transhumanism, their stance is clearly that all experiments on embryos should cease. They appeal to UNESCO’s “genome as commons” as authority, interpreting its call for a collective responsibility to future generations as including the sanctity of the embryo.
La Manif for whom?
Pictured L to R: Xavier Bongibault (celebrated by some as a “gay voice against gay marriage”), Frigide Barjot (former celebrity face of La Manif pour tous), and Tugdual Derville (CEO of Alliance VITA) (image via Flickr/Serge klk).
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Alliance VITA was a leader of the first-ever rallies of a French movement called “La Manif pour tous” (the Strike for all), a coalition of anti-abortion, anti-LGBT organizations (many professing the Catholic faith) that organized a very visible campaign to oppose the fight for “marriage for all” in France from 2012 to 2014.
For a United States audience, visible opposition to gay and lesbian couples getting married is not novel, although public opinion polls show increasing acceptance. But many the world over were taken aback by the size of the crowds marching in Paris in early 2013 holding blue, pink, and white signs that read “One man, one woman, we don’t lie to children!” The number of marchers, which was hotly debated, was between 150,000 and 1 million.
These recent events could sound like a bell twice tolled for those seeking to narrow French and international discourse on and regulation of what counts as “family” and “life.” But Alliance VITA has rebounded from these two developments by capitalizing on the grassroots power amassed with La Manif pour tous, focusing on other issues related to death and conception (e.g. surrogacy, embryo selection) and launching the new “citizen’s campaign” against CRISPR experiments. Two recent research reports on CRISPR research using nonviable human zygotes have catalyzed the debate about certain cellular masses of particular interest to this movement: “des embryons.”
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Crowds march in Paris in 2013 to oppose extending marriage and adoption to LGBT couples (image via Wikimedia).
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Flying Colors Wave
Frigide Barjot, a devout Catholic, noted in 2012 that the three colors of La Manif pour tous’ protests represented blue for men, pink for women, and white for LGBT people who were included to show that “they were loved by protestors, who were not homophobic but rather wanted to protect the very idea of ‘family’ and ‘civilization.’” Barjot’s outsider status compared to the movement’s leadership of traditional Catholic and far right political groups led to her replacement in 2013.
Left. La Manif pour tous protest in Strasbourg on February 2, 2013 (image via Wikimedia). Right. La Manif pour tous protest in 2013 (image via Flickr/Arslan).
Left.“GMO, I don’t want any.” Greenpeace protestors march in Montpellier in May 2015 (image via Flickr/Pete).
Right. "92 groups mobilized in defense to inform the public of the issues posed by CRISPR-Cas9.” (image via Twitter).
“The French Republic was founded on the ideas of equality and a French concept called laïcité—the complete absence of religion in governmental affairs. This means political discourse in France must be entirely free of religious rhetoric…battling civil rights, not with religious ideals, but with science, sociology, and cold, reductive rationality.”
In other words, Alliance Vita needed to invoke science to support a campaign premised on denying gay and lesbian marriage and adoption rights. So the group used a widely cited – and widely discredited – New Family Structures Study by American sociologist Mark Regnerus on the “differences” seen in children raised by same-sex couples. The study is riddled with methodological problems, and was denounced by the American Sociological Association and 200 scientists and doctors in a 2012 open letter. But Alliance VITA’s “scientific” evidence for the superiority of traditional families goes beyond the debunked significance of Regnerus’s interviews.
Tugdual Derville, CEO and General Delegate of Alliance VITA, led the group’s March 24 press conference, and coordinates media statements with Research Director Blanche Streb. Derville is currently on tour for his newly published book Human Ecology. In various French media venues, he attacks what he refers to as “gender theory feminism,” and argues for biologically determined and distinct gender roles for men and women in family creation, education, and society. It’s what he calls the “sexus,” the natural “family ecosystem” which depends on a “Father-Mother” distinction to prevent the “self-made man.” Derville equates transhumanists with animal rights’ activists, eugenicists with feminists, and the “radical cult of youth” with the “disconnected gerontocracy.” It’s all an indistinguishable bunch of individualistic nonsense to him. “In settling their accounts with their own personal stories, their advocates endanger us all,” he states in a recent interview.
“[T]alking about ecology allows religious arguments to appear in the public debate in a more acceptable way (that is to say as secular arguments). My sense is that there’s no thorough investment on environmental issue (it is mostly used strategically).”
University of Chicago law professor Mary Anne Case, a U.S. expert on the Catholic Church’s rhetoric, doesn’t see contradictions in the environmental packaging of Alliance Vita’s various campaigns:
“Human ecology” is a favorite framework of Benedict XVI, who used it to warn of the potentially devastating effects of what he called the “ideology of gender.”
“[I]t is troubling that, when some ecological movements defend the integrity of the environment, rightly demanding that certain limits be imposed on scientific research, they sometimes fail to apply those same principles to human life. There is a tendency to justify transgressing all boundaries when experimentation is carried out on living human embryos. We forget that the inalienable worth of a human being transcends his or her degree of development.” Laudato si’, par. 136.
Case noted in an email, “Seen from within the mindset of those Catholic writers invoking the need to safeguard human ecology in their campaigns against a whole host of sexual rights and law reform efforts, religious and secular motivations openly go hand in hand in the same direction.”
The “secular science v. religious ideology” binary can get in the way of acknowledging that people across the religious and political spectrum have voiced concern about the prospect of using a new generation of genome editing tools to produce altered embryos for the purpose of human reproduction. But the Pope’s and Derville’s framing, in which environmental advocacy somehow mandates accommodating the idea that human embryos should be accorded the status of human lives, doesn’t sit well with me either; it reminds me of a “zero-sum” game, when we need to be in a “grow the pie” mindset given our volatile political climate.
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Laudato Si’: On the Care of Our Common Home (image via Catholic.com).
Dangerous Political Territory
Many voices from France have joined in international mourning for the 49 slain and 53 injured victims of the massacre at queer dance club Pulse’s Latin Night in #Orlando on June 12, 2016. In the multi-dimensional public investigation that has followed, a number of tweets using the hashtag #Manifpourtous called out Alliance VITA and its allies for their role in inciting homophobic violence around the world. On June 26, Pope Benedict called on Christians to apologize to gay people and other marginalized groups.
Back in 2012 Alliance VITA and the La Manif pour tous coalition happily cited the Regnerus study, but they weren’t the only ones citing the flawed sociological research promoting homophobic laws. Among others leveraging the “science” to wage their defense of the “natural family” was nearly every American organization opposed to LGBT rights, including the controversial National Organization for Marriage.
One of Alliance VITA’s biggest admirers is Brian Brown, National Organization for Marriage’s president. Brown spent time with La Manif pour tous campaigners in France and this year was elected as President of the World Congress of Families. WCF is an almost 20-year-old effort to organize international spaces for conservative organizers and lawmakers from around the world to collaborate on an anti-LGBT, anti-abortion, “natural family” agenda to support legislation in multiple jurisdictions. (I recommend this historical overview by the Southern Poverty Law Center.)
“Uniting Leaders Worldwide in Defense of Family, Faith, and Freedom”, World Congress of Families 2016 (images via Eventbrite 1, 2).
The WCF’s 10th international convening in May 2016 was held in Tblisi, Georgia, where it bestowed honors on former president George W. Bush. He declined to appear, but sent a letter saying,
“I commend your efforts to recognize the importance of families in building nations. Your work improves many lives and makes the world better.”
The event drew far right politicians from around the world, including WCF representative to France Fabrice Sorlin, and granddaughter of French National Front party founder and youngest French MP in history, Marion Maréchal-Le Pen.
The founding family of the far right National Front party in France, pictured L to R: Marine Le Pen, her father Jean-Marie Le Pen (grey suit), and her niece Marion Maréchal-Le Pen (images via Wikimedia).
In addition to a shared support for a British-Exit, Le Pen’s bid in the French regional elections last year was eerily Trump-like. She beat former presidents Nickolas Sarkozy and François Hollande in the first round of the regional parliamentary race in December 2015, but lost in the second. (For many, the rise of Trump in U.S. politics echoes the rise of the extreme right in the British and European contexts; others argue that the Trump phenomenon is distinctly American in nature.)
As the world wrestles to reconcile global warming, unprecedented inequality, refugee crises, and mass shootings, and now the potential for a new era in European politics, how do we confront the political extremism bubbling up in reaction as we engage in sensitive policy debates that shape the world we will leave to future generations?
Ongoing political and religious controversies over abortion and embryo research may fuel partisan ways of thinking and reactionary policies that fail to serve the public interest in this arena. As increasing awareness about CRISPR takes shape, it will be important to be clear about the many “non-embryo” reasons to be critical of some emerging human biotechnologies. We cannot let the far-right capture the conversation about the social and ethical issues surrounding heritable human genetic modification technologies.
The development of new genetic techniques such as CRISPR-Cas9 demands a reflective debate on the sort of future world we want to build, the meaning of being human, and how far we’ll go to engineer individuals to fit the society we currently have. My hope is that this debate can spark discussions about deep structural social changes that we already know are needed to improve the lives of communities around the world.
This article was cross-posted on The Niche, where a reader commented: "Great piece, thanks. Just a correction regarding the Dec. 2015 election in France: this was not presidential election (which will happen in 2017) but elections to regional parliaments. The far-right party of Mrs LePen indeed registered a political victory by leading the first round in many regions, but the party’s candidates including Mrs LePen lost in all regions during the second round of elections." The blog has been edited to reflect that Marine Le Pen beat Nicolas Sarkozy and Françoise Hollande in the first round of France's regional elections, not a presidential election. Seemore.
Posted by Jessica Cussins, Biopolitical Times guest contributor on June 8th, 2016
Douglass Turnbull and Mary Herbert, Wellcome Trust Centre for Mitochondrial Research,
In February 2015, the UK decided to create a controversial exception to its law against any form of human germline modification to allow the creation of “three-person embryos” to prevent the transmission of some mitochondrial disease. Then and now, unresolved scientific concerns remained, and many people have been waiting to see whether the science will indeed come through.
Adding to anxiety to see these data is the enormous global attention on a different technology proposed for human genetic modification: the gene editing technique CRISPR, and current controversy over varied attempts to try it on human embryos.
However, there is only one central place where the mitochondrial research is being carried out in the UK – the Wellcome Trust Centre for Mitochondrial Research at Newcastle University. But despite opening its doors in 2012 and encouraging excitement about the importance of this research, none of the specific research requested by the Human Fertilisation and Embryology Authority (HFEA) had been published until now.
Today, that changed. Well-known Newcastle researchers including Mary Herbert and Douglass Turnbull have just published an update to their six-year-old Nature paper, which originally described how their preferred form of mitochondrial replacement – pronuclear transfer (PNT) – “has the potential to prevent the transmission of mtDNA disease in humans.”
Shockingly, their new paper reports that the proof-of-concept studies upon which everyone had been basing their enthusiasm “were not well tolerated by normally fertilized zygotes.”
In other words, the scientific basis for the controversial UK law and HFEA policy change turns out to have been unfounded. It did not work.
This overly positive characterization is perhaps understandable given the small but eager group of patients who wish to use this technology to decrease the chances of passing on mitochondrial disease to their offspring.
Yet as of this writing, only The Telegraph is giving weight to the range of unknowns still at play:
The new paper describes the alternative method as early PNT or ePNT because the researchers found it works better to transplant the pronuclei from one embryo into another immediately after meiosis rather than right before the first mitotic division. In 79% of the resulting embryos, less than 2% of the unhealthy mitochondria of the first embryo had transferred over to the new embryo, which might be enough to help a child avoid symptoms of mitochondrial disease. On the other hand, it might not. In decidedly less confident language than has often been used up to this point, the researchers conclude, “PNT has the potential to reduce the risk of mtDNA disease, but it may not guarantee prevention.”
Part of the reason for this caution is because of a Cell Stem Cell paper published just days earlier by US researchers including Dieter Egli called “Genetic Drift Can Compromise Mitochondrial Replacement by Nuclear Transfer in Human Oocytes.” This paper highlights their findings that even small amounts of carryover mitochondria can cause “genetic drift,” which can “lead to the restoration of the original donor mitochondrial genotype” and undercut any positive outcome from the technique. They suggest “although vertical inheritance of mtDNA is not required, it is critical to ensure inheritance of a single maternal mtDNA lineage.”
As in 2010 when Turnbull and Herbert first published research using PNT in nonviable embryos, the conclusions from these recent data is still "we're working on it" not "this is safe." Such data support previous warnings from scientists, and the fact that we are still unsure about the extent of the role of mitochondria in the overall functioning of our bodies.
So, what’s the moral of the story? Perhaps that humility is the best path forward if we are ever to seriously contemplate bringing new lives into the world this way. And maybe also that policymakers should not be so easily won over by over-zealous promises of science not yet confirmed.
Though the CRISPR-Cas9 genome editing platform is only some four years old, universities and industry are racing forward with a range of research projects, including in human embryos. Given the speed of uptake, and the recent approval of non-clinical experiments with embryos in a number of countries, many are wary of this kind of CRISPR research because it could so easily pave the path to high-tech fertility clinics vending eugenic upgrades.
A vast diversity of publics, communities, and stakeholders are deeply concerned about this prospect of heritable human genetic modification. Yet, a recent comment in JAMA Forum by Eli Adashi seeks to funnel this textured landscape of opinion into a tale of two cities in an international biomedical arms race in which the American research establishment is falling behind.
On one side, Dr. Adashi places a mostly British cohort of pioneers, including two groups of research charities and stem cell researchers that have separately gone on record advocating for clinical research into genetically modifying embryos for human reproduction, once certain thresholds are met. He writes:
Many UK scientists quoted in the lay and professional media welcomed the HFEA decision. Professor Sir Robert Lechler, MB, ChB, PhD, President of the UK Academy of Medical Sciences, offered that “studies such as [that proposed by Dr Niakan], that focus on asking basic questions about human-embryo development, are needed to help answer the many scientific and ethical questions remaining in this field.” Similar sentiments were echoed by other UK-based groups, including the Hinxton Group, an international consortium on stem cells, ethics, and law, the Wellcome Trust, an independent global charitable foundation dedicated to improving health, and the Medical Research Council, a leading funder of medical research. Some prominent US scientists also spoke approvingly of such work going forward.
On the other side, he places two lone voices termed “bioethics groups,” CGS included, whose concerns are vaguely glossed:
In contrast, some bioethics groups on both sides of the Atlantic criticized the HFEA’s action. Marcy Darnovsky, PhD, executive director of the Center for Genetics and Society, in Berkeley, California, warned that genome editing poses “dire safety and societal risks.” Calum MacKellar, PhD, of the Scottish Council on Human Bioethics, in Edinburgh, said that “allowing the gene editing of embryos opens the road to genetically modifying all the descendants of a person as well as full blown eugenics which was condemned by all civilised societies after the Second World War.”
A good number of bioethicists have spoken up in the human gene editing debate to voice concerns around informed consent of future generations, the sharing of risks and benefits, and the distributional justice problem of inequitable access to genetically enhanced reproduction. CGS' concerns with heritable genetic modification include those and others: they extend far beyond problems inherent to the individual doctor-patient relationship. As a public interest organization advocating for human biotechnology to serve the common good, we are deeply concerned about the social justice implications of moving forward with the human re-engineering project of germline gene editing under the mislabeled auspices of medicine and science.
What's on the international policy table is the potential creation of genetically modified humans. The substantive issues at hand strike at deeply held values across nations and cultures, including commitments to social justice, human rights, and the public interest. Yet many aspects of the futures that CRISPR would enable, and of the context of unprecedented health and wealth inequalities in which it would be deployed, are not being discussed democratically.
Who is most vulnerable of being “edited out” of future generations, and why aren’t their voices at the policy table? Groups and voices dangerously under-represented or missing in these conversations include those under consideration for editing: disability rights and justice, racial justice, reproductive rights and justice, public health, global health, environmental justice, religion and spirituality, LGBTQI rights and justice, and indigenous rights and justice. How would the unquantifiable lives and interests that these voices represent be affected by the fantasies and projects of a technology-enabled-and-optimistic few?
Recent public opinion studies show that a majority supports the development of accessible gene therapies for consenting patients. By contrast, the polled public is overwhelmingly opposed to genetically modifying human embryos for reproduction.
The history of eugenics and its goal to competitively optimize human reproduction is a century-old, and deeply fraught, enterprise. Without a federal law banning human germline modification, the United States is vulnerable to private interests moving forward uninhibited. This could usher in a new form of high-tech eugenics that would exacerbate existing inequalities, and create new forms of discrimination. We cannot proceed with germline interventions for human reproduction without imperiling the existence of a just and sustainable world for future generations.
The latest season of Orphan Black takes a cue from Donna Haraway’s “A Cyborg Manifesto” to probe the boundaries of identity, humanity, and perfection, as it reminds us that mainstream genetic and reproductive technologies are closer to the show’s more radical technologies than we might think.
In “A Cyborg Manifesto,” originally published in 1985, Donna Haraway describes a cyborg as “a cybernetic organism, a hybrid of machine and organism, a creature of social reality as well as a creature of fiction.”
The clones of the BBC America television show Orphan Black seem to fit that definition well – they all possess snippets of synthetic DNA entwined in their genome, and often exist in an at least partially fictitious reality designed to better control their actions. However, the latest season explores the possibilities and meanings of cyborg-ness in greater depth. Fittingly, each episode is named with a quote from Haraway’s work: “The Collapse of Nature,” “Transgressive Border Crossing,” “The Stigmata of Progress,” “From Instinct to Rational Control,” “Human Raw Material,” and “The Scandal of Altruism.” And as Orphan Black engages with what it means to be a cyborg, this fourth season also situates itself in the ongoing conversation on new human genetic and reproductive technologies in the real world, including genome editing.
Neolution is the name of the show’s pro-eugenic movement, whose goal is to take control of human evolution. In the first episode of the season, a character reads from the book on Neolution: “The individual can only begin the journey to the extraordinary by casting off the genetically mandated human shell.” Sarah retorts that Cosima calls this stuff “sound bite science.”
The season reveals one of Neolution’s experimental genetic technologies: a synthetic worm-like organism implanted into people’s cheeks to act as an ongoing gene therapy delivery system. We find out that Sarah has had one implanted against her will and knowledge. But just as some transhumanists in real life choose to implant a range of devices in their bodies for numerous reasons, some Neolutionists in the show have opted for the “cheek worm” in order to produce a desired alteration to their body.
Whereas previous episodes have established a clear distinction between the clones as non-consenting research subjects and the Neolutionists as willing bio-hackers, the line between coercion and choice over one’s bodily autonomy is increasingly blurred in this season. In a particularly memorable moment, Cosima holds the decaying head of former Neolution leader Dr. Aldous Leaky to investigate his still-thriving “cheek worm” and asks, “Who’s the science now, bitch?”
In another heart-chilling scene, one of the clones agrees to withhold potential treatment from a child diagnosed with a genetic disorder who was made from her own cells, declaring the data learned from the disease’s progression to be more valuable for humanity than saving the child.
A more broadly relevant way in which the distinction between coercion and choice is tested comes in the form of a cutting-edge fertility program called BrightBorn. By this point of the show we know that Neolution’s leaders have extensive influence over the cloning programs; now we learn that cloning is only one mechanism of reproductive control in which they are interested. An acquaintance of suburbanite Alison has finally gotten pregnant thanks to BrightBorn Technologies, without having any idea that there may be a link between the company and more nefarious ends. Although BrightBorn keeps itself out of the public eye and does not publish its scientific findings, it is notably available to anyone willing to pay. BrightBorn is run by Neolutionists, but is marketed to all. In language reminiscent of the fertility clinic scene in GATTACA, the BrightBorn ad declares:
We can provide you with a healthy and thriving newborn, but why stop there? All of our children are born stronger and healthier. At BrightBorn Technologies we’re making the world a better place, one baby at a time.
Cosima points out:
“Mainstream reproductive technology: it’s like a whole new side to Neolution.”
After sneaking into Brightborn’s facilities, Cosima not only finds a variety of experimental technologies ranging from embryo screening and selection to illegal germline modification techniques, but also what seem to be well-paid surrogate mothers under continuous surveillance while carrying the trial embryos. It is apparent that not all of the experiments go as planned, as Cosima witnesses the birth of a severely deformed baby in the limited time she is there. Afterwards, Cosima (italics) discusses what she saw with none other than the woman who created her:
“These are human beings that you’re tinkering with. Trial and error without consent.”
“These carriers are very well compensated.”
“And does that justify the baby that I saw? Look at me, I’m sick. I never gave permission for any of this.”
“No one gives permission to be born. I created you as a beautiful baseline to unlock the mysteries of the human genome.”
In a later conversation with the leader of BrightBorn who is competing for control of Neolution, Cosima learns that some people find cloning to be a crude mechanism for evolutionary control compared to gene editing:
“We don’t need your baseline. We can fix people now.”
“You can’t perfect the human genome. You can’t know what perfect is.”
“I do know. I was born sick.”
“I’m sick too. That doesn’t justify this.”
Season Four of Orphan Black also introduces the role of commercial genetic ancestry testing companies within the overarching project of understanding genetic identity, as Felix finds a “real [genetically related] sister” using an online DNA service. This poses a strange juxtaposition with the non-traditional clone “sestras,” as well as with Sarah, who was raised by a foster parent with Felix and who resents the implication that she is somehow less related than this “real sister” whom Felix has only just met.
Orphan Black has always been good at pushing the boundaries of what family and sexuality look like. The show has also made a move that destabilizes binary biological sex. Given Haraway’s claim that “the cyborg is a creature in a post-gender world,” it is fitting that we learn that the original DNA for both the female and male lines of clones came from a single chimeric woman.
Interestingly, even as everyone is enormously concerned with the well-being of “the original” in order to access her valuable DNA, she keeps secret the fact that she has leukemia. Perhaps she sees this as a way of reclaiming her death for her own, a kind of bodily autonomy she has been denied in her life. Sadly, she is murdered in episode six, and so she is unable to have even that. But her desire to go untreated for her cancer is an interesting reminder that we often make different decisions when it comes to our own body than when it comes to the bodies of others.
This latest season of Orphan Black encourages us to question whether the kinds of technologies and ideologies presented in the show are less radical than they seem, and are in fact already with us in more innocuous forms today. Now that we have effectively donned smartphones as additional appendages and live in a world mediated by algorithms, to what degree are we all already cyborgs? And with the increasing normalization of assisted reproductive technologies to select and possibly even modify embryos, how far are we really from Neolutionism?
The quest towards perfection is a powerful narrative – in the show as in real life. But as the characters in Orphan Black prove repeatedly, biology and identity are marvelously complex and never compliant with even a single notion of perfection. And thank goodness for that. The show would be a lot less compelling if the clones really were all the same.
[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.]
"Can science produce a superman?" science writer Waldemar Kaempffert wondered in the New York Times in 1928. "What kind of a superman do we want? And who shall dictate his specifications?"
In the early twentieth century, new genetic discoveries prompted supporters of eugenics to ponder the potential creation and characteristics of a superior human race. Many believed that encouraging the eugenically “fit” to mate and isolating or sterilizing the eugenically “unfit” would yield over time a superior population. They argued that breeding a better race represented the next step in human evolution. After all, careful husbandry had improved crops and livestock. Surely the production of "human thoroughbreds" could not be much different.
With new scientific knowledge and technologies, eugenists believed that they at last had the tools to create improved people. They were particularly interested in developing technologies for assisted reproduction, including the human application of animal husbandry techniques like artificial insemination. Dr. Julian Huxley, grandson of champion of the theory of evolution T. H. Huxley, predicted that such techniques would allow eugenically fit men and women to marry whomever they chose, but—regardless of their partners' fertility—have children with third parties who had been specially selected for their genetic qualities. (Those who might object to this cold calculation were merely exhibiting "outworn sentimentalism," said Huxley.)
Exhibiting similar thinking, Dr. George L. Streeter and Dr. Charles Davenport released a bulletin through the Carnegie Institute of Washington in 1933 discussing the eugenic implications of the quality of gametes. They wrote, "Every poultryman knows that in a setting of eggs not every egg will hatch a perfect chicken. Some eggs do not hatch at all; others produce defectives that soon succumb; from still others come chicks of inferior quality." Both in pigs and in people, as many as 25% of ova are "not good enough to hatch." According to the authors, the identification of gametes that would produce not only viable embryos but superior people could only be a worthwhile endeavor.
To detect superior gametes, scientists would need to examine genes more closely. Kaempffert wrote that marriage and childbearing between eugenically fit people was insufficient to breed a superhuman race. Successful eugenics would require a more "scientific" mode of thinking: Scientists needed to determine how to manipulate the genes that would be passed on to successive generations. "Unless we can control the interaction of the genes it is practically impossible to produce a race of supermen," Kaempffert wrote.
British scientist J. B. S. Haldane stated that with more knowledge about human genes, we could examine a newborn baby and say, for example:
He has got iso-agglutinin B and tyrosinase inhibitor J from his father, so it's twenty to one that he will get the main gene that determined his father's mathematical powers; but he's got Q4 from his mother . . . so it looks as if her father's inability to keep away from alcohol would crop up in him again; you must look out for that.
If we can understand the correspondence between genes and discrete characteristics, eugenists argued, we can largely determine the life trajectory of each human being. With such knowledge, we can facilitate the birth of the best individuals and eventually mold the human race into a finer shape.
Eugenic Health Certificates and Registries
Accordingly, selecting healthy eugenic partners for better raw materials became paramount for building super-people. In order to help fit members of the public find eugenic mates, many eugenists supported physician-issued eugenic health certificates and a eugenics registry office.
Continuing the comparison with livestock, Dr. J. H. Kellogg argued that since pedigree registries existed for horses, cattle, cats, and dogs, why not for people? "If a lady wishes to establish the standing of her pet poodle," he said, "she can do so by appealing to an official record and the puny canine may lift its head above its fellows as a born aristocrat, but nowhere on earth, as far as I know, is there to be found a registry of human thoroughbreds.” In an address before the second National Conference on Race Betterment in 1915, Kellogg argued that the world needed a "real aristocracy made up of Apollos and Venuses and their fortunate progeny." Without a eugenic registry, how could laypeople judge superiority and inferiority? How would we identify the human aristocracy?
The development of the eugenic aristocracy relied on classification schemes. One commenter, a Mr. Field of New Zealand, suggested the grouping of individuals into "three or four grades" based on their family health history. Field mused:
The “a” or top grade certificate given to a thoroughly sound and well developed person would be something worth having; a “b” would be tolerable; a “c” would conjure up visions of doctor's bills and physic for a family of future weaklings; and a “d”—well a “d” would be a pity.
Similarly, W. M. Hays, the Assistant Secretary of Agriculture, in an address before the American Breeders' Association, proposed a numerical classification of all people in the world. These numbers would "join genealogies into one numerical system, so that all relationships would be traced." Each person would be given a number that could be averaged with those of his or her family members to determine the family's quality. Hays acknowledged that this system would "somewhat divide people into classes," but stressed that "the classification would be beneficent, because it would be based on racial efficiency." Eugenists contended that a hierarchy based on "racial efficiency" would certainly possess greater validity than our current materialistic model. The Very Rev. William R. Inge predicted in 1931 that by the year 3000, individuals classified as "A-1" via mandatory mental and physical health examinations "will be as much sought after [for marriage] as wealth and titles are now."
Privacy of Genetic Information
Eugenists sought to assuage concerns about the exposure of personal genetic information, but their assurances may not have satisfied. Mr. Field promised readers that under his proposal, a eugenic examination would be "perfectly private and confidential" and "the person receiving it could then do as he or she thought fit with it." Nonetheless, he added that if a prospective bride or groom refused to present her or his certificate to the other party, the latter should be able to break an engagement without fear of a "breach of promise" reprisal in court. Furthermore, a copy of each person's certificate would be interred in government archives. Field proposed that officials could eventually use these records to determine the ancestry of all individuals committed to institutions.
Charles Davenport, the director of Cold Spring Harbor Laboratory and the Eugenics Record Office, argued that eugenics had been unnecessarily hindered by anxieties over revealing unfavorable family secrets. Davenport claimed that this fear was unwarranted because the careful collection of records would both improve the race and benefit the individual. For example, teachers could be given information on the “family and racial characteristics of each of their pupils" so that they could instruct their students differently. Also, state eugenic boards could "scientifically" regulate marriages and childbearing. If couples who were denied permission to have a child did so anyway, "the penalty shall be sterilization of the male." In spite of eugenists’ insistence that genetic privacy would be maintained—or would not be necessary—their proposals made it clear that exposing individuals’ genetic information was essential for achieving their desired goals.
While some supporters of eugenics stressed that the enhancement of the human race required not merely better breeding but also environmental and educational adjustments, others were skeptical. Men such as Leonard Darwin, son of Charles Darwin, and Henry Fairfield Osborn, the president of the International Eugenics Congress, argued that education and environment could not, in the words of the latter, "offset the handicap of ancestry." Plant specialist Luther Burbank added that environmental improvements could "bring individuals up to their best possibilities" but the practice of eugenic selection was "10,000 times more important and effective." Los Angeles Times science writer Ransome Sutton even wrote in 1933:
Education and environment may enable an honest-minded person to overcome inborn tendencies to a limited extent, but at heart no one can ever be much better than the two sets of chromosomes which come together when individual life begins.
Because many eugenists believed that genes dictated human potentiality and that social problems largely resulted from individual moral failings, the solution to social problems lay in improving genes. Reforming society was a palliative, not a cure.
Despite the common conviction that the United States teetered on the precipice of utter mental and moral depravity, eugenists still believed that America was particularly well positioned to breed the great race of super-people.
Prof. Scott Nearing of the University of Pennsylvania's Wharton School, known in his later life as a left-wing economist, educator, writer, and political activist, was among those who believed that America had the "most potent opportunity the world has ever known . . . for the creation of a race of Supermen and Superwomen"—a contention perhaps incompatible with his other views that pajamas should be accepted evening attire, and that all women are leeches who need men's "sufferance and generosity" to survive. A New York Times article summarized Nearing's view that the United States could best produce a stronger race due to its “national resources, the stock of the dominant races, the possibilities of leisure, the emancipation of women, the abandonment of war, the knowledge of race-making and of social adjustment, and the widespread educational machinery." That half of the population consisted of parasites presumably would not hinder this outcome.
Appearance and Characteristics
Eugenists held varying views about the possible physical appearance and characteristics of super-people, as well as the implications of a super-race for society. Nearly all believed that super-people would be healthier, taller, more muscular, and more physically attractive. Some thought that super-people would have lower child mortality and life spans extending as much as 100 years. Many also expected that super-people would possess greater intelligence and social skills. While some eugenists predicted that a number of geniuses and great leaders would emerge from this superior stock, others thought that the race would experience a more general uplifting, with no increase in the rate of human stand-outs. Due to the prevailing belief that social problems originate from poor heredity, eugenists commonly thought that a superior race would produce social and moral improvements like fewer incidents of crime, violence, "violent eroticism," "extreme indolence," and divorce.
Several eugenists described at length the traits of a super-people and the outcome for a super-society. For example, Scott Nearing argued that the six core traits of a superman would be "physical normality, mental capacity, aggressiveness, concentration, sympathy, and vision." Dr. Ales Hrdlicka, curator of the division of physical anthropology at the National Museum in Washington, had perhaps the most precise projection. He believed that super-people would enjoy larger and more organized brains, greater height, longer legs, shorter arms, deeper-set eyes, thinner skulls, more prominent but narrower noses, smaller mouths, larger chins, smaller and fewer teeth, a tendency toward baldness, unaffected beards, thinner bodies, shorter intestines, narrower hands and feet, and diminishing fifth toes. Even so, man would be more handsome. But he would pay for these developments with greater mental disorders and physical impairments, until eugenics once again righted these defects.
Many eugenists maintained that these "improvements" wouldn't impact all races, classes, and genders equally. Unsurprisingly, their visions of the super-future corresponded to and reinforced the prevalent prejudices of the day. Hrdlicka predicted a "widening of the breach between the more civilized and backward people" and between "the front and the back ranks." He said, "There will always be masters and servants, the pioneers of progress and the drags." French scientist and professor Daniel Berthelot contended that as humans became more "advanced," human skin "evolved" into lighter shades. One day, super-people would have skin so white, it would reflect ultraviolet rays.
Naturally, men more than women would power the super-race. According to Prof. L. Bolk, the director of the Department of Anatomy at the University of Amsterdam, the development of the human skull had gradually slowed down, which had allowed the human brain to form over a longer period of time. Since boys mature more slowly than girls, their brains must develop more slowly, so men must be the superior sex. This trend would continue and intensify in the super-race; it would take men a long time to grow up, but they would be a formidable force when they did.
Even though supermen would, of course, eclipse superwomen, male scholars did not withhold their predictions for future women’s physical appearance. Dr. Richard Root Smith attested that “the imperfect or defective type of woman is . . . very slight, thin-chested, and nervous.” In contrast, superwomen would be “compact in build, deep-chested, with steady nerves and fleshy enough for the anatomical angles to be nicely rounded out.” Dr. A. J. Read, a professor of hygiene, told a race-betterment conference audience:
The ideal woman of the eugenic age will be taller than the average woman of today. She will be plump and well rounded, but not fat. Her complexion will be ruddy or brown, not pale, because the pale skin is a badge of disease rather than health.
Perhaps unusually for an Anglican priest, the Very Rev. William R. Inge predicted that clothes for both sexes would become more “scanty” such that “beauty [could] be recognized in the body and limbs as well as in the face.” It appeared that the perfect women of tomorrow would embody the ideal of the imperfect men of today.
Not everyone who supported eugenics in whole or in part believed that the creation of a super-race was possible or even desirable. Despite J. B. S. Haldane’s tendency toward biological determinism, he rejected the possibility of perfect people because he believed that society relied upon human diversity. In a 1932 interview with the New York Times, Haldane stated that in the ideal community, all people would be able to contribute their unique talents and would be afforded the opportunity to develop and thrive as individuals. Instead of altering people to fit an arbitrary notion of perfection, “the community should be fitted to the people of which it is composed rather than the misfits [fitted] to the community.” That certain people are considered “misfits” in our society, he said, does not mean that they wouldn’t be “happy members” if society were different.
Other individuals grappled with the outcome of achieving eugenic perfection. If we could indeed, through the proper breeding of the correct gametes of the right individuals, create nearly god-like people with greater concentration, thinner skulls, fewer teeth, whiter skin, rounder angles, and diminishing fifth toes, what then? What would happen to society after we had managed to—in the words of Scott Nearing—"model the plastic, living clay of humankind into nobler, finer, more spiritual forms"?
Not all observers were sanguine. Humor magazine Life offered this uncharacteristically serious picture in 1914:
The Eugenists dream of a race of Supermen and Superwomen. Let us dream of them, too. Imagine such a race suddenly created in the United States. Thirty millions of Superpeople—each one having the strength of Jack Johnson, the mental efficiency of Edison, the moral greatness of Lincoln. Meanwhile the economic scheme remains unchanged—a small class of Superpeople owns all the land and machinery, while the other Superpeople compete with each other for jobs. What about the Superpeople who don’t get jobs? Supermen in the breadline, Supermen piling into the Bowery Mission to get out of the wind and rain, Superwomen on the streets selling their bodies for bread, Supermen on the street-corners in the Supercold of a winter evening waiting for some Supermillionaire to give them the price of a night’s lodging. It is a pretty scene, and it provokes reflection.
This Life piece captured the fundamental objection to the attempted creation of genetic super-people: that eugenists were seeking answers to social problems inside human bodies instead of through social reforms. Eugenists believed that perfecting the human genetic code would create a healthier, more intelligent, more moral, and more perfect race of man, which would naturally improve the society in which it lived. However, opponents argued that even if we could collectively conceptualize health, intelligence, morality, and perfection and then operationalize these concepts in our genes, our success in this regard would have little bearing on problems that result from the societies we build, not the cells in our bodies. Moreover, encouraging unequal treatment and opportunity on the basis of a hierarchy that we claim is inscribed in human bodies is not a way to produce a more moral and just society. Creating a better world is more complicated than we hope.
During his interview with the New York Times, Haldane turned to passing scientist Dr. F. E. A. Crew of the Institute of Animal Genetics in Edinburgh and asked him, “What is the perfect man?”
Crew replied, “There isn’t any. Define us a heaven and we will tell you what an angel is.”
1. “Americans of the Future to Be the ‘Super Race.’” San Francisco Chronicle, Mar. 31, 1912.
2. “Brain Power Is Stationary.” Los Angeles Times, Jan. 1, 1915.
3. “Calls Thin Woman an Imperfect Type.” New York Times, Jan. 9, 1914.
4. “Case for Eugenics: Results Achieved Through the Use of Artificial Insemination.” New York Times, May 14, 1944.
5. Darwin, Leonard. “Babes of the Future: Major Leonard Darwin Tells True Purposes of Eugenics.” New York Times, Dec. 21, 1912.
6. “Eugenics As Basis of New Aristocracy.” New York Times, Aug. 8, 1915.
7. “Eugenists Dread Tainted Aliens.” New York Times, Sep. 25, 1921.
8. “Eugenics Is Urged to Lengthen Life.” New York Times, May 15, 1937.
9. “Eugenic Women to Be Tall and Dark.” Sacramento Union, Aug. 6, 1915.
10. “Hope of Better Brains for All.” New York Times, Sep. 27, 1912.
11. Hrdlicka, Ales. “Man’s Future in the Light of His Dim Past.” New York Times, Apr. 28, 1929.
12. “Human Race Improvement: Collecting Data for Plan of Practical Eugenics.” Los Angeles Times, May 12, 1912.
13. “Huxley Sees Life Prolonged in Future.” New York Times, Oct. 29, 1926.
14. Inge, Very Rev. William R. “Eugenics Will Aid Physical Beauty and Clothes Will Be More Sensible.” Los Angeles Times, Dec. 4, 1931.
15. Kaempffert, Waldemar. “The Superman: Eugenics Sifted.” New York Times, May 27, 1928.
16. “Life’s Traits to Aid Eugenics.” Los Angeles Times, Nov. 30, 1914.
17. Laurence, William L. “Huxley Envisages the Eugenic Race.” New York Times, Sep. 6, 1937.
18. Laurence, William L. “Not a ‘Perfect Man’ in Haldane’s Utopia.” New York Times, Aug. 29, 1932.
19. P. H. D., in the Masses. “Eugenics and Economics.” Life, Apr. 2, 1914.
20. “Race of Super-Men.” Los Angeles Times, Feb. 12, 1914.
21. “Says Glands Cause Gloom and Crime.” New York Times, Oct. 2, 1921.
22. “Says Man Will Grow for Ages to Come.” New York Times, Apr. 20, 1929.
23. “Scientists Agree With Dr. Depew That Men Ought to Live to Be 100 By Observing Rules of Health.” Washington Post, Nov. 26, 1916.
24. “Scientists See Eugenics Aid in Doing Away With Crime.” New York Times, Jul. 29, 1923.
25. “Social Problems Have Proven Basis of Heredity.” New York Times, Jan. 12, 1913.
26. “Superman a Being of Nervous Force.” New York Times, Jan. 11, 1914.
27. “Supermen to Be Propagated Artificially, Says Biologist.” Los Angeles Times, Sep. 6, 1937.
28. “The Superrace: A Plea for the Evolution of That Rather Strange Production.” New York Times, Jun. 16, 1912.
29. Sutton, Ransome. “Some Born Great and Others ‘Out of Luck.’” Los Angeles Times, Jun. 25, 1933.
30. “To Breed Fine Race: W. [M]. Hays Would Begin By Classifying All People.” Washington Post, Dec. 30, 1911.
31. “Will Breed Men Like Fine Cattle.” San Francisco Chronicle, Oct. 20, 1912.
Some years ago, in deepest Asia, an American was reportedly kidnapped and hypnotized into doing his captors' bidding any time the Queen of Diamonds was played. Oh, wait, that was the Manchurian Candidate (1, 2, 3). We're talking about the Transhumanist Candidate. Let’s start again.
If you pay attention to the lamestream media, as a former VP candidate called our mighty organs, you may think that the pool of those running for President has or soon will have tightened from 23 (six D’s, don’t forget Lessig, and seventeen R’s) to two. You would be wrong.
In fact, it has shrunk from 1,711 to something like ten. According to Ballotpedia, four Democrats other than Hillary Clinton (or Bernie Sanders) will be on more than 5% of presidential ballots, along with two repeat offenders (Libertarian Gary Johnson and Green Jill Stein) and possibly Jesse “The Body" Ventura. Add in He Trump, and that makes nine. But wait, there’s more!
Zoltan Istvan is running.
The Federal Election Commission, stick-in-the-muds that they are, insist on calling him Zoltan Istvan Gyurko. He calls himself an American-Hungarian but this Magyar site seems to say, according to Google Translate, that he is a Hungarian-born American. That could cause a bit of difficulty, though certain other candidates seem to have evaded or redefined the “native-born” requirement. [ETA: He was born in Los Angeles, after his parents escaped from Hungary.]
Also, the FEC lists his party affiliation as “Other.” But Zoltan is actually running on behalf of the Transhumanist Party. The two other officers are Zoltan’s wife Dr. Lisa Memmel (who is an ob-gyn) and a big fan currently writing a “guide book” to Istvan’s transhumanist philosophy. The advisors include Aubrey de Grey and Gabriel (son of Martine) Rothblatt, as well as one of the Alcor Directors, and other low-wattage luminaries.
The Transhumanist Party and Zoltan Istvan's US Presidential campaign is politically-centric. It aims to support voters with future-inspired policies that will enrich America and the world. We believe science and technology can solve most of the world's problems.
Among the specifics are:
Lay groundwork for rights for other future advanced sapient beings like conscious robots and cyborgs.
Create stronger government awareness and policies to protect against existential risk (including artificial intelligence, plagues, asteroids, climate change, and nuclear warfare and disaster) [but not including protection of humans qua humans]
Implement policy for the phasing out of all individual taxes based on robots taking most jobs in the next 25 years. Advocate for a flat tax until we reach that point.
Develop international consortium to create a "Transhumanist Olympics”
Encourage private industry to develop and support usage of a cranial trauma alert chip that notifies emergency crews of extreme trauma (this will significantly reduce domestic violence, crime, and tragedy in America)
Work to use science and technology to be able to eliminate all disabilities in humans who have them.
But the big deal is downplayed in the official list, which does however refer to this statement of intent, which explains, right up front, as the first “primary goal” of his political agenda:
1) Attempt to do everything possible to make it so this country’s amazing scientists and technologists have resources to overcome human death and aging within 15–20 years—a goal an increasing number of leading scientists think is reachable.
(Presumably that’s why Aubrey de Grey is on board.)
Zoltan wrote a book a couple of years ago, and he seems to be having quite a lot of fun with this “campaign.” He raised $27, 250 on Indiegogo to create an Immortality Bus. (He accepts no financial contributions, on principle.) That's a "mobile 40-foot coffin" that he drove around the country "to ignite the next great civil rights debate in America and around the world." He did it, too, and even got some press.
He’s done a very respectable job boosting his profile among the notoriously small circle of transhumanists, but not without making enemies there. Notably, James Hughes can’t stand him. They had a “salty” debate in April, which was written up in Motherboard, with many lovely quotes, the best of which they kept for last:
Extra Sick Burn: Hughes on Zoltan’s novel, The Transhumanist Wager: “It’s like Ayn Rand wrote Atlas Shrugged and then ran for office as a Democrat… At least in Atlas Shrugged the rich people buggered off and left everybody alone.”
The public is firmly — overwhelmingly — opposed to using gene editing for heritable “enhancement” purposes. Many people, if pressed, will support the concept of heritable “cures” that for the foreseeable future, at least, are not practical and rarely needed, if at all. It is not clear, however, how many of the public (and perhaps the pollsters) have an adequate grasp of the issues involved in heritable human genetic modification (HGM).
CGS has for a decade been collecting polling data going back to 1986: over 50 polls, some of them international, on HGM and/or human cloning are summarized here. Assessing that data, however, has always been tricky.
Polls tend to show that public sentiment about human biotechnologies is strongly ambivalent. Most people value their potential to alleviate suffering, yet are apprehensive about the social consequences of some applications. Public opinion on HGM is particularly difficult to assess because of the ambiguity of some of the questions and the terminology used. Opposition decreases with increased emphasis on cures, and increases with emphasis on non-medical or “enhancement” uses, such as improving intelligence.
Interpreting the data is now of much more than academic interest. Many scientists and policymakers have begun looking for a “broad societal consensus” to guide decision-making about the limits that should be put in place for human genetic applications.
Prompted by this, Robert Blendon, Mary Gorski and John Benson published a survey article, "The Public and the Gene-Editing Revolution" in the New England Journal of Medicine on April 14th. It analyzes, and links, 17 U.S. polls over the last three decades. (Several of them were not previously in the CGS collection, but they are in line with the several dozen that were.) The article concludes:
Most of the public favors gene therapy for clinical use in patients with serious diseases. The majority do not support gene editing in human embryos or germline cells, but the level of opposition varies depending on its goals. Of course, public opinion could change over time as discussions of these issues continue to evolve and as more is learned about the implications and safety of gene-editing technologies.
It’s possible to draw quite a different conclusion. The opposition to using enhancement technologies in HGM has been quite consistent for decades. Moreover, the “medical” arguments in favor are much weaker than the questions asked by pollsters generally imply. Inevitably, hypothetical questions assume success, which in this case is by no means guaranteed, or even likely. How different might the responses be if those being polled fully understood the risks involved, the slim likelihood of success in the foreseeable future, and the availability of alternatives?
Eric Lander, one of the most distinguished current geneticists, addressed these points in his presentation last December at the National Academies of Science gene editing summit (15-minute video here, strongly recommended), and elsewhere. For instance, he wrote in NEJM last June:
… Some observers might propose reshaping the human gene pool by endowing all children with many naturally occurring “protective” variants. However, genetic variants that decrease risk for some diseases can increase risk for others. (For example, the CCR5 mutations that protect against HIV also elevate the risk for West Nile virus, and multiple genes have variants with opposing effects on risk for type 1 diabetes and Crohn's disease.) … It has been only about a decade since we first read the human genome. We should exercise great caution before we begin to rewrite it.
More bluntly, he told the Washington Post in April that we don’t understand the genome well enough to be confident that the changes we make will be salutary in the long run:
"We’re crummy at it," he said. "We are terrible predictors of the consequences of the changes we make."
The most recent poll included in the NEJM survey was conducted in January 2016 [pdf] by STAT and the Harvard T.H. Chan School of Public Health. Sharon Begley, for STAT, wrote an analysis that opens:
Most Americans oppose using powerful new technology to alter the genes of unborn babies, according to a new poll — even to prevent serious inherited diseases.
They expressed the strongest disapproval for editing genes to create “designer babies” with enhanced intelligence or looks.
The poll showed significant support for gene therapy, skepticism about genetic testing (shared by doctors) and the usual, solid opposition to enhancement:
Do you think that changing the genes of unborn babies to improve their intelligence or physical characteristics should be legal?
Yes: 11%, No: 83%, Don't know: 6%
(A Global Social Media Survey
published on May 5th shows somewhat more support [27%] for editing embryos to change "any
non-disease characteristic," but the authors recommend great caution in
interpreting results that may not be representative.)
Moreover, the STAT survey revealed this remarkable finding:
Do you think the federal government should fund scientific research on changing the genes of unborn babies that aims to improve their characteristics such as intelligence or physical traits such as athletic ability or appearance?
Yes: 14%, No: 82%, Don't know: 4%
These are, or should be, devastating numbers to anyone who thinks that the public supports human heritable genetic modification.
We advocate preventing any application of genome editing on the human germline until after a rigorous and thorough evaluation and discussion are undertaken by the global research and ethics communities.…Despite the significant scientific and ethical issues involved, however, we believe that it is necessary to keep developing and improving the technologies for precise genetic modifications in humans.
Many found the latest CRISPR human embryos experiment to be ethically problematic in design and implication:
“Introducing CCR5Δ32 and trying repair, even in non-viable embryos, is just playing with human embryos.” – Tetsuya Ishii, bioethicist at Hokkaido University in Sapporo, Japan, Nature News
“The paper does not in my opinion strengthen the case that CRISPR’ing of human embryos with reproductive intent is ever something that could work well enough to be done clinically.” – Paul Knoepfler, associate professor of Cell Biology and Humanity at UC Davis School of Medicine, The Niche
“If you were serious about not wanting to go down this path where wealthy people are having children who have been genetically modified to have capacities that aren’t available to the children of poor parents, then the time to try and stop it is now.” – Robert Sparrow, associate professor at the Monash University Centre for Human Bioethics in Melbourne, South China Morning Post
A number of scientists commenting on the new publication distinguished its clear objective of refining human germline engineering for reproduction from the basic research goals of other ongoing CRISPR embryo experiments, including the HFEA’s February 2016 approval for Kathy Niakan’s embryo development research at the Francis Crick Institute in London. George Daley, stem-cell biologist at Children’s Hospital Boston in Massachusetts, categorized the new CRISPR embryo research as a “proof of principle for what would need to be done to generate an individual with resistance to HIV,” meaning “the science is going forward before there’s been the general consensus after deliberation that such an approach is medically warranted.”
“At least in the scientific community, I sense more support for basic-research applications," argued Fredrik Lanner, assistant professor at the Karolinska Institute near Stockholm, who was approved in June 2015 to use CRISPR in embryos to study early human development. In addition to UK and Sweden, a government bioethics panel in Japan on April 22 approved basic research using CRISPR in embryos, but denounced moving forward with clinical germline research.
New tools and research for hacking the CRISPR patent war
Even as CRISPR investments, biomaterials, and research licenses proliferate internationally, the ongoing patent fight between prominent American universities has had a major impact on the landscape. Jacob Sherkow, associate professor of law at New York Law School, argues in Nature that “pursuit of profit poisons collaboration” and the “CRISPR-Cas9 patent battle demonstrates how overzealous efforts to commercialize technology can damage science” by pitting schools against one another and “erod[ing] scientific collaboration.”
Shobita Parthasarathy, associate professor of Public Policy and Women's Studies at University of Michigan, puts forth two important lessons. First, she argues that “patent systems no longer fit the realities of how science works, and patents give their owners significant control over the fate and shape of technologies.” She also notes that licensing decisions by CRISPR patent holders may subjugate democratic deliberation over “what kinds of research will take place in embryos … [and] what kinds of human genetic engineering might become commercially available.”
Meanwhile, researchers are publishing tweaks and upgrades to CRISPR-Cas9 on a near-weekly basis, causing observers to wonder if the patent fight will soon become a moot point—a “historical footnote.”
Recent CRISPR breakthroughs, setbacks, and related research include:
“Attempts to wipe out HIV with the CRISPR gene editor only made it stronger” [Source]
A number of researchers have been excited about the potential of CRISPR to deliver a long-sought cure for HIV—in living patients. Using an older gene editing method known as Zinc Finger Nucleases to snip out the CCR5 gene linked to HIV resistance, Sangamo Biosciences (Richmond, CA) is one of a group of biotech companies investigating HIV somatic gene therapies. On April 7, researchers working with CRISPR published some sobering data which showed that using gene editing to disable the HIV virus backfired, as the virus developed mutations near the sites of cuts which blocked RNA-guided CRISPR from making more cuts needed to disable the virus. A number of researchers still have hope for CRISPR providing a one-and-done fix. Some aim to use CRISPR to “carpet-bomb HIV” at multiple sites at once. Others are skeptical about the practicality of CRISPR-ing HIV, given the virus’ renowned resistance, the number of T cells that need to be successfully modified, and the existence of pre-exposure and post-exposure antiretroviral drugs that are being used to manage the disease with increasing success.
A week later on April 27, researchers laboring under the weight of compelling acronyms reported a new CRISPR method dubbed “CORRECT” (COnsecutive Re-guide or Re-Cas steps to Erase CRISPR/Cas-blocked Targets). Given the messiness of the CRISPR-Cas9 system, the research seeks to enable two new capabilities: stopping Cas9 from cutting again and again, and editing one but not both copies of a target gene. Scientists reacting to the news noted with caution that the CORRECT hack requires inserting three to twenty times the number of molecules into cells as does traditional CRISPR. (Others have previously noted delivery challenges with CRISPR due to the comparatively large size of the Cas9 protein.)
The story was that researchers had worked through almost 600,000 human DNA sequences—the majority from 23andMe users—and found 13 profiles whose medical records showed a lack of symptoms despite the fact they carried a genetic mutation linked to one of eight Mendelian diseases. The researchers have no way of contacting the individuals to confirm their “superhero” status, but the study has excited some researchers about the potential gold to be found at the end of the precision medicine rainbow: a deus ex machina buffer gene to fight monogenic disease. As several observers noted, these “lucky 13” could also lead to dashed hopes at the human margins of sequencing errors.
The genetic unicorns study conjures a handful of philosophical questions relevant to the future of gene editing: What are the biological mysteries that determine phenotype beyond genetics? What are the implications of widespread embryo screening for genetic conditions when false positives are rampant and embryo mosaicism is poorly understood? What unknown unknowns in the realm of genetic mysteries might forestall the precise genetic modification of future human beings? What known social and political realities caution against gene editing future generations regardless of technical safety?
Creative and potentially exciting, recent CRISPR and related research papers speak to the vast ocean of biological uncertainties that face those venturing into the genome with the intention of divining the cut-and-paste malleability of the human condition. On the eve of a major annual meeting on gene therapy in D.C. on May 4-7, Jocelyn Kaiser writing for Science culled a long list of additional obstacles for researchers to overcome in an article titled “The gene editor CRISPR won’t fully fix sick people anytime soon. Here’s why.”
What harm can a bit of enthusiasm do? For starters, unchecked techno-optimism frustrates the scientific enterprise. It also thwarts the funding of basic public health measures whose impact would be felt more broadly, beyond the upper echelons of biomedical access.
The hubris is alarming; but the more subtle element of the propaganda campaign is the biggest and most dangerous improbability of them all: that CRISPR and related technologies are “genome editing”…That is, they are capable of creating precise, accurate and specific alterations to DNA …
Why is this discussion of precision important? Because for the last seventy years all chemical and biological technologies, from genetic engineering to pesticides, have been built on a myth of precision and specificity. They have all been adopted under the pretense that they would function without side effects or unexpected complications. Yet the extraordinary disasters and repercussions of DDT, leaded paint, agent orange, atrazine, C8, asbestos, chlordane, PCBs, and so on, when all is said and done, have been stories of the steady unraveling of a founding myth of precision and specificity.…
[W]e are once again being preached the gospel of precision. But no matter how you look at it, precision is a fable and should be treated as such.
As with many “disruptive” technologies in biotechnology, CRISPR pipedreams are rapidly assembled, dismantled, reassembled; moonshots are breathlessly announced, then fail to rise, then quietly recalibrate. A world cleansed of genetic disease is repeatedly cast as the carrot to be dangled before an American public starved for more basic health investments. Will the CRISPR revolution bring vegan cats? Who decides what the future of (synthetic) biology looks like?
For three days, panelists and participants engaged with assisted reproductive technologies (ARTs), reproductive justice, contractual parentage and procreation relationships, genetic testing and selection of embryos, gestational and transnational surrogacy, in vitro fertilization, abortion laws, constitutional rights to procreation and assisted reproduction, LGBT access to adoption and ARTs, selective reduction, and fertility professional negligence.
The keynote address by Dorothy Roberts, professor of law and sociology at the University of Pennsylvania and CGS advisory board member, painted a rich picture of the complex systems of oppression that backdrop free trade reproduction. Roberts highlighted the wide-ranging reproductive injustices of abortion bans, neoliberal public healthcare disinvestment in the United States, dependency courts and disruptions of families of color, and centuries of ongoing racism that make it impossible for baby markets to be “liberating” for women of color.
Roberts also reflected on the “new eugenics” that pressures parents to make “the right genetic decisions,” leading to the widespread use of pre-implantation genetic diagnosis to select against disability, and the support of a few enthusiasts to attempt next-generation genetic engineering with CRISPR-Cas9 to “edit” the traits of future children. Roberts concluded that debates on the ethics of commercial assisted reproduction must center the people hurt most by market logics: people of color, disabled persons, transgender and intersex persons, and people acting as surrogates. “We can’t solve social problems with better technology,” she said.
Marcy Darnovsky, executive director of CGS, and Radhika Rao, professor of law at UC Hastings, separately introduced emerging technologies in reproduction that heighten a number of ongoing concerns about eugenics, informed consent, and elite access to what Roberts earlier referred as a “reproductive caste system” of “built” children. These new technologies include egg freezing, uterine transplants, gametogenesis (stem cell-derived artificial gametes), and CRISPR-Cas9 germline gene editing.
The ART Working Group’s Reproductive Justice panel
The ART Working Group, a collaborative effort between CGS and the Pro-Choice Alliance for Responsible Research (PCARR) that grew out of The Tarrytown Meetings, organized a panel introduced by CGS consultant Emily Galpern that focused on reproductive justice insights into assisted reproduction. UC Davis Professor of Law and CGS fellow Lisa Ikemoto discussed her research on egg providers and the “repro-stratification” of eggs based primarily on race. She noted that “currently we use ARTs to reproduce the nuclear family,” instead of collaborative reproduction marked by reciprocity and kinship.
PCARR co-founder Susan Berke Fogel gave an overview of reproductive justice, focusing on the centrality of women of color in the movement, and the shift away from the reproductive rights conversation about “choice” and privacy toward a holistic understanding of “justice” that looks at oppression and intersectionality, and that doesn’t privilege reproductive rights over other rights.
Daisy Deomampo, assistant professor of anthropology at Fordham University, presented research looking at surrogacy and the treatment of intended parents and gestational surrogates in India as a site of racialization that isn’t just “reflective” of oppressive racial hierarchies in the world, but which produces race. She noted that reproductive justice seeks to change structural inequalities, instead of liberating individuals from experiencing them.
Regina Tamés Noriega from the Grupo de Información en Reproducción Elegida (GIRE) in Mexico discussed the recent expansion of transnational surrogacy in Tabasco and Cancún. She described policymakers’ sudden focus on regulating surrogacy despite their lack of interest in regulating other forms of assisted reproduction, potentially because it represents a way to control women’s bodies.
Reproductive Justice Film Festival
The 10th Baby Markets Congress also included a Reproductive Justice Film Festival. Three documentary films were screened during the weekend: Misconception (forthcoming), dir. Civia Tamarkin, showcases the “collateral damage” and “friendly fire” of the abortion wars, and the political indoctrination of youth into the anti-abortion movement. Young Lakota (2012), dirs. Rose Rosenblatt and Marion Lipschutz, follows three youth living on the Pine Ridge reservation of the Oglala Sioux tribe who experience political awakenings around the issue of abortion.
Beautiful Sin (2014), dir. Gabriela Quirós, documents the political battle around embryo personhood and assisted reproduction in Costa Rica. A ban on IVF that passed in 2000 was finally lifted by a presidential decree ruled valid by the Inter-American Court on Human Rights in February 2016.
We learned so much from the fascinating papers, discussions, and research presented by the scholars, policy-makers, civil society advocates, journalists, and activists in attendance. Thanks to Michele Goodwin and all the participants!
About the Baby Markets Organizer and Sponsors
Michele Bratcher Goodwin’s research engages law’s interaction with the body across multiple spheres, encompassing organ transplantation, reproduction, tissue harvesting, sex and marriage trafficking, and international surrogacy, among other topics. Goodwin recently edited The Global Body Market: Altruism’s Limits, published in 2013.
Following an abusive childhood, Muir’s mother committed her to Alberta's Provincial Training School for Mental Defectives at the age of eleven, falsely claiming that she had cognitive disabilities. The Sexual Sterilization Act of Alberta allowed the province to sterilize any ward of a mental health institution whom its Eugenics Board considered "mentally defective" and at risk of transmitting “defective genes” to future children.
Under this act, nearly 3,000 residents of Alberta were sterilized between 1928 and 1972, when the law was finally repealed.
When she was fourteen years old, Muir was brought before the Provincial Eugenics Board and briefly questioned. After this session, the board recommended sterilization, citing as the reason "Danger of the transmission to the progeny of Mental Deficiency or Disability, also incapable of Intelligent parenthood."
Told doctors would be removing her appendix, Muir was sterilized without her knowledge. She only learned what had happened to her many years later when she and her husband were unable to conceive a child.
She grew determined to achieve justice for herself and others impacted by forced sterilization. In 1996, Leilani Muir became the first individual to sue the Alberta government for wrongful sterilization. She won her case, Muir v. The Queen in Right of Alberta, in a judgment that stated:
The circumstances of Ms. Muir's sterilization were so high-handed and so contemptuous of the statutory authority to effect sterilization, and were taken in an atmosphere that so little respected Ms. Muir's human dignity that the community's, and the court's, sense of decency is offended.
Muir's case served as a precedent for many more lawsuits against the Alberta government on behalf of hundreds of survivors of eugenic sterilization. All told, the government paid more than $80 million to over 800 survivors.
In the years following the court decision, Muir became an advocate for other sterilization survivors and for the rights of people with disabilities. She continued her quest to educate the public about the history of eugenics in Canada. Muir wrote a book about her life called A Whisper Past, gave talks around the country, appeared in several documentaries and television programs, and even ran for a seat on the Alberta legislature in 2000 as a New Democratic Party candidate. Muir was recently featured in the 2015 documentary Surviving Eugenics which documents the survivor narratives of Alberta’s provincial schools.
Muir said of her experiences:
When I was born, God made me a whole person. When they sterilized me, they made me half a person. You never get over that hurt. . . . I don't want this to ever happen again to other children. My philosophy is that history repeats, but as long as I keep talking about it, it will not happen again.
Leilani Muir will be remembered for her courage to speak out, her strength to fight, and her determination to seek a more just world.
Currently, California – like many countries – allows women who provide eggs for research to be reimbursed for travel, lost wages, child care, and other expenses connected to the egg retrieval process, but not to be paid beyond that.
Despite opposition from women’s health and public interest organizations, including the Center for Genetics and Society, AB 2531 sailed through the state’s Assembly Health Committee on April 5 with a 17-0 vote. It now goes to the Assembly floor, and after than to the state Senate.
What’s wrong with expanding the market for women’s eggs? After all, women are allowed to sell their eggs for other people’s fertility treatments. Here are key reasons it’s important to hold the line:
The health risks of egg harvesting are significant, but they’re woefully under-studied. A well-known and fairly common short-term problem is ovarian hyper-stimulation syndrome (OHSS), but no one is sure how many women get the serious – sometimes life-threatening – version of it. Data on long-term outcomes, including follow-up studies on reports of cancers and infertility in egg providers, are notoriously inadequate.
It is impossible for women to give truly informed consent if adequate health and safety information can’t be provided.
Offering large sums of money encourages women in need to gamble with their health. It’s what bioethicists call "undue inducement."
Women who provide eggs are not research subjects, despite the inaccuracy in AB 2531. In clinical studies, researchers follow the health outcomes of participants. In egg retrieval procedures, researchers are interested in acquiring eggs for raw material for their studies, not in effects on women who provide them.
AB 2531 would overturn an existing California law, authored in 2006 by then-state Senator Deborah Ortiz, a well-known champion of women’s health and medical research. It would also conflict with guidelines from the National Academy of Sciences, and with the rules of the California stem cell agency. All these policies state that women who undergo egg retrieval for research can be compensated for their expenses, but not paid beyond that.
This isn’t the first time the fertility industry has sponsored legislation to expand the market for eggs. An almost identical bill was vetoed by Governor Brown in 2013. His veto message said in part,
"Not everything in life is for sale, nor should it be....The long-term risks are not adequately known. Putting thousands of dollars on the table only compounds the problem."
Letters of opposition to AB 2531 were sent by these organizations and individuals:
Posted by Gabriele Werner-Felmayer & Carmel Shalev, Biopolitical Times guest contributors on March 23rd, 2016
Valerie Gudenus was inspired to make her award-winning film on surrogacy in India, Ma Na Sapna – A Mother’s Dream(2013), by American sociologist Arlie Russell Hochschild’s work on the outsourcing of emotional services (The Outsourced Self: What Happens When We Pay Others to Live Our Lives for Us, 2012). As Gudenus says in an interview, she wanted to make a film about “how different worlds and different areas are connected through certain dependencies.” Following one month of research in India on her own, she and her team went there to shoot the film in the world’s largest surrogacy clinic: the Akanksha clinic, in Anand, Gujarat run by Dr. Nayna Patel. Indeed, the film shows surrogacy as an “amazing example of worlds being connected in a very interesting way” (Gudenus).
The clinic had already taken center stage in Zippi Brand Frank’s documentary Google Baby (2009), and it was key to sociologist Amrita Pande’s in-depth ethnographic work Wombs in Labor (2014) on transnational commercial surrogacy in India. Despite this existing coverage, Gudenus brings a new and sensitive view of the surrogate mothers who are otherwise largely invisible – whether in the public perception or to the customers from abroad whose babies they carry – and allows them to speak for themselves.
Over a period of three months, Gudenus and her team spent every day with the women either at the Akanksha clinic or in the home for surrogates which it runs in a secluded by-road. The film opens with Madhu, a surrogacy "scout" who recruits women to become surrogates. Heena donated eggs four times to pay grocery bills, and she wants to buy a small hut for her daughter. She is one of six women the film follows. They live in the home with 70 others, many divorced or widowed, in close quarters that at one dramatic moment brings about a verbally violent fight.
Sometimes Dr. Patel (pictured above, far left) comes to visit. The distance between her and the women is tangible. She is the professional doctor, a powerful business woman who reigns benevolently over her domain and insists the surrogates learn to sign their names before they leave. The women call her "our mother goddess" and bow in reverence and gratitude to touch her feet. They are in service, living in confinement far from their own children, lying on their backs most of the time, subject to strict quality control with regimens of nutrition and invasive medical procedures, including hormonal injections throughout the pregnancy and 100% rates of cesarean delivery.
At some moments, it becomes evident that not everything is as the women expected. Bikhi (pictured below), for example, is carrying a triplet pregnancy. Three months into the pregnancy she is shocked and heartbroken to learn that the doctors want her to undergo embryo reduction. If she had known about the reductions, she says, she would not have come here. “That a child will be killed in my own womb is really shocking.” To her relief, ultrasound shows that two of the fetuses are conjoined twins already dead.
Gudenus and cinematographer Gabriela Betschart created a gentle and respectful intimacy with the women whose stories they follow, without being intrusive. The film captures the atmosphere of a woman’s cosmos that seems quasi-intrauterine yet situated within a technologized environment of breeding. The sound track brings in the noises of machines beeping in the neonatal intensive care unit, and the clacking of plastic breast milk pumps in the wards where the women recover after giving birth.
Papiha (pictured below) is a central character. We see her first at an ultrasound test toward the end of her pregnancy. The camera focuses on her rather than on the screen. She is carrying twins and is told that they both weigh more than 2 kilograms. Her face shows she is proud and happy. Later she gives birth to twins, half drugged with partial anesthesia. Someone asks her: "What will you do with the money?" She answers, "I'll buy a house." Then she is left alone in the delivery room, sprawled on the surgical bed like a bundle of rags. "Her" couple will arrive only 3 weeks later, with the reason for the delay unclear. Perhaps they are advised to wait, to make sure the babies survive and are healthy. Perhaps they were busy with their lives.
After five days she is pumping milk, which her husband takes to the infants. He wants a rickshaw, and that's what they get. Madhu says there are no houses available for the money the women earn, not any more, even in a slum.
After ten days, Papiha goes to have a look at the babies and hold them for the first time. One of them stops crying when she picks her up. A few days later she is taking care of them in her room, and she names them. When it appears they are not gaining weight she starts breastfeeding. But she says, "it's better not to think I'm their mother" because it would make her sad. When Papiha's couple finally arrive, the situation is awkward. They seem not to know what to say or how to thank her. She changes their nappies for the last time, obviously in inner conflict. The intended mother (pictured below, right) tells her "don't cry, come on, smile, visit us tomorrow at the hotel" but it is obvious that this is good bye.
Parul also stays for three weeks to give milk and is not happy when she departs. She says she gained money but lost the respect of her neighbors and friends. Her son stopped talking to her. The job is "bad:" it's seen as selling children even though it's legal with stamped papers.
“How can you make a film about somebody else’s feelings?” asks Valerie Gudenus in the interview. Well, you obviously can, if you are able to look and listen as carefully and sensitively to the stories of others as she did. Understanding and showing that there is a mother's dream for a better life is the way in which Ma Na Sapna gives so-called ‘surrogates’ a face, a voice and a touching human story.
 The condition is rare with only a few case reports and seems to be
connected to in vitro manipulations causing trauma of the zona
pellucida. Usually, the pregnancy of the unaffected fetus goes on
without further complications. See Hirata T. et al. Conjoined twins in a
triplet pregnancy after intracytoplasmic sperm injection and
blastocyst transfer: case report and review of the literature. Fertil
Steril 2009;91:933.e9–e12, doi:10.1016/j.fertnstert.2008.07.1730
Gabriele Werner-Felmayer is Associate Professor of Medical Biochemistry at Medical University Innsbruck working at the intersection between basic biomedical research and bioethics, and chairs the bioethics network Ethucation [Austrian unit of the International Network, UNESCO Chair in Bioethics (Haifa)].
Carmel Shalev is the founding chair of the Department for Reproduction and Society at the International Center for Health, Law and Ethics, Haifa University, and a member of Israel's National Bioethics Council.
Posted by Emily Beitiks, Biopolitical Times guest contributor on March 22nd, 2016
My son hugs a stuffed dino. (Kachine Blackwell, used with permission.)
This article was cross-posted on Disability Remix, the blog of the Paul K. Longmore Institute on Disability at San Francisco State University.
Lately, I’ve been learning a lot about dinosaurs. Or, I should say, my three-year-old son has been learning a lot about dinosaurs, and I have been caught in the crossfire. My mind is often churning to relate any new information I take in to my own passion of disability studies. I didn’t expect to find a link to dinosaurs… but I did.
Dinosaur science has advanced remarkably since my childhood. (Did you know, for example, that scientists now believe many dinosaurs had feathers?!)
But while our notions of what dinosaurs could have been is constantly evolving, we still cling to certain tenets of what I like to call “dinosaur normalization.” (I haven’t lexis-nexis’d it, but I think you just witnessed the birth of a completely original school of academic thought!)
Dinosaur normalization is the idea of prescribing what dinosaurs would have been like based on our own narrow worldview.
For a quick example of dinosaur normalization, when scientists first discovered the Iguanodon (see right), they assumed he had a rhino-like horn on his nose. After further skeleton discoveries, it turns out the Iguanodon actually has two horn-like thumbs, something we’ve never seen before.
But you don’t have to be an obscure dinosaur like the Iguanadon (that only three-year-olds and their parents are likely aware of) to be a victim of dinosaur normalization.
Here’s a children’s song about the stegosaurus:
My name is stegosaurus,
I’m a funny looking dinosaur….
My front two legs are very short.
My back two legs are long.
My body’s big, my head is very small
I’m put together wrong!
You know… a little judgmental. Plus, if the stegosaurus is “put together wrong,” isn’t that kinda our bad since we literally put them back together?
But even the almighty T-Rex is not spared from the hammer of normalization. There’s a general fascination with the T-rex’s tiny arms, each with two small claws. Many books ask: why did such a ferocious beast have such puny, useless arms? One fictional children’s film that I watched recently spent a solid 30 seconds joking at the t-rex’s expense.
When the newest movie in the Jurassic Park franchise was released, I was itching to see it for it promised a genetically modified dinosaur. I don’t condone genetic modification, but I thought this premise was brilliant, as it would allow the filmmakers to take all the scariest parts of dinosaurs and jam them together (which, inevitably, makes a really strong argument against genetic modification). Much to my surprise (and many other disappointed fans), the resulting dinosaur mostly just looked like a t-rex with longer arms and a full hand of claws. Sure, it had a few other hidden tricks but if you freeze-frame the film, that’s it. It’s as if there were a bunch of dino-fans who were sitting around saying, “I’m not afraid of the t-rex because its got those tiny arms. But if you had a t-rex with proportionate arms, well, now that’d be scary!”
There’s so much we are still learning about the t-rex. Scientists are now hypothesizing that the tyrannosaurus rex might not have made the ferocious roar we think of from the movies, but something more like a loud bullfrog croak. There’s also a lot of uncertainty about how fast the t-rex runs. Just yesterday even, an article announced the discovery of a pregnant t-rex, which is providing new data on egg-laying. So why aren’t we culturally more open to exploring what purpose the t-rex’s tiny arms might have served? The paleontologists are, but the children’s books and films don’t seem to be.
The disability rights movement pushes us to rethink our assumptions about how the body is supposed to look and what the body is capable of. Many disabled performance artists celebrate how their bodies are “put together wrong” to show us what the anomalous body can do once you embrace creativity and challenge bodily assumptions (see, for example, the many examples in Sins Invalid’s film An Unashamed Claim to Beauty). While the disability movement is pushing us away from normal, our dinosaur education for our kids lags behind.
Everything about dinosaurs is so totally not normal. When I stop and think about dinosaurs, the t-rex’s tiny arms and the stegosaurus’s small head seem so completely uninteresting compared to how bizarre it is that there were dinosaurs like this once living in North America:
Or knowing that this dinosaur-relative once swam in our oceans…yikes!
That our normalizing tendencies have extended to a species from over 65 million years ago shows us just how far our counter-efforts to take down normalcy must also go.
I’m going to encourage my kid not to think twice about the t-rex’s small arms. That’s just how they look, and from what we know about the t-rex (his FAVORITE dinosaur), they were pretty bad-ass, small arms or not.
*Believe it or not, this is actually the second blog by someone at the Longmore Institute with a connection to dinosaurs. Read the other, about Pixar’s access features in The Good Dinosaur, here.
Emily Beitiks is Associate Director of Paul K. Longmore Institute on Disability at San Francisco State University, and a former staffer at CGS. Beitiks earned her Ph.D in American Studies from the University of Minnesota with the dissertation "Building the Normal Body: Disability and the Techno-Makeover".
Posted by Alison Irvine & Katayoun Chamany, Biopolitical Times guest contributors on March 21st, 2016
Katayoun Chamany, left & Alison Irvine, right
"I've done this because of my poverty. Otherwise I would never have taken this step."
The words of Aasia Khan, an Indian woman acting as a surrogate for an American couple in the documentary Made in India, echoed through the sound system at The New School’s panel entitled “Whose Body, What Choice: Egg Provision, Gestational Surrogacy, and Extending Parenthood”. In addition to viewing clips from Vaishali Sinha and Rebecca Haimowitz’s award-winning documentary, panelists spanning health psychology, queer studies, law, media studies, and life science came together to discuss how emerging reproductive technologies support new forms of family making, invoke bodies in labor and care, and provide bioresources for a burgeoning stem cell industry.
Psychologist Lisa Rubin, queer studies scholar Laura Mamo, and filmmaker Vaishali Sinha described the ways that Assisted Reproductive Technology (ART) has become a common practice in Western countries, yet increasingly more dependent on bodies abroad. As more individuals view ART as a “natural” part of their personal reproductive journey, many assume that the techniques involved in ovarian hyperstimulation, in vitro fertilization (IVF), and surrogacy are FDA-approved and safe. But few are aware of the necessary labor involved and the potential inequities that can arise with increased use of ART.
As a result of shifting legislation, there is both limited access to and varied payment for bodies, cells, and tissues used in the reproductive and stem cell contexts, with little regard to the labor and potential health outcomes of all involved. As one attendee commented, she was unaware of the details involved in the egg retrieval surgical procedure which requires puncturing hyperstimulated ovaries—a separate puncture for each egg removed. Additionally, the ripple effects of the stress of living with economic constraints can influence the health of the egg provider or surrogate, and the health of the potential child through DNA reprogramming events.
Using visual narratives from the newly launched Stem Cells Across the Curriculum project, biologist Katayoun Chamany, showcased how ART can involve multiple bodies, including those of the egg provider, the potential surrogate, the embryo, and the future child. Some children are conceived though a combination of IVF and Preimplantation Genetic Diagnosis (PGD), a genetic screening technique that can exclude embryos with gene variants associated with disease risk, but improve the probability of an immunological match to a sibling living with disease. Stem cells can be obtained from the cord blood, peripheral blood, or bone marrow of the “savior sibling” to support the treatment of the sibling living with disease. The labor involved in hormone stimulation of the mother’s ovaries and the retrieval of stem cells from the sibling, create new forms of kinship and responsibility in families that have the means to engage in such practices.
During her presentation, law scholar Lisa Ikemoto touched on the issues of labor, property, and informed consent. Participation in surrogacy, tissue and egg donation, and clinical trials is not commonly thought of as “labor” as it is defined in The Labor Theory of Value. When it comes to regulating ART practices, this perception influences how compensation for surrogacy and egg donation is determined. Providing a history of property law and practice, Ikemoto, illustrated how bodies and cells used in the service of ART may be considered property secured through “purchase” or “labor of invention.” In the past, informed consent was 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. As Ikemoto illustrated using three case studies, it seems that informed consent now serves the purpose of a contract in which the cell or tissue provider gives up all property rights.
As Ikemoto detailed, the landscape in the U.S. is complicated and inconsistent from state to state and case by case. Thus, other countries have emerged as leaders in commercialized gestational surrogacy supporting contract pregnancies and creating a multibillion-dollar-a-year industry. In this context, IVF is used to create embryos that are then transferred to the uterus of the person willing to serve as the gestational surrogate and undergo caesarean section to deliver the child to the intended parents.
During the dialogue moderated by Lisa Rubin, the panelists discussed the consequences of a new law enacted this year put forth by the Indian Council of Medical Research (ICMR), a government-appointed body. The law bans surrogacy services to foreigners and is driven by a desire to “safeguard the rights of the surrogate mothers.” A similar ban is already in place in Thailand. However, as Sinha pointed out, there has been concern that these bans will push surrogacy to the black market, increasing the danger to surrogates. Instead of outlawing transnational surrogacy, many women’s rights advocates in India have come out in support of more regulation of the surrogacy industry, as depicted in Amrita Pande’s ethnographic work Wombs in Labor: Transnational Surrogacy (mentioned in Ikemoto’s presentation). Many of these advocates believe the process of putting regulatory measures into place encourages discourse around the subject, and keeps surrogacy out in the open and off the black market.
Laura Mamo extended the conversation regarding rights, protections, and benefits by asking “From what towns, communities, and countries will the bio-materials be drawn...to fulfill the American Dream?” The conversation then turned to who is most likely to benefit, as it is clear that most of the economic gain benefits some stakeholders, such as surrogacy clinics and medical professionals, and not others, such as the surrogates. This disparity calls into question society’s ability to put the emotional, mental, and physical well being of surrogates in front of a profitable industry and the desire to create genetically related families. Shamina Shafiq, head of the nonprofit Progressive Organization for Women’s Empowerment and Rehabilitation, states that the main beneficiary of surrogacy should be the surrogates, not the medical fraternity. Even if regulations were put in place to ensure that providers are the main beneficiaries of their labor, would it be enough to shift the balance of power and prevent surrogates and egg providers from being exploited?
In addition to fair payment, appropriate guidelines, and regulation, the panelists also discussed procedural justice issues associated with ARTs. That India and some states in the U.S. restrict access to ARTs to those who are married or in heterosexual couplings exemplifies the ways in which family making is not accessible to all. Not surprisingly, a new market catering to homosexual couples and singletons has emerged, with Mexico serving as one site of such services.
The panelists also raised questions around the recruitment practices for egg “donors” that seek individuals with high SAT scores and other desirable characteristics and juxtaposed this practice to those used for egg provision in stem cell research. In June 2009, New York became the first state to allow taxpayer-funded researchers to compensate those who provide eggs to scientific research, stating that the compensation was socially just. Similar to the varied regulations for surrogacy, compensation rates for egg donors for reproductive purposes fluctuates by state. Thus, the Ethics Committee for the Empire State Stem Cell Board used the caps put forth by the The Ethics Committee of the American Society for Reproductive Medicine (ASRM) at no more than $10,000 per egg retrieval cycle. Though the matching amounts for egg provision across the reproductive and stem cell research sectors can be described as equitable, the payment scales have come under question. Some feel that the pay exploits those with low economic means and further widens the gender equity gap in employment opportunities, and others feel that they should be able to negotiate a fair rate, and have sued the ASRM for price fixing based on the Sherman Act.
Documentaries such as Eggsploitation by Jennifer Lahl, filmmaker and founder of The Center for Bioethics and Culture Network, highlight the potential short-term and long-term health risks and overall lack of knowledge around the process of egg retrieval. The process of retrieving oocytes consists of a series of self-administered daily hormone injections to suppress the donor’s cycle, stimulate the ovaries, and trigger ovulation. Using human chorionic gonadotropin (hCG) injections is associated with many health risks, such as Ovarian Hyperstimulation Syndrome (OHSS), which could result in ovarian torsion, blood clots, fluid accumulation in abdomen and chest, kidney failure, and in rare cases, death.
Given these risks, those lobbying for the 2013 “Bonilla Bill” in California argued that without compensation, they couldn’t retrieve the oocytes that will one day contribute to the research that will benefit women’s health. Ultimately, though the bill was passed by the congressional legislature, it was vetoed by the governor who claimed that "Not everything in life is for sale, nor should it be." However, a new act was proposed in February 2016 by California Assembly Member Autumn Burke for compensation to those providing eggs for medical research on the basis that they are acting as any other human subject participating in research. However, as Chamany pointed out, given that there are no long-term data on the health outcomes of young fertile oocyte providers, bills such as this one proposed in California, and the existing order in New York, should incorporate long-term monitoring of the health of these oocyte providers if the rationale is based on encouraging research participation in clinical trials
More recently, advances in egg freezing may shift these health and economic concerns from third-party egg providers to those seeking pregnancy later in life. As Ikemoto highlighted in her presentation, earlier this year the United States military agreed to cover the costs of sperm and egg freezing for their personnel, following the trend set by Apple and Facebook in 2014. This type of policy highlights how social policy frames family making as an essential human activity, such that if an opportunity is available, one should take advantage by any means. The discussion on this panel cast a critical eye on such generalized views and presses us as we move forward to consider the trade offs of any such policy in terms of who benefits and who carries the burden or risk.
Alison Irvine is Community Manager at Genspace and a performance artist & writer based New York City.@alisonirvine1
Katayoun Chamany is Associate Professor of Biology at Eugene Lang College for Liberal Arts at The New School.@KatayounChams
“I crave that experience,” she said. “I want the morning sickness, the backaches, the feet swelling. I want to feel the baby move. That is something I’ve wanted for as long as I can remember.”
The future of reproduction has never appeared so technologically complex. Amid ongoing policy debates about gene-editing embryos, and the potential spread of “3-person IVF” from the UK to the US, we’ve also seen a rapid increase of clinical trials for a revolutionary surgical procedure: womb transplants—i.e. temporary uterus transplantation into “genetic females” born without uteruses (but with working ovaries) for the purpose of enabling pregnancy for one or two genetically related IVF offspring.
An early effort at uterus transplantation was conducted in Germany in 1931 on Lili Elbe, who is historically identified as both transgender and intersex, and who died shortly thereafter. (Her story is told in The Danish Girl.) Unsuccessful attempts were also made in Saudi Arabia in 2000, and in Turkey in 2011.
Headlines since 2014 exhibit building momentum and clinical uptake:
Setbacks for clinical patients like Lindsey are to be expected, as successes have been few and recent. The procedure’s clinical viability (and eligibility guidelines) began in Sweden—where nine transplants, seven that were ultimately successful, have taken place resulting in five babies since 2014.
For more than a decade, a research team led by Dr. Mats Brännström, professor of gynecology and obstetrics at the University of Gothenburg, conducted surgeries on animals ranging from rodents to non-human primates (including some 80 baboons) to establish a threshold of perceived safety for the transplantation of donor uteruses into humans. According to a New York Timesreport, Dr. Andreas G. Tzakis, director of solid organ transplant surgery at the Cleveland Clinic, spent a lot of time with this Swedish team, “practicing in miniature swine and baboons and observing all nine of the human transplants in the operating room.”
Notably, the Swedish researchers are the only ones to have established and documented their protocol working in animal models. They have shaped not only the technical specifics of the procedure, but also protocols and assumptions about who is considered an acceptable clinical subject. So far the majority of people targeted for the procedure have been diagnosed with Mayer-Rokitansky-Küster-Hauser syndrome in which infants are born with an intersex phenotype, including underdeveloped or absent uteruses and vaginas. It’s also important to note that all gestational surrogacy is banned in Sweden, both commercial and “altruistic”—so people set on having genetically related children may be more willing to turn to risky surgeries instead.
Media have quoted the Swedish team expressing the underlying values and assumptions that drove their research, including:
“Dr Brännström said that the nine women who had received womb transplants had already been deeply affected by the experience. ‘Some of them say that it’s fantastic just to have a period. They say: ‘Now I feel like a real woman, a normal woman, for the first time.’” (2014)
“‘We are not going to call it a complete success until this results in children. That's the best proof.’” (Michael Olausson, 2012)
In light of the birth of a handful of premature babies via uterine transplant and ongoing safety and ethical concerns, Brännström is focusing on improvements including efforts to grow a womb in the lab, a “bioengineered uterus.” He describes this process as “taking one from a deceased donor, stripping it of its DNA and using cells from the recipient to line the structure.” According to news reports, he has “started preliminary tests in animals and estimated it would be another five years before the technique can be tried on humans.” This may impact a key concern with the transplant: maternal and fetal exposure to powerful immunosuppressants.
Bioethics and Biopolitics: Making Policy in the Lab?
As these clinical trials migrate from Sweden to clinics around the world, ethical concerns have been mounting. A lonely set of formal ethical guidelines, “The Montreal Criteria,” was published in 2012, and slightly revised in 2013. There was immediate pushback to the criteria; one concern: the guidelines are narrowly applicable, myopically reflecting the context of wealthy countries with well-developed biomedical sectors.
In the 1970s, only 1 out of 10 women in the United States made it to menopause without giving birth to a child. Fast-forward to 2010 and that number had doubled according to Pew Research Center, roughly 1 in 5, or 20% of women end their “child-bearing years” child-free. (More recently, Pew found childlessness is actually decreasing among highly educated women.) Which is to say that even in these modern times of single ladies, egg freezing parties, and the increasing legal acceptance of LGBT relationships—and interdependent upon factors such as income, ethnicity, and education—some 80% of women will become pregnant and give birth in their lifetime.
With this in mind it’s important to start asking a wide range of questions about the assumptions and values that underlie current excitement about the potential of uterus transplants:
Why should the procedure be limited solely to “genetic females” when the majority of clinical subjects are on the intersex spectrum of sexual difference? Should men and transgender women have access given the congruent technological advances of gender-affirming surgeries?
What influence and relevance does the long-standing and recent history of medically unnecessary and coercive surgeries on intersex children and adults have in this context?
How do we ensure long-term clinical follow up for women and children who participate in this brave new world of gestational place-making?
What are the health impacts for all parties involved that would caution against using either living or deceased donors?
Omer Ozkan, et al., Preliminary Results of the First Human Uterus
Transplantation from a Multiorgan Donor, 99 FERTILITY AND STERILITY
2:470-476 (2013) [Turkey], available at http://www.ncbi.nlm.nih.gov/pubmed/23084266.
CRISPR-Cas9 “gene editing” has been a source of hype, hope, and caution for the past several years, and its presence in labs, patent fights, policy discussions, and headlines has grown exponentially.
But in the finale of The X Files’ comeback season, it is aliens who first harness genome editing. “CRISPR patent belongs to aliens,” Sara Reardon comically claims in the Nature books and arts blog A View From the Bridge. As she notes,
it is human genome editing that forms the season’s backbone: a concept that is far more scientifically plausible today than it was in 2001 [around when The X Files went off-air] — or even 2012 [when CRISPR-Cas9 was developed as a genome editing platform].
In The X Files, the aliens use gene editing in the service of population control campaigns on other planets. In the real world, the range of potential CRISPR applications triggering social and ethical controversy includes
human “germline” gene editing, i.e. creating modifications that will be passed down to future generations by engineering germ cells (gametes or embryos) prior to initiating a pregnancy — what the media sometimes call “designer babies” and
The science in The X Files finale is discussed rather breathlessly, so for those who might have missed it:
In an earlier era of Roswell crash-landings and secretive extraterrestrial research, scientists discover that aliens had developed a “Spartan Virus” to “manage” overpopulation. At some point in the last century, motivated parties on earth co-opt this viral population-control method by creating a germline gene therapy to slip into mandatory smallpox vaccinations.
In real life, routine smallpox vaccination ended in the United States in 1972; in The X Files finale, regardless, the Spartan Virus continued to infiltrate the population for decades because everyone who was vaccinated passed on the CRISPR complex to future generations. Fast-forward to 2016, and a prominent villain from earlier seasons has decided it’s time to activate the Spartan Virus in order to CRISPR-edit out a gene to turn off people’s immune systems. (The reference is to the adenosine deaminase (ADA) gene, which is associated with “bubble boy syndrome.”)
How does the villain activate this CRISPR mechanism? With chem trails of aluminum nanoparticles! The only way to survive? An elite cabal has exclusive access to a secret germline technique using alien DNA (literally) that disables CRISPR from editing out the ADA gene, thereby preserving immunity.
Some of the described or implied science here is pretty far-fetched, but some not so much. The time-delay germline engineering described in The X Files finale, for example, bears at least some similarity to the CRISPR complex recently reported [PDF] by the Stanley Qi Lab at Stanford University. In that study, a “dead Cas9” protein is used to regulate gene expression through activation or interference. This seems to suggest that it may be possible to design platforms like these, capable of being designed to hang out in the genome until sometime later (in The X Files’ case, decades), when they could be activated and begin to carry out programmed edits or regulatory activity.
The science of how CRISPR is delivered into living children and adults to affect their germ cells is not made clear in the finale. This is an important point to clarify regarding the state of the science, as many in the ongoing policy debate, including the Center for Genetics and Society, draw a clear line between gene therapy that would affect the body of just one patient (somatic), and interventions into gametes or early embryos (germline).
Familiar Political Themes
What about the politics embedded in The X Files finale?
Since the days of Thomas Malthus, alarms about overpopulation have often been accompanied by xenophobia, elitist attempts to control reproduction, and racialized crackdowns on borders and migration. In The X Files finale, the plot situates itself among the fears of anti-vaxxers and conspiracy theorists, but concerns over anthropogenic climate take center stage. The villain’s purported goal in undermining human immunity is to “to kill everyone but the chosen.” He cites “40-percent loss of bird life, the decimation of the ‘megafauna.’” He applauds the aliens for divining this efficient method of population control for their own planets, an eerie tribute to the American eugenicists who embraced forced sterilization for ”defectives” and better breeding among the “chosen.”
In the finale, CRISPR is controlled and distributed by those in power: the villain holds captive the antidote to immunity breakdown, and doles it out (in exchange for “favors”) to those he deems worthy to survive. In our twenty-first century reality of global inequality, both human and nonhuman applications of CRISPR involve a lot of private investment and patentable content. Will nonfictional biotechnological advantage become the province of the wealthy? Will it exacerbate existing disparities in living and health conditions between the wealthy few and the majority of humanity living in poverty?
In The X Files, CRISPR was portrayed as a magical techno-fix to global climate change and overpopulation; in real life, some are similarly hyping it for disease prevention. The New York Times recently discussed the vast biotech menagerie of Randall “RJ” Kirk, whose Intrexon empire includes the gene-edited-pests company Oxitec, which is currently releasing 250,000 GM mosquitoes per day in Brazil in attempts to combat the spread of a virus linked to birth defects. And the FDA is “greatly expediting” Oxitec’s application to begin testing out their GM mosquitoes in the Florida Keys. What makes Kirk eyebrow-raising, among various eccentricities cited in the article, is his portfolio of controversial, financially struggling, but nonetheless bio-revolutionary firms, and his willingness to take unilateral leaps forward into the biotech unknown. Whether chasing techno-enthusiastic solutionism or the risk-laden profit margins of spread-thin solvency, Kirk symbolizes many of the concerns raised by the undemocratic development of biotechnology.
Science, Storytelling, and Public Debate about Emerging Technologies
The X Files director Chris Carter recently called on long-time science consultant and University of Maryland virologist Anne Simon to brainstorm a technology that could help tie together the series’ ongoing plot lines. A number of reporters have asked Simon whether she feels that the plot’s reliance on CRISPR could escalate public fears about the (real-world) game-changing technology. Some of Simon’s responses have been dismissive:
[I]f you think that people are going to avoid vaccinating their kids because of imaginary aliens doing things on a TV show, that is just ridiculous. There isn't any hope to begin with for anyone that dumb.
Simon wants it made clear that in the real world, CRISPR and other genetic engineering techniques are tools for good, not evil. ‘The X-Files’ may be spooky, but it’s just a TV show. “The whole idea of trying to get something into everyone’s cells – that’s not a viable system,” she told GeekWire. “We keep trying to say these are aliens doing this. … It’s aliens, OK? Aliens can do anything.”
Simon doubts that the episode will fuel fears of CRISPR. “It’s just a tool,” she says. In fact, when director Chris Carter asked her to create a world-destroying technology, she took care to avoid stoking real fears. GMOs and common vaccines were right out. She settled on the smallpox vaccine because it hasn’t been routinely given since 1972. And relegating vaccination conspiracies to the same level as aliens and chemtrails might even be helpful.
Simon does hope that the entrance of CRISPR into popular culture will stimulate discussion of its many applications and ethical ramifications, primarily those involving editing humans. “I think we have to be careful about modifying the human germline because we don’t know what we’re doing,” she says. The public, not just those who wield the technology, should be crucial players in making such decisions.
As Simon indicates, CRISPR’s potential use on the human germline – the third rail of genetic technologies – threatens to escalate public distrust in science. A concluding statement issued by the organizing committee of the three-day international summit on human gene editing in D.C. last December stated that it would be “irresponsible to proceed” with germline gene editing in the absence of “broad societal consensus.”
In 1998, the National Academies founded The Science & Entertainment Exchange, which has consulted over a thousand times on films and television shows. As this project indicates and as many observers recognize, popular narratives that engage with emerging bio-engineering technologies can shape public sentiment and facilitate broad debate about the multi-generational and societal impacts of research and experimentation.
The X Files is the first television show to feature CRISPR gene editing, the alternate futures it enables, and the social and political questions it raises. Let’s hope the writers now working on 12 new episodes of the British hit show Black Mirror are taking note.
Corey Pein has written another excellent piece in The Baffler, this time focusing mainly on Alcor, the cryonics company he describes as "technophilic necromancers." His starting point is actually a very unfortunate New York Times article.
Narratives are made by the artful omission of facts. Never was this maxim more evident than in a gullible feature story that landed on the front page of the New York Times last fall, about a young woman's last-ditch bid for life extension as she succumbed to the ravages of brain cancer. A sober look at the case would have revealed it to be but the latest botched mortuary procedure conducted by a gang of creepy scam artists. Instead, through the good graces of the Times, this grim tale was spun into an inspirational saga of one person's courageous quest for a second chance at life, aided by medical visionaries on the verge of miraculous technological breakthroughs.
(Incidentally, the Times also gave Alcor publicity back in 2005, though in a less hagiographic article.)
Pein details the gruesome facts of the case, with splendidly straight-faced humor: "a crack team of quacks shaved her head and drilled a number of sizable holes into her skull." He then delves deep into the history of Alcor and indeed the origins of modern transhumanism.
Of particular interest to those of us who have been following transhumanism and the like for a while is that Alcor's head nowadays is Max More, the quondam Max O'Connor, who reinvented himself and devised the Extropy Institute in the late 80s. He also coined the "proactionary principle" and for a while there was quite the philosopher of transhumanism. The Extropy Institute declared victory and shut down in 2006, but More evidently landed on his feet, apparently back where he started: in 1986, he co-founded "Britain's first cryonics organization, now defunct."
The Baffler piece is nearly 7000 words long. You'll laugh, you'll cry, you'll despair of humanity and then you'll realize that a human made this too. Read the whole thing, and check out this video, which is mentioned but not linked in the article. For extra credit, see Pein's equally astonishing article last year on the Singularity Institute.
Posted by Jessica Cussins, Biopolitical Times guest contributor on March 8th, 2016
We have become accustomed to ascribing individualistic agency to our genes. We speak of gene x doing thing y. However, our biology is not a collection of independent actors, but a highly interdependent ecosystem. And every now and then a story comes along that reminds us just how foolish we are to forget that.
In what is being called the first of its kind in the UK, the birth of a pair of genetically identical twins provides a striking case in point. Despite having split from the same embryo, one of the girls has brown eyes and darker skin, while the other girl has blue eyes and fairer skin. Other couples have defied the odds with the birth of two sets of twins with different skin and eye colors, but the notion of identical twins looking markedly different is much more unusual.
Studies have shown that identical twins growing up in the same household with largely the same opportunities and experiences can still develop quite different personalities and skills. This has largely been attributed to the growth of new neurons in the brain. But the rest of our bodies are also far from static.
Massive studies of identical twins have discovered that hundreds of genes can end up contributing to just 1% of the heritability of a disease or trait; moreover, epigenetics – the expression of genes – can profoundly alter phenotypic outcomes.
Such visual divergence of identical twins is very rare, but even rare findings have important consequences. As I tweeted last week, the finding “sure throws a wrench in that whole genetic determinism thing…!” And as Dorothy Roberts (Professor of Law and Sociology at the University of Pennsylvania as well as an Advisory Board member of the Center for Genetics and Society) responded, this case particularly complicates the notion of biological race:
"Black" and "white" identical twins also throws a monkey wrench in that whole biological races thing. https://t.co/HpCvqkpnWJ
Recognizing the multiplicities of our bodies and identities matters. For one thing, we can refute those who try to justify inequality on the basis of (purported) genetic differences, and make the critical point that, for example: Genes Don't Cause Racial – Health Disparities, Society Does. And that, “There is no inherent reason why children from low-income families cannot succeed as much as those from affluent homes.”
None of this is to deny the role of genetics, which is obviously a necessary and critical component to us all. However, as long as the myths of “individualistic” genes and genetic determinism continue to circulate wildly, it seems worthwhile to take the opportunity to remember that DNA is neither static nor prescriptive. Just as every locust is a genetic grasshopper facing a phase change brought on by hard times, so too are humans radically impacted by their environments. No amount of physical tinkering will ever erase the also necessary and infinitely messier importance of the outside world.
On the heels of the U.S. Supreme Court’s 2015 marriage equality decision, some argued that “family equality” was the next LGBT movement priority, which was described in part as increased access to surrogacy for gay men. Media scrutiny of commercial surrogacy can tend to be myopically focused on the gay couples using it, which is unfair given the high rates of heterosexual couples who also enter into surrogacy agreements both domestically and abroad. Yet the need for a diverse discussion of LGBTQ families and communities’ needs in a post-Marriage moment persists, as does the problem of excluding the voices of women who engage in the physically risky acts of gestational surrogacy and egg donation—particularly when they work for wealthier couples traveling to their country because of decreased costs.
On February 19, a symposium was held at UC Berkeley* entitled “Making Families: Transnational Surrogacy, Queer Kinship & Reproductive Justice”. A key goal of the symposium was linking up these three areas of practice and study to address the social justice implications of the growing, unregulated tool shed of reproductive biomedicine.
Lab mice are probably not the happiest of creatures. Food is not much of a problem (unless they are in one of those starvation-diet experiments) but roaming is discouraged, the environment is not that cozy and I imagine they don’t get given the wifi password. Even so, most of them don’t have to put up with researchers deliberately making them depressed.
All in a good cause, naturally, from the human point of view. Researchers, mostly at UCSF, identified a variant form of the PER3 gene in humans, which is involved with the circadian clock. The variant also seems to be linked to a tendency to sleep and wake very early (Familial Advanced Sleep Phase, or FASP) — and also with seasonal affective disorder (SAD). SAD is a relatively common kind of depression related somehow to changes in the length of the day, especially in the fall.
There is a long, long way to go before anyone can even think about using this linkage in therapeutic approaches, but it could be an important clue as to how sleep and mood disorders may be linked.
Bring on the mice. The scientists made transgenic mice with the human gene variant. And controlled the lighting to match the changing seasons. Bingo:
The model mice slept and behaved normally when their days and nights were of equal length, but developed depression-like symptoms as nights became longer than days.
You can’t do talk therapy with mice, but basically when they are feeling under the weather they don’t wriggle as much and they give up quick when something disturbing happens, like someone with a white coat picking them up.
The variant gene produces a less stable protein, and affects the performance of related circadian-linked genes. The authors note that this provides "a mechanistic explanation for the circadian trait.” This clearly could be a significant finding, eventually, but in the meantime, the poor old mice get bummed out.
They’re not the only ones. The researchers made mutant fruit flies too:
Although we were not able to test mood in fruit flies, we did uncover a sleep trait similar to that seen in humans in flies carrying the human variants.
Fruit flies are, or course, classic research subjects, and this is real science, but the observational work seems ... challenging. Imagine someone trying to test an alleged “criminality gene” in insects? Would they bite harder, perhaps? Or more often? Or both?
Concerns about cross-border fertility arrangements – especially human rights violations of women serving as surrogate mothers or providing eggs – brought 23 participants (including myself) from 14 countries to a three-and-a-half-day workshop at the Brocher Foundation near Geneva, Switzerland in January.
In addition to intensive discussion, we were treated to a screening of an award-winning documentary about surrogacy in India, Ma Na Sapna (A Mother’s Dream), which to my knowledge has not been widely screened in North America. Austrian director Valerie Gudenus was present, and answered a flurry of questions about the film and the several months she spent with a camera crew at the Akanksha Infertility Clinic.
Workshop sessions were devoted to exploring the meaning of an “ethic of care,” and how it would apply to surrogacy, third-party gamete providers, and embryo selection. Not surprisingly, a range of views surfaced among the gathered public interest and women’s health advocates, bioethicists, biologists, physicians, anthropologists, legal scholars, and others. But there was enough shared perspective for a series of recommendations to emerge, and a report explaining the background and reasoning for them is planned.
Many of the troubling aspects of the cross-border fertility industry that we discussed have become somewhat familiar. One concern that is still overlooked in some media accounts, but that was emphasized in these discussions, is the invisibility of the women who assist infertile couples and individuals in having a child. Another, even less commonly considered, is the rights and well-being of children born as a result of arrangements involving women working as surrogates or to provide their eggs.
We also discussed the contribution that a “human rights ethic of care” might make to the practice of inter-country assisted reproduction. Even in jurisdictions with significant public policy, and especially in those where regulation and oversight is absent or inadequate, there is still no satisfactory standard of care that takes into account the vulnerabilities and interests of everyone involved in such arrangements for bringing a child into the world. As one participant put it, “Reproduction takes place in response to people's desire or need for child, and it is only appropriate that if people want to start a caring relationship, their efforts should be founded on an ethic of care.”
Two other topics that are less commonly included in conversations about cross-border reproductive care also emerged. One concerned the unique status of First Nations / indigenous peoples. Participants stressed that these groups may hold wider concepts of community ownership, rights, and responsibilities with regard to genetic materials than others, and that their views should be considered in consultations about best practices, regulations, and guidelines for the applications of assisted reproductive technologies.
The session on embryo selection that I chaired together with Australian scholar Andrea Whittaker prompted a discussion of the connections among assisted reproduction, genetic selection, and new germline gene editing techniques including CRISPR-Cas9. There was wide agreement among the participants that pre-implantation genetic diagnosis should be used only for serious medical conditions, wide concern about the cross-border reproductive market for non-medical sex selection, and a strong view that these genetic screening/selection technologies could negatively affect social values of equality, solidarity and diversity.
There was also wide concern about new genetic modification techniques posing the potential for an international market in genetic traits and for genetic stratification. Participants cited the principle of intergenerational responsibility – mandating that the interests of future generations are represented in considerations of these technologies – and encouraged international dialogue that includes civil society groups and community participation.
CGS Advisory Board member Dorothy Roberts on race and intelligence in genetic research
Important research that casts doubt on many uses of racial categories in genetic research is discussed in a recent article co-authored by CGS Advisory Board member Dorothy Roberts and published in Science.
The perspective piece begins by citing to scientists and historians who undermined the scientific validity of the concept of biological race—including W. E. B. DuBois some 100 years ago. While the Human Genome Project found that humanity was 99.9% genetically the same, the authors note an uptick since 2000 in the use of race in genetics research as a data stratification factor. To avoid confusion, they helpfully define two separate but often conflated concepts: ancestry (“a very personal understanding of one’s genomic heritage” based on individual lineage) and race (“a pattern-based concept” used to “draw conclusions about hierarchical organizations of humans”).
They put forth two recommendations:
“Scientific journals and professional societies should encourage use of terms like ancestry and population to describe human groupings in genetic studies … Historical racial categories that are treated as natural and infused with notions of superiority and inferiority have no place in biology.”
“The U.S. National Academies of Sciences, Engineering, and Medicine should convene a panel of experts… to recommend ways for research into human biological diversity to move past the use of race as a tool for classification in both laboratory and clinical research.”
As a social scientist, looking at biologists treating these groupings as if they were determined by innate genetic distinctions, I'm dumbfounded. There's so much evidence that they're invented social categories … It in many cases leads researchers down the wrong path and leads to harmful results for patients. … It's not only that there's scientific evidence that humans aren't divided into discrete biological categories we'd call races. But there's also evidence of the harm these biological meanings of race have caused for centuries.
Dorothy Roberts breaks down the widespread use of race to make false biological predictions in her new TedMed Talk, where she highlights problematic ongoing diagnostic practices, including some developed during the American era of—and in justification of—slavery.
any research that bolsters the hereditary concept of intelligence could actually hurt the disadvantaged, since it almost inevitably would be used to support ‘racist, classist, gendered notions of intelligence.’ The bottom line, to Roberts, is that studying the genetics of intelligence ‘cannot possibly be socially neutral—and in fact will intensify social inequities.’
ACLS Public Fellow: CGS Project Director on Race, Genetics & Society
As we announced back in January, recent PhDs can apply to the American Council of Learned Societies (ACLS) Public Fellows Competition for a shot at joining CGS for a two-year position as Project Director on Race, Genetics & Society. We are eagerly looking forward to bringing a new colleague on board to grow our organizational work and capacity on the social justice implications of leveraging race in genetics research. You can find more information about the application process on the ACLS website, and learn more details about the position via this PDF. The application deadline is March 24, 2016.
CGS Resources on Race & Genetics
As a part of our communications program, we collect news and commentary on racial justice issues in human genetic and reproductive technologies. Here’s a sampling of some recent resources that you can find on the CGS website.
Race and ethnicity have no real biological meaning, by Kevin Loria, Tech Insider (November 20th, 2015). Genes can identify a person and find related people, but trying to fit groups of people into "races" was biologically inaccurate in the first place. (Re: recent Reddit AMA with Switzerland geneticist Manolis Dermitzakis)
Posted by Jonathan Chernoguz on February 11th, 2016
This year the Center for Genetics and Society will be overhauling our website, and we’d value your suggestions as we embark on what we expect to be a major improvement.
The new website will be implemented on an open-source platform, with a streamlined user interface and inviting design. Please take a few minutes to fill out this quick 10-question survey about your experience with the current CGS website and your suggestions about the new one.
Your feedback is very important to us and we greatly appreciate your responses.
A committee of California’s state stem cell agency met on February 4 to consider whether it should fund genetic editing of human embryos, and if so, whether such experiments require any change of its rules or regulations.
Back in 2004, 59% of Californians voted to allocate $3 billion of public money to establish the California Institute for Regenerative Medicine (CIRM), persuaded by promises that stem cell-based cures were imminent, and by frustration about the Bush administration’s restrictions on federal funding of techniques that destroyed human embryos. Now, as CIRM considers whether to underwrite research involving the genetic modification of human embryos, decisions at the federal level are again playing a role. National Institutes of Health director Francis Collins said in April 2015 that it won’t fund such research because “altering the human germline in embryos for clinical purposes….has been viewed almost universally as a line that should not be crossed.”
CIRM’s mandate to support research that can’t be federally funded was mentioned several times during the February 4 Standards Working Group meeting. According to CIRM staffer Geoff Lomax, current agency regulations allow research using human embryos, but prohibit their reproductive use. Much of the discussion at the meeting focused on identifying questions that new gene editing techniques raise about the conduct of such research. The resulting list of issues includes whether the research should be funded at all, and if so, how the use of modified embryos to initiate a pregnancy could be prevented. New considerations about informed consent from people donating gametes and embryos for research were also raised. As a next step, a subcommittee will examine the identified issues and draft recommendations that the Standards Working Group will consider and then pass on to CIRM’s governing board.
The meeting was live-streamed, but the audio quality was so poor that remote participation was quite challenging. David Jensen’s California Stem Cell Report coverage of the meeting here and here includes the complete list of identified questions as provided by CIRM. An account by Kevin McCormack, CIRM's Senior Director of Public Communications and Patient Advocate Outreach, can be found here. And writing at Stat, Charles Piller put CIRM’s deliberations in a broader policy context.
Having attended the meeting, three points stand out for me as takeaways:
On the final panel of the day, Charis Thompson raised key issues about CIRM’s ethical and social responsibilities. Her invited presentation included reminders that CIRM is mandated to serve not only patients with unmet medical needs, but also the taxpayers and voters of California; that disability justice experts as well as patient advocates should be consulted about gene editing directions; that CIRM should ensure that the work it funds does not exacerbate health disparities; and that if evidence of health disparities or eugenic trends emerges, “real consequences” must ensue. She concluded by saying that “It is not `anti-science’ to note that historically, slopes are indeed slippery,” and that “California deserves – and can have – both the best science and the best ethics.”
Jeff Sheehy, a member of both the Standards Working Group and CIRM’s governing board, is quite concerned about the following prospect: CIRM might decide to fund research involving the genetic modification of human embryos but then have little recourse if grantees used other funds to initiate a pregnancy. “Where does our reach start and end?,” he asked. “Does it start at the purpose of the proposed research? Do we just say you can’t implant?” Sheehy suggested that if CIRM approves any grants for research that would produce modified human embryos, it include as a contractual requirement that those embryos cannot be used to initiate a pregnancy, whatever the funding source for that final (and trivial) step.
Finally, an unsettling (if unsurprising) note about David Baltimore, who has played an influential role in the current controversy about germline gene editing and who chaired the organizing committee for last December’s International Summit. In previous comments about human gene editing, Baltimore has talked about responsible science; at the CIRM meeting, he came out explicitly in support of human germline modification. In his invited presentation, he said – as if this were a matter of scientific fact – that the desire for biologically related children is genetically hard-wired. He acknowledged that people at risk of transmitting genetic disease can already almost always have unaffected children in a variety of ways, and that therefore germline gene editing would at best benefit very few. But, he continued, "there are circumstances where it is the only opportunity for doing what a patient wants....To me, that’s sufficient reason to bring it to clinical use."
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 recounts in WIRED the story of 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 WIRED story was published online, 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. Schech