The FDA Commissioner on Vaccines and Public Trust

0:05The Trump administration is making a lot of changes to public health policy, particularly under the head of Health and Human Services Robert F. Kennedy Jr. One of the most contentious areas is around vaccines. This summer, Kennedy fired all of the CDC's vaccine advisory panel and has taken heat for what critics say undermines confidence in the system. And two weeks ago, the White House fired the head of the Centers for Disease Control and Prevention, reportedly because of disagreements around vaccine approval. One of the government officials in charge of approving vaccines and who reports into Kennedy's department is Dr.

0:41Marty McCary, the commissioner of the Food and Drug Administration. In the summer, McCary's FDA decided to narrow the number of people who are supposed to get this year's COVID booster, approving it only for people over the age of 65 or with adverse health conditions. This week, we sat down with Dr. Marty McCary to talk about how he sees the FDA's role in this moment of vaccine politics and how health officials can rebuild trust at a time when trust in public health policy is at historic lows. Welcome to The Journal, our show about money, business, and power. I'm Ryan Knudsen. It's Tuesday, September 9th.

1:21Coming up on the show, Dr. Marty McCary on the FDA, vaccines, and trust in public health.

1:41— Commissioner Marty McCary, thanks so much for coming back to the podcast. — Great to be with you, Ryan. — So I'm going to talk a lot about vaccines and vaccine policy. We're heading into the fall flu season, and there have been a lot of changes under the Trump administration so far. Can you just, first of all, for listeners, lay out just what the role the FDA plays in vaccine policy in the United States? — Yeah, first of all, vaccines save lives, and any death from a vaccine-preventable illness is a tragedy. The FDA's role is that of a regulator. So we don't recommend a vaccine. We don't engage in the practice of medicine.

2:18But we do have a job, a charge by Congress in the statute that says that we have to ensure that the claims that vaccine makers are making are in line with the data that they submit to us. So that's our job. You don't recommend vaccines, but you do approve them. And then a decision that the FDA made earlier this year, effectively not to approve the COVID booster for the broader population. Instead, you only approved it for people who are older than 65 or have adverse health conditions. Why did you make that decision? That's right. So we adopted a risk-stratified approach. Dr. Prasad and I outlined this framework in the New England Journal of Medicine back in May.

3:01And we wanted the world to know that we're moving to a risk-stratified approach. What does that mean, a risk stratified approach? It means that the potential need and clinical benefit of the vaccine in somebody at high risk is different from a young, healthy 12-year-old girl. So does a young 6-year-old boy in America need another 70 COVID shots in his average lifespan? Or can we make a move towards the model that Europe has embraced? In France, you have to be 80 or high risk to get the vaccine. In the U.K., it's 75. But the entire world has moved to a risk stratified approach. And I think that's generally where most people are in the U.S.

3:42Why is that something that the FDA, because you're talking about approval from sort of a safety perspective. The Centers for Disease Control, the CDC, they are the ones that make recommendations about should people be taking this or not. So why do you feel that it's the FDA's role in saying it's not something that you can approve for a different age group? So we have this charge where we get applications and we have to decide whether or not to approve the updated vaccine that is tailored to the circulating strain at the time. The circulating strain hasn't really changed much over the last year and a half.

4:15But we had applications for a new generation of vaccines and we decided to approve it for high-risk individuals because we think that's where the preponderance of evidence lives. And we are getting back to gold standard science, which means if a company wants an approval for a COVID booster in a young, healthy individual, we'd like to see a clinical trial. It's been four years since we've had a clinical trial. So we're getting back to our gold standard system at the FDA, and that is we're going to approve based on data, not blindly. Getting back to – you don't think the FDA has been doing that previously?

4:47No, they were rubber stamping COVID boosters every year, and we're on a path to do that in perpetuity. and there was a general theory, it was a hypothesis in the medical community that everybody should get it every single year. Well, I think people have moved on and recognized as the rest of the world has that the risk to benefit profile is different based on your age. And in fact, I think that was one of the great errors of COVID. It should have been recognized earlier. The risk of the COVID virus in a young, healthy teenager is 10 ,000-fold different than the risk in an older individual with a comorbid condition.

5:27There were internal memos that FDA staff scientists thought that there should be a broader approval for the wider public for the COVID booster. Help me understand why you decided to disregard those. It was mixed. I mean, it was mixed. I mean, you're going to hear different things. There were a lot of scientists that we consult inside. And so it was mixed. Look, we have to do what we think is right. On one hand, there is a group in America that thinks we should ban all COVID vaccines in perpetuity, that there are hundreds of thousands of Americans that claim vaccine injury. And then there's another extreme of people that may want to take a COVID booster every three months.

6:07So we are doing what we think may not be popular, but we think is where the data leads us most. And that is a risk stratified approach. And by the way, it's available for anybody who wants it, but it is only indicated for those where we think there's a preponderance of evidence, and the companies have agreed to go back and do a clinical trial. So what would you need to see in the data in order to change your view on this and say that, yeah, the booster is something that should be recommended every year? We've been pretty flexible with the clinical endpoints of the trial and designing them with the companies, and we're saying the study just has to show that the vaccine is providing a clinical benefit, and you define for us what clinical benefit could mean.

6:47It could mean a positive test, could mean hospitalization, sickness, death. And so there's a number of clinical endpoints. These clinical trials are not the perfect evaluation of safety. We have to look at big data. We have to listen to individuals. We have a reporting database at the FDA called VAERS where if an individual feels that they've been injured by the vaccine, they will report it. But we have started our own investigation, starting with children where they have died from the COVID vaccine per the self-report. So people that have reported into the system, my child died, I believe it's because of the vaccine.

7:22That's right. So we are investigating because a self-report is not any reliable data where you can make inferences on rates. So we are going back and doing an investigation. investigation, recalling the families, talking to the doctors, reviewing the autopsies. And I think Americans have a right to that information. How many healthy young teenagers or children have died from the COVID vaccine? When do you expect to have the results of that investigation? Hopefully in the coming weeks. We're doing this the right way. We've got doctors conducting this investigation. Some of these families had been contacted in the past, but there was no conclusion or a conclusion where we're getting more information around.

8:02I think that this is the type of information that I think parents want to know. So one of the things that your boss, Robert F. Kennedy Jr., the head of Health and Human Services, has been taking a lot of heat for this summer is his decision to fire everybody on the Advisory Committee on Immunization Practices. This is a group at the CDC. Obviously, I know that's not your agency, but what do you think of that decision? Well, first of all, I think if you were to grade the ACIP committee over the COVID years, I would give them a failing grade. I don't think they did a very good job because they were monolithic in their thinking.

8:41And this is what happens. Like-minded people attract other like-minded people to the committee. Now there's a diverse committee. You have a diverse group of ideas, including some very highly respected individuals. There are a lot of medical groups that have been highly critical of this decision. And the American Academy of Pediatrics said that the move stokes distrust in life-saving vaccines. Are these groups wrong? How do you take that criticism? I think more opinions are better. I think if somebody has an idea you don't like, we need more ideas, not to censor ideas. The American Academy of Pediatrics has made some massive mistakes over the years, igniting the peanut allergy epidemic with a dogma that kids should avoid peanut butter until they're three years of age.

9:26I mean, that was a 15-year disaster that ignited the modern-day community. It was based on dogma. And so they have a history that's very mixed. But look, I think we should have a diverse group of ideas. And if they have an opinion, they're entitled to it. So ACIP, the vaccine advisory policy of the CDC, they're meeting next week. They're going to be voting on the measles, mumps, rubella vaccine, chickenpox, hepatitis B, RSV. Do you see any changes to the recommendations coming? Oh, look, there's an incredible value to childhood vaccines and that vaccine schedule. But if a parent wants to make a modification where they get the hepatitis B shot at age 10 or 12 as a personal decision for their child instead of at birth and then two more shots before age two, they're not a heretic.

10:16And I think this sort of absolutism where physicians engage in the most dangerous thing you can engage in in public health, and that is to insist that somebody comply with a recommendation, even though the evidence doesn't support it, that leads to distrust. The reality is hepatitis B is a sexually transmitted infection, and it's fine to get it before somebody is sexually active. The idea that you have to give it at birth is medical dogma. So amid all this season of trust and distrust in the medical health establishment, states are starting to splinter off into their own health coalitions. You've got Oregon, Washington, California joining.

10:59There's a bunch of states in the Northeast that are basically saying we can't trust the CDC anymore for its recommendations. We're forming our own. What do you think this means for public health? Well, look, you're seeing some folks' backlash against the medical establishment. Trust in public health is down in a JAMA study from 71 % before the pandemic to 40 % last year. That's a study in JAMA. A 31-point drop in public health trust. We made some catastrophic mistakes in winning over public trust during the pandemic. And I think we're seeing some repercussions to that. What do you think of Florida's decision to try and end all vaccine mandates for children in schools?

11:44Look, personally, not a decision I would have made if I were Florida policymakers. I did not advise them on it, but if I had, I would have advised against it. But you are seeing a sort of post-COVID era now where there's general distrust. So, I mean, that is one of the schools of thought in public health policy, which is that there should be a unified message across governments and health organizations so that people have clear guidance as to what they should and shouldn't be doing. If there is now a bunch of different voices out there, a bunch of different opinions, how can Americans make sense of what they should and shouldn't do?

12:18Well, look, it's nice when everybody agrees, but the reality is the scientific process itself is a discussion of different ideas. And to say that we can't have that discussion because somebody could interpret the discussion around vaccines as potentially leading to vaccine hesitancy and therefore we have to censor those individuals is the dark period we just came out of over the last four years. And the reason why I think many people don't trust public health institutions, if we don't have a healthy debate, we may not get at the truth. And I'm not one to say we cannot allow other experts to weigh in on something because somebody could hear it and then make a decision.

12:58We have to have that discussion. Look, the medical field got the demonization of natural saturated fat as a cause of heart disease wrong for 50 years. American Academy of Pediatrics got peanut allergies wrong for 15 years. The medical establishment and all the leadership of the big organizations got opioids or non-addictive wrong for 20 years. We have got to have a healthy scientific discourse. So I do believe in that. Do you feel like vaccines have become too politicized? Yes. Yeah, look, we need to be able to talk about the grade of the data to support each individual vaccine and the timing of those vaccines.

13:37And I think if we're more honest with the public, I think we'd win more trust. For example, some pediatricians say, here are the vaccines that are recommended. I'll tell you right off the bat, here are the ones that I think are really critical. The hepatitis B one, the timing, for example, can be delayed a little later in childhood. And they're willing to work with individuals that might have concerns about some of the vaccines. And ultimately, they get to a good place. And then there's other people that say, look, here's the schedule, take it or leave it. And if you don't accept it, you're going to get kicked out of our pediatrics practice.

14:13Those are two radically different approaches. And I think you win more bees with honey than fire. I think we need to be more, listen more to parents. After the break, Commissioner McCary on the FDA's plans to crack down on pharmaceutical advertising.

14:42I want to ask you about the way that you talk about vaccines and the messaging. You've said a lot in our conversation today that vaccines save lives. But you've also, you know, you talked about how you know friends who've lost loved ones from the mRNA COVID vaccine. And you said on CNN the other day that we do know at the FDA that there are children who have died from the COVID vaccine. What are you trying to accomplish by calling attention to those anecdotes? Well, people want to know the real data on COVID and young, healthy individuals. So this sort of media environment where you're not allowed to speak about COVID complications, We now know that the Biden administration directly reached out to Facebook and other media outlets saying, take down true stories of vaccine complications from social media.

15:35And so this idea that you cannot talk about the actual data. We're trying to get to the real data. I don't think anybody would disagree with that. I mean, I certainly want to see the data. It seems to be very important. But we don't have data yet. We're getting the data. Right. So that is part of our investigation. But talking about it, talking about that we know that children have died, it's a— I was asked the question, so I'm going to answer it honestly. It's a big difference. If there are five children who have died or 20 ,000, that's a huge—the risk profile is obviously hugely different. But do you think that that might make people more fearful of the COVID vaccine and vaccines generally?

16:15You know, I do not believe in the notion that we cannot have scientific discourse because somebody could interpret it a certain way. And that's the era that we just lived through. So ask, you know, a person who is, you know, insisting that the COVID vaccine is 100 % safe in young males. Ask them what the risk of myocarditis is. It's not an unknown anymore. We have good studies. It's one in 2 ,600. What is myocarditis? chioditis. Oh, it's inflammation of the heart. Is it deadly? It's usually mild, but there have been deaths from it, including some of the deaths that we have identified in our investigation.

16:54And by the way, if the risk-benefit ratio significantly favors getting the COVID vaccine in the young, healthy individual, those advocates for that situation should welcome the data, because then we'll have clarity about the next 100 years. So, do you feel like the FDA is going to be able to get that data under your term? We're doing our best. And so we're doing our own investigation of the deaths reported to the FDA through VAERS. Now, it is a fraction of the number of deaths typically out there. And also that's a self-reporting system. And there have been reports of people who may be opposed to vaccines putting in false reports, which I believe is a crime.

17:36But... That's right. That's why we're investigating. That's why we're calling the doctors, the families reviewing the autopsies. It should not be an opinion. This should not be a political opinion. We should have good data to drive the decision-making. It seems like you're laying out sort of like a different vision for public policy in that like in one that is saying the American people are smart, sophisticated, and if you try to obfuscate anything, it's just going to make them skeptical and distrustful. You studied public health policy back in college. is that something like when did you develop this view that things should sort of be done differently well science has always been an open discourse it has always been a presentation of different ideas among experts it has always been listening to individuals including patients only in the last recent era did you see this intense censorship of ideas i want to ask you about Tylenol.

18:34The Wall Street Journal had a story last week about how the Department of Health and Human Services plans to release a report saying that taking Tylenol during pregnancy could be one possible cause of autism, among others. The makers of Tylenol said they don't believe there's a causal link, but the FDA obviously approves medicines. Where does FDA stand on that? Well, first of all, that report on autism is not yet written. There are discussions, and so you may have seen a recent Harvard study that reviewed the literature on Tylenol and autism. So that is data that we are reviewing. And so we don't want to make any premature conclusions about that.

19:11But Tylenol is not the central point of the autism report. We have to look at every single thing out there. And that's the beauty of the report. We're doing a comprehensive review. And I think you're going to see some very interesting findings. Like what? Well, again, It's not yet written, but look, this is a problem that no one has really tackled in a comprehensive way. Autism. Autism, until now, in a completely comprehensive way. So what would you say right now to pregnant women when they have pain? What should they take? Well, look, I'm a regulator. I'm going to stand by our labels, but we are reviewing data.

19:48Which says Tylenol is safe for pregnant women. We're reviewing data on an ongoing basis. Some of the studies were just recently conducted, so we're actively reviewing them. So could the FDA make a change in its recommendations? Well, I don't want to get ahead of any announcement, but we always have to be willing to show humility and say new data has come in, and therefore we may need to evolve our position based on new data. You've also got some news coming out about stepping up enforcement on direct-to-consumer marketing for medicines. Tell me about what the FDA is planning to do here. Well, first of all, we want companies to be able to advertise their products, and we're not banning direct-to-consumer pharmaceutical ads.

20:32But many of these ads are misleading, and the FDA has had a lax approach over recent decades. It's one of the reasons why these pharmaceutical ads went from being rare to extremely common today. I mean, you watch a TV program. It's basically nonstop people singing and dancing with a pharmaceutical product. So we are finally taking action on our regulation, that is our law at the FDA, that says ads cannot create a misleading impression. And it's not just on television. It's paid social media influencers. It's online pharmacies, as we saw in the Super Bowl, last Super Bowl. And so we are going to enforce this regulation.

21:10Enforcement letters used to be 100 plus a year back when pharmaceutical ads were rare. Over the last couple of years, it's dwindled down. It was one letter in 2023. Only one letter. One letter. And last year it was zero. So we are sending out 100 letters this week so that companies know we are taking this regulation very seriously. And we're also changing a regulation to close a loophole that says you can just put the side effects on some other website or something. And we're going to be tough on this. This is something where we are an outlier country. We're one of two countries in the developed world that even allow pharmaceutical ads.

21:51And companies spend, drug companies spend 20 to 25 percent of their budgets on marketing and ads. I'd like them to spend that money on lowering drug prices for everyday Americans. There's a lot more to talk about there, but I think you're, we're out of time. Dr. Martin McCary, thanks so much for joining us. Great to be with you, Ryan. Really appreciate it. My pleasure. That's all for today. Tuesday, September 9th. The Journal is a co-production of Spotify and The Wall Street Journal. Special thanks to Liz Esley-White.

22:26Thanks for listening. See you tomorrow.