HMM: F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works.
Related thoughts here: “Given the current data, I do not think that aducanumab should be approved. I don’t believe that Biogen’s clinical trials have really demonstrated efficacy against the disease, and the FDA briefing documents show that there are many people in the agency who agree with that position (see that second link above). . . . There’s another huge factor that is not officially under the purview of the FDA (not directly, anyway). And that’s the huge pent-up demand for something, anything, that can treat Alzheimer’s. That is a moral hazard, as I’ve said many times over the years, because it puts pressure on regulators to approve things just to show that they’ve approved something, and it puts pressure on companies to try to push marginal projects over that regulatory line in hopes of reaping a huge immediate windfall from millions of desperate families.”