FDA Commissioner Martin Makary said the government must show greater humility and be more transparent if it hopes to rebuild public trust in its health guidance, which he said has been badly eroded since the pandemic.
In an interview with NPR’s Steve Inskeep, Makary addressed recent controversy over an FDA memo that cited rare reports of child deaths linked to COVID-19 vaccinations. He said the information was not new but had not been made public, and argued that officials failed to clearly communicate how risks varied by age and underlying health conditions, even as vaccines saved many lives.
“The most dangerous thing you can do in medicine is to put out a recommendation with such absolutism when the data is really flimsy,” Makary said.
According to Makary, the FDA is applying basic scientific thresholds to vaccines including its decision not to approve an mRNA-based flu shot that showed no benefit in late-stage trials. He also said the hepatitis B vaccine remains recommended, but that insisting it be given within hours of birth for infants born to hepatitis B–negative mothers reflects an “absolutism” that can undermine trust, and that flexibility is warranted where the science supports it.
Listen to the full conversation by clicking the blue play button above. Makary also appeared on the program Friday to discuss testosterone treatments. You can find that interview here.
The radio interview was produced and edited by Adam Bearne and Lilly Quiroz. The web copy was written by Majd Al-Waheidi and edited by Obed Manuel.
Transcript:
STEVE INSKEEP, HOST:
The commissioner of the Food and Drug Administration says he is in favor of vaccines. Marty Makary is an experienced surgeon with a controversial boss, Robert F. Kennedy Jr., the Secretary of Health and Human Services. Before becoming secretary, Kennedy founded and led a nonprofit that advocated against vaccines. This year, Kennedy fired an advisory panel and installed new members who changed the recommendation for hepatitis B vaccines for infants. Marty Makary’s FDA recently produced a memo highlighting child deaths from COVID vaccines. So when we talked about vaccines, that memo is where we started.
What did this much-publicized FDA memo say recently about COVID vaccines and child deaths?
MARTY MAKARY: Well, it really just said that there are reports of children who have died from the COVID vaccine. It’s nothing new. It’s been reported in the New England Journal of Medicine, a young adult who died from myocarditis. The memo – internal memo basically said, this is a rare complication, but we have reports into the FDA on about 10 kids who have died after the COVID shot where the link has been made by independent physicians who looked into it. And so the moral question is, does the government have a moral obligation to make these data public, or should they not make it public and keep it secret?
INSKEEP: I’m glad to hear you say it’s not new because I’m recalling during the depths of the pandemic, getting vaccines myself. I was aware there was a risk. They make you sit around for 15 minutes in case there’s a reaction. Same thing with my kids. So it’s been known that there was a risk. Why emphasize this now?
MAKARY: Well, we came into office and knew that these data were inside the FDA. They were internal and not public, so we took time to do that investigation. Look, the COVID vaccine saved many lives. It was a success story. But one of the failures of the COVID pandemic from a public health standpoint was the failure to recognize the 10,000-fold risk difference between an older individual with a comorbid condition and a young, healthy child.
INSKEEP: Of course, you’re looking at many kinds of vaccines, not just COVID vaccines. Broadly speaking, do you see yourself as shifting the burden of proof on vaccines, raising the standard of proof that a vaccine is safe and effective?
MAKARY: I think we’re using basic scientific principles that we use for all drugs at the FDA. For example, there is a new mRNA-based flu shot. Now, there was a lot of anticipation about it. I personally like mRNA technology. But this mRNA flu shot in its randomized control trial in seniors failed. It showed no benefit. Well, we basically said, we’re not interested in approving a drug that has failed in its Phase 3 randomized trial.
Now, we are interested in a universal flu shot, and we’ve talked to companies who are developing a shot that you could get potentially once in your life that could protect you in the future, every year against whatever flu strain mutates that year, including mutations we have yet to see. And so some of those target a different part of the influenza virus. We’re very interested in that concept of a universal flu shot because even though we recommend the flu shot each year, its efficacy is not great certain years, including this year.
INSKEEP: Is there a risk that you will raise the standard for approving vaccines to the point where no vaccine would really qualify?
MAKARY: I don’t think so, no. Vaccines save lives. And any death from a vaccine preventable illness is a tragedy that should be avoided. We believe in a set of core essential vaccines that everybody should get. But at the same time, we do believe in that doctor-patient relationship.
INSKEEP: Did you agree with the changed recommendation on hepatitis B vaccines?
MAKARY: I think it’s been misconstrued. It’s not that we don’t recommend the hepatitis B vaccine. It’s that…
INSKEEP: You want it later.
MAKARY: The idea that a hepatitis B-negative mother absolutely must get the hepatitis B shot for their baby on Day 1, within hours of birth, is an absolutism that can threaten public trust. When a mom might say, hey, can I wait till the kid is 8 or 10 or 12, for whatever reasons they offer, we can listen to those mothers, and we can have some flexibility where the science supports it.
INSKEEP: And when you hear some critics of this policy change say, as they did, that hundreds of people may die because they didn’t get the vaccine right at the beginning, which is a time that’s important to have it, you don’t accept that claim?
MAKARY: That’s not true at all. As a matter of fact, ACIP is recommending the hepatitis B shot in a hep B-positive mother or in a mother where the…
INSKEEP: Immediately at birth, if it’s a…
MAKARY: Immediately at birth.
INSKEEP: …Hep B-positive.
MAKARY: Right.
INSKEEP: So you believe that in the cases with the greatest risk that you’re covered.
MAKARY: We live in a new era of very partisan news coverage and the echo chambers of social media. And what we have lost is medical nuance.
INSKEEP: I had a chance to see Secretary Kennedy speak recently, and he said that his agency that he leads had in the past been guilty of malpractice. He said the agency had not been doing its job and that as a result, people had lost trust in HHS. And I’m sure that is true for people who support Secretary Kennedy and many people who voted for President Trump. Now, because of the agency’s actions and the way they’ve unfolded over this year, it seems that there is a new group of people who no longer feel they can trust the medical advice coming from the federal government – the way that people have been fired, the way that policies have been changed. What do you do to address that loss of trust?
MAKARY: Well, I can only speak for the FDA. And at the FDA, we’re trying to use basic gold standard science. But, yes, I do think over the last four years, mistakes were made in sort of an arrogance. The most dangerous thing you can do in medicine is to put out a recommendation with such absolutism when the data is really flimsy, insisting schools close for nearly two years, shutting kids out, causing lifelong learning loss.
INSKEEP: That was a big one.
MAKARY: Insisting…
INSKEEP: Yeah, sure.
MAKARY: …On cloth masks on a toddler for nearly three years, when the evidence never supported it. Our job as physicians around him are to use basic scientific gold standard principles.
INSKEEP: But, I mean, how do you address that loss of trust now with people who maybe trusted the advice before and no longer do?
MAKARY: Look, I’m very proud to be a physician. I’m very proud to be a surgeon and public health researcher at Johns Hopkins. But that trust the public has bestowed upon us has been massively eroded in ways we’ve never seen before over the last four years. Trust went from 71% down to 40%. That’s a 31-point drop. And so the mistakes of COVID caused significant problems. What we’ve got to do to remedy that is to show humility. Sometimes, as a doctor at the bedside, the right answer to a patient’s question was, I don’t know, but I’ll try to find out.
INSKEEP: Commissioner Makary, thanks so much for your time.
MAKARY: Great to be with you, Steve.
INSKEEP: He’s the head of the FDA. We also had him on the program Friday, talking about testosterone, and you can find that interview at npr.org.
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