OK, so long as 1, the drug and related costs are covered by the pharma (otherwise fraudsters would enter drug candidates into eternal clinical trials that never end in order to keep milking revenue from compassionate use patients while waiting for the results), 2, it doesn't interfere with recruiting for other clinical trials for the disease.

The drug did not show promise. It did what other failed drugs in the same class did: it dereased amyloid without showing that decreasing amyloid ameliorates the course of the disease. I mean, are you saying the FDA should go back and approve all of the other failed amyloid based Alzheimers drugs too? They can probably find some with a better safety profile. Along with the moral hazard, this decision also makes it harder to develop real Alzheimer's drugs in the future. So no, the FDA got it dead wrong.

It would have been a reasonable assumption except for the many, many other trials of other failed drugs that decreased amyloid plaques without providing any other significant benefit.

People being allowed to make their own decisions on what substances they put into their own bodies is one question. Companies being allowed to sell those substances for the for a profit is a second question. And the third question: Should Medicare be on the hook for $56k per year plus another ~$10k per year in imaging and other related costs?

Actually I think there's a good chance straight corruption wasn't the deciding factor. Politicians deciding which way to go on this decision would look to the incredible amount of anger and disappointment that would be focused on them for rejecting the drug. And patient advocacy groups (funded by pharmas, natch) have weaponized that anger and disappointment. Self interest means kicking the can down the road so that someone else has to deal with it. A few were probably hoping that the damage will be short lived: a better drug will get approved in a year or three, and then it will be safe (for them) to revoke the approval for aduhelm.

Conditional approvals by design require a "phase IV" trial. But considering the non-trivial safety risks and cheesy efficacy data for this drug, Biogen should not get the liability protections that usually come with FDA approval. If they sell it and it is subsequently proven not to work, they should be fully responsible for refunds and damage caused.

And reactions like yours to anecdotal evidence are exactly why the FDA needs to stand strong and keep to the science even when there is immense pressure for them to approve a drug. If they don't, it just becomes a stream of charlatans hoping to manipulate their data enough to get conditional approvals and the chance to sell their still unproven drug for a few years.

Actually, over 3.5B per year from the NIH alone. And Pharmas (Especially Eli Lilly) has been throwing billion after billion into the black hole that is Alzheimer's drug development.

You're assuming the FDA has a sort of continuity between those decisions made in the past and the decision announced today, similar to an individual person. But really the committees (and their approvals) have been getting cheesier and cheesier over the past 7-8 years.

Sometimes the compassionate use model works. But for rare diseases, that can shut down recruitment of patients for trials of other drugs that might prove to be much better.

If the FDA approves the drug insurance companies will be expected to pay for it (Expected cost: $56k per year). You're welcome to take as many expensive placebos which may cause your brain to swell and bleed as you want. What you aren't (or at least shouldn't) be able to do is market those placebos as effective treatments with the FDA's blessing.

In this case the side effects are dangerous, the benefits (if any) were minor, and approving this drug complicates development of future Alzheimer's drugs. The ethical answer is to run another phase III trial - not to approve the drug.

But the side effects (brain bleeds and inflammation) aren't minor, and neither is the moral hazard. Also, this will complicate and delay approval of future Alzheimer's drugs.

"tort reform" usually refers to laws protecting corporations from class action lawsuits, but what we really need is parity between the class and their lawyers when it comes to the judgement. The lawyers need to be tied so closely to their clients that if you cut the clients, the lawyers bleed:

Parity in kind. If the class gets paid in coupons, so do their lawyers. If they would prefer cash, the lawyers are free to sell their coupons on the open market.

Parity in time. The lawyers get paid when the class gets paid, not before. If the judgement creates a trust fund to pay out medical claims over decades, the lawyers get paid incrementally over decades too.

Parity in amount. There are generally guidelines on this, but costs for deciding which members of the class get paid how much and then disbursing it should come out of the lawyers' share, not the class's share.

You are talking about edge cases. The vast majority of boomers that haven't retired can't afford to, and most companies are much more likely to lay off people in their 50's than allow them to keep their job until retirement age (66-67 for Boomers).