An overlooked lesson from Glantz harassment and fraud cases: tobacco is way out of FDA’s skill-set

by Carl V Phillips

I have written repeatedly about how FDA is totally outside their comfort zone and skill-set in dealing with tobacco products. The most obvious example might be them trying to deal with data from e-cigarette manufacturers, which caused their computer systems to melt down multiple times. I would guess it is a bigger database than every other database they have, combined, and is still growing. Similarly, their comically quaint attitude toward illicit markets, apparently genuinely thinking that the huge illicit market they would create by banning e-cigarettes or most e-liquid flavors, or removing the nicotine from cigarettes, will be as easy to handle as the tiny markets they deal with (not really very effectively) in counterfeit drugs and raw cheese. But the Glantz affair (see this post and what it links back to) brings up a more subtle problem.

FDA is used to dealing with criminals in the iron triangle they share with pharma and other big businesses. But it is the genteel world of halls-of-power crime.  People in that world clean up their own messes, cover up, and pay hush money and fines when necessary, and always create plausible deniability. But the tobacco portfolio puts FDA in bed with tobacco control, who are more like the Sopranos: They also get away with what they are doing, but not because create an image of respectability that deflects allegations. Their behavior is obvious for all to see, but they use intimidation, omerta, and corruption of those who should be policing to let them to get away with it.

This is not FDA’s preferred kind of crime. It puts them in a position for which they are not prepared.

A new BuzzFeed article by Stephanie M. Lee claims that FDA has no policy in place for dealing with sexual harassment charges against extramural researchers. Since this is a direct quote from an FDA spox, I suspect it is probably accurate, even though so much of the rest of Lee’s article is naive or out-and-out wrong.

(My personal favorite is when she credits Retraction Watch with breaking the story of the Glantz settlement in an article that came out… a mere week after I published my much deeper and more accurate analysis of the settlement. And I read at least three other stories about it in between those. My seven-year-old also sometimes does that too — thinking that whoever he first heard about something from is the one who discovered it — so I guess he is ready to write for BuzzFeed. I am still ok giving her a link, though, because she gets legacy credit for originally publicizing the story last year.)

More interesting is Lee’s naivety that probably generalizes to other observers, that FDA’s lack of a policy should be seen as nothing deeper than an outgrowth of NIH’s less-than-muscular response to situations like this. A key bit of background here (which Lee and most others may not realize) is that because doing grants is outside of FDA’s comfort zone, they were officially outsourced to NIH and thus are subject to NIH rules. NIH recently put a stronger policy in place and put out an article that at least says all the right stuff about #MeToo. It is not difficult to connect the dots here: It would not be surprising if UCSF raced to get this case against Glantz settled without an admission of guilt because of NIH’s new positions. (As I noted in my analysis of the settlement, the plaintiff got rolled into agreeing to get almost nothing, perhaps because her lawyer decided she would not be convincing on the stand.) The alleged acts of sexual harassment are actually a minor part of what Glantz is accused of in that and another suit, but they are what pop press readers understand.

But today’s point is how FDA itself has no institutional capacity for dealing with such matters. NIH is not exactly good at dealing with these issues, but at least they have experience creating subsidiary shops at universities and thus with all the potential complications this creates. It seems safe to assume that there is plenty of harassment in the companies FDA works for …er, regulates, to say nothing of scientific fraud, but they cover their own messes and FDA can pretend it does not exist. They cannot ignore what happens in their subsidiary shops, and have no idea how to deal with it.

Lacking institutional capacity, and given that the Commissioner is a stuffed shirt, FDA’s response to this matter will probably default to the Center for Tobacco Products leadership. That is, it will default to career tobacco controllers. Chances are they will do what they usually do about fraud and other misdeeds: pretend they do not exist. Oh, but oops, tobacco controllers are also out of their element here too: Normally nobody looks closely at their misdeeds and they can bedazzle the press with faux-science. But a government-funded sexual harasser (to look at this case with the inaccurate simplicity of the pop press) gets traction.

It could be hard for both FDA and tobacco controllers to ignore if it is a recurring tangent in everything anyone writes about FDA for a while. They will have no clue how to deal with it. It will be amusing to watch.