Prasad’s lifelong commitment to scientific rigor will help rebuild lost trust in regulatory bodies.
Whether it’s with COVID or RFK Jr., my writing is fundamentally about doctors who spread misinformation to numb us to obvious but grave risks, while being sheltered from the consequences of their words. In a previous article titled Go Ahead, Make the Case that Science, Free Speech, and the NIH are Thriving Under Dr. Jay Bhattacharya, I invited doctors who assured us that Dr. Bhattacharya was competent and qualified to make the case that they were right. So far, none have done so.
With that in mind, we can turn to two “medical conservatives,” Drs. Adam Cifu and John Mandrola, who run Sensible Medicine, a monetized Substack that publishes propaganda such as Why Doctors Should Learn to Stop Worrying and Love MAHA. Not long ago, they wrote an article there titled Sensible Medicine endorses Vinay Prasad for Director of the Center for Biologics Evaluation and Research (CBER) at the US FDA. It said:
Vinay Prasad is leaving Sensible Medicine to take a senior role at the US FDA. He has our enthusiastic support. Prasad is slated to be the incoming CBER director, where he will regulate vaccines as well as cellular and gene therapy. In our opinion, there is no better candidate…
We can’t think of anyone more qualified to lead the biologics division. Prasad’s lifelong commitment to scientific rigor will help rebuild lost trust in regulatory bodies.
Dr. Mandrola followed that up with an article titled Can We Give the New FDA Leadership a Chance that said:
When Marty Makary and Vinay Prasad became leaders at FDA, many pundits worried they would damage public health. Both had “anti-vax” tendencies, went the narrative. Adam and I knew that was not true… I am excited and optimistic about the new leadership at FDA. They speak with clarity, humility and in a language the general public can understand. The transparency will begin to restore some of the lost trust. Good on them.
None of this was true of course. Drs. Makary and Prasad had an atrocious COVID track and both of them behaved in a juvenile manner towards anyone who corrected their basic factual errors. There was no reason to think either of them was qualified for their current positions. Why would the author of We’ll Have Herd Immunity by April be a competent steward of the FDA? Why would a doctor be able to restore trust when he treats lab values after vaccination more seriously than literal death from COVID?
Prasad rarely attends center meetings with office directors, and that their questions about the budget, HR functions, and IT systems have gone unanswered.
Drs. Makary and Prasad have been in the news a lot recently, and we can begin to evaluate their performance so far. According to the article Vinay Prasad Named Chief Medical and Science Officer At FDA:
Multiple agency 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. Prasad did not consult career staff before unveiling a new regulatory framework for Covid-19 vaccines with Makary in May.
Nearly every article about the FDA contains quotes from “agency employees, who requested anonymity to protect against retaliation.” The reason they might feel this way are obvious. Thousands of FDA employees have already been fired, and according to an article about a purged FDA expert, Dr. Nicole Verdun:
Verdun, and her deputy, Rachael Anatol, were placed on administrative leave by Prasad, and escorted out of FDA headquarters on Wednesday, STAT reported exclusively. Verdun told staff she was not given an explanation for the firing. She declined to comment for this story.
Longtime FDA employees noted that immediately escorting employees out of the FDA is unusual, and was seen by some staffers as cruel. Multiple employees could be heard voicing outrage over the move during a call Verdun convened to tell staff of the news Wednesday, according to a recording that was obtained by STAT.
Marching employees out of their offices is a bigger deal than a private organization canceling a single speech, isn’t it? Previously, this incident warranted an hour-long Sensible Medicine podcast.
Another article titled FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say said:
ProPublica spoke to 10 current and former FDA staff members and leaders in recent weeks, including inspectors who said that the loss of support staff has slowed critical investigations and that little relief has materialized. Most declined to be named because they were not authorized to speak publicly or feared backlash within the industry as they search for new jobs.
Another article titled FDA Head Falsely Claims No Scientists Laid Off, As Agency Shutters Food Safety Labs said:
The head of the Food and Drug Administration has repeatedly claimed in recent interviews that no scientists have been laid off at his agency, but one of the scientists in a food safety lab shuttered by the FDA’s cuts says he is either “blatantly lying” or “out of touch.”
“There were no layoffs to scientists or food inspectors,” FDA Commissioner Dr. Marty Makary told CNN on Wednesday. Makary previously said in an April 17 interview with Megyn Kelly that there “were not cuts to scientists, or reviewers, or inspectors. Absolutely none.”
“That just made me so mad, that he said no scientists were cut,” said one laid-off FDA scientist, a chemist who had worked for the agency for years.
Another article titled Inside the Collapse of the F.D.A. said:
One thing that appeared not to have changed was the F.D.A.’s relationship with drug makers. In June, Makary and his deputies began a six-city listening tour with drug-industry executives that was, despite all the talk of radical transparency, closed to the public. (According to Nixon, the communications director at H.H.S., the tour was focused on industry stakeholders, and public transparency would be preserved through other forums.) Later that month, Makary announced a voucher program that would shorten drug review times from 10 to 12 months to just one or two for companies whose products met certain criteria. He also laid out a new list of agency priorities in The Journal of the American Medical Association that, for drugs, seemed to come down to two things: faster reviews and more approvals. “Their paper reads like it’s straight from pharma’s playbook,” Ramachandran told me. “They criticized expedited drug reviews for years, especially with respect to Covid vaccines, saying that it turned the F.D.A. into a rubber stamp. But now they want to do the exact same thing for as many other drugs as possible.”
Reports from inside the agency remained bleak. Some of the civil servants fired in February and April were now being invited back (the office of generic drugs had been reinstated), but most were not. Those who remained were being asked to volunteer for essential tasks for which there was now no dedicated staff. Scientists and technicians still did not have ready access to the scientific journals they needed to do their work. More than one drug review had been delayed, and political appointees had interfered in several others. And, ultimately, Vinay Prasad, the agency’s new chief medical and scientific officer, overrode expert recommendations on the Novavax and Moderna Covid-19 boosters slated for this fall. As expected — and perhaps as intended — many of the F.D.A.’s remaining employees were now looking for jobs outside the government.
Another article titled Inside the Staff Exodus and Tanking Morale That Threaten Makary’s FDA said:
FDA employees are spooked by increasing political involvement in regulatory decisions, frustrated by the impact of cuts to administrative staff who supported drug reviews and inspections, and fed up with proclamations from the commissioner’s office that they contend rarely take career staff’s expertise into account…
The mood has plummeted in the drug and biologics centers in particular. Prasad, who has also been named the agency’s chief medical and scientific officer, pushed out top gene therapy official Nicole Verdun and her deputy in June. Shortly after, drug center director Jacqueline Corrigan-Curay announced that she was retiring. Makary and Prasad bypassed career vaccine scientists to write a new Covid-19 vaccine framework in May, and Prasad overruled staff to narrow the approvals of Covid shots from Novavax and Moderna…
Employees told STAT they wished Makary and other leaders would solicit more input before announcing major initiatives to the public. There’s little communication from Makary to staff outside of selfie video snippets he sends trying to cheer up employees. Staff have been left out of key decisions in their areas of expertise, like the development of the Covid-19 vaccine framework and a new priority review program…
As many as 600 reviewers have recused themselves from regulatory decisions due to interviewing for work with pharmaceutical companies, former FDA Commissioner Scott Gottlieb said in April. STAT’s agency sources said a high number of reviewers continue to be recused.
Leaders in charge of entire FDA centers, as well as those at the forefront of AI policy, cybersecurity, cell and gene therapies, and drug safety surveillance are gone, according to information compiled by STAT.
“I think anybody would be dumb not to be looking,” said a reviewer in the drug center. “We could be paid more in the private sector and appreciated more.”
Dan Gold, president of life sciences recruiting firm Fairway Consulting Group, said that in the past, he would receive unsolicited calls from interested FDA employees once a year. Now, he speaks to someone from the FDA or the Centers for Disease Control and Prevention every week.
Dr. Makary, along with RFK Jr. and Dr. Bhattacharya, is also being sued for his role in restricting COVID vaccines. According to the article Medical Groups Sue HHS, Kennedy Over COVID Vaccine Policy Changes.
The plaintiffs also include an unnamed pregnant doctor who has been barred from getting a COVID-19 booster, based on the recommendations that Kennedy announced unilaterally in May. The doctor contends that she is at high risk for exposure to infectious disease due to her job working as a hospital-based physician. The groups that signed onto the lawsuit are the American Academy of Pediatrics (AAP), the American College of Physicians (ACP), the American Public Health Association (APHA), the Infectious Diseases Society of America (ISDA), Massachusetts Public Health Alliance (MPHA), and the Society for Maternal-Fetal Medicine (SMFM).
The lawsuit mentioned Dr. Prasad, as well as Sensible Medicine author Dr. Tracy Hoeg, and an article titled Top F.D.A. Official Overrode Scientists on Covid Shots shed some led some light on how Dr. Prasad worked behind the scenes to impose his will on millions of Americans. It said:
Dr. Prasad overruled those recommendations by the end of May and instead advised restricting the use of both Covid vaccines…
The Food and Drug Administration’s top vaccine official rejected broad uses of two Covid vaccines, citing unknown risks or injuries despite assurances of safety from dozens of staff experts, newly released documents show.
The decisions by the official, Dr. Vinay Prasad, the agency’s new chief medical and scientific officer, stunned agency veterans. Records show that the F.D.A.’s vaccine staff members had signed off on approving the Novavax vaccine, an alternative to mRNA shots and weeks later on the next-generation of the mRNA Covid shot by Moderna for anyone 12 and older.
So much for radical transparency.
However, this article wasn’t just noteworthy for its depiction of “stunned agency veterans.” It had over 400 reader comments, nearly all of which blasted Dr. Prasad for his unscientific intrusion on to their medical freedom and bodily autonomy. Here are some samples:
- The vaccines should be available to everyone. Let people make the decision with their physician. Gatekeeping a vaccine is morally wrong.
- I have elderly parents and a best friend with a liver transplant. Who is this guy to tell me I can’t protect my loved ones? Because I’m 10 years too young? I can’t work from home, I have to work from work and I could easily bring something home with me to my family.
- Was Vinay Prasad at the frontline in 2021 and 2022? No; he was making podcasts in which he claimed that the US response to COVID-19 was like the rise of Nazism in 1930s Germany.
- For those of us who know, Dr. Vinay Prasad from medical Twitter, none of this is surprising. Childish taunts, vulgar insults, pseudoscientific nihilism, we’ve seen it all. Dr. Prasad was such a toxic character that an account was created entitled “blocked by Vinay Prasad” which had over 1000 examples of medical professionals who were blocked. Having spent the past five years cheering for SARS CoV2 and the Covid contrarians, Dr Prasad is now moving in on US public health. We are doomed.
- It seems that refusing to approve a vaccine due to imagined possible consequences, when there are real consequences from not getting vaccinated, is poor science.
- This is beyond frustrating. I am a “healthy young person” but am constantly around immunocompromised people in both my immediate family and at work. I want to continue getting vaccinated to keep my loved ones and students safe, however I don’t know how this will work if I myself do not have a medical reason to need to vaccine. If people want the vaccine, they should be able to get it without having to pay ridiculous amounts of money and jump through extra hoops.
- As someone who knew Dr. Prasad professionally, this does not surprise me. He is an extremely difficult person to work with and is widely disliked by his colleagues, largely for his dismissive nature, arrogance, and constant need for provocation as a tool for self-aggrandizement. He is not inherently a bad scientist (though he appears to have gotten this one wrong per the genuine experts quoted), but the problem is that you cannot know if his opinion is based on facts and data or is shaded by his need to be contrarian. I personally don’t know the data here well enough to have a defensible opinion but I know him and have no faith that his opinion is not swayed by his opportunistic nature. It is clearly more politically advantageous in this administration to discourage vaccination. As a final aside, you know who wasn’t in the hospital seeing patients who were dying of Covid? The oncologist who is now in charge of our nation’s vaccine program.
Virtually no readers defended Dr. Prasad, and none of them did so in an intelligent, coherent way.
This sort of criticism isn’t just limited to print journalism. Leading experts such as Dr. Paul Offit, Michael Osterholm, and the hosts of This Week in Virology routinely lambast Drs. Prasad and Makary. They have become objects of scorn and ridicule amongst many doctors on social media as well. Conversely, anti-vaxxers are furious with Drs. Prasad and Makary for not having banned COVID vaccines altogether. Their attempt to be “nuanced” only led to no one trusting them at all.
Meanwhile, Drs. Prasad and Makary have nothing to say as their boss takes a wrecking ball to vaccines, both domestically and internationally, and as measles and pertussis spread under their watch. This will part of their legacy too.
They just cheerlead for the establishment
But hey, maybe I am wrong about all this. I have an open mind and am willing to learn. As such, I hope Drs. Cifu and Mandrola will have the integrity to defend their words. I hope they can explain why things are going great at the FDA, that it’s a bastion of open debate, and that its leaders are restoring trust. Unlike Drs. Cifu and Mandrola, I do not constantly boast of my “nuance” or claim to be a master of “clinical appraisal.” They have so much to teach me.
If future news headlines report one success after another at the FDA, I will happily share them. But something tells me Drs. Cifu and Mandrola will be as silent as church mice about what’s currently happening there. As Dr. Prasad informed us, there are some doctors- “motherfuckers” and “fucking morons”– who “just cheerlead for the establishment.” He may have been premature in making this vulgar accusation, but it turns out he wasn’t fundamentally wrong.
