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

by AndrewBissell • 5 years ago

49 21 5 years ago

cnbc.com

readonthegoapp• 5 years ago

Damn props to those folks for resigning

Too much regulatory capture with all our agencies

Sucks and is dangerous

echelon• 5 years ago

So they get replaced with whom? Industry insiders?

AndrewBissell• 5 years ago

At least then it can be their names on the rubber stamp.

unishark2• 5 years ago

This is more like the opposite of regulatory capture. Patients are free to use the drug or not.

wbsss4412• 5 years 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.

wahern• 5 years ago

Patients are free to use the drug or not

Insurers aren't.

chronolitus• 5 years 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• 5 years ago

andredz• 5 years ago

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

qzw• 5 years ago

For context, this is from November 2020:

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• 5 years 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• 5 years 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.

MattGaiser2• 5 years 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• 5 years ago

And evidently there still isn’t, as this drug doesn’t appear to work.

vipa1232• 5 years ago

I have a drug that is just as effective, will the FDA approve it too?

MattGaiser2• 5 years ago

If you can get people to believe it, maybe.

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

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