On June 7th, 2021 FDA approved the amyloid beta-directed antibody aducanumab (Aduhelm) for the Treatment of Alzheimers. This approval of aducanumab was not without controversy.   Actually, let me restate that.  The approval of aducanumab was a hot mess, inside a dumpster fire, inside a train wreck. 

After the approval, three members of the FDA advisory panel, which unanimously was not in favor of the approval of aduhelm, quit.  One of them, Aaron Kesselheim (who we have on our podcast today) described it as “the worst drug approval decision in recent U.S. history" in his resignation letter. Then the FDA had to revise the label one month after publishing it because the original didn't even come close to looking like the population in which treatment was initiated in clinical trials.  Then, wait for it, after a firestorm of criticism the FDA’s commissioner had to ask for an independent investigation to look into the interactions between Biogen representatives and FDA members.  And now CMS is deciding if and how to cover Aduhelm, a drug that will cost at least $56,000 a year per patient not incluiding the doctor’s visits, amyloid PET scans, and frequent MRIs that will be necessary to monitor for side effects.

On today's podcast we talk all about aducanumab with Aaron Kesselheim, Professor of Medicine at Harvard Medical School and previous member of that now famous FDA advisory committee, as well as Jason Karlawish, Professor of medicine, medical ethics and health policy, and neurology at the University of Pennsylvania Perelman School of Medicine.

I’d love to point you to the journal articles for the two phase III trials on aducanumab, but as of yet, they are unpublished (this should tell you a little about the faith Biogen has on its drug data), so I’ll leave you with these resources instead:

• Our podcast with Gil Rabinovici on “All things Amyloid, including Aducanumab and Amyloid PET scans”
• AGS’s preliminary advice on prescribing Aducanumab - 
• Jason Karlawish’s book, The Problem of Alzheimer's, and the previous podcast that we did on it 
• FDA’s document dump on Aduhelm 
• Biogen’s open letter to the Alzheimer’s disease community complaining about the “turn outside the boundaries of legitimate scientific deliberation” that has occurred with aduhelm (while ignoring the fact that the trials have not been published yet).
• CMS’s request for public comment for their National Coverage Determination analysis to determine whether Medicare should cover the drug and any other monoclonal antibodies directed at amyloid

The last one is particularly important as whether you are for or against the coverage of aducanumab, your voice matters. There is a letter being circulated by physicians who care for people with Alzheimer's Disease urging CMS not to cover aducanumab given the limited clinical evidence for benefit, known harms, and exorbitant cost. You can find the letter here.  If you would like to sign the letter, you can add your name by clicking this link.