Ep. 16 — The Abracadabra of the FDA’s Surprise Approval of Biogen’s Alzheimer’s Drug, Aduhelm / Dr. Robert Pearl, Physician, Author, Podcast Co-Host, “Fixing Healthcare,” & Joanne Silberner, Freelance Health and Science Journalist.
Jul 29, 2021•58 min•Ep 16•Transcript available on Metacast Episode description
Ever since the disease was recognized more than 100 years ago, patients with Alzheimer’s, and their families and caregivers, have longed for an effective drug for this brutal and tragic disease.
But last month, when the Food and Drug Administration finally approved a drug named Aduhelm for use as the first Alzheimer’s drug in 18 years, there was little rejoicing. Instead — a big uproar from critics both outside and inside the FDA who say that there’s no clear evidence that Aduhelm has any benefits. And, that it could actually have serious side effects including brain bleeding. And at $56,000 a year per patient and counting, they say it not only will break patients and their families but also stress Medicare — federal health care for the elderly and disabled — to the utmost.
Today, I have invited two wonderful guests to help us understand what just happened at the FDA, the implications, the fallout, and what happens next.
Dr. Robert Pearl is the former CEO of the nation’s largest medical group, Kaiser Permanente. A Forbes Health Contributor, Dr. Pearl’s latest book is titled, “Uncaring: How the Culture of Medicine Kills Doctors and Patients,” the proceeds of which go to Doctors without Borders.
Dr. Pearl also co-hosts the popular podcasts Fixing Healthcare and Coronavirus: The Truth.
Also joining me is my very dear friend and former NPR colleague, the award-winning health and science writer, Joanne Silberner. She’s currently a freelance journalist living in Seattle. Silberner has covered the FDA for decades while at US News & World Report and at NPR — where she worked for 18 years. Joanne has written a piece on how Aduhelm came to be approved — published last week in the online media outlet STAT+ — and it’s a fascinating look at how the FDA responds to pressure from drug companies and patient groups, very relevant for this story.
Read the Transcript
Download the PDF
Chitra Ragavan:
Ever since the disease was recognized more than 100 years ago, patients with Alzheimer's, and their families and caregivers have longed for an effective drug for this brutal, and tragic disease. But last month when the FDA finally approved a drug named Aduhelm, for use as the first Alzheimer's drug in 18 years, there was little rejoicing.
Chitra Ragavan:
Instead, a big uproar from critics both outside and inside the FDA, who say that there's no clear evidence that the drug has any benefits, and that it could actually have serious side effects, including brain bleeding. And at $56,000 a year per patient and counting, they say, "It not only will break patients and their families, but stress Medicare to the brink." That's the federal health care for the elderly and disabled.
Chitra Ragavan:
Hello, everyone. I'm Chitra Ragavan, and this is Techtopia. Today I've invited two wonderful guests to help us understand what just happened at the FDA, the implications, the fallout, and what happens next. Dr. Robert Pearl is the former CEO of the nation's largest Medical Group, Kaiser Permanente.
Chitra Ragavan:
His latest book is called, Uncaring: How the Culture of Medicine Kills Doctors and Patient, the proceeds of the book go to Doctors Without Borders. Dr. Pearl also co-hosts with Jeremy Corr, who happens to be my wonderful executive producer, the popular podcasts, Fixing Healthcare and Coronavirus, The truth.
Chitra Ragavan:
Also joining me is my very dear friend and former colleague, the award winning health and science writer, Joanne Silberner, she is currently a freelance journalist living in Seattle. Silberner has covered the FDA for decades while at the US News and World Report, and an NPR where she worked for 18 years.
Chitra Ragavan:
Joanne has written a piece on how Aduhelm came to be approved, published today in the online media outlet, STAT+, and it's a fascinating look at how the FDA responds to pressure from drug companies and patient groups, very relevant for this story. Dr.
