A Mayo Clinic neurologist resigned from the FDA's Peripheral and Central Nervous System Drugs Advisory Committee yesterday after the FDA approved an Alzheimer's drug over the panel's recommendation.
To hear the doc, David Knopman, explain it, the resignation was practically noble. "... if I ever were asked to serve on a future panel, I wouldn't have wanted to be treated in the disrespectful way that the aducanumab external advisers were treated," he said in an email to CNN. Translation: He's pissed off that the FDA overruled him.
In fact, it's rare for the FDA to ignore a recommendation. In this case, nobody knows whether the drug, to be called Aduhelm, makes any difference. It wasn't until the drug maker, Biogen, reanalyzed the drug trial results that anybody thought that giving it to patients was a good idea. Biogen now says it seems to slow down memory decline if it's given in large doses.
Biogen has priced the drug at $56,000 a year. For a drug that doesn't produce obvious results, that's a lot. It's more than half the cost of a full year in a private room in a fancy nursing home, according to a company called Genworth (https://www.genworth. com/aging-and-you /finances/cost-of-care.html).
But this is Alzheimer's, society's most expensive illness, which afflicts six million mostly elderly people in the United States alone. Nobody has come up with a new drug in 17 years. In an aging population, the need for a treatment is dire.
It's regrettable that this drug is not a treatment. You have to wonder whether money changed hands somewhere along the path to approval.
I'd say to David Knopman that there's plenty of reasons to resign over FDA's approval that have nothing to do with feeling you've been dissed.
Update: Two more advisors have since resigned.
https://www.cnn.com/2021/06/10/health/fda-adviser-resigns-alzheimers/index.html?fbclid=IwAR35nMJCCbCNJpETkYqaTHYwDvqYE6wNmk_s78nL3hUqgB2a6TvwBPSxuw0
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