Another good reason to be back on bluesky - catching up on colleagues' work. @medlawdan.bsky.social & @weparmet.bsky.social packed *a lot* of info into this piece.

An essential piece from a dream team of scholars!

I have been off bluesky for a while - but this is a good reason to be back. Check out the latest from me, @reshmagar.bsky.social & @hollylynchez.bsky.social! With thanks to the many folks whose work informed this piece, incl @rachelsachs.bsky.social , @sbagen.bsky.social @drjoshs.bsky.social...

What does it mean to have a human in the loop of medical AI? Here's a fun place to look: a 2022 FDA guidance that's about what *doesn't* count as a medical device! Had a blast exploring this quasi-standard, out in the Penn J of Law & Innovation: papers.ssrn.com/sol3/papers.... #MedicalAI #law

This should be a bigger story. A government official had the YouTube channel of a private citizen shut down bc he didn’t like what that citizen was saying. This administration’s version of free speech is a joke.

BREAKING: Big moment as CDC staff stage a mass walkout. They have lined the street outside its HQ to greet and salute the four top officials who have resigned in protest at RFK Jr’s attack on the agency’s science base. (🎥 AP)

Enough is enough. The health of the country is in danger. Read our resignation letters: insidemedicine.substack.com/p/breaking-n...

And this makes it much worse. The CDC is losing a swath of outstanding, senior public servants. These are really terrific people who have served the public health with distinction across administrations. An enormous loss. open.substack.com/pub/insideme...

Funding cuts to the National Institutes of Health and the US Food and Drug Administration could sharply reduce the number of new drugs available to Americans in the coming decades, according to an analysis released on Friday by the Congressional Budget Office. www.nytimes.com/2025/07/18/h...

My university (@westernu.ca) is offering up to $160,000 CAD in funding to support doctoral students impacted by recent changes in higher ed in the US. And I'm keen on supervising students who may be interested (and who conduct research in public health ethics). DM me. grad.uwo.ca/finances/wes...

Out today is my review of Allison Whelan's excellent article about pediatric predisposition genetic testing and a right to future privacy. Given my own interests I started thinking about a right to future privacy for transgender children, but I suspect it will be relevant to all sorts of topics!

Really good thread. I'd add two things. (Mini-thread.)

I just want to re-up this Health Affairs Forefront piece co-authored with @rickweinmeyer.bsky.social. We're working on the concept of a "Public Health Law Vacuum" as a form of governance failure. Who is creating these vacuums? Why? What are the consequences? And what can we do about it? ⤵️ #PHLaw

FDA staff are already missing deadlines, and the future consequences could be even more dire as workers head for the exits. www.statnews.com/2025/07/07/f...

As someone who has been on the business end of nationwide injunctions that I thought were improper, I find the question of what rules we should adopt for them to be genuinely hard. But yesterday's decision deserves massive criticism, for at least two reasons. (Thread.)

The Affordable Care Act's requirement that insurers cover preventive services dodges a bullet in Braidwood. That's good. But the broader effect of the opinion is probably to reinforce RFK and Trump's politicized control over the medical, scientific, and public health professionals who work at HHS.

#PedSky #MedSky #EpiSky #policysky #polisky 🧪🛟 Fantastic real time skeeting from the FDA ACIP meeting. Thank you!!!

Must-read by @hollylynchez.bsky.social on FDA's new "Commissioner's National Priority Voucher" program. www.medpagetoday.com/opinion/seco...

Kudos to the AAP for taking this step and for speaking with such clarity. Exactly the kind of approach and focus I outlined in NEJM last week.

Everyone’s crisis indeed. Well said, @pzettler.bsky.social and @nathancortez.bsky.social jamanetwork.com/journals/jam...

Well, two months later I'm not feeling any more optimistic, to put it mildly. cc: @nathancortez.bsky.social

As hot as this summer is, it’s also one of the coolest we’ll ever enjoy again. Just how much hotter and deadlier summers will get is still up to us. Right now we’re working hard to make them worse 🎁 link to my @opinion.bloomberg.com column: www.bloomberg.com/opinion/arti...

Basic science is essential. "Most drugs don’t begin with research intended to make that drug. In fact, the results of their study showed that 80% of the medicines on their list led back to a discovery from basic research without any intention of creating a new drug" www.chronicle.com/article/in-d...

For those following Loper Bright, the final version of Robin Craig's empirical analysis of the first 6 months of court decisions just came out. Among other findings: in challenges to agency rules, lower federal courts invalidated the rule in ~84% of cases. minnesotalawreview.org/article/the-...

Truly...struggling to find the right word...awful, repugnant, terrible? (Also dumb.) "Worse than a crime, a blunder." Also, remember to vaccinate boys. Most HPV+ women are infected by men.

This story, like so many others, is heartbreaking. "I see what MAHA is offering. It’s not really about making America healthy. It’s about giving people the illusion of agency in a complicated and scary world." www.nytimes.com/2025/06/20/o...

"as a 35-year-old man, I take all the supplements with proven health benefits—that is, I take none of them" "there’s a massive industry here profiting off our ignorance, and very little incentive for anyone to investigate whether these pills actually work."

How We Can All Respond to Misinformation academic.oup.com/book/60489 by @leticiabode.bsky.social @ekvraga.bsky.social Needed: "...correcting publicly to build social norms around responding to misinformation." Platforms must "promote corrections & take action against toxic behaviors."

Must-read thread if you care about drug policy and approvals.

First opinion: SCOTUS blesses blatant forum-shopping by tobacco companies challenging FDA marketing denial orders. Now they'll all be filed in the Fifth Circuit, regardless of where the tobacco company is headquartered. SMH. www.supremecourt.gov/opinions/24p...

If you're interested in seeing what the conversation on X looked like on Saturday morning, as the information warriors there went to work framing the shootings of Democratic lawmakers for political gain, I made an interactive graph: faculty.washington.edu/kstarbi/Spot...

With the same person in the role of FDA Center for Biologics Evaluation and Research, Chief Medical Officer, & Chief Scientific Officer, here's how the Scientific Dispute Resolution process at the agency will now look like. #MedSky

Things are very bad for U.S. vaccination policy these days and are only going to get worse. In @nejm.org, I examine the recent news about COVID-19 vaccines and ACIP, what likely lies ahead, and what the medical and public health communities should do to lessen the damage www.nejm.org/doi/full/10....

With the pall of political violence looming heavy here in Minnesota, I was reminded of this piece I was invited to write for @jamanetworkopen.com in 2022 on threats to the public health workforce and elected officials. This call to action is even more urgent today. jamanetwork.com/journals/jam...

After Peter Marks was forced out, "the CEO of a gene therapy maker told STAT, 'We value continuity, so having Verdun stay at the FDA is really important.'" This news also comes in the middle of the annual BIO conference.

How will Trump's action on EMTALA affect patients? Check out Kimi Chernoby & my latest in @bmj.com, arguing that though Trump's action on EMTALA will likely harm patients by increasing confusion, EMTALA still requires hospitals to provide emergency abortions. TLDR below. www.bmj.com/content/389/...

BIO CEO John Crowley takes a subtle? (not so subtle?) swipe at Trump admin this am: We must recognize that if any nation, whether the US or elsewhere fails to support science and innovation, their citizen's health, prosperity, security all hang in the balance. #BIO2025

🧵 I filed adverse public comments today on 13 individual rules from the Dept of Energy. 😮‍💨 The bee in my bonnet was the agency's improper use of a very specific procedure called "direct final rule." Buckle up for some in-the-weeds admin law!

It has been a while since I've been on an IRB but several of the changes surprised me, especially #3 and 4. I've asked people who know more what they think.

What about those conflicts of interest he mentioned when firing all the prior members???

New in @jama.com: @pzettler.bsky.social et al. warn about politicization of COVID-19 vaccines at the FDA. "[I]nfusing political considerations and political appointees into individual product decisions imperils public health and innovation." jamanetwork-com.azp1.lib.harvard.edu/journals/jam...

“Ending a $5 million research study when it is 80% complete does not save $1 million, it wastes $4 million.” ✊🏼🧬 www.standupforscience.net/bethesda-dec...

It's low hanging fruit to point out these kinds of inconsistencies -- there are so many of them -- but, still, 1000 times yes on this one.

"[T]he US uninsured rate has never risen as far, as fast as it will if the House bill and other looming policy changes affecting insurance coverage take effect." Always read @mattafiedler.bsky.social. www.healthaffairs.org/content/fore...

Thank you @by-cjewett.bsky.social @nytimes.com for chatting with me about this piece and my concerns that the priorities outlined by our national regulator read like PhRMA's own FDA playbook 👇 in calling for speedier reviews & less evidentiary rigor. www.nytimes.com/2025/06/10/h... #MedSky

This will be remedial for medical product development experts, but I worry that glossing over the details can lead to incorrect perceptions. Hopefully, this will help--safe doesn't mean free of any adverse effects! substack.com/home/post/p-...

"We are speaking on behalf of hundreds of NIH staff who are standing up together to say: WE DISSENT. I am so scared about doing this but I am trying to be brave for my kids because it's only gonna get harder to speak up." Thank you to Dr. Jenna Norton and NIH scientists for your courage!

A good piece on why RFK's purge of ACIP is a big problem for us all. open.substack.com/pub/caitlinr...

If people are interested in learning about the ACIP and its decades of contributions to US vaccine policy successes, here’s a short 2014 piece I wrote in NEJM with Adel Mahmoud (timed with its 50th anniversary) www.nejm.org/doi/full/10....

Skip the WSJ op-ed & read this from @pzettler.bsky.social, Steve Cha, Sarah Despres & @cspinet.org's Peter Lurie in @jama.com: "Political interference, or even the perception of political interference, in the FDA’s approval decisions could undercut public confidence." jamanetwork.com/journals/jam...