Patti Zettler

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)

Breaking News: Read three top CDC officials' resignation emails. The end of an era.

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...

Health Cuts Would Result in Fewer Drugs for Americans, Budget Office Reports

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...

Doctoral Excellence Award Western University, in vibrant London, Ontario, delivers an academic and student experience second to none.

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.)

Public Health Law Vacuums: A Present And Future Threat | Health Affairs Forefront The COVID-19 pandemic has led to a dangerous trend: the intentional creation of public health law vacuums, in which no governance efforts are exerted to address a defined public health problem.

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

Inside the staff exodus and tanking morale that threaten Makary’s FDA FDA staff are struggling and missing deadlines, and the future consequences could be even more dire.

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!!!

"[S]uggesting that there are regularly 6 months of wiggle room in important FDA reviews that prior administrations have missed is a tough pill to swallow. Far more plausible is that speed will be traded for review quality and confidence, despite protestations to the contrary..."

Opinion | How Fast Is Too Fast for FDA Drug Review? 'Common sense' and the FDA Commissioner's National Priority Voucher Program

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.

The FDA’s Crisis Is Everyone’s Crisis This Viewpoint discusses the Trump administration’s firings of thousands of US Food and Drug Administration employees and the ramifications of those actions on the agency’s congressionally given publi...

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

The Heat Dome Wants a Word With Climate-Change Deniers The temperatures gripping the US this week were made up to five times more likely by the fact that the atmosphere is simply hotter.

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...

In Defense of ‘Silly’ Science Basic research and the value of curiosity.

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.

Opinion | Holy Water Couldn’t Save My Husband. MAHA Wouldn’t Have, Either.

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...

Because of FDA approval, this is, of course, in contrast to drugs.

& for more on why we need rigorous premarket effectiveness evidence for drugs, check out my, @rachelsachs.bsky.social, @stevejoffe.bsky.social, & @hollylynchez.bsky.social's recent @jama.com piece:

jamanetwork.com/journals/jam...

"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...