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doverhog posted:This sounds like a bunch of gobbledegook intended to say healthcare isn't a human right. The tax details are complicated, the principle is not. Huh? I had a different reading of that post, I thought the OP was saying that under the current healthcare system in the US, trying to implement a %income cap as an incremental change would be extremely complicated due to the profit motives of insurance companies. Which is another argument in favor of UHC/M4A, it would actually be "easier" to operationalize at least in this specific regard I also found the OP a little tricky to parse though so I may still be misinterpreting
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Oct 21, 2020 00:45
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Jaxyon posted:Who said it was easy? Do you want to engage with actual arguments or what Full disclosure, I work in pharma. I’m basically a grunt and am deeply conflicted about the industry and have no ambition to advance my career at this point and I’m constantly thinking about finding a job in a different industry and one of these days I’ll actually do it. I understand if that makes me untrustworthy but I’m coming at this from the lens of “sharpening your arguments against the current US healthcare system”, not from a place of disagreement or opposition. And fwiw I will vote in favor of M4A and just about all progressive healthcare reform 10 times out of 10 even if it means i could lose my job or otherwise jeopardize my personal finances, because that poo poo is way more important than me. In other words, maybe I can be in like the middle of the line once the guillotining commences? --- As others have touched on, basic research is heavily funded by the US government, clinical development by pharma companies. So yes NIH research is involved in a huge amount/all of marketed drugs’ development and this is massively expensive, but clinical research is still much more expensive than basic research and is largely funded by pharma. Here’s an article that talks about this, I only can read the abstract so can’t vouch for the full paper: https://www.researchgate.net/public...eory_to_Therapy And although the success rates as you move through clinical trial phases are higher than they are in basic research, they’re still pretty low. So the problem isn’t so much the government’s capability to conduct clinical research, as it is their ability to keep paying for new trials while weathering all the failures. I don’t know if the M4A plan addresses this, I’m not that familiar with all the details, but I couldn’t find anything in a quick google. But if it doesn’t, then I do think, in a sense, drug development innovation would slow down. But personally I don’t actually think that’s a net bad thing for society given all the benefits of M4A, and the fact that US health outcomes are still extremely poor relative to the amount we spend on prescription drugs, and the fact that a lot of pharma “innovation” is pretty questionable in terms of benefit to patients (with some notable exceptions of truly incredible medical advances, but I do think those are the exceptions). More on this last point later... quote:Also for a bonus data, since you just post things and don't back any of them up, here's a study that says your'e wrong about spending less on healthcare bringing down innovation. The objective and methods of this paper are unconvincing in my opinion. From the methods: “[Drug patent] information was used to assign each [newly invented drug] to a country on the basis of inventor location. In addition, on the basis of the patent information, the patent was assigned to an inventor company. If the inventors listed on a patent were from multiple countries, we assigned only the first country listed as the source country.” The problem is that the vast majority of major pharma companies are multinationals that derive a plurality (to borrow an electoral term) of their revenues from the US because of our outrageous lack of price regulations. This paper is suggesting that because many inventors/companies are not from the US, that US drug spending isn’t responsible for funding the “innovation”, but it doesn’t account for the fact that many of the biggest pharma companies that make more money in the US than anywhere else because of pricing, are headquartered ex-US. Roche, Novartis, Astrazeneca, GSK, Sanofi, Novo Nordisk are all massive companies that make most of their money from the US despite having European headquarters. If the authors wanted to support the conclusion that US drug spending doesn’t disproportionately fund “innovation” then I think they would have to adjust for the proportion of a company’s revenue that comes from the US? I’d have to think about that more, but point is that using inventor/company location as a proxy for contribution to “innovation” is not a solid premise at all. And again I think “innovation” is the word the industry uses as a euphemism for “all drug development, whether it’s actually innovative or not.” In a sense I think that whether the US does or doesn’t contribute proportionally more than other countries to drug development costs is already accepting the pharma industry’s framing that “drug development = innovation, and who doesn’t love innovation?!?!”, when the real issue is that a huge amount (I wouldn’t be surprised if it was a majority but don’t have a handy reference to back that up) of drug dev spending is on drugs that offer marginal at best value to medicine and society. --- Anyway just reiterating that I’m debating here for the sake of improving arguments in favor of M4A, I hope that intent comes through but obviously you have the right to tell me to suck poo poo or whatever and that’s fine too
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Oct 21, 2020 07:04
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Jaxyon posted:As for drug company financials, we both know that drug companies are more accurately described as marketing companies than researchers, spending twice as much on it. Getting a drug through FDA approval requires a lot of spend, and so does that dinner with "thought leaders" at the steakhouse. I have to imagine that without spending billion on stock buybacks and advertising that is only legal in 2 countries in the entire world, they could be a lot more efficient about research. And that's with the taxpayer covering all the actual developments and giving them more or less free to the industry. I'm skeptical of this claim -- I think it's plausible but the evidence for it is flimsy. The problem I've seen is that it's actually not easy to pin down what pharma companies spend on sales & marketing. The typical accounting in financial reports lumps sales & marketing into a broader category of Selling, General & Administration (SG&A), where the S comprises sales/marketing and G&A comprises things like general operational overhead and legal fees. I honestly don't know the breakdown of S vs. G&A expenses, but there are at least some estimates that the S part of S&GA is less than R&D spend (source, source). Another factor is that over the past decade+, many big pharma companies have effectively outsourced their early-stage development programs to small biotechs that they then acquire once they've produced positive results. So while the big pharma companies definitely do spend too much on marketing, there are also a lot of small-to-mid sized biotech companies that spend very little on marketing and primarily spend on R&D. I *think* that the cost of acquisition of these companies does get accounted for in R&D spend figures for big pharma, but this still underestimates R&D spend in the industry overall because of survivorship bias -- big pharma are only paying for the early-stage programs that are successful, but there is a lot of money that is spent on unsuccessful programs that die before ever hitting a big pharma financial statement. At the end of the day, regardless of whether any given pharma company's R&D budget is higher or lower than it's marketing budget, I think we probably can agree that the marketing budget is too high, that a lot of pharma marketing doesn't add value to society, and that with improved pricing regulations pharma would need to spend less on marketing so they could be more efficient with R&D. Jaxyon posted:I also believe that drug companies are amply able to cover that, and will specifically fail to innovate on types of drugs that are not likely profitable, nor are they willing to to significant basic research. Agreed. A good case example is antimicrobials, where the current hospital capitated reimbursement system means that if hospitals use newer, more expensive antimicrobials they lose money, so instead they stick with less effective generics, so the pharma companies don't make as much money as they thought, so they divest from antimicrobial R&D even though it's objectively one of the most pressing needs in drug development globally. Even though it may cost $2billion+ to bring a new antimicrobial to market, there are quite a few major pharma companies that pull in $10billion annually in net profit, so maybe that value should be returned to society instead of shareholders... Here's an article on the antimicrobial crisis in case anyone hasn't read about it before, I can post the full text if needed: https://www.nytimes.com/2019/12/25/health/antibiotics-new-resistance.html
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Oct 21, 2020 23:45
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WampaLord posted:Amazing how all of these other countries with universal healthcare manage to have plenty of medicine and innovation without charging patients thousands and thousands of dollars for necessary medications. Going to have to disagree with your first point. Completely agree with your second point though. A lot of medical innovation happens at a global level. Pharma R&D budgets are primarily funded by the outrageous prices we pay for drugs in the US — I think for most big pharma the US generally accounts for around 40-60% of total sales — and when they are ready to bring a new drug to market, regulatory applications are generally submitted to a ton of countries. So the same medical innovation gets distributed globally, but in the US we pay more for it, thereby funding the next breakthrough drug (but also funding the next me-too drug that adds nearly no value to society and is still expensive as gently caress). If US revenues were cut, pharma R&D would need to become much more efficient, and even if it did I think overall productivity would decrease. Which is where I go back to my previous posts and say that this only matters if we accept the premise that more R&D productivity is necessarily a good thing, which I think is highly debatable if not outright wrong. I think if you could “turn off” medical innovation tomorrow, maybe it wouldn’t be such a bad thing. Maybe it would help us spend fewer resources on finding ways to make people live a little longer, and more on allowing people to live better, which entails thinking about healthcare but also about other sectors of society. The idea that a lack of innovation is anywhere near the top of the US healthcare system’s problems is laughable, so if someone says “we can’t have M4A because it would kill innovation!”, I think the stronger rebuttal is in disproving the premise that more innovation = better healthcare, rather than trying to make a more tenuous case that innovation wouldn’t decline.
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Oct 22, 2020 05:10
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Jaxyon posted:I already posted a study that says you're wrong on this. I don't follow this reasoning. My point is that the distinction of drug companies HQed in the US or ex-US is basically irrelevant because ALL these companies have extensive US operations that drive the plurality (if not majority) of total revenues, which is how they fund R&D. Any company with extensive US operations (read: effectively all development and commercial stage pharma companies) DOES benefit disproportionately, and from a lobbying/extorting the government perspective I suspect that the fact that they all have tens of thousands of employees in the US even if they're HQed in e.g. Britain or Switzerland is sufficient to reap a political proximity benefit. Taking a few prominent examples, we can look at GSK, Roche, Novartis, Merck, Pfizer & BMS -- the first 3 being major ex-US companies, the latter 3 being major US companies. Here's the % of 2019 sales coming from the US for each company, from lowest to highest: Novartis (ex-US HQ): 35% GSK (ex-US): 41% Merck (US): 43% Pfizer (US): 46% Roche (ex-US): 56% BMS (US): 56% This isn't just my belief, or me defending the status quo because I think it's a good thing (I don't), but it's the reality of how pharma companies fund their R&D (as well as how they fund marketing and share buybacks and sales rep bonuses, etc etc) on the back of unfettered pricing in the US. That's why I think the study you referenced is flawed -- just to quote its conclusion from the abstract: "many countries with drug price regulation were significant contributors to pharmaceutical innovation." That's nominally true, but it's papering over the fact that these countries contributed to pharma innovation due to having HQs of major multinational companies that derive the plurality/majority of their sales from the US. It would be interesting to know the # of approved NMEs developed by companies/organizations that don't operate in the US; I suspect there would be vanishingly few examples. quote:And pretty much all drug innovation has come from basic research done on the public dime, including basically every novel drug in the past 10 years(see my earlier citation). R&D may be developing new products, but it's not developing innovation. I'm sorry but this is just incorrect. Innovation requires ALL of basic research, translational research, and late stage development. Take any of these out of the equation and you no longer have medical innovation. It's wrong to say that all innovation is done on the public dime, and it's wrong to say that industry is wholly or even primarily responsible for innovation. The fact is that the way the system works today relies on massive levels of private funding, particularly for late stage development, and if we reduce that private funding by cutting into pharma sales in the US (as we should) then the question is whether R&D productivity can stay stable by realizing gains in efficiency to offset decreasing budgets. And as far as I know, the best we can do here is speculate. My personal opinion is that we'd probably see a moderate decline in R&D productivity, but then I go back to my point about this not being an inherently bad thing, which I won't rehash again here.
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Oct 22, 2020 21:32
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Jaxyon posted:My argument is that for-profit pharmaceutical companies are not major drivers of innovation. Due to how little they spend on bringing drugs to market vs simply marketing them, the result of reduced revenues for them is unlikely to make a huge impact on innovation because it's not what's driving innovation. My argument is that pharma companies spend MASSIVE amounts on R&D -- this article suggests that the top 10 companies in 2019 spent $82B on R&D, which is 2x the entire NIH budget -- and that reducing their revenues will necessarily reduce R&D budgets which are the primary channel through which publicly funded basic research innovation gets translated into clinical practice innovation quote:The fundamental disagreement between us probably lies on whether you feel that getting a drug through FDA approval, regardless of whether it's a new treatment or just a slight reformulation intended to make money on an existing treatment, constitutes innovation. On this I think we're basically aligned, I agree that the industry wants to frame innovation in terms of productivity, but from a societal perspective that's irrelevant if it doesn't result in better health outcomes, which I think in the US we can categorically say that it doesn't
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Oct 22, 2020 23:57
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wins32767 posted:I think defining innovation will help move that conversation forward because I don't think there is agreement on what it means. My pushback here is that I think we should consider the opportunity cost of how we decide to invest in healthcare as a society. QALYs are calculated on the basis of data generated in a clinical trial; how frequently do people in the real world get care that’s as high quality and accessible as in a clinical trial? Not often. If the rest of our healthcare system isn’t up to snuff, then it doesn’t make sense societally to allocate all this money to drug development. Even if you use QALYs to argue in favor of label extensions as being positive innovation, I think it’s kind of missing the forest for the trees when overall health outcomes are so poor despite our exorbitant healthcare expenses. The innovation becomes irrelevant if it’s not built on a foundation of quality and accessible healthcare, which doesn’t exist because of our hosed for-profit system. Jaxyon posted:Is Merck spending most of it's R&D budget to find new markets to sell Keytruda(a drug they didn't invent) over the next few years creating innovation? I’m not contesting this point as a generalization, but just wanted to share a little context about Keytruda because I think it’s actually one of the few examples where all the investment on using R&D to find new markets as opposed to using it to develop new drugs is worthwhile. Keytruda is a type of cancer immunotherapy drug called a PD-1 inhibitor. Keytruda is the most commonly used one, but there are about a half dozen others on the market that basically do the same thing (more on that later). This class of drugs has really revolutionized the treatment of a huge percentage of metastatic/advanced cancer types, and data coming out now is starting to suggest benefits for some early stage cancers as well. Depending on the cancer, generally about 20-50% of patients will respond to these treatments, so it’s not a cure all. But for the patients that do respond, the responses can be extremely durable. Like durable enough that in late stage lung cancer, you can see 20% of patients still alive after 3... 4... 5... years, even though treatment is given generally only up to two years, and we don’t have enough longitudinal data to know how long those patients will keep living. Really remarkable stuff. I think Keytruda has a case to be the single most important drug in the past 20-30 years on the basis of the magnitude of efficacy, the severity of disease treated, and the breadth of applicability. Trying to find another 10 cancer types where it can be used is probably going to deliver more value to society than trying to come up with another 10 drugs. But all the other drugs in the same class? Great example of inefficient allocation of resources, and of the failures of the US capitalist system applied to healthcare. All these other drugs in this class are effectively identical to Keytruda. There are minor differences in how they’re engineered, but there is no clinical evidence to suggest that this matters one iota in terms of patient outcomes. Since they all work the same, the companies compete by trying to race to get approved in new cancer types first. The rewards for getting there first (I.e. unfettered US pricing) are so great that they’re taking more and more risk by moving into pivotal studies even where there isn’t very compelling biologic or clinical rationale to do so. A lot of these studies are still successful because the drugs are that good, but a lot of them fail too. Have we ever had a study that’s compared any of these drugs head to head? No, and at this point it’s unnecessary because we know they’re effectively the same. But there’s no medical benefit to investing in the R&D for the other drugs in these new tumor types as opposed to just using Keytruda. So what benefit do we get from capitalism’s purported sledgehammer of justice, market competition? Frivolous R&D expenses (and commercial expenses, including TV ads) from multiple companies with the same product, and big shocker, no (or negligible) price competition. They all cost in the $13-15K/month ballpark IIRC, a difference slight enough that insurers generally don’t consider the price to be a deciding factor among the drugs, let alone doctors or patients. Current regulations prevent generic/biosimilar versions from entering the market for another 10+ years, so no price competition there. And regulations prevent the biggest insurer in the country, Medicare, from negotiating prices. It’s outrageous, which is a word I swear I don’t use frequently but can’t stop myself from using it every time I post about US healthcare. So Keytruda might not be the individual drug I’d pick to as the poster child for inefficient/non-innovative R&D, but its numerous step-cousins do an excellent job illustrating the fuckedness of the system. Sorry for the screed, hope at least one of you nerds finds it interesting or informative! Sharks Eat Bear fucked around with this message at 22:22 on Oct 23, 2020 |
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Oct 23, 2020 05:52
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To be fair, NIH does fund a significant amount of clinical research; they don’t exclusively fund basic research. The funding generally goes to individual academic investigators for smaller trials, and networks of academic investigators (called cooperative groups). There are frequently international collaborations between cooperative groups, as far as I’m aware mostly between the US and EU-based groups. And as a caveat, I’m only personally familiar with this model in cancer research so I’m not sure if other disease areas have similar arrangements. Nonetheless I think it provides a blueprint for what scaling a nationalized R&D industry could look like. One area that would be new to these groups AFAIK would be selection of pre-clinical candidates to enter in-human trials (I.e. IND stage), which could be a trickier decision to make than their current focus of deciding which research proposals to fund for drugs already in the clinic. Right now it’s “easy” for pharma to prioritize at the IND stage based on NPV — they want to invest in the drug candidates with the best shot at making lots of money. In a nationalized model there would still need to be some prioritization, but off the cuff I’m not sure what the right metric would be. Maybe something like the QALY metric that purports to measure value of a drug by its impact on both the quality and quantity of life for a patient, but tbh I’m not familiar enough with it to know if it’s legit. But whatever the metric is, I think it probably would require creating a new governmental body, rather than having an already-activated network of investigators like there is for clinical research. Despite working in the industry and having a moderate degree of knowledge about these topics, I’m definitely not an expert so if I’m off base here please correct me!
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Oct 26, 2020 06:50
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Jaxyon posted:We've already nationalized a bunch of research via the NIH. My whole last post was about what a model for nationalizing pharma company clinical stage R&D could look like? It's pretty surface level because I'm not an expert in that domain, but I don't think it's fair to say that my argument (or the arguments of other pharma posters ITT so far) have been that single payer will reduce innovation, therefore single payer BAD. I think there's unanimous support for single payer, and the discussion has been around 1) whether pharma could maintain its current raw R&D productivity if their budgets shrink from less US revenue due to price regulations (I think raw productivity would decrease if we assume that pharma companies remain for-profit), 2) whether raw R&D productivity = innovation/societal benefit (I think this is a categorical NO, and belies why pharma wants to frame the argument against single payer as a threat to "innovation"), and 3) whether nationalizing drug development would be able to overcome a potential decrease in for-profit pharma R&D productivity, on the basis of more efficient allocation of research budgets (e.g. less spend on "me-too") and ability to prioritize areas of high unmet need that are currently hosed by the for-profit system (e.g. novel antibiotics) My take is that if we accept (2), then it makes (1) kind of irrelevant, which is helpful because I think the thread has pretty thoroughly laid out the arguments for and against (1) and at this point we don't have much more than speculation. If you're convinced that you KNOW that raw R&D productivity will either increase OR decrease under a single payer system, then IMO it's a sign that you (the abstract "you", not specific to any poster) might be too confident in a hypothetical with lots of uncertainty. I like that the thread is moving to (3), because unlike UHC/single-payer, I'm not aware of any really robust international examples of nationalized drug development from basic research through regulatory approval*. Even though I think nationalized drug R&D is The Correct Thing, I personally lack the expertise or cleverness to imagine how it would work. This isn't to say that it's unworkable, but I think there's value in discussing what it would look like, given we can't just point to the rest of the world and say "it would work like that" as with UHC. We want to discuss a detailed plan because if we just say "nationalize the rest" then there's not really any discussion to be had? That doesn't mean that "nationalize the rest" is a bridge too far. That said if this is too much of a rabbit hole into a niche topic relative to all of US healthcare, then maybe it's worth spinning off into a separate thread? My sense was that this thread didn't get a ton of traffic prior to this discussion so that it was OK to keep it going here, but understand if it might be drowning out other topics of discussion on US healthcare... *I'm aware that Cuba has a nationalized drug development system, but from my (admittedly limited) reading on the subject, it doesn't sound like it's anywhere close to the scale that we would be talking about for the US. But if others have more familiarity with it, would love to learn more knox_harrington posted:Well, I've worked quite a bit on academic multi-centre trials funded by research councils (MRC and Horizon framework etc) and they take a really long time and are not suitable for generating registrational level data as implemented. Not that they couldn't be but it would need huge organisation and lots of money. You could form a company to do it funded / owned by the constituent countries in the same way big defence projects are run, but they're not exactly paragons of efficiency and value. In the US, the cancer cooperative group studies frequently generate registrational level data. The timelines do tend to be a bit slower than industry-sponsored trials currently, but that might not be true if public-sponsored trials didn't have to compete with industry-sponsored trials for enrollment. And again going back to my point (2) above, maybe slower timelines are actually a GOOD thing if it means higher quality study designs & outcomes in terms of using robust endpoints and representative patient populations in trials, which IMO is a major issue with industry-sponsored research. The issue of putting together a regulatory package for submission to the FDA or EMA or whatever may also be mitigated if the drugs aren't owned by private companies; if the drugs are also publicly owned then there's no need for the confidentiality that underpins regulatory submissions, there could be complete transparency between the research sponsors and the regulators such that the administrative burden of submissions is much lower. Again, this is my speculation, I haven't personally worked on regulatory submissions myself so I'm sure it would require an overhaul of systems and personnel etc etc, but just saying that there could be an advantage from a nationalized R&D system in this respect. quote:QALYs are absolutely a valid measure of drug utility (or rather $ per QALY) and the US would need something like the much-maligned but actually pretty good UK NICE in a single payer system to work out if they'll pay for a treatment (cue screeching about death panels from the Right). While you don't know the efficacy you would need to have a rough guess at it and likely cost, and then factor that into whether you want to research a particular therapy. I think a discussion about pricing could be interesting, but I'm not sure what the nuance is beyond what you already described re: NICE -- having a strong single payer to negotiate prices & make formulary/reimbursement decisions. Seems like a relatively "plug and play" model compared to the unknowns of nationalized R&D.
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Oct 26, 2020 18:45
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Yesterday the FDA made a monumental decision to grant an Accelerated Approval to a new drug treatment for Alzheimer's Disease, made by the major biopharma company Biogen. This was one of the most hotly watched events in the pharma industry due to the unmet medical need in AD and the massive commercial potential since there are so many patients. The data package that Biogen submitted was considered extremely contentious to say the least; I'm not deeply versed in the data or drug development in AD, but my understanding is that their pivotal trials failed to show a clear benefit in patient outcomes. As a result the FDA convened an advisory committee to debate & vote on the potential approval and give a (non-binding) recommendation to the FDA on what to do. To nobody's surprise, the committee voted against the approval -- this is a slight over-simplification, but effectively 10 voted against it, 1 abstained, and nobody supported it. The two most shocking things about the approval IMO were: 1) That FDA decided to grant the accelerated approval, which is not just a term for an approval that happens quickly, but actually a very specific regulatory pathway for drug approval. The idea is basically that for diseases with high unmet need, a drug can be approved on a surrogate endpoint that's reasonably likely to predict an actual outcome benefit, in the absence of more robust outcome data. Biogen's drug was approved based on data showing that the drug can reduce beta amyloid plaques in patients brain, which has been the orthodox hypothesis as to what causes AD for the past couple decades but has become quite contentious as numerous studies haven't really been able to support this. Of note, an accelerated approval based on this type of surrogate data wasn't even on the table when this was brought to the advisory committee. The accelerated approval stands until there are results from a larger trial that confirms an actual clinical outcomes benefit, and if the confirmatory trial fails, in theory the approval should be rescinded. Yesterday the Biogen CEO disclosed that they have 9 years to complete a confirmatory trial, which many think is an unacceptably long time 2) That Biogen announced a list price of $56K, which was roughly double what most industry analysts were expecting. Biogen has defended this price by saying it's going to offer rebates/discounts to specific channels so that the net price will be lower, that it's cheaper than other new drugs for other diseases like immunotherapies for cancer (which btw have incredible amounts of proof of their effectiveness relative to Biogen's drug), and that they'll be investing in providing many support services for AD patients. These defenses are, of course, total obfuscation. What's worse is that most AD patients are covered via Medicare, which has very limited ability to negotiate price or impose formulary restrictions, which means that Biogen can basically gouge as much as they think they can get away with without causing a massive public and political outcry. And clearly they think they can gouge the gently caress out of us. Here's a quote from an analyst to put this in context: quote:Bernstein’s Ronny Gal... also noted that if 1 million patients use Aduhelm at the current price point, total Medicare part B spending would double. That figure is probably out of range, as there are about 500,000 new Alzheimer’s diagnoses a year in the US. But a more realistic scenario, he said, is “equally mind-boggling”: If half of newly diagnosed patients start Aduhelm at the current price, the total cost to Medicare will be equal to the top five drugs in Medicare part B combined: Keytruda, Eylea, Opdivo, Rituxan and Prolia. --- I actually do think this could have big ripple effects and further ramp up political pressure on drug pricing regulation. I also think there needs to be some sort of hearing/investigation into how the FDA came to its decision. I can't really understate how shocking it was, this editorial does a pretty good job summing it up. For context - this author is the founder/head of this popular industry newsletter and is not someone you'd peg as a critic of the industry at all. "John Carroll posted:Just how sadly misguided is the FDA on aducanumab?
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Jun 8, 2021 18:14
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My $0.02 as someone in the industry who’s very familiar with a lot of the generalities but not the specific details of this approval... Bribes: unlikely Regulatory capture either in the FDA review chain of command or in terms of pressure from outside/above the FDA: entirely plausible and to your point, absolutely warrants investigation 10 years ago I viewed the FDA as one of the better regulatory agencies in the US (at least for drugs, not familiar with foods), and not one of the primary contributors to indescribable dysfunction of the US healthcare system (admittedly not a high bar). I really can’t overstate how shocking and upsetting this Alzheimer’s approval is, and how far a fall it signals compared to the relative strength of the agency in the past. Would be curious to hear from other posters who work in healthcare too
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Jun 9, 2021 20:56
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In case anyone's wondering: a couple of House dems announced they'd open an investigation into the Biogen Alzheimer's drug approval & pricing. Good riddance, hopefully it can move quickly and uncovers enough scandalous material to cause more public outcry and pressure for drug approval & pricing reform! https://finance.yahoo.com/news/house-panels-launch-investigation-alzheimer-225645951.html quote:Two House committees announced Friday that they are launching an investigation into the controversial approval and pricing of Biogen’s new $56,000-a-year Alzheimer’s drug.
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Jun 29, 2021 00:08
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