The last time I worked directly for a pharmaceutical company was over a decade ago. I have, since, worked indirectly: I’ve been involved in pharmacokinetic trials and proof of concept trials using established or older medications. However, I had the audit peopel from Cochrane query if I was biased recently.
Most researchers in medicine have a relationship with Pharma. The big therapeutic trials are run by Pharma. Those who are not are bureaucrats, medical officers of health or medical journalists.
And they have run our health system and FDA. This may change, and the protests are in the NEJM.
Gottlieb has been enmeshed in highly remunerative relationships with the biopharmaceutical industry, including sitting on various corporate boards. As FDA deputy commissioner, he repeatedly had to recuse himself from decisions involving companies from which he’d received payments.4 This conflict-of-interest list has only grown in the past decade. Although the most recent commissioner, Robert Califf, was also scrutinized for possible conflicts, his industry ties were research-based, growing out of his expertise in academic cardiology and clinical trials management. Gottlieb seems unlikely to have earned his corporate-board perches with scientific expertise.
Gottlieb’s background places the agency, and the public, in a difficult position. Controversy has occasionally arisen over commissioners’ actions — for example, Mark McClellan’s rejection of his staff’s recommendation to allow over-the-counter access to the emergency contraceptive Plan B, or David Kessler’s spearheading of efforts to regulate tobacco products as nicotine-delivery devices. Yet past commissioners all brought to the position scientific or public credibility and dedication to the agency’s core mission.
FDA commissioners rarely enter directly into deliberations about approving a drug or device. But until now, when the FDA has put its imprimatur on a product, physicians, patients, and investors knew that an agency led by an official with scientific expertise and managerial experience had scrutinized and validated those claims. That representative was never someone whose career had depended on investing in drugs without studying them scientifically.
It seemed clear from Trump’s short list for commissioner that the primary qualification was not scientific acumen, public health credentials, or a successful career in biopharmaceutical science and innovation, but rather an ideological commitment to creating a “free marketplace” of therapeutics.1 But by ensuring our safety and the effectiveness of treatments, the FDA’s approval of products provides a foundation for confidence in our entire medicine cabinet. Our health system depends on the shared belief that drugs and devices work as advertised, that mechanisms invisible to the eye nonetheless cause healing. The underpinnings of this belief are that “somebody out there” has tested these products and shown, with at least some scientific evidence, that they work as claimed.
I am not on such boards.
What interests me is the examples used; emergency contraception is as much a moral issue as a technical one, and there is a harm reduction argument for permitting vaping. The FDA became political and converged about two administrations ago. In the rest of the world, we trust it as much as the DSM5, that is, in part only.
And converged organizations die on the vine or are taken over.