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...

Detailed breakdown of the DOJ’s questions and the misunderstandings they reveal in this thread:

Meanwhile, DOJ lawyers are threatening medical journals for not providing adequate "viewpoint diversity" and for misinforming their readership, which I suppose means not publishing enough of the stupid shit that RFK Jr., JB, etc. keep saying. This is an outrageous First Amendment violation.

It was entirely clear this is what they were doing. They say it's about immigrants but nothing would stop them from using this on citizens. It's a clear violation of the privacy act. They're combining databases from DHS, HHS, SSA, and IRS to surveil everyone. www.wired.com/story/doge-c...

Google, X and Facebook Are Modern-Day Tobacco Companies Just as tobacco companies knew they were poisoning people, today’s social media titans knowingly poison our politics, peddling lies and stoking angry divides for profit. www.scientificamerican.com/article/goog...

Noticeably silent amid the upheaval at HHS? Big pharma. Every new drug has NIH somewhere in its DNA--and NIH funding supports the training of their workforce. Now they're finding out FDA isn't safe, either. Wrote about how keeping quiet isn't working My latest @opinion.bloomberg.com (gift link):

This is absolutely devastating for public health, for scientific integrity, for innovation, for all Americans. I can't string together more coherent thoughts - just absolutely devastating.

While, in recent years, we complained about the FDA, little did we know that, one day, we’d be looking back at those nostalgically as the good ol’ days

New eNeuro(@sfnjournals.bsky.social) 📄! 🤩 "Promoting Open Discussions of Scientific Failure within the Annual Society for Neuroscience Conference" w/ @kristinbigos.bsky.social @flagel-lab.bsky.social @amayoco.bsky.social @drxilma.bsky.social @comm4rigor.bsky.social www.eneuro.org/content/eneu...

Universities around the world are now actively soliciting for US PhD candidates to apply. Also, medical professionals are being told that they can be fast-tracked in other countries. The brain drain is going to be severe. Yet more dumbing down of the United States.

The dynamic version is even more disturbing...

[email protected], would you agree that much of your uncle's anger toward Zelesnkyy is because, as he says, he's insufficiently grateful...he hasn't kissed the ring/feet to the degree that all narcissists require, like so many others have, in the US and abroad?

So is this the end of FDA advisory committees?