Steve Joffe

How long before robots are trained to check the "I am not a robot" box?

Leucovorin lacks evidence to use as autism treatment, FDA says The FDA approves leucovorin for a rare brain disorder while retreating from top officials’ earlier insistence that it could benefit many children with autism.

News: Federal health officials are retreating from earlier endorsement of leucovorin as a drug that can treat autism.

www.statnews.com/2026/03/10/f...

Director D - Academic Affairs University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school co...

CHIBE is hiring a Managing Director! See details below and share with your network. wd1.myworkdaysite.com/recruiting/u...

We showed a 72% drop in FDA advisory committees this past year from their 20-year average. Is this a problem? A lot of folks, incl former FDA leaders and CEOs of firms that prepped for canceled meetings think so. Link to @statnews.com article below (paywall) & free link to PDF in replies.

Institutional Review Board Obligations Regarding Study Funding Sufficiency Given their obligations to ensure ethical research, we argue that institutional review boards (IRBs) bear a responsibility to minimize the possibility that proposed clinical studies will terminate ea...

New pub w/ my fab Penn JD/MBE student, Tasneem Mohammad!
Prompted by an ALS drug sponsor's announcement that it was considering launching a trial before it had all $ in hand, we addressed the ethical role of IRBs in making sure studies have adequate funding.
onlinelibrary.wiley.com/doi/10.1002/...

Please please read this from the archbishop of Chicago

www.archchicago.org/statement/-/...

😆

Claude's response to this @postopinions.bsky.social op-ed about problems with review of early-phase clinical trials in the US seems just right. I'd especially worry about the loss of expert technical review that the change would involve. wapo.st/4b8xAxw

An unnamed FDA official agrees with you.

The FDA, urged to avoid controversy, creates a new headache with attack against UniQure Recent decisions at the FDA threaten to turn its disagreements with the drugmaker UniQure into another political headache for the Trump administration.

We all knew but here's confirmation the anon official is Prasad:

"You all know that as background, I’m a professor and I’m a practicing [hematology-oncology] doctor. I do miss my clinic and I miss teaching, and I miss being able to run my podcast and speak freely."
www.statnews.com/2026/03/06/f...

1. It is not *necessarily* unethical to run a sham surgery trial for a serious disease. It depends on whether it's necessary to answer the relevant scientific questions and if risks can be minimized enough for the benefits of answering those questions to outweigh them.

For kicks, I pasted your question into Claude, which really is amazing, and got this response. Is one of these the one?

I nominate for Headline Of The Year award.

www.npr.org/2026/03/03/n...

"Aside from the internment camps used to incarcerate Japanese Americans in the 1940s, such facilities have no precedent in American history..."

US Conference of Catholic Bishops statement on Trump's new mass prison camps.

Full statement at the link:

www.usccb.org/news/2026/th...

Four Conditions Make Cash Transfers Save Lives The success of other countries shows these programs can work in the United States.

Why does cash save lives in Tanzania but barely move the needly in Texas? New piece in @theatlantic.com with @hthirumurthy.bsky.social:

We break down the conditions that make cash transfers improve health, and why SNAP gets closets to what works globally.

www.theatlantic.com/health/2026/...

🎉Introducing Dr. David Powell as a new Senior Fellow at Penn LDI!

Dr. Powell is a health economist with research on the opioid crisis, population aging, working conditions, and end-of-life care.

Learn more about his work: https://ldi.upenn.edu/fellows/fellows-directory/david-powell-phd

Good morning. On this *freezing* cold Atlanta morning, this news warms our hearts 💚

This is the most incredible footage of blue whales I’ve ever seen

One Pivotal Trial, the New Default Option for FDA Approval — Ending the Two-Trial Dogma | NEJM This Sounding Board announces a new FDA policy that the default requirement for FDA approvals will be one robust pivotal trial plus confirmatory evidence, rather than two trials.

Lots to unpack about the 1 pivotal trial default.
www.nejm.org/doi/full/10....
For now a few points:
1. FDA is not legally permitted to set policy by journal article. This must stop.
2. This is not likely to give industry much stability. FDA can decide any time that the default doesn't apply. 1/

Thread.

Adding to @hollylynchez.bsky.social's comments: according to @cnbc.com, Makary says drugs should be OTC unless they're unsafe, addictive, or require monitoring.

We'd add antibiotics to this list, given likelihood of overuse & antibiotic resistance, threatening the public health.

Wow.

Yesterday morning kids were sent running from their bus stop in panic because ICE showed up. This guy at today’s ICE Out of Lindenwold protest is a must watch 😭. @maddow.bsky.social

How does one "repeal" a scientific finding?

www.nytimes.com/2026/02/12/c...

Another instance of a center director acting unilaterally to overrule other staff (which here also involved ignoring FDA's previous statements to the company).

As @reshmagar.bsky.social and I have argued, the bar should be much higher for such unilateral action:
www.nature.com/articles/s41...

Opinion | Universities are sending Trump a dangerous message Higher education is under attack. Drop the appeasement.

Worth a read. wapo.st/3ZrXzur

Call for Papers - The ELSI of Genetic Selection: Pronatalism, Eugenics, and Reproductive Justice The Center for ELSI Resources and Analysis (CERA) is sponsoring a special report of the Hastings Center Report that considers the ethical, legal, and social implications (ELSI) of reproductive technol...

📢Call for Papers: The ELSI of Genetic Selection, a special report of the Hastings Center Report.
We welcome contribution on reproductive technologies, practices, and policies that enable the selection of genetic characteristics.

More info: elsihub.org/news/call-pa...

The effect of shingles vaccination at different stages of the dementia disease course A natural experiment found that herpes zoster vaccination reduced the occurrence of mild cognitive impairment and deaths due to dementia, indicating that the vaccine may slow the progression of dement...

I may not live to see the full story play out, but the evidence of an association between the chicken pox virus (varicella zoster virus), a vaccine-preventable illness, and dementia is increasingly tantalizing. www.cell.com/cell/fulltex...

One of the most important scientific achievements of the last 50 years was making the causal links between prior viral infections (e.g. EBV) and subsequent serious diseases.

We would like to recruit a stellar junior faculty member in the Division of Child Health Research and Policy @deptpopmed.bsky.social at Harvard. Please circulate this announcement widely!

www.populationmedicine.org/divisions-ce...

In response my colleague @jimswift.bsky.social had chatgpt create new scenes for Coalie. I just spit out my tea