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 ($$$!!!).)

Leucovorin devotee PI seems to have continuous difficulty w/trials. See pp.4-5 from FDA www.thetransmitter.org/wp-content/u... The technical term for enrolling subjects in a trial that FDA says you may not initiate is BAD.

This still feels strange. Drugs have always been approved on the initiative of drug companies. Here, the FDA is saying *it* initiated the approval. It's as if Makary did this to placate RFK Jr and his odd beliefs about autism. @akesselheim.bsky.social

Every single one of these clips was taken today in downtown Portland. Portland doesn’t want or need a federal takeover. If Trump insists on sending federal “resources” he can start with funding health care, bridges, affordable housing, and wildfire protection to name a few.

Portland declares ICE facility out of compliance, demands its clearance. www.portland.gov/mayor/keith-...

Secret photo shows that Portland has already established an autonomous free zone! They're going to call it the Portland Saturday Market! #WarRavagedPortland #Portland

War-ravaged Portland, 5 minutes ago

War ravaged Portland.

War-ravaged Portland

FDA news release www.fda.gov/news-events/... says: "The FDA is working with GSK, the innovator of Wellcovorin (leucovorin calcium), on a process to include the essential scientific information needed for the safe and effective use of these drug products for adults and pediatric patients with CFD."

"Ending publication bias: A values-based approach to surface null and negative results" Paper out today in PLoS Medicine by many of us who would like to see publication bias reduced or eliminated. Especially happy that Registered Reports got shout-outs. journals.plos.org/plosbiology/...

Dr. Kesselheim @akesselheim.bsky.social also noted that the study cited by the F.D.A. showed only small improvements in autism symptoms among people with certain folate levels in their spinal fluid.

Before prescribing leucovorin, doctors would first need to determine whether a patient suffered from the deficiency, Dr. Kesselheim said. How they would arrive at that diagnosis short of a risky, expensive spinal tap was not clear, he said. www.nytimes.com/2025/09/23/h...

A couple of new articles on the current FDA leadership's crackdown on Direct-to-Consumer (DTC) advertising. Excerpt: "...all three of Boehringer’s letters concern a different one of the company’s musical theater-themed Jardiance ads." I must admit those commercials are very irritating.

Now Tidmarsh is saying he "never said" he'd abandon Advisory Committee meetings. www.biospace.com/fda/fda-flip...

For #PeerReviewWeek, I just published my BlueSky posts and notes from the 10th International Peer Review Congress, held 2 weeks ago in Chicago. #PRC10 @peerreviewcongress.bsky.social Part 1 is here: scienceintegritydigest.com/2025/09/16/p...

Can't think of any but will repost. (Might there be a starter pack for child shrinks?)

Reprint of my Substack with @ylepidemiologist.bsky.social today in @statnews.com. Check it out if you’re interested in recent “moves” the FDA is making on drug ads. As with most claims this admin makes … IBIWISI: www.statnews.com/2025/09/13/p...

Another pleasant surprise! Will we truly be rid of those annoying TV ads showing people dancing in the streets? www.nytimes.com/2025/09/13/o...

Another move toward the abandonment of FDA's Advisory Committees. "The agency 'wd like to get away' from assembling panels of experts to examine and vote on individual drugs, because 'I don’t think they’re needed',” said CDER Director George Tidmarsh" www.fiercepharma.com/pharma/under...

Well, here's a pleasant surprise www.nytimes.com/2025/09/09/h...

News article: "FDA publishes more than 200 archived CRLs (Complete Response Letters) for transparency". Article doesn't provide the link, but it wasn't hard to find: open.fda.gov/apis/other/a... It's a zip file containing 203 letters, each with an application number in the title but no drug name.

If you’re zip-tying grandmas protesting losing health care maybe you’re not the good guys in the story?

This should come as good news for advocates of psychedelics being approved by the FDA. The incoming CDER Deputy Director is a former FDA-er who went to Usona, a non-profit developing psychedelics.

We're tired of the false information and wrote this letter to the NIH director Jay Bhattacharya. FACT: clinical trials have been halted. With real ethical impacts. Is this what Americans want to be known for? Let's see what the director says.

Although maybe it is now better to read the 2024 paper we wrote on this topic: www.tandfonline.com/doi/full/10.... We explain why Registered Reports are the best implementation of preregistration, summarize the surveys on p-hacking, and counter common criticisms on preregistration.

Timely article!

Considering RFK Jr’s statements that the FDA erred in not approving MDMA-assisted psychotherapy, I’ve been wondering whether /how the FDA’s attitude would change toward drug companies trying to get their products approved and marketed. Well, this story sheds light on that.

This is a really shocking attack on the independent role of medical journals.

I’m attending the annual meeting of the American Society of Clinical Psychopharmacology, which is mostly companies presenting on their drugs in the pipeline. Psychedelics and drugs derived from psychedelics are definitely “in”…

User fees, paid by pharma to the FDA, have made the FDA $ dependent on industry, setting up a conflict of interest and regulatory capture. Now FDA is considering restructuring that program. Seems like a good thing, though as they say, be careful what you wish for... www.raps.org/News-and-Art...