Thoughts on Vinay’s Leaked Email, Part II

Two of Vinay Prasad’s emails have been all over the media in the last week. The emails warrant attention for several reasons. The first email concerned research within CBER. I thought this one raised some interesting issues about the differences between doing research in a government job and in an academic one. The issues covered in the email were a bit arcane, though, and it didn’t get that much attention.

The second email, which dealt with COVID vaccine injury, is important and has been widely covered. John beat me to posting about this on Sunday, but I still wanted to have a say. I will not read John’s piece until after I finish this one, so our comments are individual and independent. I also write without any information from Vinay about events surrounding this email, so I am basing my opinion solely on what I read. I am obviously far from an unbiased observer of Vinay Prasad’s work, but I also promised that I would try to be a fair judge of him while he is at the FDA.

I’ll start by writing that I find it troublesome that we are reading internal emails. There have been times when I’ve applauded the leaking of information. We live in a democracy -- government of the people, by the people, for the people -- and we have a right to know what our government is doing. On the other hand, in order for an office to work, some things must stay private. From the email, there are clearly strong beliefs and disagreements at the CBER, which are probably affecting the work that is being done.

A few notes on the email

I linked to the email above, and it is probably worth giving it a read or having it to reference for this commentary to make much sense.

I find the paragraph that begins: “This is a profound revelation…” unnecessarily inflammatory. We have already gone too far down the path of politicizing medicine, and it needs to stop. Knowledge of these deaths, which occurred between 2021 and 2024, and necessitated, what I expect was, a detailed forensic chart review, could not have changed our response much earlier. Writing like this is meant to score points with a few, and it isn’t good for most of us. Dr. Makary echoed the language on Sunday news shows. I understand that this administration loves to use the language that disrespects their “rivals,” but I’d like to think that those of us in medicine are above this childishness.

I take it at face value the report’s contention that at least 10 children died from the COVID vaccine. I do not find that number surprising. We vaccinated millions of children. We know the vaccine has rare side effects, myocarditis being the most important. Of course, a small number of children would be harmed. To those who dismissed this data, I’d encourage you to have a more open mind. Of course, a temporal relationship between vaccine and death is not proof of causation. But a detailed review, as would be possible with a small number of cases, could show us when causation was likely. (If you think Drs. Makary, Hoeg, and Prasad are just making stuff up, then we disagree.)

In the paragraphs that follow the question, “Did COVID-19 vaccine programs kill more healthy kids than it saved?” I do not think it is stated strongly enough that it would be a fool’s errand to try to figure out if, on balance, the vaccine prevented more deaths in children than it caused.¹ As Dr. Prasad alludes to, we are comparing case reports, which I trust have been well-researched, with large cohort studies, with all their inherent confounding, that show 70–90% efficacy against COVID–19–related hospitalization and >90% efficacy for protection against ICU admission and the need for life support. In children 5–11 years, vaccine effectiveness against COVID‑19 hospitalization is on the order of 70–75%. (These data were all early in the era of COVID vaccination.) My personal sense with “back of the envelope type calculations is that the harm/benefit was essentially a wash in this population.²

The paragraph that begins page three, stating: “There Is no doubt that without this FDA commissioner…” is clearly aimed at the CBER staff. Prasad asks why CBER has fallen short. This is the problem with analyzing leaked emails. We know little of the culture he is addressing.

Vinay’s discussion of COVID-related myocarditis is clear. We know that COVID and the COVID vaccine caused myocarditis. We have pretty good data on the rate of vaccine-induced myocarditis and flawed data on virus-induced myocarditis. The case that, by now, almost everyone has had both the vaccine and COVID makes the data even more confusing. We will never know what was, or is, more dangerous.

The fourth page of the email discusses the problems with leaks and the unique finances of vaccines. We have alluded to these issues on Sensible Medicine.

The last page of the email is dedicated to a path forward. Many who objected to this email were clearly struck by this page, and some labeled it as “antivax.” I do not think this is true. I think I read it as I expect Vinay intended. Vaccines, despite the recent politicization, or maybe because of it -- and mindful of the unique product they are for companies -- will be treated the same as other drugs. We need to wait and see how this is actually accomplished and what its impact will be.

I find the discussion of third-party benefits interesting, but not terribly important. Most of our medical treatments provide benefits to people other than patients. As Prasad notes, antipsychotics benefit not only patients but their families. It is a rare medication for which these benefits have been meaningfully considered. The MMR vaccine, polio vaccine, and directly observed therapy for TB are treatments that clearly benefit people other than the patient. But how about the influenza and rotavirus vaccines in children, and their impact on parental lost wages? Do we begin to consider all the downstream savings of preventing a fracture with a bisphosphonate? I do not think we are at a place to really consider these effects.

Conclusion

I do not think we should be reading every communication between Vinay and his staff. They have a job to do, and it can be done best by figuring out a way to work together. Leaks are useful if something egregious is happening. The identification of a rare harm associated with a treatment and a plan to treat vaccines like other drugs does not warrant a leak, especially before the information is announced to the public. I worry that in the future, staff will learn of important policy changes when they are announced publicly because it will be considered risky to communicate privately. This would be unfortunate.

In my opinion, there are certainly parts of this email that could have been better. The partisan attacks should have been deleted. There should have been clarity regarding the unknowability of the retrospective balance of risks and benefits of the COVID-vaccine in young people. I don’t believe we will ever be at a place where the impact of our treatments on third parties (besides financial impacts) can ever be routinely considered in drug approval.

Now, I will read John’s piece…

Photo Credit Mariia Shalabaieva

1. It is a measure of how divided we remain on this topic that just reading that sentence will inflame passions on both sides of the issue.

2. The vaccine was clearly beneficial in older age groups.