Third member of FDA panel resigns over approval of Biogen Alzheimer's drug
cnbc.com
cnbc.com
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.
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 is. See how EMA approved Covid-19 vaccines.
> 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.
There hasn't been a drug for this in 20 years.
Too much regulatory capture with all our agencies
Sucks and is dangerous
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.
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.
Insurers aren't.
``` Props for resigning
Regulatory capture
Sucks and brings danger ```