6 ms·
It's crazy how this drug got approved despite the evidence. A mixture of greed from the drug manufacturer and wishful thinking from the afflicted. Ugh. I've los
by msie 3y ago
It's crazy how this drug got approved despite the evidence. A mixture of greed from the drug manufacturer and wishful thinking from the afflicted. Ugh. I've lost my trust in the system.
- frodo8sam 3y agoAgree, the Alzheimer's and ALS treatments that were approved recently were both cases where the patient advocacy groups stopped listening to experts and ironically harmed the people they are trying to help. It shows how important it is that the FDA keeps some emotional distance from the people they are trying to protect.
- ta8645 3y agoThat's an interesting narrative, but are you sure that's actually what happened? It seems to elide the role of the drug manufacturer who pays for all these trials in the first place. Why would they pay for such doomed trials, just for the emotional hopes of patients? Are they that irresponsible with their stockholder's money? If so, they should probably be ousted and replaced with people who have more business savvy. Or alternatively, this really didn't have anything to do with hopeful patients or their advocates, but rather the greed of the pharma companies, hoping to push through unproven drugs for the sake of profit. I don't have any special insight into which narrative is true, but we've seen a lot of the second narrative historically.
- jfengel 3y agoThey can't profit if it doesn't work. There is that bizarre case with the Alzheimer's drug, but that seems rare and not something they should pin their hopes on. It sounds to me as if the drugmakers and the patient advocates are coming from the same place. They are desperate for it to work, and will convince themselves of it on any thin evidence. Probably something like "it did X in a petri dish so it must work eventually." There are surely executives making a calculated risk, but I think they couldn't do it if there weren't also scientists who feed them over-optimistic guesses because they want it to work for the patients too.
- wesselbindt 3y agoWhy do you think they can't profit if they don't work?
- jfengel 3y agoThe FDA won't usually approve a drug that doesn't work. Yeah, regulatory capture occasionally happens, and the FDA's definition of "work" is looser than you might hope. But it's just not a profitable strategy to keep throwing good money after bad on a drug that simply doesn't do anything.
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- rafaelero 3y agoAnd, curiously, the Alzheimer drug do work, just like hypothesized by the "dumb advocacy groups". You just have to take them earlier in the profession of the disease.
- sambull 3y agoA symptom of larger problems
- rafaelero 3y agoNonsense. I'ld rather have a safe drug with >50% of chance of working approved than waiting for 3 more years and find out when I am already debilitated. That some drugs turn out to not work is not a reason to "lose trust in the system", unless you are an immature child.
- lotsofpulp 3y agoWho is paying for these drugs that have insufficient evidence of efficacy?
- rafaelero 3y agoI don't know and don't really care. It's about giving people the option, not forcing them to buy it.
- lotsofpulp 3y agoAre people prevented from paying for it? Or do manufacturers simply not think it is worth their while / liability if Medicare and other governments will not pay for it? If a billionaire went to the employees of Amylyx Pharma, and asked them to make this medicine for them, would they refuse?
- lotsofpulp 3y ago> A mixture of greed from the drug manufacturer and wishful thinking from the afflicted. Neither of those entities have the power to approve a drug.
- mlyle 3y agoRegulators are political amalgamations; as we've seen recently with Alzheimers and this drug, those entities can be quite powerful.
- ejb999 3y agonot to mention the revolving door between drug company execs and regulators - which is ripe for conflicts of interest.
- azinman2 3y agoWhat percent of FDA scientists and committee members who are in charge of approving drugs have been part of the “revolving door?” And how do we know this is inherently bad? It may be, but I can also see how niche expertise would cause you to float between entities as appropriate. Keep in mind 90% of drugs fail clinical trials. The situation cannot be THAT bad.
- mlyle 3y agoThe specific cases we're talking about is where FDA political appointees have overridden and/or appointed new advisory committees for a redo.
- lotsofpulp 3y agoWhile the current participants in the system might not be perfect, it should be appreciated that humanity has seldom had it better in terms of being able to trust civic institutions. I don’t see the purpose of complaining about it in a situation where the institutions are working as intended (and desired).
- slibhb 3y agoThe drug didn't hurt patients, did it? This kind of failure seems relatively benign.
- tester89 3y agoIt’s not as bad, true. But you have to consider the amount of money wasted in the phase 3 trial, resources which could’ve been put to better uses.
- rafaelero 3y agoYou don't have to worry about that, because companies are the ones financing it and if they don't believe the drug have a good chance of working they won't fund it.
- skwirl 3y agoI don't think there were many better hopes out there for ALS. That's why they approved the drug despite weak data supporting it. This outcome is devastating for people with ALS and their families.
- Karunamon 3y agoAs someone with ALS, This drug was prescribed for me by my doctor as equivalent to other ALS medications, namely that they barely slow the progression of the disease. We are talking three to six months of life extension. You are overselling the effects of this drug harder than the manufacturer did.
- skwirl 3y agoIt wasn’t the manufacturer that was what convinced the FDA to approve this drug. It was people like you.
- chowells 3y agoDrugs shouldn't be approved on hope. They should be approved on evidence. And there was never any evidence for this one. Just letting it inspire hope was hurting its victims.
- ethanbond 3y agoWhat? It didn’t get approved. It failed Phase III as designed.
- mlyle 3y agoWhat? It got approved, on dubious evidence from a dubious phase II, against the original advisory committee's recommendation. The manufacturer had agreed to conduct a phase III and remove it from the marketplace if it failed the next trial. It has now failed that trial.
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