Aducanumab (Aduhelm) for the Treatment of Alzheimers: A Podcast with Aaron Kesselheim and Jason Karlawish

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What is Aducanumab (Aduhelm) and why is it controversial?

Jason Karlawish 0:01

The JerryPow podcast is brought to you by Artstone Foundation, improving the health and well-being of older Californians and their caregivers.

Eric Widera 0:10

Welcome to the JerryPow Podcast. This is Eric Quadera. This is Alex Smith. And Alex, I am very excited today. We're gonna be talking about Aju Canab or Aju Helm with two national experts on the subject. Who do we have with us today, Alex?

Alex Smith 0:24

Just to be clear, Eric's been talking about AduCanomab on every single podcast we've reported recorded since it was approved. We're delighted to welcome today Aaron Kesselheim, who is an internist, who is a professor at Harvard Medical School, who is a lawyer, who runs a program on uh the intersection of law and regulation for clinical therapeutics. He was also on the FDA advisory committee that uh recommended against approval of AGICANMAB and then resigned six weeks ago and says he hasn't heard the end of it since then. Welcome to the JerryPow podcast, Aaron.

Aaron Kesselheim 0:59

Thank you both. It is a uh it is a pleasure to be here and to talk about these issues.

Alex Smith 1:04

And we're delighted to welcome back Jason Carlowish, who is a physician and writer. We had him on our podcast about his uh book on the history and the of uh of Alzheimer's disease. He's a professor at the University of Pennsylvania School of Medicine and is co-director of the Penn Memory Center and is a self-described reluctant prescriber of ADCANMAP. Welcome to the Jerry, welcome back to the Jerry Pell podcast. Yes, Jason.

Jason Karlawish 1:30

It's great to be back, Alex and Eric. Sorry I had to be under these circumstances.

Eric Widera 1:34

Well we'll we'll have a link to our past podcast with Jason and to his book on the show notes. Um and we also did a podcast with Gil Rabinovich on amyloid PET scans and Aju Canab. Um so we're gonna dive into Ajucanimab in full today, but before we do, Aaron, do you have a song request for Alex?

Aaron Kesselheim 1:56

I do as an homage to where I grew up in New Jersey and it turns out where Jason also grew up uh in New Jersey. Jason I'm from Cherry Hill, New Jersey. Where are you from?

Jason Karlawish 2:05

Oh wow. I'm a little more north, Ramsey, New Jersey, Bergen County, a little more north on the Garden State Parkway.

Aaron Kesselheim 2:10

All right. Well, uh so somewhere in between us uh was uh where Bruce Springsteen is from and so we're requesting uh Born to Run.

Alex Smith 2:18

All right, great choice. I love I love the boss. Uh I slowed this down and I don't have a full band, so it's my acoustic version.

Unknown 2:26

In the day we sweated out on the streets of a runaway American dream. At night we ride through the mansions of glory and suicide machines. Sprung from cages on highway, nine chrome wheel, fuel injected and stepping out over the line. Whoa baby this town rips the bones from your back It's a death trap It's a suicide rap We gotta get out while we're young Cause tramps like us, maybe we were born

Eric Widera 3:09

around. Excellent job. Have you guys been to a concert by Bruce? I heard they're amazing.

Aaron Kesselheim 3:19

A lot, for sure.

Eric Widera 3:20

Yeah, you you kinda have to as a New Jersey in, right? That's right.

Alex Smith 3:23

I mean, I saw him like three years ago. He was still stage diving. Successful aging. Hey Eric, did we mention that we're now sponsored by Biogen?

Unknown 3:39

You know, you're probably the last of of of their efforts to throw some coin around to try and dump this business model.

Eric Widera 3:47

Well, let's dive into this topic. Let's kind of think about it broad. I'm gonna assume some of our listeners have not even heard of Alju Canamab or Aljuhelm. Um Jason, what the heck is it and why should we care?

Jason Karlawish 4:06

AGANIMAB is a drug manufactured to use the uh an antibody to target amyloid in the brain of a human. The theory is that if you can remove uh amyloid, particularly uh oligomers, seems to be the target that that drug particularly seemed to target. uh that that would um uh affect one of the underlying pathologies that's well associated with Alzheimer's disease dementia, namely elevated amyloid the presence of uh amyloid plaques along with of course tangles of tau protein. It's one of a number of therapies of a similar A b uh thi uh model um that's been tested in humans. And this particular drug uh made it all the way to phase three.

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Chapters

8 chapters

1 What is Aducanumab (Aduhelm) and why is it controversial? 0:01–5:44 2 How does Aducanumab work and what did the phase‑III trials show? 5:44–11:40 3 Why did the FDA advisory committee vote against approval and what changed? 11:40–17:21 4 What are the safety concerns and side‑effects associated with Aducanumab? 17:21–22:34 5 How is Aducanumab priced and why is the cost a major issue for patients and Medicare? 22:34–28:16 6 What is CMS’s role in determining coverage for Aducanumab and what criteria might be used? 28:16–33:45 7 How are memory centers and clinicians handling the drug’s availability and patient care? 33:45–39:44 8 What are the key take‑aways and future actions suggested by the experts? 39:44–44:21

Speakers

3 identified

Jason Karlawish 16 min Eric Widera 6 min Alex Smith 3 min

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Topics in this episode

Alzheimer's disease 1 Alex Smith 1 Eric Quadera 1 Biogen 1 JerryPow podcast 1 Artstone Foundation 1 Janet Woodcock 1 Aaron Kesselheim 2 Jason Karlowish 2 Alfred Sandrock 1

Source

Recorded29 Jul 2021

Publisherrss.libsyn.com ↗

Transcriptspeaker-named · 100+ languages

Handlerec:20524683

Show notes

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.

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