He deactivated his YouTube channel (www.youtube.com/@vprasadmdmph) when he went to the FDA, but perhaps he'll start it back up and we'll hear more about this resignation.
07.03.2026 01:13
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He deactivated his YouTube channel (www.youtube.com/@vprasadmdmph) when he went to the FDA, but perhaps he'll start it back up and we'll hear more about this resignation.
Vinay Prasad resigns from the FDA. Well, he did resign in August but was brought back in a few days, but maybe this time it's for real.
www.nytimes.com/2026/03/06/h...
Makary apparently wants his FDA reviewers to be about as thorough as the "security guard" in this meme.
The speed of the the reviews is already plenty fast due to mandated deadlines for completing the reviews. This is just going to incentivize reviewers to reduce scrutiny, potentially missing serious problems
Hey, here's a thought...
How about offering bonus payments for staffers who complete CORRECT reviews and recommend approval ONLY if the drugs are truly safe and effect?
apnews.com/article/drug... to offer bonus payments to staffers who complete speedy drug reviews
This could be extremely harmful. False positives, power issues, & rare adverse events come to mind if there is only one trial required 🤦♀️
or donate to the ballroom or T-Kennedy Center projects or etc, etc
Note there's a tiny study w N= 11 x 2 = 22 that was published with positive results. If a similarly-size study yielded negative results, something tells me that the investigators and/or journals would have been dismissed it as underpowered and not worth publishing.
Yep, an SMD of 1.8 for any antidepressant is hard to believe. Seems more like what you'd get for open-label (placebo-free) studies. I'd suspect outcome switching and/or burying other studies with less over-the-moon results.
STAT piece first-authored be @lizzylawrence.bsky.social. Perhaps she has insight into the politics.
I can’t imagine RFK Jr NOT supporting a psychedelic, so was this a defeat for him?
(Apologies if this is addressed in the full text of the article, but I lack access.)
Last summer, RFK Jr criticized the FDA for not approving MDMA-assisted psychotherapy for PTSD. Now that he's been given power over the FDA, I figured that any psychedelic would be on a glide path to approval this year. But apparently not!
It seems that decisions at the FDA can go either way based on a combination of science and politics.
www.statnews.com/2026/02/04/p...
Article: Missing data about missing tissue ⬇️
dx.plos.org/10.1371/jour...
Nice article, providing an overview of the various types of spin:
Although the article relates spin to research on acupuncture, it applies to research in general.
www.sciencedirect.com/science/arti...
This “stellar groups” has a North Star…@floriannaudet.bsky.social An honor to be helping shine some additional light!
Finally, good to see that they not only used a sham control but also tested whether blinding was successful. Apparently, it wasn't great (screenshot), raising the Q of whether that could have biased the participants and investigators, so the positive results should be taken with a grain of salt
Kudos also to the authors or reviewers for showing not only P values but also effect sizes (Cohen's d). On the primary outcome--the most important result-- they found d = 0.37. That's in the upper end of the range for second-generation antidepressants, but not worthy of hyping it as a "breakthrough"
Just saw a news item abt this article in Nature www.nature.com/articles/s41.... Glad 2 see that the authors provided (or the reviewers insisted) that the figure w the primary outcome results show the full range of scores, showing not only the treatment effect but also how much was NOT treated (lots)
Agree, there's no amount of research one could stop these rumors from spreading.
I'm reminded of a cartoon years ago: "My mind is made up. Don't confuse me with the facts!"
Who could this old colleague be? I have an idea but would rather not speculate. We should find out soon via another news piece.
More from the FDA soap opera. I don't subscribe to the (very expensive) Pink Sheet, so apologies for the teaser.
"As diff's emerged betw FDA staff & senior political leaders over its COVID-19 safety review, CBER Dir Vinay Prasad added an old colleague & critic of COVID-19 policy 2 the center."
The fact that the NEJM seems eager to publish their every utterance makes one wonder whether they're more interested in publishing good science or something that's newsworthy and good for their JIF
bsky.app/profile/etur...
The plot thickens when weighing the one (or two) positive trial(s) vs the evidence from multiple negative trials. If, in some of them, the drug is statistically inferior to a comparator, should that be ignored?
Right, there's the weird split screen going on. They seem to want to make it harder to get vaccines approved but easier to get drugs approved.
Most people have been surprised upon learning that you only need 2 positive clinical trials to get approved. Wait till they hear that now you need only one!
