“I must have tweeted 100+ times the need for randomized data for all these pandemic questions”
Few disinformation doctors used methodolatry, the disingenuous deification of randomized-controlled trials (RCTs), more effectively than Dr. Vinay Prasad. He often said his philosophy was “RCT or STFU for all” and falsely portrayed anyone who recognized the practical and ethical limitations of RCTs as actively opposed to them. For example, in his article The Scientists Who Undermine Randomized Trials he said:
There have been several examples of scientists trying to undermine randomized trials— arguing they are not possible, not practical, or not useful. All of these arguments are false.
Of course, no one was trying to undermine RCTs.
Dr. Prasad was extremely proud of himself not because he conducted RCTs, but rather because he “called for” them. “I must have tweeted 100+ times the need for randomized data for all these pandemic questions”, he boasted, though he was probably right about that number. In his telling, dreaming up RCTs on social media was hard, actually doing them was easy, and prior FDA leaders were too stupid to figure this out. “I want them to admit they didn’t run any studies even though people told them to,” he said in the profane video below. People told them!
In reality, Dr. Prasad’s predecessors didn’t need him to tell them anything. Even as COVID raged in 2020, they delivered multiple successful RCTs in under a year via Operation Warp Speed. Nonetheless, Dr. Prasad said they were lying “pieces of shit,” underserving of forgiveness for their supposed failures in this regards.
“I want them to admit they didn’t run any studies even though people told them to.”
I previously discussed that Dr. Prasad glorified RCTs not to genuinely advance medical research, but rather to cast fear and doubt on unwanted COVID mitigations. I also noted that “having an idea for an RCT is infinitely easier than actually doing an RCT“, though Dr. Prasad is hardly unique in recognizing their value. I volunteered for a COVID vaccine RCT myself and encouraged SBM readers to enroll in them if given the opportunity.
Dr. Prasad never did this.
RCTs require trusting volunteers, and Dr. Prasad spread doubt. He gave his audience every reason to avoid RCTs, especially regarding COVID vaccines. He ignored RCTs that showed the vaccine worked and repeatedly told people to stop talking about COVID years ago. He treated rare vaccine side effects as a fate worse than death, mocked people who wanted COVID vaccines, and spread mistrust about the companies and scientists who conducted such research. He literally wrote articles titled Public Health Should Lose Your Trust. It was doctors like him who undermined RCTs.
“Pfizer, BioNTech Halt US COVID Vaccine Study After Recruitment Struggles”
Once in power, however, Dr. Prasad claimed things would change. He would finally deliver new RCTs of the COVID vaccine, and trust would be restored. While his moronic, incompetent predecessors had failed, Dr. Prasad said he had instructed companies to “generate data for the American people and doctors, who quite frankly don’t know what to do.” Once again, Dr. Prasad “called for” other people to do RCTs, though this time not as a pundit on Twitter, but as a public servant with responsibility for making sure these trials got done.
Recruiting for RCTs is never easy, and many trials, including past COVID trials failed to meet their goal. Enrolling subjects in new vaccine RCTs was always going to be especially challenging. Anti-vaxxers would never enroll in a trial where there was a 50% chance they would get a vaccine, while pro-vaxxers would never enroll in a trial where there was a 50% chance they would get a placebo. Most people don’t think about COVID vaccines at all.
Despite this, I never saw Dr. Prasad promote these new RCTs. Although he had a massive platform as the FDA’s chief vaccine regulator, he never used his voice to boost enrollment.
It’s no surprise that today under his “leadership,” the headlines read Pfizer, BioNTech Halt US COVID Vaccine Study After Recruitment Struggles. The article said:
Vaccine makers Pfizer and BioNTech halted a large U.S. trial of their updated COVID-19 vaccine in healthy adults aged 50 to 64, saying enrollment in the trials had been too low to generate the needed data…
The target enrollment was roughly 25,000 to 30,000 participants.
“This study is not ending as a result of any safety or benefit-risk concerns. We intend to stop the study due to slow enrollment and therefore the inability to generate relevant post-marketing data,” the companies said…
“This is a very difficult population to recruit,” said one executive at a contract research organization involved in the trial, who spoke on the condition of anonymity.
“Even when patients are willing to participate in COVID studies, more than 80% fail at pre-screening because they don’t meet the health criteria. It’s been a real challenge to enroll enough patients, particularly given the scale of these trials,” the executive said.
“It’s been a real challenge to enroll enough patients.” Does that surprise anyone?
But let’s be clear what happened here. Dr. Prasad rose to power by weaponizing a trial design, using RCTs to spread anger and mistrust about anyone whose job it was to stop people from dying of COVID. While he promised things would be better under his leadership, when given opportunity to prove his mettle in the real-world, he failed. It turns out that Tweeting about RCTs 100+ times is a lot easier than delivering even a single RCT. As such, we can all expect and demand that Dr. Prasad STFU once he leaves the FDA.
