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| Joining us now to discuss the actions the agency has taken during his first 100 days in office and goals during his tenure is Food and Drug Administration Commissioner Dr. Marty McCary. | ||
| Dr. McCary, welcome to the program. | ||
| Great to be with you, Tammy. | ||
| We're excited to have you back on the program. | ||
| You recently marked your first 100 days in the role. | ||
| We'll talk about some of the actions you've taken, but first, let's talk about your goals during your time in the office. | ||
| What do you hope to accomplish? | ||
| Look, I'd like to see more cures and meaningful treatments for the American people and healthier food for children. | ||
| We're interested in this administration, not just in the treatments, but also in the root causes. | ||
| Why do 40% of our nation's kids have a chronic disease? | ||
| Why do a third of children have pre-diabetes or insulin resistance? | ||
| It's not a willpower problem. | ||
| Something is going on in the food supply and the environment. | ||
| So the FNFDA stands for food. | ||
| We've taken action to remove all nine petroleum-based food dyes, and some have been implicated in ADHD. | ||
| We've had an incredible start on readdressing infant formula. | ||
| We saw titanium dioxide, another chemical of concern removed by one of the big candy makers in the U.S. | ||
| So we're moving fast. | ||
| We're going to keep going. | ||
| And on the drug side, we've got to ask a big question. | ||
| Why does it take over 10 years for a drug to come to market? | ||
| That entire process is loaded with needless red tape, idle time, and wasted steps. | ||
| We can accelerate the delivery of cures without cutting corners on safety. | ||
| And so many of the initiatives we've done in my first 100 days are aimed at doing exactly that. | ||
| You just mentioned a couple of the issues related to the food supply, the food dyes, chemicals, baby formula. | ||
| You also have focused on dietary guidelines. | ||
| Why start there? | ||
| Well, the dietary guidelines, that is the old food pyramid, is probably one of the most damaging pieces of misinformation in the history of government and healthcare. | ||
| It was a food pyramid constructed not based on medical science or good data. | ||
| It was based on what the industry wanted you to buy. | ||
| It ignored the fact that 70% of what kids eat is an ultra-processed food diet. | ||
| It ignored many other chemicals in the food supply, and it demonized natural saturated fat. | ||
| So the 70-year war on natural saturated fat is going to end in our new dietary guidelines that we hope to have out by the end of this year. | ||
| You mentioned ultra-processed foods, something that you've also been looking at is defining that. | ||
| Why hasn't that been done before? | ||
| What impact will it have? | ||
| I think, you know, first of all, it came with good intentions, the idea that, hey, grains are good for you. | ||
| And then there was mass production of grains to address food insecurity, that is starvation. | ||
| But what happened in the mass production and in the efforts by the food manufacturers to maximize shelf life is that we created basically these new compounds that don't appear in nature. | ||
| We've taken grains and stripped them of their fiber and chopped them up and it functions like sugar in the body. | ||
| So it's got what we call in medicine a high glycemic index. | ||
| It's stimulating the pancreas. | ||
| And take a look at the population. | ||
| We've got a quarter of adults now with diabetes or pre-diabetes. | ||
| It's epidemic in children. | ||
| So this is not their fault. | ||
| This is something being done to them. | ||
| And while, look, we believe in freedom. | ||
| You should be able to eat whatever you want, ding-dongs or, you know, cupcakes, donuts. | ||
| When we're using taxpayer dollars, we want it to go to healthier foods. | ||
| So you see in this Trump administration, the first ever snap waivers for the food assistance program so that it will not go to junk food and sugary drinks in some states now. | ||
| Our guest for the next 40 minutes or so is Dr. Marty McCary. | ||
| He is the Commissioner for the Food and Drug Administration. | ||
| If you have a question or comment for him, you can start calling in now. | ||
| The lines for this segment are broken down regionally. | ||
| That means if you are in the Eastern or Central time zone, the line, 202-748-8000. | ||
| If you are in the Mountain or Pacific time zone, it's 202-748-8001. | ||
| Dr. McCary, the FDA, is an agency. | ||
| It falls under the Department of Health and Human Services, which is headed by Robert F. Kennedy Jr., the secretary there. | ||
| He is leading the Maha movement. | ||
| What role will the FDA play in those efforts? | ||
| Look, we're following this charge because Republican, Democrat, and Independent moms showed up in high numbers to vote for President Trump over this very issue that Secretary Kennedy has championed to try to address the root problem in our health care system, and that is the health of the population. | ||
| So there's been a lot of talk about talk about how to fund our broken health care system, but not how to fix it. | ||
| And the ultimate way in which we address our skyrocketing health care costs is to address the health of the population. | ||
| We spend more on health care than any other country with the worst health outcomes of any developed country. | ||
| This president does not like to see Americans getting ripped off on drug prices. | ||
| You saw the new action on most favored nation status. | ||
| If the U.S. is the largest purchasers of drugs, we want the best prices on drugs. | ||
| We don't want to see people getting half the price or a quarter or a tenth the price for the same drug in Germany, France, or the U.K., which is exactly what's happening now. | ||
| So we can do a lot. | ||
| The FDA doesn't directly set drug prices, but we create incentives, create more competition by getting more drugs out there, and approve more generics and biosimilars. | ||
| So we have a big part in addressing food at the FDA. | ||
| We're doing an inventory of the thousand-plus chemicals that appear in the U.S. food supply that do not appear in Europe or Canada. | ||
| We got a commitment just last week from the maker of Fruit Loops that they're going to have the same fruit loops in the U.S. as they will in other countries where they don't have petroleum-based food dyes. | ||
| And so we have now, after our announcement to address petroleum-based food dyes, commitments from nearly half the industry already to meet this goal before our target date. | ||
| And we're going to keep going. | ||
| So we've got the inventory of all the chemicals. | ||
| We're going to keep evaluating. | ||
| We're evaluating this standard called GRASS, which means a company can recognize a chemical as generally recognized as safe or G-R-A-S grass, and then just feed it to the American people. | ||
| So we're saying, no, we want some standards, we want some science. | ||
| I wanted to ask you about a food in particular that President Trump brought up last week. | ||
| This is his Truth Social post. | ||
| It says, I have been speaking to Coca-Cola about using real cane sugar in Coke in the United States, and they have agreed to do so. | ||
| I'd like to thank all of those in the authority at Coca-Cola. | ||
| This will be a very good move. | ||
| Buy them. | ||
| You'll see it's just better. | ||
| You are a doctor by trade. | ||
| Explain the difference between cane sugar and the high fructose corn syrup that is currently used, the impact it could have on consumers. | ||
| Well, first of all, I love it, and the president's got good instincts because cane sugar or natural sugar has a lower glycemic load than what you get per gram with high fructose corn syrup. | ||
| That is, you can pack in more of those simple carbohydrates with high fructose corn syrup. | ||
| Many people have concerns also about a synthetic sugar product, and they have concerns with aspartamine. | ||
| Sometimes there have been concerns about aspartamine in pregnancy. | ||
| So, getting back to cane sugar is a start. | ||
| And look, this is going to be an incremental series of steps to try to get us towards a better food supply. | ||
| And we also want to talk about moderation because it's one thing to be eating something nonstop all day, every day, and it's another thing to have something in moderation. | ||
| So, we can do all of the above. | ||
| We have callers waiting to talk with you. | ||
| We'll start with Mary in Long Island. | ||
| Good morning, Mary. | ||
| Oh, we lost Mary. | ||
| We'll go to Michael in Denver. | ||
| Good morning, Michael. | ||
|
unidentified
|
Good morning. | |
| Thank you so much for taking my call. | ||
| And, Dr. McCary, thank you so much for being here this morning and answering some of our questions. | ||
| It really means a lot. | ||
| And so, I kind of wanted to turn the attention to an issue that has captured the attention of so many in this country: the autism issue. | ||
| You know, Dr. McCary, you've suggested in an interview that autism is caused by a range of environmental and dietary exposures, which has echoed some of the comments made by U.S. Health and Human Services Secretary Robert F. Kennedy Jr. | ||
| And, you know, he said that the agency is involved in a massive testing and research effort that will find some of the causes of autism by September. | ||
| I was wondering if you could just speak to any of the progress you've seen made towards kind of finding out what the root causes of autism are, and what, if anything, the FDA is doing to help in that effort of discovering the causes of autism. | ||
| Well, thank you, Michael, for that question. | ||
| And one of the great parts of this job that I did not expect, to be honest with you, is the incredible teamwork that we have across the health agencies. | ||
| We talk every day. | ||
| We have a series of expertise. | ||
| I myself am a cancer surgeon, a gastrointestinal surgeon. | ||
| Mehmed Oz has an incredible history as a cardiovascular surgeon at Columbia, Jay Bhattachari at Stanford. | ||
| So we put our heads together. | ||
| And this issue of autism is a real issue. | ||
| You just didn't see autism at these rates a generation ago. | ||
| And while there, yes, have been more diagnoses, you didn't see the prevalent, the high prevalence of nonverbal children and people that would engage in repeat sort of tics. | ||
| You just didn't see that a generation or two ago. | ||
| Something is happening. | ||
| We don't know why. | ||
| We are seeing now one in 31 American kids having autism, but I certainly have a hypothesis. | ||
| I do think it is multifactorial. | ||
| It may have something to do. | ||
| I don't know if it's a cause or an effect. | ||
| The microbiome of the GI tract is different in kids with autism. | ||
| I don't know what is the insult to the microbiome that is changing that microbiome, but it's been known for a long time the stool output of a child with autism is different in its biodiversity. | ||
| So look, something is going on by September. | ||
| We're going to have reviewed all the preliminary data, hopefully have some clues as to where to direct further research efforts. | ||
| And this is a big priority for this administration. | ||
| Parents deserve to know some answers, and we've got to be able to prevent it going into the next generation. | ||
| Let's talk with Christine in Rhode Island. | ||
| Good morning, Christine. | ||
|
unidentified
|
Yes, good morning. | |
| He stole my thunder. | ||
| That's exactly my conversation I was going to have with the doctor. | ||
| I guess about autism and the spectrums of a whole generation of children. | ||
| And with them cutting all these programs in school, how do they expect these kids to make it through? | ||
| But I would like the answer to this because I have grandchildren, a whole generation that has four of my grandchildren that have autism or some spectrum of it. | ||
| And they don't help these children unless they so-called pass a test of 70 and plus. | ||
| But are they really going to be honest? | ||
| They weren't honest about the food. | ||
| It is money. | ||
| I hope that they come out with the truth. | ||
| So this way we can figure it out and hope it never happens. | ||
| But I would like to thank Michael for bringing that issue up because I've been talking about that for years and years and years. | ||
| Yeah, so look, I'm sorry to hear about the children and your family. | ||
| And I do hear that story, and it's very concerning that we can't ignore this epidemic of chronic diseases that are surging in our lifetime. | ||
| These conditions were rare a generation ago. | ||
| Why is it that sperm counts are down 50% in the last 60 years? | ||
| Why is it that the age of puberty has moved up by years? | ||
| Why is it that a third of the nation's kids now have severe insulin resistance? | ||
| Why is it that PCOS is causing infertility at very high rates? | ||
| Why is it that cancer is going up in young people right now, specifically GI cancers? | ||
| Those are the cancers interfacing with what we eat in the modern diet. | ||
| We cannot ignore these issues as they have been ignored by the medical establishment. | ||
| So at the FDA, we're focused, yes, on meaningful cures and drugs and devices, but also on the food side. | ||
| And we're working with the NIH on studies around root causes. | ||
| Look, look at the Maha Commission report and look at how we now propose we study natural circadian rhythms in children and ultra-processed foods and chemical exposures. | ||
| For the first time, we're talking about these things in the mainstream of healthcare. | ||
| If you think about what we do to kids, we sort of razzle them in the middle of their night sleep when it's still dark outside in the morning. | ||
| We bring them into school after a high glycemic index, sugary breakfast, and then we ask them to sit still at a desk for seven hours with no natural light sometimes. | ||
| Sometimes a school will have less natural light exposure than a federal penitentiary. | ||
| And then we hit them with a high sugar load of food with snacks and ultra-processed foods several times. | ||
| And they can't sit still for seven hours and we tell them, you have attention deficit disorder, you have this diagnosis, and then we drug our nation's kids at scale. | ||
| We've got to stop and look around and see what's happening and re-examine these practices and look at root causes. | ||
| Elizabeth in Connecticut. | ||
| Good morning, Elizabeth. | ||
|
unidentified
|
Good morning. | |
| I just have two quick questions. | ||
| The first is, what are you going to do to make fresh, healthy food grown all over the United States more affordable than the highly processed food and also help, you know, thereby also helping small and medium-sized farms and preserve open space, help the small farmers. | ||
| Second is the Trump administration has laid off thousands of people from the FDA. | ||
| So I'm actually really worried about my food safety. | ||
| What are you going to do to ensure that our meat, vegetables, dairy, that they're actually safe for American consumers? | ||
| Thank you. | ||
| Well, thank you. | ||
| You should not worry about your food safety because of any reorganization at the FDA because no food inspectors and no scientific reviewers were part of any reduction in force. | ||
| That was a reduction of redundancies in IT, communications, HR personnel. | ||
| And that was because we had a sort of fiefdom structure whereby the centers at the FDA all had duplicative services and they are now consolidated. | ||
| For example, when I came to the FDA, there had just been 12 different travel offices. | ||
| Now there's one. | ||
| So that was what you're hearing about. | ||
| And so there's been some misreporting on what actually happened. | ||
| Again, no scientific reviewers or food inspectors were laid off actually in this Trump administration. | ||
| We're increasing the number of food inspections. | ||
| And remember, 90% of routine produce inspections are done at the state level. | ||
| On the local food and farmers markets and supporting local farmers, look, no one was talking about how important that really was in the national limelight in our healthcare government agencies until RFK Jr. brought this to the forefront. | ||
| So we have programs now to try to help schools that want to off-ramp to healthier foods. | ||
| We've got a huge emphasis now. | ||
| We're taking a look at it. | ||
| We're putting our heads together. | ||
| We've got new grant programs. | ||
| And it's important. | ||
| We've got to make food affordable and healthy food affordable because otherwise you end up with food deserts where people are eating highly addictive processed food because that's all they have access to. | ||
| And of course, if we don't recognize obesity as a glycemic addiction, then we're not going to make any progress. | ||
| So we're trying to address this problem in a new way. | ||
| I want to go back to something you touched on earlier when we were looking at treatments and cures. | ||
| You talked about the launch of a pilot program that would expedite the drug review process. | ||
| How quickly could drugs get approved? | ||
| How does it compare to the current process? | ||
| We think we can get a decision to drug manufacturers in a matter of weeks instead of nearly a year in this new pilot program. | ||
| And that's because we're doing something very creative. | ||
| We're moving the manufacturing part of the application to during the clinical trial. | ||
| That is, in this pilot program, the drug makers will submit the lion's share of their application while the clinical trial is still in progress. | ||
| So the only thing we're waiting for then is the readout of the clinical trial endpoints. | ||
| Ideally, we'd like to do it in the cloud so we're watching the trial in real time. | ||
| We'd like to run more continuous trials so there's less breaks of reapplying after IND, preclinical, phase one, phase two, and then the final application. | ||
| We think there's a lot of wasted time where we can increase efficiencies without cutting corners on safety to deliver more cures and meaningful treatments. | ||
| Another big initiative is reducing animal testing. | ||
| Turns out that can take nearly a year, and it's not a very good predictive test for how drugs are going to do in humans. | ||
| 90% of drugs that pass animal testing don't pass in human tests on safety and efficacy. | ||
| Computational modeling now, computer modeling that can look at a molecule can predict toxicity now as good or better sometimes. | ||
| And something we call organ on a chip technology is something we're doing more of. | ||
| That is, you grow the culture medium of liver cells or heart cells, and you test the drug in the cell culture medium. | ||
| Personally, my own opinion, I don't think God created animals for us to subjugate and torture in unethical ways. | ||
| So we can do a better job at predicting toxicity, cut out nearly a year in that review process, reduce R D costs that hopefully will translate into lower drug prices once drugs are approved. | ||
| A big priority for this administration. | ||
| And I think we can do this and do it expeditiously. | ||
| We found out that the FDA was still requiring routine animal testing after a drug was approved in Europe and used in humans. | ||
| So we've got to use common sense in some of these steps. | ||
| I think we can cut a lot of these wasted steps, that is a lot of the redundancies and idle time in this 10-year review process, so we can deliver cures and meaningful treatments quickly. | ||
| I'd like to see a cure for type 1 diabetes in my time at the FDA, for neurodegenerative diseases like ALS. | ||
| I'd like to see a universal flu shot so we don't guess every year what the strain is. | ||
| You get long-term protection. | ||
| There's a couple potentially promising therapies. | ||
| You know, one of the cool things in this job is you get to see what's in the pipeline. | ||
| And look, I'd love to see a cure for some types of stage four metastatic cancer. | ||
| I think we can see cures or meaningful treatments for all these conditions in the next couple years if we use common sense and create an efficient process that cuts the waste and idle time and still holds our rigorous scientific safety standards. | ||
| When we talk about an expedited review process and pushing a drug out, that was something that there was concern over when the COVID vaccine was being developed, was that it was happening too quickly. | ||
| What do you tell people who may have concerns about a faster period that a drug is under review? | ||
| So look, we need good science to make any decision at the FDA. | ||
| That's our charge with Congress. | ||
| And in the case of the COVID vaccine, you saw the regulatory process morph into a blind rubber stamping of COVID boosters in the last couple years. | ||
| There was no updated clinical trial to support a new COVID vaccine being approved. | ||
| And as a matter of fact, in the administration prior to me coming into office, the two top vaccine experts at the FDA were pushed out because they took issue with the blind approval of COVID boosters in young healthy kids. | ||
| And the reality is 85% of healthcare workers said no to the COVID booster last fall. | ||
| People want to see evidence. | ||
| They want to see some trial to show there's benefit here. | ||
| And that weighs the safety concerns. | ||
| We are now learning about vaccine-injured Americans. | ||
| That may be a number higher than we anticipate because we haven't had good studies. | ||
| We're taking a look at that now. | ||
| We've already issued Dr. Prasad and I, who runs the center that oversees vaccines at the FDA. | ||
| We've taken an initiative to publish a new framework on vaccines in the New England Journal of Medicine a couple weeks ago. | ||
| And we basically said, look, it's time to check in with a clinical trial. | ||
| We're not going to blindly approve COVID vaccine boosters for every 12-year-old healthy girl in America for them to get every year in perpetuity for the rest of their life. | ||
| We want to see some data. | ||
| We're going to return to gold standard science. | ||
| Let's talk with Cynthia in Albany, New York. | ||
| Good morning, Cynthia. | ||
|
unidentified
|
Good morning. | |
| Hi, doctor. | ||
| My name is Cindy Holt. | ||
| I'm a nurse who's worked with the population of people with developmental disabilities for 10 years. | ||
| What I'm finding, and I'm not hearing, is that there's different severity of autism, and the older folks seem to be more acute than these younger kids coming out. | ||
| I'm just wondering if some of that is just behavior issues, you know, labeled as them having autism, because I see a lot of that. | ||
| Also, I'm wondering if Robert S. Kennedy Jr. is basing, does he have some lived experience? | ||
| Because he looks like he's suffering some comorbidities right now as to why he doesn't want why he's not a fan of vaccines that have saved people for years and years and years and eradicated measles from opera vella, tuberculosis, and all those different things. | ||
| I'm just curious about that. | ||
| Thank you, Cindy. | ||
| First of all, thank you for your service as a nurse. | ||
| I've worked with thousands of nurses in my career, and I know that's a hard job. | ||
| So thank you for your dedication in that profession. | ||
| Yes, RFK does have some family members with autism. | ||
| And look, the questions that RFK Jr. are asking are questions the American people are asking. | ||
| And he, as Secretary of Health and Human Services, is posing questions for our health agencies to address. | ||
| And so he is great at challenging deeply held assumptions. | ||
| He poses questions. | ||
| And so one of the big questions is the exact question you are raising, and that is, what accounts for the variation in the severity of autism? | ||
| So look, I hope we get some good answers from some good data. | ||
| We'll have to see. | ||
| Mark in New York City. | ||
| Good morning, Mark. | ||
|
unidentified
|
Hello, good morning. | |
| I was just wondering how to contact that FDA because my concern is about fake food. | ||
| So specifically cheeses. | ||
| See, as a young kid, I used to go to Italian delis a lot. | ||
| And then now what happens today in New York, almost all the pizzerias, they have cheese that don't taste like cheese. | ||
| I mean, the textures, the texture and the look, it looks like cheese, but I hope the FDA can look into that because everybody's coming up on their sauces, but they have this tasteless stuff. | ||
| I don't even know what it is. | ||
| Thanks. | ||
| Okay, well, I have my charge. | ||
| I'll have to look into that. | ||
| I do agree with you that one of the, and I saw this as a surgeon at Johns Hopkins and where I did a lot of public health research. | ||
| There are a lot of food deserts there, and the retailers were using the absolute most rock bottom ingredients in the food that they sourced because it had the lowest price point, and it was a poor community. | ||
| So, look, I'm not blaming people, but we've got to stop and ask: why are we seeing epidemic rates of these diseases with expensive downstream health consequences? | ||
| It turns out that a lot of bread now is not wholesome, whole foods type of bread. | ||
| It is, and I say that sort of in a generic sense, not with the brand Whole Foods. | ||
| These are not whole foods that were eaten by our ancestors. | ||
| These are sometimes foods that are stripped of their fiber, chopped up, and they are basically functioning like sugar. | ||
| Let's talk with Alan, who's up either very early or very late in Hawaii. | ||
| Good morning, Alan. | ||
|
unidentified
|
Hey, good morning. | |
| I hope you can hear me. | ||
| Yeah, this is a topic that I've been discussing this with a few people who are physicians. | ||
| And I used to work in research in Hawaii on things which are similar for developmental issues with infants. | ||
| But this has to do with the big issues about autism. | ||
| A physician who's a pathologist, retired, has been bringing me a lot of stuff. | ||
| And there's studies both sides about ultrasound and the impact on prenatal exposure to different energy levels of ultrasound and how that connectivity. | ||
| Now, of course, most of the ultrasound industry has been able to prove that there isn't a super, super connected relationship, but there are some questions. | ||
| And it would really be useful, I think, to get more understanding of the linkages. | ||
| And it's going to be difficult because I'm a fan of ultrasound, but I think there potentially is risk. | ||
| The human brain at that point in development is extraordinarily sensitive to the energy that ultrasound produces. | ||
| Could you comment on that? | ||
| Yeah, so I'm not familiar with the data on ultrasounds in pregnancy, but I am aware that some have raised concerns and that some are saying, look, we have whales that are dying now near windmills, and we don't know if it is the ultrasound waves or if it changes the navigation patterns or communication of the whales. | ||
| There are some unknowns, and I do think that when it comes to humans, I think these are reasonable questions to study. | ||
| I think that there are no sort of topics in science where you should not be allowed to ask questions and challenge assumptions that may be in the field. | ||
| Now, I don't know if there are assumptions in the field of ultrasound science that have been used to make conclusions about safety. | ||
| My wife and I just had a baby and we had ultrasounds done during the course of that pregnancy. | ||
| You know, so I think we should be able to be intellectually curious and ask any question. | ||
| And that's what we're doing at the FDA. | ||
| We're convening roundtables to challenge deeply held assumptions, the blind spots of modern medicine, if you will. | ||
| We just had a roundtable on Thursday about hormone replacement therapy and perimenopausal women. | ||
| This administration believes that women's health issues have for too long not received the attention that they deserve. | ||
| And at the top of that list, in my mind, is the massive misunderstanding and dogma around hormone replacement therapy, that is estrogen or estrogen plus progesterone in women that start menopause. | ||
| And if it started within 10 years of the onset of menopause, there are tremendous long-term health benefits, reducing the rates of fatal heart attacks, osteoporosis, long-term bone fractures later in life, and reducing cognitive decline. | ||
| One study even found a reduction in Alzheimer's risk. | ||
| That's on top of the short-term benefits. | ||
| So this is something where 50 million women have been denied the benefits of hormone replacement therapy because of a dogma that it increases breast cancer mortality when no clinical trial has ever found that hormone replacement therapy increases breast cancer mortality. | ||
| So look, we're willing to challenge deeply held assumptions in the field just because all the experts believe something or the majority opinion is one way doesn't mean in science that you're not allowed to ask questions. | ||
| So we're asking questions. | ||
| You mentioned blind spots. | ||
| That is the title of your book that was out last year. | ||
| And you mentioned that hormone replacement therapy, that is one of the topics that was in there and something you're addressing. | ||
| Now, is it possible that once something is so deeply rooted in what we think we know, that you can convince the American public that it is safe? | ||
| How do you do that? | ||
| Look, the very purpose of science is to ask big questions and study them systematically and properly. | ||
| If we simply leave all scientific questions to a popularity vote, We're going to continue to make giant mistakes like getting the addictive nature of opioids wrong for 20 years, which we did as a medical establishment at the expense of nearly a million Americans who died. | ||
| We got peanut allergies wrong for nearly 20 years. | ||
| We got the saturated fat part of our diet wrong in the food pyramid for 50 years. | ||
| Some say 70 years. | ||
| We demonized a natural component of the food supply and we moved the entire food supply to a high glycemic processed, high carbohydrate, usually simple carbohydrates, which function as sugar in the body. | ||
| And so we promoted the shifting of the American food supply based on dogma. | ||
| There was never good science to support it. | ||
| So we have to do proper science. | ||
| That means asking big questions and being willing to challenge deeply held assumptions in the field. | ||
| Let's hear from Tina in Maryland. | ||
| Good morning, Tina. | ||
|
unidentified
|
Hi, good morning. | |
| I'm a physician assistant and actually a menopause certified clinician. | ||
| And I really enjoyed the expert panel that the FDA held last week on menopause and agree with so many of the things that you just mentioned regarding menopause hormone therapy. | ||
| One of the big impediments for that, especially for clinicians and patients, has been that really problematic and false black box warning, especially on topical estrogen. | ||
| What is the next step here? | ||
| Do you plan to convene a scientific advisory committee to remove that inaccurate labeling? | ||
| Yeah, so just by way of background for the viewers, hormone replacement therapy, vaginal estrogen and systematic estrogen, both have had a black box warning from the FDA. | ||
| And what happens is when the fear machine dangles something like breast cancer, such a sensitive topic for so many women, in a way that suggests that if you take this product, it'll increase your risk of dying of breast cancer. | ||
| When no clinical trial has ever found that hormone replacement therapy increases the risk of breast cancer mortality, you have a situation where doctors believed the headlines and it's sort of this bandwagon thinking and you have 50 million women who have been denied not only the short-term benefits but the long-term benefits. | ||
| So we are looking closely at that. | ||
| That's why just after around the 100-day mark of my being in office, we had convened that expert roundtable. | ||
| It was a powerful set of testimonies by experts in this field of perimenopause and hormone replacement therapy. | ||
| I encourage everyone to go to our X page or other social media to listen to the experts in that expert roundtable. | ||
| And so we are, to answer your question, taking a hard look at whether or not to remove that warning label. | ||
| It's a process, but we've begun the process. | ||
| Samantha, or I'm sorry, Susan in Pennsylvania. | ||
| Good morning, Susan. | ||
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unidentified
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Good morning. | |
| Thanks for taking my call. | ||
| I'm leading back to COVID since Mr. Macari mentioned that earlier. | ||
| I was wondering if there will be a new vaccine developed, hopefully soon. | ||
| I mean, I've been taking right now every six months a booster shot just because I had it once. | ||
| And with all the dangers of long COVID, and that there are people who really suffer from that, and that your immune system gets so run down, the more you get it, the worse it can get. | ||
| Like your body basically, I read some scientific papers, and from what I can understand, so there are chances that you have an increased risk of cancer, blood clots, all kinds of diseases. | ||
| So I'm just wondering how this will be from now on, or if there's anything in research right now, if anything is going on that we can expect a cure or a better vaccine that helps prevent spreading the virus, anything like that. | ||
| Thank you. | ||
| Well, first of all, nice to talk to somebody from Pennsylvania. | ||
| I'm from Danville, Pennsylvania, in northeastern central coal mine country in Pennsylvania. | ||
| I grew up in a small town. | ||
| So good to connect. | ||
| Look, COVID, unfortunately, has become a very polarized topic, and we haven't had good data on vaccine injury. | ||
| We just found out that the FDA was sitting on data on myocarditis from the COVID vaccine in young, healthy males. | ||
| And we responded by issuing a strong warning, a safety label change, just several weeks ago using good, solid data that we were able to get at the FDA. | ||
| The entire subject of COVID, I think, has become an issue where some people look to the government for every single health recommendation as to whether or not to get a booster or not get a booster. | ||
| And what we're doing is we're upholding a pledge that is we're not going to take away vaccines, but we're going to get away from the idea that the government is your doctor. | ||
| The health emergency is over with COVID, and we are letting companies know that to, in our new framework, that if they want to get vaccines, a new vaccine that creates a new protein to vaccinate against COVID, we want to see a clinical trial first if it's going to be a vaccine for young healthy subjects. | ||
| And for high-risk individuals, we'll continue to make those available as long as the companies pledge to study the vaccine after it's approved so we can get data to know whether or not to keep going down that path. | ||
| Let's hear from Samantha in Long Island. | ||
| Good morning, Samantha. | ||
|
unidentified
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Hi, good morning, Dr. Marquette. | |
| I have a couple of questions, please. | ||
| How do you feel about the termalite in talcum powder, as well as the E55EB in baby formula? | ||
| Who's accountable and responsible for allowing all this to happen for over the past 50 years? | ||
| I'm very, very proud of my administration. | ||
| I think we can take this all home and start putting some transparency to this and bringing some medical modeling to what's going to be appropriate going forward. | ||
| I'd like to know who's responsible for mesothelioma. | ||
| Thank you. | ||
| Great. | ||
| Well, great question. | ||
| Thank you for asking it. | ||
| So baby formula has been a huge priority for this administration. | ||
| And so within my first 100 days as FDA commissioner, we convened experts from around the world to come and help us understand how do we modernize baby formula. | ||
| Moms want baby formula without corn syrup or added sugar, without seed oils, without the heavy metals that exist in some types of baby formula today. | ||
| And we haven't changed the baby formula recipe list that the FDA insists upon in nearly 30 years, with the exception of adding selenium, which was a minor change. | ||
| Well, the field of nutrition science in infants has matured a lot over the last 30 years. | ||
| And the lack of any innovation in the baby formula space is not a private sector failure, it's a government failure. | ||
| And so we have to modernize the process. | ||
| We've got to get away from the idea that we're going to use a list of ingredients from over 30 years ago and tell baby formula makers all you have to do is include every single thing here, including a seed oil, in order for us to approve your baby formula. | ||
| So we are, this is a huge priority. | ||
| It's called Operation Stork Speed. | ||
| We have our experts working as we speak on modernizing this space. | ||
| And we've also, final point, we have to address the supply chain issues. | ||
| We can't have another infant formula shortage like we did in the past. | ||
| And so we're looking at everything we can look at to try to ensure good health for infants because most of the microbiome is formed in the first two years of life. | ||
| And what you feed a child in part constitutes the billion different bacteria that populate the GI tract. | ||
| Not a billion total, a billion different bacteria constitute the GI tract. | ||
| And those bacteria we're just starting to understand are a central organ in human health. | ||
| They're involved in mood. | ||
| They're involved in digestion. | ||
| They regulate estrogen and produce most of your body's serotonin involved in mood. | ||
| And we have seen situations, I've seen them as a physician where somebody's overweight and they do everything, they exercise like crazy, they eat right, they can't lose the weight. | ||
| What's going on? | ||
| Perhaps the microbiome has been permanently or significantly altered. | ||
| This is a big area of research and a priority at the NIH and something we are very much looking at at FDA as well. | ||
| A word Samantha used during her call was transparency. | ||
| You want to increase transparency at the FDA. | ||
| How do you achieve that and what impact will it have? | ||
| Great question. | ||
| So we've done a couple things. | ||
| We have said that our decision letters from the FDA, if we reject a drug, we're going to make them public. | ||
| Now, in the world of pharma, that was a big deal when we made that announcement. | ||
| Some people didn't want it. | ||
| But the FDA should not be a black box. | ||
| People, the public, shareholders, and scientists should be able to see exactly what our rationale is if we don't accept a drug. | ||
| Was it because we felt this study wasn't powered appropriately, that the control group wasn't the right control group, that there was a manufacturing failure? | ||
| So we think that'll help inventors and scientists develop new cures. | ||
| And we think it'll just increase the transparency significantly. | ||
| So we made that announcement. | ||
| We're starting now to redact these rejection letters so we can make them all public in real time. | ||
| Turns out that pharma companies often spin. | ||
| And 40% of the time when we say, hey, you need a new clinical trial, you didn't do the clinical trial as we specified, they don't even disclose that to their shareholders. | ||
| They might say, oh, we got good news from the FDA, even though we rejected a drug. | ||
| All they want is a few small tweaks, even though we asked for major changes. | ||
| And so we're going to stop that spin machine by just having radical transparency. | ||
| A couple more calls for you. | ||
| Let's hear from Ed in Massachusetts. | ||
| Good morning, Ed. | ||
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unidentified
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Hi. | |
| Thanks for having me on. | ||
| I come from the farmer-driven regenerative agriculture movement. | ||
| And what we've realized is that we've lost a lot of the nutrient density and spectrum in our food. | ||
| And it's because how we produced it for years. | ||
| We realized when you mentioned the biome, we've really damaged the soil biome, which brings the nutrient density to our food. | ||
| And when we do the lab work on what we produce, we find that that can be two, three, four, five times difference. | ||
| So in other words, you might have to eat four carrots to get the nutrition that you should be able to get out of one carrot. | ||
| And this is a huge factor when we measure all these metabolites in our food that are important for our health. | ||
| And so we're making great advances on that. | ||
| We need more attention to our food. | ||
| We know that when we eat a tomato, often from the supermarket in the off-season or in a burger, it doesn't taste like anything. | ||
| It doesn't taste like a tomato should. | ||
| And we know that now that's connected to the nutrient density. | ||
| And if we're not getting all the nutrients we need beyond the chemicals and the ultra-processing of our base ingredients, it's a serious problem. | ||
| And we think we can really help that issue and bring health back to people. | ||
| Thank you. | ||
| Great. | ||
| Well, nutrient-poor food is a massive issue. | ||
| And it may be a bigger issue than is recognized and appreciated by the medical establishment. | ||
| And so soil is a topic, I'm glad you raised it, that is a topic on the forefront of this administration. | ||
| Not only is Secretary Kennedy talking about this, and he was just attending a conference on soil hosted by Roger Marshall from Kansas. | ||
| So we've got to start talking about these root issues in health and nutrition, not just propagate a broken food pyramid of misinformation. | ||
| We've got to talk about nutrients and fiber and healthy whole foods that come from the ground or come from animals that are raised in a healthy and humane way. | ||
| And so that's how we get America healthy again. | ||
| We address the contaminants and chemicals in the food supply, and we get back to ancient principles of eating healthy foods. | ||
| So thank you for that question. | ||
| It's an important issue and we're working on it. | ||
| One last call. | ||
| It's Rachel in Maryland. | ||
| Good morning, Rachel. | ||
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unidentified
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Hi, thank you for taking my call. | |
| I heard you talking about the rise in cancer among young people. | ||
| And last year I was diagnosed with stage two breast cancer at age 29 with no prior history or family history and no genetic predisposition for a breast cancer. | ||
| So I know you, I was wondering about your thoughts on having on screening younger people for these kinds of cancers earlier and getting a mammogram and having insurance cover it because one of the biggest things that insurance will often not cover it unless you have unless you're a certain age or you have a genetic predisposition. | ||
| Thank you. | ||
| Well, thank you, Rachel. | ||
| And sorry to hear about your cancer diagnosis. | ||
| I think we have to stop just saying, oh, well, you know, that's too bad. | ||
| Did you hear this individual develop cancer in their 20s or 30s? | ||
| We've got to actually have a organized, powerful force to ask why are these cancers going up in young people. | ||
| So yes, we have to re-examine the age of screening for all different types of cancer that are increasing now in people under age 50. | ||
| But we also have to get to the root issue. | ||
| And that is why are we seeing these cancers go up? | ||
| There are Chemical and environmental exposures that may be implicated. | ||
| There's a rise of things that we don't really understand. | ||
| A study recently found that almost half of 1% of the brain weight is microplastics. | ||
| Well, we know microplastics can have estrogen-binding-like properties. | ||
| We know other chemicals can have estrogen-like binding properties. | ||
| And so we've got to start doing good studies. | ||
| And that is a charge at the NIH. | ||
| They're doing some good root cause analysis type research. | ||
| I hope we can get some answers and I hope we can educate the public because I don't think we should see cancer in people under age 50 as sort of a one-off. | ||
| We have to look at the epidemiology and address this issue. | ||
| So hopefully we can do all of that, increase screening in a meaningful way that improves health outcomes and study root causes at the same time while we advance new promising treatments that could deliver cures for breast cancer and other cancers. | ||
| Dr. Marty McCary, author of the book Blind Spots, When Medicine Gets It Wrong and What It Means for Our Health, and also now FDA Commissioner, you can find the work of the FDA and more about what they're doing moving forward at FDA.gov. | ||
| Dr. McCary, thank you so much for being with us this morning. | ||
| Great to be with you, Tammy. | ||
| Thanks so much. | ||
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