Marty Makary is up for FDA commissioner

In honor of his nomination, we reprint one of his Sensible Medicine essays

Marty Makary, an editorial board member of Sensible Medicine, is up for FDA commissioner. In honor of that, we reprint one of his essays. Elsewhere I have a short piece on how the media coverage of him has been biased, and why I support his nomination.

In the piece below Marty was correct that there is no data to support year over year COVID boosters, and I, like most Americans, don’t get them. If Marty is FDA commissioner, I suspect the FDA may not even approve them yearly outside of ultra-high risk groups (nursing home patients/ people over 80).

Marty Makary: Is the First Good Pick for FDA commissioner in a long time

Vinay Prasad MD MPH

Before We Push the New Omicron Vaccine, Let’s See The Data

The White House is pushing Americans hard to take a novel Covid vaccine before the studies are complete.

By Marty Makary, MD

On Tuesday, White House Covid Coordinator Dr. Ashish Jha implored Americans to get the new Covid vaccine: “It’s going to be really important, that people this fall and winter, get the new shot,” he said in a conversation with the U.S. Chamber of Commerce Foundation.

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But where’s the data to support such a sweeping recommendation? The new mRNA vaccines expected to be authorized next month have no clinical trial results that are public. In fact, we know nothing about them. Urging the American people to blindly obey to take a novel mRNA vaccine is not only bad medicine, it’s bad policy. And it’s certainly not following the science.

We just saw this data ambush approach two months ago with the Covid vaccines for babies and toddlers. Here’s how the timeline played out. The White House and public health officials promised them and pushed them hard for children between the ages of 6-months and 5 years. Then vaccine manufacturers released data and declared them safe and effective (the media blindly parroted the message). Here’s the catch. The underlying data actually showed the study sample was too small to make safety conclusions, and most of the claimed effectiveness was statistically invalid.

The Pfizer vaccine in babies and toddlers had no statistically significant efficacy. Moderna’s vaccine had an efficacy of just 4% in preventing asymptomatic children aged 6 months to 2 years. (Some European countries have restricted the use of Moderna’s vaccine for anyone under the age of 30 due to the risk of myocarditis). One frustrated CDC official told me the vaccines are so ineffective in young children it wouldn’t matter if you, “inject them with it or squirt it in their face.” Maybe that’s why after a month of pushing Covid vaccination for children under five, only 3% of them got the jab.

Supporters of pushing the new omicron vaccine might point to annual influenza vaccines that are blindly offered each year, but:

1) they use a traditional vaccine platform that has withstood the test of time. In contrast, the novel Covid vaccines have been associated with a serious adverse event rate of 1 in 5,000 doses according to a German study published three months ago by the Paul-Ehrilich Institut. While the National Institutes of health has dedicated over a billion dollars to study long-Covid (which has yielded nothing), its spent virtually no money to investigate Covid vaccine complications, like heart injury in young people.

2) There is currently no scientific consensus that a repeated Covid booster strategy is the right approach. Some scientists are concerned about what is called immune imprinting from multiple booster doses that can weaken the immune system. A recent article published in the journal Science noted a reduced immune response against the Omicron strain among people previously infected who then received three Covid vaccine doses compared to a control group that previously had Covid and did not have multiple shots.

3) The new Omicron vaccine, which is based on earlier Omicron strains, has been tested against newer Omicron strains currently in circulation—a distinct research advantage over studying flu shots. But the results have not been made public. Doesn’t the public have a right to know the results?

It may be that an omicron specific vaccine recommendation for the fall is warranted, but pushing it hard before the data is available makes a mockery of the scientific method and our regulatory process.  In fact, why have an FDA, if White house doctors feel that a new medication would likely benefit public health.

Despite the secrecy surrounding data on the new vaccine, Dr. Jha endorsed the new vaccine in his remarks.  “Based on everything we’ve seen so far, all the data suggests it should be highly effective against the new variants,” Jha said.  

Is that aspirational political talk or a scientific conclusion based on sound data? The distinction is critically important because the public has lost trust in health officials after watching them repeatedly make things up as they go and declare them as truths rather than hypotheses. We need public health leaders to show some humility, stick to the science, and be more transparent with data then they ever have been before. If Jha is following the science, we need to see the data.

Marty Makary MD, MPH is a professor at the Johns Hopkins School of Medicine, the Johns Hopkins Carey Business School, and author of the New York Times bestselling book The Price We Pay.