YouSaid · the spoken record

Daniel Carpenter

lines on the record: 80
first: 2021-05-05
most recent: 2021-05-05
sittings or episodes: 1
sources: podcast

Every line below is reproduced as it was said and linked to the record it came from. Nothing here is summarised or generated. Directory · Search · Corrections

“Thanks. I think maybe you'll disagree, but I think most of your academic visitors would agree that sooner or later you need something where when you do it, you can't think about work. Not that you just don't, but you almost can't because of the absorption into a task. I disagree with those who say that fly fishing is some kind of Zen practice. I mean, I've spent enough time, you know, freezing on a stream fishing for steelhead in the Great Lakes or the Pacific Northwest or fumbling with my knots and things like that. There are moments that are, I don't even know what Zen is because I don't practice it, but there are moments that are definitely contemplative and lovely, but it's absorbing and it's absorbing in some very beautiful places. I've got a brook trout right behind me and a picture. It's one that my students see in all my lectures. I happen to think that brook trout are some of the most beautiful creatures on the”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Practices and the way they're regulated by state governments and the kind of maze that different Native Americans have to navigate as they practice their traditional cultures.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Without getting into a long personal history, I'm not indigenous myself, but I've got a number of family members who are on different both sides. In part, it was hearing just different stories around dinner tables, family reunions, things like that that made me start to think that these are things that we should probably be studying. The work I do now is in part work on native history, allowing these people to understand, not allowing them to understand they understand it pretty well, working with them to better understand their histories of petitioning, advocacy, things like that, lobbying. In some cases, like one of the courses I'm teaching right now, part of what we do is work with particular tribal communities, nations that are dealing with some pretty significant issues like suicide and suicide prevention at the Fort Peck Reservation or traditional food gathering.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Yeah, so I grew up in a very small town in Michigan. My wife also grew up in a very small town. She actually grew up on a farm right next to an Indian reservation. And we had one near us as well. I didn't think about it for a long time. But when I got digging into this petitions project, I spent a lot of time in the archives, as I did in the FDA book. And as I began to look into the petitions, I just saw more and more petitions from Native Americans. And that's part of the reason that I emphasize them as much as I do in the book, is that on a per capita basis, maybe the French Canadians aside, few people are petitioning as much as they are. And then that got me into thinking, also, you know, why don't political scientists study Native Americans? I mean, there's, you know, millions of them, especially start to take a look at Alaska, First Nations, things like that. You've got all this variation in tribal government. So part of it was an intellectual interest.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Closure of agendas, which makes parties efficient, often prevents some of the best ideas from reaching the table of policy.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Think we're at risk of in the United States, and of course, which has happened before. And so it would basically be a way to make not just the United States more democratic, but actually to make the Democratic Republic more deliberative. And it would be inefficient, I'll be honest, you know, at some level, you could say, well, yeah, wouldn't legislators, you know, be better off reading scholarship from economists and doctors and things like that and getting presentations from people in the know. You could argue, yeah, maybe they would. But I actually think it would potentially increase social trust. And by the way, New Zealand and Canada do this now, right? Of course, you can always say, well, yeah, New Zealand and Canada do everything better. Maybe they do. Maybe they don't. But it's not unknown for this to occur in the modern day. So again, giving the people a sense of being heard. And then I would say arguably potentially opening up the legislative agenda because I think there's a degree to which”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Well, let me extend part of the logic of my book a bit. I actually think it wouldn't necessarily be such a bad idea if legislatures were to reintroduce. I'm not saying this would be the top ranked reform, but I don't think it would be such a bad idea if legislatures at all level of government had to reintroduce petition days, such as govern the United States until the 1950s and many state legislatures. And what it would mean is that I think part of the problem that we're, you know, we've got institutions that are efficient at some level. If we want to take a massive millions, hundreds of millions of people and condense their preferences down into a single platform and a single label, parties do that well. The problem is that so much gets left out of the process to say nothing of the kinds of polarization that can end up really kind of breaking a society into two, which I do.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“And benefits that directed petitions, which are the kind of petitions that I write about in democracy by petition, do. And so in part, the answer to the question is, yes, I agree that I'm not that high on the initiative and referendum process. Ohio, by the way, if I can bracket, has a policy that might be a little better, which is to say, all right, we're going to let the legislature pass a law. So we're going to respect the Republican small R process, separated powers, things like that. We're going to allow the people to veto it. But then the agenda is then set by the Republican process, mixed regime, and so forth, not untrammeled, purely discretionary lawmaking power or constitutional amendment power, again given to that 50 plus epsilon percentage points of people on a given day. And then what I will just say again is I think in part, you know, petitioning, I don't know if it's net harmful, it's definitely become.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“So let me just say that's about initiative and referendum. I'm not going to wax much more generally about, say, school financing or bond issuances, things like that. But at the level of California, yeah, I do have problems with those institutions, in part because it weakens the separation of powers. It weakens deliberation. One advantage of representative government is that there are certain kinds of deliberation investigation that go on. It weakens compromise, right? It's either we're going to have this ballot proposition or we're going to have the status quo. And nobody gets to go into the ballot and say, oh, let's think about a third option between the two that might be better than both. The ballot and the plebiscite doesn't give you that option. I distinguish for that reason between plebiscitary petitions and what I call directed petitions. I also worry about plebiscitary petitions and I don't think they have the same value institutional robustness.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Yeah, so I do agree with that. I teach a course at Harvard called Respublica, or it used to be called What is a Republic. And I argue that I think it's problematic when not just, say, a policy, but any constitutional”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Kinds of institutions that we used to impart because we don't have a petition institution that structures robust public debate as much as we used to. And I think that's a problem.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“If I can use that term, was there in the 19th century now, but like you have to make it get hot right away. I'm reminded of that there was an electronic petition signed about 10 years ago contesting new card fees at Bank of America. I think it was by somebody in Chevy Chase. And I remember the story was in the, and immediately, like within days, hundreds of thousands of signatures, Bank of America backed down. I don't know, by the way, whether that's good or bad economic policy. Probably an effective petition from the standpoint of having changed things. And can you imagine any other institution, the courts, parties through which that would have happened? Nowadays, we could say social media. Somebody could jump on the social media and say, hey, look at this awful card statement I just got. And then you get a bunch of likes. So it's some kind of aggregation mechanism like that that can do that. But I don't think we have the...”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Look, we're in a different world now, especially in the United States, where I don't think petitions have quite the societal and historical imprint that they used to. There's a whole bunch of reasons for that, but I want to answer your question. I would say now, in part, while we don't have, let me just first bracket this by saying we don't have anything like the legislative petition process that we used to have in the 19th century. And by the way, Canada still does. And Canada still gets, I think, 1,500 paper petitions per year. Now, we could get into a whole argument about whether that changes anything. I think what you're going to see with petitioning nowadays, especially of the electronic variety, occasionally of the plebiscitary variety, like the initiative and referendum, is that select groups and interests that know how to make something go viral.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Yeah, excellent question, Tyler. So I think the 19th century is easier to answer because that's what I just wrote about. What I see is particularly during this crucial period, say the 1820s to the 1850s in the United States, Canada, parts of Mexico, people who didn't already have organizations, didn't already have parties, which of course in the United States especially were really important technological innovation, didn't already have lobbies, didn't already have interest groups. We're able to successfully harness the petition to make their voices better heard, to set the agenda. I think agenda setting is really important when we think about democratization and also to organize. I mean, what I argue in the book is that everything from anti-slavery societies to new parties such as Canadian reform parties, the American Whigs and others drew much of their energy and structure from early petitioning campaigns.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“In the United States. Finally, as I mentioned, and there are other historians who have really, I think cemented this story better than I have. Malcolm Chase, who's arguably the historian of the Chartists, working class reform in Britain depended heavily upon lessons that the Chartists and other working class agitators in Britain learned from the French Canadians. They called them our brothers in oppression in the 1830s, and a whole host of things that happened as the suffrages open, as a whole bunch of changes happen in 19th century Britain were taken with at least partial inspiration from French Canadians, the patriot movement, as I described them, and these petitions.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Petition of the Atlantic world of its time, a single petition with over 90,000 names attached that was signed in what is today Quebec and with which the French Canadians did several things. First off, they fought off colonial fusion. If you ask yourself, you know, why does French Canada still French Canada and why is Canada bilingual? You kind of have to point to these petitioning campaigns as one of the reasons that colonial fusion was fought off. The other thing that they did, which was not easy to do at the time, was to depose a colonial governor, even in British North America, you know, the 13 colonies that eventually became the United States, getting a colonial governor deposed was much easier through elite mechanisms going through the colonial office, going to the crown than by massive protests. And that's exactly what they did with deposing Governor Delhousi.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“No, and by the way, your questions have been challenging and thought-provoking all along. This has been great. So, yeah, I think actually, you know, we tend to think, oh, what are the big petitioning societies? The United States, Britain, Anglo-American societies, and in part French Canada is that because it's still technically a colony. But I would say two things happened. At some level, it was kind of a Jacksonian revolution before Jackson, 1822 and even 1827 and 1828 before Jackson was president. You get what would be called kind of a producer's revolution in favor of parliamentary responsibility and parliamentary sovereignty. And at some level, you could say, well, weren't they just doing what had already happened in the United States with the American Revolution? And I would say no. And let me be clear. What I'm talking about here is arguably, you know, the largest on a per capita basis.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Great question. So, I think if you think about the International Women's Rights Movement, not just the United States, but also New Zealand, Australia, Canada, even France And they saw that, especially white women, as they learned actually at some level, Native American women in the United States were petitioning in ways that were more innovative, even compared to white women. But as they saw this, what I call the accountability of voice, the idea that their voices could matter not only in the arguments they put forth, but also in the weight of the numbers. I think that became a much more powerful motivator for women's rights movements to make bolder and bolder claims for the vote.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Institutions is also important. Back when I wrote the book on the FDA, I spent a little bit of time in India and thinking about its issues in regulating drugs. And of course, there's a lot of drug manufacturing in India, a lot of generics manufacturing and so forth. I don't know the stats offhand, but the FDA has any number of times had to crack down on generic drug manufacturers in India. There have been a whole host of quality problems there. If we think that a country has weak scientific and kind of credibility-based institutions, then I'm fine with allowing the trials there. But I'm also fine with regulators in advanced so-called advanced industrial countries saying, yeah, we're not going to allow those trials or we're not going to accept those trials as pivotal for approval.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Think it should be allowed, but I also think that the FDA is or any other regulator, say it's Britain's regulator, which by the way, I don't think is that laissez-faire. I think compared to Europe, if anything, European pharmaceutical regulation from which Britain has just only recently broken has long been at least as procedurally conservative as the US, say, since the 1990s. I think it's entirely fine for some of these wealthier countries to say, well, we don't trust those trials, and we're not going to rely upon those trials alone in, say, a pivotal phase three or a really important phase two trial. You get into problems with what's the quality of a country's institutions. And this is something we usually think about from the standpoint of, say, somebody like Robert Putnam or Douglas North or Margaret Levy. But I think institutions and the credibility of scientific”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“We kind of already do. I mean, vitamin D was that way for a long time, right? And so that's one of the things that, again, there's where we get into a different kind of form of regulator. In part, it's the FDA, but in part it's state medical societies and practice boards.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Label There are some people who say, Well, then the label beyond the block box really isn't effective. I actually agree. It's not that I'm generally a glass half full guy. I just happen to think that actually 50 to 60% of people reading the actual label is actually something that we should be pleasantly surprised about.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Actually, so there's an argument so that I think one of the findings out there is that BlackBox labeling definitely changes behavior, sometimes for the worse. So there's an argument out there that when you added suicidality to SSRIs, that one of the results was that people were psychiatrists and primary care physicians were prescribing them less commonly to teenagers, adolescents, and others. and that we had increased suicides as a result. And so I think we need to think very carefully about there ought to be, just call it a cost-benefit analysis, I think is both right and wrong. I think there needs to be a perspective consideration of what the costs are of putting the health costs, of putting something on a black box label that would do it. The other thing I would say is the usual argument is that what doctors only, what, 50 to 60% of the time read.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“So, again, I'm going to put out a different counterfactual, Tyler. I wonder, again, and a part of this is inseparable from the fact that we just had a really, really divisive election. But I actually think one big feature of the increased confidence in the vaccines is that they were approved after the election. I'm not saying they should have been, but I'm saying if you would have rushed things out in September and October, which was precisely when vaccine confidence was at its Nadir, was actually much higher during the summer beforehand, but it had sunk again 10 to 15 percentage points. You would have had a vaccine that tens of millions of people were not taking.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“You miss with the good housekeeping model. You don't have any incentive for sort of continual study of things that are sometimes like Prozac or a statin are taken for five, ten, fifteen, twenty, 30 years of a person's life.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Decisions is you get in some cases what might be rational hesitancy on the part of treatments. I think we can say right now with the benefit of hindsight, hey, look, we've got these great mRNA vaccines, we've got some other vaccines out there. Sure, if we had done things differently, that's right. But of course, that's not what I would regard as a proper rational invasion way to think about it. The question is, what decisions should we have made at the time, given the information we had? You might be saying, well, I want a value function that places heavy, heavy emphasis on the option value, that things could just go right here. I'm very much open to that. But what I want also is a world where the unknown, deeply unknown product studied or being potentially approved gets studied massively, thoroughly, and where the studies continue well after approval. And that's, by the way, something else that”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Who approved it over and above the other objections. And that's fine. He had his right to do that. But it was clear from everybody watching that this was not the usual approval process. So you say, oh, what's the problem? Mike, now we've got this drug for, you know, a deadly disease that's on the market. Well, the problem is lots of insurers now won't cover it. Still won't. In the New York Times ran a story about this, and they got one exec to say, and I'm paraphrasing, you can look up the story, but I know I just looked up a whole bunch of Blue Cross Blue Shield groups still won't cover Exondis. They basically said, we don't know whether this works. And these are not folks, this is not vaccine hesitancy where you've got all the kind of standard psychology. These are informed purchasers, right? And so part of what happens when you have procedural irregularity or corners cut or bad evidence underlying approval.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“It's that we don't trust certain kinds of procedural irregularities that are going on at the FDA, which of course are very deeply Trump-related. But I'll give you another example. It's a completely different example in a different world, but I think it's important. It's a tragic story. There's this deadly disease, Deshen's multiple dystrophy, for which was developed a really important drug called etiplersin or exandus. And it was approved under a very, and I say it's an important drug, it's an important drug therapy. It's actually still not known whether it works in many respects. But the FDA approval procedure was, shall we say, different and marked by much more controversy than usual. The advisory committee voted against it. The division director voted against it. Janet Woodcock, Cedar Director voted for it. I believe it was then Commissioner Robert Caleb.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“So two things. Number one, I think the UK is, again, kind of Sui Generis. In part, they trust their own company and they trust their national health service. They've got a very good public system, which if we recreate it in the United States would really dramatically transform that. Look, the correlation between vaccine hesitancy factors as expressed in public opinion and vaccination, first dose vaccination of eligible population in the United States is 0.6. That's an extremely high correlation. So rather than just use a story, let's actually look at data. And the data suggests, in fact, that public opinion on vaccine confidence is a very, very strong predictor of actual vaccinations in the United States. The other example I would say is part of my theory of the FDA is let's divorce it to some degree from vaccination more generally. Let's look more broadly at what happens. It's not that just that people said last summer, oh gosh, we don't trust.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Right after the convalescent plasma debacle showed a 10 to 15 percentage point decline and possibly greater in vaccine confidence. And you would have lost thousands and thousands of lives that way. At the end of the day, vaccines are only as good, especially a treatment with positive externalities. Vaccines are only as good as the set of population that takes them. And again, I emphasize it's the young that you need for herd immunity. the marginal benefit of vaccinating the young is higher for herd immunity.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“And the mathematical models would suggest that's exactly the population you want to have vaccinated sooner or later. Why? They're more mobile. They're much more likely to be vectors. So I've done some back of the envelope calculations. I shared them with Ezra. I've also presented them to this group. And if you just, you know, we start to think about what's the social value of good vaccination just for the United States, right? And we think anywhere in the area of 10 to 20 trillion, I know some economists who think it's much higher. But now we think, okay, what if the vaccine, because you could talk about, you could have said this with vaccine just about any vaccine. Pfizer's readout from its data wasn't until November, but you could have said, well, why didn't we approve that vaccine in May or June? And you would have had, I think, a social catastrophe, tens of millions of people not taking the vaccine, very consistent with those polls that”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Just to me, actually, I'm not sure that the AstraZeneca vaccine would have been taken in the United States. So you reference the Ezra Klein story. And I gave a talk recently to a group in Israel and Europe on regulation where I said the big bullet we dodged in the past year was one in which there was all this pressure in summer 2020 on the FDA to quicken a whole set of therapies for coronavirus and COVID-19. And this obviously started with hydroxychloroquine, which I think the jury is in on that now, not effective. Convalescent plasma probably very effective, but its rollout certainly didn't help. And what you see in at least two different surveys over the summer of 2020 is pronounced drop in expressed willingness to be vaccinated, anywhere from 10 to 15 percentage points. And deeply concentrated among the young.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“I disagree with that strongly, Tyler. Yeah, I disagree with that strongly. No, again, AstraZeneca has had credibility issues all along. So the idea that vaccine hesitancy is just some regulatory construct or some byproduct, I think is number one demonstrably false. And number two, I think it misses the big problem that corporate reputation matters. And AstraZeneca, I could grant that, yeah, maybe we should, you know, roll AstraZeneca out there about the thousands of lives counterfactual. I'm going to just agree because it's not clear to me, and you might see this problem with Johnson and Johnson. I clearly see it in a lot of conversations. It'd be interesting to see survey data about whether people trust certain brands more than others. And part of it is vaccine nationalism. You know, the French don't trust the British. The British trust what's endorsed by their national health service, but also their own company.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“So, I actually think the AstraZeneca vaccine is more complicated than the story that you're saying. So in part, it's what Dr. Fauci, now our national healthcare celebrity, but deservedly so, called an unforged error. So you should check out the Karen Landman op-ed at the times back on March 23rd. As she shows that AstraZeneca has had managerial issues all along with production, with testing, early problems in data reporting, manufacturing problems in Belgium. Then there were study design and data reporting issues that were called by the company's own DSMB, the Data Safety Monitoring Board. So there are a whole bunch of folks. You could say, oh, well, there's a whole bunch of folks who've approved it. Of course, as we know, in many cases in Europe, there are people who don't want to take it, in part because of its bad reputation.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“But I have no problem in saying that, yes, I think that that was an issue. But look, we can always find a single example of where an agency was too slow or too conservative. Or, and I think this is the other way, stuck to its scientific procedures too much without adaptability, which I think is one of the cases, one of the problems with the FDA and testing, and not think about all the other cases in which, no, the FDA was right to abide by a certain procedural conservatism.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Yeah, but no, I hear you. But actually, Peltzman, for what it's worth, the original article was more about sort of number of new chemical entity introductions, and it was really much more about the regulation of the research process. And people like to say, well, is it FDA too slow, FDA too fast? A lot of that just came from Congress, from legislation, including the 1962 Kefauber Harris drug amendments. In this case, I think there's a very plausible case. In the case of testing, yes, I think there's a very plausible case that the FDA was too slow. Exactly what the public health, did that cause more deaths than, say, a culture that didn't take COVID seriously, people not believing COVID was a problem, vaccine hesitancy in the United States, which I think is pretty significant. You know, that's much harder for me to, or I think for anybody to judge what the marginal contribution”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“No, so let me just say I agree with the criticism of the FDA on testing. And I'm pretty sure I mentioned this to a reporter back in the spring. I don't know whether they ever, I've said this to a number of folks. For what it's worth, again, keep in mind that that's actually not the same division that approves drugs, which, by the way, is not the same division that Sam Peltzman critiqued. So I don't think it verifies Sam Peltzman. And it's not clear to me.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Approved, say, cisplatin would be an example. The first platinum based chemotherapy. And then basically knows. I think the FDA knows that when a lot of these molecules are out there, there's going to be off-label prescribing. That's not to say, however, that off-label prescribing is not regulated. Whether something is on the label or not is still a significant decision. And I've written about the case of Bevisimab for breast cancer. And that was a pretty significant decision by the FDA and one that a number of industrial interests fought against pretty hard, in part because they knew that money was on the line.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Right, right. Excellent. No, good question. You know, I've thought about this a little bit. I think there's a lot of room for flexibility in the current system. And one of the things that I try to say, I'm not, you know, I'm happy to criticize the FDA on any number of things. And I'm sure we'll get a chance in what time we have today. But there's actually been a fair degree of flexibility. Maybe it's come slower than you might hope for in cancer. But cancer is kind of sui generis in many respects. Adherence rates are very high because a lot of the drugs are given just directly in the clinic. It's a community of researchers that essentially highly closed. I mean, there are some, you know, doctors here and there who do things, but governed immensely by ASCO. There's a kind of a community of practice there. And so what the FDA does in a lot of these cases is allows for a molecule to be”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Deeply decentralized, subject to all forms of bias, and that's juries at the state and local level, not the federal level, right?”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Yes, although keep in mind that if the doctor rolls out new medical device, which leads to a lot of surgical innovation, that device has to be approved by the FDA. There are, of course, other kinds of bodies, and it's not just the tort system, but medical professional societies, things like that that regulate that space very well. So when I say very well, very strongly, I'm not saying that's an optimum policy. But if anything, I'd say far more than in the case of drugs, in the case of surgery, it's the tort system that regulates that. And, well, pick your poison. I'm not sure the tort system is, I mean, you could say that's a system that works well. Really? I mean, do we know that, you know, surgical innovation has provided that much more in terms of health benefits than pharmaceutical innovation? I haven't seen the aggregate accounting, but if it has, the form of regulation there is...”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“But let me just stop you there because I think there's an important difference. And I think you're an economist. I'm not professionally trained. My wife is spend a lot of time around economists. I think the biggest difference here is that cars are experienced goods, maybe even inspection goods, and drugs are credence goods. We can't really know whether or not, even if we were cured, whether the drug was the cause. And that gets into a lot, and I've written about these kinds of issues and other things. And so I don't usually buy the model of, you know, cars or other kinds of experience goods as mapped onto drugs because I think the information structure of those markets is quite different. And I think that the role of beliefs is far, far more important, collective beliefs, if you will, Bayesian priors about whether or not such things work is absolutely central and deeply endogenous to the value of the product itself.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“But why if you can just go and sell it offline and then advertise your way into the marketplace? This is exactly the way that patent medicine industry worked.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“But that's kind of a partial equilibrium story. I'm talking about a world where these institutions didn't exist, where neither the UK nor the US had anything like the FDA, anything like an approval regulator.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Consumers. And I mean consumers at all levels, so payers, physicians, nurse practitioners, pharmacies, folks who decide on formularies, and then relevant to vaccination, the people who get the shots in their arms or whether or not they adhere to the drug. Well, they've got other ways to do that, and that's advertising. And so you could have a world in which it's kind of like a lemons equilibrium in which essentially you would have lots of bad products out competing good ones.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Yeah, I think I would say two things. Number one, it's a brute mechanism, but the mechanism of what I would call approval regulation, which is basically the FDA as a veto player granting access to profitable markets, creates very, very powerful incentives for R&D. And those are incentives that we would otherwise not have. My worry is that in the Robin Hansen case, and by the way, I haven't read this particular case, but I've seen some, you know, FDA is good housekeeping seal of approval. We basically, you know, there are different ways of generating information. We want the good stuff. We want the RCTs. We want credible information. I'm happy to talk about Bayesian clinical trials, so-called real-world evidence. That's a term that's thrown around a little too much without definition. But if we're thinking about ways that, say, a pharmaceutical company can inform its potential.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“See, yeah. So I'm going to say again, it would be easy for me to say underrated or overrated. I'm going to say, you know, it really does depend. The revolving door constraints might be overrated. I think I worry a little bit less about people moving back and forth than others do. It turns out there's some evidence that banks and other firms, companies that want talent are most likely to get the regulators who are toughest earlier on. And so I'm not sure it leads to the usual kinds of stories. In terms of small favors, let me say that I think that's underrated. I think the psychological literature has demonstrated that small gifts are sometimes the most powerful ones.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“For our globe, for our country, kind of creeping authoritarianism, I think FOIA is and strongly enforced because it was just weakened by the Supreme Court is one of the most important laws that we have”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Depending on how enforced, I would say underrated, they have had one cost, which is it used to be the case, I don't want to say it's a cost, but they've changed an equilibrium in one sense, which is that it used to be the case that kind of reporters had to cultivate a relationship with an agency insider, a bureaucrat in order to get information out of that person. And what that led to sometimes was, of course, while we didn't see as much, but it also meant that the reporter became better informed about what was going on in the agency. And there are stories you can tell, you know, reporters and mid-level agency folks who would talk on a semi-regular basis for years. Now, they kind of don't need to have that relationship to get the information they want. And so they just file a FOIA request and they get it. Now, that said, and again, going from the experience of the last few years, going from what I regard as a critical worry.”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source
“Folks in Fairfax County, the NIMBY folks, the anti-nuclear power folks, they're already pretty well represented in this process”
2021-05-05 · Conversations with Tyler · Daniel Carpenter on Smart Regulation · IDENTIFIED FROM THE TRANSCRIPT · source