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Ryan Knudsetson
The 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. Marty Makary, the commissioner of the Food and Drug Administration. In the summer, Makary'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 or with adverse health conditions. This week we sat down with Dr. Marty Makary 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 Knudsetson. It's Tuesday, September 9th. Coming up on the show, Dr. Marty Makary on the FDA, vaccines and trust in public health.
Narrator/Promotional Voice
Charlie Sheen is an icon of decadence.
Ryan Knudsetson
I lit the fuse and my life turns into everything it wasn't supposed to be.
Narrator/Promotional Voice
He's going the distance.
Dr. Marty Makary
He was the highest paid TV star of all time.
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When it started to change, it was quick.
Narrator/Promotional Voice
He kept saying, no, no, no, I'm in the hospital now, but next week I'll be ready for the show. Now, Charlie sober, he's gonna tell you the truth.
Ryan Knudsetson
How do I present this with any class?
Dr. Marty Makary
I think we're past that, Charlie.
Narrator/Promotional Voice
We're past that.
Ryan Knudsetson
Yeah.
Dr. Marty Makary
Somebody call action.
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AKA Charlie Sheen.
Ryan Knudsetson
Only on Netflix September 10th.
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Ryan Knudsetson
Commissioner Marty Makary, thanks so much for coming back to the podcast.
Dr. Marty Makary
Great to be with you, Ryan.
Ryan Knudsetson
So I'm gonna 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?
Dr. Marty Makary
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 vaccine, we don't engage in the practice of medicine. But 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.
Ryan Knudsetson
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?
Dr. Marty Makary
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. And we wanted the world to know that we're moving to a risk stratified approach.
Ryan Knudsetson
What does that mean, a risk stratified approach?
Dr. Marty Makary
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 UK at 75. The entire world has moved to a risk stratified approach. And I think that's generally where most people are in the us.
Ryan Knudsetson
Why is that something that the FDA cause? 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?
Dr. Marty Makary
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, in that the circulating strain hasn't really changed much over the last year and a half. But 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, 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 gonna approve based on data.
Ryan Knudsetson
Not find that too. You don't think the FDA has been doing that previously?
Dr. Marty Makary
No. 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 any older individual with a comorbid condition.
Ryan Knudsetson
There are 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 recommendations.
Dr. Marty Makary
I mean, it was mixed. I mean, you're going to hear different things if 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. But so 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.
Ryan Knudsetson
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.
Dr. Marty Makary
We've been pretty flexible with the clinical endpoints of the trial and designing them, with the studies, 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. It 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. We have started our own investigation looking, starting with children, where they have died from the COVID vaccine per the self report.
Ryan Knudsetson
So people that have reported into the system, my child died, I believe it's because of the vaccine.
Dr. Marty Makary
That's right. So we are investigating because if a self report is not any of the reliable data where you can make inferences on rates. So we are going back and doing an investigation. We're calling 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?
Ryan Knudsetson
When do you expect to have the results of that investigation?
Dr. Marty Makary
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 with where we're getting more information around. I think that this is the type of information that I think parents wanna know.
Ryan Knudsetson
So one of the things that your boss, Robert F. Kennedy Jr. At 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?
Dr. Marty Makary
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. And 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.
Ryan Knudsetson
There are a lot of medical groups that have been highly critical of this decision. 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?
Dr. Marty Makary
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 till they're three years of age. I mean, that was a 15 year disaster that ignited the modern day. It was based on dogma. And so they have a history of. 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.
Ryan Knudsetson
So acip, the vaccine advisory policy, 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?
Dr. Marty Makary
Oh, look, there's an incredible value to childhood vaccines in 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. And 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.
Ryan Knudsetson
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. There'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?
Dr. Marty Makary
Well, look, you're seeing some folks backlash against the medical establishment. Trust in public health is down in a general 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 trust during the pandemic and I think we're seeing some repercussions of that.
Ryan Knudsetson
What do you think of Florida's decision to try and end all vaccine mandates for children in schools?
Dr. Marty Makary
Is. Look, 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.
Ryan Knudsetson
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?
Dr. Marty Makary
Well, 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. We 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 are non addictive wrong for 20 years. We have got to have a healthy scientific discourse. So I do believe in that.
Ryan Knudsetson
Do you feel like vaccines have become too politicized?
Dr. Marty Makary
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. And 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 B1. The timing, for example, can be delayed so 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. Those 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.
Ryan Knudsetson
Commissioner McCary on the FDA's plans to crack down on pharmaceutical advertising.
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Ryan Knudsetson
Wayfair Every style, every home. I want to ask you about the way that you talk about vaccines and the messaging. You've said a lot in this, in our conversation today that vaccines save lives. But you've also, you know, you talked about how you, you know, friends who've lost loved ones from the MRNA COVID vaccine. And you said on CNN the other day that we, we know at the, we do know at the FDA that there are children who have died from the COVID vaccine.
Dr. Marty Makary
Yeah.
Ryan Knudsetson
What are you trying to accomplish by calling attention to those anecdotes?
Dr. Marty Makary
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. And so this idea that you cannot talk about the actual data, we're trying to get to the real data, I.
Ryan Knudsetson
Don'T think anybody would disagree with that. I mean, I certainly wanna see the data. It seems to be very important. But we don't have data yet.
Dr. Marty Makary
We're getting the data.
Ryan Knudsetson
Right.
Dr. Marty Makary
So that is part of our investigation.
Ryan Knudsetson
But talking about it, talking about that we know that children have died, it's.
Dr. Marty Makary
A. I was asked the question, so I'm going to answer it honestly.
Ryan Knudsetson
It's a big difference if there are five children who've died or 20,000, that's a huge. The risk profile there is obviously hugely different. But do you think that that might make people more fearful of the COVID vaccine and vaccines generally?
Dr. Marty Makary
You know, I do not believe in the notion that cannot have scientific discourse because somebody could interpret it a certain way. And that's the era that we just live through. So ask a person who is 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.
Ryan Knudsetson
What is myocarditis?
Dr. Marty Makary
Oh, it's inflammation of the heart.
Ryan Knudsetson
Is it deadly?
Dr. Marty Makary
It's usually mild, but there have been deaths from it, including some of the deaths that we have identified in our investigation. And by the way, if the risk benefit ratio significantly favors getting the COVID vaccine and the unhealthy individual, those advocates for that situation should welcome the data because then we'll have clarity about the next hundred years.
Ryan Knudsetson
So are you, do you feel like the FDA is going to be able to get that data under your term?
Dr. Marty Makary
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.
Ryan Knudsetson
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.
Dr. Marty Makary
But 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.
Ryan Knudsetson
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, that's just going to make them skeptical and distrustful. You studied public health, public health policy, back in college. Is that like, when did you develop this view that things should sort of be done differently?
Dr. Marty Makary
Well, science has always been an open discourse. It has always been a presentation of different ideas among experts. And it has always been listening to individuals, including patients. Only in the last recent era did you see this intense censorship of ideas.
Ryan Knudsetson
I want to ask you about Tylenol. The 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?
Dr. Marty Makary
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. But 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 gonna see some very interesting findings.
Ryan Knudsetson
Like what?
Dr. Marty Makary
Well, again, it's not yet written, but look, this is a problem that no one has really tackled in a comprehensive way.
Ryan Knudsetson
Autism.
Dr. Marty Makary
Autism. Until now in a completely comprehensive way.
Ryan Knudsetson
So what would you say right now to pregnant women when they have pain? What should they take?
Dr. Marty Makary
Well, look, I'm a regulator. I'm gonna stand by our labels. But we are.
Ryan Knudsetson
Which says Tylenol, safe for pregnant women?
Dr. Marty Makary
We're reviewing data on an ongoing basis. Some of the studies were just recently conducted, so we're actively reviewing them.
Ryan Knudsetson
So could the FDA make a change in its recommendations?
Dr. Marty Makary
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.
Ryan Knudsetson
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.
Dr. Marty Makary
Well, first of all, we want companies to be able to advertise their products. And we're not banning direct to consumer pharmaceutical ads. But 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. Enforcement letters used to be 100 plus a year back when pharmaceutical ads were rare. Over the last couple years, it's dwindled down. It was one letter in 2023.
Ryan Knudsetson
Only in one letter.
Dr. Marty Makary
One letter. And last year it was zero. So we are sending out a hundred 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 gonna 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. And companies spend drug companies spend 20 to 25% of their budgets on marketing and ads. I'd like them to spend that money on lowering drug prices for everyday Americans.
Ryan Knudsetson
There's a lot more to talk about there, but I think we're out of time. Dr. Marty Makary, thanks so much for joining us.
Dr. Marty Makary
Great to be with you, Ryan.
Ryan Knudsetson
Really apprec. Appreciate it.
Dr. Marty Makary
My pleasure.
Ryan Knudsetson
That's all for today. Tuesday, September 9th. The Journal is a coproduction of Spotify and the Wall Street Journal. Special thanks to Liz Esley White. Thanks for listening. See you tomorrow.
Date: September 9, 2025
Hosts: Ryan Knutson, Jessica Mendoza
Guest: Dr. Marty Makary, FDA Commissioner
In this episode, Ryan Knutson speaks with Dr. Marty Makary, the Commissioner of the Food and Drug Administration (FDA), to discuss sweeping changes in U.S. vaccine policy under the Trump administration and HHS Secretary Robert F. Kennedy Jr., the FDA’s approach to COVID booster approval, ongoing investigations into vaccine safety, and the broader issue of public trust in health institutions. The conversation delves into the rationale behind recent FDA decisions, reactions from the medical community, and efforts to bolster scientific transparency and accountability in the wake of declining public confidence.
[02:44 – 03:33]
[03:52 – 04:42]
[06:27 – 07:25]
[07:32 – 09:06]
[09:06 – 10:40]
[11:44 – 12:59]
[13:18 – 14:23]
[14:23 – 15:23]
[16:33 – 19:48]
[20:12 – 21:49]
[22:13 – 24:09]
"We're getting back to our gold standard system at the FDA and that is we're gonna approve based on data."
— Dr. Marty Makary [05:40]
"We have to have a healthy scientific discourse. ... If we don't, we may not get at the truth."
— Dr. Marty Makary [13:52]
"Trust in public health is down in a general JAMA study from 71% before the pandemic to 40% last year."
— Dr. Marty Makary [12:12]
"You win more bees with honey than fire. I think we need to listen more to parents."
— Dr. Marty Makary [15:21]
"This should not be a political opinion. We should have good data to drive the decision making."
— Dr. Marty Makary [19:44]
For those concerned about how vaccine policy is being shaped in the U.S. amid political, scientific, and public trust turmoil, Dr. Makary's commentary provides insight into how the FDA is navigating these tensions in pursuit of restoring credibility and safeguarding public health.