hello everyone and welcome back to conversations with tyler today i am here with daniel carpenter he is one of the world's leading experts on regulation he is perhaps the leading academic expert on the fda he has a new book coming out this may called democracy by petition
popular politics and transformation 1790 to 1870 and he is in the department of government at harvard university daniel welcome thanks for having me tyler now we will get to the astrazeneca vaccine but first let me ask about a few other topics the pendleton civil service
act of 1883 right the goal was to replace hires by patronage with hires by merit how should we be changing that act today oh good question uh i think i would um begin by saying that um i'm not sure we need examinations which by the way still exist in many areas of
the civil service that we should have perhaps minimum criteria but the criteria should not be reduced to say a four-year college degree um i do believe that uh the pendleton act created uh the basis for the decline of patronage uh and it took a while um the pendleton
act depended heavily upon presidential enforcement and it was actually theodore roosevelt two decades after the act more than two decades after the act who really uh implemented the pivotal administrative decisions there but i would say if we were trying to do
this today i would actually reduce the number of political appointees at the top levels of the civil service it's actually relevant to some recent uh politics regarding the fda surely the leaders of an administrative agency executive branch or so-called independent commission
are appointed by the president that's an article ii power they should continue to be appointed by the president it's all of the other folks communications under secretaries and so forth uh that i think um i'm not sure about the added value of those appointments
and i think we would do better by restricting their number but the regular appointees say the g14s just people in the agency how should the standards for their hiring and firing be different or are we at some kind of actual optimum oh no i don't think we're anywhere near
an actual optimum i think it's worth pointing out by the way um that you know the federal civil service which we're talking about here um is quite different from uh the state and local level civil service one of the things that merit reform did is it
it got rid of one form of politics by uh you know reducing the link between partisanship party organization and uh appointment at the at the you know middle and lowest levels but it introduced another um it accentuated and facilitated uh the growth of employee public employee labor unions
um and i have a mixed judgment on those um i i don't think you can have a conversation about policing like we're having in this country right now um uh without uh calling into question uh the value of some of those unions and the degree to which they protect their
members from uh egregious uh uh actions um obviously there's a huge literature there as well on [Music] teachers unions and other public employees unions at the federal level i actually think the federal employee unions are pretty weak and part of that is just basic political
science just about nowhere other than a few western states and you know i guess you'd probably say parts of virginia now are federal employee unions politically strong enough to make a difference in the kind of electoral calculations of a congressional majority
um so i don't know that we've reached an optimum there um i do think um uh termination uh uh at some level should be easier uh for basic non-performance um i i do think uh using career incentives uh among a whole bunch of um positions in the civil service should be
easier to do but i would say at the federal level you've got a situation where again i'm not going to say optimum if anything i believe the last presidential administration showed us the value of having an independent civil service one that cannot be used by um
you know a party or a leader who verges on authoritarian energies while at the same time avoiding some of the problems that one sees in the worst case of public employee union abuses such as we see in some police departments if one studies the history of postal
supply and regulation as you have done postal supply what lessons can we learn about regulating the internet today oh goodness because the postal service was a kind of early internet right remarkably cheap and fast by the standards of its time everyone had a
voice it was hard to censor yeah um i i mean look there are a whole sorts of folks you could talk to about your net neutrality and its value i i i would say that that you know our political culture in the history of the united states um and much of our economy uh and much
of our education system presumed an open access i mean minimal cost for sending letters with all these cross subsidies so the letters subsidize the newspapers which was crucial because the newspapers kind of created a much more informed society um it was a platform for advertising
things like that so um i don't want to go i don't want to make a simplistic mapping from that to say net neutrality because there are a whole bunch of other issues uh involved there but i do think uh the degree to which um providers can close off access
uh or make access to uh this this large uh externality um much more costly is um is a grave concern and for what it's worth at some level yes we're we're there with the internet now and at some level it's replaced the post office but as i recently argued in
the boston review not entirely there are still a large number of magazines uh newspaper subscriptions uh for that matter now uh uh you know pharmacy activities and others that rely heavily upon the postal system and probably will for the foreseeable future
in the 19th century how was the postal service central to the progressive reform movement um i think it was seen as the both the um exemplar of what a potentially open access uh public uh public service could be in a way that nobody had really thought about any other um
function of the federal government being so universal i mean even consider the army which we would today say is okay how can you define a state without its military and its army but as we know not really until the progressive era was the united states army unified and the
civil war was fought through militias um any number of other services uh were of course decentralized to the state level sometimes to the local and so progressives saw at one moment in the uh postal service um well here's actually something that the national government can do
and it can provide this platform this platform for you know a democratic republic open deliberation markets uh and um a much more um universalized cultural dialogue i don't want to say singular cultural dialogue you know pluralism was there um but a much more uh
globalized dialogue that said i think the other thing they saw in the postal service and this is something that theodore roosevelt saw in the postal service was something that was being eaten from within by the patronage system uh and it was in part uh the folks in
the pendleton act but i would argue even more the presidents who kind of really pushed civil service reform forward with their administrative decisions who said if it's going to happen anywhere it has to happen in the postal service in part because uh there's a big part of our economy as
well as our society that depends upon it and roosevelt uh before and after uh he made these very controversial moves to cover in as it said thousands of postmaster positions under the merit system actually received a lot of support from shipping industries and
sort of medium-sized smaller size retailers if we just outright privatized the entire postal system in america today what is the most significant change that would result i think you'd be cutting off um vast sections i mean truly privatized without a universal service standard
right right no price yeah we're not doing mob l you know we're not doing truly privatize i think basically you would accentuate and and accelerate um the uh bi-coastal concentration of culture uh uh uh wealth talent um and economic uh innovation uh in the
united states that may be isn't that a good thing though right to induce people to move to higher productivity regions uh agreed um i think uh there's all sorts of reasons to to think that you know depopulation of some rural areas uh might be potentially a good thing
um but i also think that there are ways to do that uh we certainly have you know lots of those pressures right now um and there are also i think ways to do that that um still i mean the the concern i have is that you know you're cutting off of a vast number i mean tens of millions of
people um from a part of their culture again that they still use those people can use federal express today right or ups yeah but i don't think that's going to be at least not until we get different models i don't think that's going to be a viable model
for express scripts i mean express scripts uses the postal system for good reason they don't use federal express what kinds of records should the postal service keep about itself uh great question um well there's uh you know there's a whole set of things that they don't since the
griswold decision and since the uh kind of you know first amendment decisions they don't keep as much uh they don't keep as much records of of kind of uh what goes through uh the mail they can't prohibit things like pornography contraception um
i think you know well i guess it depends on what you mean by itself i i would start uh with the idea that i think basic privacy restrictions which governed the postal system as much through norm as by law in the 19th century and early 20th century should govern the system so you know
it's a crime if if i were to walk past your mailbox and open your letter i'm i'm committing a federal crime uh uh but there were also norms that uh you know the seals were not to be broken things like that so i do think um whichever way the postal service goes
and it's quite possible that you could imagine an electronic platform uh for the u.s postal system um i think basic privacy restrictions uh have to be guaranteed i also think actually in some respects i think we need to know a fair amount about what postal workers do
without say calling for amazon like tracking but if we think that postal workers are misplacing ballots are uh you know not providing uh birth control pills or something like that then you know we should probably have some way of picking up on that kind of
uh nefarious behavior if we consider regulation in general at the state and local level should we think of that as simply a one-way ratchet that basically just goes up over time and hardly ever goes down and eventually gets to be too complex too cumbersome too restrictive
no i think that narrative is pretty easily falsified uh in the united states as well as some other countries um definitely as a one-way ratchet i mean if we want to talk about pure monotonicity um you know taken take into account first that um the
degree to which we see price regulation um which was exactly what the chicago school and and other capture theorists were so concerned about so long ago we've seen a whole range of areas where the government regulates prices far less and governments i should say regulate prices
far less we see far less regulation of antitrust m a than we used to i actually think that's a problem and i'm happy to say i think that i think the case against price regulation especially micro level regulation of prices um is is generally a strong one uh the case
against price regulation um we've seen uh a fair degree of deregulation in environmental spaces um and i would argue depending on which part of the fda you want to look at uh even in medicine's approval and things like that we've seen some deregulation um this is state and local level right
if you look at say freedom to build many more cities are putting restrictions on building than are liberalizing and you might expect over time the entire southeast will become a bit like say the california cities or cambridge mass for that matter where they just
don't want that much new to be built isn't that a one-way yeah in essence so i i think i think this gets to some of the differences between an economist and a political scientist i i see what you're talking about as a kind of regulation although to me um i see it much more as
kind of housing policy um and i think there are folks who say well let's try to construct a unified theory that puts you know uh the epa installing smokestack scrubbers uh mergers and acquisitions regulation zoning regulations because it's called a regulation
um and say some set of price constraints and puts them into a unified theory i think it's the the point that you're talking to right now whether it's kind of i i think there's a development in uh local level valuation of housing in american culture um that is leading many governments i agree
to crack down on on building you know happens in my own town uh to make building new construction harder and i could see that as ratcheting one way except of course now let's talk about some of those very rural areas uh that we just mentioned a few minutes
ago that are depopulating um it would be interesting i don't know the answer to this question to see whether uh there's more freedom to build in areas like that my guess is where you're going to see less freedom to build if you want to use that metaphor
um is in precisely the kinds of places uh on the coasts and maybe in certain aspects of the southeast um places that are uh driven in part by racial and ethnic discrimination but also by wealth discrimination that are going to crack down much more heavily upon
uh you know new building especially new residential building which are the most and least captured federal agencies and the technical use of that term oh good question so i don't i don't have a rank ordering for you um from which i can draw the top and the bottom
um i think knowing some people who've been involved in the space um and hearing seeing also what's gone on worldwide i would say one agency that has been captured uh or or plausibly captured would be the nuclear regulatory commission and i think there's a complicated story
there um the story in france where they also have nuclear regulation is that so many of the folks who work at that agency um come through the age uh the country's formidable technical schools and they're trained in a certain kind of way that leads them to be
much more likely to see nuclear regulate or nuclear power is a good thing for what it's worth uh i happen to be a a believer in nuclear power as part of a bundle of uh non-carbon-based uh energy sources that said i think it's very plausible that due to kind of professional
training things like that uh nuclear regulation may be a plausible case of capture both here and again in other countries and who has captured it in the u.s i think it would be some of the very power companies and uh you know interests there again they're the arguments the case where the
state and local governments are so restrictive right you cannot really get a new nuclear power plant built today that that limits the supply that's the one-way street we were talking about earlier and it's just harder and harder to access what seems to be a pretty good
solution for a lot of climate change problems uh i think that's right um but let's let's keep in mind that that restriction of supply uh you know raises the price and some equilibrium sense for those who supply nuclear power um and so it's not that i think i think
you're right that it's it's state and local governments it's a certain degree of of you know nimbyism on on nuclear power plants um uh but i would also suggest that uh there are um uh it it's not like you have a really robust coalition uh pushing for stronger or or
shall i say more laissez-faire attitudes on um [Music] more laissez-faire attitudes on whether to build more nuclear power plants or not let me just flip it by one i would say for the moment um probably the least captured agency and i wouldn't say the least a an agency that
is newer and less captured would probably be the consumer financial protection bureau that's not to say that i believe in every decision it makes um i do think there's something to the way an agency gets set up that when it's new um it's assuming it's set up in a certain way
it's got certain kind of staffers it's got merit service protection things like that that it is less likely to be captured and this is at some level a difference between the early political science theories of capture and the stiglerian theory stigler i'm about to participate
in a 50th anniversary um uh it's another podcast with luigi's ngalas on the 50th anniversary of stigler's theory of economic regulation his theory was really much more about legislative design um and much of the ways that you and i have been talking
about but before him there were two political scientists who were um thinking in similar but not identical terms one was my late colleague sam huntington who actually wrote in the icc and not the other was marver bernstein and marver bernstein who was at one
point dean of the woodrow wilson school he talked about the life cycle of agencies um and so capture wasn't something that was designed kind of you know de novo uh into an agency it was something that evolved in an agency that wasn't originally captured but became so
i'm not saying that's a better model necessarily but clearly sometimes that happens when capture by design does not if your least captured agency is a very new agency doesn't that make you out to be a lot more sympathetic to the capture theory than your published work might
make it sound well you have to remember uh my published work in uh in um uh the the book with david moss suggests that uh you know capture the problem with capture is it's too sexy a term um you know david and i wrote during the midst of the financial crisis when every
time somebody didn't like the decision of a regulatory agency a pundit an academic the the term capture would be thrown around and you can think that an agency is uh doing a good job a bad job efficient not efficient and capture can be potentially orthogonal to that that's the first
thing i would say the second and we really got hit um i'd arguably say more from the left than from the right on this is we actually we actually argued it's kind of hard to prove capture um you know you have to have a counterfactual of what an agency that wouldn't be
captured would in the same situation keturis paribus be doing and a lot of the existing empirical studies and this goes back you know generations and i'm i'm indicting a set of things in political science as well as economics suffer from the usual omitted variable
bias problems um and some of them i think we're making the wrong inferences from uh from the evidence that exists such as um you know noticing for instance that in certain kinds of patterns of regulatory decision making larger and older firms uh did better um
uh enjoyed say quicker or more favorable decisions than did smaller and newer firms and as i you know wrote in a uh it was a mathematical essay published almost 20 years ago that can be true even when uh the underlying regulator or the regulator in question
has zero implicit or explicit preference over the kind of firm it's regulating uh it has everything to do with kind of not even risk avoidance but uncertainty avoidance how can we improve the process for public comments on regulations or pending regulations
this is something i'm actually working on a bit right now let me say two things the first is uh there's a paper that uh your audience should check out by uh my student brian lieb gober he's a collaborator of mine too and what he did uh an ex excuse the
digression but i think it's a very important paper so if you look at the volcker rule for instance um uh it was a multi-agency rule issued under dodd-frank um long before the comments rolled in there were a set of hundreds of meetings with the agency that happened even before the
notice of proposed rulemaking and essentially the architecture that we have in the administrative procedures act doesn't regulate those meetings at all and a legal scholar named kimberly kravik i believe she's a duke or she was when she wrote the article
notice that the vast majority of these meetings and i i just go to the article but i'm going to say 90 we're with either large bank holding companies so not you know the smaller regional banks fifth third things like that we're talking you know jp morgan goldman sachs city
um law firms representing those companies like sullivan cromwell uh and um uh associations representing those companies get into a whole question about why the hybrid representation uh in in another but but that was one one thing is so so pre pre-rule making
pre-proposed rule making earliest agenda setting meetings are dominated by industrial interests the second um and this was an asset pricing study by uh professor lieb gober who's now at ucsd showed that the banks that met um uh though uh with the fed and he only looked at the fed
um and then he used a very small window for when the proposed rules were announced um and they uh witnessed and enjoyed a statistically significant and financially significant continual abnormal positive return on their stocks the moment the proposed rule was
announced not so much the final rule because that comes much later but the first and he totaled up i think 40 to 70 billion dollars of positive abnormal returns just from those meetings with the fed just in the first hour which is what an intraday study has to do uh
after the uh a proposed rule was announced so you're telling me this is good yes i'm not so sure i mean yes capitalizing banks it's making them more valuable it means the trading isn't all that risky not so let's go back to your original question though tyler because your
original question was about procedure and to me um i guess i'd like to see open access um so i'm not saying look i'm not by any means saying hey we need to get rid of these meetings i do think we need to embed consumer and non-industry uh perspectives more and what that might
mean is inducing rule writers to more regularly meet with advisory committees uh consumer labor other groups uh folks like the the group at better markets uh you know americans for financial reform things like that i'm not saying i agree with all of these folks but i do think
that right now all of our attention on notice and comment rule making and for that matter cost benefit analysis as khan comments into it this is the fact that there are people who are close observers of this space and now a very empirically sophisticated
observer in this pl in this space brian liebhgober who believe that most of the action is actually occurring before notice and comments starts if we take say nuclear power regulation do you think that giving all these groups you mentioned a bigger role in
nuclear power regulation would improve the outcome or make it worse it seems to me it would make it worse well why do you think that citizens groups mostly don't want nuclear power homeowners organize try to build a nuclear power plant in fairfax county you have zero chance so i so i don't
know look you know asking whether i know uh how folks would um whether the policy would be better or worse is is a tougher call but here it might operate in some um unpredictable ways uh so nuclear power regulation um you might get um you know uh stephen
pinker-like voices he's a person who you know harvard scholar who wrote um uh a kind of a pro-nuclear power op-ed in the new york times recently you might get some other voices at the table uh less voices less organized particularly if you embedded them in and
there are some there's a great chapter in our book preventing regulatory capture by daniel schwartz who's shown that at least an insurance regulation in minnesota um that minnesota has been able to do this whether it's made folks better off or worse off that's much harder to tell
um but uh i would argue in fact that if you proactively embed uh voices interests that wouldn't otherwise be represented um that you'll actually open up the conversation my guess if i had to if i had to think would be the folks in fairfax county the the nimby folks the
anti-nuclear power folks they're already pretty well represented in this process is the impact of foia laws overrated or underrated depending on how enforced i would say underrated um they have had one they have had one cost um 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 um it used to be the case that kind of uh 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 what we didn't see as much but it also meant that the reporter became better informed about what was going on in the agency um 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 i'm going from what i regard as a critical worry
for our globe for our country kind of creeping authoritarianism i think uh foia is uh and strongly enforced because it was just weakened by the supreme court uh is one of the most important laws that we have in the area of regulation the impact of ethics laws overrated or
underrated uh just clarification what do you mean by ethics laws like revolving door that would be one example but restrictions on people who work say in federal agencies if you work uh at a financial regulator you can't just let the people at goldman
sachs take you out for a fancy dinner right that's an ethics law we have lots of them i see yeah so i i'm going to say again it would be easy for me to say underrated or overrated i'm going to say uh you know it really does depend um i the revolving door uh constraints um
might be overrated i think uh i i worry a little bit less about people moving back and forth than than than others do um it turns out there's some evidence that that uh that banks and other agencies excuse me other firms companies that want uh talent are most likely to get uh the
regulators who were toughest uh earlier on and so i'm not sure it leads to the usual kinds of stories um in terms of small favors let me say that i think that's underrated i think the the psychological literature uh uh has demonstrated that small gifts are
sometimes the most powerful ones okay now the fda you've written yourself that the main function of the fda is often about information rather than safety if that's the case why don't we have what my colleague robin hansen called the banned product store that is the fda
would announce what it has approved but uh say treatments or drugs or vaccines that had not approved within reason would be available for purchase you just would know you were taking your chances why not do that have the fda provide the information only
um yeah i think uh i would say two things uh number one um uh it's a it's a brute mechanism but uh the mechanism of uh 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 uh robin hansen case uh 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 um we basically you know uh
you know there 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
um but you know if we're thinking about ways that um say a pharmaceutical company can inform its potential consumers and i mean consumers at all levels so payers physicians nurse practitioners pharmacies uh you know folks who uh 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 um well they can they've got other ways to do that and that's advertising um and so you could have a world in which um uh you know it's kind of like a lemon's equilibrium
uh in which uh essentially you would have uh lots of uh bad products out competing good ones for what it's worth why would they have to keep the good ones so the uk approved the fights are vaccine the u.s hadn't approved it yet i would have the option
of going to a special store and trying it right we would have saved thousands of lives well that's but that's but that's that's kind of a partial equilibrium story i'm talking about a world where these institutions didn't exist where where neither the uk nor the us had
uh anything like the fda anything like that have an fpa but it issues judgments that are like a good housekeeping seal if appropriate yeah but then there's no then there's no incentive uh or very weak incentives for anybody to do randomized clinical trials which i would
argue is one of the most important scientific revolutions of the 20th century you want to get the seal of approval right that's one reason to do a trial but why if you don't if you can just go and sell it offline and and then advertise your way into the marketplace
this is exactly the way the patent medicine industry worked well look at tesla all the r d they've done to create a better version of their car which they sell for a higher price let me ask you a different question but i think let me just stop you there
because i think there's an important difference and i think you know you're an economist i'm not professionally trained my wife is spent a lot of time running economists i think the biggest difference here is is that you know cars are experienced goods uh 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 um and that gets into a lot and i've i've written about these kinds of issues in in other things um and so uh i i don't usually buy the model of um uh you know
cars or other kinds of experienced goods uh as mapped onto drugs because i think the information structure of those markets is quite different um and i think that uh the role of beliefs is is far far more important uh collective beliefs if you will bayesian
priors uh uh about uh whether or not such things work is is abs absolutely central and deeply endogenous to the to the to the value of the product itself a doctor today can attempt a new method of surgery without getting fda approval right should we change that um
and it seems to work fine right well and there's plenty of rct's for surgery yes although keep in mind that if the doctor uh rolls out a new medical device which is leads to a lot of surgical innovation that device has to be approved by the fda um there are of course you know other
kinds of bodies and it's not just the tort system uh but uh you know medical professional societies things like that that um uh uh regulate that space very well um i say 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 uh 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 uh
you know surgical innovation has provided that much more in terms of health benefits than pharmaceutical innovation i haven't seen the aggregate accounting um but if it has uh the the form of regulation there is deeply decentralized subject to all forms of bias and that's and that's
juries it's at the state and local level not the federal level right take off-label prescriptions for drugs right which are highly significant phenomena as you know right that's not subject to fda approval should we change that in essence a lot a significant
percentage of total drug usage is not regulated directly by the fda yeah for the purposes it's being used for right right excellent no good good question um you know i've thought about this a little bit um i think uh 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 uh the fda on any number of things um and i'm sure we'll get a chance uh in what time we have today but um 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 you know swedeneris in many respects um adherence rates are very high because a lot of the drugs are given just directly in the clinic um uh it's a community of researchers that uh uh is it's essentially highly
closed i mean there are some you know doctors here and there who do do things but um uh you know it governed immensely by asco um there's a there's 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 um
approved say cisplatin would be an example or 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 bevacizumab for breast cancer and that was a pretty significant decision by the fda um and one that a number of industrial interests fought
against pretty hard in part because they knew that money was on the line if we think about testing for covet 19 you know starting maybe with paul romer and glenn weil who have been on this podcast michael mina a variety of commentators alex tabarok now ezra klein
all have believed and in some cases shown using measurements mathematics statistics that if much earlier covet 19 testing had been available although imperfect that the united states would have been much better off and the fda only now this week in uh the end of march is
allowing such testing doesn't that verify the old style sam peltzman argument that the fda is too risk averse too slow and when the fda finally did let some of that testing through you had to do it with a prescription which seems makes no sense under any world view yeah right so with
sam peltzman right about the end so so let me just say i agree with the criticism of the fda on testing um and i pretty sure i mentioned this to a reporter you know back in the spring i don't know whether they ever i i've said this to a number of folks
um 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 um so i don't think it verifies sam peltzman and it's not clear to me um that the fda is too slow right yeah
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 um including the 1962 two key fobber harris drug amendments but you know 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 um exactly what the public health uh you know did that cause um more deaths than say uh you know a culture that didn't take uh kovitz seriously um uh uh people not believing covid was a problem uh vaccine hesitancy in the united states which i think is pretty
significant um you know that's much harder for me to uh or i think for anybody to to judge what the marginal contribution but i have no problem in saying that yes i think that that was a 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 um and not think about all the other cases in which uh no the fda was right
to uh you know abide by a certain procedural conservatism but shouldn't there be a button within the fda that can be pushed where the fda goes into a kind of wartime mode let me give you another example the astrazeneca vaccine was approved by over 15 nations including
canada and the united kingdom fda still has done nothing you might think now much later well only approve it for men who are over 50 due to some data on thrombosis but basically it seems many responsible countries approved astrazeneca fda did nothing had we had
that vaccine earlier would have saved thousands of lives fda didn't seem to care why isn't that an example again if the fda being too slow and too concerned so i actually think the astrazeneca vaccine um uh is more complicated than the story that you're um saying so in part it's
what uh you know dr fauci uh now our national healthcare celebrity but deservedly so called an unforced error um so you should check out the karen landman op-ed at the times back on march 23rd um she shows that astrozenica 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 uh by the company's own dsmb the data science 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 who've um 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 so to me that comes from the regulators
itself right macron i don't know i disagree with that i disagree with miracles i just agree with that strongly tyler yeah who should take it below 60 above 60. 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 you could you we could i could grant that yeah maybe we should you know roll astrozenic out
there about the thousands of lives counterfactual i'm gonna disagree because um it's not clear to me and you might see this problem with johnson and johnson i cl clearly see it in a lot of conversations uh be interesting to see survey data about whether people trust
certain brands more than others um and uh you know part of it is vaccine nationalism uh you know the french don't trust the british uh the british trust uh what's uh endorsed by their uh uh national health service but also their own company uh far more uh things like that
look it's the same astrazeneca company so the british saved many thousands of lives by being prompt with astrazeneca surely we don't think that is a mistake we've had a supply constraint on the vaccine side in the united states maybe up until now we could have done the same had we
approved astrazeneca so the company made big mistakes but why penalize the people who can get the vaccine for that when again you could save thousands of lives i just don't get it i i just to me actually i'm not sure that the astrazeneca vaccine would have been
taken uh in the united states um uh so you referenced the ezra klein story um and i gave a talk uh recently to um uh a group in israel and europe on regulation where i said the big bullet we dodged in the past year um was one in which there was all this pressure in
summer 2020. on the fda uh to quicken a whole uh set of uh uh therapies for uh uh um coronavirus and covid19 um and this obviously started with hydroxychloroquine which we i think i think the jury is in on that now not effective convalescent plasma probably
very effective um but its rollout certainly didn't help and um what you see in at least two different surveys over the summer of 2020 is a pronounced drop in expressed willingness to be vaccinated anywhere from 10 to 15 percentage points and deeply concentrated among the young
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 um so i've done some back of the envelope calculations i shared them with
ezra um i've also presented them to this group um and if you just you know if we start to think about what's the social value uh of you know 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 this could have said this with vaccine just about any vaccine um you know fighter fizer'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 um and you would have had i think a social catastrophe uh you know tens of millions of people not taking the vaccine uh it's been very consistent with those polls that that right after the convalescent plasma debacle showed a
10 to 15 percentage point decline uh in uh and and possibly greater in uh uh vaccine uh confidence um and you would have lost thousands and thousands of lives that way um 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 hurt immunity the marginal benefit of vaccine vaccinating the young is higher for herd immunity if we look at actual behavior if you
take the united kingdom which was the first to approve fight sir was quick with astrazeneca has a government that in some ways has a reputation for being reckless right they have arguably weaker approval procedures than the fda they've been one of the countries with
the least vaccine hesitancy they got vaccines out there the results already are shown to be good more people want the vaccine they see that their uncle is not keeling over dead why isn't that a better theory of public opinion that if you get people good
vaccines quickly that make them healthier more people are going to want vaccines so so two things number one i think that the uk is again kind of sweet generous in part they they trust uh their own company and they trust uh their national health service they've
got a very good uh sort of public system which if we recreate it in the united states would really dramatically transform that look the correlation between vaccine hesitancy factors is expressed in public opinion and vaccine has a vaccination first dose vaccination of eligible population in
the united states is 0.6 that's an extremely high correlation so you know rather than just use a story let's actually look at data and the data suggests in fact that public opinion uh on vaccine confidence is a very very strong predictor of actual vaccinations
in the united states the other example i would say is you know what part of 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 trump it's we that we don't trust certain kinds of procedural irregularities that are going on uh 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 um uh there's this uh deadly disease duchenne's multiple dystrophy um four which was uh developed a really important drug uh called etiplersyn or uh exondus um and it was approved under a uh very um and i say it's an important drug it's an
important drug therapy it's actually still not known uh whether it works in many respects but the fda approval procedure was shall we say uh different and marked by much more controversy than usual the advisory committee voted against it uh the division director voted against
it janet woodcock cedar director voted for it uh i believe it was then uh commissioner robert calif who uh approved it um over and above uh uh the other objections and that's fine he had his right to do that but it was clear from everybody watching uh that uh this
was not the usual approval process so you say no what's the problem mike now we've got this you know 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 and the new york times ran a story about
this and they got one exec to say um and i'm paraphrasing you can look up the story um but i know that i just looked up a whole bunch of blue cross blue shield groups still won't cover uh exondus 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 standards psycho these are informed purchasers right um and so part of what happens when you have procedural irregularity or or uh you know corners cut or bad evidence underlying uh approval decisions
um is you get in some cases what might be rational hesitancy on the part of treatments um i think we can say right now uh with the benefit of hindsight hey look we've got these great mrna vaccines we've got some other vaccines out there um uh you know
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 uh 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 um i'm very much open to that but what i want also is a world where the unknown deeply unknown product studied uh or being potentially approved gets
studied massively thoroughly uh and where the studies continue well after approval and that's by the way something else that you miss with the good housekeeping model um you don't have any incentive for sort of continual study of things that are sometimes safe like something like
prozac or statin are taken for 5 10 15 20 30 years of a person's life now you can often get better data when you do a human challenge trial right so do you favor those should the federal government have started those and say may yeah i can i can see an argument for
that i don't have any yeah i um a challenge trial um i'll just yeah i think that's fine yeah it seems like a huge gain right it's not a small thing hardly any public health people came out for them derrick lowe said he wasn't on board would have saved
hundreds of thousands of lives if our public health establishment i'm not sure about that causal estimate they'll say the vaccines would have been ready by october right the whole winter wave we would have had significant protection against and yeah so again i'm going to put out a
different counter factual tyler i i i wonder again and a part of this is inseparable from the fact that we just had you know a really really divisive election um but i actually think uh one big feature of the uh of the uh the increased confidence in the vaccines
is that uh 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 that it's nadir it was actually much higher during the summer
beforehand but it had sunk again 10 to 15 percentage points you would have had you would have had a vaccine that that tens of millions of people were not taking how should we improve our system of drug labels does anyone read them do they give real information actually you know
so there's an argument so that i think one of the findings out there is that is that uh black box labeling um definitely uh changes behavior sometimes for the worse um so there's an argument out there that when you added uh suicidality to ssris uh
that um one of the uh results was that people were psychiatrists and primary care physicians were prescribing them less commonly to uh 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 to call it a cost-benefit analysis i think is is is both right and wrong i think there needs to be a prospective consideration of what the costs are of putting the health costs of putting something on a black label uh black box label um that would do it
the other thing i would say is you know the usual argument is that what you know doctors only what 50 to 60 percent of the time read the label um there are some people who say well then the label beyond the black box really isn't effective i i actually agree it's not that i'm generally a
glass half full guy um i just happen to think that actually 50 to 60 percent of people reading the actual label is is actually something that we should be pleasantly surprised about should we allow for placebo prescriptions for depression for back pain it seems they might work
we do already in a sense right yeah we kind of already do uh i mean that vitamin d was that way for a long time right um and so uh and so that's that's you know one of the you know one of the things that again you know there's we get into a different
kind of form of regulator uh it's you know in part it's the fda but in part it's state medical societies and practice boards if if major pharmaceutical companies want to run drug trials in poor countries often it's africa but it could be latin america other parts of the
world outside of the scrutiny of u.s regulators should we allow that should we encourage it should we stop it um i think it should be allowed but i also think that the fda is uh um or any other regulator say it's britain's regulator uh which by the way
i don't think is that cons is that uh laissez-faire i think uh you know compared to um you know europe if if anything european uh pharmaceutical regulation from which britain is just only recently broken uh has long been at least as procedurally conservative as the u.s
say since the 1990s um i i think it's uh entirely fine for some of these wealthier countries to say well we don't trust those trials and we're not going to um rely upon those trials alone uh in say a pivotal phase three or a really important phase two trial
um you get into problems with uh you know what's the quality of a country's institutions and this is something we usually think about from the standpoint of say somebody like you know robert putnam or douglas north or margaret levy um but i think institutions and the
credibility of scientific institutions is also important um back when i wrote the book on the fda i spent a little bit of time in india and thinking about its issues uh in regulating drugs and of course there's a lot of drug manufacturing in india a lot
of generics manufacturing and so forth um i don't know the stats offhand but you know 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 so if we think that a country has weak
scientific and and kind of you know credibility based institutions um then i'm fine with allowing the trials there but i'm uh also fine with regulators in advance 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 okay we now get to your new book again i'll repeat the title democracy by petition popular politics and transformation 1790 to 1870 it helped me think about a whole host of issues anew first question how and why were
petitions key to the women's rights movement in the 19th century well i think really uh great question um and uh 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 uh britain
um in part women saw themselves signing these petitions not just individually but collectively they saw the weight of numbers and they saw that especially white women as they learned actually um at some level uh native american women in the united states were petitioning
in ways that were more innovative uh even compared to white women but as they saw this what i call the countability of voice the idea that um their their voices could matter not only in the arguments they put put forth but also in the weight of the numbers um i think that became a much
more powerful motivator for women's rights movements to make bolder and bolder claims for the vote why was early 19th century french canada so important for the history of petitions this is the hardcore podcast in case you hadn't known no i and and by the way your your
your questions have been challenging and thought-provoking uh all along uh this has been great um so uh yeah i think actually you know we tend to think oh you know what are the big petitioning societies um you know the united states britain um anglo-american societies and in part uh
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 uh 1822 and even 1827 and 1828 before jackson was president you get um 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 uh you know the american revolution and i
would say no um and let me be clear what i'm talking about here is arguably you know the largest on a per capita basis petition of the atlantic world of its time a single petition with over 90 000 names attached excuse me eighty seven thousand names roughly ninety thousand names
attached that was signed in what is today quebec um and with which uh uh uh the french canadians did several things first off they fought off colonial fusion um 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 uh colonial fusion was was fought off the other thing they did which was not easy to do at the time was to depose a colonial governor um even in uh you know british north america you know the 13 colonies
uh 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 exactly what they did with uh
deposing governor dalhousie in the united states finally um you know as i mentioned and there are other historians who um have really i think cemented this story better than i have malcolm chase who's you know arguably the historian of the chartists you know working class reform in britain
depended heavily upon lessons that the chartists and other working class uh agitators in britain learned from the french canadians um they called them our brothers and oppression uh in the 1830s and a whole host of things that happen uh as the suffrage is open there's 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 let me ask you an analytical question and please try to give me an answer for
both the middle of the 19th century and then for today so there's a bunch of different hypotheses you might have about petitions that they strengthen the relative power of what is truly popular or you might think it strengthens the relative power of groups who organize
well or maybe groups who are good on the media groups that are good at fundraising on net overall on average for each of those two periods what do you analytically see as the major effect of petitions apart from any particular case yeah excellent question tyler um i so i
think the 19th century is easier to answer because that's what i just wrote about um what i see is um uh 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
uh organizations didn't already have parties which of course in the united states especially were you know really important technological innovation didn't already have lobbies didn't already have interest groups were 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 you know 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 uh and structure from early petitioning campaigns um look we're in a different world now especially in the united states where um i don't think petitions have quite the um uh uh 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 um in part what we don't have let me just first bracket this by saying we don't have uh you know anything like the legislative petition process that we
used to have in the 19th century by the way canada still does and canada still gets i think 1500 paper petitions per year now we could get into a whole argument about whether that changes anything um i think what you're going to see with um uh petitioning
nowadays especially of the electronic variety occasionally of the publicity variety like the initiative and referendum is that select select groups and interests that know how to make something go viral and and viral virality if i can use that term was there in the 19th century now
but but 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 um new card fees at bank of america i think was by somebody in chevy chase uh and i remember the story was in the
and immediately like within days hundreds of thousands of signatures bank of america back down i don't know where by the way whether that's good or bad economic policy um probably uh an effective petition from the standpoint of having changed things
um and can you imagine any other institution the court's 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 um the kinds of institutions that we used to impart because we don't have a a petition institution that structures robust public debate as much as we used to and i think that's
a problem if i look at state-level referenda i tend to think it's a bad idea to make them too easy california being exhibit a do you agree with that view or or differ from it and if you agree with it doesn't it mean you now think petitions actually
have become on that somewhat harmful yeah um so i do agree with that um i teach a course at harvard called uh repub res publica or it used to be called what is a republic um and um and i argue that i think uh it's problematic when uh not just say a policy but any
uh constitutional amendment as has occurred in several states uh can occur with just 50 plus epsilon percentage of the vote of the people who happen to show up on a given day and we know that some of these are are you know uh small turnout elections so let me just say that's about
initiative and referendum i'm not gonna you know 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 um one advantage of representative government is that there are certain kinds of deliberation investigation that go on um it weakens compromise right it's it's either we're going to have this uh 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 um the ballot um and the plebiscite doesn't give you that option um i distinguish for that reason between probitary petitions and what i call directed
petitions um i uh also worry about publicitary petitions and i don't think they have um the same value institutional robustness uh 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 i you know agree that i i'm not that high on the initiative and referendum process ohio by the way if i can bracket uh has uh you know 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 our process separated powers things like that we're gonna 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
law making power or constitutional amendment power again given to that 50 plus epsilon percentage points of people on a given day um and then what i will just say again is i think in part you know petitioning i don't know i don't know if it's not harmful it's definitely become
less beneficial in part because of the way that plebiscites uh have transformed the petition what would be an example of a reform you would like to see that would make current american government more democratic at any level well let me let me extend um
let me 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 uh 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 um such as govern the united states until the 1950s uh 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 um if we want to
take a mass of you know millions hundreds of millions of people and condense their preferences down into a single platform in a single label parties do that well the problem is 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 the society into two um which i do think we're in at risk of in the united states and of course which has happened before um and so it would basically be a way to make not just the united states more democratic
um but actually to make the democratic republic uh more deliberative um which would be to inter and it would be inefficient i'll i'll be honest you know and at some level you could say well yeah wouldn't legislators you know be better off you know reading uh
you know scholarship from economists and doctors and things like that and getting presentations from people in the know you could argue yeah maybe they would um but i actually think it would uh 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 um but uh you know it's not unknown for this to occur uh in the modern uh in the modern day and um uh so again giving the you know 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 you know the closure of agendas which makes parties efficient um often prevents some of the best ideas from you know reaching uh the table of
policy last two questions first can you tell us a bit about your work with native americans and indigenous peoples more generally yeah so i grew up um in a very small town in michigan um uh my wife also grew up in a very small town uh she actually
grew up on a farm uh right next to an indian reservation and we had uh one near us as well um 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 on the fda book um 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 you know maybe the french canadians aside um you know few people are petitioning as much as
they are um and then that got me into thinking also you know why why don't political scientists study uh native americans i mean there's you know millions of them uh you 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 um and then 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 um in part it was uh you know hearing
just different stories around dinner tables family reunions uh things like that that made me start to think that these are things that we should probably be uh studying the work i do now um is in part uh work on uh native history uh allowing these people to understand not allowing them to
understand they understand it pretty well um uh working with them to better understand um uh their histories of petitioning advocacy things like that um lobbying um and in some cases uh like one of the courses i'm teaching right now um part of what we do is work
with particular tribal communities uh nations that are um dealing with some pretty significant issues like you know suicide and suicide prevention at the fort peck reservation or um you know food traditional food gathering practices and the way they're regulated by state
governments and the kind of maze that different native americans have to navigate as they uh you know practice their traditional cultures last question how and why do you enjoy fly fishing thanks um i think maybe you'll disagree but i think most
of your academic visitors uh would agree that sooner or later you need something uh 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 on a stream fishing for steelhead uh uh in the great lakes or the pacific northwest uh or fumbling with my knots and things like that um there 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 it's absorbing and um and it's absorbing in um some very few beautiful places um 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 planet um proof for the existence of a divine and i like spending time around brook trout daniel carpenter thank you very much thanks so much tyler it was an honor