Third Member of US FDA Advisory Panel Resigns Over Alzheimer's Drug Approval

[DEAD7]

Third Member of US FDA Advisory Panel Resigns Over Alzheimer's Drug Approval


Aaron Kesselheim, a Professor of Medicine at Harvard Medical School who had served on the FDA's advisory committee for nervous system drugs since 2015, told Reuters on Thursday he was stepping down from the panel. "My rationale was that the FDA needs to re-evaluate how it solicits and uses the advisory committees ... because I didn't think that the firm recommendations from the committee in this case ... were appropriately integrated into the decision-making process," Kesselheim said in an email. He cited FDA's decision to approve Sarepta Therapeutic's drug, eteplirsen, for Duchenne muscular dystrophy in 2016 as another example of the regulator approving a drug against the recommendations of its advisory committee.

On Tuesday, a member of the advisory group who voted against the approval, Washington University neurologist Dr. Joel Perlmutter, resigned from the committee, citing the FDA's approval of Aduhelm. Mayo Clinic neurologist Dr. David Knopman said he resigned on Wednesday. The 11-member committee voted nearly unanimously in November that Biogen's drug should not be approved, citing inconclusive evidence that the drug was effective.

 

[Spiritual Stratocaster]

As someone who relies on certain medication this has me on my toes

 

[Professor Emeritus]

I mean, it's a pretty crazy precedent.


1. Drug costs $56,000 a year per patient
2. With the publicity it's received there are millions of people with Alzheimers in the USA who might want it
3. It's not at all clear that the drug works and there are serious side effects
4. Almost the entire advisory panel voted not to approve the drug


Imagine just 25% of Alzheimers patients start using the drug, that's $84 billion/year that we'll be spending on a drug that might not even benefit patients. Then imagine if they start approving other similarly expensive drugs with similarly unclear results for other diseases. You'd be in danger of bankrupting the health care system for no one's benefit other than drug companies.

 

[Json]

Considering how many people are expected to develop Alzheimers and the associated cost, it just seems like throwing stuff at the wall but having your name attached to something with no proven benefit is probably heart breaking.


Lack of trust in drug companies is partly why the vaccine rollout came with such skepticism.

 

[ADevilYouKhow]

Very disturbing and sad honestly

 

[ORDER_66]

I mean, it's a pretty crazy precedent.


1. Drug costs $56,000 a year per patient
2. With the publicity it's received there are millions of people with Alzheimers in the USA who might want it
3. It's not at all clear that the drug works and there are serious side effects
4. Almost the entire advisory panel voted not to approve the drug


Imagine just 25% of Alzheimers patients start using the drug, that's $84 billion/year that we'll be spending on a drug that might not even benefit patients. Then imagine if they start approving other similarly expensive drugs with similarly unclear results for other diseases. You'd be in danger of bankrupting the health care system for no one's benefit other than drug companies.

That's the serious major question.... does the shyt even work to begin with?!?