Recent Biopolitical News: Ethics, Guidelines, History, and Pure Fantasy

It’s been a busy couple of months in biopolitics, with developments in the US, UK, China, Japan, and implicitly on Mars. Time for a brief roundup. 

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Bioethics needs an update

The National Research Act is now 50 years old. It was signed into law on July 12, 1974, as a direct response to publicity about the 1932 “Tuskegee Study of Untreated Syphilis in the Negro Male.” The Hastings Bioethics Forum celebrated its anniversary with an article by Mark A. Rothstein and Leslie E. Wolf that accurately describes it as An Ethics Landmark in Need of an Update. The authors examine the Act’s history and the limitations of its “common morality principlism” approach, with some appropriate skepticism. 

The points they make are specific to regulation within the US, recognizing that the US is an outlier – “the only country to prohibit their research ethics review bodies from considering societal implications of research.” The quote they used is excerpted from a July 11 article in Science (usefully summarized in Medical Xpress), which proposes that bioethics, especially in the US, may need updating beyond the traditional emphasis on informed consent and individual rights:

The emerging field of translational bioethics maintains that the social, economic and psychological implications of pioneering health research – such as gene therapy, xenotransplants and artificial intelligence – should also be considered.

Whose genome is the human genome?

The turn-of-the-century Human Genome Project (HGP) also came under new ethical scrutiny in July, 24 years after the announcement of a "working draft" of the human genome sequence.  James Watson, the original head of the Project, had addressed ethical challenges by allocating 3% of its funding to Ethical, Legal, and Social Issues, but according to Lori Andrews, a member of the original ELSI committee, that was a canny diversionary move: Watson wanted the committee to “talk and talk and never get anything done.” Apparently, some of their most important recommendations were quietly ignored or overridden.

On July 9, Undark and STAT co-published an investigation of the Project that raised more than a few eyebrows. It runs almost 8,000 words; STAT also published five key takeaways. It focuses on a key early ethical decision: that the reference genome would be a mixture of DNA from many volunteers. The Project’s consent form included:

“If we use the blood you donate, we expect that no more than 10% of the eventual DNA sequence will have been obtained from your DNA.”

That is not what happened. The publicly funded Project came under time pressure, especially when its rival, Craig Venter’s privately funded Celera Genomics, seemed likely to finish first. So it dropped its commitment about the reference genome. In the end, Venter’s human genome sequence was mostly based on Venter’s own DNA, while the public Project’s sequence was almost 75% based on a single volunteer, code-named RP11. And 10% came from one of the scientists.

After 22 years, a key article is retracted

In mid-June, Nature retracted a paper on human stem cells originally published in 2002, more than two decades ago, which claimed to show how adult stem cells could be manipulated to mimic “most, if not all, somatic cell types.” The article has been cited 4,482 times, almost twice as often as the second-most cited retracted article. It had suggested not only a route to curing diseases but specifically that it would be unnecessary to use the controversial human embryonic stem cells, a very hot topic at the time, politically even more than scientifically. 

There had been questions about the paper for many years, and a correction was issued in 2007. Moreover, stem cell researcher Elisabeth Bik had reported further problems with images in it in 2019, and expressed surprise that the retraction had taken so long. The most telling criticism came from Peter Aldhous on July 2 this year; he and Eugenie Reich had discovered duplications of plots in the paper and published them in New Scientist in 2007–09. His latest article, over 1,000 words long, is paywalled and “the views expressed by the author or authors are not necessarily those of Scientific American”:

… The paper’s tortured history illustrates some fundamental problems in the way that research is conducted and reported to the public. Too much depends on getting flashy papers making bold claims into high-profile journals. Funding and media coverage follow in their wake. But often, dramatic findings are hard to repeat or just plain wrong. …

This focus on willful misconduct is itself a problem, in my view: it’s very hard to prove intent and assign blame. Junior scientists are often the ones who take the fall. More importantly, papers beset with errors borne from the haste to publish can be just as misleading as outright fraud. …

My profession of science journalism shares the blame, … selling a story of “breakthroughs” that frequently amount to little. … We should rethink the incentives that propelled this paper to prominence and then kept it circulating for so many years.

A call to retract racist “research” articles

On June 20, STAT published a major article with seven distinguished authors and a trenchant headline:

Journals that published Richard Lynn’s racist ‘research’ articles should retract them

For background on Lynn, see the SPLC, which describes him as an “unapologetic eugenicist” who has made “a high-profile and profitable career” out of his racism. STAT followed up with a podcast titled “Why is eugenics still alive and well in scientific publishing?”

SCOTUS undercuts policy and expertise

Publishing, while important, may be the least of our worries. On June 28, the US Supreme Court made one of the most consequential decisions of recent decades, overturning the 40-year-old legal precedent known as the “Chevron doctrine.” The New York Times reported:

Justices Limit Power of Federal Agencies, Imperiling an Array of Regulations

A foundational 1984 decision had required courts to defer to agencies’ reasonable interpretations of ambiguous statutes, underpinning regulations on health care, safety and the environment.

Michael Hiltzik wrote a blistering column in the Los Angeles Times, noting that the original Chevron ruling was seen as giving conservative policies protection from progressive judges, quite the opposite from how it has been interpreted lately. Justice Elena Kagan, in dissent (joined by Justices Sonia Sotomayor and Ketanji Brown Jackson) wrote:

In one fell swoop, the majority today gives itself exclusive power over every open issue – no matter how expertise-driven or policy-laden.

Further analysis can be found at the Yale School of the Environment where several experts discuss the potential impacts of the Supreme Court's decision. It is grim reading.

China’s new rules on CRISPR babies; He Jiankui redux; human embryo models

Guidelines and regulations do continue to be developed around the world. In a classic case of slamming the barn door long after the bull had escaped, China’s Ministry of Science and Technology published ethical guidelines to regulate human genome editing research, which drew some token approval. 

The bull himself – the notorious “CRISPR-baby” scientist – made a brief and unenlightening appearance at a subscriber-only roundtable presented by MIT Technology Review, “CRISPR Babies: Six years later.” He Jiankui hasn’t changed a bit; he remains both unrepentant and perniciously optimistic.

In the UK, Cambridge Reproduction and PET (the Progress Educational Trust) published a Code of Practice for the Generation and Use of Human Stem Cell-Based Embryo Models. The guidelines do prohibit any human embryo models from being developed into a viable organism in a womb or in the lab, but enforcement relies on “funding and opprobrium from their peers.” That is less than fully reassuring.

Musk’s struggles with ethics

Finally, no roundup of biopolitical news would be complete without including the world’s most newsworthy human – or at least he seems to think so. Yes, Elon Musk. The New York Times reported on July 11 that Musk has volunteered his sperm to help seed a human colony on Mars, where he expects civilization to be secured “for sure” by 2054. [The Times later added that Musk has denied volunteering his sperm.]*

Here on Earth, eight former employees are suing Musk for wrongful termination after they called his public behavior “a frequent source of distraction and embarrassment.” 

Musk did seek and receive permission from the FDA to implant his Neuralink device into a second human, but had to call it off because the patient had “additional medical issues.” Doubts have been expressed concerning his attitude to conventional ethics.

*This post has been updated to include Musk’s denial.