Opinion: Why we may never know whether the $56,000 Alzheimer’s drug actually works

Alzheimer's, cardiovascular, and other chronic diseases; biomarkers, lifestyle, supplements, drugs, and health care.
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Fc1345linville
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Opinion: Why we may never know whether the $56,000 Alzheimer’s drug actually works

Post by Fc1345linville »

Elisabeth Rosenthal is editor of Kaiser Health News and author of "An American Sickness How Healthcare Became Big Business and How You Can Take it Back". Rosenthal received her MD from Harvard Medical School and residency at NY Hospital-Cornell Medical Center.

https://www.washingtonpost.com/opinions ... lly-works/

Fc
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Re: Opinion: Why we may never know whether the $56,000 Alzheimer’s drug actually works

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Fc1345linville wrote:Elisabeth Rosenthal is editor of Kaiser Health News and author of "An American Sickness How Healthcare Became Big Business and How You Can Take it Back". Rosenthal received her MD from Harvard Medical School and residency at NY Hospital-Cornell Medical Center.

https://www.washingtonpost.com/opinions ... lly-works/

Fc
Did you see the news today that the FDA is now limiting approved ("on-label") use of Aduhelm to those with MCI/mild AD--the two populations studied in the clinical trial? This is from the NYTimes story: In Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug
“The revision of this label is yet another piece of evidence that should cause the American public to be concerned about how F.D.A. is practicing its regulatory science,” said Dr. Jason Karlawish, a co-director of the University of Pennsylvania’s Penn Memory Center.
Dr. Jason Karlawish also happens to be an expert on the ethical need to listen to and put the needs of those at risk of AD or living with AD at the center of decisions.

Many current trials and planned trials for these same patients and those with preclinical Alzheimer's pathology (normal cognition with amyloid beta oligomers and plaques or tau) are using drugs with far less (or none of ) the 40% risk of ARIA-E (edema) and ARIA-H (micro-hemorrhages) seen in aducanumab. Just as importantly, I've seen conference presentations that show evidence from Phase II trials of much more consistent and clinically meaningful benefit. Some of those drugs (donanedab and BAN2401) are likely to go to the FDA in 2022 or 2023.

I suspect that Aduhelm may be the Kodak Brownie camera--exciting to see, but soon out-classed by rapidly improving metrics and developments.
4/4 and still an optimist!
Fc1345linville
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Re: Opinion: Why we may never know whether the $56,000 Alzheimer’s drug actually works

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The Brownie camera was introduced in 1900, opening up a new fabulous, harmless technology of photography to everyone on the planet at an affordable price, at no risk to our health, for over 100 years. Aduhelm? Let's see what the US Congress has to say after they investigate the FDA/Biogen decision.
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Re: Opinion: Why we may never know whether the $56,000 Alzheimer’s drug actually works

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Fc1345linville wrote:The Brownie camera was introduced in 1900, opening up a new fabulous, harmless technology of photography to everyone on the planet at an affordable price, at no risk to our health, for over 100 years. Aduhelm? Let's see what the US Congress has to say after they investigate the FDA/Biogen decision.
You're right--terrible example on my part!!! Especially with three generations and lots of extended family members who worked at Kodak in the good old days. I still remember the excitement of my first Brownie camera one Christmas morning.
4/4 and still an optimist!
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