Posted by Gina Maranto, Biopolitical Times guest contributor on October 21st, 2016
The most unsettling line in the recent Forbes article on the ambitious infertility startup Prelude comes about halfway through. “The IVF industry in the United States,” writes Miguel Helft, “has everything private equity likes—scale (about $2 billion annually) and growth (more than 10% a year), along with being fragmented and having outdated marketing.”
In an era with precious few opportunities for double digit returns, why not turn the reproductive health sector into the next big thing by furthering its consolidation and selling services using lifestyle content? “Hey,” Prelude’s hipster-chic splash page calls out, “how’s your fertility doing?”
If that piques your interest, scrolling down takes you on a kind of virtual stroll through the streets of Williamsburg, Wicker Park, or the Mission District, where you encounter edgily coifed, tatted, and bespectacled folk who presumably are spending as much time thinking about their reproductive fitness as they do their next Americano or Kimchi taco. But you’ll find scant information about financial, psychological, or medical risks of egg retrieval (unless you count the presumed donor pictured alongside the quotation “I was worried about the discomfort, but seriously, it was no worse than a bikini wax—and for a much higher purpose”) or about failure rates after eggs are thawed and implanted. Everything is upbeat and empowering, geared toward the “millennial mindset of health, wellness, and control.”
Prelude is targeting 20 to 30 year olds and the main product it’s selling them is their own eggs and sperm on ice. The site proclaims, “If you are in your 20s or early 30s, there is no better time than now to bank your eggs and sperm. They are stretchy and full of reproductive life force, just like you!” (Must be all that hot bikram yoga, huh?)
With $200 million in funding, Prelude founder, chairman, and CEO Martin Varsavsky, who bills himself as a “serial tech entrepreneur,” laid the foundation of the company by acquiring controlling stakes in one of the largest IVF clinics in the country, Reproductive Biology Associates in Atlanta, which in 2016 had net sales of just over $5 million; and their partner, My Egg Bank, which gives would-be parents access to frozen eggs through a network of infertility clinics. Already profitable, Prelude also offers a product line for 40-somethings in the form of “screened donor eggs.” Helft writes that Prelude’s aim is “to take [egg and sperm freezing] mainstream, giving it scale and Silicon Valley pizzazz.”
It all puts one in mind of nothing so much as the international market in animal sperm and embryos. Reproductive technology in animals far predates that in humans: British scientist Walter Heape (himself a serial entrepreneur) produced the first successful mammalian embryo transfer in 1890 with rabbits. By the mid-1960s, animal sperm banks could be found around the world, and one study estimated that the cattle industry had by then performed artificial insemination on 59 million cows, 47 million ewes, 1 million sows, 125,000 mares, 56,000 goats, and 4 million turkeys. Businesses like Bovine Elite, Cattle Visions, and Cattle Genie are part of a multimillion-dollar global trade in cattle semen and embryos that has all but eliminated traditional mating and led to stacked pedigrees and reduced genetic variability. (One Wisconsin bull who sired some 500,000 offspring made national headlines when he died.)
While American Society of Reproductive Medicine guidelines currently suggest limiting the use of a single male’s sperm to 25 recipients (there are no suggested limits for donor eggs or embryos), what’s to say we won’t see the human version of cattle breeding as marketing takes precedence and consumer demand drives clinical practice? History provides ample evidence of the ways in which global capital tends to push enterprises toward greater scale and homogeneity—from fast food to pop culture to higher education.
Fifty years from now, historians could look back and see that Prelude, along with other egg banking and IVF-clinic networks duking it out for international market share, laid the groundwork for branded gametes and embryos, all under the soothing guise of offering customers “insurance” on their reproductive viability.
Gina Maranto is a fellow at the Center for Genetics and Society. She is Director of Ecosystem Science and Policy and Coordinator of the Environmental Science and Policy program at the University of Miami's Leonard and Jayne Abess Center. 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.
The first World Bioethics Day, sponsored by the UNESCO Chair in Bioethics, is taking place on October 19. This year’s theme of Human Dignity and Human Rights will be celebrated in 55 countries worldwide (see here for a list of participating countries and here for a list of planned events).
While most countries are hosting one or two World Bioethics Day events, India has planned a whopping 29. The only event scheduled in the United States is at Indiana University Northwest, which will include presentations on bioethics and human rights and a screening of “No Más Bebés,” a documentary about Mexican-American women who were coercively sterilized at Los Angeles County-USC Medical Center in the 1960s and 1970s. (Filmmakers Virginia Espino and Renee Tajima-Peña joined CGS on the UC Berkeley campus in 2016 to screen the film as a part of the Being Human in a Biotech Age series. They were also interviewed for the CGS online series Talking Biopolitics by eugenics scholar and CGS advisory board member Alexandra Minna Stern, see here and on YouTube.)
Human dignity and human rights, in addition to being the theme of this first annual World Bioethics Day celebration, form the primary framework of most of the international and national legislation worldwide that prohibits inheritable genetic modification, also known as human germline modification. The most notable among these is the Council of Europe’s 1997 Convention on Biomedicine and Human Rights (see here for a global list of national legislation banning inheritable genetic modification).
It is surprising that human genetics has such a low profile among the list of World Bioethics Day events. 2015 and 2016 have seen unprecedented technological developments with troubling implications for human germline modification – such as the public policy controversies surrounding reproductive applications of gene editing and human experimentation with mitochondrial manipulation techniques (or “three-person IVF) in Mexico and the Ukraine.
Out of 88 events today, only one sponsored by the Bosnia and Herzegovina Unit features genomics as its main theme. Five others, two in Italy and one each in Slovenia, Macedonia, and India, will include individual presentations on the wider topic of human genetics. The Bosnia and Herzegovina event is Bioethics in the Era of Genomics and Personalized Medicine, an international conference that will take place in Sarajevo on October 28.
Posted by Jessica Cussins, Biopolitical Times guest contributor on October 18th, 2016
The UK Nuffield Council on Bioethics’ recently released report, Genome Editing: an ethical review (full version available here) is the most substantial and thorough assessment of its kind. It delves deeply into the ethical, social, and political underpinnings and implications of genome editing, and touches on related, converging technologies including synthetic biology, gene drives, and de-extinction. A second report with ethical guidance regarding the use of genome editing for human reproduction is due in early 2017 from a Council working group chaired by Karen Yeung
This first report will be an important reference for people across disciplines for some time, and I will not do justice to its scope and breadth here. However, I want to draw attention to just seven concepts that are particularly helpful and illuminating, as much for their framing of the questions at stake as for their content. I briefly summarize each point, and select key quotes from the report.
1. On emerging technology and innovation
Contrary to frequent assumptions, innovation in science and technology is neither linear, autonomous, nor pre-destined. It is continuously co-produced in relation to a complex intersection of actors, institutions, market-drivers, and serendipity. Momentum and sunk costs can however encourage adherence to certain technological pathways, meaning the choice of paths we take should not be undertaken blindly, or lightly.
“A commonplace but now largely discredited perspective viewed science as a resource from which innovators draw, leading to new technological innovations that provide social or commercial benefits, such as increased wellbeing and productivity. The flaws in this ‘linear model’ are generally thought to stem from its failure to give due attention to the complexity of innovation processes, the importance of feedbacks, the role of markets and other actors, and the effects of uncertainty and serendipity. Science now tends to be seen less the wellspring of technological innovation than a ‘co-producer’ along with these other forces and actors.” (15)
“The factors that act to attract, secure and consolidate investment may also have the effect of confirming a course for innovation, creating both ‘lock in’ of contingent technological forms and forward momentum along a particular technological pathway. The reasons for this include factors such as sunk costs, learning effects, increasing returns to scale, high transaction costs associated with any change of direction and the mutual adaptation between technologies and associated conditions of use, including the structure, governance and practice of institutions, and not excluding social conditions, normative rules and standards, and public acceptance.” (18)
2. On the “editing” metaphor
Discussion of “genome editing” as opposed to “genetic modification” or “genetic engineering” has a re-framing effect that serves to distinguish the newer technological capabilities as more “precise,” as well as to diminish their consequences by avoiding connotation with such loaded terms as “GMO.” The “editing” metaphor instead conjures images of easily altered language or computer code.
“Whether intentionally or not, the ‘editing’ metaphor distinguishes the approach from less ‘precise’ forms of genetic ‘engineering’ and, simultaneously, distances it from their associated connotations, including the range of public responses that these terms typically excite. The editing metaphor also plays on characterisations of the genome as the ‘book of life’ containing ‘sentences’ (genes) made up of a ‘genetic alphabet’ of four ‘letters’ (A, C, G and T, the initial letters of the four chemical bases comprising DNA) that were common around the time of the Human Genome Project. The editing metaphor transfers easily to the more contemporary image of modifying computer code. The metaphor suggests not only the type but also the significance of the intervention: it is technical, is not dependent on scale (as it applies equally to changes large or small) and is seen as corrective or improving (at least in relation to the editor’s vision).
“In this way, the concept of editing has a certain thickness, whereby, while apparently descriptive, it implies a tacit evaluative judgement. It also implies an editor (the one who does the editing) and, by deeper implication, may distinguish the editor, who merely corrects and improves, from a putative, creative ‘author’. But whether authorship is assigned to a divinity or not, the implication is that the work of editing is trivial in comparison.” (19-20)
3. On the public interest
Science and technology are intimately connected with the public interest. They are forged through public funding and support, and they act upon and within the world, with impacts on the well-being and welfare of the public.
“There is a public interest in research for at least two main reasons. The first is to the extent that a great deal of research in the academic sector is publicly funded, from money collected through general taxation. This implies a public interest in the fact that this money is spent in a way that reflects public priorities and pursues them with the greatest possible efficiency. The second, more profound, reason is that products and practices, processes and tools produced by the application of knowledge gained through research may have a direct or indirect impact on the wellbeing and welfare of the public (including their moral and social welfare). The public have an interest in science, in terms of its expectation of net social benefits, and invests in science both financially and through the trust placed in scientists to contribute to the delivery of these benefits. But more profoundly than this, the public have an underlying public interest in the overall moral and ethical texture of the society in which they live. How technologies like genome editing are taken up and regulated both reflects and influences the broader moral values on which common social life is based and the social meaning of the practices in question.” (21)
And, quoting from Sheila Jasanoff’s article “Technology as a site and object of politics”:
“…technology, once seen as the preserve of dispassionate engineers committed to the unambiguous betterment of life, now has become a feverishly contested space in which human societies are waging bitter political battles over competing visions of the good and the authority to define it. In the process, the virtually automatic coupling of technology with progress, a legacy of the Enlightenment, has come undone. Uncertainty prevails, both about who governs technology and for whose benefit. No matter which way one looks, the frontiers of technology are seen to be at one and the same time, frontiers of politics.” (21)
4. On normality, moral norms and rights
Should we judge what constitutes an acceptable or unacceptable biological intervention using a concept of what is “normal?” What would that mean and who would decide? What lessons must we heed from 20th century eugenics programs about desires to direct humanity?
“While nature contains many prodigies, the normal can serve to orientate moral action (for example, in terms of whether that action tends to support what is regarded as normal functioning or produce divergence from it). What counts as normal is therefore a legitimate question but often one that is highly contested with regard to the extent to which norms are related to natural states or socially constructed, particularly in relation to issues of disability, medical intervention and enhancement. Disability justice and rights scholars have made a range of moral arguments against selective technologies, from individual rights based arguments such as the right to life of people with disabilities, to arguments for the social and emotional value (e.g. vulnerability to contingency) of biological difference, to the value to humankind of conserving disability cultures, and the importance of the visibility of disability in establishing social attitudes, behaviour, and structures.” (28)
“A particular concern that has been raised is that genome editing combined with social liberalism may facilitate the ‘consumerisation’ of human biology, and the spread of ‘consumer’ or ‘liberal’ eugenics, driven by the choices of parents rather than by state policy, but with possibly similar, socially divisive results. Objections here concern the practice as well as the consequences: that the biological conditions of human existence should not be the subject of choice since they allegedly interfere with identity of the person in morally significant ways.” (52)
5. On social justice and a just society
The advantages and opportunities of science and technology in general, and of genome editing in particular, may not be fairly distributed among different groups, different nations, or across generations. Developments cannot therefore be seen outside of the context of social, intergenerational and global justice.
“Such concerns require us to attend to the need to ensure that measures (such as the introduction of a new biotechnology) that affect welfare do so without discriminating unfairly among people. Although people may be equal in dignity and the enjoyment of rights, they are not equally situated with regard to the benefits and harms of biomedicine and biotechnology. Certain people may be disproportionately affected, may find themselves (perhaps involuntarily) in circumstances that render them particularly vulnerable, or be excluded from access to decision making or to benefits that are available to others. As a result, they may experience unfair discrimination and systematic disadvantage. It is argued by many that dignity and rights discourse is, in fact, insufficient to ground socially just action and that a specifically social justice perspective is called for: they consider it to be essential to put in place means for tracking social justice outcomes over time, and social justice goals in regulation of genome editing technologies.” (29-30)
6. On public policy
Public policy initiatives around genome editing are high-stakes, representing a collective vision of a desirable future, and determining those actions deemed unacceptable to the public interest. Public policy is both reflective of and impactful upon the society in which it functions, and in the world at large.
“As well as forestalling or redressing unjust treatment of individuals, public policy measures both reflect and affect the kind of society in which they are implemented, including the relationship between public and private, how and to what extent different groups and members participate in social life, how different priorities, preferences and values are resolved or tolerated, how equal or unequal in power, status and wealth its members are, and how open or closed the society may be. The features of any society are complex, interdependent and dynamic, but public policy measures often imply and express consistent common values and may be articulated around a collective vision of the desirable future state that they are expected to contribute to bringing about. These, in turn, influence the behaviours, institutions and culture of the society, for example whether it is welcoming or hostile to difference in terms of ethnicity, belief, appearance or ability.” (30)
7. On looking forward
Genome editing is a new development that has garnered enormous excitement. It is important to discuss the impacts of this disruptive new technology, but it will also be useful to avoid inevitability arguments, sky-high expectations, and to remember that it is just one element of a number of larger converging technologies. Future discussions would benefit from beginning with real human challenges or problems, rather than with a technology for its own sake.
“It should be remembered that most prospective technologies fail, and that some lead to undesirable consequences, a fact often obscured by ‘whig’ histories that reconstruct the history of successful technologies and their beneficial social consequences. Scientific discovery and technological innovation is important but not inevitable. Most important among the factors shaping technological development is human agency. It is human agency, in terms of decisions that are made about directions of research, funding and investment, the setting of legal limits and regulatory principles, the design of institutions and programmes, and the desire for or acceptance of different possible states of affairs, that will determine whether, and which, prospective technologies emerge and, ultimately, their historical significance.” (112)
“We are convinced that it makes little sense to treat the questions raised by genome editing as if they belonged to a single field (a hypothetical discipline of ‘genome editing studies’). Rather, they should be addressed as part of different technology convergences (e.g. with ART, with gene drives, with agricultural technologies, etc.), which also includes political technologies (regulation, legislation, etc.). But, more than that, we conclude that it is not the scale at which questions are posed but also their orientation that is important. Beginning with questions about what can be achieved at the genome level risks reducing all questions to ‘ELSI’ questions (questions about the ethical, legal and social implications of genome editing, as if that were the only or most obvious pathway available to address a complex set of real world challenges) and leaving questions about the appropriateness of genome technologies in any given case unaddressed. This is why the next, normative, phase of our work should begin with problems or challenges (and the potential diverse framings of those challenges), rather than technologies, and adopt a comparative methodology.” (115)
The unapproved technique involves injecting sperm into an engineered two-person egg via intracytoplasmic sperm injection or ICSI (pictured).
The first baby born as a result of the “3-person IVF” technique known as maternal spindle transfer (MST) was reported by New Scientist on September 27. To avoid US regulation, a team led by Dr. John Zhang of New Hope Fertility Center performed the unapproved and controversial procedure in Mexico. Now five months old, the child appears healthy but may encounter serious problems later in life.
Media coverage of this event in the United States and United Kingdom has been overwhelmingly celebratory, downplaying the serious health risks involved for the child and future generations, as well as Zhang’s flagrant disregard of established US regulatory policies (see New Scientist, New York Times, BBC, and The Telegraph). Zhang’s widely cited self-justification – “To save lives is the ethical thing to do” – has not been examined, despite the clear conclusion in the recent Institute of Medicine report that this technique “does not address a medical need,” let alone save lives, as it “would not treat an existing person for a disease, illness, or condition.”
Outside the US and UK, media coverage has been more tempered. While less celebratory, the German press has been surprisingly uncritical, despite emphasizing the fact that the procedure is illegal in Germany. The Portuguese language press has tended to syndicate translations of the English language press, although the Observador published a thoughtful piece raising questions about potential “Lego-babies.” The French language press has tended more towards the critical side, often including a section devoted to the health and/or ethical risks associated with the procedure. An article by Grégory Rozières at Le Huffington Post (France) warned, “This can be seen as the first step on a dangerous path…The risk of eugenic abuses is evident.”
A number of news stories did include comments from public interest advocates, scientists, and policy experts voicing a range of concerns. Nature News quoted biologist David Clancy saying, “They just went ahead and did it. The number of issues that are still unresolved — it’s just staggering.” In the same article, University of Miami (Florida) legal scholar Rosario Isasi “question[ed] the wisdom of performing the procedure in Mexico.” Isasi commented, “You have all these negatives, and it’s not a place that can offer the scientists a high-tech environment.” For other examples, see coverage at NPR, NBC News, Forbes, and BBC.
Several statements and articles explored the concerns in more depth. The Center for Genetics and Society released a press statement emphasizing the unsafe nature of the procedure, its unknown health consequences for the child and future generations, and the dangerous precedent set by renegade science, urging scientists and policy makers to “condemn rogue experimentation that takes advantage of families’ misplaced trust in people who wear white coats.” CGS executive director Marcy Darnovsky, PhD, stated,
No researcher or doctor has the right to flout agreed-upon rules and make up their own. This is an irresponsible and unethical act, and sets a dangerous precedent.
Paul Knoepfler, Professor in the Department of Cell Biology and Human Anatomy at UC Davis, expressed his deep concern about the ethics and safety of the procedure on his blog, emphasizing the need to recognize it for what it is, namely a “living human experiment” that has produced “a genetically modified human being.”
David King, PhD, director of the UK watchdog group Human Genetics Alert, issued a press statement condemning the news, stating,
This is entrepreneurial reproductive technology at its most unethical and irresponsible. It is outrageous that they simply ignored the cautious approach of US regulators and went to Mexico, because they think they know better. Since when is a simplistic “to save lives is the ethical thing to do” a balanced medical ethics approach, especially when no lives were being saved? These scientists have used an experimental technique that many scientists still think is unsafe, in order to create a world first. When are the world's governments going to stop rogue scientists crossing crucial ethical lines?
What we now know for certain is that national regulations without international cooperation may be almost useless in today’s interconnected world. Meanwhile, gene-editing technology is advancing rapidly…. Among the most worrying possibilities is the creation of children with genetic modifications that could change forever what it means to be human. “Designer babies”, for short.
What if we come to a consensus about what should not be allowed… and then some renegade scientists, convinced that they know best, just go ahead and do it?
Rumors have been circulating since 2014 about various research teams around the world applying the genetic engineering tool CRISPR-Cas9 in human embryos. Surprisingly, only two experiments have been officially reported in scientific journals—both of them in nonviable embryos incapable of being used for reproduction, and both out of Guangzhou, China.
CRISPR in viable human embryos
On September 22, NPR’s Rob Stein reported an exclusive look inside the Karolinska Institute in Sweden at ongoing but previously undisclosed work using CRISPR in viable human embryos. Stein had traveled to Stockholm to interview researcher Fredrik Lanner and his colleagues about their program of injecting CRISPR into viable human embryos to “knock out” genes potentially linked to early development. NPR quoted CGS executive director Marcy Darnovsky who cautioned:
It's a step toward attempts to produce genetically modified human beings. This would be reason for grave concern. … If we're going to be producing genetically modified babies, we are all too likely to find ourselves in a world where those babies are perceived to be biologically superior. And then we're in a world of genetic haves and have-nots...
The next day, Hank Greely, director of the Center for Law and the Biosciences at Stanford University, told Eric Niiler in Seeker that there is “good valid medical use” for basic scientific research using CRISPR in embryos, but followed that with a warning:
Still, Greely acknowledges that some scientists or the public might say that the Swedish experiment could be an ethical "slippery slope" toward a gene-edited human. “Even if you don't intend to, it makes it easier for someone else to do it,” Greely said.
Rogue actors: “Bioethics, get out of the way”
While many scientists, scholars, legal experts, and public interest advocates oppose using human gene editing for reproductive purposes, others question why anyone would dare stand in the way. There are longer and shorter answers. Our knowledge of both CRISPR and genetics/genomics is poor—not just on its own terms, but also in relation to other spheres of knowledge, particularly the ways in which they each interact with evolution, environments, public health, and social justice. For the foreseeable future, it would be reckless for a scientist to implant CRISPR-injected embryos for pregnancy not only because of serious safety concerns, but also in terms of democratic governance—especially given the select echelons to which most of the debate is currently restricted, and the range of social and political threats that genome editing poses to the human species.
In Seeker, legal scholar Rosario Isasi of the University of Miami voiced concern about edited human embryos being misused to produce genetically modified humans.
What are the oversight and controls to prevent this technology from being misused and go to a stage that, for now, the scientific community has agreed is a no-go?
In the italics (added) above, Isasi refers to the concluding statement from the International Summit on Human Gene Editing in D.C. in December 2015, in which the organizing committee argued:
It would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved…and (ii) there is broad societal consensus about the appropriateness of the proposed application.…any clinical use should proceed only under appropriate regulatory oversight.
Ensuring that researchers work within the bounds of existing national and international prohibitions against heritable genetic modifications in early human cells can be difficult when: (1) commercial and reputational incentives interfere, and (2) rogue scientists exploit basic research for socially and scientifically unsafe ends. Isasi noted in Seeker that the Karolinska Institute has been the venue of an ongoing controversy involving Paolo Macchiarini, a stem cell researcher whose implants of artificial trachea into people led to deaths between 2012 and 2014. Isasi asked:
How did they supervise that [artificial trachea] research, which makes me wonder, what mechanisms were in place to oversee this (gene-editing) proposal [?]
Concerns about end runs or misbehavior by individual scientists have recently grown. On September 27, the news heard ‘round the world was that a fertility doctor based in New York City went to Mexico to use scientifically controversial mitochondrial manipulation techniques to produce a child from an embryo engineered from the DNA of three people. New Hope Fertility Clinic’s John Zhang will take the stage and present the methods used to produce this “three-parent baby” at the upcoming conference of the American Society for Reproductive Medicine, the trade organization for fertility practitioners. The scientific portion of the annual meeting this year is aptly titled: "Scaling New Heights in Reproductive Medicine". It will be instructive to see whether Zhang is met with applause for his “disruptive” and “innovative” foray, or whether his colleagues will criticize the ways he short-circuited public policy and democratic discussions of emerging biotechnology regulations.
Swedish law is clear that genome editing is only allowed within the first 14 day[s] as long as the embryo is not transferred back for a continued pregnancy. This means that heritable genome editing for clinical purposes would not be allowed in Sweden. The clear legislation has been key in us moving ahead with these plans…. I’m actually pretty skeptical that the technology will be used for genome editing in the early embryo anytime soon.
The situation in China is different. While that country has regulations that would technically ban gene-edited embryos being used for pregnancy, it is unclear whether these regulations are enforced. On September 24, news emerged out of China that a CRISPR testing facility for genetically modified animals was under scrutiny for “faking inspection records and using students instead of certified technicians to conduct tests.” The testing center was established by the Chinese Academy of Agricultural Science, whose website lists partners including the Gates Foundation and UC Davis. It is a subsidiary of the Chinese Academy of Science which co-sponsored last December’s International Summit on Human Gene Editing with the U.S. National Academies and the UK’s Royal Society. Chief researcher Huang Dafang noted:
The incident has exposed management problems of some similar institutes, and serves as a warning…
Where does that leave the U.S.?
Many across the spectrum of opinion have noted the alarming speed with which CRISPR is being applied in research labs, including to human embryos, outside public scrutiny. Absent consistent laws or guidelines, many are concerned that rogue researchers may conclude that it is “safe enough” to implant edited embryos for pregnancy.
Given the competitive pressures in the world of science, the commercial incentives to be “first to market,” and the forum-shopping inherent to today’s biomedical enterprise, the “three-person IVF” child born in Mexico is a cautionary tale. Someone, somewhere could soon decide to try for a CRISPR baby. We should aim to protect future children from being born stripped of their privacy and guaranteed a life of medical display and tracking that was justified on their behalf to service goals like parental genetic connection.
We need a federal ban on any private or publically funded research aimed at clinical tests of human germline interventions and specifically against the use of gene-edited human germ cells in assisted reproduction. We also need an international conversation on how to pressure the biomedical sector in a range of political contexts to stay away from the human germline.
Posted by Daphne Martschenko, Biopolitical Times guest contributor on October 6th, 2016
Image via Wikimedia: "Lithograph of a North American skull from Samuel Morton's Crania Americana, 1839. Morton believed that intelligence was correlated with brain size and varied between racial groups".
Intelligence is a highly charged word with ties to racist, classist, and eugenic narratives. In the United States, it has been used historically to assert and establish racial and class hierarchies, especially those between Blacks and Whites, and has long been linked to notions of biological difference.
In the early twentieth century, these notions were frequently explicit. As one example among many, Princeton psychologist Carl Campbell Brigham, creator of the SAT and member of the Advisory Council of the American Eugenics Society, wrote in 1922:
According to all evidence available…American intelligence is declining, and will proceed with an accelerating rate as the racial admixture becomes more and more extensive…There is no reason why legal steps should not be taken which would insure a continuously progressive upward evolution… The steps that should be taken to preserve or increase our present intellectual capacity must of course be dictated by science. (Brigham, 1922: 210)
Even in the years following World War Two, when overt claims of racial differences in intelligence were often muted, Nobel Laureate (in physics) William Shockley could openly argue:
I sincerely and thoughtfully believe that attempts to demonstrate that American Negro shortcomings are preponderantly hereditary is the action most likely to reduce Negro agony in the future… I propose a serious scientific effort to establish by how much the distribution of hereditary potential for intelligence of our black citizens falls below whites…If those Negroes with the fewest Caucasian genes are in fact the most prolific and also the least intelligent, then genetic enslavement will be the destiny of their next generation. (Shockley, 1971: 244)
In June 2000, when the completion of a preliminary sequence of the human genome was announced at the White House, President Bill Clinton famously said,
One of the great truths to emerge from this triumphant expedition inside the human genome is that in genetic terms, all human beings, regardless of race, are more than 99.9 percent the same. (GenomeTV, 2012)
But this did not end debate about race, genes, and intelligence. In fact, many observers have noted that the years following this announcement saw an uptick in claims that race is a biologically meaningful system of classification. In 2005, Francis Collins himself suggested that “we now need to study how genetic variation and disease risk are correlated with self-identified race” (Krimsky, 2011: 25).
Among those who study genetics and intelligence today, the discourse about race is couched in more subtle and humanitarian terms than it was in the twentieth century. Take for example G is for Genes, published in 2013 by behavioral psychologist Kathryn Asbury and behavioral geneticist Robert Plomin. The book advocates for “genetically sensitive” schools that use genetic information to maximize a child’s abilities through a system of personalized learning. In a chapter titled “Mind the Gap: Social Status and School Quality,” the authors discuss the impacts of low-income status, poor parenting, and teacher quality on a child’s success in the classroom. Race is remarkably absent from the picture.
Of course, conscious and unconscious assumptions about links between race and cognitive ability haven’t simply disappeared. Although race is not valid as a biological system of categorization (Cooper et al, 2003), it remains an important causal social factor. Any research that has a history of marginalizing certain groups needs to address race explicitly—both as an inherited colonial system of classification and as a form of social inequality.
Recognizing the detrimental impact of race on an individual’s life circumstances is important for creating meaningful and effective improvements and change. Talking about race as a social factor that shapes an individual’s everyday experiences is a way of challenging vast and recurring misapprehensions that locate race in notions of the biological. Failing to talk about it makes that challenge far less likely to succeed.
Both in the social sciences and hard sciences, discomfort, confusion, and even denial often accompany conversations about intelligence. Each side habitually questions the rigor, benefit, and legitimacy of the other’s work. My own research as a PhD candidate sits between these fields, where the tensions between the two are inescapably clear.
My work focuses on four terms with burdened histories: intelligence, genetics, race, and socio-economic status. I examine how genetics research into intelligence and educational attainment affects the United States education system, where documented racial and socioeconomic disparities prevail and where teacher perceptions of student ability are known to affect student performance and referrals for gifted education programs (Elhoweris et al, 2005; Gillborn et al, 2012; Grissom, 2016; Slate et al, 1990).
On the one hand this means that I’m reading Genome-Wide Association Studies on educational attainment or intelligence, and engaging with geneticists who produce a form of scientific knowledge (Davies et al, 2011; Plomin et al, 2013; Rietveld et al, 2013; Selzam et al, 2016). On the other hand, I’m working with teachers in the classroom who are trying to make sense of why some bodies are less visible in gifted education programs than others (though gaining access in schools has been remarkably difficult, highlighting the charged and controversial nature of this project).
This is terrain on which it should be possible to connect the social sciences to hard sciences. But it is a landscape fraught with competing and underlying political debate. Two of the key questions: Are hard scientists socially responsible for how their work is interpreted and disseminated? Are social scientists truly informed about the science behind the work they often critique?
As an anthropologist, I am aware of the murky origins of my field as a whole—its expansion to legitimize Western colonialism, its use of scientific language and eugenics to validate social hierarchy as naturally occurring and biologically based. Anthropology, like other disciplines, has mobilized the concept of intelligence to maintain racialized matrices of power and hierarchies of inequality.
Scientists, on the other hand, often see their work as separate from social structures and narratives, rather than embedded in them. But insisting on the inherent objectivity of science is dangerous. In the case of genetics research on intelligence, its social impact on the US education system is potentially vast. Those who choose to research the biological basis for intelligence or educational attainment have a special responsibility to recognize this, and to understand its historical and foreseeable pitfalls. Collaborating with social scientists can help to make social implications more clear. While socially neutral research might not exist, socially responsible research certainly should.
Social scientists also have a responsibility. They can understand the methods and techniques of scientific research. And they can engage with geneticists in an open and inquiring manner. Intelligence researchers see legitimate benefits for individuals and society in their work. The social sciences can understand what the argued benefits are and why they are deemed valuable. Having a background in basic genetics and understanding the methodological practices at work in the field can strengthen critiques of the risky assumptions built into the methods and techniques of genetics research or highlight weaknesses in findings.
Scholars working in the hard sciences have faulted the media for misinterpretation, oversimplification, or sensationalism of their work (Asbury and Plomin, 2013: 96). Those in both social and hard sciences have noted that misleading hype often emerges in university press releases associated with the research (Evans, 2016: 11-13). Understanding the conditions and constraints of research, and what published academic journal findings can actually demonstrate, might test whether this is, in fact, the case and keep researchers and public media in check.
Prospects for Reconciliation
So how do we collaborate across the social and hard sciences? And how do we as researchers make our ways through our work detached from personal lived experiences, appearances, and backgrounds that might inform how we look at another discipline? How might we try and set apart our work from the history that precedes it? Is it too dangerous to even try? Would doing so perpetuate systems that marginalize or make peripheral certain groups? I know my experiences as an ethnic minority and my work in the education system with underrepresented groups certainly inform my approach to research; denying this would ignore potential biases I carry.
Whatever collaboration might look like, finding a common language for discussion is paramount. Part of the disconnect between the soft and hard sciences stems from different academic vocabularies and expressions, making one field at times seem like a foreign language to the other. I think, for instance, that hard scientists might have trouble reading this piece, filled as it is with an anthropologist’s lexicon. Creating a shared language centered on the pursuit of knowledge could be one good starting point, since both sides already seem invested in this area in their own way. Shared language that acknowledges the social consequences and historical context of knowledge production would also be enormously beneficial. Together, these sets of common concepts and vocabulary might help bridge the existing divide between the social and hard scientists.
Intelligence. Genetics. Race. Socio-economic status. Using these four words in the same sentence has closed doors for me as a researcher. Each is difficult to talk about on its own—and they’re almost explosive when joined together. Despite this, I strongly believe in combining these concepts through a full range of biological and social science methodologies—and in the value of picking up some diplomacy skills along the way.
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The billion-dollar patent battle over CRISPR/Cas-9 “gene editing” technology is layered with blockbuster scientific papers, media storms, superstar researchers, and legal drama, which are all the right elements to make up a thrilling graphic novel. Illustrator Andy Warner helps to break down the complexities of the still unraveling CRISPR story through a recent comic strip, “Bad Blood: Who gets credit for the technology to cut-and-paste the human genome?”
“Bad Blood” animates the key players in the ongoing legal fight between the Broad Institute and UC Berkeley, focusing on the increasingly recognizable trio of CRISPR co-discoverers Jennifer Doudna, Emmanuelle Charpentier, and Feng Zhang. The strip also illustrates journalists Antonio Regalado (MIT Tech Review) and Sharon Begley (currently STAT) who have been closely following the patent case and technical developments, and cites their thoughts on the ambiguities of credit for CRISPR and its potential social conseqeunces.
Strikingly, after explaining the nitty-gritties of the science and patent law underlying gene editing technologies, Warner leaves readers with a thought-provoking parallel: the historic development of the nuclear bomb, and the anguishing dilemma it posed for the scientists involved with the effort. His portrayal of Albert Einstein invokes the volatile political climate during which the atomic bomb was developed, and suggests the current need to question the social and political context of CRISPR and how this will shape the potential outcomes of its uses.
We are in a critical moment to make decisions that would safeguard future generations. And we are in a critical moment for artists, cultural groups, and various non-scientific communities to actively come together to interpret the present debates about gene editing technologies, creatively examine their unknowns, and engage in conversations about how to shape our future.
In the last panel of “Bad Blood,” Warner recognizes the urgency of an ongoing discussion to discuss the potential impacts of gene editing on our humanity:
For more information on CRISPR, you can visit CGS’ resources:
ScienceDebate.org was launched in 2007 with a goal of promoting a Presidential debate entirely on scientific topics. That hasn't happened yet, but the organization, which includes a broad selection of establishment figures and is co-organized by the National Academies, AAAS, and the Council on Competitiveness, is still trying.
Meanwhile, they set a perhaps more realistic goal of agreeing on 20 science-related questions and getting written answers from the candidates. The answers from Hillary Clinton, Donald Trump and Jill Stein are now online. Libertarian Gary Johnson has not yet responded.
Here’s what you get from the candidates for each question (illustrated with extracts from responses to the opioid problem):
From Clinton, three or four paragraphs that read as though they were drafted by a competent policy analyst and edited, or at least approved, by the candidate.
Sample: "We must work with medical doctors and nurses across the country to treat this issue on the ground, from how patients are accessing these medications to how we are supporting them in recovery."
From Trump, one paragraph that might have been extemporized by himself and then translated into a form of English.
Sample: "As this is a national problem that costs America billions of dollars in productivity, we should apply the resources necessary to mitigate this problem."
From Stein, short paragraphs (often several) that frequently make a lot of utopian sense.
Sample: "We will end the 'war on drugs' and redirect funds presently budgeted for the 'war on drugs' toward expanded research, education, counseling and treatment."
The Center for Genetics and Society’s core concerns about human biotechnologies are not explicitly covered. There are no references in either the questions or the answers to germline or other gene editing, or to genomics, stem cells, eugenics or precision medicine, to name but a few. Privacy is mentioned only in the context of the Internet in general.
Press reactions are listed on-site. Science had an anodyne but reasonably accurate summary. Lawrence M. Krauss in the New Yorker took a wry approach. Trump’s contributions were dissected at length by Martin Longman at Washington Monthly, who calls them variously “straight unresponsive pablum,” “almost unbelievable,” showing “no clue” and, on nuclear power, “positively Palinesque.” (Read the whole thing!) Michael Schulman at The Cubit blog (part of Religion Dispatches) has an entertaining summary that accurately concludes:
ScienceDebate.org asked questions about forces that will affect the basic well-being and survival of the United States’ citizenry. In theory, that’s the stuff of democracy. Not one of them, though, felt like something that will even remotely sway the election.
At almost the same time, Neal Lane and colleagues at Rice University issued a report arguing strongly that the White House Office of Science and Technology Policy (OSTP) and the position of science adviser should be retained by the next president, who should, as Science notes, "lay out priorities for science and innovation within the first 100 days of taking office.” The report is not specific on issues, but very strong on process.
On the lighter side, there are reports that Trump intends to nominate Peter Thiel, the notorious billionaire transhumanist, to the Supreme Court. Everyone involved denies this on the record, but the rumor is said to derive from sources close to Mr. Thiel. Someone allegedly close to the candidate confirms (on background) that there has been discussion but cautions:
Trump’s offers often fail to materialize in real life.
One set of CRISPR questions that poses hugely significant threats to future generations goes something like this:
Can we engineer human germ cells and embryos to re-wire genetic risk factors?
And if we think it’s safe enough, should we try to create genetically modified babies?
To address these questions, the video raises some helpful points. It notes the likelihood of market pressures and consumer incentives and how they might impact what sort of children and what sort of modifications become popular (”Buy two enhancements, get the third free!”).
It also illustrates the massive iceberg of unknowns facing those who are interested in pursuing genetic upgrades in the IVF clinic.
Yet the video is restricted in its ability to fully countenance the future of designer babies by its cheery optimism, by its unsupported claims that a new biological era of “intelligent design” is just inevitable, and by its assumption that people will naturally warm up to the idea as time goes on.
One of the video’s sanguine assumptions is that any social downsides are confined to scenarios of evil dictators and mad scientists. While North Korea’s current situation makes it easy to construe our own social and political context as reasonable by comparison, there is no shortage of social justice concerns that transcend crude state-sponsored violence.
The video also indulges in some anti-aging hype—a key cornerstone for much of the Silicon Valley collective's future-making projects, and a generator of headline gems like this recent one:
The company’s visuals bring to mind the TED Talk that entrepreneur Juan Enriquez gave in November 2015 entitled “We can reprogram life. How to do it wisely.” Enriquez's slides used emoji to describe the coming era of “intelligent design” in which humans “re-program” the “lifecode” of future generations. For all the policy wonks in the house, Enriquez has a super thorough plan for containing this GMO explosion:
We should take about a quarter of the Earth and only let Darwin run the show there. It doesn't have to be contiguous, doesn't have to all be tied together. It should be part in the oceans, part on land. But we should not run every evolutionary decision on this planet. We want to have our evolutionary system running. We want to have Darwin's evolutionary system running. And it's just really important to have these two things running in parallel and not overwhelm evolution.
Like Enriquez, Kurgesagt’s CRISPR video, for all of its unbound future visions, adopts an exceedingly narrow vision of democratic progress and governance. “The only thing we know for sure,” it asserts, “is that things will change irreversibly.”
By this logic, technology’s impending arranged marriage to biology is inevitable, and we might as well sit back and watch the Silicon Valley “cradle of innovation” unburden us from our human imperfections—one human birthing experiment at a time.
But before we give up on the current reproductive order, it seems only fair that we first admit our troubling assumptions about what it means to be human:
Departures from the optimum—and certainly most disease and disability—simply equate to abject suffering without individual or societal value, and should be de-selected, prevented, secluded, avoided, exterminated.
Some genes are just “bad”—or at least “inconvenient” in our society—and not worth bringing into the world. Some genes are just “good” and worth increasing in the population.
Each of us has a moral duty to cleanse our children’s genome before birth to maintain a superior human race—I mean, for the state’s interest in public health.
These assumptions are in fact the rationales of eugenics past. Do we really want to marry them to the angel-winged free market of Big Biotech?
Let’s be clear about what’s at stake. Let’s interrogate the assumptions that tell us our children must be bred from the finest stock available. Let’s challenge ourselves to forego conceiving of our children as value-enhanced property in a biopolitical marketplace. Let’s fight back against the politics and social pressures that tell us our bodies are the sole source of our value. Let’s ignore folks who say that we are internally deficient, that inequality is natural, and that we are each personally responsible when systems of power and oppression cut off our ability to thrive. Let’s allow all of us to be a little more human – imperfections, genetic variants, and all.
David Jensen, who writes the essential California Stem Cell Report blog, published a detailed front-page article in the Sacramento Bee on September 2 with the eye-catching headline:
Stem cell company paid $443,500 to former head of state agency that funds research
As has previously been reported, Alan Trounson joined the board of StemCells Inc. in 2014, about a week after he resigned from a six-year stint as President of the California Institute for Regenerative Medicine (CIRM) to return to Australia. CIRM, which is funded by California taxpayers, had previously allotted some $40 million of grants to the company, based just across the Bay from Stanford.
As Jensen recounts, some of those grants had raised questions; one was made despite having been twice rejected by the grant committee. In addition, Irving Weissman, the Stanford University-based co-founder of the company, has received research grants amounting to $30.5 million from the agency. Weissman notoriously appeared in 2004 television ads promoting the establishment of CIRM, while wearing a white coat and identifying himself as a doctor (which he also is), but not as a stem cell entrepreneur. Weissman’s academic institution, Stanford University, has received over a quarter of a billion dollars from CIRM, including over $40 million for a new building.
The new information that Jensen turned up in SEC filings was how much StemCells Inc. paid Trounson after he joined its board: $59,500 in cash over a year and a half (far more than any other board member) and nominally $384,000 in stock options. (The stock has since tanked completely.)
Did Trounson or StemCells Inc. do anything illegal? Quite likely not. Was this transaction appropriate? Absolutely not! It’s scandalous, but it’s the kind of scandal that was built into CIRM from its very inception. Nature, in September 2004, during the run-up to the state election that established CIRM, opened an article this way:
Opponents of California's $3-billion plan to fund embryonic stem-cell research say that the proposal would give researchers carte blanche to rewrite well-established ethical guidelines to suit their needs. They say the research institute planned under the initiative will be exempt from legislative supervision and, if established, will be able to make its own rules about conflicts of interest and informed consent.
Among those opponents was the Center for Genetics and Society, whose extensive pre-election analysis is archived here. In January 2006, CGS examined CIRM’s first year and published a detailed “report card” [pdf]. The overall grade we gave CIRM was C–, and on several issues, including minimizing conflict of interest, we handed out a D.
Jesse Reynolds, then Director of Project on Biotechnology Accountability for CGS, deserves particular credit for drawing attention to the conflicts of interest embedded in the structure of the stem cell agency. He attended numerous public meetings of CIRM, testified for investigations of the agency before the California legislature and the state’s “Little Hoover Commission,” wrotemanyop-eds, and helped to push for reforms.
CIRM was also scrutinized by the Institute of Medicine in 2012. Its report affirmed the existence and significance of the conflicts of interest and structural flaws that CGS and other public interest voices had identified even before the agency was approved by the 2004 ballot measure on which backers spent some $35 million. CGS’s invited testimony to the Institute of Medicine, and its press release welcoming the IOM’s report, provide details.
CIRM is now slowly running out of the $3 billion of public funds allocated to it in 2004, and is expected to wind up in 2020. It has provided an object lesson in how not to set up and run an independent public-funded agency. These latest revelations should end any speculation about extending its charter.
Posted by Emily Galpern, Biopolitical Times guest contributor on September 8th, 2016
The Center for Genetics and Society and allies are celebrating the demise of AB 2531, a bill that would have allowed payments to women who provide eggs for research, effectively expanding the commercial market for human eggs from the fertility sector to the research context.
The bill, which was sponsored by the American Society for Reproductive Medicine, died in the State Legislature last week, never making it to the Governor’s desk. Assemblymember Autumn Burke anticipated a veto from Governor Brown and decided not to bring it up for a vote in the Assembly when it was sent back for concurrence, after passing the Senate on August 29 with amendments that seemed to be a tepid response to opponents’ objections.
CGS and allied women’s health, reproductive justice and public interest organizations opposed the bill because of dramatically insufficient information about the health effects of egg provision; the impossibility of true informed consent given the lack of data; the likelihood that low-income women, women of color, and immigrant women would most likely be affected; and the bill’s conflict with national recommendations for federal policy and with state law. For a full explanation of these concerns, see the opposition floor alert and CGS’ letter to the Senate Health Committee.
The bill was covered by veteran journalist David Jensen in the Capitol Weekly (Senate eyes human egg business), and was criticized in a number of op-eds and columns, including one by former Senator Deborah Ortiz, author of a 2006 law that assured certain protections for egg providers:
We hope legislators have come to understand the complexity of this issue and, instead of bringing payment and undue incentive to the table, begin to call for long-term studies to provide the information women need to make truly informed decisions about their bodies and their health.
Emily Galpern works with the Center for Genetics and Society as a consultant.
Ruth Hubbard — prominent biologist, feminist scholar, multi-faceted social justice advocate, and critic of what she termed “the gene myth” — died on September 1 at the age of 92. Her scholarly and public interest efforts to track and shape the politics of human genetics were an important inspiration to many working on these matters today, including those of us who helped establish the Center for Genetics and Society.
Ruth took on a range of political and social challenges related to the politics of science, genetic determinism, race, and gender. Among these was human germline modification, which she strongly opposed. In 1999, she co-authored Human germline gene modification: a dissent with Stuart Newman and Paul Billings in The Lancet.
In 1993, she wrote in Exploding the Gene Myth:
Clearly, the eugenic implications of [human germline modification] are enormous. It brings us into a Brave New World in which scientists, or other self-appointed arbiters of human excellence, would be able to decide which are “bad” genes and when to replace them with “good” ones….We need to pay attention to the experiments that will be proposed for germ-line genetic manipulations, and to oppose the rationales that will be put forward to advance their implementation, wherever and whenever they are discussed.
The Boston Globe’s obituary for Ruth provides details about her long and influential life and career, as does an obituary written by her family that can be found here.
Maybe you haven’t heard of CRISPR-Cas9. To be honest, if I hadn’t previously worked at the Center for Genetics and Society, I probably wouldn’t have heard of it either. It’s a new genetic technology that brings modification of the human germline closer in reach than ever before.
Driven by the promise of allowing parents to avoid passing on incurable genetic diseases to their offspring, the use of CRISPR to engineer human embryos presents serious risks with particularly strong implications for people with disabilities—in the present and future. It’s been getting plenty of press. And yet, as someone who tries to stay up to date constantly with what’s trending in the disability social media scene, it has seemed to me that CRISPR has been more or less absent.
Why aren’t people in the disability community talking more about this?
Why should people with disabilities have to keep spending their time justifying their existence rather than just enjoying it at present?
I recall a conference I organized with the Longmore Institute in 2013, “Future Past: Disability, Eugenics, and Brave New Worlds.” Disability studies scholar and activist Marsha Saxton began her panel by sharing a memory of talking with a genetics counselor while contemplating getting pregnant. The counselor exclaimed, “Gee, if I’d have known Spina Bifadas turned out as well as you, I would not have recommended selective abortion as much as I’ve done!”
Similarly, a conversation comes to mind that I had with another disability activist, who previously focused on the neo-eugenic uses of genetic technologies but left because she was burnt out. As a person with a disability, she didn’t want to continue spending her life’s work validating her own existence, and moved into the arts instead to celebrate the beauty that disability brings.
Despite the disability rights movement’s progress, both of these stories help illustrate why people with disabilities might not want to waste their time thinking about these issues. Indeed it suggests that my own lack of understanding of why people with disabilities aren’t more interested in following this comes from a place of privilege as a nondisabled ally. It seems that for many, engaging in the debate is just too hurtful. Why should people with disabilities have to keep spending their time justifying their existence rather than just enjoying it at present?
Yet when it comes to CRISPR for human reproduction, disability is at the center of it all. Whether or not CRISPR takes hold in the fertility clinic, the scientific and philosophical debate is constantly centered on disability. So here are five reasons why CRISPR and disability are dangerously intertwined, exemplifying why we need the perspectives of people with disabilities weighing in on this debate, as unappealing as diving in may be:
Modern-day eugenics. For me, it’s pretty much that simple… and that scary. Advocates of using CRISPR for heritable genetic modification argue that we can distinguish to ensure this is only used for deselecting genetic diseases (“germline therapy”), rather than using the technology to select for more desired traits (“enhancement”). But even this binary presumes we can draw clean lines to eliminate diseases that don’t also suggest preventing disabilities. It brings up questions of what we should and shouldn’t value in future generations. Knowing that these choices are being made in a deeply ableist culture—where people like Marsha Saxton would likely not have been born because of fear of the “spina bifidas”—illustrates how hard it would be to draw lines about what genetic diseases “we” agree to engineer out of the gene pool and which are allowed to stay.
We are moving backwards. Even as opponents of CRISPR germline modification make their case, it often hinges on the idea that we don’t need CRISPR because we already have preimplantation genetic diagnosis (PGD) to allow parents to have children free from genetic abnormalities. However, disability advocates still contest PGD as socially harmful genetic selection and disability prevention. The Center for Genetics and Society’s Executive Director Marcy Darnovsky recently shared with me that when she points out this tension to the press, they rarely if ever include it.
It’s selling disability as tragic. This isn’t new. It’s how preimplantation genetic diagnosis was sold. It’s how stem cell therapy was sold. Before we even develop the technology, we develop the story: people with disabilities are living a sad, tragic existence, and only through progress in the genetic sciences can we spare their suffering in future people. This tragedy gets retold and retold, creating urgency for the technology in question: Forget the vibrant disability community. Forget the changes in technology, art, and culture that people with disabilities bring to our world from the insights of living with a disability. We don’t have time to worry about ethics or risks! Selling the need for the cutting edge technology comes on the backs of people with disabilities, so science policy and debates become one more place where the tired trope of disability as “the worst” thrives.
Nondisabled people won’t get it unless people with disabilities are part of the debate. Nondisabled proponents are arguing we need to use CRISPR to prevent disabilities. Nondisabled opponents suggest we should be wary of CRISPR for its threat to disability justice. Both sides are talking about disability, but the conversation would carry more weight if disability activists were involved.
This is why the work of disability activist and writer Harriet McBryde Johnson was so powerful. In a series of conversations with philosopher Peter Singer, one of the most outspoken advocates of preventing children with disabilities from being born, McBryde Johnson put a face to his theoretical exercises and argued that they had life or death consequences for people like her. (Still image via Vimeo)
When I share my interests in these sorts of debates, I often get this wave of enthusiasm from other nondisabled people who seem to find it fun to sit around and discuss how much better the world would be if we could prevent or cure all disabilities. They want to talk it out through thought experiments and philosophical exercises. I mean no disrespect to those who think that way. After all, I’m married to someone with a philosophy degree, and some philosophers with disabilities have made important contributions to the way disability is theorized in ethical debates (e.g. Adrienne Asch and Anita Silvers). However, I think the debate needs more perspectives and personal stories coming from people with disabilities who help us to attach faces and lives to the debate and to remind us what a loss it would be to live in a world with less disability.
(At the 2015 National Academies' International Summit on Human Gene Editing, the conversation did not include any featured speaker open about being a person with a disability. There were efforts to invite one or two, and Ruha Benjamin did give a wonderful presentation which you can view here, but the omission was startling.)
It impacts the fight for disability equity today. When cures and the end of disability are always cast as “just around the corner,” it continues to make it harder to fight for what we need today. We continue to invest millions of dollars on anything that might help us eliminate disability. Meanwhile people with disabilities struggle to implement things to make our society more accessible right now, as these social changes are always framed as “too costly.” This doesn’t mean that we need to be entirely anti-cure and certainly not anti-research, but again, we need people with disabilities to play a central role in this debate. A diversity of voices speaking to their experiences with disability can teach us that we don’t need CRISPR to “solve” the disability = tragedy equation. Social changes to the built environment and cultural changes to discriminatory attitudes are a safer bet with more widely shared impacts.
2017 will mark the 20th anniversary of GATTACA’s release, a film which brought to the big screen issues of genetic discrimination resulting from the effort to control human reproduction (for a great disability take on it, read here). The “not too distant future” imagined in the film grows closer with CRISPR. I wish I could just turn away from CRISPR to hope it’ll pass over—I far prefer spending my time on our disability film festival or promoting disability history. Yet disability culture and arts are more related to CRISPR than one might think. They provide a powerful illustration of how disability enriches our world. It just might be worth making time for the CRISPR debates (even though the emotional labor of doing so is huge), to help ensure a long-term future for disability as a creative and generative force.
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 Gina Maranto, Biopolitical Times guest contributor on August 9th, 2016
Deep brain stimulation, image via Wikimedia.
Permit me a brief digression before I comment on the latest Pew Research Center survey of Americans’ attitudes toward biomedical technologies meant to “enhance” human performance.
I am married to a bioengineered man. Almost three years ago, after having been steadily eroded by Parkinson’s disease for over a decade, my husband Mark Derr braved deep brain stimulation (DBS) surgery. His incredible surgical team at Johns Hopkins implanted electrodes into his brain and a battery-driven stimulus device in his upper left pectoral, and the results seemed, at the time, nothing short of miraculous. With a mere incremental upping of the voltage during an initial adjustment session, the DBS instantaneously stilled Mark’s tremulous hand and foot, giving him relief that the standard drugs had only intermittently provided.
Much as DBS has improved his quality of life, Mark is far from cured. DBS cannot address the muscle stiffness, balance problems, and neurological pain he experiences daily. And the instrument requires constant attention. Mark’s days consist of frequent monitoring of his device; his weeks, of periodic adjustments of the voltage; his months, of consultation with his medical minders in Baltimore, where he travels every five months or so for “tweaking.” His latest technician there told him, “You are your own experiment.”
Based on direct experience, then, I would advise that heady promises regarding biotechnology should be viewed with a high degree of skepticism. DBS, for example, may eventually get better at addressing Parkinson’s symptoms, but cannot reverse the neuronal damage that lies at the base of the disease. Many other biotechnological interventions also carry with them an almost guaranteed set of deficits, inadequacies, inconveniences, and risks that are conveniently ignored in the valedictory narratives woven around them.
In some ways, the Pew survey, which looked at attitudes toward three hypothetical “enhancements” (although one, which would involve genetic enhancement of future children, is presented as a preventative medical measure), suggests that Americans get that biotech interventions raise profound social and ethical questions. In the chart below, more respondents said they were concerned rather than enthused about fiddling with babies’ genomes, following in the footsteps of Johnny Mnemonic, or engaging in blood doping squared. Not only did most of those surveyed expect that the cons would outweigh the pros of such interventions, a majority believed such interventions “could exacerbate the divide between the haves and have-nots in society…[and that] inequality would increase because only the wealthy could afford these enhancements.”
But Pew itself seems oddly disposed to undercut its own findings in the large accompanying piece probing “expert” opinion on enhancement in general. David Masci, in “Human Enhancement: The Scientific and Ethical Dimensions of Striving for Perfection,” seems to take the side of the pro-enhancement champions, giving ample play to the “sky’s the limit” point of view of self-avowed transhumanists and giving the final world to a futurist who says, “We’ll probably start by taking a human version of nirvana and creating it in some sort of virtual reality,” and then “we’ll transition to realms of bliss that we can’t conceive of at this time because we’re incapable of conceiving it.” Masci also strives to normalize enhancement, starting his piece with the claim that, “Human enhancement is at least as old as civilization.”
This claim, often advanced in pro-enhancement camps, suggests that education and exercise are equivalent to chips in the brain or performance enhancement through genetic alterations that would increase, say, fast twitch muscles. Call it argument by sleight of hand or by failure to make proper category distinctions. If we really want an accurate analogy, we should think about phase changes: water becomes colder and colder, and then becomes ice. A quantitative change leads to a qualitative change. Step by step, biotechnologists alter us; at a certain point, a qualitative change ensues. We cannot perfect the human; we can only push genes and protoplasm past a certain point—and no one quite knows where it lies, but many have agreed that the germline is certainly one clear and present possibility—and we will have crafted a new entity. But to what purpose is questionable.
Instead of leaving a person’s physical well-being to the vagaries of nature, supporters of these technologies contend, science will allow us to take control of our species’ development, making ourselves and future generations stronger, smarter, healthier and happier.
To this I say hooey and hooey again. Even the most exquisitely engineered of artifacts—take the Large Hadron Collider for example—are prone to error and screw ups. Surprise, chance, and unpredictability are hard wired into our universe. Whether breakdowns come from passing birds or wayward weasels, breakdowns will come. Even when our biomedical and bioengineering prowess achieves its best, there will always be downsides.
Gina Marantois 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 inDiscover,The Atlantic Monthly,Scientific American,The New York Times, and other publications. She is the author ofQuest for Perfection: The Drive to Breed Better Human Beings.
In the past month, the media has reported seven patient deaths of subjects enrolled in separate gene therapy clinical trials being conducted by Juno Therapeutics and by Ziopharm Oncology, Inc., both aimed at immunotherapy-based cancer treatments that have sparked widespread hope. Despite these deaths, the trials continue to move forward.
Media coverage of trials related to gene therapy has portrayed the clinical research rollercoaster. Just this past week, The New York Times ran an unusually lengthy and high-profile series of articles in the Sunday paper about immunotherapy treatments for cancer, some involving genetic modification of immune cells. The articles describe the promising aspects of engineering one’s own immune system to fight cancer, including dramatic stories of tumors “melting away” and promises of complete remission.
Yet commentary on the ethical implications of these events has been scant, and these events raise a number of concerns about what bioethicists call “therapeutic misconception” – vulnerable patients seeking enrollment in a clinical trial with the mistaken belief that the gene therapy is approved by the FDA to be safe and effective. The clinical trial deaths also highlight lingering questions about transparent reporting of adverse events to the FDA and appropriately navigating financial conflicts of interest. Instead, numerous articles have focused on how these deaths impact the bottom line: corporate stock prices.
The excitement has been building for some time. In June 2015, MIT Technology Review described Juno’s experimental T-cell immunotherapy for leukemia as “Biotech’s Coming Cancer Cure” and profiled the “miracle” recovery of 20-year old leukemia patient Milton Wright III. Wright signed up for the clinical trial because “they hyped it up, like it was going to be amazing” and MIT Technology Review has characterized Juno’s immunotherapy trials as “remarkable.”
Some scientists are hopeful for a breakthrough, particularly for patients whose cancer has returned after multiple rounds of traditional chemotherapy. For vulnerable patients seeking a “miracle cure,” such characterizations blur the distinction between approved therapy and clinical research that may or may not produce a viable therapy. As a disclaimer, I have not seen any of the informed consent documents from Juno or Ziopharm. But whatever these documents say, media descriptions of a “coming cancer cure” make it challenging to fully convey the risks to sick people with few other options who are considering enrolling in clinical trials as a last-ditch treatment effort. This is precisely the kind of situation that the term “therapeutic misconception” addresses.
We must cautiously tread when describing Phase I and Phase II clinical trials to patients who are simultaneously acting as research subjects, and take care not to inflate our words when we discuss this research in the media. Despite the misleading name, these early gene therapy trials are not approved therapies, but experiments to assess safety, dosing tolerability, and effectiveness. The goal for this stage of research is not to provide a treatment for this specific person, but rather to contribute to generalized knowledge. It focuses on asking: Will this method of gene therapy work? Is it safe? Are there adverse risks so severe or frequent which constitute an unacceptable level of risk?
It is not clear whether the patients recognize the uncertainty of benefit, especially when measured against the magnitude of risk. Gene therapy poses a distinct, and an arguably riskier, profile of possible adverse effects compared to drugs alone because it can permanently alter the recipient’s cells and holds the potential for severe latent adverse effects such as cancer, immunologic, neurologic, and autoimmune complications.
When unexpected serious adverse reactions do occur that are related to the trial, the sponsor must report these to the FDA. Several months ago in May 2016, Juno reported one death to the FDA of a subject who was enrolled in one of its CAR-T protocols for leukemia, asserting: “It is not clear what caused the death, and a change at this time is not warranted.” In July, Juno reported two more deaths, this time stating that they resulted from compounding factors (a chemotherapy drug Fludarabine used in conjunction with the CAR-T protocol). Juno subsequently updated its statement, disclosing there have been four total deaths from its CAR-T protocols.
In response, the FDA temporarily (and very briefly) suspended the clinical trial, causing a fleeting plummet in Juno’s stock prices. Juno quickly submitted a modified protocol that removed Fludarabine, updated the trial brochure, and amended the patient consent form to the FDA. The FDA deemed these modifications acceptable and expediently lifted the hold within days, despite the alarming disclosure. Juno’s trial – and stock prices – were back in business. Articles (here and here) characterized these deaths and the corresponding swift response as a “bump in the road,” myopically questioning how it would impact the clinical trial progression and corporate financial outlook. Minimizing patient deaths that may have resulted from the gene therapy rather than their underlying illness is dehumanizing and ethically inappropriate, even if we reason that these patients were near the end of life.
One biotech analyst questioned FDA’s decision to quickly lift the clinical trial hold, observing, “They are trying to referee a game while the rules are still being written. And it appears to be causing some deaths that should have been avoided.”
Ziopharm made similar headlines in the past few months relating to its Phase I clinical trials designed for glioblastoma patients. Ziopharm partnered with the synthetic biology company Intrexon, and has been studying a gene therapy technique using a genetically engineered virus that is directly injected into the subject’s tumor. According to Ziopharm, the third subject died 15 days after beginning the trial of an intracranial hemorrhage. Prior to this report, two other enrolled subjects also died, albeit months after the initiation of one of the trials. According to a press release, Ziopharm maintains the intracranial hemorrhage death “is an isolated case” and the other patient deaths were unrelated, and attributed those outcomes to pre-existing illness, stating, “these patients are all, unfortunately, medically fragile.”
The problem with reporting adverse events, including deaths, to the FDA resides in a substantial loophole that awards discretion to the investigator to decide whether the adverse event is serious and whether it reasonably resulted from the gene therapy. Although the investigator theoretically stands in the best position to sort through the noise of the confounding variables of underlying illness or other drugs the subject may be taking, this nonetheless creates a troublesome reliance upon the corporation whose stock price and profitability are tenuously tied to clinical trial performance. This creates an undeniably powerful motivation to shift the blame of any adverse outcomes.
As Professor Osagie K. Obasogie has noted, profit motives remain entrenched in medical research, which can further complicate relationships where industry and medical care become intertwined. The arrangement between Ziopharm and MD Anderson Cancer Center exemplifies such enmeshment: Ziopharm and Intrexon executed a deal with MD Anderson to provide $100 million in stock, and recently appointed MD Anderson physician Dr. Laurence Cooper as Ziopharm’s newly minted CEO. Similarly, Science’s recent profile of competitor Dr. Carl June’s work at the University of Pennsylvania also flagged the potential conflict of interest arising from its partnership with Novartis to develop gene therapies for which June would hold a financial stake arising from related patents.
Despite assertions that these relationships will be managed according to institutional conflict of interest policies, such heavy financial ties heighten the stakes and necessarily raise concerns about independent judgment and transparency. The call to uphold ethical tenets of research is nothing new, particularly when there is a franticcompetition to bring an FDA-approved product to market. Back in 2007, Obasogie raised similar concerns after a patient death in a gene therapy trial for arthritis: “Time is money; in the rush to get products to market, patient safety can inadvertently take a backseat.”
These vulnerable patients have a stake, too. We must ask the right questions to see whether they appreciate the risks they decide to undertake. We must stop blindly accepting these dismissals of deaths and assurances that conflicts of interests are mitigated, especially when there is so much riding on clinical trials’ success.
Katherine Drabiak, JD is an Assistant Professor at USF Health in the College of the Public Health. You can follow her updates here: www.katherinedrabiakjd.com.
Posted by Jessica Cussins, Biopolitical Times guest contributor on August 3rd, 2016
Untitled DocumentPhilosopher Tina Rulli argues that three-person IVF is not a “life-saving therapy” or even a medical treatment at all. Rulli explains why the technology does not meet a plausible social value standard that would justify public research investment, and why other germline modification techniques may not either.
If you have seen any of the countless descriptions of three-parent or three-person IVF, also called mitochondrial replacement, as a “life-saving treatment,” you might find the question in the title confusing. How could any life-saving treatment not be of value?
As Rulli explains, the claim that this technology would save lives is “inaccurate and exaggerated.” Three-person IVF would not cure, treat, or save anyone. At best, it would allow women affected by a particular kind of mitochondrial disease to have an unaffected child who is mostly genetically related to her.
The experimental procedure works by genetically engineering an embryo to combine the intending mother’s nuclear DNA with another woman’s mitochondrial DNA. The choice a woman would make is not “do I save my child?” but “do I want to have a child in this way?” Rulli makes a strong argument that these are not morally equivalent, and that it is irresponsible to act as though they are.
How one thinks about this distinction between creating an unaffected genetically related child and saving lives may have implications well beyond three-person IVF. As Rulli points out, the creating-saving distinction probably holds for any form of germline genetic modification:
The argument here might provide a template for objections to other germline modifications or gene therapies that are valuable solely or primarily because they may enable prospective parents to have healthy genetically related children who would not otherwise exist.
For example, it would probably mean that the experiment carried out in April using CRISPR to introduce an HIV-resistant mutation into the DNA of embryos could also not be called a life-saving treatment, even if it worked well (it didn’t) and even if it was going to be used to generate a person with altered risk factors (it wasn’t).
Rulli further undermines the medical relevance of three-person IVF by pointing out that it isn’t the most effective way to reduce the transmission of mitochondrial disease. Only a small subset of mitochondrial disease could even hypothetically be addressed by this technology, since most cases involve mutations in nuclear DNA (instead of or in addition to mutations in mitochondrial DNA). And the procedure would only be accessible to women with far more financial resources than most have.
The alternative to three-person IVF – using an entire egg (rather than an egg that has had its nucleus removed) provided by another woman – would completely eliminate the risk of transmitting mitochondrial disease. In other words, the real value of the experimental procedure is not about health at all, but about the personal preference to have a genetic connection to one’s child. Rulli refers to this as “medicalization of a social preference” that works by “preserving the dominance of the bionormative family schema.”
Based on these points, Rulli asserts that three-person IVF lacks the social value that proponents have claimed for it, and that would be a necessary precondition of ethical clinical research, both in order to use limited health resources responsibly and to avoid human exploitation. She therefore concludes, despite the Institute of Medicine’s report endorsing the potential of “clinical trials,” that any public research investment in three-person IVF would be unethical.
Rulli reaches this conclusion even without addressing the multiple safety and efficacy concerns that have cropped up regarding three-person IVF. She takes it for granted that the technology will do what it says it will do. But she does note:
If the concerns about the safety of three-parent IVF for children and future generations are legitimate, then these considerations are not over-ridden by proponents’ claims about the great, life-saving potential of this technology. We know those claims to be fictional.
Throughout the push for legalization of these three-person IVF techniques, some advocates have painted any concern raised as anti-science or anti-technology. Rulli takes pains to point out that she is neither. Her argument is not against the technology per se, but whether to invest public resources in its development when the opportunity cost of that research includes, among other things, diminishing resources for investigating treatments for people suffering from mitochondrial diseases today.
Given the firestorm of attention to CRISPR, and the relative ease of genetically modifying an embryo versus an adult, we may well see arguments about germline gene editing as a “life-saving treatment.” Proponents are already pointing to three-person IVF as a pioneer technology that is paving the way for other forms of germline modification, so it is critical to set the record straight. Rulli’s report will be a useful framework to have on hand.