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 Administrations approval of Biogens controversial Alzheimers 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 Womens Hospital, who submitted his resignation Thursday after six years on the committee.
He said the agencys 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 theres 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 committees 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
dalton99a
(81,091 posts)elleng
(130,156 posts)JohnSJ
(91,968 posts)hlthe2b
(101,730 posts)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.
cstanleytech
(26,087 posts)I_UndergroundPanther
(12,452 posts)Money to taint the approval process.
Me.
(35,454 posts)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.
Sgent
(5,857 posts)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.
Deminpenn
(15,246 posts)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.
KS Toronado
(16,918 posts)They're all about money and $56,000 is not small change.
ck4829
(34,981 posts)Last edited Tue Jun 29, 2021, 12:12 PM - Edit history (1)
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