Aducanumab (Aduhelm) for the Treatment of Alzheimers: A Podcast with Aaron Kesselheim and Jason Karlawish
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. \xa0 Actually, let me restate that.\xa0 The approval of aducanumab was a hot mess, inside a dumpster fire, inside a train wreck.\xa0
After the approval, three members of the FDA advisory panel, which unanimously was not in favor of the approval of aduhelm, quit.\xa0 One of them, Aaron Kesselheim (who we have on our podcast today) described it as \u201cthe 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.\xa0 Then, wait for it, after a firestorm of criticism the FDA\u2019s commissioner had to ask for an independent investigation to look into the interactions between Biogen representatives and FDA members.\xa0 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\u2019s 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I\u2019d love to point you to the journal articles for the two phase III trials on aducanumab, but as of yet, they are unpublished (this should tell you a little about the faith Biogen has on its drug data), so I\u2019ll leave you with these resources instead:
- Our podcast with Gil Rabinovici on \u201cAll things Amyloid, including Aducanumab and Amyloid PET scans\u201d
- AGS\u2019s preliminary advice on prescribing Aducanumab -\xa0
- Jason Karlawish\u2019s book, The Problem of Alzheimer's, and the previous podcast that we did on it\xa0
- FDA\u2019s document dump on Aduhelm\xa0
- Biogen\u2019s open letter to the Alzheimer\u2019s disease community complaining about the
\u201cturn outside the boundaries of legitimate scientific deliberation\u201d that has occurred with aduhelm (while ignoring the fact that the trials have not been published yet). - CMS\u2019s 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.\xa0 If you would like to sign the letter, you can add your name by clicking this link.
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