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?

Stats experts, do you know of any references taking the FDA to task for using archaic stats methods, esp making approval decisions based on NHST + trial counting (& not MA)? Thanks. @f2harrell.bsky.social @stephensenn.bsky.social @statsepi.bsky.social @healthstatsdude.bsky.social

Sure feels like the great political cartoonists of our time are really stepping up and meeting this dark moment in our history. And brilliantly.

Interesting read shared by @eturnermd1.bsky.social.

Overdosing on Ozempic news. Lots of things about GLP-1 drugs - costs, quality of the evidence, drug safety, who/what is driving the market, politics, conflicts of interest - sometimes minimized or ignored in the overdose of GLP-1 news. open.substack.com/pub/garyschw...

Emergency Video: will Congress do to itself what they are demanding of other departments? Cut congress’ budget and shrink THEIR staff now!

New article: "Is ketamine efficacious for rapid treatment of acute suicidal ideation in an emergency setting? Lessons learned from a pilot randomized controlled trial" Short answer: Not really. No sign diff between ketamine and control (midazolam) bmcresnotes.biomedcentral.com/articles/10....

This seems like a good idea for increasing transparency www.clinicalleader.com/doc/ciscrp-s...

The NIH overhead cut doesn't just hurt universities. It's deadly to the US economy. The US is a world leader in tech due to the ecosystem that NIH and NSF propel. It drives innovation for tech transfer, creates a highly-skilled sci/tech workforce, and fosters academic/industry crossfertilization.

RFK Jr claimed FDA is suppressing HBOT www.washingtonpost.com/health/2025/...

Paper of ours just out in JAMA Network Open @jama.com "Characteristics of Trials Preceding FDA Approval of Novel Psychiatric Drugs" @akesselheim.bsky.social jamanetwork.com/journals/jam...

"In scientific publishing, control of authorship doping is almost non-existent – it is difficult to prove that a listed author has or has not contributed enough to warrant authorship credit."

Article just out: "The Deadly Secrets Behind “Breakthrough” Alzheimer’s Drugs" www.levernews.com/the-deadly-s...

On the migration of the scientific community to Bluesky: www.nature.com/articles/d41... 🧪

EU medicines agency quits X & moves to Bluesky "EMA will no longer post updates and content on X. We believe the X platform no longer suits our communication needs” the agency said in a statement www.reuters.com/world/europe...

This one hour of day seven of the presidency.