← Becker’s Healthcare Podcast
Becker’s Healthcare Podcast
Building Trust and Modernizing Healthcare with FDA Commissioner Dr. Marty Makary
00:30:09
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- [00:00]
A
This is Scott Becker with the Becker Healthcare Podcast. We're thrilled today to be joined by a very special guest. We're joined by a brilliant surgeon, physician leader. We're joined today by the Commissioner of the FDA, Dr. Marty Makary. And Dr. Makary has had a brilliant career. Immediately prior to being back at the fda, he was at Johns Hopkins, also a Harvard master's in public health and just a fabulous career. Dr. Mercary, can you take a moment and tell us a little bit about yourself and your background and then we'll talk more about the FDA today, some of the trends, some of the discussions of vaccines and autism, and a lot more. We are so thrilled to have you on. Take a moment and introduce yourself.
- [00:46]
B
Well, thanks so much, Scott. It's great to be with you. You know, I don't think you can really prepare for a job like heading the FDA. The FDA regulates 20% of the US economy, and it's everything from food and mangoes coming across the border to MRI machines to vape stores and what's in those vape stores to devices and wearables, to drugs, which is what many doctors traditionally think of when they think of the fda. I guess I've been intellectually curious through my career. I've done research in almost every medical specialty with colleagues at Johns Hopkins. A lot of big database work. And so I think a lot of my colleagues thought that my career was sort of nomadic. I just thought it was interesting to sort of dip into every different topic. But in the end, I think it ended up being good background for this role.
- [01:44]
A
And talk a bit more. You and I have met before, it's been some time, but talk for a moment about what parts of your career have stood out to you is the most satisfying, the most interesting. And then we'll talk about your current situation serving as commissioner of the fda. But what throughout your career has been you thought of as highlights or some of the most interesting things?
- [02:04]
B
Well, I love the research. You know, you're told in medical school to specialize. You get asked the question about 50 times a day, every one you bump into in the gym. When they find out you're in medical school, they want to ask you next, what specialty are you going into? And then once you're in a residency, they ask what subspecialty? And once you're in a subspecialty, they ask what special Sub. Sub especially. And so there's this sort of empire building. It's a culture in medicine to hyper. Subspecialize. And it's Financially rewarded, it's academically rewarded. And we need that. And I did that with laparoscopic pancreatic surgery and eyelid transplant procedures. That was my area of focus at Hopkins. But we also have to look at the body holistically. And that's where research is so interesting. Because practicing and doing research, you get to challenge deeply held assumptions in the field. And the reality is there is medical dogma that runs deep in many areas of medicine. And challenging that dogma with good data and evidence is an incredible exercise that we need more of. And at the fda, we need to challenge many deeply held assumptions, like why does it take 12 years for a new drug to come to market? And why do we have a chronic disease epidemic in children? We can't blame them. It's not a willpower problem. This is something going on in the food supply and in the environment. So we've got to stop and ask, what are we doing just treating these conditions when we should be going upstream talking more about root causes?
- [03:50]
A
And I think that is fascinating root cause discussion. And one of the challenges seems like in our political environment, what you're saying, of course, makes complete sense. And at the same time, anything that comes out of D.C. gets immediately politicized on one side or the other. And we'll come back to the moment when we talk about vaccines. I was not aware of when it comes to childhood vaccines that we've gone from when I was growing up 5 to 7 recommended vaccines to today something like 65 or 68 to 78 recommended vaccines for young children. I don't think a lot of us are aware of how much there's been an explosion in the amount in use to vaccines because so many of us are very pro vaccine. But we also, I don't think, had any sense of the amount of vaccines being utilized with young children. And we'll come back to those discussions in a second. Take a moment and talk about root causes and some of the trends and things that you're watching in healthcare currently. Dr. Makary?
- [04:57]
B
Well, I think we are seeing in our broader society outside of medicine, a general move towards more tribalism. And it's fueled by sort of the anonymity of the echo chambers of social media, of a more partisan source of information and news that people receive that just affirm what they already believe. And it happens on both sides. And we should, as scientists be independent of that. We should rise above that. But unfortunately, it does have an effect where we start seeing tribalism in medicine. And what we have to do is really Stick to the data and the evidence, not to deeply held assumptions in the field. One of my goals is to try to rebuild public trust. During the four years of the pandemic, I had serious concerns that insisting that a young healthy teenager needs a Covid booster, even though they recently recovered from COVID and had natural immunity, was going to create a tremendous amount of distrust. And I was worried it was going to create anti vaxxers. And I think to some degree those concerns became true. The way to address bad ideas is with more ideas and good ideas. And I think when we resort to the mindset of censoring experts with different opinions, it leads to distrust. Trust in doctors and hospitals, according to a recent JAMA study, went from 71% of the public having trust in doctors and hospitals in 2019 down to 40% just last year. That's a 31 point drop. And so we're doing everything we can at the FDA to try to be radically transparent from making our rejection letters public information so that if we don't accept a drug, the public deserves to know why they can see why, to publishing articles in the New England Journal of Medicine of what we consider to be an evidence based approach to vaccine regulation. So we're doing everything we can to try to be open and honest because I think the way you rebuild public trust is to show humility.
- [07:20]
A
And you're one of sort of the. I don't view you as a partisan person at all. I've known you for a long time, just a very bright scientific person. And you run into this challenge when you say follow the data or follow the evidence. Each side almost takes that itself as a political statement. How do you manage that, that people aren't even willing to have open discussions? I mean, I grew up on the cusp of the MMR vaccine, the Salk vaccine, the polio vaccine, et cetera, et cetera, and viewing those as life changing things for our culture. And somehow or another between the combination of pharma companies in Washington, everything else, we've blown that up from a handful of vaccines to dozens and dozens and dozens of vaccines. But when you discuss this on either side of the table, you're exactly right. You've got one group that's become anti vaxxers on one side, partly coming out of the COVID situation and the other side, which is, you know, and I view myself as quite centrist, as trovaccine, but also understanding of the fact, hey, some of this might have been pushed too far or where the middle ground is. How do you sort of get people to discuss this and talk about it without completely getting into the different partisan tribes.
- [08:42]
B
Yeah, well, that's the challenge. And I think, first of all, what you said about the advent of vaccines is 100% correct. These are miracles that have averted tremendous morbidity and mortality in the Salk vaccine is a classic example of that. You know, I think there's too much influence from extreme, extreme elements, and I think there's too much interest from pharmaceutical companies. We took, for example, the strongest action in a generation to limit direct pharma advertising, and some of it is actually online pharmacies now that are promoting drugs and paid social media influencers paid by the pharmaceutical companies. And so we've got to steward these ads appropriately. That is, there are regulations that say there has to be a fair balance of information and that these ads cannot create a misleading impression. When you see people endlessly singing and dancing in these ads and they're making it sound like you're instantly cured and happy and all your problems have disappeared once you take a medicine that's not, in my opinion, consistent with the regulation. So I sent out over 100 enforcement letters a few weeks ago. Last year, the FDA sent out zero. And the year before they sent out one enforcement letter, I sent out 100. And I sent out 1,500 letters warning the industry that we're going to take this piece very seriously. So I think we have to get back to good bedside clinical judgment. We have to empower physicians. We have to listen to what parents are asking and not ridicule them. One of the things that frustrates me is when I hear that a parent may want to modify the vaccine schedule for their child, and they're told it's all or nothing, take it or leave it, and if you don't comply, you will be kicked out of the pediatrician's practice. Now, in my opinion, that is not the right way. We should be working with the public to increase vaccine compliance. As a matter of fact, most other countries have a vaccine schedule that is not as rigorous as ours is, that doesn't have as many vaccines. So if somebody comes in and says, I want to use the Japanese vaccine schedule for my child, or the German vaccine schedule or the Danish vaccine schedule, I think that should be a conversation and we should have less tribalism and.
- [11:22]
A
Talk about that for a moment, because I take it these other countries that have vaccine schedules, there's still things that are either mandatory or considered near mandatory, I assume, like MMR and polio and so forth. Is that not accurate or what does that look like in other countries compared to our country in terms of what's mandatory versus what's suggested?
- [11:43]
B
Yeah. Both polio and the MMR shot are considered essential common vaccines throughout all the vaccine schedules worldwide. And many of them have identified a group of, say, eight to 10 essential vaccines. And then beyond that, they may recommend other vaccines, but they certainly don't tell kids that they cannot go to school if they don't have, for example, a hepatitis B shot at birth. Hepatitis B, for example, in a hep B negative mother, is a vaccine that can be given in the early teens before a child is sexually active in the opinion of many physicians. So insisting that a child has to receive it in the delivery room is one of the first medical interventions we do to a newborn is an example of the type of absolutism that can alienate individuals. And look, we want to see a healthier population, we have to listen to their concerns, and we have to be honest, because the worst thing you can do in public health is to insist that people do something with such absolutism if the data actually suggests that there are multiple ways to go about doing something or that you can be more flexible than what the recommendation is and.
- [13:03]
A
Talk about the absolutism. Because that absolutism on either side is what tends to push people into totally different camps on what they want to hear, what they don't want to hear, and so forth. It's that attitude of there's no room in between that seems to drive people really into very different camps. Is that a fair sense?
- [13:25]
B
It is a fair sense, Scott. And look, we see it at the fda, we had a lot of absolutism when it came to drug approvals. There was an absolutism that all drugs had to be tested in two species of animals first. Even though we learned that computational modeling can be more predictive of toxicity than animal studies, and that we were still requiring animal studies when a drug was already approved in humans in other countries, which makes no sense at all, we had absolutism when it came to baby formula and suntan lotions. These are products where the FDA has said, you have to follow this recipe very strictly or else your any new product will be considered a new drug and have to go through the long, arduous new drug process with a clinical trial. Well, as a result, there's been no innovation in infant formula. There's been no new suntan lotion products in the US as there have been in Europe. And so we've got to modernize. We've got to update the regulatory process with the way that science is advancing. And it applies to everything. It applies to AI as a medical device. We can't tell people they can't use Google because there's a risk that one of the search hits could be medically inaccurate. We've got to use both common sense and gold standard science. And a lot of that is addressing this sort of absolutism.
- [15:06]
A
Let me ask you another question. If you grow up here like I did, and I know you moved here very early, you have this concept that the US Is ahead of a lot of other nations in a lot of medicine and approvals and so forth. And then there's different things that happen throughout one's life where you start to realize there's different pockets of the world that are speeding ahead in different places. How do you bring us up to speed in different areas? Like you talk about the 12 year wait to approve a drug or a therapy. How do we accelerate that but accelerate that safely?
- [15:42]
B
Well, I think there are two key steps to modernizing the FDA and how we get more cures and meaningful treatments to the American public. One is we have to cut the red tape. And the other is we have to use the idle time in the regulatory process. So for example, when a phase three trial is being conducted, everyone sits around waiting. It's a lot of idle time. And then the company submits a gigantic 50,000 plus page application to the FDA. Well, how about submitting that application? Clinical trial is going and just did clinical trial results as soon as the trial reads out. And so we have a new program that'll do exactly that. And it's a priority review program that'll put to the front of the line drugs that are in our national interest, that is drugs that are made in the United States to secure domestic manufacturing. And as a national security issue, drugs that meet a large unmet public health need. Drugs that reduce downstream healthcare utilization. That is a medication that will reduce the number of insulin shots a child needs or the number of dialysis sessions that someone needs. And finally, companies that are playing ball with most favored nation status pricing. We are the biggest purchasers of drugs. We deserve the best price and affordability is a public health problem. So we are identifying products that are incredibly promising that meet one of those criteria and we're putting them to the front of the line for a review so that we as an FDA can get a decision out in weeks instead of a year. And we're also looking at the whole broken process of reapplying at the FDA after pre clinical studies and phase one and a phase two and then again after the phase three, you wouldn't apply for college at four different points after each year. And so we think there are many opportunities to modernize that process. And we've given our scientific reviewers a powerful new AI tool that they love, and it's allowing them to work much more efficiently. And we have to do it.
- [18:00]
A
And we'll talk about sort of. There's so much I'd like to talk to you about, and we've only got so much time. Today you talk about medical dogma, of course. Recently the administration came out in the last couple days with some discussions around Tylenol and autism and so forth. Can you help us connect the dots there? Because obviously those of us that grow up with Tylenol as a regular thing hear the administration and have a hard time reconciling our experience over the last 30, 40 years with Tylenol, with what the administration is talking about on autism. Can you help us understand and bridge a little of that gap?
- [18:40]
B
Sure. So the Boston Birth Cohort study by researchers at Columbia, Yale and Harvard identified an association between prenatal Tylenol use and neurodevelopmental disorders, including autism. Other studies have also supported that association. And a Harvard Mount Sinai study four weeks ago reviewed the entire body of literature and not only concluded that there was an association, but found that the higher quality studies favored an association and the lower quality studies favored no association. It resulted in the dean of the Harvard School of Public Health concluding that there is a causal relationship between prenatal acetaminophen use and neurodevelopment and the neurodevelopmental disorders of ADHD and autism spectrum disorder. Now, when the dean of the Harvard School of Public Health has a safety concern and it is supported by 27 studies, we felt obligated to let the public know and to include that information on the label of acetaminophen. We made the very clear disclaimer that it's an individual decision, that there are exceptions, but that this is information people should be aware of. Now, because we live in a very partisan times. You've seen that information get dogmatized and turn into a sort of political punching bag issue. It shouldn't be. We have a crisis of an expanding autism epidemic that now affects 1 in 12 boys in California. It was rare just a generation ago. Autism can be a cruel medical condition, and so we owe it to people to share information as we get it and with that announcement, what I thought was the bigger part of the announcement that was not picked up was that we are about to approve a treatment for some children with autism and that is leucovorin, a medication that can bypass the blocked folate receptor at the blood brain barrier. Studies have shown that in the right population of children with autism, two thirds of kids can see a clinical improvement and some a dramatic improvement in their autism symptoms. That's good news. And I think as we get information, in the spirit of transparency, we want to make sure it's available to the public.
- [21:23]
A
Fascinating. It's so great to get a chance to visit with you because I know you and I know you're a straight shooter and when I hear you, I understand this so much better because certainly when I originally heard the announcements, you know that Tylenol is going to be banned or something else, you know, you immediately think, well that doesn't make sense. And then I hear you explain it and I get Tylenol's not being banned. It's like many other substances, there might be a label on it or information on it, but then people choose to use it or not use it. And I find that very helpful and very sort of centering around where we're at. Tell me, Dr. Makary, what else are you most focused on and excited about as we sort of move towards the end of this year into next year, where else are you most focused and excited?
- [22:09]
B
Healthier food for children. It's a huge priority. People forget that the F and FDA stands for food. There was even one FDA employee who thought the F stood for the word federal, but that's not stand for the word federal. It stands for food. We have a huge jurisdiction over food. And so we took action to remove concerning chemicals from the US food supply. We we've got over 1,000 chemicals in the US food supply that are banned in Europe and other countries. So we're working stepwise, we're doing good research, we're working with the companies. And I'm proud to report that the majority of US manufacturers have agreed to our plan to remove all nine petroleum based food dyes from the US Food supply. The next tier of chemicals, titanium dioxide and other chemicals. We have pledges now from the Mars Candy Company and from Tyson, one of the largest food makers in the US to remove titanium dioxide. Tyson just recently announced they're going a step further to remove high fructose corn syrup and also bht, that's a preservative that does not appear in the food. That Children consume in some other countries. So we're seeing tremendous commitments by the food industry. Sam's Club is going to make an effort now to remove 40 of the most concerning chemicals. But we're seeing massive strides to make our food supply healthier. We have a SNAP waiver now such that we don't have to force states to use taxpayer dollars for sugary drinks and junk food. We have some hospitals now that are stepping up and saying, hey, we're supposed to promote healthy living. We're going to start by serving healthy food in our cafeteria and to our patients. And we're tracking that. Look, we want to encourage that. We want to see more health promoted. And if a hospital is making a dramatic switch to healthier food like Tampa General Hospital, we're going to give them kudos and credit and all the attention they deserve.
- [24:18]
A
Thank you. And Tampa General Hospital happens to be ran by Jan Korra, John Korra, one of the brilliant leaders in our country. So that is fascinating in terms of talking for one more moment about how can the administration use the pulpit to reinforce that of course certain vaccines are needed and so important and we don't want to take 100 year step back on MMR and the Salk vaccine and the polio vaccine. And at the same time, hit this down the middle somehow, where it doesn't seem like the administration seems like an anti vax administration. How do you hit this down the middle? So you both clarify, of course, we're pro vaccines. We just don't know that we need 70 vaccines. How do you manage that? Or is that, can you give us any thoughts on that? Because it seems to me that that's what comes out of this, is that people hear, or maybe we just heard purposely, that RFK the team is anti vax when. When. That's a vast overstatement as I hear you talking about it.
- [25:24]
B
Yeah. And look, the questions that RFK is asking about vaccines, if we're being honest, are questions that many Americans are asking. They're the exact same questions that many parents are asking. And so let me be clear. RFK has been in a position where he's provided tremendous leadership on many topics, but he will defer and always has to his scientific team. And so he is a good boss in the sense that he will pass something along or suggest an idea or a topic to look into. But ultimately it always comes with the disclaimer, Marty, you're the doctor here, do what you think is best. Ultimately, it's your decision. And so I think we have to listen to People who have questions about giving the hepatitis B shot at birth. I don't think it's necessary if the mom is hep B negative. I think there are valid points there. At the same time, let me be very clear. There are essential vaccines and those vaccines save lives. And any vaccine, preventable illness is a tragedy. The recommendations come out of a different agency, not the fda. But I think we've done our best to try to make it very clear that we're committed to the basic regulatory framework that we are charged by with Congress, and that is to allow companies to make claims based on data that they present to us. And so we're going to keep doing that.
- [27:00]
A
Dr. Makary, it is just a great pleasure to get to visit with these issues and to hear directly your thoughts on it. And it's so enlightening. It's so refreshing. Is there anything else you'd like to add today or anything else you'd like to say?
- [27:15]
B
Well, I think, look, I'd love to see more cures and meaningful treatments for the American public. If there are two very clear cut goals that I have at this agency is to focus on our core mission of delivering more cures and meaningful treatments promptly and healthier food for children. And one of the cool things, Scott, in this job is you get to see some really promising things in the pipeline. I think in the next couple years we're going to see a powerful treatment for type 1 diabetes, for neurodegenerative disorders that are otherwise hopeless for some forms of pediatric blindness and deafness cancers. Now where we are seeing treatments where there are promising results suggesting it may melt a cancer away completely to the point where they no longer need surgery or chemotherapy or radiation that would change the landscape of the American hospital system in a powerful way. These are treatments that when they show promise, we have to look at the safety profile and ask what can we do to get a decision out promptly? And can we use big data, big national electronic health record data to track a medicine after it's approved? So we're not learning five years after Vioxx was approved that it may have killed 38,000 people, or 15 years after OxyContin was approved, that we may have lost nearly a million Americans to prescription opioids. We should have eyes on a drug immediately. And that's what we're doing with our new big Data initiative. I'd also like to see, and I'm optimistic that we will have a universal flu shot with long term protection, even against future mutant strains of influenza that have yet to occur in nature. There's some promising new treatments. And finally, one of my big priority areas is a treatment for PTSD. You know, we lose 8,000 veterans to suicide a year. That's more than the entire Iraq and Afghan wars combined. We lose that each year in suicide in veterans. And so many of these wars were unnecessary. These men and women served in good faith. We owe it to them to get the decision out promptly on any potentially promising treatment for PTSD.
- [29:38]
A
Dr. McCary, I can't tell you how much I appreciate having the chance to visit with you again. You are a tremendous leader, a tremendous thinker, and we appreciate you doing what you're doing and love the concept of improving the food supply and improving the pipeline of pharmaceuticals in our country and getting us to pay no more than what they pay in other countries, too, for our pharmaceuticals. Thank you so much for joining us today on the Vectors Healthcare podcast. What a great pleasure.
- [30:05]
B
Great to be with you, Scott. Thanks for having me.