Looks like the FDA is finally waking up to the truth that the decision to risk an experimental treatment should rest with the patient.

For years now the FDA was the single most obstinate barrier to new pharmaceuticals; research was done and shelved, because of burgeoning red-tape requirements. Now in this Adulhelm debacle we finally have the chance to see the rats come out of the woodwork---it appears it was mostly these "expert advisors" that were holding back drug development, and are now outraged that their nitpicking objections are no longer heeded. How terrible, patient needs outweighing formal requirements! It also seems that many of these offended advisors have been triggered into resigning---well, good riddance to them.

Hope that the FDA has found its cojones for good, and the same Accelerated Approval will be used for the many new cancer, arthritis, antibiotic, anti-senescence, and other much needed treatments that have been waiting in the wings for years.

Let the top medical community regulate itself rather than FDA cartel for big pharma that is destroying medicine and has been for a very long time. A better system that rests with what's best for medicine should take shape.

@Ralf Biernacki
Agree about accelerated approval when there are no alternatives - But the argument here is about the efficacy rather than safety and a sudden (and dubious) change of end point. This is about the approval of a very expensive (profitable) drug without proven efficacy of an end point that shows patient benefit and with cost that could cripple health budgets with minimum patient benefit..

Perhaps the FDA need to put a new qualification which is the cost of the drug. If it was $1 per year treatment, no argument its worth the risk but at $56,000 per annum with its poor efficacy it isn't!

Maybe this is just another example of the way we reward research companies (by high selling costs) for the development of new drugs and treatments, there must be a better way?

There have been many comments that the FDA is far too cosy with 'Big Pharma' so I guess this is the point when it becomes so evident, that it causes a revolution.

First it was the FAA approval process relying on Boeing to self police itself,which after the crashes resulted in foreign governments not trusting the FAA process,and doing their own certification. Now the FDA is approving an expensive Altzheimers drug on the off chance it might help some patients. The U.S. is slipping badly in areas they used to lead the world in.

"The FDA approval came despite an expert advisory panel almost unanimously concluding there was no convincing evidence the drug worked."

The key phrase is "almost unanimously". Seems like an audit of FDA leadership relationships to the Pharma companies might be called for here.

The FDA has a well-established reputation for being too slow and bureaucratic , but that does not seem to be the issue here.

I keep reading about how bad the drug is, but my father (who was a doctor and is 83) has been on it for a month or so and claims it has really helped him. Both in memory retention and retrieval of long term memories.

$56k/yr for a treatment that hasn't been shown to work in good size trails. Yeah that is a good idea!! s

"Looks like the FDA is finally waking up to the truth that the decision to risk an experimental treatment should rest with the patient." If the patient were actually PAYING for the drug- maybe. But this an insanely expensive drug which will be paid for out of Medicare, with NO evidence it actually helps the targeted symptom (cognitive decline) and considerable side effects. Fail.

Ralf's comments are on the money. What, exactly, does FDA approval mean in the real world? The FDA's mandate is to verify drugs that are "safe and effective". Is this some sort of guarantee? If so, how come FDA approval doesn't protect the drug companies from lawsuits for injuries that occurred after various drugs are taken? Or require repayment for drugs that do not help a patient?

Donald Trump's "Right To Try" proposal was the right thing to do for folks who have no other options.