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Biopolitical News Highlights of 2017
What might have been the story of the year turned out to be a disappointment. On February 14th, the National Academies delivered a valentine to those who want to commit germline gene editing. Its much anticipated report, Human Genome Editing: Science, Ethics, and Governance concluded that scientists should “proceed with caution.” This was the first time that human germline modification has ever been given a green light by a comparable body – the U.S. National Academies is an influential non-governmental organization, funded mostly by the federal government through contracts and grants from agencies. The move represents a radical departure from a long-standing international consensus that human germline modification should remain off limits.
Given the current scientific and political realities in the U.S. and globally, as well as public opinion and the standing policy of the National Institutes of Health, the debate is far from over. There is no clear consensus among scientists, biotech industry figures, bioethicists, or other scholars – and certainly no agreement among ordinary people. Meaningful public and civil society discussion remains an urgent priority.
Meanwhile the Trump administration showed little interest in biotechnology beyond attempting to reduce regulations. The White House has been slow to appoint scientific advisors, and seems more interested in headline-grabbing talk of Mars exploration than in the details of policy.
The Center for Genetics and Society (CGS) continues to monitor these and related developments, and attempts to encourage their responsible use and effective societal governance. Here is a brief overview of some of the most important biopolitical developments of 2017, roughly grouped by topic.
Germline and Gene Editing
As noted above, the National Academies issued a deeply problematic report on human germline gene engineering, which recommended proceeding carefully. In contrast, the German Ethics Council called for “global political debate and international regulation,” specifically asking the German government to raise the issue at the United Nations. The Parliamentary Assembly of the Council of Europe also adopted a recommendation to the Council of Ministers that included urging Member States that have not done so to ratify the Oviedo Convention without further delay, or to put in place a national ban on germline editing for reproduction. The 20th anniversary of the Oviedo Convention (the European Convention on Human Rights and Biomedicine) included debate on the germline ban in the Convention, and demonstrated continued strong support in Europe for such a ban.
CRISPR continued to fascinate both scientists and journalists, perhaps even the public in general. A Chinese team edited “normal” human embryos with greater success than last year’s experiment, but noted that technical obstacles remain before any move to clinical use could be reasonably considered. In the U.S., Shoukhrat Mitalipov claimed a surprising result in editing embryos. He also stressed that his technique was not ready for the clinic, though he remains unabashedly eager to use gene editing for reproduction. In London, Kathy Niakan used CRISPR to investigate early human development, stressing that this work was strictly for basic research; as such, the work actually bolsters the case for prohibiting germline interventions for human reproduction.
The patent battle over CRISPR continues. The Broad Institute won a victory in the U.S., but lost in Europe; the feud seems likely to continue, perhaps until scientific advances make the patents irrelevant.
A baby girl was born in Kiev, Ukraine, after pronuclear transfer, better known as 3-person IVF (or mitochondrial replacement or nuclear genome transfer). That is the second such baby, and the fertility doctor who carried out the first apparently successful experiment last year in Mexico (widely critiqued after he finally published a paper on it) would like to commercialize the process as a “cure for infertility.” The FDA stepped in to prevent this, but the issue is likely to appear again.
Meanwhile, biohackers achieved new notoriety with do-it-yourself genetic engineering. One injected himself, in public, with a needle “containing CRISPR-Cas9 and a gene to promote muscle growth.” (“I’ll let you know how it turns out,” he said.) The FDA does not approve.
For the first time, the FDA approved a gene therapy for use in the U.S. It is likely, however, to be beyond the reach of the vast majority, with a base price of $475,000 just for the drug, and a total cost that could easily reach $1,500,000. Indeed, the first such product approved, in Europe, has been pulled from the market for lack of demand, no doubt partly because of its million-dollar price tag.
The second U.S. approval is not far behind, and we may see another 20 or so in the near future.
Sangamo Therapeutics announced clinical trials of in vivo human gene editing; Sangamo uses zinc finger nucleases, not CRISPR technology, and the company has been a vocal opponent of germline modification. The first clinical trial for a CRISPR-based approach, involving the stem cells that make red blood cells, is expected early in 2018.
Generally, gene therapy seems to be showing more technical promise than it has in years. Whether it will be available at a price that health systems, insurers, or individuals can pay remains an open question.
Congressman Trent Franks immediately resigned from office following allegations of asking at least one of his employees to become a surrogate (without using IVF) in exchange for $5 million. The sum is astounding, and the front-page news highlighted surrogacy as an issue.
Regulating surrogacy was a major issue around the world this year, though mostly left unresolved. New laws and regulations were considered in many countries. The approaches varied considerably. Russia, Turkey and Cambodia began to consider banning surrogacy outright; India looked to encourage compensation for surrogates, based on economic empowerment for women, while prohibiting access for single people and gay couples. A court in France, by contrast, ruled that both members of a gay couple could legally adopt a baby born to a surrogate.
Australian courts wrestled with issues involving children born overseas, who might be legally stateless. Canada has begun a process to update its federal regulations; Canadian feminists, with support from counterparts in the U.S. including CGS, are raising important points. Ireland and Ghana began to create child protection laws covering surrogacy and adoption. Meanwhile, Ukraine became a major source for reproductive tourism generally.
Despite its regulation of the surrogacy industry, California continues to be confronted with cases of arrangements gone wrong, including several this year. Under the suspicion of abandonment and neglect, a surrogate from California is fighting for custody of triplets whom she carried for a man in Georgia. In another case, a gestational surrogate carried two babies – one that was from the transferred embryo of the intended couple, while the other was her own biological child. She continues to find support to get her son back. California also wrapped up a three-year investigation of bribery and fraud by the founder of California surrogacy agency Planet Hospital, Rudy Rupak, who was sentenced to two years in jail, plus a fine and restitution to his clients.
Overall, the television adaptation of The Handmaid’s Tale looks more appallingly prescient by the month.
Embryo selection was increasingly discussed as an ethical issue, in the U.S. and in China, among others. Iceland has come fairly close to eliminating Down syndrome, and termination rates after Down syndrome is diagnosed through prenatal tests seem to be rising generally.
The risks for women who supply eggs for other people’s fertility treatments continue to be discussed, without much effect. But calls may be mounting for a national registry to monitor long-term effects of egg retrieval, a move that CGS and many allies have been promoting for many years. Meanwhile, the egg freezing business keeps expanding, in spite of continuing criticisms that the procedure is a problematic techno-fix for a social problem. It has been bolstered this year by more tech companies offering egg freezing as a benefit in an attempt to address Silicon Valley’s dismal retention rates for women, and by egg freezing start-ups targeting younger women with misleadingly carefree marketing that omits mention of egg retrieval’s risks.
Finally, a baby was born in Dallas to a woman who had had a uterus transplant. This is the first case in the U.S., though at least eight have been born in Sweden. In future the cost is likely to be similar to a kidney transplant, perhaps $250,000.
In California, there are increasing calls for compensation to be paid to victims of sterilization, with CGS Advisory Board member Alexandra Minna Stern playing a key role. In Tennessee, a judge in 2017 offered reduced sentences to prisoners willing to undergo a vasectomy or contraceptive implant; this was justified as “voluntary” and more plausibly criticized as eugenics.
The growing influence of neo-Nazis and their fellow-travelers on national politics is of particular concern to the disability community. Concern is well founded: The President himself keeps boasting about his own “great genes.”
The California Institute for Regenerative Medicine (CIRM) was founded to promote stem cell research, back when it was touted as an imminent medical panacea. That was in 2004, as a result of Proposition 71, which allocated $3 billion, plus as much again in interest, paid by state taxpayers. Now CIRM is beginning to run out of money. In the short term, they are looking for a quick fix of $222 million in private funds, which would almost double its cash on hand. But Robert Klein, who was behind the original proposition, has been widely reported to favor a new one, perhaps even in 2018. CIRM is due to discuss this proposition on December 14.
Stem cell scams, however, continue, with hundreds of clinics in the U.S. and hundreds more elsewhere offering unproven and in some cases dangerous treatments. The good news is that the FDA and some state governments are beginning to take action. California passed a useful if inadequate law, North Dakota is investigating at least one clinic, and even in Texas there are rumblings of complaint. Australia is also looking to increase oversight. The less optimistic view is that the FDA will pay lip service to regulation and stick to sending a few letters of guidance.
Gene Drive and Synthetic Biology
Gene drive, the much-touted techno-fix to the problem of invasive species, is not ready for use, and not close – this according to its principal booster, Kevin Esvelt, who called it “an embarrassing mistake.” Simultaneously, however, he co-wrote a piece in PLoS titled, “Conservation demands safe gene drive.” So, don’t relax yet. And specific proposals keep appearing.
Synthetic biology continued on its merry way, assisted in part by funding from the Defense Advanced Research Projects Agency (DARPA, an agency of the United States Department of Defense). Some of this funding was for gene drive, as revealed after Edward Hammond / Third World Network made a request under the Freedom of Information Act and published 1200 files, which also reveal a major industry lobbying effort to influence international policy. The revelations were themselves controversial, with some critics egregiously comparing the FOIA request to illegal hacking.
Scientists at Scripps succeeded in producing a “Semi-Synthetic Organism that Stores and Retrieves Unnatural Information.” They designed a bacterium with six DNA bases – not just A, C, G, and T but also X and Y. And these bases successfully produced a new protein. Ultimately, they hope to use this technique for medical purposes; they are funded by NIH.
A more immediate question involves the use of synthetic biology techniques, and indeed gene editing with CRISPR, for agricultural purposes. There is an attempt to avoid regulation by distinguishing GMOs (which many people distrust) from “genetically edited foods.”
We cannot leave the topic of synthetic biology without mentioning the failure of the glowing plant initiative. The company raised lots of money, but the plants just did not glow. Now they are working on a patchouli-scented moss.
Direct-to-Consumer and Forensic Genetic Testing
Watch for gene tests under the Christmas tree! The industry is stirring again.
23andMe, the most prominent company in the field, was severely hampered when the FDA issued a strong warning letter back in 2013; but early in 2017, the current administration’s regulators agreed to allow some predictive tests to move forward again. The move was criticized for a number of reasons, including that many consumers remain unaware of the company’s aim of reselling data for research. This business model was again confirmed when 23andMe raised $250 million to finance expansion.
In November the FDA moved to drastically simplify the approval process for direct-to-consumer gene tests. If the proposed regulations are approved, from now on the company rather than the specific product will need approval. Subsequent products – tests for other conditions – would move through the pipeline automatically.
Concerns about DTC gene tests have risen to the U.S. Congress, where Senator Schumer has raised questions, especially about privacy. Yet the industry seems set to grow, despite scientific criticisms, and new players are entering the scene. Some customers do get disappointed, including white nationalists who discover that their ancestry includes (wait for it) African genes. They seem to think there is something wrong with the technology.
Abuse of forensic DNA testing has been revealed in many locations. Attorney General Sessions, however, has reduced oversight, then re-launched it, appointing a former prosecutor with a history of opposing stricter standards to head the in-house team. This does not bode well, perhaps especially for immigrants.
Prediction is very difficult, especially about the future, as Nobelist Niels Bohr probably said. So let us simply hope for massive and meaningful public and civil society involvement on the major issues of our time. Specifically, from the CGS point of view, for effective regulation of valuable human biotechnologies and a refusal to move in socially dangerous directions.
Also, expect to be surprised!
Image via Pixabay