As one of the few who called for RCTs
Although COVID vaccines were brand new in February 2021, Dr. Vinay Prasad promised they would end the pandemic and berated people who took a medically conservative approach to them. He also praised pharma at the time, saying:
It’s really good news to see that covid cases are falling. Vaccine is amazingly effective & was developed so fast, I was impressed I’ve long been a critic of pharma, but they did a good job here. Good news.
He was right about this at least, and I still consider Operation Warp Speed to be the greatest scientific achievement of my lifetime. While countless people deserve credit for its success, one hero was Dr. Peter Marks, Dr. Prasad’s predecessor at the FDA. As early as April 2020, Dr. Marks formulated the plan that would lead to lifesaving vaccines before the end of the year.
While Dr. Marks was busy delivering RCTs, Dr. Prasad was busy glorifying himself for being “one of the few who called for RCTs” and castigating others for not doing the trials he “told them” to do in juvenile, profane rants. As I discussed previously, Dr. Prasad did this not to genuinely advance medical research, but rather to spread doubt and mistrust.
An evidence-based catastrophe of low quality evidence
Though this technique was manipulative and dishonest, it was undeniably effective. Today, Dr. Marks, who blasted Kennedy’s need for “subservient confirmation of his misinformation and lies” in his resignation letter, is no longer at the FDA. Dr. Prasad, however, is still weaponizing EBM to spread doubt and mistrust about vaccines. Nothing’s changed.
In his recently “leaked” memo, Dr. Prasad spoke of an “evidence-based catastrophe of low quality evidence” and demanded improvement. He wrote:
I want to outline a path forward. Our general approach in CBER will be to direct vaccine regulation towards evidence based medicine. This means: we will take swift action regarding this new safety concern, we will not be granting marketing authorization to vaccines in pregnant women based on unproven surrogate endpoints (any prior promises will be null and void), and we will demand premarket randomized trials assessing clinical endpoints for most new products. Pneumonia vaccine makers will have to show their products reduce pneumonia (at least in the post-market setting), and not merely generate antibody titers. Immunogenicity will no longer be used to expand indicated populations– these populations should be included in premarket RCTs.
We will revise the annual flu vaccine framework, which is an evidence-based catastrophe of low quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods. We will reappraise safety and be honest in vaccine labels. I look forward to hearing your thoughts on how to do this better.
Additionally, at FDA, we have not been focused on understanding the benefits and harms of giving multiple vaccines at the same time. This is a concern shared by many Americans. The FDA’s standard has been to require randomized studies too small to draw any conclusions from– creating a false sense of efficacy and safety.
It would be unethical to use placebos and let people get pneumococcal pneumonia.
Of course, no one actively opposes better evidence, and Dr. Prasad is not unique in his desire for RCTs to answer every question about vaccines. Some of just also know that there are practical and ethical limitations to this approach. As the article FDA Official Proposes ‘Impossible’ Standards for Vaccine Testing That Could Curtail Access to Immunizations reported:
Demanding an RCT would prevent pregnant women from receiving most vaccines, said Jake Scott, MD, a clinical associate professor of infectious disease and geographic medicine at Stanford University School of Medicine.
That’s because pregnant women are almost never included in RCTs of vaccines or other drugs due to potential risks to the fetus, Scott said. Instead, the FDA does careful safety monitoring and measures antibody levels in women’s blood, which can show whether the vaccine is generating an immune response.
In his memo, Prasad also wrote that “pneumonia vaccine makers will have to show their products reduce pneumonia,” at least after they’re licensed, rather than provide indirect evidence of protection, such as antibody levels.
Prasad appears to refer to a childhood pneumonia vaccine that blocks infections with pneumococcus bacteria, which has been updated and improved several times over the years, said Dorit Reiss, PhD, a law professor at the University of California Law, San Francisco. Although the first version of the vaccine protected children from seven bacterial strains, the latest iteration protects against 20 strains.
Pneumococcal vaccines on the market today are approved based on antibody levels that correlate with protection and have been validated over decades, Scott said.
Proving that childhood vaccines prevent cases of pneumonia would be difficult, Scott said, because so many pathogens can cause pneumonia, including the flu, COVID-19 and respiratory syncytial virus (RSV).
Requiring manufacturers to conduct additional clinical trials every time they want to add additional viral or bacterial strains would delay updates by several years, all the while leaving people vulnerable to the bacteria, Reiss said. Some companies may decide that conducting such trials is too expensive.
“You’d need massive, expensive trials that many companies won’t pursue,” Scott said.
Conducting RCTs of proven vaccines could also be unethical, said Jesse Goodman, MD, who previously filled Prasad’s role at the FDA and now directs Georgetown University’s Center on Medical Product Access, Safety and Stewardship. “It would be unethical to use placebos and let people get pneumococcal pneumonia,” Goodman said.
Indeed, in a Prasadian universe, the results of RCTs would be available in 2027 to tell us exactly what we should have done in 2026. Pharma companies will be portrayed as villains for failing to conduct proper studies, and Dr. Prasad will portray himself as a heroic defender of EBM against barbarians who are indifferent to evidence. Meanwhile, pathogens will spread, and people will suffer preventable harms.
They need to do studies
It’s possible that Dr. Prasad’s critics are wrong about all this, and fresh RCTs are required for every tweak to every vaccine for every demographic subgroup. However, the techniques that catapulted Dr. Prasad to power aren’t sufficient now that he has power. He is the medical establishment now. As such, it’s not his job to merely “call for” RCTs- that’s our job as citizens. Rather it’s his job to deliver RCTs and to do so in a useful time frame via independent agencies that skeptical Americans will trust. Many people wouldn’t trust a study of the Pfizer vaccine paid for and carried out by Pfizer, and Dr. Prasad deliberately stoked mistrust of such research, writing:
If you run vaccine trials for Pfizer, the conflict doesn’t go away when the trial ends, because you’re going to run another one after you ram through their garbage products.
Fortunately, Dr. Prasad claimed to know exactly how to do these RCTs himself. Last year, along with Dr. John Ioannidis, he wrote an article titled Evidence Base for Yearly Respiratory Virus Vaccines: Current Status and Proposed Improved Strategies in which he said:
Well-conducted experimental studies, particularly randomized trials, are necessary to address persistent uncertainties about influenza and COVID-19 vaccines. We propose a new research framework which would render results relevant to the current or future respiratory viral seasons. We demonstrate that experimental studies are feasible by adopting a more pragmatic approach and provide strategies on how to do so. When it comes to implementing policies that seriously impact people’s lives, require substantial public resources and/or rely on widespread public acceptance, high evidence standards are desirable.
An entire section was titled “clinical trials are necessary and feasible.” He made it all sound so easy.
Even as a brand-new virus raged in 2020, Dr. Marks provided a template for Dr. Prasad on how intelligent, competent FDA leaders can produce concrete results for the American people. He tested and provided new vaccines in under a year. Now it’s Dr. Prasad’s turn to dazzle us all with his real-world prowess and abilities. As he put it when he was out of power and fluffing Kennedy:
The establishment, the people who set the policies, they have to strive to get things right. They need to do studies. They need to course correct. They have to admit their errors. They need to be held to the highest standard.
It’s hard to argue with that.
