Third member of FDA panel resigns over approval of Biogen Alzheimer's drug(cnbc.com)
cnbc.com
Third member of FDA panel resigns over approval of Biogen Alzheimer's drug
https://www.cnbc.com/2021/06/10/third-member-of-prestigious-fda-panel-resigns-over-approval-of-biogens-alzheimers-drug.html
5 comments
> It's a pretty tough call.
It’s actually not a tough call. It just reveals how broken the system is.
There should be a way for drugs to be experimentally approved, where patients can only take them with extra consent / oversight (e.g. recommended by an ethics committee, or after a 6 month waiting period & clear understanding of side effects), specifically for cases where the potential benefits outweigh possible risks. Alzheimer’s sounds like a good candidate, or near-fatal diseases (6-month-to-live cancer) - you literally have nothing to lose! Another example is a pandemic, where the vaccine was experimentally approved, but presumably only because of the enormous scale & economic benefits (but the individual benefits are equivalent, or even greater, in the cases above).
It’s actually not a tough call. It just reveals how broken the system is.
There should be a way for drugs to be experimentally approved, where patients can only take them with extra consent / oversight (e.g. recommended by an ethics committee, or after a 6 month waiting period & clear understanding of side effects), specifically for cases where the potential benefits outweigh possible risks. Alzheimer’s sounds like a good candidate, or near-fatal diseases (6-month-to-live cancer) - you literally have nothing to lose! Another example is a pandemic, where the vaccine was experimentally approved, but presumably only because of the enormous scale & economic benefits (but the individual benefits are equivalent, or even greater, in the cases above).
> There should be a way for drugs to be experimentally approved, where patients can only take them with extra consent / oversight (e.g. recommended by an ethics committee, or after a 6 month waiting period & clear understanding of side effects), specifically for cases where the potential benefits outweigh possible risks.
There is. See how EMA approved Covid-19 vaccines.
There is. See how EMA approved Covid-19 vaccines.
That, and with respect to:
> Alzheimer’s sounds like a good candidate, or near-fatal diseases (6-month-to-live cancer) - you literally have nothing to lose!
But others have a lot to lose. No matter how experimental the application and how much consent and oversight - if the drug is being used on people before finishing all testing and without taking all necessary precautions, you increase the risk of side or adverse effects. That in turn will likely delay the approval of the drug for all patients.
So in the end, a couple of people get experimental treatment but might delay the treatment for a large group of people. That's no easy trade-off, and is certainly not a sign for a broken system.
> Alzheimer’s sounds like a good candidate, or near-fatal diseases (6-month-to-live cancer) - you literally have nothing to lose!
But others have a lot to lose. No matter how experimental the application and how much consent and oversight - if the drug is being used on people before finishing all testing and without taking all necessary precautions, you increase the risk of side or adverse effects. That in turn will likely delay the approval of the drug for all patients.
So in the end, a couple of people get experimental treatment but might delay the treatment for a large group of people. That's no easy trade-off, and is certainly not a sign for a broken system.
As I understand it, safety testing has already been done but it's apparently more difficult to test the efficacy.
"Three FDA Advisers Resign over Agency’s Approval of Alzheimer’s Drug"
https://news.ycombinator.com/item?id=27468756
At a certain point even the most robust regulatory processes are going to give way to desperate searches for hope, no matter whether they make sense.
There hasn't been a drug for this in 20 years.
There hasn't been a drug for this in 20 years.
And evidently there still isn’t, as this drug doesn’t appear to work.
I have a drug that is just as effective, will the FDA approve it too?
If you can get people to believe it, maybe.
Get people to believe I have a drug that hasn't been proven to work yet despite attempts to do so?? That seems pretty easy.
Damn props to those folks for resigning
Too much regulatory capture with all our agencies
Sucks and is dangerous
Too much regulatory capture with all our agencies
Sucks and is dangerous
This is more like the opposite of regulatory capture. Patients are free to use the drug or not.
That’s not what regulatory capture means in this context.
People were free to take any drug they wanted before the FDA was created, under your framework, it’s impossible for the FDA to exhibit regulatory capture, even if it’s simply a rubber stamp agency.
People were free to take any drug they wanted before the FDA was created, under your framework, it’s impossible for the FDA to exhibit regulatory capture, even if it’s simply a rubber stamp agency.
Certainly my point about was to argue a different meaning than the parent commenter's.
But I don't follow your second sentence. Without the FDA there were no regulations to capture, hence no regulatory capture to worry about. A rubber-stamp agency would indeed operate similarly. One might argue it's a case of rubber stamps only for market leaders who have the clout to "capture" them, but Biogen doesn't seem like much of a market leader.
But I don't follow your second sentence. Without the FDA there were no regulations to capture, hence no regulatory capture to worry about. A rubber-stamp agency would indeed operate similarly. One might argue it's a case of rubber stamps only for market leaders who have the clout to "capture" them, but Biogen doesn't seem like much of a market leader.
For some reason, my brain thought your comment was a Haiku at first. Here it is in actual Haiku form (don't ask me why):
``` Props for resigning
Regulatory capture
Sucks and brings danger ```
``` Props for resigning
Regulatory capture
Sucks and brings danger ```
So they get replaced with whom? Industry insiders?
At least then it can be their names on the rubber stamp.
https://www.cnbc.com/2020/11/06/biogen-suffers-setback-after...
Patient advocacy groups were pushing for approval pretty strongly. From the article:
>In a letter sent to the FDA ahead of the meeting, the Alzheimer’s Association said the publicly released data so far “justifies approval accompanied by a Phase 4 post-marketing surveillance study.”
“The alternative, requiring completion of an additional Phase 3 trial, would deny broad access up to four years while it is completed. A four-year delay is too long to wait for millions of Americans facing a progressive, fatal disease. A four-year delay is too long to wait for millions of American caregivers,” the organization said.
I have a family member who suffers from Alzheimer's, and it's a devastating disease. She's progressed too far for this drug, whether it works or not. But I can understand the desire for all the patients/families that still have some hope to have something, even if there's only a small chance it would work. On the other hand, if the FDA begins approving drugs not backed up by data, then it opens up the flood gates for all kinds of snake oil. It's a pretty tough call.