(260)S11E6/5: Medical Propaganda in the Real World w/David Pudwill
Welcome back to the Fourth Way podcast. In this interview, I had the opportunity to speak with David Pudwill about conspiracy and propaganda in the medical sphere. David spent a number of years in the FDA and is currently doing medical consulting. I wanted to speak with David for a number of reasons. First of all, his experience makes him a good person to to talk to because he's seen both the business and the governmental side of things a
David Pudwill:little
Derek Kreider:bit. Also, he was an easy mark for me because he's my cousin, and I've known him my whole life. And so I knew that that having come out of the FDA and no longer being there and maybe having to cover all of his bases, he would be able to speak a little bit freely and might be willing to talk with me. So, and I know he's smart. Right?
Derek Kreider:So I was in, when I I remember my senior year, I went to Calculus. And in my calculus class, in the 1st day, I look at my syllabus, and I'm like, oh, no way. So I dropped it for consumer math, which was a lot harder than I thought it would be, you know, doing taxes and stuff. But, whatever. I dropped calculus.
Derek Kreider:Meanwhile, he was in you know, when he was in a freshman or sophomore in high school, he's taking maths that I'd I'd never heard of. You know, he's in, like, calc 3 as a freshman or something like that. So he's he's super smart, and and knows what he's talking about and has educated opinions. So I thought it would be a good conversation. Because David and I chat quite a bit, I I made this one a kind of, freewheeling conversation of sorts.
Derek Kreider:We just kind of we didn't know exactly where we were gonna go. I mean, I had told him a little bit about my season on propaganda before. And so we had we had had some discussions, but I didn't have as much of a script as I do with other people where I send them questions and, you know, they're able to have notes and and think through their responses before we speak. We just kind of went with it. And so you're you'll probably get a different sort of feel from this interview than you do from a lot of the other interviews.
Derek Kreider:Because it was a little less guided, and David's experience is a little bit different, we didn't actually get to some of the the emphasis that I I discussed in this section on medical propaganda. Now one of the things that we talked a lot about in regard to medical propaganda is sort of the the deification or the, religiosity of of the, the medical sphere and the scientific sphere in our culture, as well as, you know, some of the the these ideas of benevolence where some sometimes things can happen and the medical community or the scientific community will spin it as well. We're doing these bad things because we love you. You know, we we know what we're doing. We we seek a greater good.
Derek Kreider:The ends justify the means. We got a little bit of that in this conversation, but it it wasn't quite as emphasized. A lot of our focus was a little bit less on propaganda and a little bit more on conspiracy and how structures of conspiracy conform. And so one of the things that we brought up was George Carlin's, famous dialogue you can get on YouTube, where he just basically says, hey, look. You don't need, you don't need a technical or a formal conspiracy when interests converge.
Derek Kreider:And so you get this idea of convergence versus conspiracy. And David talks a lot about that. Right? He's not this, big conspiracy theorist who sees a conspiracy behind everything. But because of the way that systems are structured, you're gonna end up seeing convergence.
Derek Kreider:And you're gonna end up seeing these things which later look like conspiracy as people figure out how to manipulate the systems that have formed. But one might call them convergence over conspiracy. And so that gets a little bit into the this gray area of definitions. You know, how do you define conspiracy? Do people have to know that they're conspiring for it to be a conspiracy?
Derek Kreider:How how much manipulation constitutes conspiracy? All that kind of stuff. Before you listen to the conversation, I do want to highlight 3 things that I think were particularly important to note as you listen. First of all, David talked a bit about this idea of, the importance of diversity. Or on the flip side, as we've talked about propaganda throughout the season, the, the problem of polarization.
Derek Kreider:Polarization is one of the hallmarks of being propagandized, this this extreme polarization. And so David talked about the importance of a diversity of voices, and how that at this point doesn't seem to happen too much, especially in institutions, large corporations, governmental offices. Right? Things become politicized. There's a particular narrative or ideology that needs to be ascribed to.
Derek Kreider:There are certain agendas and goals that everybody has. And so at some point, you don't really have a diversity of voices who are willing to, to kind of kick against the goats, who are willing to to push back and put their necks on the line. Everybody just kind of goes along with the flow with one voice, and that's really dangerous. It's it's diversity a lot of times in science, and and anything that leads to revolutions and breakthroughs and knowledge. When you don't have a diversity of voices, not only do things become stagnant, but you you lose the perspective of diversity that allows you to see things that you don't see when everybody's just kind of going with the grain.
Derek Kreider:And so there are there are dangers to not discovering things, but there are also dangers to when you have one voice and there's dissonance, and and you're the cause of that dissonance that there can be problems for you. The second thing that you can note is we weren't originally planning on talking about the vaccine. It's one of those things, like I said before in some previous episodes, I don't want to really talk too much about the vaccine because that's one that that's still fresh for a lot of people and, for the COVID vaccine. And so I don't want to spend a lot of time on more controversial things that people might have some some different, opinions about, and it might be too difficult at this point emotionally for individuals to to assess those, rationally. But I thought that it it was important as our discussion progressed.
Derek Kreider:I thought it was important to bring up the vaccine because David was talking about diversity and was talking about polarization, and it did sort of, tie into our discussion on the religiosity of of science and medicine. Because as David was saying, you've you've got people who are essentially they've become religious either way about the COVID vaccine. Right? I'm going to vaccinate my infant. I I don't know if anybody vaccinated their infant, but, you know, that extreme.
Derek Kreider:You have people who are are, like, I'm gonna just vaccinate as soon as I can, get as many boosters as I can. It doesn't matter if if my kid has, like, hardly any risk. And it doesn't matter if this doesn't really protect, my family members from having the virus spread to them because my kid can still get it. It doesn't matter. None none of that matters, because this is gonna make me feel safe, and this is gonna be my savior to vaccinate, my my kid.
Derek Kreider:At the same time, you've got this, religiosity that that seeks a savior in something like like freedom, where it's, no way am I gonna get my vaccine because the government's, nobody can be trusted. All of the the doctors who are out there, anybody who who, who would say that the vaccine is good is on the government payroll, part of a conspiracy. You've got people who who just can't see any good in the vaccine and can't understand why why, the vaccine would be pushed and any legitimacy to it. And so you've got just this religiosity, this polarization on all sides, and and there's not really a look at the data. There's not really, a rational stance.
Derek Kreider:And so we did get into the vaccine, and and I think that's a good place to take a look at this idea of polarization, religiosity, you know, that this how polarization leads to savior complex on on either side. Something's gonna be your savior. And that's what propaganda does. Right? It instills fear, and it creates these these poles that can't think objectively or rationally, and then it ends up providing you with a savior.
Derek Kreider:You got a different savior at each pole, but all propaganda is gonna provide you with a savior. And so that leads us to the the final thing, you know, if we're if we are polarized and we are we are very far apart from individuals at the other pole, how do you deal with those people who are essentially enemies? And if you're in the middle and and you're getting shot at by both sides because everybody hates you. Right? Because propaganda, if you're not with us, you're against us.
Derek Kreider:And so both polls hate anybody in the middle. And David talks a little bit about this. He he, discusses how do you how do you try to change people's mind? How do you have discussions with people? And he talks about the importance of listening, of course, which is is vital.
Derek Kreider:And then he talks about the importance of love, which listening is a form of love a lot of times, like truly listening, not just listening so you can respond and chime in, but truly listening in love because you care about other people and you care about what they think. And I've I've mentioned him throughout the seasons here, but Daryl Davis is a great example of this. Right? You've got people who go out and hate the KKK because the KKK is just, I mean, atrocious in their their thinking and and the things that they've done throughout the years. And so people will be terrible to them, and, of course, the KKK is terrible to people.
Derek Kreider:But then you've got this this black guy, Daryl Davis, who sits down, listens to them, and talks with them, and shows them humanity. And he doesn't change everybody's mind, and he might not even change most people's mind. But because of his love and listening, he has changed the minds of over 200 KKK people, I think it is, at this point. And that's something that we're gonna get into at the end of the season when we assess all the things that we've learned and looked at. What do we do with this?
Derek Kreider:What do we do with the idea of truth? How do we come to know things? And then what do we do with that? How do we propagate love and truth? And the answer is gonna be for if you want kind of a sneak peek, but, the Bible's model is discipleship.
Derek Kreider:That's what Jesus did. And I think that it is even though it's similar to propaganda, right, depending on how you define propaganda. Right? You're just propagating a belief. So discipleship is propagating a belief, but it does so in a different manner.
Derek Kreider:And And so we're gonna get to that at the end of the season, but I think David gives you a sneak peek at that where, love and listening and, and and conversing with somebody else. That that is seeking to propagate truth, but it's seeking to do it in a nonobjective manner. Because rather than objectifying somebody nonobjectifying manner. I'm sorry. Rather than objectifying somebody as as some, end goal ideology to disseminate, you know, like a virus getting inside of them and changing their mind, it views them as another human worthy of love and somebody who you want to love in truth as well.
Derek Kreider:You want them to be able to love in truth. And so discipleship and and this polarizing propaganda are very different things. And this, my brief conversation with David kind of alludes to some of of what we're gonna get to later. One final note before we get to the discussion proper, there are a number of images referenced in the episode, and I always put things that that we mentioned or talked about in episodes. I put them, links to those in the show notes.
Derek Kreider:So definitely go and check out the show notes for links to some of the things that we reference. So without further ado, here is my conversation with David Pudwill.
David Pudwill:I'm I'm David Pudwill, and I do medical device consulting for a number of companies. I've worked at FDA. I've worked for a couple different medical device manufacturers, and I've I've also known Derek, for for for my you know, just about my entire life. So, that's, that's that's some useful, you know, background, I think, maybe at a high level.
Derek Kreider:Yeah. You only wanna say things that are gonna give you credibility.
David Pudwill:But knowing you for a very long time, doesn't that doesn't that lend a degree of credibility? I don't know. Maybe maybe we're colluding. There's, there there's something to be said for, I think, the path of the discussion here, but anyway. It's true.
Derek Kreider:Yeah. So, you know, we've been talking for for a while. We talk every couple of months. And so while I'm going through this this propaganda season, I've been talking to you and and bouncing some ideas off of you. And so, of course, when, when I got to the medical section of propaganda, you were the first person that came to mind to talk about maybe how you see propaganda or conspiracy or don't see it in in the real world.
Derek Kreider:So you you shot me a bunch of different ideas, and you are the expert completely here in this episode. So why don't you go ahead and talk about your first impressions when I was talking to you and what came to mind?
David Pudwill:Yeah. So, you know, some some of the first things that that come to come to mind for me when when we're thinking about, you know, conspiracy and we've heard a lot of of this language in the last couple of years in particular since we've had, you know, the pandemic situation with COVID. And there's a lot of things happening around FDA and you know, and other government agencies. And, you know, my my general views, you know, on this is that we've we've set up a lot of institutions and and and those institutions in the way that they've operated have fundamentally eroded public trust in them and how they operate. And so there's a lot of grasping at straws as that happens and as institutions that, you know, you've come to trust and rely on as you find out the information you're getting from them is not as good as it used to be.
David Pudwill:Maybe it never was as good as you thought it was. And you start to go down these rabbit holes of, you know, questioning everything you've ever known. And that that's a very common, you know, thing. I think once you find out one thing is false or some falsehood, you know, happened, it's like, you know, okay, we're in December. Right?
David Pudwill:And, I I don't teach my kids a whole lot about Santa Claus. They know about the guy, but they've always for their entire lives, been the ones who showed up and teachers complained because they're telling other kids that Santa Claus doesn't exist. It's like this this kind of thing. All the other kids are, like, horrified, and the teachers are, like, you know, calming them down. No.
David Pudwill:No. No. You know? Don't don't worry about that, you know, that thing. So, you know, I I'm I I have no problems popping people's, you know, bubbles about, you know, some, like, shared narratives that we have, you know, culturally, which, you know, sometimes, you know, sometimes serve a purpose, you know, but but aren't necessarily true.
David Pudwill:Right? And then when people find out they're false, they've, like, all of their belief and everything is shattered. It's like, what else is is a lie that you've told me? And so I think that's just a very common human reaction. So I've even had some of that myself definitely over the course of the last couple of years.
David Pudwill:Like, wait, what else is not true that I, you know, that we've been led to believe? But I've worked directly within government institutions and within that bureaucracy. And, you know, my my view is mostly it's a it's a systemic, you know, you know, kind of an issue in terms of how institutions are set up, how they interact. And one of my biggest concerns is the revolving door in in the medical space between our government institutions and the industries that those institutions regulate. And also the flow of money, that that happens between the the, the corporations and FDA and other groups in terms of funding for review of submissions.
David Pudwill:And a lot of people, you know, can tell you, oh, well, that money is not tied to an outcome to which I will tell you, but there is a percentage approval that FDA leadership expects, you know, of, of these products. So, any individual product may not have to be approved. They can disapprove that one individual product. But overall, there's an expectation that a certain percentage of products that go through FDA will get approved. And that means that if you are a very large company submitting a very large number of products, at some point, you will get some of these products through and approved at a relatively high certainty.
David Pudwill:So any There's actually a quota? Yes. There are quotas.
Derek Kreider:Oh, I would have just thought that, you know, it it either passes or it feels like it's
David Pudwill:safe or it's And and it's not that the quote again, the quota doesn't apply to any individual submission, but there is a sense overall, especially for clinical studies, that there's a certain percentage of those that are gonna get approved at each round of review. So, so that drives certain incentive structures, right? And it's the same thing for overall products that the incentive structures are set up at FDA where it's very difficult to disapprove a product and it's relatively easy to approve it. Now that, just from an FDA standpoint, I don't mean from a company standpoint. The company does need to do a lot of work to get a product approved or cleared in some cases.
David Pudwill:So there are different tiers that FDA will review and and and allow a product onto the market, with. So we we can call them all marketing authorizations, but they're not all approved. Like, not not all products are approved. But for those products that are approved by FDA, there are certain legal protections in in many instances then for those companies, for those products that have now been reviewed by FDA, and it limits the ability of end users like you and me who may use that product to sue those those manufacturers. So there's there's some limitations on liability, and we've seen that very much so with the vaccines, for instance.
David Pudwill:There's a lot of leak legal liability protection that's that's come into play with, with that.
Derek Kreider:Okay. So
David Pudwill:yes. Yeah. Go ahead.
Derek Kreider:So so basically, just to to make sure I'm understanding correctly, and and we talked about this a little bit earlier too where where you said, well, you're not really a big conspiracy theorist, but when things get institutionalized, stuff happens. And I think George Carlin, when he was having a discussion with Bill Maher before, and he said
David Pudwill:The big club and you're not in it. But anyway, you were gonna say that.
Derek Kreider:That too. But, he said, you know, you don't need a formal conspiracy when when interests converge
David Pudwill:or Converge.
Derek Kreider:Yes. So it's okay. You've got a quota that needs to be filled. You've got a company that has the resources to do the legwork and pay the pay all the financial burden of submitting, and they can submit a lot of things. And so okay.
Derek Kreider:May maybe there's not a, a conspiracy where people are in the technical sense conspiring, but the system is is sort of conspiring, yes, unintelligently just And the way that
David Pudwill:And I would say it's deeper than that too. And this is this is one thing for a lot of companies to keep in mind is the relationship with FDA can at times be adversarial. But, generally, in the pre market space, the FDA reviewer wants to see products approved because it is something that they can point to as having been a part of and having participated in. It's much harder to sell a disapproval as a win. It's much easier to sell, look, I help this company and get their product onto the market and approved.
David Pudwill:You know, I was part of that team that got this product that now everybody's aware of approved on the market. There's a fundamental incentive for those people within FDA to see an approval. So it's even deeper than just, let's say, quotas, which I would say quotas maybe not quite the right terminology, but these are metrics, they're key process indicators, let's call them KPIs, that FDA tracks. And because that's something that they're tracking, you know, everybody, you know, internally is, you know, is very much aware of that. And there's a pressure to some level, at least, to see more approvals.
David Pudwill:Now that can be managed in a positive way, let's say, which is that the reviewers at FDA can reach out to companies and let them know what evidence they need to be able to approve a product. Right? And so you're not necessarily lowering the bar, but you are helping the company provide better evidence. But even then, if you have a predetermined level of evidence or set of information that you're looking for, we know statistically that, okay, let's say you're looking for a 95% confidence in the dataset you have. What does that mean?
David Pudwill:That means, one out of 20 times, you will get a false positive. Right? So if, if, if you have companies that are just throwing everything at the wall, occasionally you will get compelling evidence at a 90 or 95% confidence interval, that is just pure happenstance that, you know, a product that doesn't really work on a population level, did happen to provide sufficient evidence that FDA is happy to look at it and put that on the market. And so we try to set those thresholds high enough that that's not a very common occurrence, but it's set at a point where it does happen in real life and we see this. You know, I mean, FDA looks at, you know, literally thousands of products every year.
David Pudwill:You know, maybe more if you're going to count, you know, you know, you know, across various divisions and what they're you know, going out and inspecting. But in terms of new products that make it onto the market in medical devices alone, there are about 4,000 products that go through what, this 5, 10 ks process at FDA, which is sort of a me too. I'm just like this other device that's already on the market. There are 4,000 of those products every year, and then there are another, let's say, you know, 30 to 50 products that are truly novel that come onto the market every year. And that means even for the very novel products, at the at the kind of statistical confidence, you know, that, you know, levels that we expect, a couple of those products might make it to market and not actually work on a population
Derek Kreider:level. I I don't know if this was I don't remember if it was, if it would have been up your alley there at the FDA. But are you familiar with Elizabeth Holmes?
David Pudwill:Yes. Very, very familiar with that. I had actually, my, my wife was just reminding me of this because I had, been talking, talking with them. I hadn't gotten into. I forget if I had done an initial interview with them.
David Pudwill:I think I'd actually spoken with them and done an initial interview with these people before this all went truly sideways, because, it was a group at the time when I was looking at this before all this came out, it had looked like they just needed good regulatory help and not that there was, like, malfeasance. You know, it was just it it appeared from the outside that they were able to do what they were claiming scientifically, but they lacked, you know, adequate guidance, let's say, and, and assistance with somebody who was savvy about the regulatory landscape. But it turns out, you know, as far as I can tell, you know, from from from what what's come out in in the intervening years, it looks like there's nothing I could have done to really help these people because because there were some real fundamental underlying issues about the truthfulness of the information that was being presented.
Derek Kreider:So I read, Tyler Schultz has I mean, it it came up as one of my free reads and I was like, oh, conspiracy. This this would be perfect for the season. So I was it was a really short read, but it's this guy who is a part of the project. And he started like seeing red flags fairly early or earlier than a lot of other people. And, it's gonna be his story.
David Pudwill:You have to be careful about it though too because, like, on the flip side, I believe that what they were trying to achieve is possible. And the the problem is, what we're finding out with a lot of lab developed tests and FDA is now trying to push Congress to make some changes to how lab developed tests and and these sorts of, you know, you know, diagnostics that that Theranos was working on, how they end up getting reviewed and and and and and approved or put on the market that there would be sort of fundamental shifting in how that whole landscape is managed. That may very well have been one of the things that was messing Theranos up was that they were trying to use some of these tests. And these tests are not interchangeable. You know, you know, some of them perform better than others.
David Pudwill:And when they started getting these really wonky results, the problem that that that that ended up manifesting was they started obfuscating truth to people that they should have been truthful with. So it's very possible if they'd gone a different route, even though they ran into those challenges of having these discrepancies, if they'd actually pushed into that, it's possible they would have made their way through it. And I think somebody could end up doing effectively what Theranos was trying to do. The problem is instead of actually trying to pursue truth and trying to get to the bottom of what was causing the discrepancies, they decided to, like, paper over it. And then, you know, just, you know, the whole the whole thing went sideways.
David Pudwill:And that that gets into something else, I think, that that that's similar to what we've talked about, you know, in terms of just how you wanna operate in the world. You know, if if you are pursuing truth, you know, then then then you can, you know, you can build you can build something meaningful. Whereas if, you know, if you start lying even to yourself, I mean, you very quickly you very quickly bring just all kinds of calamities down upon yourself and the people around you.
Derek Kreider:Yeah. Reading that book, it it was interesting because there are there are a number of different ways, you know, that you can lie or obviuscape truth. So, you know, some of them I took a statistics class, terrible at
David Pudwill:it, but Lying with it.
Derek Kreider:Oh, I did appreciate I appreciated all the various ways that you could just manipulate things. It's like, well, you know, I can just change the test and it'll give me, you know, a different a different outcome. And it's it's kind of cool what you can do, but it it also gave gave me a lot less a lot less, faith in a lot of these statistics and tests and things. So with with, Theranos, you know, they've got I forget exactly how it worked, but he talked about how, you know, let's say you need 95%, in order to to move forward. It's like, well, they they might have been at like 60%, but they were, if they increased a little bit well, they were 95% better than what they they were before or something like that.
Derek Kreider:I I forget exactly what they did, but they they would change the numbers. So you have people who are purposefully changing numbers, but then you also have, like, he talked about the just how gregarious Elizabeth Holmes was, how just outgoing and, like, how confident she was. And, like, he'd look around and be like, well, everybody else, like, believes it, and they must just see things that I don't and how easy it is to put your head down. And it's not really a conspiracy when you've got people who really believe this stuff to a certain extent, a conspiracy the way that we call things conspiracy, but it's you've got a lot of people going along with with things that are are really shady, and they just don't see it.
David Pudwill:So I wanna, I wanna bring up, an image that I, that I love. It's this, it's this interesting image and we can drop it. We can drop it into something later. Data information, knowledge, insight, conspiracy theory. And, you know, and again, my my view is when you connect those dots in that sort of final sort of picture where it's a it's a flying unicorn, okay, it's a it's a pink flying unicorn.
David Pudwill:You know, it's conspiracy theory. You sit here and you go, well, it's only conspiracy theory if your intuition is wrong. You know, if you're putting all these dots together into that shape ends up being, you know, false, then then sure it's conspiracy. But, you know, sometimes your intuition is leading you in correct directions about how some of these various bits and pieces are connected. The thing we need to be careful about is what conclusions we draw from that.
David Pudwill:And that's what I'd say about FDA, you know, in general and, you know, our government agencies and and the way that we navigate, you know, health information and, you know, medical products and other products coming onto the market. You know, and even in situations like, you know, like Theranos where they were, you know, they were taking actions that were not in the best interest of their customers, of patients, of of the rest of us, and even of future people who might solve the problem that they said they wanted to solve. So they've actually made it harder because of what they did for anyone else to come along and try to solve that same problem because you you you now get painted with the same brush that Theranos got painted with as, you know, okay. Well, that's a really nice story, but, you know, the last time anybody did this, it was a bunch of lies. And it's just a shame.
Derek Kreider:You know, I remember a while ago studying apologetics and and, you know, the case for the resurrection of Jesus. And so this this, one cold case detective out there in LA, he actually he he wrote a book and he talked about how, one of the things that that is difficult to do when you have conspiracies is to have a lot of people involved. Because when you have a lot of people involved, you can't have conspiracies, because because they, you know, they'll squeal, they'll change the stories, they'll lie, all that stuff. And so as I've been studying conspiracies, I found that that's not true. Like, it's not completely true.
Derek Kreider:And so there there are 2 other factors that play in, and you identified 1 when we were first starting. So the the two other things that I think there are. So let's say you've got a lot of people, right, involved. Nobody's gonna squeal, like, it's not in their interest to squeal unless there's pressure on them. Yes.
Derek Kreider:Right? So if you're, if you're the president of the United States, you can pretty much do whatever you want and somebody's going to cover it up for you. Or if you do, get, get caught, like you're probably not really going to have a lot of ramifications on you. So there's there's little pressure compared to somebody else. But then there's there's a third one, which is idea
David Pudwill:It cuts both ways though too, you know, because then all of a sudden there's a lot of upside to revealing that because you can, you know, you you you you can become the famous whistleblower like, you know, who who who took down an administration. You know, this was the whole thing with, oh, what, you know, these, these journalists, with the Nixon administration. Right? So, you know, there there is some incentive there. Maybe not for the people involved to share the information, but for other people to reveal it.
David Pudwill:So you you you do get some interesting counterbalance there in some cases.
Derek Kreider:Yeah. I think a lot of times the people in in positions are egotistical and so Hitler. I mean, if you if you're killing, massacring millions of people, you've got to know that there's gonna be a significant consequence if you fail. But he's like, well, I'm in charge. I've got the power.
Derek Kreider:I'm not gonna fail. So I think
David Pudwill:you see the same thing as interesting because they, you know, a lot of the recordings, because they have a lot of, like, table discussions and things, and there's a lot of hinting around the edges about this. And I haven't gone and listened to all of them, but my understanding is they they tend I I don't know that they ever came out in some of these sort of settings and said any of this explicitly. And, you know, so it's very interesting how some of these things happen where they don't get discussed openly. You know, everybody knows what's going on, but there are a number of settings in which it still doesn't get brought up. And that's the kind of thing you do see happening.
David Pudwill:You know, I would say, you know, in some context with, review of various medical devices and drugs and these kinds of things at FDA where, okay, here's the, you know, here's how the system works. And people are just going about doing their, you know, their, you know, their, you know, various, you know, pieces of the puzzle there. But nobody's going in and and revisiting, you know, is this the right approach? You know, nobody's taught like, there are all kinds of things that aren't talked about. And and you could either say, well, you know, so in the case of, let's say, Hitler, those so I I always hate going to Nazis, you know, because it's sort of like the edge case.
David Pudwill:Right? But it's like, well, they're not talking about it, which means, like, something is going on because nobody's talking about it. Sometimes they're not talking about it because they don't either there's not something going on or there's not a conspiracy in the way that I would say, you know, we had with, let's say, what was happening in Germany in World War 2, you had, you know, a very clear set of malfeasance, you know, operations, you know, going on. Whereas a lot of our institutional challenges, you know, a lot of people may not be saying some of the quiet parts out loud, which is concerning. So whenever there are, you know, things that are known sort of more generally, you know, but nobody talks about it, You know, that's always a concern.
David Pudwill:You know, but as far as I'm aware, you know, being pretty deep on, you know, on this, you know, having been pretty deep on the industry side and on the FDA side. You know, the challenge in terms of our institutions is that most people believe that the system is operating, you know, as intended, or that it's operating appropriately. You know, but I would argue that operating as intended doesn't mean that it's operating in the best interest or as well as it could to actually, fulfill its stated purposes. So, if we were designing a system that was focused on advancing the public health, then that system would do more to bring in new entrants. That system would do less to crush, new ideas and advances, which can help people.
David Pudwill:And there there's much more of a focus, and it's just sort of a default focus on preventing harm as opposed to accelerating, advancements that can be positive. And so so there's this very conservative bent to bureaucracies as they grow and to people who are in charge. I mean, just take a look at COVID policies. What's the what's the, you know, primary driver? You had some states that took different actions.
David Pudwill:But in a large state, you will get blamed for anything that goes wrong. And the big thing you can see that could go wrong is that a bunch of people could die in a pandemic. And so if you're overly draconian, most people will end up forgiving you even if you were wrong. If you aren't draconian enough, you will be seen as, you know, just totally inept and incapable, you know, regardless of why you were, you know, less heavy handed, you know, in terms of your approach. And we've seen that, you know, work out, you know, where the only reason that people who were less draconian, you know, in certain states, the only reason they've gotten, you know, positive press, let's say, in Florida, for for Ron DeSantis is because he ended up being right.
David Pudwill:Not because the actions he took were, you know, more in alignment with, let's say American values of, you know, liberty and freedom. If a bunch of people had died, he would be a goat. You know, nobody would have any respect for him. It's only because he was right that he was able to get away with, you know, holding on to, let's say the, you know, these kinds of values, which is sort of a scary thing, you know, for me being someone who, you know, wants to see those values of individual autonomy and liberty, free association. You know, I wanna see those things advanced.
David Pudwill:But, I think the only reason the public tolerates that is when it works. And if people start dying, the public will very quickly turn on you and expect very, very draconian measures, and they're willing to tolerate very draconian measures. I mean, the public has been willing to tolerate things that I never would have imagined you could get away with doing, you know, in in, you know, in this country. And you've seen it, you know, in a couple different, you know, sort of cultural contexts. But I I don't wanna derail us too far into that direction.
Derek Kreider:Right. Yeah. Going back to the, you know so I think you I think you identified how a system can just work out, with with people just kind of complying and and kind of doing status quo assessments and thinking why everything's working. The the third thing is right? So if you have a lot of people involved in conspiracies, but also if, if there's not a lot of pressure.
Derek Kreider:The third thing is is the one that you, I thought, identified at the beginning and and hope you can talk a little bit more about. But you, if you have people who have a very strong ideology, you know, very zealous about something or or believe something very strongly, then even if there's a lot of pressure and even if there are several people involved in the conspiracy, that ideology can unite them and actually, you know, solidify them in their position in spite of pressure and everything. So you were talking a little bit I I don't know that that you would have called all the people in, in government and business and the scientific community zealous for an ideology, but you did talk about a lack of diversity.
David Pudwill:So there
Derek Kreider:is kind of one one, preeminent ideology. Could you talk about
David Pudwill:that? Yeah. There's a monolithic culture. I think that's that's that's emerging out of, you know, out of that. And we've seen as in some other people have talked about this where, you know, a lot of the drug companies, for instance, they will, bow to just about anything that FDA, you know, asks of them or is looking for, because to some extent, it's in their best interest for survival as an organization to just do whatever FDA is asking of them.
David Pudwill:And I see this leading to, in many cases, some fundamentally unscientific approaches to the way that we manage risk and the way that we advance public health. And so one clear example in my mind is around something called biocompatibility testing. And some experts could, could very well disagree with me. But I've looked at literally 100 of, of medical device submissions. So I'm, I'm talking specifically about medical devices here.
David Pudwill:And I've heard of situations where the biocompatibility testing results required a change in materials. I've heard that this has happened. I've personally never seen it. So the only thing I've ever seen happen is that more tests are run, and those additional tests demonstrate that the materials are fine. So if over the course of 100 and 100 of devices, we have a less than 1% likelihood that a particular test is gonna find anything meaningful.
David Pudwill:Probably we should be looking at other metrics and other approaches to find out what that thing is that we should be controlling for, as opposed to slaughtering lots of animals, doing lots of expensive testing for very little, if any benefit in most cases. And it you actually have a delay in time. So all of this testing takes a certain amount of time, and that means that these innovations take longer to get to market. They take longer to get a first sale. It takes longer to get into, you know, a patient to see if it works.
David Pudwill:And that means that for most of those products that are perfectly safe, and they get demonstrated to be safe by just conduct conducting more testing that takes more time, Those products end up not getting to market as quickly, and then you're not able to see whether it works or doesn't work, you know, and and sort of fail fast, which is kind of the Silicon Valley approach to, you know, more software kinds of products. And the concern within the medical community and at FDA is, well, we're really worried that bad things will happen. Right? So it's this hyper focus on the negative outcome as opposed to being aware that not seeing the positive outcomes is also a type of a harm that you are inflicting as a system. And so we're spending a large amount of time and energy on solutions that don't work, that we don't know don't work until much later in the process after we spent lots and lots of money developing them and doing all of this testing.
David Pudwill:And there are probably some slightly different approaches to make sure that we're adequately controlling for those risks, while accelerating the overall process so that you can get a solution into a subject. Because even if it's safe, let's say. So let's say that there's a product which is safe from a material standpoint, right? So if you put it inside your body, it's not gonna cause some really scary side effect, right? Even then, if it doesn't provide the benefit, the benefit, if there's no benefit, then no level of risk is tolerable, right?
David Pudwill:So if it doesn't help you, it doesn't matter that it's safe because we shouldn't bother to spend the time and energy and take the risks of a surgical procedure to put it inside of you. And we didn't find that out until years down the line after we'd done all of this preclinical work. And so a lot of that work is something that we're doing simply because we've always done it. And there's some initiatives to try to get away from certain types of animal testing and do other tests. But I would say, you know, my view in the current landscape that we have, there should be some alternate approaches to, to how we manage safety.
David Pudwill:So if you use these particular materials that are manufactured using these specific approaches, using, you know, these specific molds and, and manufacturing aids, then we don't have any questions for you. So you could like put this into a totally different bucket, but that's not what we do right now. And that would significantly help advance innovation and help advance the public health. But nobody's talking about those kinds of things. Everybody's just very fixated in the ruts that we've already, you know, made in the road, and nobody's looking for alternate solutions to address this on a more systemic level.
David Pudwill:And the and the issue we run into here is no individual company will be served by trying to rock the boat. Right? But the overall industry is harmed because we've just locked ourselves into this particular approach and everybody takes longer. There's another interesting diagram, you know, about strings and springs and traffic conditions. So this idea that, you know, you can have a fastest route, if it's just one car or a small number of cars on a small road.
David Pudwill:But what ends up happening is you get to an equilibrium where, everybody's taking longer to get to their destination than if everybody just used an optimal route. So and there's no way to optimize the system to speed it up once it's already in place because everybody has their individual incentive, which drives the overall system to be less efficient. And that's what I see happening within medical device review and drug review, and just in terms of how FDA, you know, operates. So, you have you have that side of things where you have this inefficiency. But then on the flip side, you have this very large barrier to entry for new people, you know, coming in.
David Pudwill:And it's almost inefficient by design because it will kill, you know, new companies coming in. So whether that's what the system intended or it's just a happy accident for big players, there's no real incentive for the big players today for the, you know, 1,000,000,000 and, you know, larger valued companies to change the system because currently it works in their favor to prevent competition from coming and eating their lunch.
Derek Kreider:Yeah. No. I think that that describes conspiracies. What I, what I'm finding most conspiracies to end up being is they're happy accidents. But with some of them, at some point, people recognize the accident that happened and start to take advantage of it.
Derek Kreider:And, so it's not like this, you know, decades in the making, people conspiring to create this elaborate system. It's just, you know, interests converge, and now you you have what you have, and people know how to manipulate the system. So if you're a big company, it's advantageous to you because you've got your your team of lawyers and you've got all your money and you know the system and you can flood the system with your stuff and you could prevent competition from from coming in. Yeah. I wouldn't want it to change.
David Pudwill:And it's the same thing with, standards development. It's sort of an interesting maybe there's a broader application for this. So whenever you're standardizing an approach to how you go about something, there's a baseline or there should be a baseline assumption. If you're ever trying to standardize something that it's worth standardizing because you already know everything there is to know in a space so you can optimize it. But what we find, so the International Standards Organization develops a lot of standards.
David Pudwill:FDA participates in helping to write those standards. Those standards are mandated in much of the rest of the world. In the US, they typically, let's say on, in terms of FDA, are quote unquote, let's call them voluntary. Though, you know, it's strongly suggested that you comply, right, with these standards. And what you end up finding out is that these very large organizations spend energy and resources staffing those standard writing committees, right, with people who are aligned with their interests, and either on purpose or as a happy accident, end up codifying standards, which are to their benefit and not to the benefit of their competition.
David Pudwill:I've seen this directly happen when I was working in industry where one of the competitors ended up writing their own version of a connector that they'd already implemented in their devices, they made it mandatory. So, we had to change all of our devices to use that connector that was their proprietary connector of the competition. You know? So we had to spend all this this time and money and resource, and maybe it's just because, hey, this is a good idea. Everybody should use this.
David Pudwill:Right? But the cynic in me says, you know, that that, you know, there was a little bit more to it, you know, than, you know, than that, especially when it became the, you know, expected standard that FDA and the rest of the world, you know, were pointing to as what you should be doing, you know, in this space. And, you know, any number of arguments you have that may or may not be valid, just fall on deaf ears at that point because everybody's decided. And there's a lot of energy and and, momentum, you know, behind staying the course once you've decided to do something. And you you just can't get anybody to to change their minds once, you know, once it's been codified or it's very, very difficult for anybody to change their minds.
David Pudwill:And so this is the other way that, you know, that that can work. And and the the little aside there, I would say, which is a little bit shocking, is that FDA, a government agency, now effectively directs people to go to an international standards organization to go purchase copies of those standards so that they can apply them to their products. But by all, you know, for all intents and purposes, it's required by FDA. Now they can tell you there are alternatives, but, you know, that's gonna cost you way more time and money than just giving these guys a couple bucks to implement their, you know, their, you know, approach. And, you know, you could say that that benefits small companies, maybe, but really it's it's a very strange thing that you've got a government agency directing people towards, you know, paying for standards from a private or, you know, at least a non, you know, US, you know, government, you know, entity.
David Pudwill:You know, you're you're now instead of getting, you know, the the the input for free, which FDA does, you know, give you in their guidance documents generally. You're now getting you're you're now having to pay some 3rd party, you know, to do what the government wants you to do. It's it's a very it's a very interesting twisted, you know, situation from my perspective.
Derek Kreider:Okay. So there there was a lot there, but I want to
David Pudwill:Yes.
Derek Kreider:And we
David Pudwill:haven't even gotten into where where I wanna get to, which is the revolving norm. But that's that's that's that's that's later on. So continue.
Derek Kreider:Yeah. One of the things that you mentioned, and if you don't want to get into it at all, I I know that we want to avoid vaccines a bit. But there's one thing that you said, and you can choose to answer it or not. But you're talking about how you think that that things should be data driven, and, that that the system as it's set up does not do that, in in regard to but you also said that you want to get things out to help people, as opposed to to kind of being too hard on them on the front end. So it seems like with with the vaccines, there are a lot of people complaining that, they, you know, we don't know what they what they are and what damage they could do.
Derek Kreider:And on the one sense okay. That's true.
David Pudwill:There's there's some of that which is hyperbole, but but continue. Yeah. We we we've got some good data on both what's in them and, and, and, and also what they can do. Those, I, I, I, I can appreciate the nuances of, of that concern, but most of the people shouting that are disingenuous actors. Right.
David Pudwill:Right. So, but, but continue.
Derek Kreider:Yeah. So so you've got this, this vaccine that's like, okay. Well, we really don't know what it's gonna do, but you've also got this this virus that could potentially be bad. We didn't know. Right?
Derek Kreider:You don't know. You have to take your your best guess, and it could have been bad. And the only reason people aren't being flayed right now, who who took the the freedom route is because it ended up working out in the paper. The 2 point conversion was good. So but but at the
David Pudwill:same time you would have been yeah. Otherwise, you know, let's lock them up and throw away the key, man.
Derek Kreider:But when we were talking, you did have reservations in the push for this being on on, done on youth and and certain demographics because you said
David Pudwill:And especially pregnant women. I mean, that that's the thing. I I have still not seen good data, and I still see communications people from FDA pushing, you know, that everybody should go get themselves vaccinated and boosted. And getting vaccinated is not the same as getting boosted. And this is the thing, like nuanced medical people, you know, can tell you about the accumulated risk that is inherent in getting additional booster shots.
David Pudwill:And that somewhat depends on whether you've been exposed to the virus as well. And so, you know, the individual risk profiles are gonna vary. So, there's a lot of disinguity, if that's a word, in how a lot of this is communicated. And there's a lack of nuance projected. And the communication tends to be go out and get yourself fully vaccinated.
David Pudwill:Well, one, that's a moving target. 2, we also know that if you have natural immunity, it's actually, it's once you have natural immunity, it's better. Before you have natural immunity, you might be in a population that would be better served having some protection from vaccinations, but that protection wears off over time. So, this is sort of a double edged sword. You almost want and I I'm not advocating for this, but, like, it almost sounded like you wanna go get yourself, you know, vaccinated to blunt the effect of, you know, of the virus and then go put yourself in a position where you will get COVID so you can have some of the like longer term, you know, benefits of immunity.
David Pudwill:But at the same time, both the vaccination and COVID itself have certain like negative health, you know, effects. And anybody who's gonna tell you otherwise that, you know, vaccines are perfectly safe and there's no side effects, they're lying. But anybody who tells you that vaccines are the most dangerous thing, you know, even these vaccines, which aren't really vaccines as we normally think of of a vaccination, because it only confers a limited protective benefit. Right? So it really depends on the individual circumstance.
David Pudwill:And this is where my view is you should have access to treatments. Right? So, I'm in favor of enhancing access, right, without necessarily telling everybody that they ought to go do this, especially young people. You know, unless you have a 5 year old or a child who is at some really enhanced risk, I don't know why we are pushing, vaccinations in those age ranges based on data which is not very good. I mean, the the, you know, the the the the data, you know, didn't didn't meet at least initially when we started rolling a lot of this out into into children.
David Pudwill:The data did not demonstrate just sort of the basic level of what I would have expected that data to show for us to broadly expand it and recommended in everybody. Now, it's one thing to say it's available. And so if you're high risk, you should talk with your doctor and think about going and getting it. And so we have this like lack of nuance in how we have these discussions. It's kind of an all or nothing.
David Pudwill:It's like, you know, either all of the children should go get vaccinated, or we don't have an approval and no one can get vaccinated. It's like, that isn't, it's somewhat anti scientific and has become very tribal because everybody wants a counter position. But reality is a lot more nuanced where you say, no, I actually want there to be available treatments, recognizing that maybe we don't have really robust data yet, but we have enough data maybe that certain populations should consider it at a higher, you know, level of adoption than the general public, you know, or or at least than children generally. And, you know, I'm I'm also I I look it's a family decision, you know, for a lot of these things, but if we're gonna vaccinate children to protect, you know, vulnerable adults, I generally see that, you know, dimly as well. There might be instances where it makes sense, but, you know, this is sort of where we've gotten to in the discourses that we are vaccinating children to either protect, you know, actually vulnerable adults or to protect adults who feel vulnerable.
David Pudwill:You know, so a lot of adults wanna go get their child vaccinated because it's gonna make them feel better about either their child's safety or their safety or the safety of the community when the evidence does not necessarily support that. And so we get a lot of people making fundamentally unscientific decisions about their medical care. And it's sort of shocking that we've gotten to this point where, you know, we have such a tribal, you know, approach to medicine. And we see this, especially at our institutions. You know, I would say historically, you know, FDA, you know, has been, it has had a political bent, but it has been scientific in its approaches and its decisions.
David Pudwill:For all that I don't always agree with what FDA may do, they've tried to be at least scientific in the decisions that they made. Even if they even if they are more aligned politically with one side versus the other. What we saw in the pandemic is the CDC and the NIH, I would say, and other health agencies ended up becoming much more partisan players. And we've seen FDA to start following suit where they are starting to make decisions that are much more tribal and much less scientific. And that that's just bad for overall public trust in the institution.
David Pudwill:And I get why some of these decisions are made, but it's, it's disheartening to see that tribalism is winning out over the scientific method and approach.
Derek Kreider:Alright. Last question, then I'll let you get to your, your revolving door. Yeah. So so let's say you're talking about whether it's the COVID vaccine or whether it's, you know, vaccines and autism and, and other sorts of things. You get, you get people who are tribal, you know, on, on all of those things.
Derek Kreider:And maybe you would agree with tribalism when it comes to, you know, the vaccine and autism link because that that seems like something that's a little bit more clear. But,
David Pudwill:how would you, like let's say And and again, it you know, there's a difference between this being, you know, you know, a broad population effect and this potentially being an individual, you know, adverse event. I mean, we both have an aunt who, you know, potentially suffered vaccine side effects from, I believe it was the polio vaccine.
Derek Kreider:Right.
David Pudwill:And, you know, so I I don't know if that actually happened or not, but there's at least a reason to suspect it and to, you know, to potentially explore that. And so it's interesting when, you know, people who are very aware of that situation, you know, are blind to, you know, the potential for vaccine side effects in a novel vaccine, much less, you know, one from, you know, from years ago. And it's interesting too, when we look at the data. And so I'll back up a little bit and then sort of frame most of this with, you know, with the statement that the issue we're running into around COVID specifically is that we were not scientific in our approach. So we didn't run randomized control trials.
David Pudwill:We don't know. The data doesn't exist anymore, and we've confounded the data set, so we can't even run the trials today to figure out what we don't know. Because we've totally confounded the data set, with the approaches that we took that were fundamentally unscientific. So rather than running studies to see which intervention in a randomized control manner actually are, you know, better or worse, what the safety effects are, we didn't require that. We just did a population level, study without a control group.
David Pudwill:And that is just, it's appalling from a scientific standpoint. So we just don't have good data now. And you can basically say anything you want, and, you know, nobody can prove you wrong around certain, you know, sort of positions about COVID and vaccinations, etcetera, because the data is just not good because we didn't bother to collect it. So, I'm not gonna take one side or the other, except to say we were unscientific in our approach. And I don't think there's any question about that.
David Pudwill:And that I hold against the regulatory agencies. The regulatory agencies should have been more scientific in their approach and less driven by fear of what was happening, because then we would have actually had information to drive future decision making. But instead we had years of very little, if any, good information followed by population level interventions, again, without good information. And so it's like we have not learned from our mistakes. And most of the people who were in charge of those agencies and making those decisions are not the kind of people we need running scientific agencies.
David Pudwill:Like that's, you know, like fundamental number 1. You want people running scientific agencies who are scientifically minded and are actually gonna take the steps needed so that we can have the information, to make good decisions in the future. And And you
Derek Kreider:don't want politicians and bureaucrats running scientific agencies? Generally
David Pudwill:not. And and. Yeah. And that that is very much what, you know, what it's gotten to. And this is back to, again, this sort of tribalism that we have at the moment, which is, you know, agencies that are coming out and making statements that are not driven by science.
David Pudwill:They're not driven by scientific evidence. They're driven by a particular tribal opinion and perspective. And it could have gone the other way.
Derek Kreider:Like So so how do you how do you deal with that in conversation? You have people who, you know, they get their their 5 year old vaccinated when when they're completely healthy. They're not around anybody, who who's, you know, susceptible.
David Pudwill:They probably already had some level of natural immunity at that point. I mean, the the the the number of school age children who who had it based on tighters. I mean, when we go and look at who's had it and been exposed, just about everybody at this point, you know, has already been exposed. And most of those that are children were exposed naturally and develop some kind of natural immunity. So, and I'll continue with this other point.
David Pudwill:The problem with not having data is that, so there were some population level, there's some population level information that's come out about the overall, let's say, you know, excess deaths, risk of mortality, right, in various populations. So those who weren't vaccinated, those who got the in the US and in other countries, it will vary. But in the U. S, the Johnson and Johnson vaccine, which is more of a traditional vaccine, and then the mRNA vaccines. And what we've seen is that the risk of dying in the Johnson and Johnson vaccinated population is less than in the unvaccinated group.
David Pudwill:And the risk of dying in the mRNA vaccinated group overall is higher. But the problem is you can't just even take that at face value because who would have fallen into each of these groups is different. And so their basic level of risk on a population within these cohorts that have self selected, it may not be that the mRNA vaccine is any more dangerous than the Johnson and Johnson vaccine. It may just be more vulnerable, more vulnerable people were more likely to get that vaccination. We don't even know at this point.
David Pudwill:I, you know, it's really tough to parse the data, you know, looking back, and smarter people than I are exploring this and chasing it and trying to make heads or tails of a lot of this excess debt data. But I just point to it to say, we fundamentally don't know the things we ought to know If we had approached this much more scientifically from the beginning, we would already have the answer. People wouldn't have to go try to do some, you know, obtuse statistical analyses to try to figure out, you know, what's the better approach, what should have we done. On top of which is, even if that data does come out, I'm fairly convinced based on how people have operated that people aren't gonna change their minds about what decision they made. Most people are gonna double down that what I did was the right thing, and everybody else are a bunch of morons for not doing exactly what I did.
David Pudwill:And my view is what you should do in an individual circumstance is gonna vary, and and I probably can't tell you one way or the other what you should do. Though, you know, I I I have a framework for how I would deal with that in different cases, And it's mostly based on sort of the risk benefit and trying to overall reduce the risk that you're exposing yourself to. And there are certain circumstances where, you know, getting the vaccinations is probably a higher risk, especially if you're getting boosted. Like, we know that for certain young men, the more boosters you get, the higher the likelihood is that you're getting certain sort of, you know, heart related issues. And so, you know, it's gonna it's gonna be very nuanced and depend on the on the particular, you know, situation.
David Pudwill:And then I see, you know, blatant lies come out, you know, about the data that we know. You know, there were, I believe it was animal studies, but, you know, we saw in certain animal studies that the spike proteins accumulated in ovaries, which means that there are certain risks for women that are probably higher than men, because we didn't see a similar, you know, kind of, you know, effect for testicles, you know, for testes, for instance. So, you know, just there's just a, like and whenever people are fact checking these statements, there's like an obfuscation. Like, this is the thing I've noticed looking at news and looking at fact checking. They have a side that they wanna be on, and then they fact check the argument they don't like and find the narrow way in which it's either true or false to fit their narrative, as opposed to talk about how it's true and false, you know, narrative aside.
David Pudwill:You know, and this is the thing that drives me nuts about just about everybody involved as a side they're trying to tip the scale towards. And, maybe that's always been true. But
Derek Kreider:Yeah. So so that's one thing that that, comes up probably the most out of out of all of, you know, the things that we discussed in propaganda is polarization. That's that's kind of how it it thrives in the sense that it creates an us versus them. It creates an enemy over there, and then it supplies the savior. And I think that's you talking about how I mean, it really is religious for both sides.
Derek Kreider:If, I see I see a lot of people in, the more conservative groups that I run-in, they they're posting news articles all the time, like, you know, spike in in stroke deaths and young people and all kinds of stuff. And they're like, see, you know, we Or
David Pudwill:this guide suddenly documentary that's that's that's going around. I don't know if you've seen this, but anyway.
Derek Kreider:Yeah. And so they're like, we'll see. You know, we did the right thing. And it's like, well, maybe it was the right thing for you. Right?
Derek Kreider:Maybe it was, but it might not be.
David Pudwill:There's no way, even if it is, there's no way you could have known that when you made the decision. Like, it's like my intuition, this again, the flying unicorn, hopefully you can show it somewhere. You know, this flying unicorn is true, is real. You know, it's like, but when you, when you saw it first, there was no way for you to know that that was true.
Derek Kreider:Yeah. Yeah. But then, then vice versa, you get, get the people who are, you know, they would they would, immunize their their infant, their newborn if they could because that vaccine is their savior. And it's like when you can't really have rational discussion where you say, well, some people should and some people shouldn't. It's like, how do you bridge that gap between that tribalism?
Derek Kreider:Because like you said, I completely agree with you. If data would come out, whichever way that data would go, the group that, it it disproved would completely not and and it might not even disprove a group. It might even just say, hey. There's a right and a wrong. Some people should, some people shouldn't.
Derek Kreider:Like, nobody would ever buy into that. So how do you bridge that in conversation?
David Pudwill:It's it's I I try you you can bridge that in conversation. Usually, there's some basic rhetoric rhetorical tools you can use if you know somebody. You know, you can come alongside them and you can sort of walk in the same direction that they're walking in about certain things that you can agree with. So the biggest thing, if you're trying to talk with people and based on this conversation and just, you know, your audience is probably pretty aware that I just can ramble on and on and on. Like, that's not what you do if you're trying to change somebody's opinion.
David Pudwill:The way to change somebody's mind is actually to listen, to hear what they have to say, find a point of agreement that you can chime in on and agree with them on something. It lowers somebody's guard. So it opens the possibility for them to receive something from you because otherwise, if you're guarded and I've got my shield up and I'm just looking over it at you, there's no way anything you tell me is gonna penetrate those defenses or it's it's very unlikely that anything you say will penetrate those defenses. Whereas if we're on the same side about something, if we see something in the same way, all of a sudden, I can lower that guard at least for some area of our conversation. And it gives an opening potentially for you to drop, some truth, you know, into a situation if you do it in a kind and loving way.
David Pudwill:And that's where most of us get that wrong. It's like you get somebody to drop their guard, you agree with them, and then you like stab them with truth. It's like there, take that. You know, we disagree on something fundamental and now I've stabbed you with it. Like, that that is not helpful to change somebody's opinion or to or to take you seriously or lower their guard in the future with you.
David Pudwill:You know? So, you know, so that's that that's the basic thing is is is just trying to treat other people in a, in a kind and loving way and find, you know, find ways, you know, in conversation where you can agree with somebody and you can find a point of alignment and then you can push back on some of those things gently where there might be a misalignment, and they might settle into a slightly different place. It's a long and slow dance, I would say. You're not gonna get them to your position, even if you're right. And I think most of us should actually have a little bit more humility in recognizing that there are things we're not even aware of that we're wrong about.
David Pudwill:So that would be my like first, you know, call out is find a place of agreement that might be a more likely place that you're right is if there's a point of agreement with someone else. But then be open to those areas that you might be wrong about. And that's actually where it can be really powerful is if somebody who you think is wrong about some area actually tells you something that challenges your perspective on reality enough that you shift your position. Like, that can be really powerful when, you know, you, you know, you find a point of alignment. You even change, you know, your position because they're you know, you think they have a good point about how something should be, you know, addressed.
David Pudwill:Maybe it's just a nuance about your, you know, position, but being willing and open to, you know, to that, I think is helpful. And then on a population level, you know, on, you know, let's say at least on a national level here within the states, you know, the the way forward is that we need to be doing things within our institutions that restore trust. And that requires our institutions to stop being political actors and stop being used as as political weapons. You know, we fundamentally need scientifically minded and oriented institutions. And and that's something that's gonna take a long time to rebuild.
David Pudwill:And, and that's something that I'm working with.
Derek Kreider:Right. Good good answer. Love. Okay. I'll let you get to the, the revolving door now.
David Pudwill:So I'm I'm actually in some ways, you know, represented in this. Right? So I had I had been at FDA for a number of years. Before I was at FDA, I was in a medical device company. I was in a lower level position and then, you know, had some hands on experience with devices and ended up going and working at FDA again under relatively low level, you know, position doing reviews of, you know, medical device, you know, submissions, you know, ended up in middle management when I was at FDA, ended up in some more senior management at a company when I left FDA.
David Pudwill:They had a specific challenge that they needed some help with navigating what FDA needed for some submissions. And most of what I did at that company was actually helping them go get the testing that they needed to present to FDA so FDA would be satisfied with what they saw, much like what we were talking about, you know, earlier on. And, you know, and then at that point, I ended up going into consulting. I've helped, you know, some small startups, some medium sized companies navigate FDA bureaucracy and regulations, and help them prepare for FDA to show up so that they can, you know, do a better job of giving FDA what they need to get a positive result. And, you know, there are a lot of people like me who've served in government and now are more in the private and consulting space.
David Pudwill:The real challenge though, you know, we, you know, this, this is a, it's a situation though, which I, you know, I think can cause a lot of consternation, you know, among people that you get this movement of people from industry to FDA and then from FDA to industry. It's mostly a big issue at the senior, very senior levels within FDA and senior levels at very large multinational companies. And it's most suspicious when you have somebody who's either come from industry, gone to FDA, and then goes back to the same company, or you get somebody who's been at FDA in a senior, you know, sort of capacity, and then they are involved in making a favorable decision for some company who shortly thereafter, you know, ends up hiring them into some senior role or as a consultant, you know, paying them, you know, very high fees to advise them. And some of that is just how the system is set up. And there are certain guardrails against that.
David Pudwill:You know, I can, I can link an article, you know, that I wrote about exactly this recently just just about a week ago? I don't know when this will get, you know, get published, but, you know, I I I I wrote it before we spoke. We can, you know, we can, you know, post a link to it for people to check out if they want. But, you know, fundamentally, there's a real issue here in terms of public trust when it comes to this revolving door, which I've been through. Right?
David Pudwill:So I've gone from industry to FDA and FDA to industry. And there's something we really need to do about that revolving door. And and some some of it's making, you know, people aware of what guardrails there are against this. You know, but but but it's also, you know, it's also important to, you know, to ensure that there's not this situation where we get a monoculture developing because you get this revolving door of people. So whenever people spend a large amount of time together, you start to build a specific culture.
David Pudwill:And we talked about this a little bit with the medical, you know, companies or drug companies where they're very incentivized to do exactly what FDA is asking them to do. And some of that can even be driven, you know, by the fact that some very senior FDA people may now be at that company. And there's now this alignment in terms of vision and purpose, that knits these companies and FDA together in terms of what direction, you know, is being, you know, forged. And and I think that that can be that that can present certain dangers because we're likely to miss things. We're likely to just settle in on status quo.
David Pudwill:Or settle in on a particular tribal way of seeing things. Because FDA and the drug companies tend to be fairly aligned on certain perspectives. You wouldn't be at FDA reviewing drugs. You wouldn't be at a company developing drugs unless you shared certain basic, you know, world views, right, just to begin with. And then that can get further exacerbated by this revolving door and people passing back and forth.
David Pudwill:And and you get, you know, these well worn tracks that I talked about in terms of, you know, this is the way we're doing it. This is the way we've done it. This is how we've been successful. And there's a real inherent trap there in in getting to where we need to be and making sure that we can restore public trust because the public is not going to be very trustful, you know, about a system which is which has got this revolving door between industry and FDA and where there's a perception, at least, that FDA is allowing all kinds of things onto the market. Which, you know, for, you know, for the public, you know, may in some cases be you know, be hazardous.
David Pudwill:And that's back to this idea that, you know, the the the incentives politically and for agencies is, to avoid harm, not to advance innovation, which is going to, you know, bring some, you know, bring some benefits. It's it's it's the harms that are easily calculated. Right? That, you know, those that happen for a product that was approved by FDA, that you can point to very easily and say, look at the harm that was caused that FDA didn't stop. But it's very hard to, you know, to be able to characterize and to quantify those harms that are caused because FDA is not moving fast enough to put other innovations on the market that would have done, you know, a lot of good, potentially even been lifesaving for certain people who didn't have access to them.
David Pudwill:I mean, one really good example here in the drug space is HIV drugs, and there was a public outcry about that. But, you know, basically FDA, you know, doesn't tend to move on, you know, in some of those kinds of ways unless there is a public outcry and a demonstration right outside their front doors. And maybe a
Derek Kreider:little bit more specific on on that delay? Yeah. So I'm not familiar.
David Pudwill:Yeah. So it used so this was, in Rockville, Maryland. There there were some demonstrations that happened. Oh, I've got I've got a picture of that too somewhere. 1988, AIDS protest at the at the FDA.
David Pudwill:October 11, 1988, AIDS activists occupied the Food and Drug Administration headquarters in Rockville, Maryland to protest for improved treatment and care. At that point, there were drugs that were being developed to help AIDS patients, and they weren't available, on the US market. And they weren't available to people experimentally or otherwise. And so you would actually I think this, there there was a, there was a movie, you know, about one of, you know, one of the guys involved, you know, here, you know, in a lot of in a lot of this where I believe they were going to Canada to get drugs and bring them in, I think legally so that people would have access to lifesaving drugs in the US because the US FDA wasn't, you know, wasn't allowing, you know, access to those, you know, to those drugs. And so it fundamentally changed FDA's approach, you know, to managing drug access.
David Pudwill:I would argue it didn't move the needle far enough, You know, in terms of access, I would, I would like to see actually more broad availability of drugs, even experimentally to physicians, with appropriate consent to patients. But I also see that on the flip side, we end up, putting, you know, labeling for, you know, for drugs, you know, in terms of what indications they can be used for, what they can treat, which I consider to be, you know, something that's bogus. And the drug companies would argue they'd done studies and they showed some defined benefit. But like for instance, there's one drug a doctor had been trying to convince me to take. And when I go and I look at the studies, the control group, so that the group where nothing is done, 3 out of 10 of those people get better without any intervention.
David Pudwill:Okay? And in the treatment group, 4 out of 10 people better. So the improvement is a 10% improvement on a population level, right? Because 3 out of 10 of those people were getting better without any intervention. You've seen an improvement of in in one out of 10 of those, subjects with the drug.
David Pudwill:But you also see some really scary and sometimes fatal side effects. You you you have this interesting, you know, situation where, you know, I would argue we don't put enough drugs in the hands of physicians to use with, you know, with appropriate safeguards in terms of patient, you know, consent, etcetera. But at the same time, we then approve the drugs that are on the market, again, for those big existing players, similar to something we talked about earlier about, you know, the incentive structures benefiting current companies and current, you know, supplier relationships, etcetera. We, you know, we're we're we're expanding the indications for what existing drugs, you know, can be marketed to do, know, what, you know, what they can treat. And that's, I don't know.
David Pudwill:It's just it's very interesting if you if you start, you know, going down that rabbit hole.
Derek Kreider:Yeah. I think I've I've exhausted all of my my questions that I can think of. I think you've covered, you've covered, pretty much everything that, I could have imagined getting to. So it's just like a short recap, and then you can maybe correct me on anything or or fill in any important points that you think I missed. But, so it seems like today, people are very tribal and and that seems to extend into the institutions, which are tribal or what we'd call probably political, right, being political instead of seeking truth, seeking position power, advantage of some sort.
David Pudwill:And the agencies themselves accrue power to themselves as opposed to serving the interests of the constituents that they're, you know, tasked with serving and the people that they're supposed to help. So, you know, there's there's that power dynamic
Derek Kreider:as well. Yeah. And because of that, they they do things that are either deceitful or untruthful or not in the best interest of their constituents. And therefore, they they lose trust and which polarizes people even more because, you know, some groups see conspiracies everywhere and and other groups, who agree with the political decisions are like, well, they've got my interests at least, so I'm all on board. And what we end up seeing is that maybe there's not one overarching big huge conspiracy, Illuminati type conspiracy thing.
Derek Kreider:But when interests converge and you get these systems that can be manipulated or systems that, by happenstance have kind of landed the way that they are and advantage to people that they advantage, those things get solidified, and you get this cyclical revolving door effect, which just perpetuates and and exacerbates and maybe, you know, grows the problem over time.
David Pudwill:And I would just add, it's oftentimes not out of a nefarious intention. Right? But there's a willful blindness to those things, that aren't in service of my interests. Right? And, and, and I think to some extent that's human, but we see it permeating our institutions at the moment where people are willfully blind to counterfactuals that don't suit their particular narrative.
David Pudwill:And and that's a very easy thing to fall into as a human being, you know, be because we don't see reality as it is. I mean, even our visual system, you know, is is is, you know, we're talking about, or or you were talking about detective work. Right? I mean, it's it's notorious how faulty human vision is in terms of seeing things that aren't there or not seeing things that are right in front of you. And so we do the same things in our minds in terms of the positions that we hold and maybe the reasons we should reconsider holding those positions in the first place.
Derek Kreider:Yeah. There are all kinds of of mental, illusions and and things that go on. So confirmation bias is something that happens a lot. But then, I don't know if you're familiar with change blindness, but where you kind of just, you just see what's normal and, and you don't notice the change even when it's drastic. I don't know if you've ever seen that, the, the basketball one, you know, where they're
David Pudwill:all different. I love that. I love that with that, with the, with the guy in the gorilla suit or something.
Derek Kreider:Yeah. Yeah. It's just, I mean, every nobody ever gets it. I didn't get it. And it's just, it's astounding that you can miss something so obvious.
David Pudwill:And the things that are right under your nose, you tend to start ignoring as well. And that's, that's one of the things that, you know, so like right now I've got a lot of clutter in front of me on the desk, but I, my, my brain spends a certain amount of energy just ignoring it. Right? Whereas if I'd actually gone and cleaned it up, spent some real energy doing that, my brain wouldn't have to constantly spend cycles ignoring, you know, the clutter. So And it's it's yeah.
Derek Kreider:It it's amazing. Like, our house will be cluttered. We are we are not super disorganized, but we just, you know, we have different priorities, I guess. And I don't notice the clutter until it's like, hey, we've got company coming over today. When did the house become such a mess?
Derek Kreider:It's like that, that trigger of, oh, we have company coming over today helps me to see things that I didn't see just a minute ago.
David Pudwill:And and that's fundamentally one of the challenges with bureaucracy. Right? So one, the clutter accumulates. But 2, we've gotten used to ignoring a lot of what's there. So we don't even see or people within the bureaucratic state don't see the impact that that clutter has on everybody around them or on the, you know, sort of on on on how things would otherwise operate if they cleaned it up a little bit.
David Pudwill:And there's also this situation where there's not a lot of reinvention. Right? It's like this is what we've been doing. We've been doing it for a long time, and you don't necessarily recognize the reasons that people started doing that thing in the first place. And the situation on the ground may have changed such that it doesn't make sense to be doing that anymore.
David Pudwill:So, you know, one one for instance there that I'll leave you with is, you know, FDA started as a small number of people, and basically, I believe it was called the poison squads back, you know, late 1800, early 1900. You know, the the the these folks were tasting, like, trying out different commercial, like, foods and seeing if they got sick. And if they did, they do some further investigation. Right? And at that point with a group that small, it made sense that you had to bring everything to you.
David Pudwill:But any more the the size and and scale of what we're doing at an institution like FDA, there are so many people there, they could actually go out and visit all of the facilities directly. They wouldn't have to bring everything to them. And so fundamentally, when you hit certain scales, the way that you should operate in being most efficient and most effective, might change. And I would argue, that we've gotten to that kind of a situation right now with a lot of our institutions where they continue to do the things the way they've always done. But the reasons they used to do those things in the manner that they did them, it's no longer the situation.
David Pudwill:And we should be rethinking how we go about doing business at some of these, you know, federal agencies because they can be a lot more effective if they go out instead of bring everything to them.
Derek Kreider:Alright. Well, I, I told Catalina at midnight, and it's it's, right about that.
David Pudwill:It's a little bit after. About that time.
Derek Kreider:So Well, thank you for your
David Pudwill:patience and and, you know, we we always tend to go long, but I'm I'm, I'm I'm glad you put up with my, you know, long winded, you know, conversational stuff.
Derek Kreider:No. I appreciate it.
David Pudwill:Yeah. Yep. Now now you've gotta send it to the editors. It'll be like a 10 minute, you know, edited clip. You know, you can take out all the, all the extra bits and pieces.
Derek Kreider:Yeah. Unfortunately, I'm the I'm the editor. So I which
David Pudwill:So not so much publishing in its full on adult you know, on on unedited
Derek Kreider:Most of the time I do. I do very, very little editing. I'll have to do a little bit more on this one just because of the the breaks and because of the breaks. But, yeah. I generally I I've got a list of questions, but with this one, it was more of just chatting and seeing where it went.
Derek Kreider:So
David Pudwill:Well, hopefully, we covered all the bases. And if we didn't, I'm sure we can chat again soon.
Derek Kreider:Alright. Sounds good.
David Pudwill:Well, thank you very much. I I hope it was useful and helpful for your audience. And, I I, inquire, you know, about, you know, negative feedback from people, or or I solicit it and welcome it. So Yeah. If anybody, you know, has, you know, some ideas about where I'm horribly wrong in any particular, I would I would love to hear it.
David Pudwill:You know, so please, so please do send Derek your negative feedback so that I can get it. Thanks. Yeah.
Derek Kreider:Alright. Sounds good.
David Pudwill:Alright. Thank you.
Derek Kreider:That's all for now. So peace, and because I'm a pacifist, when I say it, I mean
David Pudwill:it.
Derek Kreider:This podcast is a part of the Kingdom Outpost Network. Please check out the links below to find other great podcasts and content related to nonviolence and Kingdom Living.
