Biopolitical News of 2018

The biggest biopolitical news of the year was also the most significant, as is not always the case. Despite the perpetrator’s hype, it was also apparently a failure.

The big shock was the revelation on the eve of the Second International Summit on Human Genome Editing that the Chinese researcher He Jiankui had already (probably) “created CRISPR babies” – although the Summit was supposedly convened to discuss whether, when, how, and why scientists might make inheritable alterations in the human genome. In retrospect, the news should perhaps have not been so surprising: There were harbingers of it throughout the year, in human gene editing and also in several related fields of activity. And a number of US and UK scientists and bioethicists had heard intimations from He Jiankui that it was coming.

The Center for Genetics and Society, which advocates for keeping human germline modification legally off limits, continues to work to raise public awareness, inform policy debates, and ensure that a wide range of public interest perspectives shape the way human assisted reproduction and biotechnologies develop. Here is a brief overview of some of the most important developments of 2018, roughly grouped by topic.

• Human Germline Gene Editing
• Eugenics and Race 
• Assisted Reproduction, Etc.
• Genetic Testing and Forensics
• Stem Cells and Business
• Other Technologies

HUMAN GERMLINE GENE EDITING

Calls for public dialogues about gene-editing technologies were the most constant leitmotif of the year, though opinions differed about what that means. Marcy Darnovsky, Leah Lowthorp, and Katie Hasson, all of CGS, emphasized in February that reproductive gene editing imperils universal human rights and called for both discussion and formal prohibitions.

Meanwhile, the UK Royal Society had been conducting an investigation into human applications of gene editing. They interpreted their survey as indicating that the UK public was “cautiously optimistic about genetic technologies.” However, they also conducted focus groups that were less enthusiastic.

Sheila Jasanoff and J. Benjamin Hurlbut called in Nature for a global observatory for gene editing, to consider “what questions should be asked, whose views must be heard, what imbalances of power should be made visible, and what diversity of views exist globally.” Simon Burall simultaneously but separately called for “a new architecture for democratic debate.” Also in March, a mostly European gathering of scientists launched the Association for Responsible Research and Innovation in Genome Editing (ARRIGE) to promote global governance on behalf of all stakeholders.

In July, the Nuffield Council on Bioethics, an advisory body partly funded by the UK government, raised the stakes with a report on “Genome editing and human reproduction: social and ethical issues” that essentially green-lighted germline intervention. As Marcy Darnovsky wrote, it “has given its blessing to an unneeded and societally dangerous biotechnology.”

Meanwhile a Pew survey showed that “Americans are more likely to anticipate negative than positive effects from widespread use of gene-editing technology,” and consider that testing on human embryos would be taking technology too far. Like many other samplings of public opinion, this survey did not offer pre-implantation genetic diagnosis as an alternative to gene editing of embryos, a pattern that casts considerable doubt on other surveys that find public support for using germline modification to prevent transmission of disease. Chinese researchers, however, went right ahead and did base editing in viable embryos, and Shoukhrat Mitalipov, of Oregon Health Sciences University in Portland, continued to defend his work in the same area. Next up was gene editing of embryonic mice in the womb.

So the Second International Summit on Human Genome Editing, held in Hong Kong on November 27–29, seemed to be well timed and well placed for a thorough discussion of the issues around human germline gene editing. But on the 26th, the news broke that Dr. He Jiankui had tried to edit babies to make them resistant to HIV, and two baby girls had been born. Shortly thereafter, based largely on testimony presented by He, it became clear that the experiment had failed on its own terms; even when the targeted gene was altered it was apparently accompanied by unwanted edits. No peer-reviewed publication has yet appeared, though some American scientists had already seen at least some data before the news broke.

The Scandal and the Summit, in Biopolitical Times, describes reactions to the announcement. The most troublesome came from scientists, including several influential ones, who worried that “the startling claim will lead to knee-jerk regulations and damage the public’s trust in gene editing.” The concluding statement by the Organizing Committee of the Summit tut-tutted over He’s irresponsible procedure, but focused on establishing a “translational pathway to germline editing.”

This view was opposed by many scientists, bioethicists, public interest advocates, and others. It is also contrary to the prohibition on germline intervention enacted as law by some 40 countries, and detailed in the Oviedo Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine. 

Human Genetics Alert and the Center for Genetics and Society organized a statement signed by 136 individuals and 13 organizations (which a participant read to the Summit in the Q&A that followed their closing statement) expressing “dismay and outrage” and calling for “enforceable moratoria prohibiting reproductive experiments with human genetic engineering.” Human Genetics Alert launched a new campaigning organization in the UK: Stop designer babies!

Critical reactions were also quickly penned by a number of those who have long followed the issue, including Françoise Baylis in Impact Ethics and J. Benjamin Hurlbut, Sheila Jasanoff and Krishanu Saha in the Washington Post. Baylis, one of those who have provided particularly incisive commentary over the last couple of years, followed up quickly with Landon J. Getz and Graham Dellaire in The Conversation and later in Bioethics Forum. Sheldon Krimsky in Nature Biotechnology [paywall] identified “Ten ways in which He Jiankui violated ethics.” Hurlbut in Nature rightly and eloquently insisted that the proper question to consider is “whether, not how.”

While it is clear that many scientists are cautious, skeptical, or outright opposed to proceeding with human germline modification, how many will be willing to go public with their views remains to be seen. Pressure from famous figures in the field is a strong force. There is certainly a lot of work to be done, and soon.

EUGENICS AND RACE

Eugenic attitudes were explicitly and usefully discussed throughout the year, which got off to a good start with a discursive and positive review in Nature by historian Nathaniel Comfort of Social by Nature: The Promise and Peril of Sociogenomics by sociologist Catherine Bliss. 

David Reich provoked a brief but major controversy in the spring with an article in the New York Times Sunday Review titled “How Genetics Is Changing Our Understanding of ‘Race’.” A professor of genetics at Harvard, he was promoting his new book Who We Are and How We Got Here: Ancient DNA and the New Science of the Human Past. His science was fine, naturally, but his understanding of ‘race’ was “seriously flawed,” as a substantive rebuttal signed by 67 experts explained. (Signatories included people associated with CGS – Marcy Darnovsky, Osagie Obasogie, Dorothy Roberts – and many close allies.) Several letters to the Times (including one co-written by Darnovsky) also took Reich to task, but there was one ironic exception: Former staff writer for the Times Science section Nicholas Wade, whose book Reich specifically criticized, wrote to say how much he appreciated Reich’s defense of the concept that there are indeed genetic differences between human races.

There were also attempts at atonement for past governmental eugenic practices. In Japan, one woman sued the government for redress for her 1972 involuntary sterilization under the “Eugenic Protection Law” that was in force until 1996. Lawyers set up hotlines in five cities to encourage other victims to come forward. Similar efforts are being made in Peru, where forcible sterilization was widespread in the 1990s in poor and indigenous communities; the number of victims is unclear but certainly reached many tens of thousands. In California, a bill to compensate survivors of twentieth-century state-sponsored eugenic sterilization was introduced and unanimously approved by the state Senate, but eventually stalled in the Assembly Appropriations Committee. There was a lot of support for the bill, which may be reintroduced this year.

There were also a number of less encouraging episodes. The Silicon Valley city of Mountain View formally commemorated the Shockley Semiconductor Laboratory, avoiding talk of Shockley’s racist history. The University of Arizona was revealed to have been accepting, at least until very recently, grant money from the Pioneer Fund, which was founded in the service of “race betterment.” 

University College London, however, chose to re-examine its past links to eugenics and students there are campaigning to remove Francis Galton’s name from a lecture theatre and a laboratory. PBS produced a documentary and website about the 20th-century eugenics movement in the US, which is a valuable, if flawed, resource. And some enterprising San Francisco high school students completed a project to document on two websites the history of eugenics and California’s important part in it.

ASSISTED REPRODUCTION, ETC.

In the UK, the Human Fertilisation and Embryology Authority (HFEA) confirmed in February that they had given permission in 2017 for researchers to create two “three-parent babies” by nuclear genome transfer to avoid mtDNA disorders; there still has been no announcement of success or failure. In Ukraine, one clinic was already selling this procedure for infertility (no mitochondrial disease involved), as was John Zhang in New York, who had earlier flouted US law by going to Mexico to use the risky experimental technique.

Ukraine is also a growing center for commercial surrogacy for the international market, and is notorious for “scams and shoddy practices.” Business is also both booming and problematic in China, Cambodia, and elsewhere; Canada has been considering legalizing payment above expenses for surrogacy, though there is significant opposition.

Armenia is now another country with “missing women” due to sex selection. In the US, the infamous fertility clinic entrepreneur Jeffrey Steinberg continues to sell sex selection, and has again being talking about selling choices of hair, eye and skin color and maybe other traits. Some in the assisted reproduction industry, which is already facing questions about health risks and unnecessary procedures, are clearly hoping to be the commercial purveyor of modern eugenics.

GENETIC TESTING AND FORENSICS

A shocking new way to use DNA samples in forensics emerged in 2018: instead of searching databases maintained by police departments and the FBI, police investigators used public databases that were mostly set up to enable people to find ancestors and relatives. The “Golden State Killer,” who was wanted for 12 murders and at least 51 rapes committed between 1974 and 1986, was apparently caught (the suspect awaits trial) because a DNA sample from one of the old crime scenes was similar to the DNA of a close relative that was included in a public genealogy website. Amid much relief at the long-delayed apprehension of a serial murderer and rapist, there were widespread ethical concerns; indeed, the first suspect tested in the investigation was innocent. 

The Center for Genetics and Society and the Equal Justice Society, represented by the Electronic Frontier Foundation (EFF) and the Law Office of Michael T. Risher, sued the State of California for retaining the DNA of innocent people, after the State Supreme Court upheld mandatory DNA collection from arrestees. The editorial board of the San Francisco Chronicle immediately supported the suit, which was filed in December.

In a development that is supposed to be unrelated, the National Institutes of Health (NIH) launched the All of Us Research Program, to gather massive amounts of data at enormous expense from, eventually, a million people. Privacy is of course an issue, though NIH insists that personal data will be protected. Dubai went further, unveiling plans to sequence the DNA of its entire population.

Senator Elizabeth Warren stirred up a different, but related, controversy by taking and publicizing a DNA test to “prove” her claims of Cherokee ancestry, much to the righteous annoyance of many Native Americans. Suspicions about other possible abuses of genetic databases have started to grow. By the end of the year, there were calls for a “Genetic Data Protection Act.”

Meanwhile, the Food and Drug Administration (FDA) is gradually loosening the legal limits it placed on, specifically, 23andMe. Many direct-to-consumer companies are pouring money into advertising, and the industry as a whole seems still to be growing, despite widespread comments that their tests don’t work very well and perhaps never will. Consumer sale of full-genome sequencing is on the way, using Blockchain technology. Finally, as MIT Technology Review said, “DNA tests for IQ are coming, but it might not be smart to take one.” 


STEM CELLS AND BUSINESS

The FDA began to move against some of the hundreds of dubious stem-cell clinics in the US, and not a moment too soon. A further crackdown this year is likely to follow the warning letters already sent.

The California Institute for Regenerative Medicine (CIRM) is running out of money. Apparently Robert Klein, the man behind 2004’s Proposition 71 that financed the agency, is planning to gather signatures for a 2020 proposition that will ask the California public to pony up an even larger investment than the $3 billion already provided (actually, something like $6 billion when the financial costs of the bond sales are included). The San Francisco Chronicle is among those who are skeptical; it editorialized that “The results to date don’t argue for expanded public spending.”

Biotech stocks slumped late in the year, along with others, but that followed a run of successful public offerings. There were also suggestions that gene therapy as currently envisaged is not a viable business model.

The fight over CRISPR patents ended with victory for the Broad Institute over the University of California at Berkeley. How much difference this makes is unclear, but a good bet is, not much. The Nobel, if that happens, would be a much bigger deal.


OTHER TECHNOLOGIES

Dog cloning made a comeback, and apparently is becoming a fad in China. Monkey cloning may be more significant for future research on humans, and the gene editing of monkeys with brain disorders and fetal mice even more so. Reports of disturbing side effects in gene-edited animals – extra vertebrae, enlarged tongues, and the like – could also be very important for the prospect of human applications. So, presumably, could Neanderthal “minibrains” grown in a dish.

The European Court of Justice ruled that gene-edited crops are genetically modified, thus blocking an end-run against regulation. The regulation of gene drives has become an urgent question. Some scholars have proposed using patents to regulate gene editing, for a variety of applications including in humans.

The Defense Advanced Research Projects Agency (DARPA) is working on genetically modified viruses that could be a breach of the Biological Weapons Convention, but no one seems surprised.
Finally, pet genetic testing companies are making promises they can’t keep. Well, why should they be different?