Yes, ethics! "The technical skills relevant for today are not going to be relevant even two years from now. It really is more soft skills—critical thinking, adaptability. Also ethics—where human judgment comes into play."

Very interesting survey results re: a bill I've tracked for several years, the Promising Pathway Act. jamanetwork.com/journals/jam... @gregggonsalves.bsky.social @reshmagar.bsky.social @alsadvocacy.bsky.social

Very cool: a new six-month fellowship from @theopennotebook.bsky.social and @retractionwatch.com for reporters and editors at local newsrooms to report stories of scientific integrity unfolding at research universities or institutions in their areas. www.theopennotebook.com/2026/02/26/a...

Ole Skøtt, U. of Southern Denmark's health sciences dean, tells @rollingstone.com: “Your enquiry contains new information in relation to the validity of the ethical approval. I have decided this should be investigated. The Hepatitis B project has been put on hold to assess the new information." /6

On Monday, FDA is slated to announce draft guidance on its plausible mechanism pathway for individualized therapeutics. Here's a podcast (w/ me from @weareprimr.bsky.social) to get you up to speed - why the pathway is needed, what's great about it + some concerns. podcasts.apple.com/us/podcast/t...

CNN's Kristen Holmes reports that Trump blew up during a meeting after learning of the SCOTUS ruling on tariffs. "He started ranting about the decision, not only calling it a disgrace, but started attacking the courts and at one point saying these effing courts, but using the actual language there"

Kavanaugh is attempting to manufacture the legal doctrine of pointus de noreturnis: If the regime’s unlawful actions are too difficult to unwind, we apparently have no choice but to see them through.

This is so sad. He was only 53. ALS is such a cruel disease. Eric Dane, McSteamy on ‘Grey’s Anatomy,’ Dies at 53 www.nytimes.com/2026/02/19/a...

Today's the deadline for abstract submission. Come join the health law profs (broadly construed!) at Georgia State June 3-5. See you there!

O'Neill, an investor in anti-aging technology who worked on HHS policy, would be the first non-scientist or engineer to lead NSF. His background will be a 'major concern' to the science and technology community, former NSF director Neal Lane told me. @maxkozlov.bsky.social and I report:

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/

In light of Makary's comments calling for more drugs to move OTC, here's my 2020 paper w/ @stevejoffe.bsky.social + Maddy Kilbride arguing that the default should be switched in favor of OTC status for new drug approvals. It's not as extreme as it sounds. 1/ onlinelibrary.wiley.com/doi/10.1002/...

There is going to be so much to empirically study when Makary/Prasad are through. "FDA’s default position is that one adequate and well-controlled study, combined with confirmatory evidence, will serve as the basis of marketing authorization of novel products." www.nejm.org/doi/full/10....

On their face, the Epstein files have nothing to do with IRBs. But they certainly show the extent to which academics can be blinded by their science, which is exactly why they (we) need independent oversight. www.nytimes.com/2026/02/16/u...

America 2026. www.nbcphiladelphia.com/news/local/f...

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

Interested in Expanded Access to investigational drugs? FDA will host a webinar on 4/15. www.fda.gov/drugs/news-e...

From Alec Gaffney at @agencyiq.bsky.social: "There doesn’t seem to be a coherent approach to evidentiary requirements at the FDA at this time, other than one that demonizes vaccines."

I don't know enough about this product/data supporting it to know whether CRL was appropriate. But I will say (a) I'm glad the CNPV is not a ticket to automatic approval, (b) there were a lot of resources devoted to meet the tightened review timeline... 1/ www.statnews.com/2026/02/13/d...

Follow @margaretrutheby.bsky.social for her expertise in eugenics, which is scarily modern again.

Precisely. FDA's "expert panels" are "engineered to give the appearance of a true advisory committee...without requiring the FDA to actually have to face an independent advisory committee making clear recommendations it cannot predict." jamanetwork.com/journals/jam...

Sums it up well, from Politico Pro's newsletter re: the Moderna vax debacle (but more broadly relevant): Former fed officials said FDA's move "was both shocking, based on regulatory norms, + expected, given the current political leadership, w/ 1 calling it 'entirely predictable + yet also so bad.'”

“This is like asking, how do you think dropping an atomic bomb on New York City will affect the future of Broadway musicals? This is a generational loss of innovation, technology, and economic power.” Powerful reporting this week by @bostonglobe.com 👇

So embarrassing that I hope SNL does a skit about it.

Some interesting ideas for how to encourage companies to offer Expanded Access, including one Alison Bateman-House + I tentatively floated in a recent paper: speedier review for companies that offer meaningful EA. It'd need a lot more work to flesh out pros/cons. www.statnews.com/2026/02/11/r...

Likely-historic photo by NBC News of all the Epstein victims asked to raise their hands if they've not yet been asked to meet with the DOJ as Bondi testifies in foreground

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...

Playing Calvinball with potentially lifesaving new vaccines

Almost all university presidents and trustees are in high appeasement mode. It won’t work and it emboldens the autocrat. Brilliant piece by David Pressman & Arne Duncan. Will anyone heed their warning? www.washingtonpost.com/opinions/202...

Wow, NBC edited out the audience booing JD Vance at the Olympics. And this is one of the few remaining news outlets NOT owned by right-wing billionaire Trump sycophants www.theguardian.com/us-news/2026...

1. It was not an accident. 2. It was not a staffer. 3. While the president may have dementia his racism is not due to dementia. 4. He isn’t sorry. He means every racist thought he shares. 5. His base agrees with him. 6. He will do it again. 7. No one in power will hold him accountable.

Not really the "Commissioner's" Priority Review Vouchers, I guess (and not the Secretary's either). On the other hand, I agree it's best for Compass to avoid anything that will cast the pall of politicization over their psilocybin application. www.statnews.com/2026/02/04/p...

This is unreal. An AUSA talking like that in open court is about as close as you can come to a total breakdown. Never heard of anything like it.

Ah yes, the old “you should smile more” every woman has heard at least once (and more likely dozens of times) We do not exist to please you or make you feel more comfortable.

Trump: “I had the nastiest, most vicious joke about John Roberts"..."If you think I’m going to tell that joke you can forget it.”...“I’m going to kiss his ass for a long time." Haha, hilarious, checks and balances are dead and gone. www.washingtonpost.com/politics/202...

The reason journalists are so particular about what’s off the record and about granting anonymity is that many of us take that very seriously. If I promise to protect your identity, I’m not just saying I won’t print your name. I’m saying I will go to jail for refusing a court order to name you.

Join us on February 17, 11-12pm ET as @rachelsachs.bsky.social, @profgenkanter.bsky.social, Chris Meekins, and I discuss "FDA and Its Changing Relationship to Industry" This event is for Health Affairs Insiders only - but if you'd like to attend, let me know! www.healthaffairs.org/do/10.1377/h...

After being held in two of them as a boy, I fought for decades urging America to never again build concentration camps and put human beings in them. It breaks my heart to watch this happen twice now in my own lifetime.

Alex Pretti’s coworkers take a moment of silence this morning

I'm perturbed by the HHS response. Yes, of course we have to speculate when govt regulators fail to follow proper procedures for changing FDA policy. And no, "an open door posture" isn't the same as formal opportunities for public comment/response. Keep your podcasts, give us regs+formal guidance.

Thanks to @jasonmast.bsky.social for highlighting our analysis of FDA's new plausible mechanism pathway in @statnews.com. Key pts: - Plausible mech is a great idea for n of 1/few - FDA needs to stop advancing policy via journal article - Impt open Qs on scope www.statnews.com/2026/01/26/f...

A teacher literally shaking as she describes the threat from her own government to the children she teaches www.theatlantic.com/politics/202...

He wasn't going to a protest. There was no planned protest. It was people in a neighborhood witnessing & recording public actions by secret police. Gun-at-protest is a lie & distraction.

“You cannot bring a firearm, loaded, with multiple magazines to any sort of protest that you want. It's that simple.” — FBI Dir. Kash Patel

Attack = video record Repercussions = execution

The best headline I've seen about MN murder was "Gunmen still at large."

A reminder to the news media: “conflicting accounts” is what you say BEFORE the incontrovertible video evidence appears. After that, your job is to ask why one side is lying, not to repeat the lie and pretend no one knows the truth.

Protesters in Los Angeles projected an anti-ICE video onto the Twin Towers, an ICE-linked detention facility where the Los Angeles Sheriff’s Department actively collaborates with ICE for deportation screenings.

Kare 11 local news just read, in full, this statement from Michael and Susan Pretti, the parents of Alex Pretti. "Please get the truth out about our son."