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.