Pushback against aducanumab (Aduhelm)

As reported in the New York Times today, two prominent American medical institutions, the Cleveland Clinic and the Mt. Sinai Health System in New York, have announced that they will not allow administration of aducanumab (Aduhelm) in their facilities.  Physicians in those systems may still prescribe the drug, but it would have to be administered elsewhere. This is just the latest example of pushback against what many see as the FDA’s ill-advised approval of this anti-amyloid monoclonal antibody. As I have said in previous posts, I have mixed feelings about aducanumab.  I was in the phase 3 trial and suffered severe side effects requiring ICU care, but I fully recovered.  I am not particularly concerned about the side effects because I think they can be managed safely by those experienced with the drug.  I am more concerned about the questionable efficacy.  Recall there were two identical trials.  Both showed a strong effect in removing beta-amyloid, but there was no benefit in slowing cognitive decline in one of the trials and only a borderline slowing in the other. I’m not ready to give up on aducanumab and similar anti-amyloid drugs.  There are hints that they be more effective in the earliest stages of the disease, before a lot of nerve cells have died. Ongoing clinical trials are looking at this now. I think we need to know more about how and when to best administer these drugs.

1 Response

  1. Anne says:

    It’s good to hear from a careful and balanced professional on this.