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Experts Have Resigned from an FDA Committee over Alzheimer's Drug Approval
- JadeNB 5y agoThis is from June—it's interesting, but is there some particular reason to resurface it now? Has there been some recent development?
- lowkey_ 5y agoPersonally, I don't remember seeing this in June. It doesn't seem that there's a recent development, but it seems important and interesting enough that it's worth posting.
- busymom0 5y agoSeemed relevant as I saw it was referenced in another recent news from couple weeks ago where “Two senior FDA vaccine regulators are stepping down: Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency.” https://www.cnbc.com/2021/08/31/two-senior-fda-vaccine-regulators-are-stepping-down.html https://www.cnbc.com/2021/08/31/two-senior-fda-vaccine-regul...
- datavirtue 5y ago"patients' copayments for the drug could cost around $11,500 annually." For drugs like this the drug company pays the patients' total out of pocket (co-payment) in full on the first infusion. The patient never has anything to pay in this case...if they have insurance.
- whoknowswhat11 5y agoThis is actually how they manipulate / overcharge on pricing. Because the person paying is not the person getting, they can charge anything, and there is HUGE pressure to proscribe still. If instead they even required patients to still cover out of pocket portion, prices would need to be way lower. You see this overseas. People pay out of pocket. I was in a fair number of developing countries, it's actually a bit nuts for westerners. The process to get for example things like basic antibiotics is near over the counter. Other items are INSANELY cheap. And accessibility (if you have USD) is good.
- rootbear 5y agoMy sister, who is on Medicare, is paying over USD 10,000 a year for her cancer drugs (ALK-positive lung cancer). That's out of her pocket.
- mcguire 5y agoWhat are "drugs like this", and why is the drug company paying for it?
- macintux 5y ago209-comment thread at the time: https://news.ycombinator.com/item?id=27472107 https://news.ycombinator.com/item?id=27472107 Also related: https://news.ycombinator.com/item?id=27734268 https://news.ycombinator.com/item?id=27734268, https://news.ycombinator.com/item?id=27671127 https://news.ycombinator.com/item?id=27671127
- busymom0 5y ago> Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 71 (32.0%) were affected by a postmarket safety event. Postmarket safety events were more frequent among biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval, and those with near–regulatory deadline approval. From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%)” https://jamanetwork.com/journals/jama/fullarticle/2625319 https://jamanetwork.com/journals/jama/fullarticle/2625319
- qwerty456127 5y agoBy the way, I've got a question to whoever is into the Alzheimer research: I have recently heard Alzheimer symptoms instantly disappear shortly before the patient's death - people regain their sane mind in full (or close to) capacity but then die in just about a day. Is this true or a myth? Were there at least some such cases documented credibly?
- gameswithgo 5y agoAlzheimer patients have moments, brief, at random times, where lucidity seems to be there for a bit. This could certainly happen in the moments before or day before dying, and for family this might seem meaningful when it happens. But there is not any kind of connection between the things. Patients just get worse over time until they die.
- merpnderp 5y agoNot sure why you're being downvoted. I spent years visiting family in Alzheimers wards and this was my experience too. Some days patients would have a brief moment of clarity, but usually it was just the typical symptoms. For instance the sister for a famous (for the state) news reporter would seem to come out of it a bit to talk about her sister, but mostly she just walked along the walls, tracking the trim with her fingers and mumbling to herself.
- TedDoesntTalk 5y ago> Is this true or a myth? It is a nice myth to pull at your heart strings
- burning_hamster 5y agoYour cynicism is misplaced as terminal lucidity is, in fact, a well documented phenomenon. https://en.wikipedia.org/wiki/Terminal_lucidity https://en.wikipedia.org/wiki/Terminal_lucidity
- AdmiralAsshat 5y ago
- tapoxi 5y agoThe company behind this drug - Biogen - was also dumb enough to hold an international conference in downtown Boston during the beginning of the pandemic, and spread COVID throughout the state.
- encryptluks2 5y agoThat had their drug approved by the same FDA that you suddenly trust in that regard.
- EamonnMR 5y agoPeople where still working in offices and going to school then. Heck, I was at Pax East just before that went down. We where concerned about Corona, talked about it, but we still went along with tons of others.
- macintux 5y agoStill, you’d think a medical company would be a bit more sensitive to the topic. Other conferences had already been canceled. And in fact it may have had a massive impact. > Between 205,000 and 300,000 coronavirus cases across the U.S. can be traced back to the Boston conference, say the scientists, whose findings were published in the journal Science on Thursday. https://www.cbsnews.com/news/boston-biogen-medical-conference-300k-covid-19-cases/ https://www.cbsnews.com/news/boston-biogen-medical-conferenc...
- mountainriver 5y agoRick Doblin had recently brought this up as the FDA forced his MDMA research to have a 2nd phase 3 trail even though they had stellar results in phase 2 and 3. Such an odd contrast as they passed a drug which had a number of failed studies and only one marginally successful one.
- fighterpilot 5y ago> odd contrast It probably makes more sense if we view the FDA not as a monolith but a collection of lots of individuals, some of which don't communicate or work together directly.
- zepto 5y agoNot really. You’d expect an organization like the FDA to be policy based.
- LeifCarrotson 5y agoAll organizations, even ones which are policy based, function like an artist's collective at some level - the human level. They all employ humans, who have to interpret those policies, and can interpret them in favor of or against something they personally have an opinion about.
- zepto 5y agoIf the difference is a matter of interpretation, we should be able to tell by comparing against the policy.
- cmrdporcupine 5y agoSure, you'd expect and demand that, but that's the goal to strive towards not the reality of large organizations. Which is why permanent pressure and scrutiny is required on any government or corporate entity. That's democracy. But in terms of analyzing these organizations it's an excellent point that we can't assume consistency. They are complex and contradictory.
- hellbannedguy 5y agoThere's still a bit of ethics in some people. Now--I wish the FDA would revisit approval data on every anti-depressant since Prozac, and including Prozac. Irving Kirch was the first to look at all the drug trials, and not just cherry pick. His study is in Lancet. https://www.psychologytoday.com/us/blog/psych-unseen/201802/do-antidepressants-work-yes-no-and-yes-again https://www.psychologytoday.com/us/blog/psych-unseen/201802/...
- eli 5y agoThis was a few months ago. Congress is now investigating the FDA approval of Aduhelm.
- encryptluks2 5y agoAnd likely will cover themselves as the corruption is widespread.
- foolzcrow 5y agoThe FDA is compromised by industry hardliners crossing overbfrom corp jobs to gov jobs. They sell us out to corps every time.
- MeinBlutIstBlau 5y agoNot to be a little harsh here, but is it really all that bad? People with alzheimers are basically knocking on deaths door. They aren't even themselves anymore when it gets real bad. They constantly are in a state of of "who are you people being nice to me?" with friends and family. It's like getting upset over a risky drug for cancer patients in stage 4. It's not like in the grand scheme of morality it's going to do much if any harm. And unfortunately, some people need to be test subjects.
- busymom0 5y agoI think giving false hope is definitely bad. Also the price of the drug alone (regardless of who covers it) is ridiculous for something which is useless.
- MeinBlutIstBlau 5y agoIf you're expressly told before taking it the same information we know now, is it false hope? Also isn't praying to a god false hope? Rolling dice in Vegas...false hope? Everything in life is a gamble. How you interpret the results is you own undoing.
- busymom0 5y agoThat's not what's happening here. If someone really wanted, they could have gotten the drug under Right to try Act if it was life saving drug or something. This instead is FDA approving the drug as if it actually works which based on current reporting isn't the case. Also this drug is crazy expensive for something which doesn't even work.
- CamperBob2 5y agoThe fact that money is involved makes it a zero-sum game. Money spent on Aduhelm won't be available for other therapies that might potentially be more effective.
- s1artibartfast 5y ago>Everything in life is a gamble. How you interpret the results is you own undoing. The biggest problem is this is a gamble with other people's money because medicare and the taxpayers are on the hook for the bill.
- rocqua 5y agoI recall from a previous HN article, there is a _lot_ of controversy in the Alzheimer research area. Specifically about whether the amyloid plaque in Alzheimer actually is the root cause of Alzheimer. With the dissenting opinion being that the plaque is actually just a symptom. As I recall, the claim (by the dissenters) in the article was that big names in research had staked their reputation on the plaque theory. Those big names were claimed to use their weight to suppress any research into alternative theories. The article then stated that the little bit of research into alternative explanation seemed promising, and that there were trials on removing plaque that did not seem to cure Alzheimer. This news about a controversion FDA approval feels like it is related to this controversy. And to my mind, it strengths the case for 'plaque does not cause Alzheimer'.
- ajkjk 5y agoMy understanding from having a few friends / family members in the field is that no on believes amyloid plaques are the cause anymore -- as you said -- but also that there isn't actually much controversy about this. So it's not that alternative theories are being suppressed, really, but that that's a media spin you might have picked up somewhere.
- JamesBarney 5y agoI think few people believe amyloid plaques are the sole cause but there is still quite a bit of evidence that amyloid is heavily involved in Alzheimer's. Genetically almost all of the genes associated with Alzheimers have to do with the productions or cleaning up of amyloid beta.
- oldgradstudent 5y agoYet, this drug was approved solely on it's ability to reduce amyloid plaque, without any cognitive effects.
- fabian2k 5y agoAlready 20 years ago there were serious discussions whether the fibrils were actually responsible, or maybe instead some toxic intermediates might be the cause. As far as I understand the case against fibrils as the main cause only got stronger, and the mainstream view among scientists is that it is quite likely that there is more going on there and the fibrils alone are not the full explanation.
- arc-in-space 5y ago...But not over stalling the mRNA vaccines for half a year
- rossdavidh 5y agoAnother industry expert, with much the same opinion: https://www.science.org/content/blog-post/open-floodgates https://www.science.org/content/blog-post/open-floodgates
- xibalba 5y agoI heard a theory on some podcast that the ulterior motive here may be to try to incentivize more R&D into Alzheimer's pharma. This approval is thus a green light signal.
- DebtDeflation 5y agoWe may very well see a repeat of this situation in the next couple days when the FDA considers a different Advisory Committee's recommendation on the Covid vaccine boosters. There is speculation that the FDA may ignore the recommendation to limit boosters to 65+ and those with risk of severe disease and instead approve it for a broader population. At the end of the day, the Advisory Committee is just that - a committee that advises and the FDA is not bound by that recommendation. It seems a bit disingenuous of the committee members to expect the broader FDA to just rubber stamp their recommendation, particularly when it was a split decision.
- setgree 5y agoScott Alexander's "Adumbrations Of Aducanumab" is essential reading on this subject IMO [0]. He makes an interesting point that when the FDA approves a drug, it means that Medicare is automatically on the hook to pay for it, and that a more sensible system might decouple approval and mandated reimbursement by having multiple levels of approval (e.g. 1 star = this is probably safe, 2 stars = it's definitely safe, 3 = there's weak/controversial evidence for efficacy, 4 stars = it is safe and it works, etc.). But it's interesting to me that we hear about FDA scientists resigning when a panel is too permissive, but not when it's too restrictive. Can we chalk this up to something about the kind of people the FDA recruits? I can recall just one instance of an FDA official pushing the institution to go faster, and that was when the doctor's wife died of cancer [1]. [0] https://astralcodexten.substack.com/p/adumbrations-of-aducanumab https://astralcodexten.substack.com/p/adumbrations-of-aducan... [1] https://www.nytimes.com/2016/01/03/us/politics/fda-regulator-widowed-by-cancer-helps-speed-drug-approval.html https://www.nytimes.com/2016/01/03/us/politics/fda-regulator...
- Brakenshire 5y agoWe do have to make drug discovery vastly more efficient, but we want to make it more efficient at making useful drugs available, not just making drugs available. If you decouple availability from effectiveness then drug companies will just market unproven drugs to people who are desperate or who don't know any better. Or even if the drug companies do nothing people will just start taking drugs on the basis of recommendations from Facebook. Maybe that means building randomized trials into treatment in a much more regular way (like with the Covid RECOVERY trials, where any doctor could enroll patients with a web form, and source the candidate treatment from the local pharmacy), which vastly reduces cost for treatments already on the market with other indications. And perhaps altering the balance of risk for patients with life-threatening or terminal diseases.
- civilized 5y agoOne reason your proposal isn't happening today might be because we don't want tons of doctors choosing to enroll in these "field" randomized trials, if they might be experimentally treating people with drugs that aren't safe. We want to know about safety first before unleashing on the world, even in a randomized trial context. And since the FDA bundles verification of safety and efficacy together, so we can't do your proposal without unbundling them. Now, imagine that after safety is verified to a 1 or 2-star level, we don't make the drug approved for general use, but doctors can freely enroll in randomized trials as you proposed? That way we're getting the efficacy data quickly but safely. Maybe a minor point, but we do have to unbundle safety from efficacy in some sense to get off the ground here. The question is, what exactly is allowed to happen after safety is established but efficacy is not yet established?
- alexfromapex 5y agoWill there be any criminal charges? They could've been paid off and then all that happens is they resign?
- busymom0 5y agoI think you are misunderstanding the resignations. They resigned because they didn't agree with the approval. > The latest exit comes from Dr. Aaron Kesselheim, a professor at Harvard Medical School who is also director of the Program On Regulation, Therapeutics, And Law at Brigham and Women's Hospital. He said the FDA is greenlighting Aduhelm despite not having enough proof that the drug will help Alzheimer's patients.
- georgewsinger 5y agoI wish we could "resign" the FDA from telling us which drugs we can and cannot experiment with under threat of imprisonment.
- Factorium 5y agoGiven the extreme wealth and aging condition of baby boomers, I feel like we are going to see a lot of money dumped into for-profit drugs and health services designed to 'counter' their normal mechanisms of aging. You could argue that society-wide COVID lockdowns and forced vaccinations, in reaction to a virus which is really only driving excess deaths in that generation, would never have been supported if that cohort was smaller or less influential.
- mrtweetyhack 5y agomake sure you purchase this drug even if you never use it and wait for the lawsuit settlement
- m0zg 5y agoPeople at FDA are working real hard for their post-FDA do-nothing six figure paychecks and board seats. It's great to see, however, that not everyone is just cynically milking the system like that.
- xyzzy21 5y agoFDA, CDC, NIH, etc. are all 100% captured! https://en.wikipedia.org/wiki/Regulatory_capture https://en.wikipedia.org/wiki/Regulatory_capture This kind of story is all too common. These are NOT scientific or medical organizations anymore because of how corrupt they are.