#aduhelm — Public Fediverse posts
Live and recent posts from across the Fediverse tagged #aduhelm, aggregated by home.social.
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@Lupposofi A couple of years ago, I coauthored a paper trying to measure the applicability of the #aducanumab (#Aduhelm)'s results applied to the real world practice of a #geriatric outpatient clinic (with special focus on older persons with #cognitive impairment). Less than 1% of patients were potentially eligible. And this on the top of the unclear/arguable effects...
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Smart medical folks I know said 3 years ago that the #FDA's conditional approval of #Aduhelm, an expensive drug of dubious value for #Alzheimers, was a mistake. They were right. https://www.nbcnews.com/health/health-news/biogen-stop-alzheimers-drug-aduhelm-rcna136619
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An expected news from Alzheimer therapies, https://www.alzforum.org/news/community-news/adieu-aduhelm-biogen-stops-marketing-antibody
A bit nostalgic, though, because I was one of the few whose cognition improved (relatively, i.e. compared to the control-group) during the years I got the antibody 10 mg / kg, enough for Biogen to apply for license.
It was a marvellous box-seat to observe pharmaceutical research with all it's intricacies, and live neurological expertise within an arm's reach was invaluable.
Here is the history of aducanumab, rest in pieces, https://www.alzforum.org/therapeutics/aduhelm
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Biogen dumps dubious Alzheimer’s drug after profit-killing FDA scandal - Enlarge / The exterior of the headquarters of biotechnology company Bio... - https://arstechnica.com/?p=2000435 #clinicaltrial #aducanumab #alzheimers #science #aduhelm #health #biogen #fda
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Four senior #FDA leaders forged close ties with #Biogen ahead of #Aduhelm's approval. Now they've all left FDA. Three of those four senior officials, who managed and worked closely with the clinical and biostats reviewers assigned to the Aduhelm application, have now ended up working at drugmakers
https://endpts.com/four-senior-fda-leaders-forged-close-ties-with-biogen-ahead-of-aduhelms-approval-now-theyve-all-left-fda/ #revolvingdoor #quidproquo -
"The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documents showed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found."
#Aduhelm #MonoclonalAntibody #Alzheimer #AlzheimersDisease #Aducanumab
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#Aduhelm never should have been approved by the #FDA. This was a blatant case of #RegulatoryCapture. Of course #Biogen's credibility was damaged; they DESERVED for their credibility to be damaged.
#alzheimers #MediFedi #MedMastodon
(Free link, no paywall)
https://www.washingtonpost.com/science/2022/12/29/alzheimers-fda-biogen-aduhelm/?pwapi_token=eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWJpZCI6IjI5Nzk3NjciLCJyZWFzb24iOiJnaWZ0IiwibmJmIjoxNjcyMzQzMzcxLCJpc3MiOiJzdWJzY3JpcHRpb25zIiwiZXhwIjoxNjczNTUyOTcxLCJpYXQiOjE2NzIzNDMzNzEsImp0aSI6ImY0MmNhN2ZiLTA0NTQtNGYzMC1iNTg4LTYwMzMwN2Y4N2JkZiIsInVybCI6Imh0dHBzOi8vd3d3Lndhc2hpbmd0b25wb3N0LmNvbS9zY2llbmNlLzIwMjIvMTIvMjkvYWx6aGVpbWVycy1mZGEtYmlvZ2VuLWFkdWhlbG0vIn0.J6PDbNGZIotZYPlvsEcggNUmZSXrq3BK7YB9tZYJyNM&itid=gfta -
That said, the positive assessment of @jasonkarlawish was also striking. Karlawish is not an uncritical supporter of pharma: he was strongly critical of the FDA's decision to approve #aduhelm, and said that #lecanemab's should be carefully regulated because of safety concerns. Nonetheless, he concluded that “The biomarker transformation of Alzheimer’s disease began Tuesday the 29th of November in San Francisco.... It was a historic moment.”
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Dubious $56,000 Alzheimer’s drug spurs largest Medicare price hike ever - Enlarge / Biogen Inc. headquarters in Cambridge, Massachusetts. Biogen ... - https://arstechnica.com/?p=1813120 #alzheimersdisease #healthinsurance #healthcare #coverage #medicare #premiums #science #aduhelm #biogen #cms #fda
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Ever forget stuff? You may have Alzheimer’s, says maker of $56K Alzheimer’s drug - Enlarge / The exterior of the headquarters of biotechnology company Biogen in Cam... - https://arstechnica.com/?p=1782649 #mildcognitiveimpairment #alzheimers #science #aduhelm #biogen #fda
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How an Unproven Alzheimer’s Drug Got Approved - Though some of its own senior officials said there was little evidence of benefit for pat... - https://www.nytimes.com/2021/07/19/health/alzheimers-drug-aduhelm-fda.html #regulationandderegulationofindustry #labelingandlabels(product) #foodanddrugadministration #drugs(pharmaceuticals) #scienceandtechnology #your-feed-healthcare #alzheimersdisease #your-feed-science #clinicaltrials #aduhelm(drug) #biogeninc #research #elderly #brain
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Amid firestorm of criticism, FDA narrows use of $56,000 Alzheimer’s drug - Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (... - https://arstechnica.com/?p=1779094 #drugapproval #alzheimers #science #aduhelm #biogen #fda
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Despite unproven efficacy, #Alzheimer's drug set to cost $56,000/year per patient Flushed face Current trends in medicine lean to #biologics: it's profits & patents as tantalizing as it is frighteningly expensive.
#Aduhelm #Medicine #BigPharma #Pharma #news -
FDA officials asked to step down after contentious Alzheimer’s drug approval - Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (... - https://arstechnica.com/?p=1774338 #alzheimersdrug #publiccitizen #drugapproval #aducanumab #science #aduhelm #biogen #fda
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A “disgraceful decision:” Researchers blast FDA for approving Alzheimer’s drug - Enlarge (credit: Getty | Congressional Quarterly)
The US Food and Drug Administ... - https://arstechnica.com/?p=1771616 #alzheimersdrug #clinicaltrials #drugapproval #science #aduhelm #fda