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Thu Jun 10, 2021, 08:15 PM

Three F.D.A. Advisers Resign Over Agency's Approval of Alzheimer's Drug

Source: New York Times

In a powerful statement of disagreement with the Food and Drug Administration’s approval of Biogen’s controversial Alzheimer’s drug, three scientists have resigned from the independent committee that advised the agency on the treatment.

“This might be the worst approval decision that the F.D.A. has made that I can remember,” said Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, who submitted his resignation Thursday after six years on the committee.

He said the agency’s approval of the drug, aducanumab, which is being marketed as Aduhelm, a monthly intravenous infusion that Biogen has priced at $56,000 per year, was wrong “because of so many different factors, starting from the fact that there’s no good evidence that the drug works.”

Two other members of the committee resigned earlier this week, expressing dismay at the approval of the drug despite the committee’s overwhelming rejection of it after reviewing clinical trial data in November.

Read more: https://www.msn.com/en-us/news/us/three-fda-advisers-resign-over-agencys-approval-of-alzheimers-drug/ar-AAKVatC?li=BBnb7Kz

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Reply Three F.D.A. Advisers Resign Over Agency's Approval of Alzheimer's Drug (Original post)
Yo_Mama_Been_Loggin Thursday OP
dalton99a Thursday #1
elleng Thursday #2
JohnSJ Thursday #3
hlthe2b Thursday #5
cstanleytech Friday #8
I_UndergroundPanther Thursday #4
Me. Thursday #6
Sgent Friday #9
Deminpenn Friday #10
Me. Friday #11
KS Toronado Friday #7

Response to Yo_Mama_Been_Loggin (Original post)

Thu Jun 10, 2021, 08:20 PM

1. Kick

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Response to Yo_Mama_Been_Loggin (Original post)

Thu Jun 10, 2021, 08:21 PM

2. Interesting.

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Response to Yo_Mama_Been_Loggin (Original post)

Thu Jun 10, 2021, 08:21 PM

3. It was a tough call. Families are desperate for anything, but is it false hope?

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Response to JohnSJ (Reply #3)

Thu Jun 10, 2021, 08:28 PM

5. We are sworn to "first do no harm" and giving false hope IS doing harm

This was not a defensible approval. It was a capitulation to those suffering and begging for "ANY" hope whatsoever. While I truly empathize with those demanding approval, this is NOT how we should approve drugs--especially those that will bankrupt many families and leave taxpayers paying for false promises.

Complete the needed additional trials and if evidence of efficacy and safety warrants, then by all means approve. We aren't there yet. I applaud those three who resigned in objection.

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Response to JohnSJ (Reply #3)

Fri Jun 11, 2021, 12:41 AM

8. If the science does not support the drugs claims then the answer is yes, its false hope.

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Response to Yo_Mama_Been_Loggin (Original post)

Thu Jun 10, 2021, 08:23 PM

4. Somebody is paying somebody

Money to taint the approval process.

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Response to Yo_Mama_Been_Loggin (Original post)

Thu Jun 10, 2021, 08:32 PM

6. Short Term Has Been Promising So Far

but as I understand it, it's long term that's the issue. However, some families, I saw on news report, there really is no long term for these patients. Not a doc so don't know but do understand their despair.

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Response to Me. (Reply #6)

Fri Jun 11, 2021, 01:41 AM

9. The evidience is that

it removes plaques from the brain. Unfortunately, those same patients didn't improve -- and this has been shown in multiple trials for this and other drugs. Our hypothesis that plaques were causing Az is unfortunately wrong (they are a symptom).

In addition, this drug causes brain swelling in 40% of patients, so its not benign.

The FDA isn't supposed to look at cost, but spending 60k / year + another 20-40 in MRI's for monitoring is insane.

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Response to Sgent (Reply #9)

Fri Jun 11, 2021, 06:05 AM

10. 60 Minutes had a segment on 90+ yr olds that

researchers have been following since 2014. There were several cases where the post-mortem brain autopsy and the deceased's mental capacity did not "match up". That is, one person whose brain was full of the plaques and tangles associated with Alzheimer's was sharp as a tack until his death. Another person's brain was completely absent these same markers yet he had had severe dementia that was thought to be Alzheimer's.

It's possible this drug might help some and be completely useless or counterproductive in others. Jmho, but part of the problem is the increasing tendency for general dementia to be labled as Alzheimers when that's not necessarily the case. There's still a lot of study to be done on the deterioration of brain function and its causes.

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Response to Sgent (Reply #9)

Fri Jun 11, 2021, 08:47 AM

11. INteresting

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Response to Yo_Mama_Been_Loggin (Original post)

Fri Jun 11, 2021, 12:40 AM

7. Is there some left over Qrump appointees in the decision making process in the FDA?

They're all about money and $56,000 is not small change.

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