Holly Fernandez Lynch
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hollylynchez.bsky.social
Holly Fernandez Lynch
@hollylynchez.bsky.social
Academic lawyer/bioethicist studying pharmaceutical policy, access to investigational medicines, IRB quality (www.aereo.org), and clinical research ethics and regulation, with a splash of psychedelics.
I miss the Netherlands so much. We went to Leiden for just a day and loved it. The Naturalis Museum was amazing/unhinged! My children participated in a "sperm race" and saw genitalia from across the animal kingdom lol
November 12, 2025 at 6:33 PM
I'm not Twitter any more and had been excited about Bsky at first but now I see more political content here v academic. Other colleagues suggested LinkedIn, which I've never liked given how corporate the posts are. But it does look like a fair number of academics + reporters are active there now.
November 12, 2025 at 10:37 AM
The first part is why I have stayed away from LinkedIn for so long. The corporate speak is also tough to take. But I also see a lot more researchers over there these days too. Not another place, ugh...
November 6, 2025 at 2:15 PM
When I called it a soap opera, I meant that it's one unbelievable thing after the next, often involving personal relationships and vendettas - and to highlight that it's so far from an acceptable way for any government official or agency to act. The real world consequences are devastating, no doubt.
November 4, 2025 at 8:50 PM
These ASOs would have fallen in Tidmarsh's domain but I can't imagine that will matter now...
November 4, 2025 at 1:30 AM
Reposted by Holly Fernandez Lynch
Long story, short: We found that looking at years of new drug and biologic approvals, that just over half were based on single pivotal trials and only a few explicitly or implicitly referenced confirmatory evidence supporting that single pivotal trial. (4/8)
November 3, 2025 at 6:35 PM
Obviously this is still a developing story. But the lack of judgment involved and the clear inability of key FDA leaders to function together is already damning.
November 3, 2025 at 5:50 PM
Absolutely! But are you guys letting @lizzylawrence.bsky.social eat and sleep?? (Thank you, Lizzy, and @adamfeuerstein.bsky.social for this important reporting.)
November 3, 2025 at 12:51 AM
In the NYT Tidmarsh suggests he's being retaliated against for raising concerns abt the commissioner's voucher program + otherwise clashing w/ Prasad. But the fact that a complaint was lodged about the LinkedIn post doesn't line up well with that story. Nothing about this debacle bodes well for FDA.
November 2, 2025 at 10:34 PM