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So now the names alone. What comes another soda tweets on the box media Potass network, a mathematical esias here with Dylan Scott for public, as darent, led we're here to talk today about some exciting. Action in the world of pharmaceutical pricing and possibly an exciting development in the world of actually treating Alzheimer's. But I guess part of the story here is that it seems not. exciting so doing you have been not only reporting on the story for practising how to say the name of the drive What what? What is it that we are talking about here and you can imagine, I think something like that

still ass. The story here is for what, for four fifty grand you can get a medicine that you can't pronounce and that doesn't actually treat Europe I was just so there. There is a long backstory here that goes back decades, even but I'll I'll. Keep it pretty brief. So, last Monday, the FDA a proved a new drugs to treat all time. As with sheer, like you said like we would think, would be really exciting. welcome news, and yet basically everybody I read or talk too, when it comes to drug development, is outraged by the fact that the FDA approved struck, and so the reason that everybody is so upset is that the effort that it actually works is not actually that strong, Bio, Jan, the company that developing the struggle are you running their clinical trials back in back and twenty fifteen and the tree we're running for a couple of years and then in March of twenty nineteen they announced that there,

actually going to stop the trials, and basically they said it doesn't seem like the drug works. I it's not gonna meet the thresholds for clinical effectiveness that we say, when we started these trials, and so yeah that seemed like it would be. The end of the story was another setback in the decades long search for treatment for Alzheimer's, but then about six months later came a twist via Jan announced that they ve been rapid up. The trial and they done some additional data analysis and it actually found that there were some patience for whom there there did actually seem to be some benefit. Some positive effect, announced that news and said you know what actually we're going to push ahead and seek FDA approval for the struck, and so that you know that's all along process in about a year later, in November of twenty twenty five Jens drug went before the FDA is Advisory Committee, who evaluates your logic,

therapy. Is that have been submitted for approval and vain? The scientists on that committee looked at the clinical evidence and they came back with. Pretty resounding no, they almost unanimously said that the FDA should not approve this drug. I'm not only was the evidence for its clinical benefit mixed at best, but they also flag that Europe that there is some evidence, for people who are given high doses of this drug. There is a risk of grain, swell so we're talking about a drug with with limited evidence of his its effectiveness and the potential for four really harmful side effects for patients. I'm so that again, kind of look like the end of the road. When, when your scientific advisers are unanimously saying that you should approve a drug, you know it naturally follows that you think that the FDA, with into its advisers and and decide not to approve the drug. You know people were encouraging.

I again to do another round of clinical trials that could maybe clear up this confused evidence, but instead, last Monday, The FDA went ahead and gave out. You can imagine their stamp of approval and a very bright indication that most patients who are suffering from Alzheimer's or cognitive impairment should be eligible to take. And so now you're the drug development people freaking out and the people who worry about healthcare Costs are also freaking out. As you say, Bojean has set up a price tag of sixty thousand dollars for this drug, and, given that there is six million people living with Alzheimer's in the United States. That could be a pretty big line. Item four Medicare specifically were now because the people who are affected by Alzheimer's, we would expect Medicare to bear the brow tough of covering the struck. So I don't think any Minos for sure where it where it goes from here that the ball is kind of in Medicare Court and they ve got a figure

What do I mean it's worth, looking at the statistical work that went into this a little bed, a minimum reading up since we ve suggested as any. It seems really like really bad to me. I'd really like worse than I had originally fight, because it's not just as you know, the benefits look very marginal in the studies, but that it looks like they found these benefits by doing a sort of like post heart statistical, we analysis white with a they had an original intent to treat population, and then they in fine like any benefits at all that they had already said this I very low bar for I get it. I guess it's called it the study and point right as defined in advance. What are we trying to do?

like we saw this with the covered vaccine swayed the reason we had this confusion like what we don't know if it boxy symptomatic transmission, is it that wasn't the study and point tried? The end point was severe covert. That. As you to the hospital. So in this case they set this. I really low bar for an end point, which was that he would slow the rate at which you see Alzheimer's related deterioration. Right, not like Hall TAT, not not reverse said, but a deceleration and they did it and they didn't find that it decelerated. There did. This re analysis and they said the boy if you categorize some of the people as like unfavourable cases, and you only look at this other sub population, then you gotta, slowing of the re relative to some others. Disk obey sign- and you know I mean I think, like we ve, we discussed a million white papers here, often absent

say low stakes, social science, contexts and like this is just like. Always the rescue have with like any kind of research that like, if you have a bunch of data and some statisticians of computers, and you like hack away at it for long enough. It's like you you're bound with something right, and it's like, if you wanna, if you wanna get that paper published, you need something for your tenure file but you're not supposed to do that. But it may be kind of happens, and it's it's not that great. But this is like you really not. I think us to do that in, like seriously go no go but big time policy decision psych this really not evident it's? It's a while to get here? about this. From the from the perspective of thinking about such a science methodology because, like in academia The notion of pre, registering your analysis, is seen, as you know, painted the into

surely honest vanguard of work because it prevents it's an honor soon way to prevent you from doing exactly this thing, and yet here where there is a fear, the institutionalize norm of a pre registration equivalent, you can just say, never mind we're going full steam ahead, and I mean you really can be reduced. If you few waved all economic considerations aside right. You say: ok, guys, like daddy's interesting now, you have to go to a new start right. You have to say ok, what we learned from this is that we think maybe it works with this define population. But, like we don't know, and now you have to recruit a new test population, do a new face three study and that war you don't show up slightly give if this result replicates in a well designed experiment. I mean that is pretty solid evidence you arrived

because these marginal, even if it's only a Truman population but as it stands now, it's like a totally untested hypothesis actual like it's, not real information at at awe and its as somebody who is very frustrated by the extent to which the FDA was being like really fussy about clinical trial design with the Extra Seneca vaccine, where Here was a situation. When you know I give you asked scientists if you were like ok looking at the information is available like do you think this vaccine is safe and effective like a little say? Yes, you don't like, like their belief, was that he has presented of exit worked, but the issue was like hand look. Would it be bad to let a pharmaceutical company get up? ass on such a kind of fucked up, try all I was kind of like a man just like give them give them a path

like an emergency. But the concern is precisely that it form suitable companies like with a lot of money at stake, get the sense that they can just kind of like snow, the FDA with I love you look at this way to look at it. That way, when you're gonna have all these scams coming through. So then they like didn't give us the vaccine they are doing the scams, seemingly because the scams, unlike the nonprofit Oxford University, has presented the vaccines. There's like big money to be made from from this medicine that probably doesn't work like they are selling into an incredibly large market. Yeah, I mean tat the perspective. I I've I've seen from scientists is certainly cause? As I understand it was, it was eight. They were actually running to concurrent trials and it was a sub group in one of the trials where they were of the kind of sad negative

the mass a little bit and were able to show some kind of a fact and so that, at the very simplistic level, the people out of the drug development people were like. Ok, you got one trial that may be works. One trial where you apparently could not. You know I managed to muster any kind of effect so like run a third trial, it and break the ties are to speak now. We ve got more information. Now. Maybe there is a patient sub group specifically target this. I am like You're saying like we would have more in kind of more finely tuned information about who the hell at the base level this drug would actually be appropriate for egg, especially recognising that there are potentially harmful side effects, but instead biology pushed ahead, and I think, what's frustrate to a link is less right. Any jump right run. A third trial will cost a lot of money would take time and money and it might get the wrong answer, of course, as you know, and there is that there is obviously a very sympathetic patient population whose kind of hang.

The balance here like we don't have any kind of effective treatment for even slowing down Alzheimer's. They ve been waiting decades at this, point for some kind of hope, and so obviously that's factoring into it. But I do think what people are frustrated by is the fact that FDA seem, to be a a willing partner and Bio Jed's share guns, and this is not necessarily the first time that this has happened either alike there. There seems too a bit of a trend now of the FDA kind of willingly going along with a drug company, pushing some towards approval, with, with Marge limited evidence of its effectiveness, then there is of course, a sympathetic patient population at play. This happened a few years ago with a muscular dystrophy drew. Where are you now? The patient's really wanted it and the FDA I now find it, and yet the science community and the people who fall drug development were like this is again outrageous, because there really is an evidence of this drugs, clinical effectiveness, the differences

as with all his high murders that size of the patient population and with the price that biotech is going to charge for the drugs it proceeds are around he'll budgetary challenge that you know our drug for must short gesture fear. Even cancer drugs would not necessarily present programme tourist. You're a lake I mean. Obviously it's not like me, FDA laid out along memo saying yes, we know that this is scientifically and valid, but we're going to do it anyway for acts. Lazy reasons like that you know give in you're, reporting and kind of your understanding yet it is an institution. What does it seem like happened here late? What was the what? What worthy dynamic that led to this being something where their airing on the side of being too fast rather than too slow Our question I mean there's, a whole history here with kind of personnel, but I am probably not equipped to go into but

guy who at the head of the neurological division at the FDA. Your has definitely been achieved. Leader for this drug and like really, you know, understandably again, like I wanna, be sympathetic like they were there. want to see some kind of treatment, something that holds a promise that for all timer stations that I think there is a belief, especially in the Alzheimer's community like if we can get just like white one first class drug across the finnish That is, gonna show all these other drug companies who have been really frustrated by the lack of drugged about the lack of success in developing all harm as drugs. That, like you, can get the green light like you can get there and hopefully, thou spur like another round of of innovation and an exploration that might lead to more effective treatments and eventually to occur like another, the Alzheimer's advocates that I've talked of a given the example of of status. As a case,

like the first one they got approve. Wasn't that great, like, especially in the context of what came afterwards with a kind of open the door for more drug development. So I think that is. That is potentially one one factor that it's at play here. I know there was a great story written by a guy named Zack Brennan rights for and points of view gets into the nitty gritty of drug development and he may, The argument basically like a couple years ago, they were reshuffling. This neurological did your vision at the FDA and he thinks frankly like if somebody else had gotten the job. Maybe this wouldn't have and so there are sort of like now. There are personal agendas in play. There is this lake complicated, Baxter, like the frustration in the scientific community with with the failure to make any real progress on on treating Alzheimer's? That I think, is a factor, and you. Have you have of a patient population that a patient advocacy community that was really behind the struggle?

this was seen as the as the most the most promising Canada that we'd had an along time when the clinical trials got started, twenty fifteen, and so I think you know the news in March twenty nineteen that they were going to stop the kind of trials was was devastating like it was like, Where do we go from here? There were stories being written by science. Reporters of like has the last thirty years of Alzheimer's sides been misguided. Have we been focusing on the wrong problem, and should we like almost starting from scratch and trying to figure out how we treat this drug. So I think that created a lot of pressure and while you know I wasn't inside The room I can't get inside of the head of the folks who are running this at the FDA. I think that the press, just became enormous to show that, like we can actually get and Alzheimer's treatment to market once they were able to do this additional data analysis that man was describing an end, at least see now hold ups thing is like here is evidence

that does actually work for some people. I think that just put off more momentum behind getting the drug to approval and and getting it to market on four where these things don't is happening, in a scientific vacuum. Like I said, we have other examples like the muscular dystrophy drug, where, if the pressure is is sufficient and the patient population sympathetic that kid. I think that can weigh heavily on FDA and I think there is good reason to think that that was a serious factor here as well continue, like the great Posts Trumpery calibration of what we expect politics to be like the idea of public pressure affecting, like especially after approvals of health treatments, kind of got sucked into this maelstrom re any ideas when each when he was it. You know their worth impartial scientists that were being improperly bullied or

by the way housings. The weight has wanted to show a political victory on the turbid vaccines, and it really is worth underlining that the pressures you're talking about or even necessarily in proper ray it's not like it's it's not a simple factor of the open, farmers successfully like bribed a bunch of officials or but he knows they're gonna get jobs. You know these come is when they leave the FDA and so they're going to it's, it's not like that. It's a bunch of legitimate they legitimately difficult. what policy problem in which you have a very exacting scientific procedure that doesn't change no matter, What the cost benefit analysis on the other side is, and so, when you other really big potential benefits and correspond.

Only a really big potential, possibly disappointing. A lot of people who have been holding out hope for several decades. That's kind of the the less dramatic way that political pressure happens. It's usually an attempt to weigh computing what he's in a process it doesnt really allow for the formalised weighing of competing equities and what kind of freaks enemies discretionary decisions as something that starts look a little more away judgment errors are biased. Yeah, let's see the break in, and I want to talk a little bit about that. The institutional context than shapeless. It feels like you, don't even have hours in the day to get everything done. Might because you're missing out on three, where those two hours cup, I fell into a deep dark abyss that opens up amongst which, between work,

Those three hours to all the productive time we miss out on thanks to at home distractions, disorganization fatigue. It's no wonder the days future work should work with clear up, it does look up, is a flexible productivity platform, the wings or you work at one place. That's all you chats apps docks and ass. One centralized Like mission control companies like Goober and Google use click up to make their days more productive, managed projects, people and goals more effectively. Four teams of all sizes industries cook up to pleasingly. features at one thousand plus integrations, must have, or anyone wanting to track manage intact. They worked in one place, you're, always back with clear up trade free. Today, click up a dot com, slash weeds Do you want to be the smartest fan at your watch party? Do you

understand the game at a deeper level. Then you need to listen to and I fell university. A new weekly episode from the SB nation and apple show every Wednesday our team of professors at any fell university. Teach you the finer points of what we want. crash course, at a time, will break down the? What how and why, everything that went down that we subscribe to the US, nation and up I'll, show today and become the best fan you can be so you don't get. The FDA goes back in some ways, all the way back to two nineteen o six, but but mostly to the third use right. There's a federal food, drug and cost Eric did need. It establishes an agency that supposedly pre clearance were view of pharmaceuticals and its supposed it check for safety and social, just a ban, false therapeutic, clean

right. So the ideas till I get rid of the snake oil salesman and the quack cures, and and stuff like that, and that's that's what the FBI was was created for right and at that time, in the late nineteenth Thirty's, there's no Medicaid, there's no Medicare threesome, even really the like employer provided health insurance network that we know and love today. So this is a regulatory question of what can be sold to the consumer with your own dollars right and we can know. We'd normally sat a certain kind of bar for stuff like that right, like Elizabeth Warren likes to talk about how you know the consumer product Safety commission knowledge, so exploding toaster. But they definitely let you sell stuff, that's like junk. You know this progress for sale, dont really do what they're supposed to do that don't meet their marketing claims. This even this whole

under world as Non FDA, approved supplements. We are able to take a lot assorted outlandish remarks about it, so the FDA has woods for a consumer product, a sort of unusually high bar, clear sweet like you, can sell cigarettes right which are not safe or effective, but because they're, not medicine, you know you, you can go, do it, but in a later periods right, we ve come to have this very big health insurance sector, which is private but regulated and subsidized. We have a lot of government health in earns programmes, and so in fact, right if a new medication comes out- and it is supposed to treat a serious disease Is an insurance company that just like now we're not going to cover? This is gonna, take a lot of shit from people. right. They could really clear as day says it works,

What are you doing right, and this is how you get into patients bill of legislation in the in the ninety nine these like the greedy insurance company, won't cover the treatment that the government's own regulator says is good and then for all members patients, your largely talking bout, a Medicare population rain, so you're spending other people's money and in Europe they have a european medicines agency, which does that kind of Fdi a role, but then they also have national health insurance. You know schemes which are all different, but they all have place, regulate rain so like a duty to do questions and, like one is, are you allowed to sell this? Two people read like? Are we saying it's so dangerous or so fake there we're gonna be like no. You can't take it and then another one is like: ok? Will the government pay for it right up

and there's lots of medicines in part, because it is that the EU may tends to be lax, sir than the FDA, and in some way as you know, like there's a lot of like skin treatments that are approved by the EU may, but not by the FDA, but they're not covered by European National Health insurance plans. You know they're like just to make your skin look nicer, so the government will pay for it, but the images fine. It's fine. It works of words in America. The FDA is like kind of a price regulator belts, but it's not a price range like right at the committee? The did this, like does not have economists on it, like they are not said. They are supposed to think about price. Where I m there they're, not the right people for it. It's not our mandate. So, like some ways. The fact that this may be doesn't work like at all sort of dodges, the issue, because obviously, there's no reason to prescribe a medicine that doesn't work

but, like suppose, we were really really confident that this had just really small but positive impact on patients. This, then, just like still the question like. Is it a good idea for Medicare to approve spending all this money right right and ended this weird where you get this dichotomy thing where you have. I mean it's clear to me just like reading the coverage tried. The people upset about this decision are very worried about the budgetary and the patients agitating for it are like they want to believe, unlike who wouldn't tray

like if you have a terrible illness and one group of people like I have a treatment that works and other Karim like I'm, not so sure about your mass, like I would take a medicine like that. You mean only mean, but then, like the question is, is like. Do you? The third party want to pay for me to take a medicine whose efficacy seems so questionable, but that's like a different end of a topic, and we don't have an agency that, like a dresses like in a systematic way into it, it there's no agency in the federal government that is like set up just answer. A question like how valuable is and we are we discuss, it is like the Democrats standard rhetoric as they want Medicare to be allowed to bargain with pharmaceutical companies It's not really like a negotiation like you know. Like I don't know, I've got an agent. I work with my book for an economic, send him to bar and what the pharmaceutical companies it's. What you might set up is like an invaluable

right nice right, yet his dress like in the UK, that, like I rise to make a scientific assessment of like the statistical value of the medicine, and then you would have to have an economic analysis of like how much do we value life extension improvements in quality wife? Doesn't we do at the EPA like we have lots of regulatory? disease that do ass and it always sounds like Chile. Why did not give the class seven million dollars to save alive? We do it if it's the EPA, but not if its d o t like they have a slightly higher bar. That's how you do policy accepted medicine like we just dumb right. I also think that lake- I wonder, if Alzheimer's, because of the nature of like what we don't know about, that following the entry into this lake politics, a desire like it's not just that we don't have effective treatment for Alzheimer's is that we still don't we understand risk factors very well

do not. You know it's not something where there is a known population even tell early in life to adopt certain behavioral modifications. So they reduce the rest of the disease. There isn't the kind of corresponding you no moral politics of light. Well, if you get us, I was you must not have let your life right. So it's not a surly worth it. For us, too. Late spend all this money on you and the as awareness MRS increase, the idea of interest for dementia has actually really gained that this Europe also is itself a really big factor, structuring the psychic life of older adults. Miserly behind like I was. I was just going to speculate. On this, when the initially disgusted was like? Maybe there's something about and of the fear of losing one's mobility is uniquely terrifying to people who like work with their minds following what else did happen like there have been there really has been

It's too codified and develop scales for anticipatory dementia in a way that you don't see for, like fear of other diseases, which suggests that it really is thing, and so it does seem like, on the one hand, you have a lot ability to imagine this would happen to me and, on the other hand, very few of the kind of inhibiting factors that might need the public, your policy makers to say, ok, but it's not worth spending that kind of money. on a certain level. You did it to yourself Think there is definitely a through no fault of their own dynamic and play here, and I mention this glancing lay but like when the Bio Jenin drugs is founded on. Let's call by amyloid hypothesis, which is basically this idea, that their there are plaques in the brain that interrupt? You know neurons communicating with each other and that's what help now manifest the symptoms of Alzheimer's Disease and win initially win biology and pull the plug on

clinical trials and in March between eighteen it it causes I have told all reckoning within the scientific community. Whether the amyloid hypothesis is is totally misguided and whether, like you know, maybe they sharing Bagley STAT News that wrote an amazing peace on this. Their increase everybody to read, but but she gave the example of like maybe that black is just do those are just headstones in a graveyard but like even if you got rid of the head stones. The plaque, in other words, that would it be that wouldn't get rid of the dead bodies. Maybe there's some underlying cause year, of which the amyloid plaques is just like a byproduct and em. So were basically targeting the wrong thing, and so I think to your point are like that. That suggests like are obviously are our scientific knowledge of this is, is still after all, these years dramatically under braked this, this drought

given that the evidence of its our lack of evidence of its effectiveness hasn't really, I don't think ameliorated that concern and so that that kind of brings us back to what would you saying that, like it's easy to imagine another country, a two step were you had like that scientific evaluation and then kind of an economic evaluation, and yet, like the UK, has nice. Australia has a prescription drug board that that evaluates its struggle and says like aright, we think, based on the opinion of the quality of life and the life extension that this drug would provide. This is what we think is a fair price, but here in the United States, Medicare Part B, which is the programme that would be charged with with cover this all homers drugs. There only real standard for whether or not to cover something is whether its reasonable and necessary, which is obviously a very vague term and for most of history, that has been synonymous with FDA approval and they base

we have no mechanism for a situation like this, where the FDA has approved its drug and yet like the best scientific evidence would suggest it is not worth early as much as by Jan is planning to charge. like. I, sir, which is this non government group up at Boston, that does kind of their own independent evaluations of drugs worth. I has pegs this budget's drugs potential value at like eight thousand dollars in and borrowed this plan to charge sixty thousand dollars, so there is obviously an enormous disparity there, and so, like you, imagine alternative universe where the? U S might say, ok, the FDA has approved this drug and so that that would seem Put some obligation on us to cover it, but like we're, gonna pay for the actual value that it provides, but Medicare doesn't Many mechanism like that like there are some. You know. That

mandated rebates that drug makers have to pay. But you know abiogenesis setting its list price with those rebates and mind, and so yeah this. This does just seem to reveal. Once again, the situation that that the United States finds itself in when it's not able to to actually evaluated drugs value in any official way and pay accordingly. Now is aware, though I swore been more from making economics viewpoint, because so the the law creating Medicare Party was like this is one of the very first policy stories that I ever covered. We ve been reflecting recently we're gonna wanna, do some so back to the future. Weeds is

in in coming once, but you know how I rise in D c in the fall of today's three. We have this Medicare Bell at the sudden like just passed, but people were still arguing about it, and this is a democratic, big critique. The bill as it was written, and it's like a very weird, very different political moment, to think about what it was. Like Republicans put this big expansion of Medicare benefits through and Democrats it a hundred percent deficit finance no pay for is no offsets and Democrats. Big critique of it was that it was to spend D. You know that if they had included these sort of price control ideas, the Democrats had at the time

and there were few different versions floating around one was to create a sort of nice like pan. All one was to create a benchmarking, and we continue to have this controversy frankly by Democrats ultimately decided in what would strike today's people to be a very odd procedural maneuver that there were two democratic votes in the Senate for the republic belle, so they had a majority, but they didn't have sixty votes and they didn't have reconciliation instructions. So Democrats could have filibustered now, but they decided that filibustering like a big popular expansion of healthcare benefits on the grounds that it was like to expensive would not be viable, so they just got a folded. It went through and then respond I can tell for the next eighteen years, like nobody ever complained about this wish. I mean to say that, like there were no like want swipe,

nobody in America was like my life today is worse, because Medicare is overpaying for old people the drugs not be. My complained about the out of pocket prescription drugs costs that non Medicare recipients, but this the Bush administration set up where the Medicare benefit was pure, give away to the providers. Actually, everybody seemed perfectly happy with, like the providers like dead, when Obama came in two thousand and nine the SBA. He had his own shady deal with pharmaceutical companies where he was, I like, you know, you know a lot of these liberals like they're nuts, like they want to do this with pharmaceutical price controls. Belike. Now I'm going to give more people, it's gonna, be just like Medicare. More people will get health insurance coverage, which means they will buy more prescription drugs, which means more money for you and then, like farm up, actually invested like substantial money in protest

adds I was working Centre for american progress. They were financing like tons of our health care, work and good health care work like get poor people medicated, because then they will be able. A prescription, drugs handling again in the twelve years since that happen like I don't know like it seems fine like it's. It's good for you to have have medical research like what is the problem with the high prices and eat. Today? I might ok, it seems ridiculous to pay fifty thousand hours a year, because I'm a strike that doesn't work but legacy Do it? Are we gonna be sitting here? Eighteen months from now being like? Oh and now, we're somehow like hobbled, like interest rates are nothing? like it, does it mechanically crowd out other spending like we don't have a price but we also have a global budget, for I see now you know, sir, I can't go to the hospital because Johnny's got this Alzheimer's medicine. So it's like what's that,

in. The eight people seems like a bad system, but also like hard pressed to say like who is going to suffer as a result of unless it cuts off some other more promising line of scientific research, which I don't know anything about. Like is there it like. Is there some other Alzheimer's drug? That's better I'd know, I don't think so I mean there are some altering or some other drugs that are pursuing kind of alternative routes to treating Alzheimer's. That, I think, are there. In much earlier, there of clinical trials got started a couple years after Bio Jen, so like they're, still probably a couple years away from really having results that we could evaluates I did hear the concern, though, from one of the drug experts that I talk to of like all right, so biologist got this drug approved with really limited evidence, and yet they're gonna be able to charge this price for it, and then you know the one reading of that is that

now we ve opened the door and maybe a much a bunch more drug development will follow this person. I talk to raise the concern of like Are we sure anybody else is gonna, be all that interested in pursuing all timers drugs, because one you know because there's no existing treatment, you have to admit at Maginnis many patients is boss. War gonna wanna have access to Bio, Judd's drugs, which kind of biases your potential patient population for running clinical trials of Europe, and on top of that, it's like. Why would we spend a whole lot of money like trying to come up with some wonder drug or cure for Alzheimer's, when all we apparently have to do? Is meat is very low threshold for clinical effectiveness to get the FDA decide on off on it like Arguably, obviously, dolls hammers tree has a different view of this, but it arguably kind of creates a disincentive for four really trying to find some kind of break through our or like a cure, because, like you apparently can can get the FDA do

prove a draw again and sell it for sixty thousand dollars a year with, with the kind of evidence base that the buyer Jack had. So I think that is that he's kind of an open question what I mean. I think. Luckily, there are some of these other treatments already in nickel trial so hopefully, here in the next few years, maybe we'll get an idea of whether they have more success. Dennis Amyloid treatment has, and I think that to your first point, it's it's a fair one like yes, like we ve massively expand health health coverage several times the century and like a lot of the kind of a pocket, lipstick warnings about what happen as a result haven't haven't necessarily come true and- and I wonder you know- I am certainly receptive to the idea that here there may be a sort of like a chicken little elements in play, but I do think what maybe I mean what everybody is worried about is just the scale here because of the

for of Alzheimer's patients, combined with the price that Bio Jan is planning to charge and just to put it in perspective, it's all preliminary. Could we don't actually know how many patients will take it but like, if you just kind of extrapolated, the number of Alzheimer's patients in Bio, gents price, we're talking about a drug that would cost Medicare Part B, basically about a hundred billion dollars a year and currently that occur. Part B spends about thirty billion dollars a year on prescription drugs and even if you bring in Medicare part D into it, the total Medicare drugs bed is about a hundred and thirty billion dollars.

And so this drug alone is nearly doubling the amount of money that might occur. The entire programme spends on prescription drugs in a given year, and so you know the trickled down effect of that, whether that's in taxes needed to be raised to cover the cost. In you know there will be four like medical. Your people on Medicare do Perry pay premiums at least some of them. Do you know that potential trickled down a fact? I think that is what is the scale of it is, I think, what's got a lot of the health care experts kind of quaking in their boots right now, and yet no, I am totally rejected the idea that the maybe we'll figure it out. I do think what, within the other thing, that storm people off is where we started, which is that this is a dream, You were talking about that kind of budgetary rest for a drug that may not even really work and, like you know, is one of the people I talked you said like. If this was a cure for all timers, you know the the system it will benefit and, and the moral imperative would be such that we would figure it out, but the fact that we might have to figure it out

for something that may not even be helping that people. That much, I think, is what some of the the folks who are so outraged. Fide outrageous saw the other thing that I think is kind of worth. Bringing up here is something there mentioned in passing through the beginning of the episode which, as you know, general like yes, slippery slope. Arguments are dumb die in a world where we ve just several months being concerned, that in a global pandemic breaking- The rules for Apt yea approval was going to lead to some kind of interpret the slippery slope problem outside the context of a global pandemic like yes, this is a very sympathetic populations, a very broad population there, all of these equities that we ve been talking about the lake. Those are just three things that could also be used by other pharmaceutical companies to argue for approval

their drugs in other contexts, in search as long as the ideas out there, the industry is still on the lake. Yes in the past. worst case scenarios haven't materialise, but there are reasons to believe that, like this should really be the distortion, everyone, the changes things it's possible: the inner, the polluter, lesson of this is that you don't need to go through the scientific hoops as long as you can make the political aren t. You really need to approve this, but this is where I kind of wonder: delightedly what you just laid out. The answer that this is going to disincentive icebreaker. Alzheimer's research seems to me: this totally negative, and what you're talking about earlier with patient, advocates, feeling this that approval of this drug was needed. To encourage, future research and lake. I can understand that both like both you ve, laid out both kind of logical arguments, but it does. He like once we're late

to be empirically plausible than the other, and I wonder which, when you think is more likely to happen, how men put me on the spot, you you get it a journalist, privilege and live nine hundred zero. If so, I think like the stands or the example. I think I mentioned for that Alzheimer's advocates will give of like if you open the door others will follow. Do wonder- and I guess worry like I don't know enough to save as confidently bustlers call it a hunch, but I wonder if, like the kind of science of hearts he's in Colombia, and that stuff was just like a little a little sounder like now. We were still trying to figure out the right mechanisms for regulating it, but like we knew what was causing heart problems and therefore, what these hard drugs would. We should be targeting, and it was this figure out a way of doing it. like I was saying before. I think it's still

pretty unsettled. Like an you said this, there are like what actually causes all timers and whether the therapies that we ve been developing are actually targeting the right thing that I could at least adding scenario where, like the Alzheimer's advocates, our rights and like this encourages other drug come is this start pursuing their own treatments. You could imagine us reaching an end point words like yeah, but as it turned out the amyloid hypothesis, all wrong and all other zero every we were already kind of in this situation and in the spring twenty nineteen, when the buyer Jane had stopped there to clinical trials, everybody was was wondering whether the I'm always have been all wrong now because biology in forged ahead and has gotten FDA approval. I think it's given that that theory some reprieve, but I don't think it's it's not early validated it for all time by any means. So I think that is that's kind of like one one risk here.

that that sort of allows almost like everybody to be right. In the worst possible way, but yeah I mean It is kind of a fundamental disagreement and, like a like, you said, I can see why both sides feel the way. I see it the way that they do. I do wonder I feel liquids English is Alzheimer's from from some of those prior examples of a first class drug then yielding second and third and fourth class drugs. Is that the site on all hammers is a lot less settled, and so now we were

Eddie putting all most of our eggs and the amyloid basket, and are we just going to take whatever eggs we might have left and throw them in? There too? I think that's potentially a risky proposition dish reminds me, you know less of a sort of drug approval issues, but its above somebody, science, funding stuff that Darin I talked about you know a few weeks ago, which is that you know I kind of get a picture of a community of research scientists who you know for whatever reason came upon this hypothesis worked on it. There have been a lot of publications on it. There is now a lot of drug company money. You know actively pursuing research programmes that are based on, as does a lot of funding for your lab, but the decision lying to do incremental work that accepts this hypothesis and that if you question the hypothesis, I mean that because people were me in but like their sincere buddy,

people who have a sincere belief in this hypothesis now have a lot of money. They have a lot of institutional backing. They clearly have the ear of the FDA right. They are there, and so, if you work broadly in this area, but like you think that high policies is wrong, it is probably easier for you to find something else to work on that, like the absent all timers, and then you could like tell a journalist. You know. I think this hypothesis is wrong, but you probably can't like add because everything is based on peer review is an submitting things. Two committees of dna age that are made up of the people who approved the previous stood straight up and that we are probably just underweight unlike maybe this is wrong, and we should pursue a different thing

as you know, like it's gonna hurt people's feelings. You know that dear there, like lots of reasons why people would want to not pursue alternate lines of research. That aren't like good reasons. you like, if we, if we wasted a bunch of money on experiments like pursuing some other hypothesis link that wouldn't actually hurt anybody, any of the other view turns out to be right, like the gains will be really really large. But that's like not how the institutions that we have function. You are much likelier to get ahead. We sort of incremental progress following this hypothesis and then the approval of this day, It is like the ultimate example of that right, like I think generically videos like said to the FDA like what, if I showed up to you, re visas scribes the nature of the statistical evidence even like why had to trials, and it only worked in one of the trial

does, and in that trial it only worked with a suggestive of re analysis. They be like I don't know. Man like that sounds pretty gets us pretty bad. It only the contact straight that this was the promising drug that was based on the consensus. I Papa says Bob Bob Bob like makes it sound like even remotely plausible right. You have so much momentum behind the idea. deadlines taking out these plaques is like what we want to do that even a very marginal progress like at deep lacking, like everybody, wants to serve applaud you, for it worries me more than that the price of the drug, but it's like what are we doing? Are we as a as a research community and as a funding community going to like decided that we want to pretend like this? This is really working, or can we admit to ourselves that, like were really like living on a prayer?

here and audit. Consider, you know, look look, look what else we can do no other than the phenomenon you just described, as is absolutely real. I've already named checked, sharing bellies Magnum Opus on their amyloid hypothesis that she wrote in twenty nineteen after biology and had had halted their trials and two to anecdotes. From that come to mind, that's just confirm what you just did. The problem that you laid out. One was a scientist who was pursuing an alternative line of research. She was submitting her articles, two major medical journals and the problem was, you know, because she'd been working on this for a couple of decades should only be ever been published in what you might call like, mid major medical journals and so like before they even got too like evaluating what she was sending. They were just looking at her credentials and they were like well he's, never really been published in the major journal before so like when I get the impression was like we're just we can really take this seriously and that that is, I think, in one example of the kind of gate. Keeping that you're

striving and the other was she quoted in the scientists who works in the pharmaceutical company, and they said, I can now think about the incentives here. If you're, just like somebody who works on drug development in big Pharma like if you propose for bring an employed drug and it doesnt work than like. You can just say like well. We were just listening to all the smartest people in and academia saddened and following that consensus, but if you prefer propose something else and it doesnt work like good luck with your career, like you're, probably done foreign you're gonna have to find some other line of work, so I think that has got, has totally manifested here with the pursuit of Alzheimer's research and, like you, I guess it's like we can progress and I think most people would agree with us like we could just be spending more money on research. Like you know, I know from the reason

perspective, that's always the answer. We also need to be. I think, there's a pretty strong case to be made that whether we should, by diversifying our research as well, we should probably talk about the white paper can still take a bank will get. The white paper on our paper today is employed in a snap. The impact of work requirements and programme participation and labour supply, its by calling gray item, leave little Prager, Cassie Bruxelles and Mary Zaki. This looks at the question of imposing work requirements on the supplemental nutrition assistance programme. Snap, a food stamps you, you could have different motives for wanting to attach a work requirement to snub right. I think an optimistic view

would be that you tell people about you, you gotta work. If you want to keep getting stop benefits so then people cannot get off their budgets and they get a job and incomes go up, but they also of this not benefits, and so living standards rise. The production possibility frontier of the economy, is pushed out all kinds of good things happen. Maybe you know true believers and fully automated luxury communism say it would be better if they didn't work, but but like normal, The success with these guys find is that that is not the case that what happens when you impose a work requirement, is some people lose benefits? But there is no. You are you're identifying some perhaps unworthy people who you? U kick off, or something like that, but you're not actually encouraging any work. I believe, from past upsets the weeds. Is the general finding about Medicaid

wow very it works as a way to cut the rolls right like if you, if you want to say, I feel unsympathetic to non working people. This successfully identifies them and gets them off it. Doesnt generate work benefits which I think is the claim one would make We have this idea the way that this study was decided, the researchers better, a decent job, saying you know it's surprisingly hard to get really data on this, because at a certain point, you're not actually measuring, be treatment. Effect, your measuring something closer to inject, to treat because you're selecting out people who would have qualified for snap, but people of people qualify for choose to go on with assistance programmes Other reasons and so what they ve done here is look at a period in which Virginia had kind of waved. Its work requirement for the great recession

the population that was, I find it snap at the end of that period, when Virginia said. Ok, it's twenty third, in great recessions over get back to work and how many of those people you know something? What lay dropped out of programme participation also takes advantage of the vat de work requirement drops at age. Fifty, which is a free, sharp disconnect by you know, by looking at that population like looking ahead of time line, is a pretty good reminder It's not that there is a consensus that you'll always go back to work. If you're being told you have to be working for with assistance. If there are times the policymakers agree, okay, clear nobody's gonna find work whether they want. You were not so we're just going away this requirement. We ve just been through another one of those with covered, and so you know it seems, like this sort of finding would be very useful right because it saying ok now that we ve all agreed that it

Not you know a moral imperative to have work in an environment where you wouldn't be able to get it. Let's look at whether this actually does the thing in more favourable employment by you say it's gonna, do I'm! No! It does not particularly do that if it does only release participation, but it doesn't necessarily affect employment and that, during this kind of back to the world question, this was able. I did adults, so it does you no kind of cut out the more sympathetic arguments for late bell. You don't deserve it against children because their parents are looking for work. You know you can't grenade against the disabled per year, and it does find that there is a lot of. You know that there is a bit participation, in fact, among people world, as we discuss the area, episodes how that's gonna, be they political question.

was Missus become guided, not as much aid consensus. These are the most vulnerable people, and so we need to help them problem, and I just I won kind of where we are not normative debate, whether it seems like the people who were hawkish on assistants, spending or academic is where, after a couple of decades, where there were these kind of way, faint sound like no we're just trying to get to a point where people will work are willing to go After saying no actually we are making a moral stance that, if you are not actively seeking employment or employed, but you do not deserve access to public benefits, regardless of whether We think that's going to engineer you to a morally superior endpoint yeah. That's it the thing I'm at all a man might have thought but, as you are describing now because I, like I had come at this as a health care reporter thinking about medicate work requirements and like, as those were being considered,

air over the last few years, a point that was made again and again by people who oppose the idea was basically that people who work on Medicaid, who are capable of working almost nothing largely already are like that that that most those people we owe our satisfying a work requirement without any kind of work required being in place, and four for the rest of the people. There is usually like good reason, quota quota gas, or maybe it's debatable, but like a good reason that they are not working, whether their elderly or disabled or taken care of young kids or what have you and that the risk of a medical work requirement is that just ends up crowding out p. who, who might have good reason not to work, but that doesn't silly have any kind of material benefits on appointment, because again, there not they're not working for a reason, and I thought To some degree, it could just be my own biases manifest. but like with the homeless population, that's like what

Obviously, these are folks who are already struggling in this kind, a multitude of ways and now you're, just like imposing a requirement on them that that it does not seem necessarily reasonable for them to be able to meet, and then, if they aren't able to meet it, you're going to take away public benefits on which they they clearly rely. no, no kind of where we are kind of the word work requirement. Course is. I don't like in the Medicaid space and it appears to be a move issue because of the successful court challenges and in that Graham in a way that I don't really know, the snap does has some like it's it's kind of stature, basis, makes our work requirement really hard to justify under the medicate law. I wonder if that's kind of what what under it's a lot of this research that shows no employment benefit. Is that the problem is it's not like? We have.

such a generous set of welfare benefits, there were actually distance, energizing, very many people to work. If they can work, they probably are, and if they're not working, there is a reason that they're not, and so that leaves work requirements, seeming kind of impotent other than the leading to some kind of cut in enrollments, because there is that population who is now being subject to a requirement that they're not gonna, be able to meet for Ex wires reason. Why did you should a general view here, because I think a lot of people miss the like sensible, empirical conclusion here, which is that you do you some on the right who were like ill disposed to social assistance programmes and they see work disincentives like lurking behind every rock you now and so there, like. Oh you're, gonna, get a child tax credit. you work or not like nobody. Nobody

work again right work requirements on staff when you work requirements on Medicaid, then, on the other hand, you have people like lefty people who have adopted a kind of like em post work utopian As- and I think you saw this in as recline slate as column. What he's talking about the unemployment insurance payments and he's saying you know what we shouldn't be threatening people with, poverty to make them work, Bob Bob Bob and what he's missing? I think what measures missing about the structure of the bonus you? Why were about the old age DC programme? Is that you lose the benefit. If you take a job right, that's a very different marge, like does giving people a benefit that will be withdrawn. If they accept, I mean, generally speaking, like a low wage, not super pleasanter, prestigious job like

think clearly there's going to be a disincentive impact and you look at IONA Marianne S, goose research on the bonus you I owe you look at the old research on, if you see, and also on the amount of grey market work, that people are doing. That gets very clear that the governments, like here's, some money, but if you get a job, we're taking the money away, if nothing else in incentivize people to cheat. you know and like not report that the income, but at the same time we see again and again that it's like look, you get the Medicaid whether or not you work just doesn't have a big impact and if you think about just abnormal middle classes, All right, if I told you Dylan, ok, you got a really hustle. You know for like the next three weeks, but if you just like crush it at work, then you're gonna get like a huge promotion. raise you're gonna, be like I've already got a job you want. Instead to visit, you get more money if you work

The exact same incentive that all people are operating on all that, like its literally the whole basis of the economy, is if you Norman, I dont, want to live at the Like Medicaid Snap subsistence level. Right like that's, why people go to college? That's a people, change jobs! Every like you know, people people want more money than they have and they are willing to do work in exchange for it and if they're not write like your at that very low living standard of like a snap and medicate beneficiary, it is almost certainly because there is like a real reason. If, just like trying a little harder would get you more money like you would you would do it, but it's totally different from saying. Ok, in his contingent, I'm not working because then you really eliminated the benefit that people have, and you can say you know, there's their side benefits to limiting labour supply and your your bidding up people's way.

Is you know way so that their reasons be five to advocate for it, but these work requirements are like their operating on a really weird, like view of like just like ask any, like. Would you try like a little bit harder in exchange for a bunch of money I think everybody word I mean or if they wouldn't it's like listening specific going, I'm like I'm sick. I need to take care of a disable partner. You know, like people have problems in their lives but like a normal, healthy, well person will like try a little harder in exchange for more money. If you give them the chance, you don't need to threaten them like that, and I just think that's what you see in these studies. Browser, like Republicans, want to come up with reasons to cut spending this. This works right like it's not. You know, they're not like highly empirical they

don't believe in taxing and spending and redistributing money is just like. I think when it comes down to the exact that's around now that man has successfully exclaimed the economy's you're ever on anyway, I saw any my thanks to anybody out there listening for university you're getting money to weed sponsors? And thanks to us It is for their own redistributive work. We are all trying to keep the economy moving in a world without work requirements as you know, just because we love it and because incentives work So thanks. So much Dylan for explaining to us for trying to pronounce this drug ethics, as always to do so to knock is news will be back on.