Vinay Prasad: Public Health in This Country Is So Broken

Public health is in this country so broken. >> How do you talk honestly about vaccines without feeding into irrational fears? >> It shouldn't be provocative that a vaccine with a known side effect of myocarditis that it would kill somebody. It is the political preference of the left to just say every vaccine is great. >> How do you think history should remember Anthony Fouchy? >> I think he's wrong about almost every single pandemic policy he advanced. At some point, the man's got to take ownership over the decisions he did make and advocated for. >> Do you think he actually committed a crime? Uh, yes. >> What were the biggest barriers that you saw in the FDA? >> Changing an entrenched organization with tens of thousands of people is very difficult. Many libertarians might think we don't need an FDA. And I'm actually >> We're going to get to that. >> Okay. Well, I'm kind of sympathetic a little bit having worked there. I'm like, I can see I can see your point. >> Vini Prasad went from COVID era public health establishment critic to public health establishment insider and back out again. He is a physician, an author, professor at University of California, San Francisco, and former director of the center for biologics evaluation and research at the FDA. Beni Prasad, thank you for talking to Reason today. >> It's good to be back with you. So we had this clearing out of the old guard, the Winskis and Fouchis and Collins's and this replacement with the new guard, the the co dissidents such as yourself, Marty McCary, Jodacharia. Um what was it like and did you have any misgivings about stepping away from the role of academia and sort of outside critic and into the public health bureaucracy? So, I guess the one thing to point out is that maybe we changed 4% 2% of the FDA. I mean, the FDA is an 18,000 person agency. There's tens of thousands of people still there. Before Marty, the commissioner, and I got there, Doge had just struck and maybe they got rid of a couple thousand people. But I think one thing to point out is the system is largely the same as it's always been. >> Yeah. >> And then I think the next thing I'd point out is there are critics of the COVID pandemic response and then there are critics. And although Marty Jay and I are critics of many aspects of the response, I think we don't go as far as some of the most extreme critics out there. >> Mhm. >> So, am I glad I did it? Yes. I think I'm glad I did it. It was an adventure. It was a learning experience. I feel like I learned more in one year than I'd learned in the prior decade about how the world works. And I'm glad to have um improved I think some aspects of government which I think will be enduring and at least tried to improve other aspects of government which may not be enduring. And yeah, I want to ask you a little bit about or actually quite a bit about what you learned from that experience. But first, let's stay on the that the context of that era, that that transition. Um, and I I think the person who personified kind of the old guard was Anthony Fouchy, and he's recently been in the news because he appeared in front of Congress yet again um pleading the fifth as uh Rand Paul kind of exposed or uh published his diaries. Um what did those diary entries reveal to you about Fouch's character, the way he was operating uh through that time? I think that Fouchy has made a lot of serious errors and I think probably the greatest news story is that the mainstream media I think refuses to be honest about his legacy. Um Anthony Fouchy was in his late 70s when the pandemic began. And had he retired, you know, at a at a ripe old age of 75, I think he would be leaving behind a stellar legacy. Um but he continued, he pushed it. He stayed through the whole pandemic and he was the face of many things that I think his diaries get into what he privately thought while he was publicly saying different things. Um where to begin uh the origins of the pandemic. Uh Fouchy has not only been a proponent that the only answer to where the virus came from is a natural spillover event. Um he's gone further than that. He orchestrated a paper published in nature medicine called the proximal origins paper written by a bunch of people who bolstered that point of view. He of course edited that paper before it was published. Then in public he pretended like he didn't know those people. It was an independent group that validated what he was saying. Whereas in many respects he sort of puppeted that paper. The people who wrote that paper Rand Paul has released their Slack channel messages showing they don't really even believe what they were writing. I mean their messages reveal considerable ambiguity about lab leak versus natural spillover event. So in terms of the origin he also funded Equal Health Alliance of course which had a subcontract to Wuhan. Um he had a huge role in the origins and sort of at least trying to frame the narrative making lab leak. You couldn't even discuss it. You know Facebook put a ban on even talking about the topic. All right that's just one thing. Then masking masking two-year-olds. I mean he played a huge role in that. uh lockdowns, school closure. He said he didn't close any schools. In his own diary, he says, "I told Bill Delasio, you need to close schools in New York City." Uh at some point, the man's got to take ownership over the decisions he did make and advocated for. When Dantis in Florida reopened schools in the spring of 2020, he went on every television show to say what a bad idea that was. Of course, now I think it's very clear, many of us said so at the time, school reopening was always the right decision. You know, maybe it could have been closed for a week or two, but certainly not beyond that. Fouchi kept it closed much longer. Vaccines. I think vaccines makes a lot of sense. Code vaccines for elderly people who had not yet had COVID, but do they need to be given to a 4year-old, a 7-year-old, a 12-year-old, a 22-year-old who' also already had COVID? This is where considerable ambiguity exists. But Fouchy, the answer was clear. You need all the shots. You need the initial series. You need a yearly booster. It doesn't matter how young you are or how many times you've had CO. And of course, Fouchy was wrong about I think he I think he's wrong about almost every single pandemic policy he advanced. Some of his defenders say to me, "Well, at least he didn't tell people to drink bleach." And I said, "Well, is that the bar for a guy who's a doctor and a scientist? I mean, of course, yes, drinking bleach is not a good idea, but that's not the bar for an Anthony Fouchy level figure. He should be saying things that are correct, and if they're not correct, he should be collecting evidence to weigh in. he did none of that. >> Why do you think that there was that such a large disconnect between his public and private thoughts on the virus throughout this? Um, just as as someone whose job it is to communicate science to the public, why wasn't he communicating what he actually knew at the time, for instance, about the origins of the virus? >> Well, in the case of the origins, I think he doesn't want to communicate then or now because he looks a little bit culpable. >> Uh, is it 2011? and he writes a Washington Post op-ed called the title of the paper is a flu risk worth taking about why we ought to fund uh gain of function research or research to manipulate the genomes of viruses to perhaps make them more transmissible or lethal in an effort to get ahead of that and cure it. Um but that's a gamble. Is that a sound strategy? I think it's pretty clear to say that it has not led to any cures and may have led to one of the worst pandemics in the last 50 years. You know, so that was a bad idea. He's on record of saying that. He's on record as having funded the Eco Health Alliance group in 2014 despite an Obama era sort of prohibition on that funding. And he has a presidential pardon that extends so far back that it covers his potential funding of Eco Health Alliance. So boy, nobody would rather you think it comes from a natural origin than this guy. He's conflicted. That's the bottom line on that issue. This is why Rand Paul is pursuing this because he seems to be wanting to uncover what the origins of the virus are which somehow we still don't know. It's unclear if we ever will. Do you have any sense uh based on what we know now what's your inclination as to where this came from? >> So I I use an analogy and an analogy is you can look at biology or you can look at intelligence. So imagine somebody comes out of the kitchen and they say, "You know what? That waiter peed in the soup." You're going to say, "As a biologist, how can I prove he peed in the soup?" You can sample the soup. You can look for urine metabolites and cells from the bladder and you can try to figure out the way. Or you could interview three people in the kitchen who says, "I saw the guy peeing in the soup." Okay. And what my point is that we have the Central Intelligence Agency, the Department of Energy, the FBI, and they have made an intelligence assessment that they believe it to be lab leak. In Fouchi's own diary, he says he was pulled into the skiff, which is sort of a confidential room, and he was given information by the CIA where they intercepted some transmissions from China that make them sort of suspicious that it was in fact a lab leak incident. To me, I think the public may never have the full evidence, but I suspect that many intelligence people do in fact know the answer, and that answer is probably lab leak. Whether it's malicious or unintentional, I think people can wonder about that. Um Fouchi's own diary admits that the the Wuhan wet market uh which he went on TV and said was the origin in his own diary he writes at best it was an amplifying event. He doesn't believe it to be the origin. >> You mentioned this pardon that stretches back to 2014 this this era when the funding was when he was authorizing funding of in contravention to current US policy which is we're not going to do gain of function research. Do you think he actually committed a crime? Uh yes, I mean I think funding I I think the other thing about it is people will say did that money go directly for this research? Uh the money went for uh viral genomic research at a Chinese institute very similar to the sorts of things we would be worried about. I think that was a crime for which he's been pardoned. I think it's not just my assessment. I think that that's what Joe Biden's autopen thought I mean when he signed or whoever signed a pardon um that he committed a crime. That's why he has a pardon that goes far that far back. I think it was a crime. Now that he's been pardoned for it, I don't know what you can do about it. >> How do you think history will remember or should remember Anthony Fouchy? >> I think very poorly. I think this is where the the media is completely enraptured by the guy. Put aside the origin. This is a guy who went on TV and told you that you should make your 2-year-old wear a cloth mask. He told you stand six feet apart. Later, he says, "Oh, the six feet. We just made that number up." He told you you should lock down schools. He called Bill Delasio in his own diary and seldom him to close schools. Later he says who started this whole school closure thing. He said you got to get a shot even if you've had COVID and um even if you're 20 years old and living in the dorm. Um even if you had myocarditis he actually told Roshelle Winsky in his diary to downplay the evidence. So let's go back to 2021. In 2021 we learned that even if you've been vaccinated you can contract and spread the virus. I think initially we didn't think that to be true, but certainly by the summer with different escape variants, we thought that to be true. The decision to mandate a vaccine was not until the fall of 2021. Long after we knew vaccinated people could get the virus and spread the virus. The moment you knew they could get and spread the virus, doesn't make sense to have a mandate. The whole prerequisite for a mandate is there's got to be enough benefit to a third party that it justifies taking away your autonomy about your body. But he knew that you couldn't justify the benefit if you could still spread it. But he writes in his own diary, "We can't have Roshchelle Winsky telling people that fact because it will undermine DOJ's efforts for a mandate." So he knowingly is hiding scientific truths to facilitate a policy preference of a Democratic president with whom he aligns himself. And he does that over and over. Finally, if you've hadn't recovered from the co virus, we've never had any evidence that you need any additional shots. And yet he never made that an exemption. You know, I think that's a very damning thing. So, I can't think of a single policy he actually got right when he was running the federal health policy. >> And you kind of rode in on this wave of anti- Fouchyism in a way. At at the head of that would be someone like RFK Jr. who the head of HHS. What was your big hope? Um, you know, we'll get into the specifics of what you were doing at the FDA, but what was your biggest hope as to what the kind of new version of public health might look like or changes that might be made? >> Well, I had a very narrow mandate because I was just in charge of biologics at the FDA, but and the hope continues, which is that public health could aspire to be honest, to use its powers proportionately and judiciously, um, to exercise humility. Uh, public health is far from these things. Public health could actually aspire to be bipartisan. Public health is not. It's becoming an incred increasingly entrenched left-wing discipline run by left-wing ideologues, reaching even more and more absurd conclusions. >> Um, so what public health can be and what it is is still light years apart. >> So that you don't think that has changed very much? >> Not much at all. No. I mean, I think changing an entrenched organization with tens of thousands of people is very difficult. There have been some changes. I suspect that um that there's sort of been a catalyst. The pandemic has been a catalyst. Um but I I don't think I don't think a real reform is possible. I suspect it'll splinter into different sort of public health sense uh groups and senses of that. >> And your role uh was at CBER uh which is the part of the FDA that oversees what they call biologics. So that would be things like vaccines or gene therapies. Vaccines obviously became an increasingly polarized and politicized issue. Um during co what was your goal going in there pertaining specifically to vaccines? >> You know people ask me like uh they say vaccines save lives. I say drugs save lives. Like the right drug given to the right person at the right time is life- saving but the wrong drug given to the wrong person at the wrong time can be harmful. >> Vaccines are the same way. You can't say anything about all vaccines just like you can't say anything about Tylenol, aspirin, and plavix all in the same breath. They're all very different drugs. And yet, I think there is a mentality in the mainstream media that vaccines are perfect. They're always perfect. More of them is always better than less of them. Uh there's no problems in the current system. Uh they can never be questioned. And I think that dogma has to go away. >> But that dogma continues. I mean, you want a recent example, this miscarriage uh argument. Fouchy in his diary he says boy you know that co shot's very reacttogenic people get fevers and they feel terrible possible that it will increase the rate of miscarriage now I read people say um we know for sure it doesn't really you know for sure it doesn't well that's the part where I call into question I'm happy to concede that the best available evidence excludes a very large risk of miscarriage there's some people on the right who said it was an 80% risk of miscarriage That's ridiculous. This is not even possible. 80% miscarriage. Like, you'd see that from a mile away. It's not an 80% risk of miscarriage. But neither do we know it's a 0% risk, >> you know, and science has to be very careful to say what we do know and what we don't know. Um, Fizer was actually asked to do a randomized study of pregnant women. They were randomizing 4,000 pregnant women. In the course of that randomized study to learn whether or not the vaccine is safe and effective and whether or not it causes birth defects or miscarriage, they're going to look at 4,000 women being randomized. During the course of that study, the American College of Obstetrics and Gynecology said all women should just get it. >> And they stopped their study with 300 some women randomized and the study is inconclusive and was never run to conclusion. So I think we should be very careful to say we actually don't know about very modest increased risk of miscarriage even to this day. this dogma that you describe of everything you you can't criticize anything about vaccines to the extent that it exists I imagine it's because of the very strong anti- vaccine movement that's been prominent in American history spearheaded by people like RFK Jr. who uh people kind of jump to these extreme claims of vaccines harms whether it's the 80% miscarriage rate um claims about autism and so forth. >> Um how do you balance that? Like h how do you talk honestly about vaccines without feeding into irrational fears? >> Yeah, that's a really good question. I think the only way to do it is to just be completely honest about it. There will always be someone on the internet who says something wrong. >> But the public health instrument, the professors of the world, the doctors of the world, you can't respond to that by lying in the other direction to give false statements that are not true in the other direction. Um, but that's what's happening on every issue. I just think hepatitis B at birth. You want to talk about that? This happened while I was there. Bobby Kennedy and others had the idea that in America if a mother tests negative for hepatitis B maybe that baby doesn't need the hep shot at birth and can wait up to two months to get the shot. >> So a rational person would look at that and say boy there pros and cons to this. Okay. Um if the mother is really negative and we know how he is transmitted largely through bodily fluids and introvenous drug use and these kinds of things there is still a small chance the baby will get hep in the first two months but it's really small. I mean, let's be honest, it's going to be quite small. And uh is there a downside to delaying two months? Um maybe you'll actually lose a few people. They won't come back and get follow-ups. It'll be an additional loss. But what's the upside? Maybe the upside is you'll give people a little bit more control over their bodies and control over their children. They might feel a little bit better. We live in a time where people are sort of unsure about vaccines. So, I think a fair narrative would be like there pros and cons about this approach. On balance, the the sort of the the numbers here are very very small. if they want to make this a provision that some people could delay two months if the mother tests negative. Um I think it's probably reasonable, you know, and but that's not the way the narrative was, >> right? >> Bobby Kennedy's gonna kill people. And then they said things that before the FB vaccine, 50,000 people died a year. Okay, sure that's true, but what does that have to do with his specific policy of shifting from zero to two months in a subset of women who test negative who are low risk? It's completely tangential. >> They've overhauled the childhood vaccine schedule. What are your thoughts on that? I think that I it's, you know, people make a big deal about it, but I don't know. It's the executive order. The I don't know how much it's actually going to do. I think we're we're going to see the endgame play out, which is the following. There are going to be different vaccine schedules. If you're in uh San Francisco, where we're sitting right now, you're going to get the the fullcourt press liberal vaccine schedule. And if you're in Texas, you're going to get the conservative vaccine schedule. And to me, there's it's going to create a probably a variety of vaccine schedules. I have mixed feelings about that. I think that it's very likely you'll get errors in both directions. You'll get you'll have some people giving too many vaccines you don't need and there's some people omitting vaccines you do need. Uh at the same time, the pro of this is that it does kind of shatter this idea that there's a one-sizefits-all federal government vaccine solution that can be deployed to 400 million people and it's going to be perfect. Um I think it creates sort of different opportunities to think about it. There have been a number of measles outbreaks. Do you attribute that to sort of either a loosening of vaccine policy or just a general skepticism, rising skepticism towards vaccines? >> I think it's difficult to attribute people like to attribute it to Bobby what Bobby Kennedy has done. >> But surely in order to have the outbreak now, people have to forego mis measel vaccines in years prior and it's also going on in Canada. So I don't know how you jumped across the border and did it. I mean the truth is there is a growing distrust of establishment medicine. It was precipitated by the pandemic and it probably is also precipitated by you know fringe antivaccine voices and they've shattered confidence in the measles vaccines and so you know there's lower uptake of the measel vaccines. There's going to be measles outbreaks. Yeah. >> Um to blame it on one person >> doesn't make sense to me. Um I want to look at a specific example of a different way that you approach vaccines than your predecessors. Um there uh Madna came to the FDA with an application for an mRNA flu vaccine. >> So you you sent that back and said this is not good enough. Um what was wrong with that? And this was like a billion dollar study. So what was wrong with that study from your point of view? Initially, the company asked for approval of the vaccine in anyone over the age of 50 and a regular approval, meaning there would be no further postmarketing efficacy commitment. That was what they asked, okay? >> Because they did a randomized control trial against uh their new vaccine against an older dilapid and an older vaccine uh in that age group. Now, we issued a refuse to file because for at least 10 years, that's not the standard of care for people over the age of 65. If you go to the vaccine experts right now, they're going to say you need a high dose or aduvented flu vaccine if you're elderly because these vaccines have beaten this older vaccine for 10 years. We've known about it for 10 years. You go to the pharmacy here, you go ask these vaccine experts, they'll say, "Well, this vaccine doesn't cut it if you're 66, 67." And yet they use that as the control arm of this study. This happens all the time in drug approval. The companies use a control arm that is not the best available American standard of care. >> In my opinion, that's unethical. That's the control arm participants are getting worse care than they would if they just walked into the minute clinic. >> So your yeah your view then is that for this to be to proceed, it needs to outperform the best vaccine on the market. The statutory language is that in order to file you need an adequate and well-controlled study and it is not well controlled on the plain English meaning of it because it is not the best available standard of care in America. In fact, it subjects the control arm to higher risk. They're getting a vaccine that's not as good as what they would get if they go to CVS or Walgreens or see you in or see me in clinic, you know. So there there it's not the best available care. So that is a refused to file. Now then they we accepted a resubmission while I was there, >> but it split the application into two parts. a regular approval 50 to 64 and an accelerated approval 65 and up which they ultimately got. People say that we've done a 180 but we've actually given a very different approval. They have a confirmatory efficacy study 65 and up and that study will answer the question whether or not their vaccine is as good or better or worse than the correct control arm. >> So the fact that the FDA has uh approved it for certain populations since your departure, you're generally supportive of that decision. I guess I'm generally supportive of the fact that it's better than what came in the door in the first place. Um I think there are open questions which people should ask which is would you rather get the shot or the flu? You can go look at the grade of rate the rate of grade three adverse events in the clinical study and compare it against the actual rate of influenza seen in the study. So lots of questions that are those are review questions. Those are questions about the review process. I wasn't part of it so I don't know the file very deep there. But the initial question was a question about what are they asking for and is that something that's an acceptable thing to consider and we changed that. I think that was the right call. Um I think the media coverage of that topic is terrible. >> I don't know a single media story that draws the distinction between the resubmission and splitting the age group and the original submission. >> I don't know a single media story that asks the control arm of that study, what evidence is there for a 67y old. You pull the control arm, you pull the package leaflet and you'll see there is no efficacy data. It's an imino bridging up agent up. So it's antibbody tighters for these older groups. It is very flimsy control arm. >> The media wants to portray it as you know you're either prom vaccines or against it. But again like I say it's just right drug, right place, right time or what? This is a the same in in your view this is the same thing that we this is the same phenomenon that we observe during co where >> you're either for the vaccine you're or you're against it you're either for this medicine or against it and not sort of breaking it down by >> what age are you how healthy are you so forth everything kind of has to be flattened or compressed >> one-sizefits-all public health where uh the shoe doesn't fit the guy with the big foot or the person with the small foot. I mean, it's just completely a completely wrong view of public health. And the CO is a great example. An 80-year-old who's never had CO who, you know, and we're talking about February of 2021, should they get a vaccine? Absolutely. A seven-year-old who's had COVID and we're talking about 2022. No, that makes no a healthy seven-year-old makes no sense. So, public health is in this country so broken it cannot appreciate these distinctions. And I think the Mona flu is another one. One more point, why do people some people like the Mona flu despite the the limits of it? They think the mRNA platform can change quicker than the older, you know, eggbased production platforms. That's a hypothesis you can actually test. You could run a study in a season where you compare the flu shot as it's conventionally manufactured against an mRNA flu shot that's made closer to the date of deployment. Presumably by being closer they can pick the antigens better than by being starting production earlier. We could ask that question but there is no appetite for asking that question. People assume the very thing they set out to prove which is this must be better because it can be adapted quicker rather than testing that formally. So yeah, th this was this this has been something you've been writing about for a long time is the poor experimental design for drugs and I assume that's something that you wanted to change uh when you came into FDA. Do you feel like you made any progress towards that goal? >> I mean I think in one year we did more than you know what our predecessors have done in a decade. You can look at just the sheer number of announcements and policy changes we've made. And we're talking a lot about one side of the coin, which is where the companies are not doing the right study to inform the American public. >> We're not talking about the other side of the coin where FDA is asking them to do things that don't make any sense at all, that burden them, that cost money, and that are wasteful. We did a lot of work in that space, too. And so, I think FDA makes both errors. I mean, of course, they also do a lot of things right, but they make both errors, and they can get better. Um, and I guess I'm I'm glad we did some of the things we did to change it. >> A memo leaked during your tenure. It was from you informing your staff that FDA's vaccine safety of Valley UAEs had discovered at least 10 children have died after and because of receiving CO 19 vaccination and that the real number is higher. Um, you wrote that a public report would be forthcoming, marking the first time that the US FDA will acknowledge that CO 19 vaccines have killed American children. Um, five months later, there's no report and you were gone. Um, an F FDA official report then came out a month after you left saying that zero childhood deaths were definitively linked to the vaccine. So, what actually happened there, >> Dra? That's the that's the reading of that. Okay. Well, I would say that that's part of that report. Ron Johnson got part of it. Um certainly linked. Okay. So, when we talk about attribution of what's the cause of death, there is certain, there's likely, there's probable, there's possible, there's uncertain, you know, um the standard for certain >> um is unattainable. Okay? You need to for instance if you give the MMR vaccine to kids occasionally they get a granuloma you can biopsy and you can find vaccine product in the granuloma if you give uh the chicken ga vaccine and somebody dies from it you can sample the CSF and you'll find the vaccine strain chicken ga in there you're not going to find that with myocarditis okay but absolutely is it the case that kids died of myocarditis from the co 19 vaccine yes absolutely it is the case and just because the death isn't coded as certain and coded as probable or possible. That doesn't negate the fact that it is attributable. In fact, the standard across all of drug development is possible and probable are attributable. >> I would say, >> well, just to be very specific about that then, um, yeah, it it said there were zero childhood deaths definitively linked to the vaccine. Um, five deaths were classified as possible and two as probably. Um, so that's still though less than the 10 that originally went out. >> They changed the report. Oh, >> I had a draft report with 10. They changed it after the media publicity of my letter. And >> who changed it? >> The people who did the report. The people who >> said that they had been looking into this issue for years. Let's make a few points. Okay, I want to back up. I want to make one point. >> Yeah. >> If a million people trip on one stair, what's going to happen? A million people fall down just one stair. >> 999,000 just walk it off, >> right? >> A thousand people twist an ankle. Maybe 10 people fall and get a gash on the forehead, but one person is going to die. Just a million people fall off one stair, somebody's gonna die, right? Like that's just the law of big numbers. Myocarditis is a known side effect of mRNA coid9 vaccines occurring at a frequency as high as one in 3,000 per the original Israeli report. And you're getting lots and lots of people to have it. We know that some of those people can actually get scarring of the heart. Some people require presser support. they go into the ICU, somebody's going to die. In fact, there are many case reports published globally. You can just look in the published literature of people who've died globally from this. There's a South Korean study that shows something like 20 deaths. So, of course, if the answer were zero people died of COVID 19 vaccine related myocarditis, that would be the controversial outcome. >> Okay. So, the media somehow wants to defend this idea zero people died, that's preposterous. Somebody's got to die. So what happened was they say they adjudicate all the deaths that come in in the vey system. This is a passively reported system. So a lot of people may have gotten the shot and died but nobody decided to report it to the FDA or they started the report process. They never completed it. We have data that most people who start the process don't complete it. >> Of the reports that get completed, they get sent to the FDA and then they start to look into them. A contractor is supposed to pull the autopsy reports, but this contractor sometimes doesn't pull the autopsy. So, we don't have autopsy reports on some of these deaths would make it difficult to adjudicate and make them unlikely to say even possible for those deaths. Um, so this is the process. Tracy Beth Hogue, who was the Cedar acting chief, she started to investigate these deaths. She thought she found some that were really kind of telling. uh kid gets the vaccine and then is found dead with a heart with lymphosytes infiltrating looks like myocarditis. Um rather plausible. Uh the staff that's worked there for years are very concerned. Um it undermines what they're supposed to have been doing all these years. Surely because if you're supposed to be looking at safety and you never found it, now some new comes along and says you got this problem. You know, you're also just like Fouchy a bit conflicted about whether or not you're the best person to investigate. M >> but having said that I still tasked them with looking into it. They sent me a report with 10 deaths possible probables and and likelies and uh I wrote my memo saying that you know a lot has to change because how come this is the first time we're ever talking about it. They downgraded the memo to seven. The point still stands seven or 10. The vast majority of these deaths are probably not even reported into the system if it you know it's a passive collection system. >> Um and I'm surprised it's provocative. Like it shouldn't be provocative that a vaccine with a known side effect of myocarditis and myocarditis is bad. You know, it can be very bad. That it would kill somebody. That's got to be not that it would be more implausible than kill zero people from myocarditis. >> Do you believe the memo was downgraded for political reasons? >> Political or professional reasons that nobody wants to look like, you know, this problem is as is bad. Do >> you know who leaked the memo? who leaked the me? Ron Johnson posted the memo. Like, it's not it's not leaked. Ron Johnson has subpoena power. So, Ron Johnson got the memo and he has the final memo. Um, there's an additional memo looking at another age group. Ron Johnson hasn't subpoenaed that. >> Maybe he doesn't even know that exists, but there's a few more deaths in that one. There's three more deaths in that one. So, it'll be something like 10 deaths. So what should the public take away from this information given that even if this higher estimate is accurate? That's sad, but it's not a lot. And even COVID can kill children, even though that's also very rare. So what should people make of all that? >> I think people should make of it. It was it it was a really bad idea to vaccinate healthy kids for COVID and force them to do it, especially college kids. There are on average college kids did in fact probably were harmed on average by that policy. I mean we published on that before I got to the FDA. >> I think public health has to take ownership of the fact that the one-sizefits-all co 19 policy and boosters was a bad thing for young people. It did damage. They won't I mean if you can't admit what you got wrong um you know so I don't know what to take away from it. I think that it's it's it's disappointing that why like I guess what to me what's disappointing is that there are people who say incorrect things about vaccines that they have microchips. Okay. Or whatever all sorts of crazy things. I hear a million crazy. Okay. They're crazy people. >> Um so is the response to that to lie about the real safety concern? I don't think that makes sense. Just be honest about it and then maybe don't mandate it in 20-year-old boys who are going to dorms who just had CO. Why did they do that? That's a Fouchy policy. That makes no sense. you know, like, so just admit we got that one wrong. >> You clearly came in wanting to raise the bar for vaccine and gene therapy approvals. Was there tension with the Trump administration's deregulatory impulses, the desire to make it easier to access certain kinds of drugs? >> I guess one thing I want to point out about right to try, which is Trump's signature policy, is it's right to try, but it's not mandate to pay. You know, okay, there's a big difference. Right to try means you should have the ability to try an investigational agent given to you either for free or at the manufacturing price. Doesn't say given to you for $4 million a pop and force Medicare to pay. I mean, that's just what the bill says. >> The next thing I'd say is I would draw a distinction between vaccine policy and gene therapy and rare diseases. In many ways, we were quite permissive with rare diseases. We created a pathway where you can approve a product that's individually made for babies with say enzyatic process deficiencies. um the plausible mechanism pathway. We debuted that sort of pathway. Um that's a lot of flexibility. That's flexibility that didn't exist before for kids who are suffering from like incurable and rare diseases. I think we did do a lot of flexible things. We didn't demand randomized studies. We gave full approval for uncontrolled studies. The vaccines is a different thing. We're not talking about people who there are some vaccines used only for people with rare diseases, but most of them are this one-sizefits-all for every healthy kid. And in that case, I think people in America want to know that they're safe and effective, including the president. You can see reading between the lines of his executive order, he has a lot of concerns and doubts. Um, he may not place them in exactly the right places, but he does have those concerns or doubts. And so, in the vaccine space, I do think the bar should be brought up higher. Um, I think it is kept low for political reasons. It is the political preference of the left to have to just say every vaccine is great and to not acknowledge that there are some serious downsides and concerns to some vaccine products to not talk about like that he B debate I think was a great example. >> I mean the me the coverage was that if you give an inch on hep at birth for mothers who test negative and by the way they're knew some ultra sensitive antigen testing so it'll be they're pretty confident they are negative. um you're going to have an epidemic of liver failure as a result and that's come on that's just not possible. >> How did working at the FDA affect your own confidence as a consumer in the regulatory system? >> I guess it gives me uh a little bit of pause sometimes. I like to uh trust but verify. I particularly um am cautious always with new therapies and uh particularly cautious that some safety information is is being missed. And I think it also makes me a bit more libertarian. You know, I can imagine a system where um we give people in America greater flexibility in what kind of products they can try. Um and maybe there's some third party agencies like a consumer report style agencies that give different levels of quality and seals of approval of different products and people can choose what they want and maybe also have a little bit more skin in the game and use their own money. And then the moment you start to use your own money, suddenly you know tiny changes in surrogate biomarkers and elevated liver enzymes takes on greater importance in a way that might not exist if you're using uh you know commercial insurance to pay for it. >> Is it just you saw something inherent to the process that creates problems or holes or gaps? >> I guess that the fundamental idea that there's this oneizefits-all balance where safety and efficacy is acceptable. I mean, what might be acceptable to you and acceptable to me might be different. I might want a little bit more efficacy information, a little bit more safety um validation, and you might be willing to try more. And the idea that a single monolithic government agency in the suburbs of DC can set that bar for every single person in America, uh that to me is a is a tougher pill to swallow. Now, >> you mentioned there's two there were two sides of this FDA reform. One was to raise the standards for things like vaccines. The other was acknowledging that yeah, it's very expensive and cumbersome to get anything approved in the United States. What were the biggest barriers that you saw in the FDA from that side of the equation? >> So many. I think I I would say that during my time at the FDA, I was often sympathetic to the people who work at companies who told me about sort of the hurdles they were forced to jump through. And to me, a big set of hurdles are if you know FDA does two things. We regulate what's approved and can be marketed and sold on the US market, but also what you can study. >> And imagine you're a researcher and you want to study something. We're not talking about approve it. You want to gather people together who may be interested in trying something new, have an informed consent, get them to volunteer, but they know that, you know, we don't know for sure it's going to work. We do so many things in that space regulating what you can study and how you can study it that I think are sensible. Sure, you don't want to let people sign up for something that's going to blind them or maim them, but some things that aren't sensible, that are overly burdensome, that are quality controls that don't make sense for small companies and super rare diseases that don't have a huge budget to study these things. So, I think the regulation in this early side of research is tremendous in the United States. A lot of it well-intentioned, but not all of it fit for purpose. >> There was a deregulatory impulse there. Um McCary talked about, you know, wanting to make more things over the counter. Um, >> good. And that still should happen. >> RFK Jr. has pushed to make testosterone and peptides and so forth more available. Um, and accessible while being more skeptical of pharma more broadly. Um, yeah, you you said you're supportive of those sorts of ideas. Making >> some of those ideas. >> Okay. So, making over-the-counter medications for instance. >> I think SVAT is a great example. Statin. Do you really need to talk to a doctor about a statin these days? You can go get a calculator and you know you can decide if you want to take a statin yourself. It's a great example of something that we over the counter. There's so many drugs that the doctor or the minute clinic or you know these sort of tell you know these services they're just a gatekeeper from you from consumers having access to these products. The peptides I think is sort of a mixed bag. There are some you know peptides that I think have very limited efficacy. There are others that have maybe more efficacy and some of that battle is not really about safety or efficacy. It's about the profitability. >> You see right now that I don't maybe I shouldn't say the exact peptide, but there's one peptide that a lot of people are using. They're getting it through these compoundingies and the manufacturer that holds a patent on that, they do not like that. They're going to lose a lot of money and so they want to kind of fight that off. So, like so many things, there's nuance there. You know, there's there's some peptides that are probably would be good for consumers to have a little bit more flexibility in getting it through a compounding pharmacy and but not all. >> Did you ever feel a sort of that you were pushing against that that if there was a deregulatory impulse, but you in a sense wanted to make things stricter in certain domains? Did you feel a tension working within that system? I guess I'm always a case by case person. Yeah. So I'm always you want to talk to me about a specific drug product, specific application, I'll get to the bottom of it and I'll give you a presentation. And what I found was that to the credit of Robert F. Kennedy Jr., he's >> he listens to when you make the case, >> you know, and sometimes I make the case to him that wasn't his initial instinct. Um, but I often think that the way the media does a disservice to him is they say his instinct is always wrong. Mhm. >> One of his instincts is that, you know, for-profit companies sometimes manipulate data to get people to use something and make a lot of money. Well, there's a kernel of truth in that instinct, isn't there? And, you know, there's a kernel of truth in that instinct. So, take that kernel and think about where it applies, but also think about where it doesn't apply because for-profit companies also make a lot of terrific products that do good. >> And and that's what I tried to do. >> Well, yeah. I I wanted to ask about a specific example that was one of the more controversial flash points in your tenure there, which was the Wall Street Journal written a scathing oped whose writer called you a one-man death panel because you pushed I see >> uh you pulled access to some of these experimental treatments including a gene therapy for a form of muscular distrophe um following some patient deaths. >> Yeah, following they following people dying of it. Yeah, we did we did restrict that. Yeah. >> Um that was a big >> the point that that writer was making is that um again these are people who have a terminal illness. They want access to this drug and you pride are gatekeeping it from them. Um what's your response to that? >> Oh my goodness. I guess I'd say that's nothing could be more further from the truth. That drug is like remains on the market and anyone can get it for an off label use. They want the indication so they can force the insurance company to pay the multi-million dollars for it or whatever it costs. Um certainly I have a few thoughts. One is the editorial board of the Wall Street Journal, they know nothing about medicine, okay? That they make they make mistakes in both directions too. They want things approved that are harmful and toxic and don't work and they're missing things that are reforms that actually would help the businesses. So I think Wall Street Journal editorial board, they they're they're making the same two kinds of mistakes. Um, I think you're alluding to uh the first time I left the agency in the summer of 2025. I mean, you have a drug product that came to the US market where there's only one person I'm aware of at the FDA who wanted that product on the US market, and that was the person who filed an override memo to approve it against the wishes of all the staff below. >> Hundreds of hundreds of people with expertise in the disease don't want to approve it because they think it doesn't work and has harms. But one person at the top thinks it does work. >> Who was that? >> That was Peter Marks. That was the Peter Marks override memo on that product. >> Okay. >> So, uh, who famously famously blundered everything about the CO boosters, too. Okay. So, >> but I'm happy to let sitting dogs lie. Sleeping dogs lie. I mean, this not, you know, it's been approved, but I can't go back and revisit every decision. But then, um, you get deaths. You get people who are getting the product who are dying. Well, what should the agency do about that? a product that has documented memos from review staff believing that they don't think it's helping and now you have people dying. I think if you're going to say what's the purpose of the FDA and you know many libertarians might think we don't need an FDA >> and I'm actually we're going to get to that. >> Okay. Well, I'm kind of sympathetic a little bit having worked there. I'm like I can see I can see your point. But so I can see that point of view and I appreciate that point of view. But if it's going to do anything, surely the one thing it's got to do is prevent people from taking something that you don't think helps at all and that can kill them. If it's going to do anything, surely it's got to take do that. And so I think that that's a very reasonable change to the label that occurred in that case where it was a group of patients and there's a group of people that are younger with lower body weight who are walking and the drug remains on the market for those people and there's an older group of people with higher body weight. The drug is dosed based on body weight that aren't walking and that's where the deaths occurred and it no longer remains on the market for those group of people but they could still get it off label. Technically, >> part of the backlash to that and this was the moment that precipitated your first departure from the agency was Laura Loomer, the MAGA influencer, was blasting you on social media. She called you a uh was it a oh progressive left sabotur of the MAGA agenda. >> Um, you didn't respond to Lumor at the time, but uh for understandable reasons, now that you're out, are you a far-left mega sabotur? MAGA sabotur or maja sabature. I think in many ways I would say I I don't know if I'm a I'm a I'm a MAGA proponent or sabotur but maja I think the idea that to make a maker healthy again I think there are lots of kernels of truth in that. There are lots of things that Bobby Kennedy is right about in the food supply dyes in food pesticides toxins um and drug reforms and vaccine reform. I think there's lots of kernels of truth in that movement and healthcare is kind of my predominant thing. Um, Laura Loomer is a new type of lobbyist, but I think people shouldn't forget that we've always had lobbyists. They're lobbyists of the FDA for decades and decades. They don't always come across as a lower loomer, but they're there and they have influence. So, anyone who thinks it's a system that cannot be lobbied. I hear some people say like Laura Loomer is the first to lobby, she's not the first, the last. >> To be clear, is this what caused you to be pushed out the first time? Uh, it was an interesting timing. I can leave it at that. >> Okay. Um, you know, you said that your time within the FDA made you somewhat skeptical or maybe more sympathetic to the libertarian critiques of FDA. What about that experience? >> I guess I I'm I'm really sympathetic in one way, which is like the the core sympathy is the following. We tax people a lot of money to pay for healthcare in America. I mean, trillions of dollars. We're taking trillions of dollars from people's paychecks, from taxation, and we're taking it for this thing that we think is a benefit to people, which is we're going to offer a service that is a maybe a human right, a societal good. And surely the service we offer, we do have some of that stuff in there. Like, you know, if you have a heart attack, you go to the doctor here with or without insurance, they're going to open up that blockage like right now. >> That's a great thing. But along with that package deal, we're going to insert a few things that may or may not work that cost a lot of money. And all that's doing is taking lots of money from taxpayers and redistributing it to the shareholders of those companies. >> It's a huge financial system with the rare adverse event of helping someone's health. >> And the libertarian comes along and says, "I'd rather not pay the tax, have more skin in the game, decide what's right for me, and I'm the best person to decide how to use my own money." And I guess I do feel a sympathy to that point of view because this system has so many places where it can be taken advantage of where people get something that doesn't help that much that only may kill without any possibility of benefit and you take a lot of other people's money to pay for that. >> Yeah. I mean one of the specific libertarian proposals and this was something that was floated by Jim O'Neal who was the deputy uh at AHS. Um, what other example of maybe the sort of interesting tension? You've got RFK and then Jim O'Neal who once said that FDA should be rolled back to its pre-1962 mandate where >> all it does is look vet for safety. It doesn't even um gatekeep based on efficacy. The market and doctors sort of will work that out. Um, my question is, are we headed that direction with the way that medicine is changing? Um, do you think the FDA is going to need to be reimagined somewhat? >> I mean, I I appreciate Jim O'Neal a lot and I think he has got a lot lot of wise ideas and I think I appreciate that he's very philosophically consistent, but let me use an analogy. When we talk about safety, I think we mean two things, not one thing. >> Okay? Okay, we say safety and efficacy is the mandate of the FDA since ' 62, since 1962. Okay, when you get in your car and you turn the ignition, the first type of safety is you got to make sure the car doesn't blow up. >> Okay, you've all seen the mafia move the car blows up. Okay, so that's a type of safety. We know the car can turn on, the gas line doesn't explode, the car like it's it's safe. The next thing is efficacy. You drive down the street, can the car actually go down the block? That's efficacy. Okay. Well, FDA, we we we definitely do the first thing. I think we definitely show in phase one and early phase testing your car is not going to blow up. >> Then we kind of do the second thing. We kind of make sure that cars go down the road a little bit. You know, some cars may not go as far as other cars and um sometimes we don't look at how far the car goes. We use a surrogate of the engine's running loud. It sounds like it's going to go so we use a sur so we kind of monitor efficacy. But that's not what we really mean for car safety. What we really mean is Volvos, a thousand Volvos have been driven 400,000 miles and we know that the rate of car accidents and driver fatalities are lower than let's say I don't know Chevy or you know you get the point. >> That type that's what people really mean by safety that the Volvo is the safest car because with 400 million miles of follow-up the driver is 20% less likely to die than other cars. >> Okay, that's the part of the FDA that we don't do a good job. We have never done a good job and we never will do a good job. It requires large sample sizes and unbiased data and I think that there's very little effort to do that. So when people say things like co 19 shots absolutely do not cause miscarriage and they cite an observational study where the women who got it and the women who didn't get it are different women. They chose to do it right. That's not really proving that it doesn't cause any miscarriage. When you administer a drug to lots and lots of people in a biased way you can't really look for small safety signals. So I think that's a huge failure. So, back to Jim O'Neal's point, Jim O'Neal wants a world where we just make sure the car doesn't blow up when you start it. >> I think it's philosophically defensible. If he wants a world where we know that the car will run for many, many miles without causing more fatalities, that's that's a tougher pill. That's not very doable. >> Yeah. I mean, this isn't this partly what McCary is trying to push for? he issued a memo um saying the FDA is going to become more basian. So we're going to look uh ba basian is statistics is kind of like you're placing small bets on like probabilities that something is safe or not safe and you can kind of try to zoom in more on a more individualized level on subopuls instead of the one-sizefits-all approach. Um, is there a way that you see from how you observed the machinery operating that that can be pushed further that um sort of tracking results at that granular level over time over those 400,000 miles is something the FDA would be uh able to do or if we're post FDA some other organization would be able to do. >> It's a great question. Well, I definitely think there's lots of value in the basian methodology and it will accelerate products to market. It will leverage data from one uh disease to another disease, one cat, one cat drug to a a sister or brother molecule. So, I think there's lots of value in basian statistics on this question of really safety. Let's talk about like let's imagine I come up with a um a drug that improves depression and it really improves depression. But what if it increases the rate of heart attacks by four percentage points? >> Not 40, not 80, not 80%, okay? But like 4% or 2% or half of 1%. At a population level, that could be very bad. Like a tiny increase in heart attacks, but it might be very very difficult to find. And here's why. I debut my new depression medicine. Who are the first people who get it? It's not the average person with depression. It's going to be the wealthiest person with the best health care and the best insurance. They're going to be the first people to sub, you know, to take it. And that person's rate of heart attack might be a little bit lower than the other depressed people who are not as well educated or literate or health conscious and these kinds of things. So I think we do have challenge with phase 4 postmarket surveillance for safety. We have a broad problem with it. We have very weak methods I think and I don't think basing will get around that problem because the problem is the types of people who take it first are different than those who take it second and third year. >> Well I mean another person who has been ra another another prominent voice who's been raising concerns about this because when you're looking at f the risks of uh of drugs there's two sides of the equation. There's the risk of approving it and then the risk of not approving it because if it is an efficacious drug, how many people who would have had access to it earlier could have had their lives saved or prolonged or improved over that time period? >> And someone who's raised that issue in the age of AI is Daario Amode, the CEO of uh Anthropic. And I'm just going to read you his cure cancer >> because he specifically called out the FDA. And I'm I'm wondering what you think of this. Um, and we've already seen AI being integrated into biotech labs. So, we know that the idea here is to try to use AI to individualize like, you know, drugs targeted to specific individuals, genomes and so forth. And he wrote that regulatory systems were designed for a slower pace of innovation and we are not prepared for the deluge of new products and advances that AI will bring. AI may also make these downstream technologies safer and more predictable in a way that violates the skeptical assumptions of regulatory agencies like the FDA. Um, if MODA is right about the effect AI is going to have on the field, do you think that the FDA is going to be able to adapt to that future? >> Well, it's a great great question. I guess let me start by saying I mean I definitely see kernels of truth in what he's saying and but maybe I'm not as much of it. I don't go all the way he goes. >> Sure. >> So what's the where I see like the big core truth is I mean the FDA tries to regulate AI itself, medical AI. You wear a watch that's supposed to give you information and the FDA wants to do a lot of that regulation. That's a very tough thing to regulate because this technology is getting so it it's changing so much faster than our ability to judge it. And I do agree with uh with Marty and others who think that that's probably not the best role for regulating all the potential aspects of digital health and health AI. And for instance, you can imagine the absurd where, you know, should should um should government regulate I'm a doctor. I'm seeing a patient later this afternoon. Should government regulate the apps I can use to read to like learn about the disease or ask questions? You know, should it regulate open evidence and those kind, you know, you could ask that question. I don't think it should. >> I mean, you could ask the question. I just spoke to a company called Doctronic that is an acting as an AI prescriber in Utah. Utah is allowing the AI to renew to refill prescriptions. So that's another example of where the these questions are going to have to be answered of where does this government step in and where where does it step back >> and I think I I have a general philos a feeling that probably government is much more likely to get in the way of these kinds of innovations. It's changing so quickly, it's going to be very difficult for government to regulate that. Now, you talk about drug discovery and drug science and those kinds of aspects of AI. I think if I was a pharmaceutical firm, I would definitely invest in AI. I think there's so many things around running clinical trials that they can we can do better with AI. Um, help us run them cheaper and faster and more efficiently. But I do think when it comes to molecule discovery and basic science, I'm not as optimistic as Daario for a couple reasons. One, I think a lot of the information that is fed into models about cancer biology is basically as close to fraudulent research as you can imagine. You know, we're talking about like the Stanford president who's western blots look photoshopped kind of research. You got research that's not reproducible. It's not just my opinion. Many companies have taken samples of the literature and they tried to replicate it in their own labs and they have massive strikeout rates, you know. So, if you train AI on garbage, it's just not going to like what can it learn? It's only it's trained on like inaccurate information. I think that's a challenge it will give you hypothesis. I suspect the limiting reactant is not coming up with ideas. We have so many we have with more ideas than we can study with people. Limiting reactant is getting the people to consent and manufacturing the products and those kinds of things. I hope he's right and if if um if he is right, it sounds like a great future. Um, but I'm a little bit skeptical that it's he's he's totally right because I think the biology of it is a lot harder. >> What about the role of the FDA in this biohacking movement which has become more popular? You mentioned uh peptides recently. That's that's the new sort of frontier of all this. People are going to these compoundingarmacies and they're getting peptides for quote research purposes and it's causing some concern in in the media and maybe in the public health establishment and calls that maybe the FDA needs to get more aggressive in this area. What do you what's your assessment? Yeah, I feel like it's it's um the same but in like we we already struggle with this tension between there are many many people selling products that are on the cusp of what we can regulate. Yeah. >> Um you know in biologics if it's how much modification does it have to undergo before it falls under our purview versus if it's just a simple like if I take a piece of your skin I can graft it on the other part of your skin. It doesn't go through FDA regulation for instance. Okay. Um, so but there people playing around on the edge of this for years and we have enforcement discretion where we choose to enforce the rules or not enforce the rules based in part on if the juice is worth the squeeze um the patient communities and those kinds of things. And I think they're going to continue to walk that line. But um to me what's interesting is where you've got the compounder and they're making like reatride Eli Liy's product >> and you got a lot of people taking it and they're losing weight and it looks very similar to the clinical study and you don't have adverse revenants different than the study reported. What do you do in that space? Of course the company has a strong interest in killing that market off and they're probably going to lobby hard to kill it. Um but is it actually a public health risk or is it the perception of public health risk? Um, people always say, "Well, you know, the compounding pharmacy can can go bad." That's true, but so can the factory, you know, the actual manufacturing plant. >> I think that a lot of people are going to watch this interview and wonder, "Why aren't you still at the FDA?" Your second departure in April of this year, then FDA Chief Marty McCary said, "Your exit was pre-planned to coincide with your leave from uh UCSF, where you still teach." Um, on the other hand, Stat News reported around that time based on talking to several of your employees that you were clashing with career bureaucrats, people within the machine, um, and that they thought your management style was creating quote, "An environment rife with mistrust and paranoia." So, what is the truth? Why did you really leave permanently for the second time? >> All right. Well, first I want to say one thing about like how they report. Okay. Um, you know, like the the reporting in this space is really bad. Okay, you got the big outlets like New York Times and Washington Post. They only want to report on a story if it has to do with Robert F. Kennedy Jr. That's their only interest because if it's not Robert F. Kennedy Jr., they don't care. They don't care about, you know, chicken ga or replemune or all these, you know, you care all these things that came up. They just don't care about those topics. They don't interest their readers. They don't think it's broadly interest. And so they poof, they're gone. Then you've got a group of people that write outlets for um you know for investors. Their audience is investors and they're writing for investors and and that's their prime business. It's like who wants to read about this small company except for the investors in the company. And what's their method to say that my leadership style is whatever they say they get one person they've known for years at the FDA calls them up says I don't like this guy and here's three of my friends who are going to call you up. They're not randomly picking up the employees to get a sense of the tenor or tone or anything like that. So, I think that's all just complete nonsense. Like the what the leadership style is. Go to SBUR and just literally pick 50 random people and ask them what you thought of me. And I'm happy to accept whatever they say if you pick them randomly. Um, I'd suspect they'll say mixed things like any boss. You know, that I'm really interested in science and I push back on some things, but then there other things I'm indifferent to. >> Okay. Uh, the next thing I'd point out is, uh, it is true that I only had a one-year leave to go do it. then who knows they'll give away my job here you know and I lived here the whole time that's no secret uh you know I was going back and forth >> and um my uh goal in life is not to be a career regulator that was never my goal in life so I was doing it because I thought it was a public service and if you talk so much uh about the agency and you get a chance to work in the agency surely you'd be a hypocrite for not taking that chance >> but I do note my leaving which um uh coincided with the commissioner leaving and with Tracy Beth leaving Cedar And what I find fascinating is there's not a single news outlet that can tell me how Tracy Beth left because Marty had left, I had left, and then Tracy was relieved of duty one day suddenly. And Politico reports that Robert of Kennedy Jr. doesn't even know she wasn't working there anymore. So who took her out? Not a single news outlet's interested in that story. I find that fascinating. People who hear about you leaving, McCary leaving, Tracy leaving, the impression that many will get in the Maha movement is well, here it is. Here's big pharma pushing out the dissident yet again. Um, how accurate or inaccurate is that? >> I think all government reform is limited by threatening the profits of a very rich people. I think all reform will be limited by that. And where Maha will succeed is where the finan where the money and the mission go together. But in the spaces that we were in, the money and the mission go in different directions. And so I think it's an uphill battle. >> There's um one of your persistent criticisms has been the revolving door. You mentioned your predecessor Peter Marx earlier. >> Oh, you mean the Eli Liy vice president? >> That's what I was getting at. Um >> how how is that still um looming over government as a problem specifically public health? >> Absolutely. And public health it's a it's the biggest uh I see Ashish Ja who was the White House COVID coordinator. He says you know he thinks it's lab leak after all. >> Yeah. >> It's funny he just came to that realization when he created what is it called? Bio radar his company that helps helps people solve lab leaks. You know it's like a coincidence. He suddenly realized it was a lab leak. They just got a company that works on this issue. Um Bob Cayiff, uh revolving door of uh of companies. Uh Scott Gotautly. Bo, he's always quoted as the FDA the FDA commissioner Scott Gotautle thinks you should get your Fiser vaccine. You mean Fiser board member Scott Gutly thinks I should get a Fiser vaccine. So why do I think it's a problem? I think that not most of the people who work at the FDA, super good people, honest people. a few people working at the FDA are definitely making decisions with the goal of wanting to work for these firms when they're done. >> So, is the fix to that to have some sort of I don't know moratorum or amount of time before you're allowed to be employed by who would do it then you know to be honest you already take the terrible pay cut to be in government service. A lot of these people are doctors and it's difficult for them to have a practice and to me like of all the things I missed the most I miss my clinic the most like I miss that part of I always say um you know you can undo everything I did at the FDA but you can't undo my last week of clinic you know you really did something it's very tangible so I think that's like a downside of the employment and a lot of these roles you don't have a lot of autonomy and so if you take away the ability to work at the industry I think you might kill off the entire like who would even work there moratorum I'm not sure that's the right answer I I'm I'm I'm I'm genuinely unsure of how to create enough incentive to get great people to work there, but also to safeguard against these perverse interests. And I don't have the answer to that. >> Are you glad that you went to the FDA? >> I am glad because I feel like, you know, how often in life do you get to do a job where you really see and learn a lot about things um you you you had only talked about or read about before. Um that's one. And you know, like anything, you get offered these opportunities only once in a life to go do something like this. So, I'm glad I did it. So you sort of rose to fame as this COVID critic, COVID dissident and a critic of the lockdowns, masking children, vaccine mandates. >> I thought you were going to say because of the book malignant. No, >> it wasn't that that didn't catch your eye. >> Uh we we talked to you at one point about a piece you wrote arguing that uh the public health establishment was right. It's right that they lost your trust. Um, do you think that anything has happened that it's time for people to start regaining trust in public health? >> Oh, no way. No way. No way. I wouldn't What still needs to happen for public health to earn back legitimately the trust of the public? >> Boy, um, you remember monkey pox? And I remember public health experts said maybe every kid should get every college kid should get a monkey pox vaccine before going to college. I said, ' Do you know how monkey pox spreads? It's it's not every college kid. Kids should wear masks in school because of monkey pox. This is what like former surgeon general said. >> They're they're completely wrong. Okay. Right. So, that was just one example. Um what can they do to regain trust? >> I don't think I don't know if it's even possible. I think it's just so fragmented now. Um you ask people and they tell you with a straight face like people I know, Anthony Fouchy, you know, he made no mistakes. literally did the best job he could with the information he had. And then I said, "Let me just let's just focus on one tiny thing." He did say, "You should take your 24month-old kid and put a cloth mask on that kid all day in daycare." That was like he said that >> you don't think he had any clues at the time that that was a dumb idea. I mean, so obviously dumb, right? So like that's their position on every issue. Um I give you another example. There was the outbreak of what is it? Cycllospora, >> right? And there is a public health doctor from San Diego who's quoted in NBC that says for the next few weeks just don't eat any fresh fruits or ve produce at all. Give up all fresh pro. Can you imagine how myopic you are? Okay. So yes, there's an outbreak. You mean to tell me for a few weeks you want everybody in America or whatever to not eat fresh fruits or vegetables. What will happen to the the agriculture industry? What will happen to my blood cholesterol? What will happen to my fiber intake? Some of those people may never go back eating vegetables a tiny fraction and they'll gain weight. Public health is so myopic. It doesn't understand that you have to look at the whole issue. And isn't that no perfect is a perfect analogy for co um you know oh ju just don't just don't go outside just stay in your house all day as if human beings don't need contact with other people and see face to face as if that doesn't matter at all. Just don't eat fresh fruits and vegetables. So public health has not learned its lesson. The problem with public health, I think, is that they're completely politically captured now. Um, public health and the far-left wing of the Democratic party are synonyms. >> There's no political balance on there. Um, I think a little balance would go a long way. A little bit of open-mindedness would go a long way in public health. A little bit of humility to just admit a few things we got wrong in the pandemic. Um, they closed schools in this city for 18 months. That was just a self-inflicted wound. Um, this hurt the kids of this city. And it didn't hurt the the rich kids in private school. Those kids went, you know, those kids those schools ran. It hurt the poor kids in public school, which is the exact opposite of the progressive philosophy. So, I never understood that. >> But I mean, the federal public health apparatus is still in control uh uh still staffed by at the top by RFK Jr., Jay Boditaria is still there. Is that not having some sort of trickle down effect or countercurren? >> I don't know. I just don't think it's um I mean, don't get me wrong, I I love Jay and I think Jay's heart's in the right place and Jay is is going to um he's already made some really important changes and I agree a lot with what uh the kernel of Bobby's ideas. I agree with the colonel. >> Um I always say the colonel because I can think of a way that they make sense and I can also think of ways that doesn't make sense. Um but we you know people before I went to government people told me that there is a a fourth branch of government and it's the career state employees. I never believed that to be true, but now I'm certain that is true. That you have a lot of people who are in government. They tend to be in just three or four counties in one area, a blue pocket of America. They have strong views and they really do a lot of the governance of this country. They make the decisions that regulate all of us in a way that's unaccountable to Congress and unaccountable to the president and I suspect they'll continue to stay. But I think the COVID pandemic revealed to so many people that we made mistakes and that distrust in medicine and public health will just continue to grow and that uh there'll continue to be more of these kind of reckonings. >> Last question. What is next for you? What are you doing now? >> I'm the vice president of Eli Liy Vaccine. No, I'm just kidding. I'm joining Peter and No, just kidding. Um, you know, me, uh, you know, I'm back to back to doing what I love. Uh, you know, uh, I'm a doctor by training. Um, you know, and so to me, that was why I I got into health because I like to be in clinic and I still like to be in clinic. I still like to be on rounds. I think it's it's the most interesting part of medicine. Um, you see a person, you think about their problem, you talk to them about their problem, you advise them, you help them make better decisions. And so I love doing that. I like making the videos like you like making the videos. I'm on YouTube and I'm on Substack writing for Sensible Medicine and um I don't know I'm I'm taking a much needed rest and uh and uh not in not in a hurry to get on to the next thing. I'm a professor. You know how professors are. We just like to sit around and talk. Yeah. >> Okay. Well, yes, you can read Veni Prasad's writing at Sensible Medicine and also your Substack Veni Prasad's thoughts and observations and subscribe to your YouTube channel. Thank you so much for sitting down and talking with me today. >> A pleasure.