There’s a big FDA decision coming up in the next few days: whether or not to approve the Biogen antibody for Alzheimer’s (aducanumab). I’ve had several people ask me what I think about this, and I can only refer them to what I said in 2019 and what I said late last year as well. 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). The agency is supposed to consider efficacy and safety, and on this basis alone I think aducanumab comes up short.
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. I don’t mind using the word “tragedy” for that outcome. That’s what it would be: a massive waste of money based on false hopes. Neither expenses nor hopes are on the FDA’s official list of issues to consider, but believe me, they’re real.
As always, I do not envy the FDA’s job here. They will face incandescent rage no matter which way they come down on this issue. But since that’s the case, why not face it for the right reasons? Reject aducanumab. Tell Biogen to go back and run a better clinical trial if they think it really works – they could have been doing that already, you know. Because as it stands now, there is not a convincing case that it will help anyone with Alzheimer’s disease.