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Lisa Booth
The Truth with Lisa Booth where we get to the heart of what matters to you. Today we're going to talk about public health with my friend and former Fox News colleague, FDA Commissioner Marty McCary. I'm going to ask him about his confirmation journey. Don't you just want to know what is that like? So I'll ask him. We'll also talk about some of the bold moves that the FDA is making and how it's being received by the media. Are they telling the truth? I mean, we know they're not, but we'll ask him about that. We'll also unpack some of the changes that the FDA is making with the COVID 19 vaccine, particularly more advanced warnings about myocarditis with young men as well. And we'll talk about, you know, some of the other changes that are happening at the fda, like fast tracking the drug review program or cutting back on some of the animal testing. Why is that done? Does it even need to be done? But I know another topic that you guys are really interested in is the Make America Healthy Again movement. So we'll talk about the changes that he's making at the FDA about that. Also pushing back on some of these synthetic dyes. I know that they're kind of in a fight right now with Mars, the maker of M&M's over synthetic diet. So we'll dig into that as well. So a lot to talk about with my friend and also just a smart guy with common sense or FDA Commissioner Marty Makary. Stay tuned. FDA Commissioner Marty Mercary. Now, I have to call you a commissioner because you're, you're a big, you're a big deal. You're a big deal now.
Marty Makary
So great to talk to you, Lisa. Call me Marty, please.
Lisa Booth
Well, I'm, first of all, I'm so proud of you. I was so excited when you got picked because, well, first of all, you're just brilliant. But secondly, you just, you use common sense, which doesn't happen anymore. So we kind of want our public health officials to obviously use their backgrounds, as, you know, you have exceptional background, but also to use common sense. So I was so happy for you and just excited for the country.
Marty Makary
Thanks so much, Lisa. There is a common sense deficiency syndrome that we're actively trying to, to treat nationwide in our health care system.
Lisa Booth
And I'm sure you're still dealing with it in terms of like the media coverage and trying to explain things to people and like, you know, like dealing with But I do want to ask you because I've just always been curious what was going through the confirmation process.
Marty Makary
Like, the biggest thing in my mind was, you know, I've been doing trauma surgery in the Past and cancer surgery and complex medical stuff. So the stress didn't bother me at all. It was actually less stressful than a complicated operation I was doing at Johns Hopkins in my career prior. But I was sort of mourning leaving clinical practice because I did my last operation the day before at the hospital. And I just realized I'm walking into this sort of crazy world of politics. I'm going to miss being a doctor. And when I was a surgeon at Hopkins, everybody wanted you to succeed. I mean, people in the community you never met, family members, the patients, your staff. And in these jobs in government, the second you walk in, a third of the country wants you to fail. And for me, that's a very funny feeling. Yeah.
Lisa Booth
Because I was even reading, like, Stat News has a piece recently about how it's sort of like, reduced workforce that President Trump has wanted across the board at all these different agencies, how they're saying it's like compromising the agency's work, and then obviously the people who laid off are upset. Have you, have you been surprised by some of that coverage or I guess, you know, any. Anything you want to kind of like weigh in on that with?
Marty Makary
Overall, I've actually been pleased with the coverage. It's been good on the whole. But there are a couple of outlets that are always going to write these pieces with anonymous sources, and it's just gossip. One thing that some of these sort of doomsday writers always leave out when they talk about the reduction in force. The FDA reduced its workforce by about 15%. The goal was to get back to 2019 levels, and that happened just before I got into office. Part of the Doge cuts in early retirement did reduce the workforce. But one thing that the reporters always leave out when they knock on it is that the FDA has doubled in size since 2007. There were 9,000 employees at the FDA here in 2007, and that went up to nearly 20,000 last year. And so nobody talks about the fact that it's ballooned up and that we had 12 travel offices and dozens of people who were chief strategy officers and 2000 HR people and budget procurement people. And so when Southwest Airlines announced, I think it was the same week as the cuts at the FDA that they reduced their workforce by 15%. No one said, well, this is going to result in airline safety problems at Southwest. They thought, well, this is a resizing of the organization. Well, the government sometimes needs to be reevaluated. And one thing I learned about the FDA is that when we walked in here, we discovered a lot of stuff. One thing is that it was a fiefdom culture. There were sort of empires that were being built with duplication of services, of websites, of it, of communication staff, of lobbyists to the Capitol Hill. We learned that cells on Americans being treated for cancer were being gene edited in China. The cells were being sent to China and then gene edited by the Chinese and sent back to the United States. We shut that down. There's just a lot of insane. We discovered a lot of insane things that we discovered. And so we've been sort of in a discovery mode, meeting with people on the ground at the fda, asking them what's on your mind, what needs to change? What do you need to do your job better. So we've been very operational. I've been very much on the ground and not floating around in the media and going to sort of all the cocktail receptions and conference panels that you get invited to in these jobs. I've been very much on the ground here trying to make the FDA more streamlined, better cut the red tape and talk about food, not just drugs.
Lisa Booth
We're also not going to get invited with that mentality. So you might not have to worry about it because they're not going to invite you. You know, part of that with, you know, obviously one concern a lot of, or, you know, Americans have a lot of concerns with public health, particularly since COVID but just the power of the pharmaceutical industry. And I know at the time that this will be made public, the FDA will announce that decisions on drug approvals will be made public. Walk us through that, the significance of that. And then also how that will sort of reduce the power of, you know, lobbyists and just, you know, that transparency that's so important for Americans.
Marty Makary
Well, first of all, this agency belongs to the American people. Some people perceive that it's captured. And I'm happy to report that we have done everything possible to ensure that the review at the FDA is scientifically independent. One of my first actions was to remove pharma members from FDA advisory committees wherever statutorily possible, and to ensure that we are entirely independent. At the same time, we have to partner with the pharma industry because we want to see more cures come to market. We want to see cures for these rare diseases and intractable neurodegenerative diseases, for diabetes, for blindness, for stage four cancer. And I believe there's some really promising stuff in the pipeline. You know, the cool thing about this job at the FDA is you get to see what's sort of on the horizon, what's possible. And it's pretty exciting. We just have to cut the red tape. So when it comes to PhRMA, you know, I have personally taken a pledge that I will not work for Big Pharma after my time as commissioner. Shareholders don't have to just listen to the spin of the companies that get these FDA decision letters. One thing we learned is that when companies get a decision, a rejection from the fda, they will spin the decision to their shareholders. Well, now these will be public and it'll also help inventors and other drug developers to understand what the FDA wants. More transparency is good, in my opinion. No society has ever ushered in transparency and then later said, you know, that was a bad idea. Let's go back to keeping people in.
Lisa Booth
The dark, you know, and to that vein, you know, I know the Trump administration has made changes across the board with the, you know, different agencies regarding the COVID 19 vaccines. I know at the FDA specifically, you guys have mandated expanded warnings about myocarditis. You know, the risks from the MRNA based Covid vaccines. Also changes in terms of shifting policy to limit the annual COVID vaccine approvals to adults 65 and older. Kind of walk us through some of the changes that you guys have made in regards to the COVID 19 vaccine and why did you make them?
Marty Makary
Yeah, so we basically said we're going to use the same scientific standard we use for other drugs for the COVID booster shot in healthy Americans. We're not going to just rubber stamp blindly Covid boosters every year without clinical data that's updated. And so that is a position that's generated a lot of controversy in the medical field. We made our framework very clear in the New England Journal of Medicine. We published it because I believe the public deserves total transparency on exactly what we're thinking. And we said, look, if you want to create a Covid booster shot for young, healthy Americans, do a clinical trial. We will review that clinical trial and we will make a decision. We're not just going to put a blindfold on and rubber stamp approve every single Covid shot booster for young, healthy kids that comes across the desk. So we're very clear, we're not playing games. At the same time, we do think Terry Kennedy's promise that if you want a vaccine, you can get a vaccine. We're not taking away people's vaccines. We are. Our philosophy is still very much aligned with the message that he's put out there on that.
Lisa Booth
Well, we've also just learned more about some of the risks with the COVID vaccine. You know, particularly when, you know, with younger people with myocarditis, young men, when they don't really need, you know, they're not at risk from COVID And so, you know, the risks from the vaccine could outweigh the risks from getting Covid. So I guess what have we learned about some of the risks from the COVID vaccine?
Marty Makary
Well, once, you know, once we got here, we learned a lot of stuff as I mentioned, and one of the things we learned is that there were concerning safety signals about myocarditis in young men after the COVID shot that were slow walked. They were not acted upon in an expeditious way when they were discovered here at the fda. And so we did a thorough review with the best available information that we had and we issued a warning about myocarditis with the COVID shot that was long overdue. And so there are many things like that where now we're going through, um, what's the, in the inventory here? What are the safety concerns of our scientists that were suppressed and how can we act accordingly?
Lisa Booth
Quick commercial break. More with FDA Commissioner Marty Makary.
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Lisa Booth
You guys have or, you know, collectively obviously with Secretary Kennedy at hhs, you know, overseeing all this more broadly, but pushed, I think you called it, love, with, you know, sort of pushing some of these companies, you know, food and beverage companies to get rid of some of these synthetic dyes that Americans are concerned about, particularly with the Amer, the Make America Healthy again movement with success, I believe, like jello. What is it? Lucky Charms? You know, there's been some companies that have said that they're gonna aim to do this by 2027. So there's been movement, positive movement. However, you know, Mars, particularly with M M's, they're saying we're not gonna get on board. They're fighting you guys with it. Why are synthetic dyes dangerous? And I guess what are sort of the next steps that the administration that you guys are planning on taking in regards to that?
Marty Makary
Well, first of all, this has been a big issue whereby Republican, Democrat and independent moms showed up in high numbers to vote for President Trump over this actual issue, this very issue that President Trump and Secretary Kennedy have championed. There are, you know, we can learn from listening to parents. When parents tell you that their child had bad behavior or had attention deficit disorder or had behavioral problems at school and then they eliminated all of these artificial petroleum based food dyes from the diet of their child and then the child suddenly improved to having normal behavior. That's not a randomized control trial. But we as scientists can learn. That is a data point. And in conglomeration, these are data points we can learn from. There are also, by the way, randomized controlled trials, for example, one in the Lancet, the medical journal Lancet, showing that petroleum based food diets were associated with attention deficit disorder. So what are we waiting for? Why do we take risks when we have an epidemic of child behavioral problems and attention deficit disorder? Why do we just blindly go down this path of drugging our nation's children at scale and not talk about the root causes? And personally, I don't think kids need glow in the dark fruit loops. I mean there are natural alternatives that can provide color. And we went on the offense and approved several natural food dyes to replace these petroleum based artificial dyes. We're going to announce another one next week. But we have been getting these natural dyes out on the market expeditiously and we took a bold step to ask companies to stop using the nine petroleum based food dyes in the US food supply. I don't think the chronic disease illness problem in American children is a willpower problem. Something is going on in the food supply. Now on Mars, you mentioned Mars. I think the reporting out there has not been accurate that I've been seeing about Mars. Mars is a family owned business. They want to make improvements in the health quality of their foods. We've had very productive conversations with them and we're going to be meeting again with them. I'm meeting with them, I think in the next week or two and I'm optimistic that they're going to join this bandwagon effect of food manufacturers Kraft, Heinz, General Mills, Danone Yogurt, Jell O, all these products that have pledged to support Secretary Kennedy's vision for a food supply for American children without these petroleum based dyes.
Lisa Booth
What would you say are the most important things the Trump administration has done so far to make America healthy again?
Marty Makary
Well, we are rewriting the food guidelines, the dietary guidelines. You know, that has been probably one of the greatest sources of health misinformation in the United States in our history. You know, the broken food pyramid written by the industry. We are rewriting that right now at the FDA and we should have that out later this year. We have Taken an inventory of all the chemicals in our food supply. We're doing things to educate the public about chemicals. It's not just the petroleum based dyes. One company took action, the maker of Skittles to remove titanium dioxide. Another concerning chemical. We are promoting whole foods and grains without the fiber stripped off of the grain, as we typically see with ultra Processed Foods. 70% of the diet of kids now is ultra processed foods. So we're bringing a lot of attention to that issue. And you're seeing for the first time ever in this Trump administration, the SNAP program changing whereby states are being granted waivers to no longer use taxpayer dollars to fund ultra processed junk food and sugary drinks. We've got to start talking about school lunch programs, not just putting every kid on Ozempic. We've got to talk about environmental exposures that cause cancer, not just the chemo to treat it. And so the NIH has a very aggressive agenda to now study the root causes of chronic diseases. Because up until now most of the focus has been just on this whack a mole game of medicating and operating on people after they are very sick.
Lisa Booth
I know that you have pledged to reduce and you know, cut some of the animal testing requirements and animal testing that's being done. What can you tell us about some of these tests on animals and why is that important?
Marty Makary
Well, a lot of the animal testing that's routinely done for drugs that are being evaluated here at the FDA are unnecessary. And just to take a step back, Lisa, I don't believe that God put animals on planet earth for us to abuse or torture. And so we can.
Lisa Booth
Fauci would disagree with you. Continue.
Marty Makary
We can modernize the agency and use computational modeling now. AI technology that looks at a molecule and can predict its toxicity in humans better than an animal test, predicting toxicity in many instances. And there's something called organ on a chip technology where the drug is tested on a cell culture medium or what we call an organoid, a mini organ in a lab. We don't need to be torturing animals and keeping them in captivity in many instances. So we have an aggressive roadmap to reduce animal testing that we introduced in one of my first weeks in office. I've been in office, Gosh, I guess 100 days now. This is the 100 day mark. And so we've had this aggressive plan to reduce animal testing, remove the petroleum based dyes. We've got AI now for the scientific reviewers, it's speeding up their process and we have a pilot program to reduce the decision Time of the FDA from nearly a year to just one or two months. All of these things are aimed at modernizing the agency and cutting the red tape so we can streamline the regulatory process and deliver more cures and meaningful treatments to the American people.
Lisa Booth
Yeah, there's been one of the, before we go, one of the big lines of attack against the Trump administration is, you know, they're saying you guys are cutting research and it's going to put lives in danger, you know, et cetera, et cetera. Has our ability as a country to, you know, do various important health research regarding cancer or what have you, has that been impacted by, you know, cutting some of these grants?
Marty Makary
Well, if we're talking about the nih, when J. Bhattacharya walked into the nih, you know, I talked to him a lot. We're friends. And he walked into a mess. 14% of NIH grants were going to health equity and diversity research. That was descriptive. It did nothing for these disparities that we see in the United States. We were funding a lab and a group that likely brewed up the coronavirus and that killed 20 million people and cost $25 trillion worldwide. And they had done very little research on the root causes of chronic diseases as the health of the population has gotten worse. I mean, if you measure health care by sophisticated gene editing or operations that we do in surgery, yeah, there are incredible success stories. But if you measure the performance of the US healthcare system over the last 50 years by the health of the population, it's been a 50 year failure. And so J. Bhattacharya is doing an incredible job, especially with all the fake news out there about NIH dollars being cut. Not one NIH dollar has been cut. There's not a single dollar to the NIH budget that has been cut. Medicaid has not been cut. There are reasonable limits to the growth rate of Medicaid. And so there's a lot of incorrect information out there on what's happening. But of course it's from the usual, you know, fear minded reporting on what's going on.
Lisa Booth
Well, you've lived through that with COVID so you're up to speed with how it works. Commissioner Marty McCary, you're a friend. Just so happy for you, proud of you and so glad you're over at the FDA and we've got people like you in government.
Marty Makary
Well, thanks so much, Lisa. Great to talk to you again. Great to connect and thanks for having me.
Lisa Booth
That was the FDA commissioner, Marty McCary and my friend. Appreciate him for making the time to come on the show. Appreciate you guys at home for listening every Tuesday and Thursday, but of course you can listen throughout the week. Until next time.
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I'm Christiana Manpour and I've been on the front lines and interviewing world leaders for more than 30 years.
Lisa Booth
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Jamie Rubin
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Christiana Amanpour
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Podcast Information:
In this episode of The Truth with Lisa Booth, host Lisa Booth engages in a comprehensive discussion with FDA Commissioner Marty Makary. The conversation delves into Makary’s journey through the confirmation process, the transformative changes he is implementing at the FDA, and broader public health initiatives aimed at making America healthier.
Lisa Booth begins by congratulating Marty Makary on his appointment, highlighting his intelligence and common sense. Makary reflects on his transition from a high-stress career in trauma and cancer surgery to the politically charged environment of government service.
Marty Makary [05:02]:
"I've been doing trauma surgery in the past and cancer surgery and complex medical stuff. So the stress didn't bother me at all. It was actually less stressful than a complicated operation I was doing at Johns Hopkins..."
Makary discusses the challenges of entering a political arena where a significant portion of the populace may wish for his failure, contrasting it with the supportive environment of clinical practice.
Booth raises concerns about workforce reductions within the FDA, linking it to broader national trends. Makary provides context, explaining that the FDA had already reduced its workforce by 15% to return to 2019 levels prior to his tenure.
Marty Makary [06:22]:
"The FDA reduced its workforce by about 15%. The goal was to get back to 2019 levels, and that happened just before I got into office."
He emphasizes that despite workforce cuts, the FDA’s size has more than doubled since 2007, growing from 9,000 to nearly 20,000 employees. Makary details efforts to eliminate redundant structures and improve operational efficiency, including addressing misconduct such as unauthorized gene editing of cancer cells in China.
Marty Makary [08:00]:
"We discovered a lot of insane things that we discovered... making the FDA more streamlined, better cut the red tape and talk about food, not just drugs."
The conversation shifts to the FDA’s commitment to transparency in drug approvals. Makary outlines steps taken to ensure the scientific independence of the FDA’s review process by removing pharmaceutical representatives from advisory committees.
Marty Makary [09:50]:
"This agency belongs to the American people. Some people perceive that it's captured. And I'm happy to report that we have done everything possible to ensure that the review at the FDA is scientifically independent."
He announces upcoming policy changes to make FDA decision letters public, aiming to reduce the influence of pharmaceutical lobbyists and enhance accountability.
Marty Makary [10:05]:
"When companies get a decision, a rejection from the FDA, they will spin the decision to their shareholders. Well, now these will be public and it'll also help inventors and other drug developers to understand what the FDA wants."
Booth inquires about the FDA’s stance on COVID-19 vaccines, particularly regarding myocarditis warnings and age-specific vaccination policies. Makary explains the FDA’s approach to maintaining rigorous scientific standards for COVID-19 boosters.
Marty Makary [12:14]:
"We're going to use the same scientific standard we use for other drugs for the COVID booster shot in healthy Americans. We're not going to just rubber stamp blindly COVID boosters every year without clinical data that's updated."
He addresses the recent warnings about myocarditis in young men, acknowledging that earlier delayed responses necessitated recent actions to ensure vaccine safety.
Marty Makary [13:57]:
"We issued a warning about myocarditis with the COVID shot that was long overdue."
Makary discusses the FDA’s initiatives to eliminate petroleum-based synthetic dyes from the American food supply, aligning with the "Make America Healthy Again" movement. He underscores the link between synthetic dyes and behavioral issues in children, citing studies from reputable journals like The Lancet.
Marty Makary [20:50]:
"There are randomized controlled trials, for example, one in the Lancet, showing that petroleum-based food dyes were associated with attention deficit disorder."
The FDA has approved several natural alternatives and is pushing companies like Kraft, Heinz, and General Mills to adopt these safer dyes. Makary is optimistic about ongoing negotiations with companies such as Mars to phase out harmful synthetic dyes.
Marty Makary [22:30]:
"We're going to announce another natural dye next week... we have been getting these natural dyes out on the market expeditiously."
Booth asks about the Trump administration’s efforts to rewrite the U.S. dietary guidelines. Makary highlights the past failures of the food pyramid and the current initiative to promote whole foods and reduce ultra-processed food consumption, which now constitutes 70% of children’s diets.
Marty Makary [23:52]:
"We are rewriting the food guidelines, the dietary guidelines. That has been probably one of the greatest sources of health misinformation in the United States in our history."
He announces the upcoming release of updated guidelines, which also grant states the authority to exclude ultra-processed foods and sugary drinks from programs like SNAP and school lunches. Makary emphasizes a shift from treating diseases to addressing their root causes through improved nutrition and reduced environmental exposures.
Booth brings up Makary’s pledge to reduce animal testing within the FDA. Makary advocates for modern alternatives such as computational modeling and "organ on a chip" technologies, which can predict human toxicity more accurately and ethically than traditional animal tests.
Marty Makary [25:55]:
"We can modernize the agency and use computational modeling now. AI technology that looks at a molecule and can predict its toxicity in humans better than an animal test."
He outlines the FDA’s roadmap to eliminate unnecessary animal testing and streamline the drug approval process, aiming to reduce decision times from nearly a year to just one or two months.
Booth mentions criticisms regarding potential cuts in health research under the Trump administration. Makary refutes these claims, asserting that no NIH funding has been reduced. He criticizes the previous focus on health equity research that lacked substantial impact and emphasizes the current administration's commitment to studying chronic disease root causes.
Marty Makary [28:05]:
"Not one NIH dollar has been cut. There's not a single dollar to the NIH budget that has been cut."
He praises NIH Director J. Bhattacharya for steering the agency towards more impactful research, particularly in addressing chronic diseases rather than solely relying on high-tech medical interventions.
Lisa Booth expresses her gratitude towards Marty Makary for his contributions and leadership at the FDA. Makary reciprocates the appreciation, emphasizing the importance of having dedicated individuals in government roles to advance public health.
Marty Makary [30:01]:
"Well, thanks so much, Lisa. Great to talk to you again. Great to connect and thanks for having me."
Leadership Transition: Marty Makary brings a clinical and common-sense approach to the FDA, focusing on operational efficiency and scientific independence.
Transparency and Accountability: The FDA under Makary is committed to making decision processes more transparent, reducing pharmaceutical influence, and publicizing drug approval decisions.
Public Health Initiatives: Significant efforts are underway to eliminate synthetic dyes from the food supply, rewrite dietary guidelines, and address the root causes of chronic diseases through improved nutrition.
Modernizing Practices: The FDA is embracing modern technologies to replace animal testing, streamline drug approval processes, and enhance overall regulatory efficiency.
Research Focus: Contrary to criticisms, the administration supports robust health research, particularly targeting chronic diseases, without cutting NIH funding.
Marty Makary on Transitioning to Government:
"I'm walking into this sort of crazy world of politics. I'm going to miss being a doctor." ([05:02])
On Scientific Independence:
"This agency belongs to the American people... we have done everything possible to ensure that the review at the FDA is scientifically independent." ([09:50])
Regarding Synthetic Dyes:
"Why do we take risks when we have an epidemic of child behavioral problems and attention deficit disorder?" ([20:50])
On Reducing Animal Testing:
"We can modernize the agency and use computational modeling now... we have a pilot program to reduce the decision Time of the FDA from nearly a year to just one or two months." ([25:55], [26:14])
This episode provides an insightful look into the ongoing reforms at the FDA under Marty Makary’s leadership, highlighting his commitment to transparency, modernization, and addressing fundamental public health challenges.