Beyond the Headlines of MAHA With the FDA

Summary

Chasing Life

Episode: Beyond the Headlines of MAHA With the FDA
Host: Dr. Sanjay Gupta
Guest: Dr. Marty Makary, current FDA Commissioner
Original Release Date: October 3, 2025

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Episode Overview

This episode centers on Dr. Sanjay Gupta’s deep-dive interview with Dr. Marty Makary, a surgical oncologist who recently became the Commissioner of the FDA. Together, they explore how the FDA is adapting—and what may change—amid growing pressure from science, politics, and public health crises. The conversation covers food safety, drug approval reform, high-profile autism/Tylenol debates, vaccine safety, abortion drug regulation, and the broader intersection of public trust and health policy.

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Key Discussion Points & Insights

1. Modernizing the FDA (03:11–05:00)

• Makary's Listening Tour: Dr. Makary describes touring to meet drug developers for input on improving the FDA.
  • Quote: “There’s no shortage of things that are broken to fix at the FDA. I want to modernize the agency.” (03:21)
• Streamlining Drug Approval: Challenges FDA's historically slow drug approval (10–12 years):
  • Proposes continuous clinical trials using real-time data, reducing bureaucratic idle time.
  • “You wouldn’t apply for college after each year. …We can get decisions out in our new program in weeks, which is unprecedented at the FDA.” (04:01–04:50)
• Maintaining Safety Standards: Stresses need for speed without compromising safety.

2. Individual vs. Public Health & FDA's Food Safety Push (05:00–08:56)

• Balancing Individual and Public Health: Makary recounts moving from clinical practice to public health, emphasizing root causes not typically addressed in medicine.
• Food Chemicals & Child Health:
  • Efforts to remove petroleum-based food dyes linked to ADHD in children.
  • Major manufacturers are eliminating controversial ingredients (e.g., high fructose corn syrup, BHT, titanium dioxide).
  • Quote: “Our obesity problem in children, which is rampant, it’s not a willpower problem, it’s not their fault. This is something we are doing to kids.” (05:48)
• Regulatory Philosophy: Advocates for gradual, evidence-based ingredient swaps versus abrupt bans, balancing health and consumer choice.

3. The "Nanny State" Debate (08:01–08:56)

• Discussion of prior public health interventions (e.g., NYC soda regulation).
• Makary stresses a “balance,” arguing that evidence should guide policy, not ideology:
  • “We shouldn’t be messing with the minds just to sell more products to children.” (08:10)
  • Highlights bipartisan public support for healthier standards (“MAHA agenda”).

4. Makary’s Transition to Leadership (08:59–10:39)

• Leaving Surgery: Discusses leaving the OR for the FDA, calling the agency role “so much bigger than anything I’ve done.”
• Resources and Reform: Expresses confidence in his team and vision, despite massive challenges and government budget pressures.

5. Accelerating Drug Review Without Sacrificing Safety (10:39–11:02)

• Makary clarifies that faster drug review and safety can coexist.
  • Proposes conducting parts of the review process during clinical trial “idle time.”
  • “We can do much faster reviews without cutting corners on safety.” (09:46)

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6. Autism, Tylenol, Vaccines: Nuanced Evidence & Communication (12:19–22:21)

Autism Research and Causation Theories (12:39–14:54)

• Population Surge: Autism has surged to affect “1 in 12 boys in California.”
• Mechanisms Under Study:
  • Immune dysfunction (autoimmune blockage of folate receptor)
  • Mitochondrial dysfunction, microbiome, even circadian rhythms.
• Potential Therapy: Leucovorin (a reduced B vitamin) may help a subset of autistic children.
  • NIH funding $50 million in further studies.

Tylenol (Acetaminophen) and Autism (12:19–21:32)

• Public Comment: Recent statements by the President about Tylenol and autism have fueled confusion.
• Makary: FDA sent a measured letter summarizing the data:
  • Some studies show an association; others don’t.
  • Advised minimizing acetaminophen use for trivial fevers, but acknowledged a strong safety track record overall.
  • Quote: “We’re simply including this information for you to think about minimizing the use of acetaminophen for routine low grade fevers.” (20:40)
• Sanjay Gupta Clarifies Presidential Statement: The President said “don’t take Tylenol” at least 10 times, but did allow exceptions—advising consultation with physicians.

Vaccines and Autism: Honest Communication (15:49–17:09)

• Makary: “I don’t think so,” regarding vaccines causing autism, but stresses no medical product is “1000% safe."
  • Warns against public health absolutism, which can erode trust:
    • “I think the absolutism around some of this stuff creates mistrust.” (16:04)
  • Says physician guidance should be measured and evidence-based, even when political leaders send mixed signals.

7. Abortion Drug (Mifepristone) Oversight & Data Transparency (22:21–26:22)

• Ongoing Review: FDA is reviewing mifepristone after pressure from lawmakers and concerns about complication data.
  • Makary emphasizes all drugs should remain under “eyes on” evaluation with anonymized patient big data, not just high-profile drugs.
• Criticism of Politicized Reports: Sanjay Gupta notes a key anti-mifepristone study cited by politicians is not peer-reviewed and not from medical experts.
• Commitment to Ongoing Safety: “No drug is a thousand percent safe. So we’re going to continue to look.” (24:58)

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8. Restoring Trust, Civil Discourse & Holistic Health (26:22–28:59)

• Personal Motivation: Makary credits his physician father for shaping his public health values—emphasizing service, humility, and a holistic approach.
  • Quote: “We want to talk about root causes and the environment and food as medicine and the microbiome, gut health, and the soul.” (26:53)
• Depoliticizing Health: Both agree that health is now unavoidably political, and Makary expresses hope for a time of more humility and less absolutism.
  • “The science is a process of asking questions and a healthy discourse among experts.” (28:29)
  • Advocates for civil disagreement as essential to winning back public trust.

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Notable Quotes & Memorable Moments

• “There’s so much idle time…You wouldn’t apply for college after each year. So we can run more continuous trials using modern technology.”
  — Dr. Marty Makary (04:01)
• “Our obesity problem in children… it’s not a willpower problem, it’s not their fault. This is something we are doing to kids.”
  — Dr. Marty Makary (05:48)
• “We shouldn’t be messing with the minds just to sell more products to children.”
  — Dr. Marty Makary (08:10)
• “I think the absolutism around some of this stuff creates mistrust.”
  — Dr. Marty Makary (16:04)
• “The science is a process of asking questions and a healthy discourse among experts.”
  — Dr. Marty Makary (28:29)
• “We want to talk about root causes…food as medicine and the microbiome, gut health, and the soul. And these are topics that traditional medicine has pushed to the side.”
  — Dr. Marty Makary (26:53)

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Timestamps for Key Segments

• 03:11 – FDA modernization & drug approval reform
• 05:00 – FDA food regulation, child health, & food dyes
• 08:01 – The "nanny state" debate & bipartisan support for food policy
• 12:19 – Autism surge, possible causes, and therapies
• 15:49 – Vaccines, autism, and measured regulatory communication
• 20:38 – FDA’s letter on Tylenol and autism evidence
• 22:21 – Political pressure and scientific rigor on abortion drug oversight
• 26:34 – Dr. Makary’s personal motivations, restoring humility, and hope for depoliticized health

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Conclusion

This episode provides a nuanced look behind the headlines involving the FDA at a time of heightened political controversy and scientific uncertainty. Dr. Makary outlines a vision for modernization, transparency, and trust-building—both for the FDA and public health at large. The conversation emphasizes humility, continuous questioning, and evidence-driven policy, urging a move away from absolutism and political polarization in health communication.

For the full, uncut interview, watch the episode on the Chasing Life YouTube channel.

Transcript

[Dr. Sanjay Gupta]

Whether it is the food in your fridge, the medicine in your cabinet, or the sunscreen in your bag, someone has to decide if it is safe. And in this country, that someone is the Food and Drug Administration, the fda. Now, it's probably easy to take it for granted as yet another one of those three lettered government agencies, but the FDA plays a pretty crucial role in all of our lives. They ensure the safety, effectiveness and security and of a very wide range of products, everything from human and veterinary drugs to vaccines to medical devices like pacemakers. And lately, the FDA has been in the news a lot.

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The FDA will now advise doctors that there is this link, they say, between autism and acetaminophen.

[Dr. Marty Makary]

The FDA has approved the vaccine for specific groups, limiting access for some who may been able to get it. In the past, Robert F. Kennedy, Jr. Has launched an FDA review of Methopristone. It's a drug used in two thirds of abortions in America. Abortion rights activists say they're worried the review could lead to a ban.

[Dr. Sanjay Gupta]

The FDA has been at the center of some of the most pressing and polarizing health debates happening right now in the country. And look, it's generated a lot of questions. So I decided to sit down with the person leading it all, Dr. Marty McCary. He's a surgical oncologist and earlier this year he stepped into the role of fda. I really wanted to know what was going to change under his leadership. What does he want to reform and how does he see the FDA's role at a time when science, politics and public health are more entangled than ever before? I'm Dr. Sanjay Gupta and this is chasing life.

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[Dr. Sanjay Gupta]

Down together in Atlanta last Friday, September 26th for this conversation.

[Interviewer]

Well, thank you for your time.

[Dr. Marty Makary]

Great to be with you.

[Interviewer]

Sandra yeah, really appreciate it. What are you in Atlanta for?

[Dr. Marty Makary]

Yeah, so we're doing a CEO listening tour. So we're listening to drug developers and companies tell us what they think the FDA can do better.

[Interviewer]

Do you enjoy those types of tours?

[Dr. Marty Makary]

Yeah, you know, I thought it would be a little bit of diplomacy, get to know people, but I'm actually getting very specific suggestions on things we can fix at the fda. And there's no shortage of things that are broken to fix at the fda. I want to modernize the agency. So a lot of what we do is along that theme of modernizing the process. Why does it take 10 to 12 years for a new drug to come to market?

[Interviewer]

Why does it? Because I think sometimes the conceit is, look, these are important things. They should take a while before a drug is approved in this country. You want the gold standard evidence, evidence that other countries even look at to determine their own drug approval process. Should it be streamlined? Is there a risk in that?

[Dr. Marty Makary]

Look. Well, first of all, you have to keep the same high standards of safety because that's our number one job. But when an application sits on a desk for three months, you're not increasing the safety evaluation by just adding time. There's so much idle time. For example, after a preclinical study, the company reapplies then for a phase one trial, then they reapply for a phase two, then they reapply for phase three, and then they do a final NDA. You wouldn't apply for college after each year. So we can run more continuous trials using modern technology to have eyes on the endpoints of a trial in real time. Our regulators look on and we have a lot of offices. It's a bureaucracy in the application. Applications get farmed out. When we could use our convening power to bring people together in a tumor board style meeting. That's something that we're starting. And so we can get decisions out in our new program in weeks, which is unprecedented. At the fda, you took care of.

[Interviewer]

Patients one at a time, and now you're a public health official. Now, individual care versus care for the masses. And this comes up with things like vaccines and FDA approvals for medications. How do you balance individualism with public health?

[Dr. Marty Makary]

Well, look, I got disillusioned in medical school after three years and kind of left and drifted over to graduate school for public health. And I've often thought we're not addressing some of the big ironies in health. That is, we don't talk about root causes. We see massive problems expand right in Front of our eyes. So one thing I love about the FDA is we get to focus on food and healthier food for children is a massive priority. You saw our action to remove the non petroleum based food dyes. We're now at the next level of chemicals. We had one of the largest food makers, Tyson remove titanium dioxide. Mars company did the same. They're getting rid of all high fructose corn syrup. Tyson food is and bht, which is a preservative. So we're starting to see some moves in the food supply because look, our obesity problem in children, which is rampant, it's not a willpower problem, it's not their fault. This is something we are doing to kids.

[Interviewer]

There's a problem with regard to obesity and diabetes and frankly overall health. We're a country that spends four and a half trillion dollars on healthcare and frankly, we don't have much to show for that. But at the same time, how do you pinpoint then food dies?

[Dr. Marty Makary]

Well, look, there's a thousand ingredients in the US food supply, chemicals that don't appear in the food supply of Europe. So getting rid of any one is not going to make our population significantly healthier. But there is a randomized controlled trial that found that these petroleum based food dyes are associated with adhd. We don't otherwise have a good explanation. And there are natural cost neutral alternatives. The FDA went ahead and approved, in my five months that I've been there about five months, we've approved four natural ingredients with natural elements, four food dyes. In lieu of the petroleum based dye. We're going to approve two more. Normally the FDA approves one every several years. We approved four. So we want people to enjoy whatever they enjoy. But if we can just take small steps towards healthier ingredients, then I think it's a win.

[Interviewer]

It seems like they, you know, they've tried removing food dyes in the past or at least curtailing them to some extent and they found that people really didn't buy those products. Their Fruit Loops, I guess, weren't bright enough or cheery enough. You know, I remember when Michael Bloomberg did this thing with sodas in New York and people accused him of sort of propagating the nanny state. Is that a valid criticism? I mean, again, I hear what you're saying. I have kids, I think about this stuff all the time. But at the same time, where do you draw the line in terms of hey, we have the evidence to act now versus we think and as a result of our thinking, we're gonna take something away from People.

[Dr. Marty Makary]

Yeah, it's a balance. Look, you're always trying to keep a balance, but you're absolutely right. The vibrant colors of the food dyes make the food more attractive. And studies have shown that it messes with the mind of a developing child to the point where they can be attracted to the food even though they're already full. And that may in part be what's behind some of this rise in insulin resistance. So we shouldn't be messing with the minds just to sell more products of children. There's a huge tide in the United States that says this makes sense. Republican, Democrat, independent mom showed up in high numbers to vote over this Maha agenda. They believe in it. The companies see the writing on the wall and are already making moves to use natural ingredients. We just want to set a level playing field and a common timeframe so that one company doesn't have an advantage over another company.

[Interviewer]

Are you still operating or are you still.

[Dr. Marty Makary]

Is that still part of your life? No, I hung it up. I was in the operating room the day before my Senate confirmation hearing, and that might have been my last operation.

[Interviewer]

You dedicated your whole life to being a surgeon, caring for people in that environment. But it may be time to move on to something else.

[Dr. Marty Makary]

This is so much bigger than anything I've done. It's such an exciting opportunity. I have a very clear goal. I want to see more of these cures and meaningful treatments out quickly, and I want to not cut a single corner on our safety evaluation.

[Interviewer]

Those two things, I think, can sometimes seem at odds with each other. And also in the wake of all this, are these significant cuts that are happening across the government, but including the medical establishments. Do you have the resources you need to do what you want to do?

[Dr. Marty Makary]

So, first of all, it may sound like they're at odds going fast and maintaining high safety standards. But if you think about a phase three clinical trial that runs for, say, two years, that's idle time. We should be doing our manufacturing inspections. We should be reviewing the lion's share of the application, reviewing the label, all the complicated stuff in the 100,000 page application that comes to the FDA for a drug. The clinical trial part is a piece of it that can read out at the end, and we can do our reviews during that idle time so we can do much faster reviews without cutting corners on safety. And we said, we're going to create a new FDA where everything is centralized and we're going to consolidate all the communication staff. And I think it's a much more efficient, better fda.

[Interviewer]

Now, do you feel like you have what you need now to do what you want to do?

[Dr. Marty Makary]

Yes. But the task is massive. Right. We're trying to follow research as it happens. We're looking in the pipeline of the drugs that are coming in saying, oh my gosh, this looks amazing. This could help people with an otherwise debilitating hopeless condition. And the safety profile looks strong. Let's put it at the front of the line.

[Dr. Sanjay Gupta]

Up next, Tylenol, autism vaccines and what Dr. Makary says is the future of drug regulation in America. We'll be right back.

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[Interviewer]

Let's talk about this past week with Tylenol and autism. How, first of all, how did that hit you? I know you guys have been talking about autism for some time and the health secretary said that there was going to be a report in September issued about this. If you can just take me a bit behind the scenes for when did this start hitting your radar?

[Dr. Marty Makary]

Yeah. So look, we have this charge from the president and the secretary to look into autism. It's now two and a half million kids in the US it's surged in our lifetime. It was rare a generation ago. It's now 1 in 12 boys in California. And as you know, Sanjay, it can be a brutal medical condition for some kids there's a spectrum, of course, of severity. But for some kids, it's sad to watch. They're crying, they can't talk. They want to talk. They know they want to talk and they can't. And so it could be brutal. So we wanted to tackle this with an evidence based approach. So what we did is we started looking into the potential mechanisms that could cause autism.

[Interviewer]

Just one thing, and I want to talk about the mechanisms. But what do you think is driving the increase in autism, I don't know.

[Dr. Marty Makary]

But I think there are a couple plausible mechanisms. Number one, an autoimmune response that may be blocking the folate receptor at the blood brain barrier. Number two, some degree of mitochondrial dysfunction that may interact with the same pathway or a different pathway. And number three, alterations in the microbiome. Maybe there's something there, maybe there's not. Maybe circadian rhythms play a role. I don't know. I'm just throwing things out there. But the autoimmune response to the folate receptor is a very interesting mechanism. And we felt like when we had at least talked to enough experts that felt that this is worth sharing with the public, we said, let's go ahead and share this ahead of any report. And leucovorin bypasses that blocked receptor and may be a therapy that some doctors may choose to use. There's a group of doctors in the United States, I don't know if you've spoken with any of them, who have reported some pretty impressive clinical results using leucovorin in individuals who test positive for that folate receptor antibody.

[Interviewer]

And that's about what, 60% or so of children who have a diagnosis will test positive?

[Dr. Marty Makary]

Yes. And maybe 20% overall may see a marked improvement with leucovorin. The rest may have some improvement, but not as significant.

[Interviewer]

You're talking about a B vitamin that is reduced to the point where it can bypass that potentially blocked, if you will, receptor.

[Dr. Marty Makary]

That's right. It's methylated, so it can go past the receptor pathway to get it through.

[Interviewer]

So this brings up this point again of evidence threshold.

[Dr. Marty Makary]

Yeah.

[Interviewer]

Do you treat something like leucovorin differently? Because we're talking about autism, something that doesn't really have a therapy. Will it go through FDA approvals more quickly than other things?

[Dr. Marty Makary]

I think because it's safe, it will go through a different process. And because it's been around for nearly a century, it will go through a different process. And because of the urgency of the unmet public health need of the burden of autism in society and the incredible experience that clinicians have now, as you know, NIH, as a part of the announcement, announced $50 million in funding to study this question more. Maybe a couple randomized controlled trials will find the effect size is small, maybe it'll find that it's large. But that's a question that we'll see answered. Maybe there's a subgroup that benefits more from the therapy.

[Interviewer]

Do vaccines cause autism, do you think?

[Dr. Marty Makary]

I don't think so.

[Interviewer]

It seems like it's a big sort of rallying cry of this administration. You've got a health secretary who said this flat out. He has said there's no vaccine that is safe and effective. He believes vaccines cause autism.

[Dr. Marty Makary]

Well, I think there's no medicine that's 1000% safe. And I think we have to remember that with everything. I think the absolutism around some of this stuff creates mistrust. And when we say they're 1000% safe and it's impossible for there to be a single complication of a vaccine, that's the kind of rhetoric I think that doesn't resonate well. So I think we have to be humble and take a very honest approach.

[Interviewer]

If, you know, you're hearing from the health secretary that there is no safe and effective vaccine, that, you know he's drawing these links between vaccines and autism, you're saying that you don't believe that's the case. But if that's the message that gets out there, could you potentially be scaring people away from something that could really be helpful for them?

[Dr. Marty Makary]

Yeah, look, I think if the media misconstrues what he's saying. Yes. It could unfortunately scare people.

[Interviewer]

Can I call you Marty? Yeah, please, Marty. I don't think mis.

[Dr. Marty Makary]

I mean, he said it, so he's also said. How do you reconcile that with the fact that he said the best way to prevent measles is through vaccination?

[Interviewer]

I feel like he was forced into that one because he was in the middle of an outbreak.

[Dr. Marty Makary]

Well, that's a theory of yours. But to only report piece of what he's.

[Interviewer]

All right, I don't have. We should follow up on that discussion for an entire podcast. But I do want to talk about this Tylenol thing, though. So you're up there, you're hearing the President say, don't take Tylenol. Nobody should take Tylenol. That was weird to me. First of all, the fact that it was the president saying that, but you've said, I agree with you, that we shouldn't be speaking in such absolutes. And yet the commander in Chief did exactly that.

[Dr. Marty Makary]

Not really. You're making it an absolute. He said, there are exceptions. Three times he said it in the same speech. And he said, it's between you and your doctor. So that part has been left out of the coverage of what he said.

[Dr. Sanjay Gupta]

I wanted to jump in here for a second and say that we did take a close look at President Trump's speech on September 22nd. In that speech, the president said, quote, taking Tylenol is not good. And quote, ideally you don't take it at all. The president used the phrase don't take it and don't take tylenol at least 10 times. However, yes, the President did caveat this a few times, saying pregnant women could take it when medically necessary and they should consult with their doctors for more information.

[Dr. Marty Makary]

But if you can't tough it out, if you can't do it, that's what you're going to have to do. You'll take a Tylenol, but it'll be very sparingly. Can be something that's very dangerous to the woman's health. In other words, a fever. That's very, very dangerous. And ideally a doctor's decision, because I think you shouldn't take it.

[Dr. Sanjay Gupta]

Okay, back to our conversation.

[Dr. Marty Makary]

Look, take it up with the dean at the Harvard School of Public Health who believes there is a causal association between prenatal acetaminophen and autism.

[Interviewer]

Did he say that? Is it causal or an association?

[Dr. Marty Makary]

He said there is a. I'm going to quote exactly what he said. There is a causal association between prenatal acetaminophen and the neurodevelopmental disorders of ADHD and autism spectrum disorders.

[Interviewer]

What is a causal association? Because I always thought there's associations and then there's cause and effect.

[Dr. Marty Makary]

Yeah, cause and effect. He thinks the acetaminophen is causing those. Now, look, he may not be right. I don't know. I don't think he said that, though. I think he said. No, he said that.

[Interviewer]

But in the rest of that quote, he said there's a plausible causation. But in the thing. But from what I read, he said that there may be an association between Tylenol and autism.

[Dr. Marty Makary]

I'll get you the quote. He said a lot of things.

[Dr. Sanjay Gupta]

Okay, jumping back in here to clarify, we went straight to the source. Dr. Andrea Beccarelli, the dean of the Harvard T.H. chan School of Public Health. And here's the statement that was sent to us. It's currently linked on the White House website this week as well. Dr. Baccarelli says, in part, as we noted in our review, animal studies have independently suggested that prenatal exposure to acetaminophen can adversely affect the developing brain. This biological evidence lends support to the possibility of a causal relationship between prenatal acetaminophen exposure and neurodevelopmental disorders, including autism. So the possibility of a causal relationship in animals. But overall, experts say there are multiple causes of autism. And the science showing A connection between autism and Tylenol is not settled. Okay, back to the conversation.

[Interviewer]

Do you believe it?

[Dr. Marty Makary]

You know, I don't know. I think my job as a regulator is to say, and we did this. I don't know if you saw the letter the FDA sent out. We said there has been an association described. Other studies have found no association. We're simply including this information for you to think about minimizing the use of acetaminophen for routine low grade fevers. And obviously there's a safety track record with acetaminophen compared to other alternatives. So we put out a very measured. I saw that statement.

[Interviewer]

I thought it was very measured.

[Dr. Marty Makary]

Thank you.

[Interviewer]

I did think it was a little bit at odds with what the President was saying. But again, maybe this is. You're suggesting maybe that being misconstrued.

[Dr. Marty Makary]

Well, yeah. I mean, look, if you don't cover the fact that he said that there are exceptions, which he said three times, and you don't cover the fact that he said between you and your doctor, it is going to seem at odds.

[Interviewer]

But when you're up there listening to him, there's not a part of you saying, hey, look, maybe we should dial this down a little bit or were you totally okay with how he presented it?

[Dr. Marty Makary]

Look, so we're the physicians, we are the physician community. And so we're going to put out what we think are the measured recommendations. If an individual who's not a physician says something, it's okay. It's a free country. How many patients have you met that have different ideas on what caused their illness or what they should do differently, even though you might not agree with it? And so people are welcome. The questions that, for example, Secretary Kennedy are asking about health and root causes are the questions most moms are asking. And so we could say that's crazy. Don't. Let's do what we can't. That can't be in the public domain. Or we can try to use data as best as we can, as we did with the Tylenol letter, to say here's what the data says.

[Interviewer]

So, mephipristone, what is happening with this? There was a letter that went out to 22 Republican attorney generals. I guess that was in response to a letter they had sent you.

[Dr. Marty Makary]

Yeah, they'd sent a letter. People have concerns about an Ethics and Public Policy Institute study that was done that shows a higher complication rate than the complication rate that has been described using self reported data. And so they have asked for sort of a look at this. And so we have an ongoing effort to look at mifepristone.

[Dr. Sanjay Gupta]

All right, let me break into the conversation one more time to fill in some of the backstory here. If you're not familiar, mifepristone is one of the drugs used in medication, abortion and miscarriage care. In the letters sent by the 22 Republican attorneys general to the FDA, they cited a report from the Ethics and Public Policy center as evidence that mifepristone is risky. Now, who is the Ethics and Public Policy Center? Well, this is a think tank that describes itself as pushing back against the extreme progressive agenda while building a consensus for conservatives. Their report, not a medical study, was authored by two of the organization's leaders, not doctors or medical researchers. And it was published on their own website, not in a peer reviewed health journal. Experts we spoke to said that the report, among other shortcomings, lacks transparency with respect to the source of the data and is not a methodologically rigorous or evidence based resource. Okay, back to the conversation.

[Dr. Marty Makary]

We look at the reports that come in. We have adverse event reporting systems and we do our own studies. So we have to do it. And I want to do it for every single drug that's approved by the fda, not just one or two here and there, not just vaccines. And mifepristone, we should have eyes on a drug immediately after it's approved. So we're going to have a new system to use big data because as you know, you can pull together electronic health record data now that protects privacy, anonymizes the patient so it's de identified and watch how the drugs are working in big data. That's one of our big projects.

[Interviewer]

Is there a point where you say, hey, look, it's good, it's safe. Methapristone, 25 years, I think roughly 2,000. I think it was approved. You have lots of data. I mean, are you suggesting it has not been evaluated along the way and there might be something new you that's of potential concern?

[Dr. Marty Makary]

Well, again, I think people get very interested in this idea that something is, we can rest assured that something is 1,000% safe. And the reality is no drug is a thousand percent safe. So we're going to continue to look. For example, we could discover in our ongoing analysis of mifepristone that there's a drug, drug interaction that we were not aware of. If we find that, we're going to let people know.

[Interviewer]

So is there ever a point where you say something is good? I mean, it's approved, it's approved. It's approved. So, I mean, but the reevaluation of something that's been approved, that's been out there for a long time seems like it's a little bit of a waste of resources considering all the other things you want to do.

[Dr. Marty Makary]

Well, we want to do it for every single drug. And so we're going to have big data analysis. Yeah, we're going to start with the drugs from last year and the year before. It's about 100 drugs now. This year, we may hit a record number of drug approvals. We're working very hard, and we may very well hit that target. But the drugs this year and last year and the year before were starting with that group. And so we can do this at scale. Now we have a charge from Congress to review the application pharmaceutical companies sent to us to decide whether or not the claims they want to make about a drug are consistent with the data they submit. That's our job. And so if safe and effective is generally the standard, and then we approve a drug.

[Interviewer]

Got it. Well, look. Okay, one thing I wanted to say, I read your opening statement. I heard your opening statement, and you talked a lot about your father. You're a medical family. How much of who you are today was influenced by your dad?

[Dr. Marty Makary]

100%. Amazing guy. How many docs have we met in our careers that are 1000% selfless? And so my dad is just one of those docs. There's a great quote that, who else knows about the value of human life than the witnesses of birth and death? And in medicine, we see that all the time. And I think people need to turn off the echo chambers of social media and realize we all want the same thing. We want a healthier population, healthier kids. We don't want to see 40% of our nation's kids sad because they have a chronic disease. We don't want to drug our nation's kids at scale. We want to talk about root causes and the environment and food as medicine and the microbiome, gut health and the soul. And these are topics that traditional medicine has pushed to the side. And so there's a movement now to say, let's talk more holistically about health. And you've done a lot of that.

[Interviewer]

I've tried to, you know, and I mean, I think that that is who most humans are. Right. We don't want to take any medicines if we don't need to. We don't want to have surgery if we don't need it. But do you foresee a time when Things don't aren't so political because you can't disentangle anything from politics nowadays. Health secretary says, hey, eat right and exercise and it becomes a political statement. In a way. It's weird. And I say that as somebody who's done this sort of work for 25 years, it's particularly weird right now. Is it going to get better?

[Dr. Marty Makary]

I hope so. I hope so. Look, I was raising a flag in the air over the last four years of COVID saying, let's be objective. You normally evolve your position as the data comes in. If you're being objective. That's what we do in medicine. And the idea of digging into a position we saw that cross over into how people saw their health. And, you know, I still see it today. I see it well, the science. And the science is clear and the science is no, the science is a process of asking questions and a healthy discourse among experts. And that I think is something we need to restore. Now I'd like to see more civil discourse, people that have different opinions. Let's talk about your ideas. Maybe you're right. Maybe the data here is compelling. Maybe it's not compelling. If we show more humility, I think we can win over some more public trust.

[Dr. Sanjay Gupta]

I want to thank Dr. Makary for that wide ranging interview and for agreeing to sit down and talk to us. Now our actual chat went more longer and you can listen to that and watch even more of it on our Chasing Life YouTube channel. Thanks for listening.

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[Dr. Marty Makary]

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[Interviewer]

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