Have a paper marinating concerning data ethics, privacy, regulation or governance in the biosciences, or know someone who does? Please consider the BMC for a special issue I am editing on bioinformatics ethics and data privacy due 13 Dec 2024!

As your students submit their seminar papers, please remind them about the opportunity to submit those papers for the 4th Annual ASLME Anti-Racism Writing Competition. Open to grad students in any discipline! Deadline is July 1.

aslme.org/aslme-insider/…

CASE IS SUBMITTED:

Folks... I think we're gonna win. I think we're gonna win by a lot. :)

Prelogar: 'The problem here is that they sued the FDA. The FDA has nothing to do [with the conscience injury]'

This isn't a rebuttal so much as a victory lap.

HAAA... I love Jackson. I LOVE JACKSON.
Alito: 'Do you think the FDA is INFALLABLE? [evil smirk]'

Jackson [5 minutes later]: 'Do you think JUDGES are infallible? Do you think they have special medical training?'

Author Holly Fernandez Lynch, UPenn Medical Ethics & Health Policy @PennCarey_Law, joins JAMA Executive Editor Gregory Curfman, MD, to discuss the science and politics surrounding the SCOTUS case FDA v AHM.

Hosted on the @amaedhub. ja.ma/4cxEbkG

📖Check out this new publication from Solomon Center Faculty Affiliate Joe Ross, Reshma Ramachandran, & Nikhil Chaudhry on 'Overruling Chevron and FDA Decision-Making,' out now in the in the Yale Journal on Regulation: yalejreg.com/nc/overruling-…

As investors pours into psychedelics, advocates who long dreamed of making the drugs widely available fear a very different future -- one in which drugs like psilocybin are expensive, specialty medicines controlled by a handful of biotech companies: apnews.com/article/psyche…

This is a great new website that clearly lays out the savings on prescription drugs delivered under the Inflation Reduction Act! In my home state of MD alone, 285,000 people will save an average of $388/yr. Take a look and share. hhs.gov/inflation-redu…

Please spread the word!
ASLME is pleased to announce its 4th Annual Health Law and Anti-Racism Graduate Student Writing Competition. Current grad students in any field are eligible, deadline is July 1. Full announcement here: aslme.org/4th-annual-ant…

I'm incredibly grateful to Lewis Grossman who led an amazing team of lawyers at Covington & to everyone who signed on I. Glenn Cohen, Nathan Cortez, Hank Greely, Holly Fernandez Lynch, Liz McCuskey, Jennifer Oliva, Christopher Robertson, Doron Dorfman & many others I can't find on twitter!

I'm nearly off this site but bc most of the patient/advocate community doesn't seem to have made it to the cloudless alternative (LMK if you'd like an invite), I wanted to make sure to post this here.

On my 'trial by Twitter' + what I've learned since:
onlinelibrary.wiley.com/doi/10.1002/ha…

On here only to share that I have 5 invite codes to the place with no clouds. Let me know if you'd like one. The discussion is getting better there as new people join. Come on over.

Looking forward to this exciting work with Dom Sisti, Amy McGuire, Logan Neitzke-Spruill, Jill Oliver Robinson!

Excellent paper stating case for U.S. FDA maintaining strong standards to ensure drugs are safe and effective. As a patient who needs new drugs to extend my life, I don't want drug companies to peddle hope-I want drugs that work. healthaffairs.org/content/forefr… Holly Fernandez Lynch

I AM ALS The pivotal trial failed to show efficacy by any measure. Twas not a minor p-value failure. It was a royal thud. Our disappointment should be aimed at a firm that wasted 3 years (& a lot of $) rearranging deck chairs rather than doing a trial designed to succeed. FDA did its job.

“There are good reasons for FDA to reject unproven drugs. 1st, doing so will help promote generation of strong evidence to support the treatment decisions facing all patients, and 2nd, it will minimize interference w/ promising drug development.”
Out now Health Affairs Forefront