Last week, I wrote about a little dustup that Dr. Vinay Prasad, a frequent topic of this blog and my not-so-super-secret other blog, had gotten himself into as the new director of the FDA’s Center for Biologicals Evaluation & Research (CEBR) when he faced the tough real world responsibilities that the job entails. I hadn’t intended to write about him again, for a while at least, but by last Tuesday night, things had, as they say, escalated quickly.
What happened is that, less than two days after my post, Dr. Prasad—shall we say?—resigned his position as CBER director, having held it less than three months. Obviously, it must have been due to my awesome post, which must have been the final straw. (I keed, I keed.) Truth be told, I was debating whether to do a followup post realizing that Dr. Prasad’s unceremonious departure had occurred nearly a week ago. In fact, I was going to write about it on my not-so-super-secret other blog right after it happened. However, life once again intervened, which turned out to be OK. I’m actually rather glad, given that I now have a few days of obtuse reactions from the COVID-19 contrarian crankosphere. More telling, though, are reactions by by doctors who like to think themselves reasonable as they ignore the quackery and antivax in the “make America healthy again” (MAHA) movement, even though the slogan was coined by the longtime antivax activist who is, alas, now Secretary of Health and Human Services, Robert F. Kennedy Jr., because they think it really is all about chronic disease and poor diet. You might also recall the dismay that many of us expressed when, after Dr. Peter Marks, who was a longtime FDA regulator and previous CBER director, was forced out, only to be replaced in early May by Dr. Prasad. By mid-June, Dr. Prasad had been appointed the FDA’s chief medical and scientific officer. Truly, for our EBM Boy Wonder Dr. Prasad, the future seemed so bright that he’s gotta wear shades.
Sadly for him, it didn’t last.
Late last Tuesday, I became aware that Dr. Prasad had been unceremoniously shown the door after a decision that he had made had provoked the ire of Laura Loomer, the editorial page of the Wall Street Journal, and much of the right-to-try movement, as well as another decision by him on COVID-19 vaccines that had ticked off the antivax movement. As a result of the MAGA and “medical freedom” pile-on, less than three months after being appointed CBER director and a month and a half after being appointed chief medical and scientific officer, the future quickly became…less bright for poor Dr. Prasad:
Vinay Prasad, a top official at the Food and Drug Administration, has suddenly departed after a series of controversial decisions about a treatment for boys with Duchenne muscular dystrophy.
“Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,” Health and Human Services Department spokesperson Andrew Nixon told STAT late on Tuesday. “We thank him for his service and the many important reforms he was able to achieve in his time at FDA.”
Karma. I can’t help but think that maybe there is such a thing as karma. After all, they sent Dr. Prasad packing not only with the classic bit about not wanting to be a “distraction,” but also with the even more classic bit the person who’s been fired wanting to “spend more time with his family.” These are two of the most classic tropes imaginable commonly used to announce the firing—or “asking for the resignation” of—a political appointee who’s become too controversial for his higher-ups. Indeed, hilariously, it turns out that President Donald Trump himself had ordered the firing, apparently overruling HHS Secretary Robert F. Kennedy, Jr. and FDA Commissioner Dr. Marty Makary, who had only three days before his firing defended him.
Beat on the Potomac.”
Given the Lysenkoist hellscape that the HHS and pretty much all federal scientific, medical, and public health programs are fast becoming under President Trump, it’s difficult for me not to feel a fair amount of schadenfreude. Even so, I was a bit more sympathetic to Dr. Prasad’s recent plight—although most definitely not to his history of having played footsie with the antivax movement that had won him his post—when I wrote about how he had found himself in the crosshairs of not just one of Trump’s more unhinged MAGA allies and her flying monkeys but of the “establishment” wing of the Republican Party as embodied by the editorial page of the WSJ. At the same time, it was truly hilarious to read articles in the WSJ opinion page accusing Dr. Prasad, ridiculously, of being a “Bernie Sanders acolyte in MAHA drag” who “doesn’t think patients can be trusted to make their own healthcare decisions” and of “mugging” the pharmaceutical company whose product had been suspended by Dr. Prasad in the wake of three deaths that were being investigated.
In fairness, it must be noted that any CBER director who makes a decision to suspend shipments of a gene therapy for Duchenne’s muscular dystrophy can expect to take heat from patient advocates and industry, but Dr. Prasad’s statements on social media and elsewhere had provided Laura Loomer and right-to-try advocates plenty of ammunition, particularly Dr. Prasad’s risibly performative “he doth protest too much” claims of being a Bernie Sanders/Warren Elizabeth progressive and some of his performative attacks on Donald Trump, all of which he routinely deployed in a futile attempt to deflect criticism over how he had been aligning himself with right wing antivaxxers and anti-public health zealots. In other words, pay no attention to the times when Dr. Prasad went full Godwin to characterize public health interventions as incipient Nazi-ism, embraced the right wing message of “do not comply” with respect to vaccine mandates, started gaslighting RFK Jr.’s role in spreading doubt about the MMR vaccine during the deadly 2019 measles outbreak in Samoa, or echoed RFK Jr.’s deceptive trope about childhood vaccines not having been adequately tested in RCTs versus saline placebo, a trope that ignores vaccine history, not to mention medical ethics.
Basically, Dr. Prasad had long courted the right wing outrage machine that went into overdrive over pandemic restrictions and mandates, and it was his very brand that brought him down in the end. It’s a message that, unfortunately, has been lost on the very physicians who, along with Dr. Prasad, helped enable Donald Trump’s war on expertise and science, as you will see from the reaction of some of Dr. Prasad’s buddies and defenders.
The rise and fall of an opportunistic contrarian
Dr. Prasad has long been a frequent topic on this blog because of his weaponization of the evidence-based medicine (EBM) paradigm. He is currently best known for his “RCTs or STFU” shtick that he used during the pandemic to cast doubt on COVID-19 vaccines and public health interventions (as well as to build his brand to the point where he was high profile enough to score jobs at the FDA for which he is manifestly unqualified). In brief, Dr. Prasad has long used a very fundamentalist interpretation of the EBM paradigm, in which any evidence that is not from randomized controlled trials (RCTs) is discounted as being so poor quality as to be worthless, a use of EBM that I like to call “methodolatry,” defined as the profane worship of the RCT as the only correct method of clinical investigation, never mind if an RCT would be unethical, completely impractical, or even not the best method to study a given hypothesis. There were few better that Dr. Prasad at weaponizing methodolatry to give the appearance that they were just asking for “more rigorous” science when in reality they were doing was to cast doubt on the existing science behind pandemic public health interventions, such as masking and school closures, and vaccines.
Indeed, I immediately suspected that the very reason that Dr. Prasad had been appointed CBER director was because of his methodolatry and receptiveness to the antivax trope that would demand RCTs of every new version of a vaccine against saline placebo, when the only ethical way to do such trials, is to test second generation vaccines against the old version of the vaccine in order to demonstrate that the new vaccine is, at the very least, not inferior in terms of safety and efficacy. Given his history, Dr. Prasad would be able to give RFK Jr. cover in his war against vaccines as being someone who “just wants more rigorous science,” or, to provide, as RFK Jr. and the “make America healthy again” (MAHA) movement has been parroting, “gold standard science.” (“Gold standard science” is aa deceptive trope that hides the production of doubt about vaccines and anything else detested by MAHA under the appearance of a quest for more rigorous science.) On the other hand, Dr. Prasad has always seemed a lot more flexible when it came to standards of evidence showing vaccine harms, implying a double standard that could have fit in well under RFK Jr.’s FDA.
As Dr. Angela Rasmussen put it:
During his brief tenure at FDA, Prasad wasted no time carrying out his masters’ bidding. He teamed up with Makary to write this odious position piece on vaccines in the New England Journal of Medicine. This piece argues that US COVID vaccine policy is patronizing and aggressive, and that vaccines have undergone insufficient testing. Prasad and Makary argued that all vaccines in healthy people aged 6 months-64 years old would require a randomized clinical trial (RCT) for FDA approval. This effectively means no more COVID boosters for most people.
There is no reason to run RCTs for vaccines that have been in use for long enough to evaluate outcomes. We don’t do this for seasonal flu shots because we know that these vaccines provide benefits that greatly outweigh the risks. If we did RCTs for booster updates, we would never be able to use them during flu season, when they matter. The same is true for updated COVID boosters. This is a mechanism to limit or ban vaccines, despite Makary and Prasad’s claim that it is “gold standard science.”
I immediately recognized the conflict that Dr. Prasad would face as director of CBER. On the one hand, he was tasked with casting doubt on vaccines by weaponizing EBM fundamentalist methodolatry, thus making it much more difficult, if not impossible, to approve new vaccines. However, CBER doesn’t just regulate vaccines. It evaluates and approves biologics, which includes all stem cell and gene therapies. Unfortunately, for Dr. Prasad, RFK Jr. had made it very clear even before Trump was elected again that he wanted to “declare war on the FDA” in order to approve more stem cell therapies, among other dubious and unproven treatments and foods:
That fundamental tension between weaponizing fundamentalist EBM methodolatry against vaccines and approving dubious biologics that RFK Jr. supports was why Dr. Prasad and his boss Dr. Makary soon got on board with—shall we say?—the more “fluid concept of evidence.” Such an embrace was necessary for them to be able to selectively apply Dr. Prasad’s usual hyper-dogmatic application of EBM (the aforementioned “RCTs or STFU) to hamper the approval of medicines that RFK Jr. doesn’t like—cough, cough, vaccines—and yet still be able to make it easier to approve the things he does like (e.g., dubious stem cell therapies). It was also that tension that tripped up Dr. Prasad so spectacularly.
I wrote about this in a lot of detail over at my not-so-super-secret other blog, but I’ll provide the CliffsNotes version here before I move on to discussing the fallout of Dr. Prasad’s dramatic ouster. The countdown to Dr. Prasad’s downfall began on July 20, when Trump supporter Laura Loomer published an article entitled Meet Vinay Prasad: The Progressive Leftist Saboteur Undermining President Trump’s FDA, in which she described Dr. Prasad as a “catastrophic vetting failure that demands immediate action to protect Trump’s transformative healthcare agenda.” (Talk about being hoist with your own petard!) At the time, I couldn’t help but note that Dr. Prasad was indeed utterly unqualified for the positions that he now holds, just not in the way Loomer thought. The real “vetting failure” was how the MAHA stans running HHS and its agencies apparently didn’t think about how Dr. Prasad’s “RCTs or STFU” ethos might impact FDA regulation of medical treatments aside from its intended effect on amplifying antivax messaging implying that vaccines are inadequately tested. They apparently didn’t foresee the obvious, namely how that same ethos would impact issues such as accelerated approval programs and “right-to-try” programs beloved of libertarian “health freedom” and “neuter the FDA” activists. By July 25, Rick Santorum was amplifying a post on RealClearHealth by Bob Goldberg entitled FDA’s Vinay Prasad Stands with Progressive Health Policies, not President Trump, in which he attacked Dr. Prasad as having mocked right-to-try and as blocking faster drug approval.
As I wrote last week, reading that he was totally against right-to-try, I almost—almost!—liked Dr. Prasad! After all, I’ve been a far harsher critic of right-to-try than Dr. Prasad has ever been, frequently characterizing it as a Trojan horse designed to neuter the FDA, and, as I’ve noted before, I mostly agreed with his critique of accelerated approval programs in oncology and the need to reform them, in order to make sure that the surrogate endpoints used to grant accelerated approval to drugs actually do result in actual clinical benefits to patients, something that Dr. Prasad found in 2019 happened only 20% of the time. In other words, even though Drs. Prasad and Makary had provoked the ire of the antivax movement by approving a new version of a COVID vaccine (even though they had narrowed its indications such that few could now access boosters), what lead to Dr. Prasad’s downfall was his hostility towards the FDA’s accelerated approval program in combination with what was actually a defensible position of putting a temporary hold on shipments of a very expensive gene therapy for muscular dystrophy (Elevidys, manufactured by Sarepta Therapeutics) to investigate three deaths, which led to the knives coming out for him:
Again, I went into painful detail about this whole affair last week, but will say that I didn’t see how any other CBER director could have done otherwise and point out that even Dr. Prasad’s ousted predecessor who had approved Elevidys agreed (sort of) with the decision to pause shipping. The whole question of what to do in a case like this is not always straightforward, and reasonable physicians, scientists, and regulators can disagree. Any CBER director or FDA Commissioner who made a decision like this was going to face some heat, though. The amusing thing is that Dr. Prasad’s social media history provided ample examples of inflammatory statements that allowed Sarepta, MAGA activists, patient advocates, and right-to-try advocates to cry bias. I won’t list them all here, given that I’ve already listed a number, but I will post this one again because of its temporal proximity and vehemence:
That Tweet, by the way, was about the approval of Elevidys and made only a month and a half before Dr. Prasad’s appointment as CBER director, making it easy for MAGA, the health freedom and right-to-try movements, and patient advocates to characterize his decision as biased and based more on settling scores than on science. It is, of course, comparatively very easy to be a social media influencer and Substack blogger pontificating from the sidelines about how the FDA and CDC should do their jobs than it is to actually do the jobs. A more politically adept CBER director without the baggage of Dr. Prasad’s long history of criticism of accelerated approval, much of which was actually not unreasonable if on could divorce it from his inflammatory attacks on Elevidys, might have survived. Dr. Prasad, however, had no experience running a large organization whose decisions could be politically charged. He was in way over his head, and it showed. He should never have been appointed, and it is satisfying that his downfall was so closely related to his overall brand and persona.
Unfortunately, his apologists haven’t figured that out, as you will see. They remain as clueless as they were before Dr. Prasad fell.
Physicians who helped enable the war against public health defend Dr. Prasad
Unsurprisingly, not everyone was happy about the attacks on Dr. Prasad or his ouster. For example, Emily Kopp from The Daily Caller posted a defense claiming that the hit pieces on him were the product of Big Pharma, a claim that found some traction in the MAGAsphere:
Meanwhile, COVID-19 contrarian and the “pandemic’s wrongest man” Alex Berenson echoed this line of defense in On Big Pharma’s demolition of Dr. Vinay Prasad, one of the most honest people in medicine. So did Geoff Pain. Most hilariously of all, Natural News ran a story entitled Vaccine truth-teller Vinay Prasad FORCED OUT of FDA post as Big Pharma tightens grip on science. Let’s just put it this way. When Mike Adams okays a post portraying you as a brave truth-teller, your medical and scientific credibility should be demolished for the rest of your life. Not coincidentally, ever since Dr. Prasad was forced out of CBER, I’ve been predicting that he will rebrand himself as even more of a “brave truth teller” who was “forced out” by nefarious big pharma forces for trying to bring The One True Version of EBM to the FDA approval process. I further predict that he’ll likely go back to being a social media influencer and to tell his highly biased and embellished “inside story” of how behind the scenes is really run by big pharma.
That last person responding to Kopp is Dr. Joseph Marine a cardiologist and electrophysiologist who appears to like Donald Trump. He definitely likes MAHA, talking the same talk (although it’s unclear whether he walks the walk). He’s a less frequent contributor to Sensible Medicine, the Substack founded by Drs. Vinay Prasad, Adam Cifu, and John Mandrola that to me seems dedicated to promoting not just COVID-19 contrarianism but also to the same sort of EBM fundamentalist methodolatry that Dr. Prasad was known for. As it turns out, Dr. Marine published some embarrassingly bad posts for (not-so)-Sensible Medicine, including, most infamously, Why Doctors Should Learn to Stop Worrying and Love MAHA, as well as a credulous post entitled The MAHA Report: A Seismic Shift in US Health Policy. It’s hard to argue that the MAHA Report isn’t a seismic shift in US health policy, but it is easy to argue against Dr. Marine’s apparent belief that this shift is a good thing for medicine and patients. In any case, Dr. Jonathan Howard deconstructed the first post, in particular Dr. Marine’s ludicrous claim when criticized for his credulity towards MAHA:
See what I mean? Physicians like Dr. Prasad and his stans at (not-so)-Sensible Medicine pretend that antivax quackery (not to mention a whole lot of other quackery unrelated to vaccines) isn’t an integral part of MAHA, in favor of deluding themselves that it’s all about getting Americans to exercise more, eat a healthier diet, and live a healthier lifestyle.
This brings us to the rest of the (not-so)-Sensible Medicine crew. Both Dr. Mandrola and Dr. Cifu are so very, very unhappy that their Substack-mate Dr. Prasad was treated so very, very horribly. Dr. Mandrola was first out of the gate, publishing on his own Substack a post entitled Prasad Being Forced Out of FDA is a Sad Day for Evidence-Based Medicine. (Hint: It wasn’t.) Truly, Dr. Mandrola is divorced from reality here:
Here are some initial thoughts.
Mainly I am sad.
Sad for Vinay because he told me how much he had learned in his short time. He was happy doing a job that had incredible meaning. You could see how much this new role meant to him in the FDA videos he did with Marty. It was a different Vinay.
I only have to ask: If Dr. Prasad was so happy in his new role, why were there news reports about how he frequently didn’t attend important directors meetings and about his seeming disinterest he showed in…oh, you know…actually doing the administrative work of being CBER director?
From STAT News:
Multiple agency (FDA) employees, who requested anonymity to protect against retaliation, told STAT that Prasad seemed uninterested in the administrative work of being a center director. One CBER agency official said Prasad rarely attends center meetings with office directors, and that their questions about the budget, HR functions, and IT systems have gone unanswered.
That sort of stuff seems rather important to me, but apparently Dr. Prasad liked overruling career scientists on vaccine recommendations more than putting in the grunt work to make sure that CBER could actually run smoothly. Don Fink, a former FDA employee, wrote on LinkedIn:
This begs the question: What has Dr. Prasad done in his Center Director’s role at CBER to earn the support of managers (yes, earn, it’s not an entitlement) when apparently he is filling this role ‘in absentia’?…Of the three hats currently being worn by Dr. Prasad: (1) FDA Chief Medical Officer, (2) Chief Scientific Officer, and (3) CBER Center Director, clearly he has little appetite or enthusiasm for fulling the obligations and duties of the latter.
That hardly seems like a description of someone who was overjoyed to be doing “important work” of running CBER and eager to learn how to do the job. Also, I saw a couple of the videos that Dr. Prasad did with his boss Dr. Makary. The Dr. Prasaad in the videos was the same Dr. Prasad, just toned down a fair amount for an “official” government channel. One can’t help but think that Dr. Prasad enjoyed making videos for the FDA far more than actually doing his job as CBER director. Maybe Dr. Makary should have tapped him as the FDA’s social media director.
In fairness, Dr. Mandrola is not entirely unreasonable—although he is clearly rather oblivious—to note:
The question I have, and surely you do too, is why would political operatives care about a specific drug for a rare disease.
Surely everyone (no matter the political affiliation) would want an FDA that reacts cautiously to any drug that could cause death.
If only Dr. Mandrola had been paying attention all these years! (I mean, seriously, how obliviously clueless can a physician be?) Is he not familiar with the deregulatory fervor of the libertarian “health freedom” contingent that birthed the “right-to-try” movement, which basically says that those with terminal (or even serious) illnesses should be able to assume the risks of taking any experimental therapy they want, as long as it’s passed phase I studies? (There’s a reason why right-to-try Senator Ron Johnson joined the pile-on. He was a sponsor of the 2018 right-to-try bill, which has been a massive failure.) Are you not aware of the tech-bro libertarian contingent that wants to replace the current drug approval system with a “Yelp!”-like online ratings system, a “Yelp! for drugs,” if you will? These forces happily teamed up with patient advocates to portray Dr. Prasad’s decision as cruel and heartless. As Dr. Rasmussen put it, “Prasad pissed off the ‘medical freedom’ component of the base that wants to be liberated from regulating drugs to ensure they are safe and effective.”
Don’t get me wrong. I have little doubt that big pharma and Sarepta in particular probably lent a hand to pushing Dr. Prasad out, but Dr. Mandrola seems blissfully unaware of the even more powerful non-pharma political forces that want to neuter the FDA, even to the point of approving drugs after they are just shown to be safe and not requiring that pharmaceutical companies demonstrate efficacy until after approval. These are the political forces of which Dr. Mandrola appears blissfully ignorant. Moreover, as I’ve said before, a more skillful CBER director who was not so arrogant and dismissive would have maintained good communications with patient advocacy groups, so that when he had to make a hard decision like the Sarepta decision they might be willing to give him a chance to investigate. A more skillful CBER director would have crafted a less tone-deaf announcement of the decision. Sadly, Dr. Prasad was not such a CBER director—and, even if he had survived, would have been unlikely to mature into one.
Dr. Mandrola did, if you’ll excuse the term, shred my irony meter here:
And if that were true, if industry could so easily extract an independent judge of evidence, then the only thing to feel is intense cynicism and hopelessness.
Gosh this is bad. I am not against medical industry. We have had great advances in this generation.
But society also needs independent judges to prevent profiteering of susceptible people with serious illness. That we had one, and he was removed this easily is simply awful. Trust is shredded.
Seriously, Dr. Prasad—and, to a lesser extent, Drs. Mandrola and Cifu as his collaborators—has been shredding trust in medicine since 2021, if not earlier. It is profoundly ironic that that same lack of trust led to Dr. Prasad’s ouster after less than three months on the job, right after he had to make his first tough decision that might run afoul of the MAHA and right-to-try forces that were important to his initial appointment.
Dr. Cifu followed soon after to lament Dr. Prasad’s “resignation,” publishing a post on (not-so)-Sensible Medicine entitled A Sad Day for EBM, which was republished in a different form in STAT News as Vinay Prasad is my former student and friend. His departure from FDA is a loss for American medicine, to its shame. He begins thusly:
I do understand that he is … well … divisive. He has strong opinions, and he is not shy about sharing them. On social media, he has at times been brash, nasty, and insulting. Being opinionated and insensitive guarantees enemies, and he made them in spades. I have many colleagues who confide that they greatly respect his intelligence and productivity and agree with him on most issues, while being seriously offended by his style.
This style, however, brought more attention to the issues he feels strongly about than the scores of sober papers he published. It probably also played a significant role in getting him appointed to a leadership position at the FDA, a role that seemed tailor-made for him. In addition to being a leader, he was rightly put in a position that required a workhorse.
“Divisive”? “Brash, nasty, and insulting”? Try saying that he’s an asshole, which is a far better description that has long applied to him dating back to well before the pandemic, when Dr. Prasad became, as Dr. Rasmussen termed it in reference to herself and him, “COVID famous.” (She also made me laugh out loud by referring to Dr. Prasad as the “Steve Urkel of COVID Twitter.”) Dr. Howard and others pointed out just how nasty and unprofessional Dr. Prasad has been, for example, here:
Dr. Prasad’s unprofessional and contemptuous behavior predates COVID-19, too. I like to relate a run-in that I had with Dr. Prasad a few months before the pandemic, in which he dismissively attacked medical skeptics who took the time to debunk quackery like homeopathy, Goop’s jade eggs, and various antivax claims, portraying their efforts as not worth his massive brain power or even the much lesser brain power (than him, of course) possessed by a typical MD. Why? Because to him it was so obvious that homeopathy didn’t work and that antivax was nonsense. He even urged me to “join him” in examining suspect pharma clinical trials, apparently not realizing that the same skillset was necessary to show why all those seemingly positive homeopathy trials didn’t actually show that homeopathy works.
Also, Dr. Prasad’s being a “workhorse” apparently didn’t extend to his actually doing the less glamorous aspects of the job, such as actually attending meetings and doing the administrative grunt work associated with the job, as I mentioned above.
The greatest irony here is that it only took less than two years after that encounter for Dr. Prasad to start praising a dumpster-diving study in the VAERS database (co-authored by Dr. Mandrola) looking for COVID-19 vaccine harms and three years to be echoing RFK Jr.’s deceptive claim that childhood vaccines are not adequately safety-tested because they haven’t all been tested in RCTs against saline placebo. Along the way, as I mentioned above, he echoed the antivax claim of “do not comply” with COVID vaccine mandates and, most recently, gaslit the role of RFK Jr. in undermining confidence in the MMR vaccine during the deadly 2019 Samoan Measles outbreak.
In the article, Dr. Cifu hilariously tries to argue that, contrary to his frequent dismissal of non-RCT evidence and his contemptuous motto of “RCTs or STFU for all” that revealed that he truly did not understand when RCTs were unethical, impractical, or the wrong tool, Dr. Prasad was really, truly, and actually open to more forms of evidence:
Vinay was also guaranteed to be labeled a hypocrite. Although his views on evidentiary requirements have always been nuanced, many critics labeled him as accepting only randomized controlled studies as adequate evidence. But that’s not right. To function in his position, he would need to be open to a spectrum of evidence, as all physicians must be — and he is.
If that were ever the case, Dr. Prasad never actually showed much, if any, evidence of it in any of his publications or, in particular, his social media statements and YouTube videos that I’ve ever seen. Seriously, maybe Dr. Cifu can point me to any statements made by Dr. Prasad before he became CBER director that showed that he seriously considered “lesser” evidence, given that his whole schtick was weaponizing the EBM paradigm to cast doubt on public health interventions against COVID, including vaccines. True, he did seem to embrace a “more fluid concept of evidence” after appointed, but I saw little evidence before that he actually believed it. On the other hand, he did embrace some pretty crappy studies that showed harms from vaccines; so maybe he could have worked it out after all if he hadn’t stumbled so early.
I will give Dr. Cifu credit for noting the conflict at the very heart of Dr. Prasad’s appointment, even as I laughed aloud reading the last sentence:
To succeed by what I know to be Vinay’s high standards, he was going to need to make difficult and unpopular decisions. The pharmaceutical industry would be angered when therapies with poor evidence bases were withheld or more data were demanded. Any limit to vaccine availability would anger those who already disagreed with him during Covid. Any support for vaccines would anger many in health secretary Robert F. Kennedy Jr.’s camp, who seem unreasonably skeptical of all vaccines.
“Seem unreasonably skeptical of all vaccines”? Seriously? How can anyone be that clueless? They’re not “skeptical’; they’re antivax. RFK Jr. is not a skeptic; he is antivax to the core and has been an antivax activist since at least 2005. Worse, as I pointed out above, Dr. Prasad has, likely without even realizing it, been echoing common longstanding antivax talking points. Indeed, the position described in that infamous opinion piece published in the New England Journal of Medicine that Dr. Rasmussen so castigated implying that vaccines have undergone unsufficient testing and that all vaccines in healthy people aged 6 months to 64 years old should require an RCT for FDA approval, represented an important step towards realizing RFK Jr.’s vision of undermining and destroying the US federal vaccination system.
Still, Dr. Cifu did perceive the inherent conflict. Dr. Prasad was brought in to weaponize EBM fundamentalist methodolatry against vaccine approvals. Even though he claimed to have embraced that more ‘fluid concept of evidence,” however, that same methodolatry was bound to come into conflict with RFK Jr.’s desire to approve dubious stem cell therapies, as well as the desires of the”health freedom” movement and right-to try to let patients basically use whatever they want and pharma to sell it to them, evidence for the most part be damned. In brief, Dr. Prasad was insufficiently antivax for MAHA and too strict an EBM advocate for “medical freedom.” That essential conflict guaranteed that his tenure was never going to end well.
Worse, as a result of this dustup, RFK Jr. now seems to realize the inherent problem that CBER presents him when it comes to realizing his twin visions of making it all but impossible to approve new vaccines and making it much easier to approve dubious MAHA-approved stem cell therapies. The two aims are in fundamental conflict, which is why there is now talk of splitting vaccine approval out of CBER into a new office at FDA. This would allow RFK Jr. to put an antivaxxer in charge of vaccine approval while putting someone more —shall we say?—open-minded in charge of approving stem cell therapies.
Finally, Dr. Cifu laments:
I am bewildered by political operatives who demand loyalty over effective work. I am disappointed that Vinay’s superiors apparently bowed to pressure over a drug whose safety is more in question than that of any of the vaccines that the HHS secretary spends so much time criticizing.
That Dr. Cifu thinks it was just about this drug shows just how oblivious he has been to the antiscience forces that I and people like Dr. Howard have been warning about for years and years. These are the same forces that put an unqualified hack like Dr. Jay Bhattacharya in charge of the NIH just because he has politically aligned with them and is willing to be the figurehead—the useful idiot, if you will—to preside over the ideologically motivated dismantling of the NIH. Similarly, Dr. Makary is the useful idiot chosen to preside over the neutering the the FDA, and Dr. Prasad was the useful idiot in turn chosen by Dr. Makary to demolish the vaccine approval process.
To sum it up, I’m with the Pandemic Accountability Index:
…nobody should let Vinay Prasad live this down. He wanted to become a celebrity, appearing on countless podcasts and Youtube videos spewing unscientific garbage to stand out and build a personal brand for himself. Now everyone knows him as the biggest clown in medicine, flaming out of the Trump Administration in a matter of just a few weeks. Was it worth it, Vinay?
Dr. Prasad is shameless. I suspect that, if he can return to social media as a martyr toppled by big pharma and can monetize that status, he will end up answering yes. He doesn’t have to be respected by his colleagues to achieve that. Don’t believe me? Just look at Dr. Mehmet Oz, America’s Quack.
Dr. Prasad and his shameless thirst for fame and influence aside, I will conclude by observing that far too many of my colleagues have been oblivious or even blind to the forces of quackery and antivax pseudoscience that are now firmly in control of the entire nonmilitary departments and agencies of public health, medicine, and biomedical research in this country, all led by a raving but clever antivax conspiracy theorist who wants to eliminate as many vaccines as possible while giving quackery the imprimatur of FDA approval. These are the same forces that have contributed to the infiltration of the very alternative medicine quackery (e.g., homeopathy) that Dr. Prasad considered a no-brainer to debunk into the bastions of academia, including the NIH and many academic medical centers. Whether he knew it or not, Dr. Prasad was brought in to weaponize EBM against vaccines while at the same time approving more stem cell quackery. He tried navigate the choppy sea between the Scylla and Charybdis of those imperatives but failed.
Don’t feel sorry for him, though. He chose this, and he’ll likely ultimately be fine. No doubt he’ll return to his career as a contrarian and obnoxious social media influencer. Meanwhile, the destruction of public health and science-based medicine by the crew with whom he played footsie continues apace.