Scoop: "Randomized controlled trials are not always necessary," new FDA vaccine chief Dr. Vinay Prasad says to staff.
Introductory comments yesterday reflected a return to nuance from a figure who had become contentious in recent years.
Yesterday, Dr. Vinay Prasad, the newly appointed Director of the FDA’s Center for Biologics Evaluation and Research (CBER), addressed around 150 of his new colleagues at the White Oak campus in Silver Spring, MD. Inside Medicine was in the room, thanks to scientists who shared footage of Prasad's 20-minute speech, which was followed by a brief Q&A.
The question on many minds among FDA rank-and-file in attendance was: Which Vinay Prasad would show up? The 2010s Prasad—a rigorous and professorial cancer research methodology expert with hundreds of peer-reviewed publications, including well-reasoned analyses that often stood up against some slippery stuff from big pharma? Or the 2020s Prasad—newly famous and admired by the Right, and newly infamous to the Left—the hot-headed firebrand who when asked about how we should move forward from the lessons of Covid-19 pandemic criticized the pro-masking contingent saying, “I don’t believe in forgiveness because, in my opinion, these pieces of shit are still lying,” and, of someone who thought that masking kids was sensible, “a fucking liar”? (Elsewhere, he has said he attacks ideas, not people.)
Having watched a video of his presentation to his new FDA colleagues yesterday afternoon, I can report good news: clearly, the 2010s Prasad showed up to work in Maryland yesterday.
A change in tone.
Prasad’s speech was perfectly reasonable and, apparently, quite successful. One FDA scientist who acknowledged deep concerns about his tone in recent years described the presentation as “charming” and even “self-deprecating.” At times, Prasad demonstrated his unusual command of under-the-hood problems of the medical literature—the kind that earned him enormous respect last decade from many physicians and scientists, myself included. Indeed, while former FDA Commissioner Dr. Robert Califf told me that he believes the Director of CBER should come from within the agency (Prasad has never worked there), most people who know Prasad and his work recognized his intelligence, and consider him to be a keen analyst on a variety of topics. With one major exception: Covid.
As STAT’s Adam Feuerstein wrote yesterday, “Covid changed Prasad. He was ostracized, and, in some cases, punished for his views on vaccines, masking, and school closures by establishment scientists. Looking back, some, not all, of Prasad’s Covid beliefs turned out to be true. But instead of moving on with his life, he embarked on a vengeance tour. The negative feedback loop of social media made him more extreme, more hostile, to his perceived enemies.”
I think that’s very well stated. As someone who went against the mainstream on a few occasions during the Covid emergency period myself, I have sometimes agreed with a subset of Prasad’s views. But, personally, it was hard to take many of his arguments as seriously as I might have, because they were paired with an ever-escalating vitriol that I felt wasn’t conducive to productive discourse. (On Twitter, he also liberally blocked dozens of respected experts in public health who dared to disagree with him.) Whatever toxicity Prasad called out from his erstwhile liberal allies, it seemed increasingly magnified behind his own podcast mic.
Another change in tone.
All of this made his polite, measured, and yeah, at times brilliant words at the FDA yesterday just a bit disorienting to this listener. With every reasonable and thoughtful sentence, I could not help but think back to a caricature of a foaming zealot version of Prasad of the last few years and think, What the hell was all that all about?
Below are some quotations from Dr. Prasad’s presentation yesterday, and some from the past. In some cases, I’ve added some commentary of my own, and bold for emphasis. (I reached out to him to ask for responses, but admittedly, it was on short notice. At the time of publication, he had not responded. Given the fast turnaround, I offered the opportunity to respond in a future piece.)
Out: highlighting FDA failures. In: flattery.
Then:
“I worry that the FDA is entirely beholden to the pharmaceutical industry. It was already approving myeloma drugs based on progression free survival — a surrogate that does not correlate with overall survival, as I explain in the video, but will lower the bar further. The FDA keeps patting itself on the back, but we have no idea what the optimal sequence of drugs is in myeloma, and the FDA’s low standards are primarily to blame.”
“The FDA lives in a bubble where they only talk to people who lavish praise on them and far more with the industry representatives than the critics of their policy. That’s fine if their goal is to balloon health care spending till our country goes bankrupt, while failing to generate evidence that optimizes survival and quality of life for patients. Sadly, it seems that is their goal.”
“Across the board, the FDA is doing a bad job. Annual boosters for toddlers without clinical trials— approving Alzheimers drugs that don’t work— and lowering the bar for toxic cancer drugs, which will enrich companies and lead to more drug use, but with uncertain effects on overall survival and quality of life.”
“If you’re talking about FDA 2024, I think that [we’d] probably be better off as a result of not having the FDA.”
Now (remarks to FDA CBER staff, yesterday):
“I’m in admiration of the work you all do. I think it’s truly a public service I think what we do is incredibly important and it’s one of the things that sets this country apart globally as a place that’s been excellent.”
“I applaud what you do and I’ve learned a lot from reading your papers over the last twenty years.”
“I support primary reviewers who are cautious about dubious products with negative clinical trials and uncertain risk benefit profile.”
“Please teach me.”
“I am honored to work with you.”
Commentary:
The line about “reviewers who are cautious about dubious products” was a direct reference and a subtle dig at past FDA decisions that have stirred controversy among experts, some of which I agree on with Prasad. Unknown (at least to me), is how the scientists at the agency view some of those highly contentious decisions.
On public trust and the FDA.
Then:
April 13, 2024:
“Interestingly, the FDA did not make the materials— a complex 100 +page analysis available to the public until two days before the meeting. That’s not enough time to scrutinize the methods. Meanwhile the FDA has been working for months on this with the applicants. It appears the FDA is colluding with companies to push through policy changes and intentionally hampering those who may disagree.”
“Worse, the FDA is not interested in a debate. Why not allocate more time to a speaker who is critical of the change? I only got five minutes [this was in reference to Prasad’s allotted time during an opportunity for public comment]. That’s not enough time to combat eight hours of propaganda.”
Now (remarks to FDA CBER staff, yesterday):
“I think public trust is delicate. It’s a delicate balance and we do face sort of a crisis of trust in a lot of products. If we approve products in low-risk populations with no credible evidence that they improve outcomes in low-risk populations with ever falling risk and if we do encounter some adverse events which do happen we may deeply impair trust in other products which are tremendously important and life saving.
“If we demonize people for asking questions, we will forfeit trust.”
Commentary:
The focus on “low-risk populations” was almost certainly a nod to Covid-19 vaccines. The FDA has approved Covid-19 vaccines for people ages 12 and over, and currently permits them for children under age 12 under emergency use authorization. Prasad has said he does not think the FDA should have authorized the primary vaccine series for use in children. (On this one, we disagree.) So, this was, in my view, an opening gambit on what could become the most controversial topic that may reach Prasad’s desk.
On randomized controlled trials. (News here!)
Now (remarks to FDA CBER staff, yesterday, bold added for emphasis):
“Good evidence is context dependent”
“And for the rare disease fans, randomized controlled trials are not always necessary, and when they are done they are not always informative. So, we have some challenges ahead of us.”
“Evidence must also contextualize the condition—how rare and dire it is, and we should be flexible for the many people who do want to try things.”
Commentary:
The line on randomized controlled trials (RCTs) will make some news in my circles. Prasad has long been on the record extolling RCTs as the be-all-end-all. And, yes, in many instances I share that view. For example, I find it frustrating that some important RCTs on masking in hospitals (and other important settings) were not done during the Covid pandemic. (Prasad seems to think those studies would have been negative; I believe that, if done appropriately, they would have been positive and shown important benefits.)
What’s fascinating here comes down to the word nuance. Indeed, if you look at truly rare diseases—ones that affect 1,000 people—RCTs are not practical or possible. Should we cling to our precious RCTs in those instances? Surely not. It was both wise and shrewd of Prasad to say this in a room with dozens of scientists who work on drugs that, at best, might save a handful of lives every year in the United States.
Overall, the softer tone (is this Prasad 3.0?) reminded me of an insight of Hannah Arendt: “The most radical revolutionary will become a conservative on the day after the revolution.”
On resources at the FDA.
Finally, there were two somewhat awkward moments related to the FDA’s library, which has quickly fallen into disrepair after the Trump administration terminations of the agency’s library staff, leaving scientists unable to access medical and scientific journals they need in order to carry out their duties. At one point during his comments, Prasad mentioned that he has tried to make all of his scholarship available for free, but that, “of course, you all have access.” This caused some grumbles and even a few nervous laughs from the gallery. “No, we don’t,” one audience member could be heard saying in the recording. Later, in a brief Q&A, an FDA employee directly followed up on this point, pointing out to a suddenly anxious-appearing Prasad that “we do not have a functioning library. Many resources are gone, including librarians…and we are in a very complicated situation…”
Prasad agreed that the scientists indeed need such access and that the point was “well taken.” While the audience had generally seemed engaged with Prasad’s presentation, even laughing along the way with Prasad’s jokes, it was the first and only time that the gallery applauded.
Update: With permission, I’ve decided to publish the complete recording of Dr. Prasad’s remarks. Note: approximately 2-3 seconds of audio have been removed to protect the identities of audience members who made comments close enough to the microphone to be audible, including one quote mentioned above which is therefore not heard in the recording. Metadata have also been removed.
Here it is:
Let us all know what you think!
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Prasad’s speech at the FDA was calm, even charming. However, he wasn’t appointed because of his past rigor. He was elevated because of his more recent firebrand attacks on public health institutions.
I’m grateful to Dr. Faust for sharing and thoughtfully commenting on Prasad’s remarks. But let’s be clear: his appointment is not a sign of balance. It is a warning shot. It reminds us what Trump has already done to public health and why any praise for Prasad should be tempered with deep caution, especially as the Prasad admiration tour starts to roll.
A calm speech doesn’t erase the reasons he was chosen.
I agree with everything Dr. Faust said about Vinay Prasad from a historical perspective. I’ve learned a lot from him over the years, but got tired of the vitriol (like a dog with a bone - it just turned me off). My thoughts in recent months have been - hey, that guy is auditioning for a role in the Trump administration (ooh - pick me! Pick me!!). But when all is said and done, I’m really excited and hopeful over his appointment and especially glad to hear that the old Prasad showed up for work.