Truth Podcast - Vivek Ramaswamy - Dr. Vinay Prasad on How FDA Gatekeeping Makes Us Less Healthy | The TRUTH Podcast #49

00:00:00.000 So most people know me as a U.S. presidential candidate.

00:00:10.000 You probably hadn't heard of me before that, most of you at least.

00:00:13.000 But actually before that, my prior career, I had started an asset management firm called Strive to compete against BlackRock.

00:00:19.000 But before that, I was a biotech entrepreneur.

00:00:21.000 I founded a biotech company called Royvan.

00:00:24.000 I led it as CEO for seven years, founded it in 2014. Today, the company just had its 10-year anniversary.

00:00:29.000 More recently, earlier this month, I've overseen the development of five medicines, five of which went on to become FDA-approved, many more which failed along the way.

00:00:38.000 But I have interacted with the FDA. And I know something about the FDA, like most people in the pharmaceutical industry do, but they're not allowed to talk about it.

00:00:46.000 Here's what one of the dirtiest little secrets is in the pharmaceutical industry is an old adage that goes, FDA never forgets.

00:00:53.000 If you criticize the FDA, you know you can expect adverse consequences in response.

00:01:00.000 Does that mean they're not going to approve your drug when it comes up to the time of approval?

00:01:04.000 Actually, it's far more insidious than that.

00:01:06.000 Most people don't understand this.

00:01:07.000 It's not like the FDA just makes a decision on the back end after you've done all of your trial work, deciding on the back end of whether or not it gets approved or not.

00:01:15.000 It's not a binary question.

00:01:16.000 Turns out the entire process, all the way from the conception of your idea in a lab, your preclinical testing, all the way to testing in animals, all the way to the early human testing and healthy volunteers, to patients, all of that, every little microstep is actually gatekept by the FDA. So if you do something the FDA doesn't like, they will actually blackball you at every step along the way in a manner that will never be visible to the public.

00:01:40.000 It's not going to be some sort of politically palpable Approval decision at the end to say they rejected your drug.

00:01:47.000 That's not how it works.

00:01:48.000 And this is a perfect example of how the deep state works more broadly.

00:01:51.000 Works not through a bang, but through a whimper, through the boring motions of the administrative process, through the technocracy.

00:01:58.000 They bore you into actually effectuating their own agenda.

00:02:02.000 Now, what could criticizing the FDA include?

00:02:05.000 Here's one example.

00:02:06.000 President Trump actually saw through a law, saw it through into passage, that expanded the right to try.

00:02:12.000 The idea that you as a patient had a right to try a therapy even if it wasn't approved.

00:02:16.000 I believe in this.

00:02:17.000 This is part of medical choice.

00:02:19.000 We've talked a lot about medical choice in the last several years in the context of the COVID-19 pandemic and the COVID vaccines.

00:02:25.000 And in that context, medical choice means that I shouldn't have to take something just because the FDA has approved it.

00:02:31.000 But the mirror image of medical choice, which I also believe in equally, is that just because the FDA hasn't approved something doesn't mean that you shouldn't be able to take it if you want to make a decision for yourself about what the health consequences are or aren't to you, especially for life-saving therapies or potentially life-saving therapies that people are otherwise desperately denied if they haven't been through the FDA process.

00:02:51.000 So President Trump, I think correctly, passed and signed into law a statute that expanded the right to try.

00:02:56.000 But then there's something mysterious that happened.

00:02:59.000 None of the biotech companies, none of the pharmaceutical companies were actually making their therapies available through Right to Try, even for patients who wanted to try them.

00:03:06.000 Why?

00:03:07.000 The dirty little secret is the FDA hates this law.

00:03:11.000 They hate the existence of this law because it creates an alternative road, an alternative path that allows patients and innovators to sidestep the FDA. And they hate that, so effectively what they, through the back door, transmitted, subliminally and indirectly, And perhaps even directly to industry, was the idea that if you use this to make your therapy available, you will face the consequences.

00:03:33.000 Not only when you try to get approval for that very therapy through the main process, but even for any other therapy that comes in through the IND, the Investigational New Drug Application Process, in the first place.

00:03:44.000 That is the retribution of the administrative state.

00:03:46.000 It's not just the FDA. You see it in three-letter agencies across the board.

00:03:49.000 There are countless other three-letter agencies that will come after you if you dare to sue them for questioning one of their regulations.

00:03:56.000 But today we're going to actually focus on the, what I call, failed drug administration, the FDA. And ask a question that I think is obvious and ought to be asked.

00:04:05.000 It's at least a question that deserves to be debated.

00:04:08.000 Are we or are we not better off?

00:04:10.000 Are Americans actually better off today because of the existence of the FDA? They could fill in the blank.

00:04:17.000 You should be able to ask the same question of the CDC, of the NIH. You could ask it of countless other administrative agencies too.

00:04:24.000 But for today's topic, we're going to focus on the health-focused agencies, particularly with a special focus on the FDA. Are American patients better off or are they worse off because of the existence and the mandate of the FDA? Are prescription drug prices higher today because of the FDA? The answer to that question is absolutely yes.

00:04:45.000 I mean, there's no doubt about that fact.

00:04:47.000 The FDA is a gatekeeper to competition.

00:04:49.000 The fact that they're a gatekeeper to competition is used, you could say exploited, but I'll just say used by the pharmaceutical industry to be able to forestall further competition to their own drugs.

00:04:58.000 And in certain categories where they know the payers are going to pay for it even when there is competition, then they'll use the FDA in those categories, say in the category of cancer drugs, to be able to shepherd drugs through because there they're going to get the minimal price that's paid for anyway.

00:05:09.000 But in other areas, they actually use the FDA as a gatekeeper to make sure that they're insulated from competition, from drugs that can be made by compounding pharmacies or even generics providers, that the FDA is able to serve as a regulatory technocratically stamped Regulatorily accepted gatekeeper to preserving the absence of competition, which actually drives up prescription drug prices.

00:05:31.000 So prices are higher, but what are we getting in return?

00:05:35.000 They say the thing we get is that we have the gold standard in the world.

00:05:38.000 The FDA approval, that seal of approval, means that we can actually trust what's behind that medicine, and that's worth those higher prices.

00:05:45.000 That's worth those delays.

00:05:46.000 That's how the argument goes.

00:05:48.000 But it's fascinating, then, that the same agency that has said for years that you cannot have a safely developed drug or vaccine unless it has been through 10 years of testing, on average, a billion dollars or more for the development of each of those drugs or vaccines, that you cannot even have the right to try that medication or that vaccine for yourself.

00:06:07.000 It would be too dangerous if it hadn't gone through that process that that same agency It's the one that shepherded right through the process of vaccine that was developed in a matter of nine months, which then the federal government not only made available and said that you have an opportunity to use, despite the fact that it only was developed in nine months, but that you have no choice but not to take after it was developed for just nine months.

00:06:29.000 You can't believe both of these things at the same time.

00:06:32.000 And the reason I'm so fascinated by the FDA is not only because it's an industry that I've dealt with, it's an agency that I've dealt with firsthand, But even more deeply, it's an emblem of how the administrative state works, wrapping around fundamentally political questions, normative questions, questions relating to values, actually.

00:06:50.000 What are the trade-offs of making a therapy available or not?

00:06:53.000 What is the proper role for an expert in adjudicating the way a doctor treats a patient?

00:06:58.000 To wrap those fundamentally normative questions, questions of values, With a technocratic veneer to say that there is one scientific answer to that question.

00:07:08.000 And there are few things that bother me more than the bastardization of science by using it as a cloak to advance what is fundamentally a political or normative choice.

00:07:19.000 There are certain questions that are answered by science through the empirical process, through the scientific method, that are the kinds of questions that are answered empirically.

00:07:28.000 But the question of whether or not drug prices should or should not be higher in favor of consumer choice, those are questions of trade-offs.

00:07:35.000 Those are policy questions that are not answered by science, but are supposed to be in our country answered by the people.

00:07:42.000 And the rise of this three-letter technocracy, the modern administrative state, including the alphabet soup from CDC to NIH to FDA, is the rise of a new class of quasi-monarch technocrats who reject the idea that we the people are supposed to create the policies that govern ourselves.

00:08:00.000 And so for that discussion today, we're going to talk about other agencies in other episodes.

00:08:04.000 But for today, with that focus on the FDA and a little bit of the CDC, I've brought on somebody who I haven't actually met before directly, but I've been following him on social media for some time.

00:08:13.000 He caught my attention during the presidential campaign.

00:08:15.000 I liked a lot of what he had to say about the FDA. It was brave.

00:08:18.000 He's a physician.

00:08:20.000 He's a trained reader of the scientific literature and is unafraid to talk about it.

00:08:25.000 Dr. Vinay Prasad.

00:08:29.000 It's great to have you on the podcast.

00:08:31.000 Welcome, and I'm excited to hear what you have to say today.

00:08:34.000 The only thing I would say is, and I know I don't need to tell you this, but we're talking about a subject that most people are very careful to dance around, especially from the medical profession, especially from scientific backgrounds.

00:08:45.000 And all I would say is, don't worry about couching what you have to say.

00:08:50.000 Open up and tell us what you think.

00:08:51.000 So good to have you on, and I'm excited to have this conversation.

00:08:55.000 It's great to be here.

00:08:56.000 Thanks for having me.

00:08:57.000 And I just want to bolster one of the points you were making, which I think was a very good point about Right to Try.

00:09:02.000 Now, one of the ways in which FDA actually, I think, prevented companies from being willing to participate in Right to Try was that they told companies that if you were to make your products available to people through the Right to Try pathway, And if something subsequently bad happened to those people, whether it was attributable to your product or not, we're going to hold those safety signals potentially against your application in the future.

00:09:23.000 So they really gave them a huge disincentive to participate in Right to Try, which has effectively, as you point out, prevented the passage and the implementation of Right to Try.

00:09:33.000 Now, I think people can debate whether or not you ought to have Right to Try, but as you point out, it was passed through a political process and it's being subverted by the administrative state.

00:09:41.000 So I think that is accurate.

00:09:42.000 I think it's worth people knowing who they're hearing from.

00:09:45.000 You know, I think that you're a trained physician.

00:09:48.000 You have a detailed, I think, respectable background.

00:09:51.000 But why don't you just share a bit of your background?

00:09:54.000 You're not a political actor, and I think it's worth people understanding where you're coming from first before we dive into some thorny questions.

00:10:00.000 Sure.

00:10:01.000 So, by way of background, I'm a professor here at the University of California, San Francisco.

00:10:05.000 I'm actually a professor in the Department of Epidemiology and Biostatistics, and I run a research laboratory where we study drug policy, drug regulation, evidence-based medicine, clinical trials through a purely, I think, scientific lens.

00:10:18.000 I'm also a practicing doctor.

00:10:19.000 I happen to be a hematologist-oncologist.

00:10:21.000 I work here at the county hospital, which is our safety net hospital, where we take care of pretty much anyone who walks through the door here in San Francisco, San Francisco General Hospital.

00:10:29.000 I've been in academic medicine since I finished my training about 10 years ago.

00:10:36.000 What is it that made you as outspoken as you've been, especially in the wake of the COVID policy backlash that we saw?

00:10:45.000 I'd love to understand what got a guy like you to be a much more public-facing figure that you've become.

00:10:54.000 Well, I mean, I think I sort of share your core philosophy that in America right now, it's important for people to just state and articulate your view.

00:11:01.000 If you feel something and you believe in it and you have a point of view and you have some basis for your point of view, we don't want people to suppress those point of view.

00:11:08.000 We don't want people to feel stigmatized for expressing that.

00:11:11.000 We'll be better off if everyone just expresses their point of view and articulates it and tries to defend it.

00:11:16.000 I think we'd have a more vibrant discussion.

00:11:17.000 And the center point, I think, of public discourse will move from, you know, where the elites want us to be To where I think the body politic actually is, and I think that's important.

00:11:26.000 Now, I just want to tell your listeners a little bit, some of the issues on COVID-19 policy that I was outspoken about to me are just such basic common sense, it would be ridiculous for a doctor not to be outspoken about it.

00:11:38.000 One example, I think, is I was extremely critical of the CDC's policy decision to make two-year-olds wear cloth masks, which was done in the United States, but not done anywhere else in the world, not done in Europe, not done in Australia.

00:11:50.000 To me, that struck me as an extremely reckless decision that's based on poor evidence and runs counter to common sense when you see a two-year-old wearing a cloth mask.

00:12:00.000 That, to me, somehow created a lot of controversy to be opposed to something which I think is obviously silly.

00:12:06.000 But, you know, I think you have to say it and you have to articulate the evidence.

00:12:11.000 What exactly did you say and what was some of the backlash?

00:12:13.000 Now that we have some distance from it, we can reflect on this a little bit.

00:12:17.000 I mean, in 2021, in the Atlantic Magazine, which is by no means a right-leaning magazine, if anything, it's a liberal bastion, I wrote an article called The Case Against Masking Young Children. 0.79

00:12:28.000 And it was extremely critical of the American Academy of Pediatrics, which I think has been captured by some of this kind of groupthink, and extremely critical of the policy decision to mask kids between the ages of two and five, which runs counter, again, to any nation globally.

00:12:41.000 That article created such a backlash. 0.74

00:12:43.000 I think there were hundreds, perhaps thousands of emails sent to the university that I should be fired, that I was sort of a misinformation peddler, for merely being in line with the policies of the European CDC and other nations.

00:12:57.000 I think we forget how hot it was back in the COVID policy debates, how much people lost their sanity and lost their cool and made, I think, a number of bad decisions, from school closure to the mandates to masking young kids, etc.

00:13:12.000 And what do you think we should learn from that?

00:13:16.000 I mean, I think you're absolutely right to ask the question of whether or not these agencies deserve the powers that they have been granted.

00:13:24.000 I mean, should the CDC be a 40,000-person agency and not have a single person in the agency with the common sense to say, you know, if we tell the public that you should make a two-year-old wear a cloth mask in daycare, except for the two hours a day when they're all mapped side by side, if you tell the public that, that that's a policy that makes sense and the CDC endorses that, You might not be surprised when a few years later they don't trust any single thing you say because what you said was patently absurd, right?

00:13:52.000 So to me, I think it does raise questions about these institutions, whether or not they should be as big as they are, what kind of oversight they have, who do they actually work for, do they work for the people, or do they work for their own intrinsic interests?

00:14:04.000 And I think the questions you're asking about FDA I think are important and the correct questions.

00:14:07.000 I mean, I think they extend to, you know, we could talk about Alzheimer's drugs and cancer drugs, which I think we will.

00:14:12.000 The question of whether or not the FDA is serving the public's interest or merely a hurdle that justifies high drug prices.

00:14:19.000 So I think you're absolutely spot on that the indisputable fact is that the FDA regulation is a key factor Yeah, I mean, I think I want to set the question up even fairly, right?

00:14:43.000 Because I think that's the way they would set it up is, do we get better, safer, more effective drugs?

00:14:48.000 I mean, at the margin, certainly, if you're going to require jumping through all kinds of hurdles that, you know, would Take 10 years and billions of dollars to scale.

00:14:58.000 You would hope that it has some at least infinitesimal improvement in the level of certainty you have in the safety and efficacy and giving doctors the ability to weigh the trade-offs between those two things.

00:15:08.000 Maybe you could even question that, but at least it would be some infinitesimal contribution to it.

00:15:12.000 The question is, is that worth the cost, right?

00:15:14.000 Is that worth the cost, not just to innovation, but even to actual prescription drug costs that are passed on to consumers?

00:15:22.000 And I come from a place where I think it's far from clear that the United States of America is better off for the FDA ever having existed in the first place.

00:15:33.000 It's going to make a lot of people mad to hear that.

00:15:35.000 People point to thalidomide.

00:15:37.000 People point to a lot of other examples.

00:15:38.000 First of all, those are examples that were in the face of the existence of the FDA in the first place.

00:15:43.000 So let's just not forget that fact.

00:15:46.000 But I think the deeper fact is Do we have some level of, there are tradeoffs to any policy choice, but do we have a level of commitment to medical choice that actually would believe that you would have private institutions that would backfill the role played by the FDA as trusted gatekeepers to consumers, but without being centrally as prone to capture as the FDA actually is?

00:16:09.000 And I think that's where I start.

00:16:10.000 I'd love to hear your views on that.

00:16:12.000 I mean, I think it's a deep question and there's just so many places to jump off there.

00:16:16.000 Maybe we could start by talking about the capture part.

00:16:18.000 I mean, the capture part of the FDA is that, you know, while the FDA employees work at the FDA, they are technically prohibited from working for consulting for pharmaceutical firms.

00:16:28.000 But when they leave the FDA, you know, 60 or 70% of people end up working for consulting for the pharmaceutical firms.

00:16:33.000 And I believe in the primaries, you were critical of Governor Haley for this particular thing, this kind of revolving door politics where, you know, you set out to do good, you stay to do well for yourself.

00:16:44.000 And so that raises the fundamental question of whether or not the FDA employees, is their real motivation to regulate these drug products in a way that's best for the American people?

00:16:52.000 Or is their real motivation an audition?

00:16:54.000 An audition to some way work across the table and take that Bureaucratic technical expertise and sell it to the companies to create the hurdles that they themselves know how to jump over and sell that expertise to the companies later.

00:17:07.000 I think that's an open question.

00:17:08.000 And so that's one of the ways in which they're being captured.

00:17:11.000 The other way they're being captured is, I think, you know, the extreme lobbying efforts that are being placed on politicians and the political pressure on them.

00:17:20.000 The other thing you said that I think is quite interesting is, what do we get for all their regulation?

00:17:26.000 And I think we have to acknowledge that Well, actually, maybe let me talk about the choice for a second.

00:17:31.000 The choice to me is an interesting one, because as you point out, that there's two types of errors being made here.

00:17:36.000 One, they can coerce you to get a medical product, maybe if that's not in your best interest.

00:17:41.000 And the other thing is they can prevent you from getting a medical product that you might want to try for.

00:17:45.000 Knowing fully well that we don't understand the safety signals and we don't understand the full information there, but you have a terminal illness, you may feel like, what do I have to lose by trying?

00:17:54.000 So they're preventing both things, and they've made errors on both ends.

00:17:57.000 I mean, I think the vaccine mandates Particularly around young men who are in college, which were implemented, you know, from the White House down and by many universities, clearly led to net harm because a college man who received dose 2 and beyond of the mRNA vaccines had greater harm from the risk of myocarditis than they could possibly have from the benefit in COVID-19 outcomes because they're young and healthy.

00:18:23.000 And so that's an example of the administrative state, actually, I think, FDA plus White House plus, you know, OSHA, plus the pressure they placed on colleges, actually causing harm to the American people by forcing them to take a product that they may not have wanted.

00:18:37.000 Now, how many people didn't get access to a product that might have helped them?

00:18:41.000 I think that's a tougher question to answer.

00:18:44.000 And, you know, we could talk more about that.

00:18:47.000 I'm not aware of any sort of really good studies that get at that, but that's sort of what you're getting at.

00:18:50.000 They're blocking both kinds of choice.

00:18:53.000 And then the question is, are they in the sweet spot?

00:18:56.000 Are they somehow, could they shift the dial a little bit?

00:19:00.000 We have little, yeah, we don't know much about that.

00:19:02.000 Yeah.

00:19:02.000 I think that, I mean, the alternative question is, Are we sure?

00:19:07.000 I mean, the bar's got to be high to say that they are going to be in the sweet spot.

00:19:10.000 If not, the market, all else equal, would be a better arbiter of what that sweet spot actually is, including physicians, customers, patients relying on other intermediary institutions to tell them what they can and cannot trust.

00:19:25.000 You'd have J.D. Power& Associates raiding cars that people used to buy, certainly in the 1990s.

00:19:30.000 You'd have equivalent institutions raiding And even many of the payer organizations are beginning to have them for themselves, rating the value of different drugs and risks and benefits and trade-offs.

00:19:39.000 So against that backdrop, what role does the FDA play?

00:19:42.000 And I think part of what's happened is that the existence of an institution like the FDA has actually crowded out the rise of those alternative intermediary institutions.

00:19:52.000 So you can't just measure it against the status quo, but what the status quo would have been or would be without the existence of that false blanket of security that the FDA provides.

00:20:02.000 And I think you hit the nail on the head here.

00:20:04.000 That blanket of security is indeed a false blanket of security.

00:20:08.000 People talk about the effects of thalidomide many years ago.

00:20:10.000 You're actually not going to hear as much in the press probably for the next 15 years.

00:20:15.000 Eventually, it'll come around to it 20 years from now.

00:20:17.000 But for the next 15 years, you're probably not going to hear about the adverse consequences by way of myocarditis or otherwise of an FDA-approved and government-mandated program, which is even worse than just a government-allowed program, which is what you had in the case of thalidomide and birth defects.

00:20:31.000 Which is the telltale example that they used to justify the existence of the FDA. And so my view, I guess my question I shared with my views, I'm curious for you is, it's hard to know, but what is your hypothesis of whether or not, on balance,

00:20:47.000 the American health system and the patients who are the most important stakeholder in that system would be better, worse, or at least arguably unknown as to whether they'd be better off If there wasn't an FDA in the first place?

00:21:04.000 I think if you're talking about FDA 2024, I think that they'd probably be better off as a result of not having the FDA. And let's unpack that a little bit.

00:21:14.000 You alluded to that the FDA is the be-all, end-all.

00:21:18.000 And in many ways, they are.

00:21:19.000 So let me just talk a little bit about my field, cancer medicine, through a number of different provisions.

00:21:23.000 When the FDA approves a cancer drug, it is...

00:21:28.000 Often mandated coverage by Medicare and Medicaid that we have to pay for it as well.

00:21:33.000 And so what you do, as you point out, you crowd out anybody's ability to say, hey, maybe we could have this available to people, but maybe there needs to be some serious co-pays for that.

00:21:46.000 Maybe there needs to be some restrictions on who should get access to it because there's a lot of uncertainty.

00:21:51.000 You're forcing the payer to pay.

00:21:53.000 And so the moment you do that, you put What would the world look like without the FDA? People talk about as if it will be a free-for-all.

00:22:12.000 There'll just be tons of products coming on the market and we won't know what's better.

00:22:16.000 In many ways, it might be like the way the cellular phone market is.

00:22:19.000 There's still fierce competition.

00:22:21.000 There's a number of websites that are rating phones all the time.

00:22:24.000 When you're thinking about buying a phone, particularly an Android phone, all these sites are rating them.

00:22:29.000 There may be different groups of people who rate cancer drugs differently.

00:22:31.000 I think I'm a very sort of a purist of evidence-based medicine.

00:22:34.000 We would put out, you know, we could arguably put out a set of guidelines.

00:22:37.000 Some insurance companies may decide to go with me because they think, you know, Prasad's guidelines are more evidence-based.

00:22:42.000 They lead to more cost-effective healthcare.

00:22:44.000 Other insurance companies might go with different guidelines, but you would get competition in the marketplace.

00:22:48.000 And then you would allow people to see who's winning.

00:22:51.000 You could actually assess it later and see which standard actually leads to greater availability of drugs, better outcomes, less toxicity, lower costs, more time at home, which is what people want.

00:23:02.000 We don't get to see that competition.

00:23:04.000 And so in many ways, when we imagine a world without the FDA, it's easy to envision the boogeyman of just a free-for-all.

00:23:11.000 That might not be what it is.

00:23:12.000 And the last thing about thalidomide, I'd just say to your point, You know, what was the story of thalidomide for the listeners?

00:23:18.000 In the 1950s, late 1950s, thalidomide was approved in the United Kingdom.

00:23:24.000 But notably, there was one FDA reviewer who famously did not want that product available in the US market.

00:23:29.000 And it was approved as a morning sickness medicine for pregnant women.

00:23:33.000 In the UK, unfortunately, thalidomide does cause—it's a teratogen.

00:23:37.000 It causes serious birth defects like the prevention of the development of the limbs.

00:23:41.000 And so you had a lot of children born without, like, their upper arms developed in the United Kingdom.

00:23:46.000 In the United States, since we didn't approve it, we didn't have that phenomenon.

00:23:49.000 Now, many people, in response to that, felt like that was a great example of why we need to strengthen the FDA. It led to the passage of the Kiefer-Harris amendments in the early 60s, and it gave FDA more authority in regulating drug products.

00:24:00.000 But strictly speaking, it wasn't an example where the regulation, had it been in place prior, would have prevented thalidomide from coming on the market because it was an efficacy requirement that they added, and this was really a safety concern.

00:24:14.000 So I think you're right about the story.

00:24:16.000 It's not always told in the crispest way possible.

00:24:18.000 I think there's more nuance to that story, as you note.

00:24:21.000 Yeah, and I think a lot of those, you know, stories that are designed, there's only a couple of them really, but that's the one that's a classic case that any modern defender of the FDA will bring up is the thalidomide case, actually aren't necessarily as powerful of a justification for the FDA as a safety gatekeeper as they claim it to be.

00:24:39.000 The stories that don't get told are the countless other instances.

00:24:41.000 I think the example you brought up in the case of COVID-19 is absolutely one of them.

00:24:45.000 Going out of their way to not only approve more quickly, but a federal government that they're part of that went on to mandate something that literally caused Heart defects, myocarditis, and other heart-related defects, cardiac defects, in patients for whom there was incremental, if no benefit whatsoever at all, that I think is something that we haven't yet reckoned with, which is also a consequence of having the FDA. Here's another one I'd sort of throw out there, I'd love to hear your reaction to, is right now we're in the middle of a fentanyl epidemic in this country.

00:25:16.000 This is the successor to the opioid epidemic in the country, and people are really familiar with how companies like Purdue Pharma and Sacklerone Enterprises may have really overstepped their bounds in overmarketing these drugs and the illicit perpetuation of opioid usage in this country.

00:25:33.000 But that itself was also downstream of an FDA decision to remove Vioxx from the market altogether, When, in fact, you could think about limiting the use of Vioxx for people who, if Vioxx was being overused, absolutely, probably was.

00:25:50.000 But to then take the knee-jerk reaction to remove Vioxx, if you're looking at the cost benefit for a country and for a patient population, you can't look at that decision in retrospect without looking at the opioid epidemic, which backfilled the loss of Vioxx in the market.

00:26:06.000 And in turn, the backlash to the opioid epidemic, which now gives us the successor to the fentanyl epidemic, there are a series of unintended consequences for every one of those regulatory steps of intervention.

00:26:17.000 Versus what an alternative world would look like as warnings through a private market mediated competitive system where health systems and universities and payers effectively blackballed the use of Vioxx, but for a few cases where the risk benefit of taking it might be better than actually moving to an opioid or now moving to even legally ordained fentanyl that were far more addictive properties than Vioxx ever had.

00:26:41.000 It's far from unclear that that wouldn't have been a better state of the world than the state of the world that actually ensued, not to mention the billions of dollars or hundreds of billions of dollars of impounded costs to keep that current system of regulation intact.

00:26:54.000 Here's what your take is on that example.

00:26:57.000 Well, that's a very interesting example.

00:26:58.000 I hadn't thought about it the way you frame it, but I think you are making a really fair point that the FDA's deterrence of the use of the NSAID drug class, which is this different type of drug class, non-opiate drug class that treats pain.

00:27:11.000 Not addictive.

00:27:12.000 Not addictive, but crucially.

00:27:14.000 Not addictive.

00:27:15.000 Absolutely.

00:27:16.000 Non-addictive.

00:27:17.000 If taken in high doses, may cause some renal dysfunction.

00:27:20.000 Vioxx had some certain particular safety claims that people were investigating at the time.

00:27:26.000 But the FDA did, sort of as a class, discourage the use of NSAIDs for pain, leading to the market for the opioids.

00:27:33.000 And I think it's absolutely the case that the FDA's actions around opioids contributed to the opioid epidemic.

00:27:38.000 They authorized every single one of the oxycontin and oxycodones that led most people to become addicted.

00:27:45.000 You know, those drugs all went through FDA approval processes.

00:27:48.000 I'll give one more example I think you might appreciate.

00:27:52.000 The Biden administration, before they had seen the results of the randomized studies for Paxlovid, Pfizer's drug for COVID-19, had already committed to buy $5 billion worth of Paxlovid, and then they later gave another $5 billion.

00:28:04.000 So we're talking about $10 billion in government Payments for this product before they saw the data.

00:28:10.000 The original data for the Paxlovid was in people who were at high risk of bad COVID-19 outcomes, who had not previously had COVID-19, never had COVID before, they're getting COVID for the first time, and they had never had any vaccine doses.

00:28:24.000 So unvaccinated, didn't have COVID, high risk of bad outcomes.

00:28:28.000 Under those conditions at that time against older strains of the virus like Delta, Paxlovid works.

00:28:35.000 Pfizer had a different randomized control trial, which looked at vaccinated people, which looked at people who had maybe also had had COVID in the past.

00:28:43.000 Actually, no, I didn't have it.

00:28:44.000 Vaccinated people in different strains, Omicron strains.

00:28:47.000 And that trial was largely a negative study.

00:28:49.000 That's the Epic SR study.

00:28:50.000 But you saw this administration relentlessly push Paxlovid in low risk populations, in part because they had already shelled out $10 billion for that product.

00:29:01.000 That product likely made very little difference to the 20-year-old tech worker at Facebook who had a runny nose and took Paxlovid.

00:29:08.000 It might have even made them worse off through Rebound.

00:29:11.000 That's a huge government expenditure, and that's the administrative state really trying to justify an error it had made in the past, which was not clarifying whether or not it works in low-risk populations before shelling out $10 billion.

00:29:22.000 So I think it's a nice example where taxpayer money, you know, so much taxpayer money is being used for something.

00:29:29.000 It's costing us all.

00:29:31.000 It's unclear if anyone's better off other than the shareholders of Pfizer.

00:29:34.000 Yeah, I think it is far from unclear.

00:29:37.000 I think I would say that both for COVID-19 vaccination as well as for...

00:29:40.000 In the case of COVID-19 vaccination, I think we can actually say we have decidedly people who are worse off for its existence.

00:29:46.000 But even in the case of Paxlova, it's far from clear, even as short-term therapeutic, what was far expansive in its use is And the crucial part, I actually didn't know this, it's very interesting, preordained that it was going to be.

00:29:57.000 The government purchased contracts long before it was approved.

00:30:00.000 It's kind of disgusting, actually, if you think about that.

00:30:02.000 The standards that the FDA would normally apply to any other company that didn't have the political connectivity of that particular one would be treated in a very different sense.

00:30:09.000 You don't even have the right to sell to privately contracting parties.

00:30:11.000 Here, the government's going to pre-contract for it before we even know or even have a shred of evidence that it works.

00:30:17.000 It's disgusting, actually.

00:30:19.000 The one area where I, you know, probably from having been in the industry, a slightly different point of view than you, and even many people who are on our sort of side of many of the questions we've talked about, is actually the role of the financial motivations here for what, when I use the word capture of the FDA, I mean actually something a little bit different, right?

00:30:43.000 Is there a major problem with the revolving door from many government agencies in the private sector?

00:30:46.000 Absolutely.

00:30:47.000 I think that drives a lot of motivation and behavior, and the FDA is not exempt from that by any stretch.

00:30:54.000 But I think there's actually something deeper going on that's cultural in nature, actually.

00:31:01.000 I think the thing that moves many of those line workers at Pfizer, right, many of them aren't actually the ones participating in the upside of From Lipitor to Paxlova, they're just not, actually.

00:31:15.000 Actually, I think that's a separate point for business organization and the pharmaceutical industry is the people who actually work on important innovations don't participate in the upside of those innovations at all.

00:31:24.000 That was something that I tried to change in Roivant, the company I founded.

00:31:28.000 But I think it's actually part of the problem that it's not standard financial motivations.

00:31:33.000 It's the motivation of a kind of benevolence, really.

00:31:38.000 It's sort of an ugly benevolence, but a benevolence that rejects the premise that America was founded on, which is that we the people can self-govern and make decisions for ourselves about what's actually best for us.

00:31:52.000 And sometimes we'll make the right decision and sometimes we'll make the wrong decision.

00:31:55.000 But at least that's what America was founded on, is that we the people get to make the decision of how we self-govern and at the level of the individual, how we live our lives.

00:32:05.000 And I think part of what I've seen in the relationship between the pharmaceutical industry and the FDA isn't just the financial revolving door, but it's the cultural nature of that revolving door.

00:32:15.000 Most pharmaceutical companies and their org structures and their R&D divisions are modeled after their counterparts at FDA, even down to the title of the rank that they have.

00:32:25.000 And that revolving door creates a kind of horizontal managerial class, such that it's the same kind of person, the breed of somebody within a big pharma company, a Pfizer, a GSK, pick your favorite one, that has a certain kind of condescension towards the everyman.

00:32:43.000 Believing that the everyman can't actually possibly be trusted to make certain decisions for himself, that's deeply culturally shared by those at the FDA and that horizontal managerial class pervading both the public sector and the private sector are really, I think, a source of quiet oppression of the everyday citizen and his will against medical choice.

00:33:02.000 Even after President Trump passes Right to Try, many of those companies could have, you could argue, could have been in their own advantage to take advantage of Right to Try.

00:33:09.000 Part of the reason they didn't do it is they were threatened by FDA is that they were going to have an adverse consequence.

00:33:13.000 But part of the reason is even in the debates you would have had in many of those corporate boardrooms or even in the debates that you would have had in the R&D meetings in many of those large companies, I can just tell you from experience, it wouldn't have just been.

00:33:25.000 One of the factors would be, well, we're going to get hurt by the FDA and otherwise we would do it.

00:33:29.000 But across an entire industry, you would have had more people speaking out adversely about it if it were just that.

00:33:35.000 It's a kind of cultural bleed that even the people in those boardrooms say, what would be responsible for us as a company to make that choice available?

00:33:43.000 And I think that that, I think, is a little closer to the flame of the culture of so many of these health regulatory institutions and their counterparts in the private sector, from FDA to CDC to NIH, is it's fundamentally a culture of condescension, wearing the mantle of capital S Science as a justification to take steps that often aren't even justified by the true version of the scientific method, which itself actually relies on competition of ideas in the marketplace of ideas.

00:34:13.000 And so that, at least for me, I think is actually, if we get to get to the truth of what's going on, even more than the financial motivations and the corruption which exists in some measure, is really this sort of elitism of a certain kind, a cultural superiority complex that is fundamentally distrustful of the everyday citizen to do what's even best for them.

00:34:37.000 And I think that's really what's going on in sort of the health regulatory culture of the United States.

00:34:43.000 That's a very interesting framework.

00:34:45.000 And maybe let me put it to you this way and see what you think of this framing of it.

00:34:50.000 I definitely concede to you, and I see the appeal in accordance with the first principles of America, that there's a model of drug regulation that really empowers choice and freedom.

00:35:02.000 And that model will look like people are free to Use what ratings agencies that they want to decide on what products that they'll take.

00:35:09.000 They're free to use their own money to purchase those products for their own health conditions.

00:35:12.000 And we'll have tons of competition, which will drastically reduce the price of many of these products.

00:35:18.000 And you really have sort of the choice being the forefront of what drug regulation is about.

00:35:27.000 On the other far end of the spectrum, I think there's some people who may say...

00:35:32.000 We need an agency that will make sure the only drug products that come out are actually pretty effective, they have very good safety profiles, that they're actually cost-effective, and we're going to tax everybody, and we're going to take that tax money and deliver evidence-based, cost-effective care to everybody.

00:35:46.000 That's sort of the extreme position.

00:35:47.000 But what is the FDA currently doing?

00:35:49.000 What we're doing is we're taxing everybody.

00:35:51.000 We're stifling the wages of the average worker, whose average living wage in real dollar has been stagnating since the 1970s because healthcare is a greater and greater percentage of GDP. We're taking their money.

00:36:02.000 We have this extremely complex bureaucratic machine that at the end of the machine, the widget they're making is not a drug that you know for sure will extend life or, you know, and at a great length and you know for sure is safe because there are many products that don't get there.

00:36:17.000 So we're taking money from every everyday people to fund this huge bureaucracy that doesn't even deliver necessarily a safe and effective product at the end.

00:36:27.000 And I think, who can defend that system?

00:36:29.000 You're absolutely right.

00:36:30.000 You can either take it all the way to choice, or you can take it all the way to, you know, we're only going to pay for evidence-based cost-effective care.

00:36:35.000 But the current system is untenable.

00:36:37.000 I don't know how anybody can defend the current system from any political vantage or any sort of, you know, framework.

00:36:42.000 I think that's actually a far more useful point than anything I was saying, because I'm giving you certainly an ideological perspective grounded in a libertarian respect for human autonomy.

00:36:54.000 And that's just where I come from in my own priors.

00:36:56.000 And that's why I support medical choice in both directions.

00:36:58.000 Don't tell me what I have to take and don't tell me what I can't take.

00:37:02.000 As long as I'm informed and we've got to make sure there's fraud laws that apply.

00:37:05.000 Somebody can't lie to you.

00:37:07.000 But short of that, if you're well informed, you should make a decision for yourself.

00:37:09.000 Your point actually is, I think, a more obvious one, which I love, which applies to so much of our healthcare system today, by the way, is this Artificial debate, right?

00:37:18.000 It's a little bit of a straw man that we've created between a truly free market healthcare system and socialized medicine.

00:37:25.000 There are benefits, you know, you could argue, at least people on both sides, benefits to both.

00:37:31.000 Right now, we have the worst of all worlds.

00:37:33.000 And I think that the FDA in many ways embodies that better than most.

00:37:37.000 In the time we have left, maybe we could shift gears a little bit.

00:37:40.000 It relates to the kinds of questions we've been talking about, but take it outside the domain of the FDA and go to the environment where you find yourself, which is an academic medicine.

00:37:49.000 What is your current state of assessing the culture of academic medicine today?

00:37:57.000 I'd love your thoughts on that and maybe I'll share a few of mine.

00:38:02.000 All right.

00:38:02.000 Well, where do you want to get started?

00:38:04.000 Do you want to get started with how we're training people, the culture of diverse ideas?

00:38:08.000 There's so many places to get started.

00:38:10.000 I think let's think about what you would think of as the rank order of some of the biggest areas for improvement, some of the biggest problems with the culture of modern academic medicine.

00:38:22.000 Have at it.

00:38:22.000 The floor is yours.

00:38:23.000 All right.

00:38:24.000 I think there are many.

00:38:25.000 One is viewpoint diversity.

00:38:27.000 Everything in academic medical centers is all about diversity, diversity, diversity.

00:38:31.000 But somebody like you and your viewpoints would not be represented fairly in academic medicine.

00:38:36.000 It runs extremely left of center.

00:38:38.000 It runs so far left of center, I think it's lost track of where people are.

00:38:43.000 We're really catering to this extreme left sort of ideology in medical schools.

00:38:48.000 And not sort of what America looks like.

00:38:50.000 And that to me is one of the biggest problems in medical training is just the extreme ideological homogeneity.

00:38:55.000 And what that spills over to is why were academic medical centers so reluctant to say schools should reopen?

00:39:01.000 Because it was a political issue championed by the left.

00:39:04.000 Why were they so reluctant to say, maybe we shouldn't mask two-year-olds?

00:39:07.000 Because again, it was a political issue championed by the left.

00:39:10.000 So you get this real groupthink.

00:39:13.000 I think it's the most corrosive force in academic medicine, not having viewpoint diversity.

00:39:18.000 The spillover to this, I think, is interesting.

00:39:22.000 I actually view it as a symptom of a deeper pre-existing condition in academic medicine, which is a An absence of courage, an absence of boldness in the first place, right?

00:39:34.000 I think this culture of write as many papers as you can and measure somebody's scholastic status based on the number of publications that follow, even if you look at the standards for what does or doesn't get published creates an incentive structure for putting something out there that You may disagree with me on this, but I think I haven't been in academic medicine, but I was, you know, many of my peers in my molecular biology track at Harvard and the track I was on were on their way to med school.

00:40:03.000 And I know what that looks like, right?

00:40:05.000 Even having been adjacent to it as a biotech entrepreneur is a culture that effectively trains sheep, right? 0.97

00:40:14.000 People who are following the pack and that's what's rewarded.

00:40:16.000 And so in some ways, what I see as the political version of that, or even the absence of viewpoint diversity on questions that have a political tinge to them, are really just a symptom of a deeper culture of the absence of courage or the boldness of hypotheses, right?

00:40:32.000 Think about Galileo understanding that he made a frameshift discovery, right?

00:40:37.000 It was a product of a thought experiment to say, yes, the facts don't quite match up, but the earth isn't the center of the universe.

00:40:44.000 Actually, the sun is what the earth revolves around rather than the other way around.

00:40:47.000 That takes gall.

00:40:49.000 It takes boldness.

00:40:50.000 In that case, it takes also Willingness to be prosecuted for heresy in his era.

00:40:56.000 You know, Einstein's theory of relativity to completely reject a Newtonian past reflects somebody to be able to think outside the bounds of what their status quo demands.

00:41:05.000 And that's where the greatest medical breakthroughs have often come from as well.

00:41:09.000 And so I think one of the underappreciated risks is the way that culture of homogeneity is not only failing patients.

00:41:15.000 And I think that's a big, it's a big factor, right?

00:41:18.000 I talked to you from central Ohio.

00:41:21.000 Many people within a 100-mile radius of where we are feel like you're spitting in their face when you adopt the modern DEI orthodoxies that adopt a racial or woke religion.

00:41:32.000 And so not only it's the disrespect to the very patients who you're supposed to prioritize, which is an important point that you made, but I think it says something about the culture of fear in medicine that is actually...

00:41:44.000 Hostile to new innovation or the ability to make new discoveries that can only be made against the backdrop of people who have a culture of boldness, a culture of being willing to take risk and be wrong that I think is, from my armchair position here, and tell me if you disagree, I think badly missing in modern American academic medicine and to the detriment of the very people many of the research communities purport to serve.

00:42:12.000 Nothing breeds obedience more than the current medical training system.

00:42:16.000 I mean, think about all the hoops, all the checkboxes you have to do to become a doctor.

00:42:21.000 You've got to go to college.

00:42:22.000 You can't antagonize anyone.

00:42:24.000 You can't have any inappropriate views.

00:42:26.000 They can't have liked your tweets, by the way.

00:42:28.000 That would get them in trouble, perhaps.

00:42:30.000 You have to do all the right things to apply for medical school.

00:42:33.000 Then you go to medical school.

00:42:34.000 You have to publish a certain amount of papers.

00:42:35.000 The papers have to have the right message.

00:42:36.000 They can't have the wrong message.

00:42:37.000 They have to have the appropriate message.

00:42:39.000 The message in vogue.

00:42:40.000 Then you go to medical school.

00:42:41.000 You got to do it again four years later to go to residency.

00:42:43.000 And then after residency, there's fellowship.

00:42:45.000 And we're talking about a 10-year program where there are many people along the way who, if you push on anything, if you act courageous, if you speak up too much, they can stop you from advancing or advancing properly.

00:42:58.000 That kind of system produces, I think, as you put it, sheep.

00:43:02.000 But I mean, I think people without courage are people who are obedient.

00:43:04.000 Medicine is great at producing obedient people.

00:43:07.000 The problem with that is when you talk about policy issues, complex, unprecedented policy issues, for instance, should we close schools for the novel coronavirus?

00:43:15.000 You have a lot of sheep who cannot think about that question with their own brain. 0.80

00:43:19.000 They're just appealing to whichever politician that they have pledged allegiance to, to take guidance from, and Lord Fauci.

00:43:25.000 And so that is a deep problem, not having the courage to question what you're taught.

00:43:30.000 And sort of my...

00:43:31.000 And I'd love to hear your reaction to this.

00:43:33.000 Maybe you agree with me, maybe you don't.

00:43:35.000 But it's not only on the question of whether or not kids should be able to return to schools or whether a two-year-old should wear a cloth mask, right?

00:43:43.000 Because those questions have a political valence to them.

00:43:45.000 And that's one filter for us to see this culture of fear in medicine.

00:43:49.000 But it is further also for the question of whether the A-beta hypothesis was indeed the right or most parsimonious hypothesis to describe Alzheimer's disease, which certainly held hostage an entire area of research and who did or didn't get an NIH grant for 20 years.

00:44:08.000 or the question of whether or not you believed in immunotherapy for cancer, right?

00:44:15.000 Which, which, you know, I think 20 years ago would have been a hostile idea or the idea that you have an immunology branch and an oncology branch of medicine that, you know, really were maybe more of a spectrum between them than separate fields of medicine altogether.

00:44:29.000 Would we have gotten to the places of even worthy discoveries that help patients more quickly if the breed of people you selected into the field of medicine were the people who were lions rather than sheep?

00:44:46.000 Not just in the political sense of it, right?

00:44:48.000 But in a deeper cultural sense of the kind of people who you select for entering med school rather than worrying about the diversity of shades of melanin in your class.

00:44:58.000 Maybe you're worried about the diversity of people's risk appetites.

00:45:01.000 Maybe you do need some people who are going to be foot soldiers and following what the medical authorities, pediatric medical associations guidelines are for how you treat children.

00:45:11.000 Maybe you need some of those people.

00:45:12.000 But maybe you need the kind of people who will be willing to take a jackhammer to that as well.

00:45:16.000 Is that something that you think is a real factor in even assessing the risks that people are willing to take in their areas of research inquiry?

00:45:25.000 Yes, I think you're really onto something, which is it's not confined merely to the political questions like, do black doctors have better outcomes with black patients than white doctors?

00:45:34.000 Or, you know, the implications of COVID-19 policy, which were inherently politicized.

00:45:38.000 It extends to even bread and butter science questions, which is, In order to advance science, you have to challenge the status quo.

00:45:46.000 All the great discoveries, you know, Barry Marshall was the one who started to think a bacteria might cause peptic ulcer disease, and he proved it by drinking a glass of it himself and gave himself an ulcer.

00:45:56.000 You have to be able to challenge what kind of, that takes some courage.

00:46:00.000 It also takes a defiant personality, the personality of being willing to say something that the majority of your peers don't think or believe, and to put yourself and your reputation on the line for that belief.

00:46:13.000 And those values are deeper than any political value.

00:46:16.000 Those run to the core of the kind of people becoming doctors.

00:46:19.000 And we do not select for those values.

00:46:21.000 We select for the opposite.

00:46:22.000 We select for people who toe the line and who have a shared sense of views on a number of issues.

00:46:27.000 And I think it does spill over into medical care I mean, I'm often at the bedside and we're taking care of somebody and I ask, you know, I finally bring all the other attendings together and I say, what are we doing here?

00:46:36.000 What's the goal of this whole big picture?

00:46:38.000 And everyone is just blindly following, well, we're trying to get the renal function a little bit better.

00:46:42.000 We're trying to get this a little bit better.

00:46:44.000 We're trying to get that number a little bit better.

00:46:45.000 Well, what about the whole person?

00:46:47.000 What do they want and what are we doing here?

00:46:48.000 And that kind of dogmatic inability to think about the big picture, inability to question In medicine, we always pass the baton.

00:46:56.000 You come on for a week, and then you go off for a week and pass the baton.

00:46:59.000 And everyone's just happy to just say, stay the course.

00:47:01.000 We're going to do what we did.

00:47:02.000 Sometimes you've got to shake it up.

00:47:04.000 You've got to say, what is the purpose of this whole hospitalization?

00:47:06.000 This person is suffering on the ventilator, and we haven't addressed, would they want this?

00:47:10.000 And so I think it does extend, as you note, to other things.

00:47:13.000 Benjamin Franklin, he was one of our founding fathers.

00:47:15.000 He was one of the great innovators and pioneers that went to the heart of the country's existence.

00:47:22.000 Not only did he sign the Declaration of Independence, not only did he invent the Franklin stove, he also invented a remedy to the common cold, and he also invented the bifocal spectacle, which today would be relegated to the realm of optometrists.

00:47:32.000 By the way, it annoys the heck out of me that we've now created this artificial division in our healthcare system between vision and dental, as though that's a separate category from the rest of human health.

00:47:41.000 But don't even get me started on that.

00:47:43.000 This guy, from common cold to bifocal spectacle to the future of existence of a political philosophy of a country, did not believe in the existence of those boundaries.

00:47:54.000 And I would venture to say Benjamin Franklin is not the type of person that's being recruited to Harvard Medical School today.

00:48:02.000 And I think that's a problem.

00:48:04.000 I think it's a little bit different than even 30 or 40 years ago I'm going to say something again.

00:48:10.000 It's probably annoying because I'm coming in from a different field and just pontificating, but it feels familiar to me because it's the world I know.

00:48:17.000 I mean, that was the track I would have been on, right?

00:48:19.000 I was pretty academically oriented.

00:48:22.000 I was at the top of my class, Harvard molecular biology.

00:48:24.000 All my peers went to MD-PhD programs at the top places, some of the smartest people in their respective domains now.

00:48:33.000 I think it started to change in the 2000s where I think today now, certainly if you look at versus 40 years ago, where were the smartest and inherently most capable creative risk-taking people going?

00:48:45.000 I think you had a much higher proportion of them going into medicine 40 years ago than today where I... I think that there's a decrement, both in terms of raw IQ, but also in terms of intellectual curiosity and ambition and willingness to take risk and question dogma.

00:49:05.000 But even just raw IQ of people who enter medicine today than was the case.

00:49:09.000 I'm just not that impressed when I meet with med students today or people who have recently become doctors.

00:49:15.000 Just at a level of intellectual ability to be able to engage even in a discussion about scientific hypotheses with a non-scientist about the mechanism of action of a particular drug.

00:49:23.000 And they might be able to tell you what the routine algorithm is for where they take a patient once they've made a differential diagnosis.

00:49:29.000 I don't even know if many of them know how to make a differential diagnosis.

00:49:31.000 I think people say the word.

00:49:32.000 I don't think they even think about what the essence or the ontology behind a differential diagnosis is in the first place.

00:49:37.000 And it's deeply disappointing to the class of people who populate this field that was once venerated in the field of medicine.

00:49:43.000 It's really important.

00:49:44.000 I think we have almost a population migration towards mediocrity And I don't know, I mean, maybe you could push back on this if you think I'm going too far there, but it has nothing to do with politics, but it's just a reflection of the loss of excellence and the denigration of the class of person who's populating a profession today that once was actually the one that recruited the best and brightest and ought to be again, but it's going to require some measure of cultural change for that to be so.

00:50:11.000 Yeah, I mean, your first point about, could you be a renaissance man in medicine today?

00:50:15.000 And the answer is no.

00:50:16.000 And I think you're absolutely right.

00:50:17.000 There is no more Benjamin Franklin.

00:50:19.000 There's nobody who can dabble and be innovative in different arenas of medicine.

00:50:23.000 And the reason, in part, is, I think, the culture, as you point to.

00:50:26.000 It's also reinforced by the federal government and the NIH grant system.

00:50:30.000 Because doctors at the universities, to be a doctor at Harvard Medical School, often you're trying to earn your salary through the National Institutes of Health, Bureaucratic administrative grant-making system.

00:50:43.000 This is a system where the government decides what you can and cannot study and gives you a budget for that.

00:50:49.000 And if I want to study one protein from the brain and one protein from cancer and one protein from heart disease, different domains, they're going to say, you're too broad, you're lock, fast, focused.

00:50:59.000 The only way to build a successful NIH career is to focus relentlessly on some minutiae And only do that for their 30 years to sustain yourself.

00:51:06.000 And so it kills Renaissance men.

00:51:08.000 It kills people with diverse interests, with diverse points of view.

00:51:12.000 It, in fact, actually encourages people to just focus on one often mundane sort of thing.

00:51:17.000 The next thing you talked about is IQ and merit.

00:51:19.000 I think we should talk about it.

00:51:21.000 You're right on.

00:51:22.000 So there has been a lot of movement in medical schools over the last 10 years to remove tests and standardized testing.

00:51:31.000 This is broadly across education.

00:51:33.000 No more standardized testing.

00:51:35.000 Step one, which used to be, you know, when your wife took step one, when I took step one, it was a numerical score that determined what specialty you would be competitive for, this sort of standardized test in medical school.

00:51:45.000 Don't get me wrong, I have a lot of disagreements with the content of step one, but I never had disagreements with the idea of a standardized test.

00:51:52.000 Standardized tests can separate people who score better and score worse, and that actually does predict job performance and subsequent grades and things like that.

00:51:59.000 You see now a lot of colleges are bringing back the SAT. Well, we did away with this in the sake of equity or some of these other principles, and we replaced it with this sort of You know, committee that looks at your CV and determines how big an activist you are, how, you know, how likely you are to be a protest or something like, you know, they're looking at all these sort of non-governmental organizations you start or what activities you start.

00:52:21.000 In many ways, that actually reinforces patterns of wealth and power even more than the standardized test.

00:52:26.000 Because in order to participate in all these things, it's helpful to have your, you know, parents be able to pay your way along the way.

00:52:32.000 Where standardized testing in many ways is actually more egalitarian in bringing up people from lower socioeconomic classes.

00:52:37.000 So we're getting rid of the assessments of merit.

00:52:40.000 Third-year clerkships used to be graded when I was a student.

00:52:43.000 Now they're all going to pass-fail.

00:52:45.000 So we're taking away grades because apparently grades are, you know, it's claimed that they have deep elements of bias in them.

00:52:53.000 This, to me, is concerning because you get people coming on clerkships and there's no grade.

00:52:58.000 So they have very little incentive to try to be the best and be a performer.

00:53:02.000 And then the final point is, who goes into medicine at all?

00:53:06.000 The incentives around medicine.

00:53:07.000 You said, you know, in the 1980s, 1990s, the best and the brightest Harvard kids are going to medical school.

00:53:13.000 I would argue that now the best and the brightest Harvard kids are going to chat GPT. They're going to the tech industry.

00:53:19.000 They may be going into corporate law.

00:53:20.000 They're doing different things.

00:53:22.000 And that is a huge problem.

00:53:24.000 Medicine, we need to be bringing the best and the brightest into medicine.

00:53:27.000 What determines that?

00:53:28.000 Maybe how long our training is, how much of these hoops you have to jump through before you get in, the incentives for doctors, whether or not we're paying them enough in all fields and those sorts of things.

00:53:37.000 But we have to make medicine a desirable field again to get the best and brightest.

00:53:41.000 I agree with you.

00:53:42.000 It's actually, I mean, who's to say that my decision not to enter medicine was a loss for the field?

00:53:48.000 I'm not going to...

00:53:49.000 I'm just going to say that at all.

00:53:51.000 But a lot of people probably say, hey, good that that guy didn't come join us.

00:53:54.000 So forget about me.

00:53:55.000 But being in that environment, I can speak to what deters other peers, the smartest people I know that might have considered going to medicine but actually went in a different direction afterwards and have done fantastically well in the world of entrepreneurship or elsewhere, is also just the culture of manual labor, to put it this way, of actually, like, certainly a PhD track or an MD-PhD track.

00:54:18.000 Toiling away of sort of, you know, you take a little pipette from one here to one here without thinking about it.

00:54:23.000 You go through the motion, but what do you do in a lab?

00:54:25.000 It's like, okay, well, you learn to actually mix chemical A with chemical Y, and then there's these things called gels, and I learned what a Western blot is, without even a culture of thinking about the Y, right?

00:54:35.000 What does that actually mean?

00:54:37.000 What was the intellectual germ that led us to go through these motions in the first place?

00:54:44.000 And I do think it's missing today.

00:54:45.000 I do think that the loss of standardized testing or the vilification of standardized testing has contributed to this. 0.96

00:54:52.000 But I think the punchline is, I think the average person who goes into medicine today Is fundamentally stupider than somebody who went into medicine 40 years ago. 0.69

00:55:05.000 Just the intellect, the raw capability is just lower if somebody chooses that path today. 0.69

00:55:11.000 And it's not an accident that we took considerations of equity or Egalitarianism as you put it into account.

00:55:19.000 You made an interesting case that we may not even be very good at the egalitarianism part.

00:55:23.000 We might just be selecting for people who have the luxury of having daddy fund your ability to start an NGO and then put it on your med school application, which I think has merit to it.

00:55:31.000 I come from a different place to say that I don't think that egalitarianism should be a factor in determining who enters a profession, certainly a profession of such importance as modern medicine.

00:55:43.000 And I think what's happened instead is what you used to have as medicine be venerated as a high-status profession that had all of the attributes, including compensation attached to it, that went along with it.

00:55:58.000 And so we just say, OK, well, now we need to be egalitarian who gets into that.

00:56:01.000 And actually, what we've done is we've destroyed the quality and status of what medicine actually represents to be effectively a service provision profession where I think this gets on the nerves of some of the people who are friends of mine who are in the field of medicine today, some of the best, but in that last era of entering it.

00:56:19.000 Now seeing actually highly successful people, you know, come into a doctor and seeing you as the equivalent of like a service provider, but they have the same respect for you that they might have for somebody who's finishing their taxes at the end of the year or somebody who's selling them a hamburger.

00:56:31.000 Each one is providing a need that you actually have.

00:56:34.000 We've desecrated the honor ascribable to a profession by bringing down the sheer quality of people who enter that profession.

00:56:41.000 But I think this is fixable, right?

00:56:43.000 These are manmade policies.

00:56:45.000 And so much of modern medicine is tackling problems of nature.

00:56:48.000 Problems of nature are hard to solve because you don't know whether they're going to be solved by man.

00:56:51.000 Sometimes they are.

00:56:52.000 Most often they're not.

00:56:54.000 But what we're talking about here is a man-made problem.

00:56:56.000 And the beauty of man-made problems is they can be solved by man.

00:56:59.000 And, you know, I think it's not common sense.

00:57:01.000 I think most people quietly would probably agree with most of what you and I have said in the last hour.

00:57:05.000 I think so.

00:57:06.000 Even thoughtful people in medicine.

00:57:08.000 It's not that we're lacking for common sense.

00:57:10.000 We lack for courage.

00:57:11.000 And I think that it's going to be people like you that hopefully within your profession prove to be rare voices that revive and, if we may say it, make medicine great again.

00:57:22.000 And I think we all ought to be rooting for that if we care about the future of innovation and human health.

00:57:29.000 I'll just say one last thing on this topic.

00:57:30.000 I mean, I do want to say, as somebody who works a lot with students and such, that I think that the ones that are good that go to medical school, the best of the students, are as good as I remember them throughout history.

00:57:42.000 I mean, the ones that come that are great are really great.

00:57:45.000 They're brilliant.

00:57:45.000 They can code.

00:57:46.000 You can do things.

00:57:46.000 Yeah.

00:57:46.000 But your point about average is the real question.

00:57:49.000 And there's another point, which is...

00:57:52.000 Whether you're great or whether you're mediocre, are we making you better?

00:57:56.000 Like, we can take a great person, make them even better.

00:57:59.000 We can take a mediocre person, maybe make them bring them up a little bit.

00:58:02.000 But what is the curriculum?

00:58:03.000 Is the curriculum driving relentless improvement?

00:58:06.000 Or is the curriculum giving up?

00:58:09.000 The curriculum saying we're not going to have grades.

00:58:10.000 We're not going to judge you.

00:58:12.000 We're not going to give you any feedback that's negative that could bruise your ego or hurt your feelings.

00:58:15.000 Whatever you want to do is fine.

00:58:18.000 What are we doing to the kids we're getting?

00:58:20.000 Are we making them better?

00:58:20.000 And what are we teaching them?

00:58:22.000 Are we teaching them bread and butter medicine?

00:58:24.000 Or are we so dominated by these political topics, these hot button woke issues, that we have forgotten the core functions of being a doctor?

00:58:33.000 And all of that does spill over into the public perception of doctors.

00:58:37.000 When the patient sees the doctor, do they respect the doctor?

00:58:40.000 Do they think the doctor is a neutral arbiter?

00:58:43.000 You know, I've been very critical of a lot of the academic medicine papers that say, you know, that I think are pejorative, you know, like Republicans didn't get vaccines and that's why they have higher deaths in these counties.

00:58:55.000 They have so many flaws in those studies and they're so dishonest from a scientific point of view to compare You know, rural and poor places against urban, you know, centers with multiple quaternary hospitals.

00:59:05.000 There's so many other problems.

00:59:06.000 And to make that about politics and not about all those other problems, I think is dishonest.

00:59:11.000 And you see an explosion of that in the academic medical literature.

00:59:13.000 So I worry we are going in the wrong way on those issues.

00:59:16.000 I think you make a good point, which I do think is a positive note to say that the people at the actual outer edge, right, the 99th percentile is every bit as good, maybe even better than the past.

00:59:27.000 I think that's a good note because actually in a certain sense, even against the backdrop of every disincentive we've created for excellence, certain people are just going to be guided by their passion that you've really selected for them and they've actually done extraordinary things on the back end.

00:59:39.000 So I think that's a...

00:59:40.000 Positive note to what was probably an overgeneralization on my part, but I do think the median problem is still one that we have.

00:59:46.000 And, you know, I do think that it's fixable is the good news there.

00:59:50.000 And we go through these pendulums and you learn from those experiences.

00:59:53.000 And as long as we're able to take stock of those learnings, I do think that the kinds of problems you and I talked about here today are different than you might talk about in your research meeting.

01:00:02.000 You don't know whether those are going to be solved or not as problems of nature, but the problems you and I talked about These are manmade problems with manmade solutions.

01:00:11.000 And the question is, do we have the courage to actually step up and tackle them, even when that comes at some personal cost or risk?

01:00:20.000 My only advice to you, you're not asking for it, but you've already taken those risks.

01:00:23.000 You've already crossed that Rubicon and you're still here.

01:00:25.000 And so keep at it, right?

01:00:27.000 I think that that's a good thing.

01:00:29.000 And I think you will give, for every person who gives you some sort of negative reaction to what you say, there's probably 10 more who I think are taking inspiration from it.

01:00:39.000 And so keep up the great work.

01:00:41.000 And I hope this is the beginning of our conversations.

01:00:43.000 I have a feeling you're going to be an important part of reviving and improving and, dare I say, saving healthcare in this country.

01:00:50.000 And so keep doing what you're doing, man.

01:00:52.000 You too.

01:00:53.000 And thanks for having me.

01:00:54.000 Yeah.

Truth Podcast - Vivek Ramaswamy - May 29, 2024

Dr. Vinay Prasad on How FDA Gatekeeping Makes Us Less Healthy | The TRUTH Podcast #49

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