On to the next one.
From my John Hopkins newsletter:
FDA Greenlights Controversial Alzheimer's Drug
From Australia: New Alzheimer’s drug ‘available to anyone who can pay for it’, but benefits are limitedBloomberg School epidemiologist Caleb Alexander recently warned that the FDA was poised to make an unfortunate decision: approving the controversial Alzheimer’s drug known as Aduhelm.
Yesterday, the FDA did just that, approving the drug despite strong warnings from independent advisers, including Alexander, who overwhelmingly concluded that there was insufficient evidence that the treatment had significant benefits for patients.
Aduhelm is the first new drug for Alzheimer’s disease in nearly 20 years—and the only drug that U.S. regulators believe can likely treat the underlying disease rather than manage symptoms like anxiety and insomnia. It is also expected to make billions for its maker, Biogen.
But it hasn’t been shown to help slow the disease, and experts are concerned that it’s been allowed to skirt regulatory standards.
“I’m quite surprised. The most compelling argument for approval was the unmet need but that cannot, or should not, trump regulatory standards,” Alexander told STAT. “It’s hard to find any scientist who thinks the data are persuasive.”
He explained his position in detail in a co-authored op-ed for the New York Times.
https://thenewdaily.com.au/life/wellbei ... 2020210620
The FDA ruling allows for anyone with an Alzheimer’s diagnosis – even one from a GP based on patient’s self-reporting – to have access to the drug. There is no requirement that the person must have proof of amyloid. The annual cost is US $56,000. Biogen's stock is soaring.Patient lobby groups pushed hard for this drug – and fair enough. The fruitless search for an effective treatment has been dispiriting for families and researchers alike.
But the celebration was tainted when three members of the FDA’s independent panel of experts resigned in protest. They said the evidence the drug slowed dementia was weak and that it shouldn’t go to market.
They also cited serious side-effects: brain swelling and brain bleeding.
Dr Aaron Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, sat on the committee for six years. He walked away, telling The New York Times: “This might be the worst approval decision that the FDA has made that I can remember.”