The rightward march of Dr. Vinay Prasad
The latest appointment at the FDA began his research career worried about conflicts of interest in medicine and the high cost of cancer drugs.
By appointing Dr. Vinay Prasad to run the Center for Biologics Evaluation and Research, the Trump regime has installed another prominent opponent of Covid-era public health policies to a key position at the Food and Drug Administration.
CBER is responsible for ensuring the safety and efficacy of vaccines, biologic drugs, gene therapies and the blood supply. When FDA Commissioner Martin Makary announced Prasad’s appointment yesterday, he noted the 42-year-old oncologist-epidemiologist has published hundreds of articles in the medical literature. I read their titles this morning. Only a few shed light on how he views the arenas he will soon oversee.
On the other hand, his recent writings on X (formerly Twitter), the substack Sensible Medicine, and his own substack Observations and Thoughts have plenty to say about school closures (“the great domestic policy failure of the last 25 years”); kids wearing masks outdoors (“whoever made the policy is an idiot”); and the annual Covid booster shot (“a public health disaster the likes of which we’ve never seen before”).
On the day after Trump’s election last November, he gave failing grades to the FDA and National Institutes of Health. He called for the elimination of 10,000 jobs at the Centers for Disease Control and Prevention, which he rated as an “abject failure.”
The rhetoric sounds more Trump/Muskian than even-handed or scientific. It is typical of his recent writings, which have taken on an increasingly strident tone since the pandemic. He has repeatedly attacked officials like Anthony Fauci and those at the CDC for ignoring alternative strategies and censoring proponents of herd immunity like Jay Bhattacharya, who now runs NIH.
One of Prasad’s recent posts called for large-scale, randomized clinical trials for the annual booster shots for COVID vaccines. That was in line with Makary’s order late last month that Novavax conduct a new clinical trial to test the annual update of its traditional Covid vaccine, which is the only alternative to the mRNA vaccines sold by Pfizer and Moderna. This new requirement may also be applied to the annual flu vaccines, which will cost the vaccine makers money (who cares?), but more importantly, will take much more time (something we should all care about).
“The FDA is a failure,” Prasad wrote last fall. “It rubber stamps too many useless products. It needs to either remove itself from the picture, or demand randomized trials measuring appropriate endpoints.”
Right turn
This rightward turn in Prasad’s public posture is a relatively recent phenomenon. He began his academic career by studying conflicts of interest in medicine (my own field when working at the Center for Science in the Public Interest). In 2017, he published a study in JAMA Internal Medicine that challenged the ridiculously high sum big drug companies claimed it cost to develop a new drug. (Full disclosure: I was invited to write the accompanying editorial, which was headlined “A Much-Needed Corrective on Drug Development Costs”).
To this day, the insidious role money plays in medicine remains central to how he views the relationship between the drug industry and government. “This is the core rot in American regulation. The revolving door politics. I find this behavior abhorrent, and it should be criminal,” he has written.
He has called for ending all conflicts of interest on FDA advisory committees and wants to set up a “new Phase IV safety detection system” for monitoring adverse vaccine events. “I think vaccine makers should face litigation, as drug makers do,” he has written. He’s also skeptical of using surrogate endpoints and accelerated approvals, which led the FDA to “rubber stamp dozens of drugs with no evidence they help Americans.”
So here we are again. A top Trump regime appointee is championing many positions held by left wing and progressive critics of weak government oversight. Indeed, Prasad has written he once considered himself a progressive Democrat. No wonder biotech stocks temporarily tanked on news of Prasad’s appointment to run CBER.
However, as I’ve said many times in writing about these appointments, let’s watch what they do, not what they say, past or present. Will the Makary/Prasad team slow or even stop vaccine approvals to please their boss, Robert F. Kennedy Jr., the secretary of Health and Human Services? Will Trump order the new team to back off from policies and decisions that tank the stock market (vaccines on their own could never do that; they’re too small a revenue item)?
If I were a gambling man, I’d bet the answer will be ‘yes’ to both those questions.
I am not sure how much of a role “politics” is playing in Dr Prasad’s perspectives.
Having followed his opinions of social media, I do sense that he’s fed up with the system of governance and misplaced regulation of healthcare, (the way laws are interpreted into agency and institutional policies, the deprofessionalization of the medical profession and the turnover of healthcare to bureaucrats who know little and care even less about patient centered/personalized decisions).
That litany of issues has the backing of many physicians and patients across the political spectrum, including libertarians and individualists like myself.
....the annual Covid booster shot “a public health disaster the likes of which we’ve never seen before” (!) Such Trumpian hyperbole, and not exactly evidence based. Worse than smoking tobacco? Air pollution? Medical errors? More to come: global warming and all its sequellae.
Anyway, hopefully he will be more reformer than chaotic disrupter. It would be interesting to be a fly on the wall to hear his conversations with RFK Jr., practitioner par excellence of BSBM.