Thoughts on Vinay Prasad's Leaked Email

Many people have had many things to say about the Friday email that Vinay sent to colleagues at CBER last week.

Here is my attempt at a Neutral Martian breakdown of the main points. Of course, I am not quite neutral because Vinay and I are friends.

First, I have read criticisms that such a vague report of vaccine related deaths—without evidence—could scare the public about vaccines.

My response: This was a private internal email, not a public statement. In a trusted organization, it would have stayed internal.

As for the vagueness, the email already had many thousands of words, and the point of it was to say that they had investigated these cases and found causation likely. Surely the evidence will be forthcoming. It’s an internal email; not a public PowerPoint.

Second criticism: You can’t determine causality from a VAERS report.

This is both true and false. It’s true that a single report cannot establish cause. But if one looks deeper into the clinical data from a report, a picture may emerge. Clinical medicine is not that complicated.

Let’s say a young person complains of chest pain days after a COVID-19 vaccine and in the hospital, the ECG is abnormal, enzymes are elevated and echocardiogram finds systolic dysfunction. That’s suspicious for myocarditis. Now an MRI finds evidence of focal inflammation. Still though, this could be viral myocarditis; but if every viral panel is negative and there are no symptoms of infection, you are left with a strong case of vaccine causality. As for death from myocarditis, NEJM has published multiple reports where (presumed) vaccine myocarditis led to death. Also, death from myocarditis is known to occur.

I suspect, but do not know, that this is the way FDA investigators will show COVID-19 vaccines caused death. I look forward to the details of the investigation. You should too.

Third criticism: Some worry that the current administration’s new approach to vaccines is too strict and will have a chilling effect on vaccine development and uptake

Well, I am not a regulator, but I can read public data on trust in vaccines—which is at a low level. Some say that this is due to anti-vaxxers. But. Is it possible that Americans saw inconsistencies during the pandemic?

For instance, everyone knew that there was steep age gradient for the risk of complications from SARS-CoV-2 infection, with the young much less likely to become ill. And if that’s the case, why would officials mandate a vaccine for everyone when young people were largely not threatened?

A possible answer was taking a vaccine would protect others. Third party benefits are a known benefit of some vaccines (measles). But then it became clear that COVID-19 vaccines did not block transmission.

Yet, despite this common knowledge, vaccine mandates largely remained. Most egregious was that colleges continued to mandate COVID-19 vaccines in the population MOST susceptible to vaccine-related-myocarditis—young people.

I would propose another possible effect from a stricter approach to vaccine regulation: it may enhance public trust in vaccines.

Cardiologists recommend at least 4 classes of drugs to patients with heart failure. It is a burden to take this many pills. But each one has been shown—in randomized trials—to add incremental benefit. Why can’t this be the norm in infectious disease?

Here at Sensible Medicine, Adam, Andrew and I discussed a placebo-controlled RCT of pneumococcal vaccine in more than 84,000 people. I tell you about this because a) trials of vaccines are possible, and b) the benefit was shockingly small in absolute terms. Indeed the study met statistical significance for benefit, but the absolute risk reduction was 0.1% and number needed to vaccinate to prevent one pneumonia was more than a 1000.

As Vinay writes in his email, vaccine makers have a long tail of profit from their product. Vaccines don’t go generic, for instance. Why shouldn’t they be forced to prove efficacy and safety BEFORE release?

Such a policy not only provides direct evidence, but it also enhances public trust because people see regulators doing regulation.

A fourth criticism was that even if COVD-19 vaccines rarely caused myocarditis, the risk of myocarditis was greater with infection.

The Lancet published such a study this month.

Vinay dispelled this misthink in his email. These are all flawed analyses because they compare people with vaccine myocarditis (a group with a known denominator) to people who present with infection-bad-enough-to-be-seen-in-clinic (a group with an unknown denominator). The proper comparison is all people with SARS-CoV-2 infection—a much larger group than in the study.

This is an impossible comparison to make. That authors do such a flawed analysis, and journal editors publish it, and 202 news organizations cover it, does little to improve public trust. People think: if the study is broken, why do it?

Conclusion:

People disagree on policy. But everyone can agree that safe and effective healthcare is a society goal.

I think we should withhold judgement on the new FDA. They haven’t had even a year.

We should judge them not on internal emails, but results. Having seen the result of bad regulation, I remain optimistic about the new FDA leadership.

Give them a chance.