Discover and read the best of Twitter Threads about #aduhelm

Most recents (3)

So, what does the @US_FDA approval of #Aduhelm, the closure of #needleexchanges in Scott County, IN, all of West Virginia and the opposition to #masking/#vaccine requirements by some governors have in common? 1/
Well, first I work on all these issues, FDA, HIV/opioids, COVID19. I am clearly on the wrong team on all these issues, always on the losing side. 😩 2/
But there is something that does tie it all together. It's about private interests elevated over the public good. Industry's profits, politicians' careers matter more than the public health. 3/
Read 8 tweets
This is the moment @ScottGottliebMD jumped the shark for me. No one thinks this drug works and has serious toxicities; @US_FDA statisticians, the agency’s advisory committee, @icer_review, insurers, health systems. This is deregulation plain and simple. 1/
The market will adjudicate here? OMFG. What is this Yelp? Are we waiting for our one star review and the “my dad didn’t get better, had a brain bleed and we paid $10K out of pocket for this shit” moment? 2/
We do clinical trials for a reason, to keep from fooling ourselves. The market has no such power and pre-Kefauver, the market was full of drugs that didn’t work. The DESI studies showed that. 3/
Read 11 tweets
Účinná léčba Alzheimerovy choroby je Svatý grál.
7. června schválila Americká FDA lék #Aduhelm (aducanumab) - první lék na toto onemocnění po 17 letech.
Pojďme se podívat trochu blíž celé této situaci, která bude přepisovat nejen učebnice, ale možná i regulační přístupy.
⚠️FDA tento lék schválila, čímž ignorovala názor své vlastní komise, která hlasovala 10:0 PROTI SCHVÁLENÍ (1 se zdržel).
⚠️Následně již 3. člen této expertní komise rezignoval.
cnbc.com/2021/06/10/thi…
⚠️Léčba #aducanumabem bude stát přibližně 56 000$ (1,17 mil. Kč)
⚠️FDA dala výrobci bianco šek na jakoukoliv léčbu Alzheimera - indikační omezení jsou poměrně široká
⚠️Za to musí výrobce provést postautorizační studii, jejíž výsledky mají být známé do 2030
accessdata.fda.gov/drugsatfda_doc…
Read 27 tweets

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