Biogen used an FDA back channel to win approval of its Alzheimer’s drug (opens in new tab)

And yes, it can make things worse:

"Most patients with AD (up to 75 percent) have a specific gene, called apolipoprotein E (APOE) ε4 allele; having this particular gene places a person at great risk of developing Alzheimer’s disease. Unfortunately, when AD patients with the APOE4 gene are given drugs like Aduhelm they are much more likely to develop brain edema and cerebral microhemorrhages. Indeed, in the BIOGEN trials, almost 50 percent of the APOE4 patients developed brain edema and hemorrhaging. In addition, these symptoms were accompanied by malignant hypertension and epileptic seizures."

Unfortunately, our government is not very good at things like passing laws, so likely it will be quite some time before Medicare is adjusted. Very clever exploitation of an opportunity to basically steal billions of dollars from the public. I can't even be that mad, it's such an evil genius plan. Nicely done, Biogen.

The reason is right there in what you're saying: the FDA is meant to protect people from predatory drug companies who know they are desperate to try anything to help their loved ones. If Biogen were selling homeopathic Alzheimer's cures, would you still think they should have been approved?

But I’m not so sure that decoupling the decision is so easy. Patients get very upset if insurance doesn’t cover something…

It would be better if they allowed any drugs to be sold, but just labeled them as "safe" or "effective".

I suppose in the medical field there's also a third party of snake oil supplement vendors, that don't even bother trying to measure whether or not what they are peddling actually cures anything.

"The FDA found this drug to improve quality of life Vs a placebo, p<0.005".

And if, during use of the drug, that statement becomes no longer true, withdraw use for all new patients.

Excerpts:

> Central to their mission was an inside ally: Billy Dunn, the agency’s top regulator of Alzheimer’s drugs. For the plan to succeed, Biogen needed Dunn to become a supportive partner, more than an independent and potentially adversarial regulator. It worked. The FDA played an extraordinarily proactive role, even drafting a road map on how the company could win approval. Several experts said that relationship was not typical and raised serious concerns.

> It was previously known that Biogen and the FDA worked together on Aduhelm. But STAT has learned that the relationship began earlier than previously disclosed, in the spring of 2019, when a top Biogen executive quietly met with Dunn — seemingly in violation of FDA protocols — to enlist his support for a long-shot effort to get Aduhelm approved despite the apparent failure of two clinical trials. And a month later, FDA officials proposed using a regulatory shortcut to get the drug approved — though the agency has claimed it raised that option only this past March. To some inside Biogen, the FDA’s tone made approval seem inevitable.

> By June 2019, only a month after the crucial meeting with Dunn, agency officials in his Office of Neuroscience were so willing to advance Aduhelm that they proposed as one option a regulatory shortcut called “accelerated approval,” according to meeting minutes read to STAT. The move stunned even Biogen’s top executives, who had considered that out of the question for a host of reasons, including the fact that the FDA had never used the pathway for an Alzheimer’s treatment.