TLDR: Strength of evidence for efficacy of gepirone ER for major depressive disorder... Based on published clinical trials: B/B+ Based on clinical trial data in FDA reviews: D+

Trying out AI to see what it says about the subject of our recent @jamapsychiatry.com paper, gepirone ER. I asked OpenEvidence to give it a grade for the level of evidence. Its initial response ⬇️

Reason to hope for a more transparent FDA: "A proposed rule planned for October would end the “longstanding presumption” that an unapproved application’s existence is confidential, enabling proactive disclosure of complete response letters, the agency’s unified agenda states." Fingers crossed!🤞

What we heard this week ⬇️👀 #MedSky "I said, 'Wait a minute. Isn't this the same drug?'" -- @eturnermd1.bsky.social, of @ohsunews.bsky.social, discussing the FDA's approval of a depression drug that had more negative than positive studies. www.medpagetoday.com/publichealth...

Happy to report that a paper of ours is out today in JAMA Psychiatry. Many thanks to co-authors @akesselheim.bsky.social, John Powers, and Rosa Ahn-Horst. The FDA’s job is to approve “effective” drugs, but what does that mean exactly? pubmed.ncbi.nlm.nih.gov/42340691/

Recently published study on reporting bias, led by @vipsmdmed.bsky.social. I might be missing something, but I'm surprised that a couple of these high-impact journals were publishing negative studies at rates of ~50%, higher than I would have expected. pmc.ncbi.nlm.nih.gov/articles/PMC...

Nick @ndevito1.bsky.social, a question for you. In ur 2020 Lancet pub www.thelancet.com/journals/lan..., ~41% of trials had reported results w/in the 1-yr deadline. OTOH ur TrialsTracker fdaaa.trialstracker.net shows a % reported = 79%. Have things improved that much or R the methods different?

"These findings suggest that longstanding concerns regarding publication bias in CAM publishing have not diminished over time and appear to have intensified..." Reports of positive outcomes have ~doubled, while reports of negative findings remain ~nonexistent. pubmed.ncbi.nlm.nih.gov/42249414/

Reminds me of thus old Far Side cartoon.

The latest episode of the FDA soap opera... F.D.A. Commissioner Marty Makary Resigns After Weeks of Pressure www.nytimes.com/2026/05/12/u...

This article's title says it all ⬇️ www.theguardian.com/us-news/2026...

The FDA has announced a new initiative. Given the FDA's history, the cynic in me suspects that this idea of "real-time clinical trials" is designed to lower the bar for industry (again). (cont'd) www.fda.gov/news-events/...

More evidence of the pervasiveness of publication bias. Article: "Publication Bias in Coronary Artery Disease Clinical Trials: A Bibliometric Review" pubmed.ncbi.nlm.nih.gov/41999643/ "The publication rate for positive studies was 92%, whereas for negative studies it was 50% (P<0.001)."

Psychedelic drug policy via podcaster influence. @garyschw.bsky.social, quoting @statnews.com: "Rogan said he texted Trump about research around ibogaine, and the president’s response was quick: 'Sounds great. Do you want FDA approval? Let’s do it.'" garyschwitzer.substack.com?utm_campaign...

Hopefully we'll C some teeth following this overly gentle "reminder". This FDA bulletin www.fda.gov/news-events/... mentions a Mar 30 message to trial sponsors intended to "provide...the opportunity to comply", hinting at poss "further regulatory action". Nice, but the FDA need not B so obsequious.

This guy picked up nearly $4000 worth of "goodies" at a dermatology conference. Multiply that by thousands of conference attendees. Yet only a fraction of what these companies spend on marketing. Just witness the plethora of ads for very expen$I've derm drugs on TV www.tiktok.com/@dr.michaelp...

F.D.A. Pushes Drug Developers to Report Clinical Trial Results www.nytimes.com/2026/04/13/w...

BMJ Open article: "Substantial undisclosed financial COIs were identified among the top 10 earners in high-impact psychiatry journals." bmjopen.bmj.com/content/15/1...

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.

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 🤦‍♀️

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.)

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!

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)

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."

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!

Story now updated w/ the answer: "Three sources close to Pazdur told STAT that concerns about the legality of a new drug review program, Makary and Prasad inserting themselves into drug review decisions, and Makary’s efforts to handpick hires for CDER contributed to Pazdur’s decision to leave."

The latest episode of the FDA soap opera ⬇️ Convenient summary of the preceding episodes along the right side. 🙄

Proud to have been a member of @floriannaudet.bsky.social's team. Great to see this out!

this is mesmerizing

Maybe I should start numbering these soap opera "episodes". Pazdur JUST turned down the offer to be CDER Director. Now he accepts. Negotiating tactic?

Today's episode of the FDA soap opera. First, Tidmarsh leaves, then Pazdur and Thanh Hai say no thanks to the "opportunity" to be CDER Director, and now they're asking for "anyone interested" to apply. 🙄 @akesselheim.bsky.social

I like what the authors have done here...apply EBM principles to a specific drug class. This brings it to the attention of specialty physicians whose radar screens don't normally cover 'meta' topics like EBM. pubmed.ncbi.nlm.nih.gov/41198383/

Latest episode of the FDA soap opera www.nytimes.com/2025/11/02/h...

New JAMA Psychiatry report on clinical trial of ketamine vs midazolam (aka. Versed, a short-acting benzo mainly used as an anesthetic). No difference in efficacy found. High rates of AEs in both gps. @floriannaudet.bsky.social @chrisaikenmd.bsky.social watermark02.silverchair.com/jamapsychiat...

Positions available to work with @akesselheim.bsky.social and his colleagues at PORTAL. Fellowship positions in Pharmaceutical Law and Policy Research. Physician Fellowship: form.jotform.com/252916841579... Postdoctoral Fellowship: form.jotform.com/252916475545...

Wow! ⬇️ via @retractionwatch.com retractionwatch.com/2025/10/16/c...

I remember reading that FDA Advisory Committee meetings were in jeopardy but didn't realize they were on their deathbed. (Screenshot from the Pink Sheet. I can't share the article b/c I don't subscribe ($$$!!!).)