5 ms·

Third member of FDA panel resigns over approval of Biogen Alzheimer's drug

49 points by AndrewBissell 5y ago

readonthegoapp 5y ago
Damn props to those folks for resigning Too much regulatory capture with all our agencies Sucks and is dangerous
- echelon 5y ago
  So they get replaced with whom? Industry insiders?
  - AndrewBissell 5y ago
    At least then it can be their names on the rubber stamp.
- unishark 5y ago
  This is more like the opposite of regulatory capture. Patients are free to use the drug or not.
  - wbsss4412 5y ago
    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.
    - unishark 5y ago
      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.
  - wahern 5y ago
    > Patients are free to use the drug or not Insurers aren't.
    - joshmn 5y ago
      That's what I'm worried about the most. How far are insurers going to prey on people's hope?
- chronolitus 5y ago
  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 ```
phnofive 5y ago
See also: https://news.ycombinator.com/item?id=27468756 https://news.ycombinator.com/item?id=27468756
andredz 5y ago
"Three FDA Advisers Resign over Agency’s Approval of Alzheimer’s Drug" https://news.ycombinator.com/item?id=27468756 https://news.ycombinator.com/item?id=27468756
qzw 5y ago
For context, this is from November 2020: https://www.cnbc.com/2020/11/06/biogen-suffers-setback-after-alzheimers-drug-fails-to-win-support-from-fda-panel-.html 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.
- tomp 5y ago
  > 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).
  - hulitu 5y ago
    > 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.
MattGaiser 5y ago
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.
- amanaplanacanal 5y ago
  And evidently there still isn’t, as this drug doesn’t appear to work.
- vipa123 5y ago
  I have a drug that is just as effective, will the FDA approve it too?
  - MattGaiser 5y ago
    If you can get people to believe it, maybe.
    - vipa123 5y ago
      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.

49 points by AndrewBissell 5y ago

readonthegoapp 5y ago

Damn props to those folks for resigning Too much regulatory capture with all our agencies Sucks and is dangerous

echelon 5y ago
So they get replaced with whom? Industry insiders?
- AndrewBissell 5y ago
  At least then it can be their names on the rubber stamp.
unishark 5y ago
This is more like the opposite of regulatory capture. Patients are free to use the drug or not.
- wbsss4412 5y ago
  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.
  - unishark 5y ago
    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.
- wahern 5y ago
  > Patients are free to use the drug or not Insurers aren't.
  - joshmn 5y ago
    That's what I'm worried about the most. How far are insurers going to prey on people's hope?
chronolitus 5y ago
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 ```

phnofive 5y ago

See also: https://news.ycombinator.com/item?id=27468756 https://news.ycombinator.com/item?id=27468756

andredz 5y ago

"Three FDA Advisers Resign over Agency’s Approval of Alzheimer’s Drug" https://news.ycombinator.com/item?id=27468756 https://news.ycombinator.com/item?id=27468756

qzw 5y ago

For context, this is from November 2020: https://www.cnbc.com/2020/11/06/biogen-suffers-setback-after-alzheimers-drug-fails-to-win-support-from-fda-panel-.html 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.

tomp 5y ago
> 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).
- hulitu 5y ago
  > 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.

MattGaiser 5y ago

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.

amanaplanacanal 5y ago
And evidently there still isn’t, as this drug doesn’t appear to work.
vipa123 5y ago
I have a drug that is just as effective, will the FDA approve it too?
- MattGaiser 5y ago
  If you can get people to believe it, maybe.
  - vipa123 5y ago
    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.