35 Burst results for "Alzheimer's Drug"
Approval of New Alzheimer's Drug Could See Surge in Blood Tests
"Last year about six million people in the us. We're living with alzheimer's disease and by twenty sixty that number could be as many as fourteen million people living with the disease. There's no cure and it's not easy to tell if someone has it from symptoms alone. The testing for alzheimer's is invasive and resource and pensive staff writer. Kelly servic is here to discuss. How testing the blood for alzheimer's might facilitate new treatments and new research. Hi kelly hi sarah alright. So this is kinda spurred on by the approval of a potential treatment for alzheimer's disease. I'm not going to say the name of the struggle. I'm going to leave that to you. It's very long but it's really put a spotlight on this issue of testing for the disease in the blood. Why is that first of all. Fda really surprised a lot of people by approving this drug called kanye mab marketed as as you home for alzheimer's and that that approval was special. Not just because there hasn't been an alzheimer's drug approved in more than a decade but also because this is the first approved drug that aims to actually interfere with the underlying disease process and slow the progression of disease and the reason that that is shaken. Things up is that essentially a lot of older people with memory problems. Who did not see care. Did not seek an alzheimer's diagnosis before. Might do so now that there is an available treatment. And what they would do to get screened would be what get speidel. Fluid take it out so diagnosing. Alzheimer's is really complicated. There other neurological conditions that can cause dementia and an older people a lot of other factors. That might contribute to their memory. Problems and as a result really confirming alzheimer's diagnosis requires waiting to get assessed by a specialist and be assured as you can be either getting a pet scan which is expensive. And there aren't a ton of pet scanners in this country or spinal tap so that your spinal fluid can be analyzed for certain
Medicare Evaluating Coverage for $56,000 Alzheimer's Drug
"Medicare's lunch the process to decide if it will cover the cost of a new controversial Alzheimer's drug that's undergoing congressional scrutiny the new drug ad you helm is costly fifty six thousand dollars a year and there are questions still surrounding who it will help after the FDA had to scale back its recommended use right now Medicare's making case by case decisions on whether to cover the drug it may have a blanket answer sometime next year meanwhile Congress is intensifying its scrutiny of the drug's approval to committees of requested documents from drugmaker Biogen including those surrounding unusual contacts between company executives and FDA regulators there was a new analysis done after company study suggested add to home was ineffective at slowing mental decline Jackie Quinn Washington
FDA head calls for probe into Alzheimer's drug review
"A loser. Despite today's Wall Street rally it lost nearly 3% after the acting head of the FDA called for a probe into the controversial approval of its adieu. Helm. Alzheimer's drug from the Bloomberg
FDA Calls for Investigation Into Alzheimer's Drug Approval Process
"The approval of a controversial new Alzheimer's drug. In a letter sent to the health and Human Services Inspector General Janet Woodcock asks for an independent review into the interactions between drugmaker Biogen representatives at the FDA Woodcock alleging that there may have been communication between the FDA and Biogen during the review process that goes against FDA policy. Biogen's new Alzheimer's drug received FDA approval in early June despite an advisory committee previously questioning its efficacy. ABC News is next get more out of
FDA Head Calls for Inquiry Into Alzheimer's Drug Review
"The FDA wants an independent watchdog to take a closer look at the decision making behind the conditional approval of a new Alzheimer's drugs that can reduce brain plaque but hasn't been proven to reverse the disease the acting head of the food and drug administration Dr Janet woodcock is calling for a government investigation into the contacts between your agency's drug reviewers and the maker of a controversial new else Hymers drug ad you help the announcement made via Twitter comes just a day after the FDA took the unusual step of scaling back prescribing information on the drug last month the health news site stat reported on it usually close collaboration between a top executive and the FDA's lead reviewer for Alzheimer's drugs Biogen has pledged to cooperate with the inquiry Jennifer king Washington
FDA Trims Use of Contentious Alzheimer's Drug Amid Backlash
"Federal health regulators are putting new limits on the recommended use of a controversial new Alzheimer's drugs a month after proving add you helm for patients with Alzheimer's disease the food and drug administration approved new labeling that the drug is appropriate for patients with mild symptoms or early stage Alzheimer's noting it hasn't been studied in patients with more advanced disease the change was to help eliminate confusion among doctors about who should be taking the medicine add to home hasn't been shown to reverse or significantly slow Alzheimer's disease but the FDA says its ability to reduce clumps of plaque in the brain is likely to slow dementia many experts are skeptical and three of FDA's outside advisers resigned over the drugs recent approval Jackie Quinn Washington
FDA Grants Accelerated Approval for Alzheimer's Drug
"So what would this pike. Sp if it didn't start with an update on adam damian's favorite drug guys. There's more news on that front this week. Catch us up right so the hot off. The presses aspect came out just thursday morning which is that. The fda restricted the label for which you helm is approved basically advising doctors to prescribe the drug solely to patients who mostly matched the population in which it was studied in face retrials this. I mean the implications of this we can. We can kind of talk about but you know one of the shocking things really probably to me. The most shocking thing on the day that agile home was approved was the breadth of the fda's label. The drug was indicated for anyone with alzheimer's disease at any stage of the disease regardless of what their sort of brain biology was. And as we know this drug is meant to clear out plaques from the brain that purported to contribute to the advanced alzheimer's and so that label was was fairly galling honestly and so the fda mostly walking it back to what people had expected for those people who even expected approval. was interesting. I feel like it might have fewer implications for the way the drug is actually used. Because i think that physicians indefinitely biogen were thinking that that it would only go to to this narrower group of patients but maybe just has more more implications for our fixation on the fda and what is going on there.
The Real Cause of Alzheimers and Dementia
"Wanna jump right in and talk about alzheimer's because you wrote a really interesting instagram post. I think it was a few weeks ago. And you were saying. Alzheimer's reversal is is real. It's not just a theory and you were hinting at a new study. Small one but something exciting. That came across your desk that you wanted to highlight and make your audience aware of so. Why are you excited about the study. And what did they cover inside of there. Well i'm hoping you'll share that study with a link. This is work that i've been aware of actually for quite some time. I know you know dr. Dale br edison and he recently published a book. Called the end of alzheimer's. The plan in the first book was invalid. And this one is the plan and i. I wrote the forward to that book and in that ford. I think it really did capture my excitement about the work that he's doing even be beyond how he's broken the mold beyond alzheimer's and let me explain in a. We live in a world where we try to really pigeonhole are diseases to think that they are caused by one thing and therefore we can fix them with a remedy and there's such an effort underway to Find an alzheimer's drug that works just last month. Eli lilly announced the results of a trial. In which they're monoclonal antibody mab was found to reduce the rate of decline of alzheimer's basis by an astounding thirty two percent When they made that announcement the stock value went up. I think twenty billion dollars. Eli lilly but what does that mean. It means. it's slow the decline by third means. People are still declining going to get worse than we know where it ends up generally So it really wasn't a stabilizing alzheimer's or can you imagine actually improving their situation. Because they're looking at one thing. This is a monoclonal antibody that is targeting the so called beta amyloid protein. That's absolutely the cause of alzheimer's.
"alzheimer drug" Discussed on The Guardian's Science Weekly
"Else called tau.
New Drug Brings Hope to Some Alzheimer's Patients
"The latest Alzheimer's drugs there is hope for patients and worry for doctors Alzheimer's patient Michelle hall was in the hardware store when she saw the alert on her phone about FDA approval of a new treatment I kind of wanted to cry but I was so happy I I need at least sort of wanted to look at everybody else and say Hey look look what just happened but doctors across the country you're still trying to figure out who should receive the drug called ad you helm which at best slows the fatal disease marginally Michelle hasn't yet found out if she's a candidate it may not be ready right now or it may not be the exact drugs later on but the fact that there's something in the pipeline it is just amazing I Shelley Adler
"alzheimer drug" Discussed on CATS Roundtable
"Lately we've been seeing in the news About some controversy. Because we haven't new drug for alzheimer's in a long time and biogen came out with outta hellman from scientists warren. So happier convinced with what's happening but you have to realize that. This is the first time that they found medicine next. Actually blocked amyloid. Amyloid is a compound that builds up in the brain. It's thought to be toxic to the brain and this medicine by biogen actually helped to delay clinical decline in in some patients. I'm meteorologist wasn't weren't as convinced with some of the data the number of people but the whole that it brings to someone with alzheimer's and the fact that it did on pet scans show that reduced this toxic amyloid accumulation. The brain was significant enough that it did get through the fda and it's been the only new drug we've had almost twenty years and it's an iv infusion that you get the sixty minutes once every four weeks and On the other general note things for our audience to know over your lifetime. You should start when you're young. Eat foods and low saturated fat and avoid foods with high cholesterol. Eat fruits vegetables. Olive oil turns out to be very important even as an anti aging factor because we can improve our health span. We won't age as quickly. Consuming whole grains fish nuts and decreasing our intake of fats. Red meat sweet sugary beverages sodium. All these things are contributing factors and Really have to look at the diet. And if you can stick to Mediterranean like diet the just like the people on the island of so then. The greek seem to do very well with minimal cognitive decline and they constantly everywhere they go so the exercise their diet and all these things. Help reduce your chances of getting alzheimer's so these are all pieces of information on our audience can use to try to help them in their loved ones to try to prevent it and also to talk to you and they're all just about some of the new treatments and there's even companies that are up in canada. There's one working on a vaccine that will try to block this and help. Maybe even prevent alzheimer's or slow it down what's happening on that people are saying. It destroys science for twenty years. What what's the big controversy. What what what is mistake. Well there is a group of scientists aren't convinced that getting rid of amyloid is really the cause of the alzheimer's or the cognitive decline and they felt that it wasn't as convincing. And i think because the law size of this study and the amount of improvement was convincing enough for some people but again i don't look at it that way..
Sen. Ron Johnson on Democrats' Obsession to Control the Narrative on Groundbreaking Medication
"The side of these sometimes super expensive treatments we've invented recently in lieu of very cheap treatments I ever met in a hydroxychloroquine. And yet I see this article in The Wall Street Journal today that the left is objecting to this new Alzheimer's drug out of helm because it's if I I hope I'm saying that right because it's too expensive. So what is it in one hand, do you like to really expensive stuff for the treatment of coronavirus? Maybe because Trump recommended the others, and on the other hand, you have a drug that could benefit patients with Alzheimer's, and they're like, no, no. Well, we don't want that. That's no good. I mean, are you do you get this from a different angle up on the hill? Or am I just stupid? What am I missing here? Well, First of all, when we do know about both Hydroxychloroquine IRA medicine is they are incredibly safe drugs that have been prescribed for decades in the billions of doses with a very low rate of adverse effects. And so my point is, I've been so why not give him a shot Your current today current Nice guideline. And Kobe this do nothing. Go home. Isolate yourself. Be afraid and hope you don't get so sick that we have to mention the hospital where your cancers are reduced that violates every basic candidate of medicine. Words. You're Diagnosed early treat early. You can have a much better outcome that we've completely turn turn medicine his head as it relates to Covid. Why is it Because people like Fauci Collins governors want the control? Is that what's going on here? I mean again. It makes no sense to me and you know, like you did. I can't even begin to getting ahead of a Democrat. Liberal Progressive. I mean, they make no sense whatsoever. Yeah. I mean, it just seems like I mean, it's almost one of these.
FDA Adviser Who Resigned Over Alzheimer's Drug Approval Speaks Out
Backstory: FDA Approval of First Alzheimer's Drug is Mired in Controversy
"Let's move this and talk about treatment for another health challenge. Alzheimer's shares of biogen are up forty percent in the month of june. Because the fda approved biogen's drug to treat alzheimer's this is the first medication aimed at slowing cognitive decline. For people with alzheimer's that regulators have approved and yet it is not without controversy. Three members of the fda advisory panel resigned over the decision. There are a couple of threads to get to here. But i guess my first question is what is going on here is like. Was this a mistake to green. Light this treatment. Well a chris. I call this nearly biotech soap opera. You can even bring in greek mythology here. first of all biogen's drug is like the mythical phoenix it. Literally rose from the ashes. I mean this was a drug that not all that long ago had been relegated to the trash heap seemingly failing late stage clinical studies badgen later came back and did some further analysis and analysis and they said hey you know we. We actually see that. There's a potential here and they they pursued and then ultimately did file for fda approval and ultimately won. But you're right it's extremely extremely controversial. The fda's advisory committee that was convened to review. The data came back and voted ten against recommending approval. One abstention no member of that committee voted in favor of this drug being approved. They thought that another clinical study needed to be conducted to to establish that the drug was actually effective. And so and and not even just that several members of the committee wrote op eds publicly urging the fda not to go ahead and approve. Distract the fda. Did it anyway. And so it's extremely
Biogen's New Alzheimer's Drug Is a Medicare Budget Buster
"New drug for Alzheimer's comes with rather controversial approval, and now we're learning a huge price tag. The drug is called Adele Adele home, I should say adult film. It was approved by the FDA last week. It's $56,000 per year for a supply. Medicare copays could reach $11,000. The Alzheimer's Association's sharply criticized the manufacturer, Biogen for that price tag. You're about to hear from Paul Seagirt. He is with PCs advisers there in Northern California firm. They help businesses manage health care costs, And he says, This is a perfect example of what is wrong with how we approve and distribute drugs. We've got great health care how we pay for? It's crazy. This is a perfect example. You've got a $56,000 drug that the FDA is just approved. Three of the scientists who were on the review panel That made a recommendation to the FDA have resigned because of the 11 in November, 10 said. No, I'm recommending to approve it and one said, I don't know. And yet they still approved a drug that Has, you know, really hasn't shown itself to be effective. They're going to build $56,000. A year for each person that's on this drug. It's incredible. The FDA advisory board gave the thumbs down to this drug. Yet it got approved by the agency. The question is why It's a great question, and unfortunately, I There's a lot of financial drivers that drive our whole system. I'm a free market person. I'm not against that. But we've a lot. We're approving this thing and then saying we're going to allow them to do a nine year confirmatory trial. Which in those nine years if they do end up confirming that it is not Very effective or not that effective or not at all, effective. We're gonna have spent hundreds of billions of dollars at that time frame. We're
"alzheimer drug" Discussed on Vox's The Weeds
"Know kind of where where kind of the were were choir. Discourse is i know. Like in the medicaid space it appears to be a moot because of successful court challenges in that program in a way that i don't necessarily know the snap does has some like you know it's it's kind of statutory basis makes a work requirement. Really hard to justify under the medicaid law. I wonder if that's kind of what what underlies 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 that were actually disincentivising very many people to work. If they can work they probably are. And if they're not working. There's a reason that they're not and so that. Leaves work requirements seeming kind of impotent other than leading to some kind of cut in in enrollment because there is that population who is now being subject to a requirement that they're not going to be able to meet for xyz reason. I wonder what did sort of general theory here. Because i think a lot of people miss the like sensible empirical conclusion here which is that you have some people on the right who are like ill disposed to social assistance programs and they see work disincentives like lurking behind every rock. You know and so they're like oh you're going to get a child tax credit whether you work or not like nobody. Nobody will work again right work requirements and snap when you work requirements on medicaid. Then on the other hand you have. People like lefty people who have adopted a kind of like Post work utopianism. I think you saw this in as reclines latest. Column where he's talking about the employment insurance payments and he's saying you know what we shouldn't be threatening people with poverty to make them work blah blah blah blah blah blah. And what he's saying. I would as missing about the structure of the bonus. You i or about the old. Afdc program is that you lose the benefit if you take a job right. That's a very different margin like does giving people a benefit that will be withdrawn. If they accept i mean generally speaking like a low wage not super pleasant or prestigious. Dob like i think clearly there's going to be a disincentive impact and you look at Nascar's research on the bonus. You i or you look at the old research on. Afdc and also in the amount of grey market work. That people are doing like. It's very clear that the government's like here's some but if you get a job we're taking the money away. If nothing else it incentivizes 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 like normal middle class people right. It's like if i told you dylan okay. You gotta really hustle. You know for the next three weeks but if you just like crush it work then you're going to get like a huge promotion and raise. You're not going to be like vertu got a job. The work incentives. That you get more money if you were just the exact same incentive that all people are operating on all the like it's literally the whole basis of the economy is normal. Don't wanna live at the like medicaid snaps subsistence level. Like that's why people go to college. That's people change jobs like every like you know. People people want more money than they have and they are willing to work in exchange for it and if they're not right like if you're at that very low living standard of like snap and medicaid beneficiary it is like 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 that's totally different from saying okay. The benefit is contingent on not working. Because then you really eliminated the benefit that people have and you can say you know. There's there side benefits to limiting labor supply. And you're you're bidding up people's wages you know so. They're they're reasons. People have to advocate for it but these work requirements are like they're operating on a really weird like view of like just like ask anybody like would you try a little bit harder in exchange for a bunch of money and like everybody would or if they wouldn't it's like there's something specific going on like i'm sick. I need to take care of a disabled 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 But also like republicans. Wanna come up with reasons to cut spending this. This works right like it's not it you know. They are not like highly empirical. They don't believe in taxing and spending redistributing money is just like i think when it comes down to. That's now that matinees success loosely. The economy's you ever on anyway. Yeah so anyway. Thanks to anybody out there. Listening for redistributing money to We'd sponsors thanks to sponsors for their own redistributive work. We're all trying to keep the economy moving in a world without work requirements. Were still hot casting for you. You just because we love it Because incentives work as thanks so much dylan.
"alzheimer drug" Discussed on Vox's The Weeds
"The impact of work requirements on program participation and labor supply. It's colin gray at leave atlantic. Prager kelsey youkilis and mary sake and this looks at the question of imposing work requirements on the supplemental nutrition assistance program. Snap a food stamps. You you could have different motives for wanting to attach work requirement to snap right. I think an optimistic view would be that you tell people. Okay you gotta work if you wanna keep getting snap benefits so then people kind of get off their butts and get a job and their incomes go up but they also have their snap benefits and so living standards rise. The production possibility frontier of the economy is pushed out all kinds of good. Things happen Maybe know true believers in fully automated luxury communism. Say it'd be better if they didn't work but but like normies we'll call it a success with these guys find is that that is not the case. that what happens when you impose work requirement is some people lose benefits But there is no you are. You are identifying Perhaps unworthy people who you you kick off or something like that But you're not actually encouraging any work. I believe from past episodes of the weeds. General finding about medicaid as well that it. It works as a way to cut the rolls right. Like if you if you want to say i feel unsympathetic to non working This successfully identifies them and gets them off. It doesn't generate or benefits. Which i think is the claim. When would make on behalf of this idea. The way that this study was designed to the researchers. Go through a decent job saying you know. It's surprisingly hard to get really good data on this because at a certain point your not actually measuring the treatment effect you're measuring something closer to intent to treat because you're selecting out who would have qualified for snap but people do qualify for zappa. Choose not to go on public assistance programs for other reasons and so what they've done here is look at a period in which virginia had a waived its work requirement or the great recession at take the population that was on snap at the end of that period when virginia said okay. You know it's twenty thirteen great recession's over back to work and how many of those people subsequently dropped out of program. Participation also takes advantage of the fact that the work requirement drops at age fifty which is a a sharp disconnect but you know by looking at that ovulation like looking at that kind of time. Line is pretty good reminders. That it's not that there's a consensus that you'll always go back to work. If you're being told you have to be working for public assistance. There are times. The policymakers agree okay. Clearly nobody's gonna find work whether they want to or not so we're just going to waive this requirement. We've just been through another one of those cove it and so it seems like this sort of finding would be very useful right because it saying okay now that we've all agreed that it's not a moral imperative. 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 favorable employment vitamins. You say it's gonna do and no. It does not particularly do that. It does certainly reduce participation but it doesn't necessarily effective and that brings us back to the world question. This was a buddied adult so it does kind of cut out some of the more sympathetic arguments for bel value. Don't discriminate against children because their parents aren't looking for work you know. You can't just renege against the disabled for and it does find that there's a lot of up there. There's a big participation effect among people who are listed we've discussed in recent episodes. How that's you know. The the political question of homelessness is become kind of not as much a insensitive. These are the most vulnerable people and so we need to help them problem. And i just. I want of where we are in that normative debate. You know whether it seems like the people who are more hawkish on assistanct spending or akkad swear after a couple of decades where. These kind of lake faints on lake. No were just trying to get to a point where people will work are willing to go back to saying no actually we are making a moral stance if you are not actively seeking employment or employed that you do not deserve access to public benefits regardless of we think that's going to engineer you to a morally superior endpoint. Now that's interesting. And i don't you know i might have thoughts on that but as you were describing that because i like i come at this. As a healthcare reporter thinking about medicaid work requirements and like as those were being considered here over the last few years a a point that was made again and again by people who oppose the idea was.
"alzheimer drug" Discussed on Vox's The Weeds
"To encourage future research lake. I can understand that both like both. You know you've laid out both kinds of logical arguments that it does seem like what is more likely to be impurity plausible than the other and. I wonder which when using is more likely to happen. Oh man put me on the spot you you do get to claim journalist's privilege not so i think like the statins are the example. I think i mentioned before that. Alzheimer's advocates will give of like. If you open the door others will follow. I do wonder. And i guess worry like i don't know enough to say this confidently so let's call it a hunch but i wonder if like the kind of science of heart disease and colosio on and stuff was just like a little a little sounder. Like yeah we. 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 heart drugs would should be targeting and it was just figuring out a way of doing it like i was saying before. I think it's still pretty unsettled. Like and you said this darah like what actually causes alzheimers and weather. The therapies that we've been developing are actually targeting. The right thing. I at least imagine a scenario where like alzheimer's advocates are rights and like this encourages other drug companies to start pursuing their own treatments. You could at least imagine us reaching an end point where it's like. Yeah buts as it turned out. The amyloid hypothesis was all wrong. And all of this. You know we were already kind of in this situation in the spring of two thousand nineteen when the biogen had stopped there to clinical trials. Everybody was wondering whether the amyloid hypothesis had been all wrong now because biogen 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 necessarily 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 writes in the worst possible way. But yeah i mean it. It is kind of a fundamental disagreement. And like like you said. I can see why both sides feel the way. You'll see it the way that they do. I do wonder. I feel like what distinguishes alzheimer's from from some of those prior examples of a first class drug than yielding second and third and fourth class drugs is that the science on alzheimer's is a lot less settled. And so now you know we were already putting most of our eggs in the amyloid basket and are we just gonna take whatever eggs we might have left and throw them in there too. I think that's potentially risky proposition. This reminds me. You know less of a drug approval issues. But that's above some of the science funding stuff that darren 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 this hypothesis worked on it. There have been a lot of public haitians on it. There is now a lot of drug company money you know. Actively pursuing research programs that are based on this. There's a lot of funding for your lab but that is trying to do incremental work that accept this hypothesis and that if you question the hypothesis i mean not because people were mean but like they're sincere but it's like 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 hypothesis is wrong. It is probably easier for you to find something else to work on that like zant alzheimer's and then you could tell a journalist. Hypothesis is wrong. But you probably can't like get. Everything is based on pure reviews and submitting things to committees at the nih that are made up of the people who approved the previous stud sway up and that we are probably just underweight unlike maybe this is wrong and we should pursue a different thing. Because you know like it's going to hurt people's feelings there. They're lots of reasons why people would want to not pursue alternate lines of research. That aren't like good reasons like if we if we wasted a bunch of money on experiments like pursuing some other hypothesis the that wouldn't actually hurt anybody and if the other view turns out to be right like the gains would be really really large. But that's not how the institutions that we have function you're much likelier to get ahead sort of incremental progress following this hypothesis and then the approval of this drug is like the ultimate example of that right. Like i think generically if you just like said to the fda like what if. I showed up to you ray. If you just described the nature of the statistical evidence he had two trials and it only worked in one of the trials and in that trial it only worked with the statistical re analysis. They be like. I don't know man like that. Sounds pretty. that sounds pretty bad. It's only the contact strike that this was the promising drug that was based on the consensus hypothesis. Baba baba. Bob that makes it sound like even remotely plausible right. It's like you have so much. Momentum behind the idea that like taking out these plaques is like what want to do that even very marginal progress like at deep lacking like everybody wants to sort of applaud. You for the. That worries me. More than the 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 like decide that we want to pretend like this. This is really working or can we admit to ourselves that like really like living on a prayer here and oughta consider you know what else we can do. Yeah no and the phenomenon you just described as is absolutely real. I've already named checked Sharon beg lease magnum opus on the amyloid hypothesis that she wrote in two thousand nineteen after biogen had had halted their trials and two two anecdotes from that. Come to mind that the just confirm what you just. The problem that you laid out one was a scientist who was pursuing an alternative line of research and she was submitting her articles to major medical journals. And the problem. was you know. Because she'd been working on this for a couple of decades she had only been ever been published what you might call like mid major medical journals and so like before they even got to 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 a major journal before select word i was like we're just. We can't really take this seriously. And that is i. Think in one example of the kind of gate keeping that you're describing and the other one was she quoted an anonymous Scientists who works in a pharmaceutical company and they said like you know think about the incentives. Here if you're just like who works on drug development and big pharma lake if you propose pursuing an amyloid drug and it doesn't work then like you can just say like well. We were just listening to all the smartest people and in academia said and and following that consensus but if you provoke propose something else and it doesn't work like good luck with your career like you're probably done for and you're going to have to find some other line of work so i think that has that has totally manifested here with the pursuit of alzheimer's research. And like yeah. I guess it's like we could probably just. And i think most people would agree with this like we could just be spending more money on research like you know. I know from the researchers perspective. That's always the answer we also need to. I think there's a pretty strong case to be made that we should by buying a research as well right. We should probably talk about a white paper. Yeah let's do it. I take a. We'll get the white paper support for this. Episode comes.
"alzheimer drug" Discussed on Vox's The Weeds
"Were financing like tons of our health care and like good healthcare. Work like get poor. People medicaid because then they will be able to get prescription drugs and like again in the twelve years since that happened. Like i don't know it seems fine like it's it's good for to have have medical research like what is the problem with the high prices and even today i'm like okay. It seems ridiculous to pay fifty thousand dollars a year. Brunell timers drug. That doesn't work but like if we do it. Are we going to be sitting here. Eighteen months from now being like. Oh and now we're somehow like hobbled like interest rates are nothing it doesn't mechanically crowd out there spending like we don't have a price regulator but we also don't have global budget for us. It's not like you know. Sarah can't go to the hospital. Because johnny's got this alzheimer's medicine so it's like what's the the. It seems like a bad system. But also i'm like hard pressed to say like who is gonna suffer as a result of this unless it cuts off some other more promising line of scientific research which. I don't know anything about like is there is some other alzheimer's drug that's better. I know i don't think so. I mean there are some alter some other drugs that are pursuing alternative routes to treating alzheimer's that i think are there in much earlier. Their clinical trials got started a couple of years after biogen. So like there's still probably a couple years away from really having results that we could evaluates i did hear the concern though from one of the the drug experts that i talked to of like all right so biogen just got this drug approved with really limited evidence and yet they're going to be able to charge this price for it and they you know the one reading of that is that like now. We've opened the door and maybe a much. A bunch more drug development will follow this person. I talked to raise the concern of like. Are we sure anybody else is going to be all that interested in pursuing alzheimer's drugs. Because one you know because there's no existing treatment you have to admit at magic as many patients as possible are to want to have access to biogen's drug which kind of biases your potential patient population running clinical trials of your own 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 a cure for alzheimer's when all we apparently have to do is meet this very low threshold for clinical effectiveness to get the fda to sign off on it arguably obviously alzheimer's tree has a different view of this but it kind of creates a disincentive for for really trying to to find. Some kind of breakthrough are like a cure because like you apparently can can get the fda to approve a drug and and sell it for sixty thousand dollars a year with with the kind of evidence base that the biogen had so. I think that is that is kind of an open question. I mean i think luckily there are some of these other treatments already in clinical trials. So hopefully here in the next few years made we'll get an idea of whether they have a more success than this amyloid treatment. Has i think though to your first point. It's a fair one like yes like. We've we've massively expand health health coverage several times this century and like a lot of the kind of apocalyptic warnings about what would 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 sort of like a chicken little elements In play but i do think what may be. I mean what everybody is worried about is just the scale here. Because of the number of alzheimer's patients combined with the price that biogen is planning to charge and just to put it in perspective. You know it's all preliminary because we don't actually how many patients will take it but like if you just kind of extrapolated. The number of alzheimer's patients biogen's price We're talking about a drug. That would cost medicare part b basically about one hundred billion dollars a year and currently medicare part. Bs spends about thirty billion dollars a year on prescription drugs. And even if you bring in medicare part d into it. The total medicare drug sped is about one hundred and thirty billion dollars and so this drug alone is nearly doubling the amount of money that medicare the entire program spends on prescription drugs in a given year. And so you know the trickle down effect of that whether that's in taxes needed to be raised to cover the cost and you know there will be for like medic. People on medicare do perry pay premiums. At least some of them do you know that is essential trickle down effect. I think that is what it's the scale of it is. I think what's got a lot of health care. Experts kinda quaking in their boots right now. And you know i i. I'm totally rejected. The idea that the maybe we'll figure it out. I i do think wh and the other thing that's thrown people off is where we started. Which is this is a drought. We're talking about that kind of budgetary arrests for drug. That may not even really work. And like you know as one of the people. I talked to said like. If this was a cure for alzheimer's you know the the societal benefit 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 find outrageous so the other thing that i think is kind of worth bringing up here is something that matt mentioned in it to be toward the beginning of the episode. Which is you know. In general like yes slippery. Slope arguments are dumb by in a world where we just spent several months being concerned that in global pandemic breaking the rules for fda approval was going to need to some kind of slippery slope problem outside the context of a global pandemic like yes. This is a very sympathetic population. Very broad population are all of these equities. We've been talking about. Those aren't distract could also be used by other pharmaceutical companies to argue for approval of their drugs in other contexts. And so as long as the ideas out. There that you just raised dylan lake. Yes in the past. The case scenarios haven't materialized but are reasons to believe that like this could really be the distortionary one that changes things. It's possible that you know the political lesson of this is that you don't need to go through the scientific hoops as long as you can make the political argument that you really need to prove this. But this is where. I kind of wonder dylan lake. What you just laid out the concern that this is going to disincentivize further alzheimer's research seems to be the photo..
"alzheimer drug" Discussed on Vox's The Weeds
"Byproduct and so we're basically targeting the wrong thing and so i think to your point dr like that that suggests like our. Obviously our scientific nods of this is is still after all these years dramatically under braked. This this drug given the evidence of its or 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 what you were saying matt like. It's easy to imagine in another country. A two step where you had like the you have a scientific evaluation and then kind of an economic evaluation. Yeah like the uk has nice. Australia has a prescription drug board. That that evaluates its drug and says like all right we think based on the the you know 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 program that would be charged with with covering this alzheimer's drug their only real standard for whether or not to cover something is whether it's reasonable and necessary which is obviously very vague term and for most of history that has been synonymous with fda approval and they basically have no mechanism for a situation like this where the fda has approved its drug and yet the best scientific evidence would suggest it is not worth nearly as much as biogen is planning to charge like icier. Which is this non government group up in boston. that does kind of their own independent. Evaluations of drugs worth Has pegged this Biogen's drugs potential value at like eight thousand dollars And biogen's plan to charge sixty thousand dollars so there's obviously enormous insperity there and so like you could imagine alternative universe where the us might say okay. The fda has approved this drug and so that would seem to put some obligation on us to cover it. But like we're going to pay for the actual value that it provides but medicare doesn't have any mechanism like that like there are some you know federally mandated rebates that drugmakers have to pay but you know bio jet is setting its list. Price with those rebates and minds and so yeah this this does just seem to reveal once again That the situation 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 snow. Here's where though. I swoop in more from mike and economics viewpoint. Because so the the law creating medicare part d was like this is one of the very first policy stories that i ever covered We've been reflecting recently. We're gonna we're gonna do some some back to the future wheezes incoming once but you know i. I arrived in dc in the fall of two thousand. Three we have this medicare bell Sort of like just past but people were still arguing about it and this is like democrats big critique of the bill as it was written and it's like a very weird very different political moment at to think about but it was like republicans put this big expansion of medicare benefits through and democrats A hundred percent deficit finance no pay for is no offsets and democrats. Big critique of it was that it was to spendy. You know that if they had included these sort of price control ideas. Democrats had at the time. And there were few different versions. Floating around one was to create a nice like panel. one was to create a benchmarking. I mean we continue to have this controversy frankly but democrats ultimately decided in what would strike today's people to be a very procedural maneuver that there were two democratic votes in the senate for the republican bill so they had a majority but they didn't have sixty votes and they didn't have reconciliation instructions so democrats could have filibuster but they decided that filibustering like a big popular expansion of healthcare benefits on the grounds that it was like too expensive would not be viable. I'm so they just kind of fulton went through. And then as far as i can tell for the next eighteen years like nobody ever complained about this situation. I mean to say that like there were no like wonks. Swipe like nobody in america was like my life. Today is worse because medicare is overpaying for old people's drugs now people have complained about the out of pocket prescription drug costs that non medicare recipients had right but this thing the bush administration set up where the medicare benefit was a pure giveaway to providers. Absolutely everybody seemed perfectly happy with like the providers. Liked it when obama came in in two thousand nine to the aca. He had his own shady deal with pharmaceutical companies. Where he was like you know you know a lot of these liberals like they're nuts like they want to do this with pharmaceutical But like no..
"alzheimer drug" Discussed on Vox's The Weeds
"The fda goes back in some ways all the way back to two thousand nine hundred six but but mostly to the thirties. Right there's a federal food drug and cosmetic act and it. It establishes an agency. That's supposed to do pre-clearance review of pharmaceuticals and it's supposed to check for the safety Ban false therapeutic claims right so the idea is to get rid of the snake oil salesman and the quack cures and stuff like that. And that's that's what the was was created for at that time in the late nineteen thirties. There's no medicaid there's no medicare there isn't 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 you. The consumer with your own dollars right and we. You know we'd normally set a 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 sell selling exploiting toaster right But they definitely let us sell stuff. That's like junk you know. There's a lot of products for sale. That don't really do what they're supposed to do that. Don't meet their marketing. Claims this even this whole like underworld of non fda approved supplements. We enabled like elijah outlandish remarks about it. So the fda has woods four a consumer product. A sort of unusually high bar for cleared. Sweet like you could sell cigarettes right which are not safe or effective. But because they're not medicine you know you can go do it. But in 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 insurance programs and so in effect right if a new medication comes out and it is supposed to treat a serious disease in insurance company. That's just like nah. We're not gonna cover. This is going to take shit from people right. They're going to be like the fda says it works right. What are you doing right. And this is how you get into patients bill right legislation in in the nineteen nineties. Right like the greedy insurance company won't cover the treatment that the government's own regulator says is good then for alzheimer's patients. You're largely talking about medicare population right. So you're spending other people's money and in europe. They have a european medicines agency. Which does that kind of fda role but then they also have national health insurance. You know schemes which are all different but they all have price regulated ray so like a deuce two different questions and like one is. Are you allowed to sell this to people right like are we saying it's so dangerous or so fake that we're going to be like no you can't take it and then another one is like okay. Will the government pay for it right. And there's lots of medicines in part because of this that the tends to be laxer than the fda and in some roles you know like there's a lot of like skin treatments that are approved by the ama but not by the fda but they're not covered by european national health insurance plans just to make your skin look nicer so the government won't pay for it but the ama is like. Yeah fine it's fine. It works whereas in america. The fda is like kind of a price regulator but outs. But it's not a price regulate like right. The the midi the did this like does not have economists on it like are not supposed to think about price. I mean they're they're not the right people for it. It's not our mandate so like in some ways the fact that this may be doesn't work like at all sorts of dodges the issue because like obviously there's no reason to prescribe medicine that doesn't work but like suppose we were really really confident that this had just a 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 on right right and and in this weird way you get to this dichotomy thing where you have. I mean it's clear to me just like reading the coverage right. The people upset about this decision or very worried about the budgetary issues and the patients agitating for it are like they wanna believe and who wouldn't like if you have a terrible illness and one group of people are like i have a treatment that works another like arm. That's a sure. Bet your math. Like i would take a medicine like that but then like the question is is do. The third party want to pay for me to take a medicine whose efficacy seem so questionable. But that's like a different kind of topic and we don't have an agency that like addresses like in a systematic way. There's no agency in the federal government that is set up to answer a question. Like how valuable is this and we discuss it as like the democrats standard rhetoric is like they want medicare to be allowed to bargain with pharmaceutical companies. But like it's not really like a negotiation like you know like i don't know i've got an agent. I work with the my book. We're not gonna send him to bargain with the pharmaceutical companies. Would you might set up is like an evaluator right like nice right. Yeah says like you. Hey that like tries 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 does like we do at the ep. We have lots of regulatory agencies that do this and it always sounds like chilling right. It's like if it costs seven million dollars to save a alive. We do it. If it's the epa but not if it's dot like they have a slightly higher bar that's how you do policy except with medicine like we just don't write it. Also think that like. I wonder if alzheimer's because of the nature of what we don't know about the disease can falls uniquely into this like politics desire like it's not just be don't have effective treatment for alzheimer's we still don't really understand. Risk factors very well. So it's not you know. It's not something where there is a known population that you can tell early in life to adopt certain behavioral modification so reduce the risk of the disease. There isn't the kind of responding. You know moral politics of light well. If you get alzheimer's you must not have lived your life right so it's not necessarily worth it for us to spend all this money on you. And the as aware of alzheimer's increased the idea of anticipatory dementia has actually really gained. The fear. ables is itself a really big factor structuring. The psychic wounds of older adults is really become a thing like i was. I was just kind of speculating on this when we initially discussed. Maybe there's something about kind of the fear of losing one's hog native ability that is uniquely terrifying to people who like work their minds for a living. But i looked it up and like there have been you know there really have been efforts to codify in develop scales for anticipatory dementia in all. You don't see for like fear of other diseases which suggests that it really is a potent thing and so it does seem like on the one hand you have a lot of ability to imagine. This would happen to me and on the other hand. Very few of the kind of inhibiting factors that might lead the public or policymakers to say okay. But it's not worth spending that kind of money because on a certain level. You did it to yourself. yeah. I think there's definitely a through. No fault of their own a dynamic and play here and i mentioned this glancing lay but like when the the biogen drug is is founded on. What's called the amyloid hypothesis. Which is basically this idea that there are there are plaques in the brain that interrupt you know neurons communicating with each other. And that's what helped you know. Manifest the symptoms of alzheimer's disease and when initially when biogen pull the plug on these clinical trials in march twenty nineteen. It did it caused this kind of total reckoning within. The scientific community of whether the amyloid thesis is totally misguided. And whether like you know maybe the sheriff bagley at stat news wrote an amazing piece on this encourage everybody to read but but she gave the example of like maybe that plaque is just the those are just headstones in a graveyard but even if you got rid of the headstones the plaque in other words that wouldn't that wouldn't give it at the dead bodies like maybe there's some underlying cause here of which the amyloid plaque is just like a.
"alzheimer drug" Discussed on The Current
"Dimension of samsung. It's dry and pardon that this happens. What's your what's your message to. I mean the p the decision makers politicians people who make decisions about why. It's so important to find those better answers and better treatments for patients with alzheimer's we don't have to wait for the perfect. Perfect answer weighed it. Make interim answers. We don't know that they covid. Nineteen vaccine is going to work in three or four years. But we've we have to take a risk and the risk is minor. Interior government is adding two hundred new beds to get people who are who have alzheimer's they need twenty four seven care. We can't keep building bands to take care of people who have to stop people from getting to that stage and asset s dry. We'll do maybe but if we don't try it how do we find out. You started by saying that when you got the diagnosis. It was really scary. Does it feel less scary now knowing that a drug like this is on the horizon at passion because when you're threatened with a terminal disease you can't get scale. You're the man. But i found out in two thousand thirteen. But i didn't get the precise diagnosis of mild cognitive impairment with alzheimer's disease in two thousand and twenty. And i said to myself. At least i now i know what i got. It's not just a broad envelope of a whole bunch of diseases. And then when this adamant read the press release by the alzheimer's association the states there is a light at the end of the tunnel. And this is the light. And then i read about all controversy and i go come on guys do something do it now. People say i don't have imagine.
"alzheimer drug" Discussed on The Current
"With by the john henry program. Tell me about your diagnosis. You were diagnosed in two thousand thirteen a scary because the first thing when you investigate dimension which is often interpreted as alzheimer's as you have six to nine years laughed out of useful life which may be your total life so i was looking at a disease which is terminal which has no cure at was race. Gary and i was newly married at that time of night. new wife. Reciting the savvy right now. Didn't know what to do. You didn't expect me to have this kind of notice. At the state of life. In the absence of new treatments life look like well. I very well. I was just north of toronto. I had all sorts of help from the trial memory program but moved to see for us which is in the rurals and my personal care. Doctor your said to me. I don't have experience in alzheimer's or dementia and any of this stuff so after a few years of living. Nc for she said to me if you can get any referrals remain. A people have been help you. I will refer you and this is a key to being. So i shouldn't say bidding assistant but you have to get into the system and you need your personal care doctor to get you on your side helping you out and i did that so in about two thousand fifteen. I started researching so the research. That i did. Why should be volunteering. Nc for to the gal from the alzheimer's society where to write about your life experiences. So i've not read nice seven collins at had rejected by the alzheimer's society or a local newspaper that in and i become a non expert experts expert by experience. But the is. And i know you're gonna ask me..
A Closer Look at the Controversial Alzheimer's Drug Approved by the FDA
"alzheimer drug" Discussed on The Journal.
"So then. Biogen's submitted their data to the fda some of it from the incomplete phase. Three trials to get at your helmet proved we've had many conversations with the company over that time and why they would say this study works even though by normal scientific standards. It couldn't work because they had stopped the study early. And i think the the answer was you know not everything is black and white and you know that you have to look at the totality of the data and the totality of evidence that we have for this drug and way in mind that there are real people out there millions of people out there who could benefit from this drug and not essentially not to be like pedantic data scolds about it and to go in with an open mind and consider that the signals that these clinical trial data were showing. You really were evidence of benefit. The drug may have shown benefits but it also came with risks in the trials forty one percent of patients treated with high doses of you helm had potentially dangerous side effects but despite the side effects and the unconventional data biogen confident the drug would get approval and that came across in late two thousand nineteen when one biogen executive spoke at a conference most famously at a conference he said you know well the choice that the fda has to make here is sure they can make us go do another study. But that's gonna take five years and over those five years. There's going to be all these patients who are not going to be able to get a drug that they could get otherwise now and that was seen as being a little bit dicey just because you know companies aren't supposed to be pressuring the fda public in a way as to put their thumb on the scales at the same time biogen was facing other struggles last year. The company lost a legal battle to keep the patent on. Its top selling multiple sclerosis drug. The litigation cost biogen a big chunk of its prophets and it made the approval of adia helmet critical for the company's survival. The stakes for biogen couldn't be higher. Asthma helm is essentially a ten billion dollar year drug. Or maybe more and is thought of as sort of a savior lifeline for the company. It's it's really state so much of its reputation on the drug and getting it approved and so for biogen. It's like there's nothing more important after the break. The controversy over the fda's decision.
"alzheimer drug" Discussed on The Journal.
"Can you introduce yourself and tell us a little bit about who you are. Okay sure my name is pam montana. I live in danville california which is in the east bay kind of near san francisco. Pam sixty six. She spent decades working as a tech executive most recently at intel. She's married with two daughters and has seven grandkids and she also loves to travel. I actually have a map behind me that you can't see but there are little pin marks on every country of vin and. I just really love to travel. I can't see the pins. Yeah yeah. That's why i mean there's way more but i really everywhere manila malaysia brazil. I mean china japan. You know i'm very happy. Upbeat person. A very strong faith around five years ago. Ham was diagnosed with early onset. Alzheimer's she. I realize something wasn't quite right at a work meeting. I remember very clearly. The first moment that i knew something was wrong and at intel. We have obviously a lot of technology. Updates it's technology company in my part of my job as a leader in the organization was to share the latest updates and on on fridays. That's when we got our updated training from corporate. And so initially. I would just grab a couple notes right. Just like some highlighted things. So that i could remember what to talk to. And then around that time i'd literally had to write down word for word what they were telling me because i like to say it wasn't sticking my brain couldn't handle it anymore. Do you remember how you felt when you were diagnosed. It was not good. I mean it was devastating. And quite frankly i thought maybe i was just going to kind of fade away pretty quickly but thankfully for me. I haven't even though. Pam still has a lot of her memory. It will continue to slip away and she's grasping for something that can helper. I need more time. That is really what all of us with this disease need. We need more time with our family with our friends with our grandchildren. I i. i've got a my youngest grandchild is one years old. His was last week and my oldest is thirteen..
Medicare Copays for New Alzheimer's Drug Could Reach $11,500
"A new drug it's been shown to reduce clumps of plaque in the brain could become the most costly medication covered by Medicare add your home from drugmaker Biogen is the first new Alzheimer's medication in nearly twenty years the company's price the intravenous medication at fifty six thousand dollars a year a new analysis from the Kaiser family foundation says the cost of the drug would raise Medicare premiums broadly and that some older patients could be looking at co payments of about eleven thousand five hundred dollars annually Medicare hasn't made a formal determination on covering at your home the Kaiser report estimated that it just happened million Medicare recipients are prescribed the drug it'll cost the program nearly twenty nine billion dollars a year the drug has sparked controversy over its price tag and questionable benefits several members of an FDA advisory panel that oppose the drug resigned over the agency's decision to approve it I'm Jennifer king
"alzheimer drug" Discussed on The Readout Loud
"Hours of recording time and and days of actual time getting ready for the thing. That happened monday. Which was the. Fda's decision on biogen's polarizing alzheimer's drug now called agile helm and as you heard earlier episode and has probably had heard prior to listening to it. The fda decided to approve that drug. I have to say. Monday was kind of exciting when the approval actually happened. I mean there was. There was adrenalin flowing and it was a surprising approach that the fda took it wasn't just an approval or rejection. It was an approval but under a surprising pathway. Maybe damian break it down for us. Yes so the. Fda has at its disposal. This concept of accelerated approval and is quite often used for new treatments for cancer. And so what. The fda will do in the name of getting new treatments to patients as quickly as possible is approved drug based on what they call a surrogate endpoint which is basically evidence that the drug does a thing that is likely to predict a thing that we all want so in cancer. That means you can get a drug approved shrinks tumors even if we don't yet know whether it prolongs survival for patients with cancer and that's because you know it's pretty well established that the fewer tumors you have or smaller whatever the healthier you will be so the teen this approach to As you helm as it's now called but in this case it isn't as cut and dry shrinking tumors. They approved it. Based on its ability to decrease levels of beta amyloid in the brain the toxic plaques. That are i was gonna say believed hotly debated the role that they play in the actual progression of alzheimer's disease. And so this is where as you can probably imagine. The controversy comes into play. Because by the fda's logic the fact that you can reduce these amyloid plaques means that it's likely to Slow the progression of alzheimer's for patients who take it but the rub is that biogen ran to very large trials keeping tabs on the cognitive abilities of patients in the study and as you probably know one was narrowly positive and one failed so to people looking at this from the outside. It seems like the fda found a compromise that might not have the strongest logical basis. Yeah i mean. I think that was probably the biggest surprise came out of monday. I mean i think. A lot of people expected the fda to approve. Adam just not leave sort. They are damian. I i know you thought that they would. It would happen. And i was kind of leaning in that direction. I'm but again this. This are curveball. This accelerated approval. Pathway is really interesting because again first of all you know that that pathway has never been used for a neuro degenerative disease before news alzheimer's and and the fact is that the kind of went about it. Like you said damian backwards in that we already have two large clinical trials with very mixed results on the clinical benefit. Endpoint point that people care about most in alzheimer's and but fda sorta through that out and said all right. Just by the fact that this drug clears bid amyloid plaques from the brain which really nobody disputes. I mean the data are pretty clear that this drug does that but what is completely unclear and unknown And i think a lot of people doubt is that whether that actually leads to cognitive improvement in patients to be that was the most interesting part of the entire thing was that the fda was essentially saying yup we believe in the amyloid hypothesis. That idea that by clearing amyloid you will affect the The progression of the disease and that is just incredibly controversial. And as you guys pointed out during the advisory committee meeting the fda actually made the statement that they were not using amyloid as a surrogate for disease progression and then they turned around and did exactly that and so that led to a tremendous amount of backlash from the advisory committee which voted no on whether these data supported approval. Yeah i think the other the other big surprise On monday was the price right By has set the price of home at fifty six thousand dollars a year. that's the sticker. Price of it will be discounted down once serve insurer. Discount in medicare discounts get factored in. But that is a what is that five times. What kind of people expected the drug people were kind of looking at like ten to twelve thousand dollars a year drug fifty. Six thousand dollars is huge. So i just want to say i actually. Who's not surprised by this price at all i. It was probably because they didn't do enough research beforehand. And i was surprised by surprise at the price because think about what kind of drug this is. I mean it's a biologic drug. They've been working on it for years. It it seems to me more along the lines of these speciality drugs which is exactly the way biogen has been positioning it and in the messaging since they announced the price talking about it in that way you have analysts comparing it to the existing alzheimer's medicines which cost something like eight thousand dollars a year but the existing alzheimer's medicines don't act on the underlying cause of the disease debate about whether i can't imagine does as well but it's a totally different category of drug and to me. I was just not surprised at all. I would've been shocked if they price it at ten thousand dollars a year. It's just not what buying does. Yeah no that's fair. And i was surprised but i think that reflects my own personal ignorance because i think it gets to magazine said there was a discrepancy in terms. Of how a lot of people on the analysts were thinking about it and how biogen was thinking about it on the analyst. People were looking at it as some people were looking at has a primary care drug that you know you would. You would see your primary care physician and get diagnosed with alzheimer's and then be put on this drug immediately. And thus there'd be a really wide net that biogen would be casting and that would assume you'd wanna lower price which you could make more money on because you get a higher number of patients by engine. I think looked at all of the facts of the drug. Like you said it's a biologic but also it needs to be administered. In infusion center patients will very likely need to get pet scans and is before they even get on the drug and then probably need pet. Scans throughout so i think biogen realize it was going to be much smaller patient population. That was going to get this drug. Then maybe a lot of people thought and probably kind of worked backwards to get to that fifty six thousand dollar number because then you're looking not not at a rare disease thing but as you said as a specialty medicine which tend to be more expensive because companies expect you know smaller number people to get them and thus if you wanna make profits which biogen is absolutely poised to do at this point you have to charge a premium price but this for exists to surprise number three. The label adam. Oh yeah we're all over this. Explain the surprise in the label will. Yeah you know often hundre when we when we get these truck approvals. Everyone goes to the label. The fda approved labeled to kind of just look sort of what the details are. What's included what's not included when we looked at the label for our home. The fda label says that it's a treatment for alzheimer's it doesn't say it's a treatment for patients with early stage alzheimer's or you know or cognitive early..
"alzheimer drug" Discussed on 1A
"And i was hiding for a while but as a journalist a i was a political investigative journalists. I couldn't multitask and do my job. And seeing i was there at my mom and dad's deathbed and i knew this was going and have prostate cancer and Right now macular degeneration. I lost forty percent of my sight. In the last two years and the doctor say there is potentially relationship between A po four macular degeneration so it. It people weren't talking about this and to for me to write about it and to talk about it kind of brings people out of the closet so to speak as the disease progressed over the last nine years it it it it goes in stages. I'm reading off now but right now. sixty percent of my short term memory can can Begun in thirty seconds. If you put me in a room with people that. I've known all my life and i don't expect to see them seventy percent. I won't know who they are But they'll introduce themselves they'll know I deal also with a lost place. Loss of self Deal with hallucinations Incredible rage and a deep deep depression. Which i wrote about their twice. I wasn't successful. But through the grace of god but i i. I tried to leave the planet. If you know that means suicide and on the if you if you if you Look online a the symptoms. What an. I wanna be brief with my comments here. But alzheimer's to some extent is like a space odyssey movie two thousand and one. We're how was the computer the astronauts to saying. How can you move the spaceship to the rider. Left and halstead now i. I can't do only so much juice. And so i only have so much juice in what i'm trying to do right now. Protect my speech in my writing. And i deal with that. Have these words down. Lord gave me a good brain. I deal with cognitive reserve. And there's a word that i wrote down here called neuro plasticity which helps helps you get along and i write everything. I'm my laptop. And i wrote my book. I wrote down two thousand pages of notes. If things don't couldn't forget him you know. I think yeah. Yeah now. Greg testified before the fda advisory committee while at you can't imagine was under review. What did you share with them. Well i i shared the patient perspective and I cut up a frog in high school. So i i can't respond to any of the medical experts and i respect their opinions and we heard i can't remember the doctor's name and i totally respect his opinion but from a patient perspective. It it gives you hope and And and and you know hope it is encouragement and to be clear Because of the stage i'm in this drug will not affect me or have any impact on a and So my testimony was for those in the early stage that that it could have an impact on and And you know what it does in percival it. Also the decision here shows that The world is listening to the patient's voice which i think is as important as The clinical voice and And and hope lifts your spirit in moves along and might encourage others to move forward and you gotta you gotta fight through this. I mean i have to fight through this interview on every day. I'm being interviewed from spalding. hospital in sandwich on cape cod. I just came from doing a baptist hospital for eight hour spine. Surgery from top to bottom fusing rods and all that stuff and What happens in alzheimer's is it. Breaks the mine down but it also breaks the body down because brings the control panel so my body's an hope is important. That's if the drug had been available when you were first diagnosed even knowing that there are questions about whether it's effective and that there are serious potential side effects which you have taken the drug. Yeah i would have. I'm not a medical expert. But i would have taken the drug greg thank you. I just want to make sure to acknowledge how much we appreciate. You adding your voice to this conversation. I know that that we're asking a lot of you. I appreciate it. I'm dr carla. Wish what happens now that the drug has has been approved. How quickly will it become available for distribution. Thank mr o'brien for sharing story It resonates So the drugs approved but the next up. Now of course is is is How will become available patients. and My hunch is is given the biogen's report of how much it will cost per patient per year which is about fifty six thousand dollars that This is headed for National coverage decision by medicare Because given the number of individuals anywhere from two to six million who could take this drug I have a hunch That given that the number of people as well as the uncertainties of well who would you prescribe to. And how would you know that. They're benefiting from it Meaning you know how to decide. This is reasonable and necessary that it's gonna lead to a national coverage decision by medicare as opposed to simply say you know We'll be paying for it. Things get more complex for example because The testing that many Physicians feels necessary to confirm someone has amyloid not currently readily available And medicare will also have to decide about that so the next step in some is decisions by insurers Much of this reflects that the fda decision to sort of Skipped past some of those questions around Who should get the drug etc. The having britain very broad label For the drug So that's the next act. I think that'll unfold in the coming months or so. I dr carl lewis. Let's talk about the landscape of alzheimer's treatment today. What other medications and therapies are currently available currently available for prescribing or a set of medications developed in the late twentieth century. that Essentially target the symptoms of the disease. they are Widely recognized as having some modest benefit and That's the pharmacotherapy What's also available but not widely available is education And skill building for both patients as well as their family members to identify their disabilities..
"alzheimer drug" Discussed on Squawk Pod
"Shares soaring in yesterday's session. All of this comes after. The fda approved the company is controversial alzheimer's drug. This is the first new therapy for the disease and nearly two decades make. Terrell joins us right now with more on this. Landmark surprise decision meg. Good morning good morning becky. This was a surprise..
Alzheimer’s Drug Likely to Be FDA Approved Despite Potential Risks
"Drug is reasonably likely to result in a clinical benefit and granted approval. Despite potential risks. NBC's Brian Clark with details The FDA s decision to grant accelerated approval to Biogen's new Alzheimer's drug is a historic first in the fight against the disease. It's not a cure. It's not a panacea, but it is a first line treatment that that does look at the underlying cause of the disease. Dr. Joanne Pike, the chief strategist of the Alzheimer's association, points out Alzheimer's remains a fatal disease. We have to have a first line treatment before we can get to a second line or a third line, Dr Pike says. This requires the health care system do prioritize Early detection. Brian Clark ABC News The Department of Justice
FDA Approves Much-Debated Alzheimer’s Drug Panned by Experts
"The food and drug administration approved the first new drug for Alzheimer's disease in nearly twenty years but there were doubts the drug is from Biogen magic can amount which is now could be marketed as and you held the FDA approved the drug saying it was based on results that seems reasonably likely to benefit Alzheimer's patients Dr Maria Correo is chief science officer with the Alzheimer's association this therapy slows the progression of the disease because it addresses the underlying biology one of the hallmarks of Alzheimer's which is amyloid plaques therapy usually manages symptoms of Alzheimer's like insomnia or anxiety FDA advisor Dr Caleb Alexander said no to the drug's approval he said the agency has regulatory standards based on evidence but in this case he thinks the product get a pass at Donahue Washington
Alzheimer’s Drug From Biogen Wins US Approval
"Service prices as we're seeing activity picking up Biogen has received approval for its controversial Alzheimer's disease, their appeal landmark decision that stands to dramatically change treatment for the debilitating brain condition. Bijan shares up now by 40.2%. Japan's A Sigh is working with Bijan on the Alzheimer's drug. It's a TRS are also surgeon today.
"alzheimer drug" Discussed on The Readout Loud
"On it leads to early onto the Alzheimer onto via including about two hundred insisted to people in Colombia and about eighty two are actually on criminals Adrienne what's the timeline for this clinical trial like? When did you start it in? When would you expect to see? I don't know if it's preliminary results or final results from the study started going back to two thousand fourteen sorts long steady of the studies the coated and we want to treat the The people it's not patients because they are cognitively normal slip out Steady will read out into long. Twenty twenty two so is similar to biogen's educate you have in that both are directed against toxic plants in the brain called amyloid but of course not all. Emily treatments are the same. What are the key differences between those two medicines to the main defense between On could he's actually been to do conham up targets Blacks and we all go make eight better. The Article Being potentially the most toxic component this Potentially actually talk. It's VM Merrick. Eight data have shown in fact in our face to study that we can reduce these articles which are highly toxic in animal potential issue in violent so They have a defense date called the backbone sill beach in killeen actually used could not come up for him. Knowledge is still the call is ninety. Four antibody in to On this one of the reasons not only one Wind see definitely differences in safety onto ability of drug Swiss Still shows a relatively high A. So it's a side effect. Which is Dima for brain? They couldn't come up actually did not show any idiom. Ah So for the purpose. Meaning the prevention of disease a criminal up has a Cockatoo. This Dick's which we won't for preventive trump he won't you have it's safe way high doses and obviously want to talking the most toxic for most relevant species. Show immunes work in. Alzheimer's disease goes beyond amyloid. Can you tell us a little bit more about the rest of the company's pipeline and how that's coming along so it's probably the company is the protest neuroscientist pipeline the pipeline is derived devour to platforms Super On the Muslim fled and lease in two platforms. In fact used to generate molecules that scenes antibodies on small molecules which are a confirmation specific in fact the only difference between also a patient in a normal person is that these proteins a betta towel acidic Before the fever quite a few Change the shape change conformation and if they do may become pathological so the closer the more specific than your monitors are for his confirmation really changed. Misshapen protein. The more efficacious in the more safe is in fact the drug so platforms really allowed to make Molecules very specific for this mischief protein. So zooming out from Alzheimer's disease specifically in recent years. We've seen a lot of major multinational drug companies kind of retreat from neuroscience research. Ac Moon obviously has continued to invest in it. What gives you confidence in the progress of the field as a whole is This PD that some of our top companies decided to Move out but I'm not surprised speakers It is a difficult field or the mid one point before because the missing tools the missing with diagnostic towards to look in the brain and select patients. So I think he noted to make immediate difference. You have to have a pretty big toy box available in order to make sure that you basically de risk can development meaning diagnostic so I think it's events why belief from scientific spins point of view Large expense.
"alzheimer drug" Discussed on The Readout Loud
"True in New York City in the span of eight hours on Wednesday. That's between ten. Am AND SIX PM. Eighty-one people in the city died from one thousand nine hundred eighty one of people. We're joined now by Helen Brands. Well stats lead reporter on the Pandemic Helen. Thank you for taking the time to join us. Thanks invading so Helen. We asked you this question a week ago but so much has changed. Seems Worth asking again? Now what are a few of the most important things we've learned or or gotten stronger? Evidence to confirm in the past week about the virus and the disease it causes. I guess I would say that. The United States is on the trajectory that people had feared it was on but hoped it might not be the lack of testing. That's gone on and two months effectively lag in getting testing up to speed in the country. It was really unclear. How much of the virus was here in where it was spreading but now as testing is ramping up and as people are starting to get sick? We're starting to see that. This is a very bad situation. There's dastardly thing about this virus. You know it takes a while for you to get enough cases to really see that it's there so I remember in late January. I think it was maybe early February talking to all sorts of people saying why aren't we seeing outside of China what we're seeing inside of China and they actually mostly said we don't really know the fact was it was just a matter of time and now you know that window has closed and we are in the point where the cases are really mounting very significant way and we're starting to see places light up so how? I wonder what your thoughts on kind of where the United States stands now relatives. To some of the other countries that have been hit. Hard by covered. Nineteen you know Italy now. Spain seems to be overwhelmed. South Korea seems to be having the situation under control whereas the United States now sadly were not on the trajectory of South Korea They as you mentioned have managed to keep us spread there to pretty low numbers the. Us has more on the trajectory of Spain or an Italy. But you know it's such a big country everywhere isn't experiencing this to the same degree as Seattle and New York and the northeastern United States. Point Florida obviously is in the thick of a two. But there could be places where this is still not such a big deal and they may be thinking to themselves you know. Why are people you know so fussed about this? But it's coming and because of the size of the country and the demographics some places are much more crowded than others you're going to see sort of rolling epidemics across the United States over a period of probably months so we're starting to hear calls to reopen the US economy. President trump wants things back to normal by Easter which is April Twelfth Helen. What are you hearing from public? Health and epidemiology experts about the potential impact of doing that. So soon you know the whole idea of getting people to Put physical distance between themselves is to flatten the curve to slow the spread of the virus. So that hospitals don't get overwhelmed. You know if you're trying to flatten the curve. Fifteen days is not going to do it. It's going to take longer than that to really slow the spread of this thing otherwise you know if you get people out and about and mixing transmission will wash back up to the levels that you had before you asked everybody to take to their homes. I think it is fair to say that regardless of what the administration advocates. The truth is that people are not going to be flying all over the place anytime soon. People are not going to be taking cruises anytime soon. Older people are going to stay in their homes because they know they're at severe risk. We'RE GONNA be talking in future about this time as sort of a B. C. A. C. Moment you know before krona virus and after Corona virus and were only at the very beginning of the after corona virus phase. But there's no way that life here can safely resume to BC ways you know by Easter. Let's switch to one of the more eyebrow raising developments of that emerged this week. That is the fate of Dr Anthony. Fauci the government's top infectious disease expert. Who has become the most trusted and followed scientists on the pandemic at least here in the United States right? And that's because Faucher who has been at the National Institutes of Health for more than forty years speaks very clearly effectively about matters of public health. However that often means contradicting president trump. Who has always been a reliable source of facts on the corona virus and it means doing it in public. You really have to hear. Fao She to understand what we're talking about. So let's play this clip of him. Subtly pushing back against trump's declaration that the country will be open for business by Easter. That's really very flexible. We just had a conversation with the president in the Oval Office. Talking about you know you can look at a date but you gotta be very flexible on literally day by day week by week basis you need to evaluate so statements like that have put. Voucher. Who's a resolutely nonpartisan scientists into a part of the narrative to the sort of hashtag resistance types on twitter foul cheese factual statements read as a rebuke of trump and. He seems to have succeeded. The likes of Robert Mueller and Michael Vanity. As a sort of hero of the moment people like that meanwhile over in the Cunanan corners of the Internet F- Ouchi is a deep state. Plant is working to spoil trump's reelection by instilling a panic over corona virus. You know in that message you know. Cleaned up to some extent is starting to be echoed by some mainstream trump supporters. But who is Tony Ouchi really? You've been covering vouch for more than a decade having known. Pfau chief for so long Helen. Were you surprised by his sudden celebrity. No in fact. It's not really sudden celebrity. I mean there may be times when he's not as a front and center as he is now. But whenever there's a health emergency in the United States be that flu pandemic or the anthrax attacks of two thousand and won a Tony Out. She has been a face that Americans would have seen and heard from repeatedly over the years so kind of on that note. What was his reputation like before the current moment in which he's become so talked about well he's a force of nature. He is a seventy nine years. Old looks at least a decade younger than that. He has sort of indefatigable energy levels. He I think works every day. I'm not sure but the current circumstances accepted if you send Tonia fetchy an email asking for an interview. You better be ready to do the interview within you know five minutes because you might get the call that quickly. He seems to have more energy and work on a different plane. In terms of the amount of things he can squeeze into a day so speaking of interviews The other day the magazine Science published the transcript of a really extraordinary phone interview with Ouchi in that interview. Vouch erased a level of candor that you rarely hear about how he's navigating some of the false things that president trump is saying at white host. Briefings asked about one of those falsehoods out. She said quote I know. But what do you want me to do? I mean seriously John. Let's get real. What do you want me to do? Helen what did you think when you read that interview? While I was very jealous I hadn't written it but So that was written by John. Cohen who's a friend of mine? He covered AIDS extensively in the early days and as a consequence has known folk Since the early days of AIDS and so he john known each other for a very long time and I guess I'm not surprised he had a candid conversation with him. I am a bit surprised. He didn't put some parameters on it in terms of what was on and off the record but it was a great read so kind of on that topic in parallel with vouchers rise in the public consciousness. We've seen reports in the New York Times and elsewhere that there's a growing rift between him and the President. So we're not gonNA speculate about what's going on in the White House. But if she were to eventually lose his job how would that resonate in the public health world amid this crisis that would be taken very very badly and frankly it's a bit hard to imagine him being cut loose at this particular moment? I guess I shouldn't rule that out at this point but you know he is extraordinarily well regarded if he were to be fired. At this point you know scientists across the country would be deeply deeply concerned but I also think politicians would be as well. There was an interesting New York Times story by Maggie Haberman. Who pointed out how unhappy the president was with some of Dr Phil Cheese corrections of him but she also went on to note that the president has been known to hold off firing somebody when he still needed them and I would suspect he may be making that. Calculus now Helen. Thanks for your time any perspective and as always keep up the great reporting thanks guys. Great to hear your voices next up. We're GONNA talk about real world evidence and why it's generating a star in the world of drug development so real world evidence is one of those buzzwords that gets bandied about quite a bit. It's fueled by data that gets collected outside of the controlled setting of a clinical trial and the goal is to try to assess the safety and efficacy of a medication and so that could be data from records of insurance payouts or from electronic health record systems that can even be collected from a patient registry or a wearable device or social media joining us today to talk about.