By B.N. Frank
The controversy continues to increase regarding the FDA’s approval and the manufacturer’s aggressive marketing of a new Alzheimer’s drug that
- May not be effective
- Would cost Americans and Medicare big bucks
From Ars Technica:
Maker of dubious $56K Alzheimer’s drug offers cognitive test no one can pass
After facing intense criticism, Biogen goes on defense, blames “misinformation.”
Do you ever forget things, like a doctor’s appointment or a lunch date? Do you sometimes struggle to think of the right word for something common? Do you ever feel more anxious or irritable than you typically do? Do you ever feel overwhelmed when trying to make a decision?
If you answered “no, never” to all of those questions, there’s a possibility that you may not actually be human. Nevertheless, you should still talk to a doctor about additional cognitive screenings to check if you have Alzheimer’s disease. At least, that’s the takeaway from a six-question quiz provided, in part, by Biogen, the maker of an unproven, $56,000 Alzheimer’s drug.
The six questions include the four above, plus questions about whether you ever lose your train of thought or ever get lost on your way to or around a familiar place. The questions not only bring up common issues that perfectly healthy people might face from time to time, but the answers any quiz-taker provides are also completely irrelevant. No matter how you answer—even if you say you never experience any of those issues—the quiz will always prompt you to talk with your doctor about cognitive screening. The results page even uses your zip code to provide a link to find an Alzheimer’s specialist near you.
Biogen says the quiz website is part of a “disease awareness educational program.” But it appears to be part of an aggressive strategy to sell the company’s new Alzheimer’s drug, Aduhelm, which has an intensely controversial history, to say the least.
The drug flunked out of two identical Phase III clinical trials in 2019 before Biogen submitted it to the Food and Drug Administration for approval. FDA statisticians firmly panned the drug, saying the post hoc trial data did not indicate that it’s effective against Alzheimer’s. A panel of expert advisors for the FDA overwhelmingly voted against approval. Still, the FDA approved it on June 7 and, shortly after, Biogen announced the drug’s list price of $56,000 for a year’s supply.
Medical experts and industry watchers immediately rebuked the approval and the price. Three FDA advisors resigned in protest. A watchdog group called for FDA officials to resign or face firing. Lawmakers opened a Congressional investigation into Biogen’s relationship with the FDA prior to the approval. The acting FDA commissioner likewise called for an independent investigation into the approval. Several hospital systems say they won’t administer Aduhelm, and several health insurance companies say they won’t cover it.
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