The context here (since the title isn't too revealing), is that the FDA expanded approval for a drug despite essentially unanimous didagreement from the scientists actually analyzing the drug. Derek Lowe, a well-respected pharma blogger, writes about how this was a big mistake and a very bad look for the FDA.
ejang0|1 year ago
Boy, was that the truth. The agency has just granted that use expansion, and it turns out that it was all due to Peter Marks, who completely overruled three review teams and two of his highest-level staffers (all of whom said that Sarepta had not proven its case)."
[The article then talks about how this may be "A positive vote, which marks an undeserved and potentially hazardous victory of emotional rhetoric and relentless patient advocacy over the scientific and medical evidence."]
This is interesting. I didn't know about the influence of the CEO and this narrative around this medications approval/label expansion.
I'm not sure why I'm mentioning this (Devil's advocacy?), some users on HN have also commented that maybe it is good that the FDA approves medications more liberally to give clinicians and patients a chance to experiment with them (if their situations are dire).
Anyways, in this case, it is interesting to think about how much influence one person can have in the FDA.
Sort of related, does anyone remember the approval of aducanumab for Alzheimer's disease? https://www.npr.org/2021/06/11/1005567149/3-experts-have-res...
And now it is discontinued: https://www.ncbi.nlm.nih.gov/books/NBK573062/ This isn't really a good source for the full story, sorry.
All this FDA approval business is much less cut and dry than I would have thought 10 years ago.