FDA scott gottlieb

How Scott Gottlieb is Wrong on the Gene Edited Baby Debacle

I am a huge fan of FDA Commissioner Scott Gottlieb.

He is by far my favorite Trump appointee — though the competition isn’t tough, to be honest— and he is doing great things at FDA on issues such as mobile health, software, and so on.

But in his comments on the news that gene edited embryos in China had led to live births, I think he has it wrong.

“The response from the scientific community has been far too slow and far too tepid, and the credibility of the community to self-police has already been damaged,” he said to Biocentury. “Governments will now have to react, and that reaction may have to take consideration of the fact that the scientific community failed to convincingly assert, in this case, that certain conduct must simply be judged as over the line.”

Gottlieb is, in this case, mistaken and misguided.

For one thing, Gottlieb’s own agency has a strong policy on gene editing in place already, and there is no need for the U.S. to “react.”

As Eli Y. Adashi and I discussed in Science back in August 2016, because of language in a rider in the Consolidated Appropriation Act of 2016, which has now been repeated in subsequent years, “none of the funds made available… [to the FDA] may be used to review or approve an application for an exemption for investigational use of a drug or biological product… in which a human embryo is intentionally created or modified to include a heritable genetic modification .”

In other words, one cannot make use of the “investigational use” exception of the Food Drug and Cosmetic Act for gene editing embryos, and any researchers who attempt to do so without explicit permission from the FDA would be acting in violation of the statute.

[Side note: Much of the reporting has discussed how gene editing is “illegal” in the U.S. The way this is phrased may suggest a straightforward criminal law idea, and not this more complicated interplay between agency rules and exceptions.]

Now, there are many reasons to think this blanket approach may not be the way to go, and that we should have a more thought-out and deliberative process, such as the UK has for Mitochondrial Replacement Techniques and other germline editing technologies (as we have argued).

Whether you like it or not, the U.S. is a place where the government has already reacted (in advance!), Gottlieb’s own agency is the one that has done it, and I am not sure what else is warranted here.

I am willing to give Gottlieb the benefit of the doubt — maybe Biocentury’s representation of the quote lost some of the context in this case.

Where I disagree with him most strongly is another quote: “The response from the scientific community has been far too slow and far too tepid, and the credibility of the community to self-police has already been damaged.”

This confuses what scientific “governance” and “self-policing” mean, in contrast to what government “governance” and “self-policing” mean.

As soon as the facts have come to light, we have seen Dr. He Jiankui attacked (albeit with a minority of defenders) by his peers as unethical, his work scrutinized, his affiliations rescinded. This is what scientific governance and self-policing looks like. There is no real “science police” — the scientific community does not have the coercive power of the state to put people in shackles and cart them off.

I fail to see how the “scientific community,” as some large brooding omnipresence, could have done more to deter what looks like a rogue actor, working off the grid and out of the mainstream, shrouded in secrecy.

Now, the emerging details of the approval and informed consent process in He’s experiments are troubling, but they suggest a disregard for violating an established regulatory structure, not a complicit scientific community.

As Christina Larson notes in the original AP story:

For his CRISPR work, He did not seek prior approval from federal regulators. He listed his study in an online registry of Chinese clinical trials on Nov. 8 — long after it began.

His lab skirted norms that many of his Chinese peers uphold.

For example, the lab did not inform all the medical staff directly assisting the expectant couples that the study involved gene editing. They believed they were assisting in standard IVF attempts, with an additional step of mapping the genomes, not manipulating the embryo, according to one of the embryologists involved in the research, Qin Jinzhou.

Patient consent forms referred to the study imprecisely as an “AIDS vaccine development” program.

Maybe we will learn that Chinese research ethics regulations are not enforced strongly enough, or that there were warning signs that were missed.

Fine.

But, it is incredibly difficult to say this is a failure of the “scientific community,” or a widespread indictment of its “self-policing,” when it seems to me that the community is acting exactly as it should when one of its members breaks the covenant.

I. Glenn Cohen

I. Glenn Cohen

I. Glenn Cohen is the James A. Attwood and Leslie Williams Professor of Law at Harvard Law School and current Faculty Director of the Petrie-Flom Center. A member of the inaugural cohort of Petrie-Flom Academic Fellows, Glenn was appointed to the Harvard Law School faculty in 2008. Glenn is one of the world's leading experts on the intersection of bioethics (sometimes also called "medical ethics") and the law, as well as health law. He also teaches civil procedure. From Seoul to Krakow to Vancouver, Glenn has spoken at legal, medical, and industry conferences around the world and his work has appeared in or been covered on PBS, NPR, ABC, CNN, MSNBC, Mother Jones, the New York Times, the New Republic, the Boston Globe, and several other media venues. He was the youngest professor on the faculty at Harvard Law School (tenured or untenured) both when he joined the faculty in 2008 (at age 29) and when he was tenured as a full professor in 2013 (at age 34).

2 thoughts to “How Scott Gottlieb is Wrong on the Gene Edited Baby Debacle”

  1. Really good blog, Glenn. I suspect this episode, which is reminiscent of Martin Cline’s premature, shoddy, and secretive attempt at gene therapy in the early 1980s (which Cline continued to defend, albeit unpersuasively, in Rep. Gore’s 1982 House hearing). NIH’s investigation of Cline was not terribly thorough, but it did result in rescinding some grants and putting Cline on grant probation for several years. And I expect China, given its humiliation, will likely react strongly to He’s work. The analogy He used was to Steptoe and Edwards, which is not entirely wrong, but will have a very different outcome here. Steptoe and Edwards actually had to work for several years before the Brown pregnancy, and the controversy was not entirely after the event, but they were defending their work before the first pregnancy. The closer analogy is to Martin Cline, who made an obvious play to be “first,” just as He’s work appears to be.

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