The New Alzheimer's Drug And Why So Many Doctors Are Furious About It
We're all desperate for a breakthrough. But this doesn't look like one.
You have probably seen news reports about the controversial new Alzheimer's treatment that the FDA approved this month. But if you don't follow health care closely, or maybe even if you do, you may be wondering why so many scientists are making such a fuss.
I explain why they are so worried — and why that should have us rethinking how the U.S. manages prescription drugs — in this article for HuffPost:
(It actually appeared two weeks ago; I’m just delinquent in sending it around.)
Nobody denies that we need a treatment for Alzheimer's. It's an unspeakably cruel disease, as too many of us know personally, with no good drugs available.
Enter Aduhelm, the new Biogen product that reduces protein accumulations, or "plaques," inside the brains of Alzheimer's patients.
Sounds great, except that drug makers have tried this before without success and the trials for Aduhelm were so discouraging that Biogen halted the experiments partway through. Now the FDA has approved it anyway, on the theory that the plaque reduction is likely to slow mental decline. A loud chorus of scientists think the FDA has no reason for such confidence and no business approving the drug without further study.
It's hard to convey how big a deal this is. Biogen says it will charge $56,000 for a year of treatment. Given how many Americans have Alzheimer's and how many of them are on Medicare, costs for the federal government could reach a mind-boggling $100 billion a year, siphoning dollars that otherwise could finance home care aides and other services that Alzheimer's patients and their families need. Of course, some costs will fall directly on individuals in the form of out-of-pocket costs or higher premiums.
It would be one thing to pay this price if we knew Aduhelm significantly slowed disease progression — or if its approval made the development of better treatments more likely in the future. But the FDA's decision could easily have the opposite effect, steering pharmaceutical research efforts away from more promising approaches.
Yes, we could end up with more suffering, not less.
All of this comes at a pivotal political moment, amid a debate over whether to pass legislation that would give the federal government power over drug prices. With Aduhelm, the case for such legislation feels even stronger. The same goes for proposals to reform the FDA, although before that happens the Biden administration might want to give the agency something it currently lacks: a permanent director.
Stay tuned for more on that subject…