Holly Fernandez Lynch

You.
Are.
Allowed.
To.
Insult.
The.
Police.

It’s a core First Amendment principle. This is utterly lawless behavior, for which there will be no (short-term) consequences.

That he does it so casually, as they are walking away, in front of cameras.

Rightly confident in his impunity.

Institutional Review Board Quality, Private Equity, and Promoting Ethical Human Subjects Research | Annals of Internal Medicine Evaluating the quality and effectiveness of the institutional review boards (IRBs) responsible for overseeing research involving human participants is critically important but perpetually challenging....

"Two decades later, researchers wrote in the Annals of Internal Medicine that the private-equity model was 'particularly susceptible to approaches that could undercut the ethical mission of I.R.B.s.'”

Stephen Rosenfeld and I are "researchers" - here's our paper:
www.acpjournals.org/doi/10.7326/...

How Private Equity Oversees the Ethics of Drug Research

“If you are just focused on [IRB] turnaround time, that doesn’t tell you really anything about quality,” said Holly Fernandez Lynch . . . She added: “It inhibits people from saying, ‘Wait, we need to pause on this. Is this the right thing to do?’”

www.nytimes.com/2025/10/04/h...

Had the exact same reaction.

FDA approved new generic abortion pill before shutdown The agency's decision has drawn conservative criticism.

Among all the lawlessness we're seeing, it's worth noting that those upset over FDA's approval of a third generic version of mifepristone are literally calling on FDA to violate the law.

www.politico.com/news/2025/10...

Read the "compact": www.washingtonexaminer.com/wp-content/u...

Then this spot on analysis: www.nytimes.com/2025/10/02/o...

It "offers an edge" like a gun wielding mugger offers "an edge" on staying alive if you hand over your $. We're talking about student loans, grants, contracts, visas, nonprofit status - those are the benefits Trump says schools are free to "forego" if they reject the compact. Try surviving w/o them!

Colleges weigh whether to sign onto Trump plan or forgo federal benefits A new proposal from the Trump administration would give colleges funding advantages if they adopt conservative priorities.

Terribly pernicious framing from @washingtonpost.com:

"A new proposal from the Trump administration would give colleges funding advantages if they adopt conservative priorities."

It's not a funding advantage, it's utter destruction of schools that refuse.

www.washingtonpost.com/education/20...

A man addresses a military audience with the caption: “. . . and then Randy Quaid yells, ‘Hello, boys, I’m back!,’ and flies his jet right into the alien ship, blowing it up, and I think you all just need to be more like that.”

New Yorker cartoon. “. . . and then Randy Quaid yells, ‘Hello, boys, I’m back!,’ and flies his jet right into the alien ship, blowing it up, and I think you all just need to be more like that.”

I work with Veterans. If I told them that they "killed people and broke things for a living" they would (rightfully) tell me to go to hell.

Those that have had to kill someone in the line of duty most often view it with sadness, regret, and one of the worst experiences of their lives.

Center directors overriding their review teams (and others) has been relatively rare - but it's happened across administrations and the stakes are very high when it does. Changing the system can help promote integrity and transparency of the approval process. 3/3

We describe 4 alternatives that could work in tandem:
1. Approval by committee
2. Mandatory public comment when a director wants to deviate from a committee's recommendation
3. Mandatory adcoms when that happens
4. Adjustments to FDA's scientific dispute resolution procedures 2/

Diffusing authority to make drug approval decisions at the US Food and Drug Administration Nature Medicine - The US Food and Drug Administration (FDA) is at a crossroads. There is an urgent need to strengthen the integrity of drug approvals and rejections by diffusing the decision-making...

With @pennmedicine.bsky.social MD student, Caleb Rhodes, and @reshmagar.bsky.social, I have a new paper in @natmed.nature.com arguing that drug approval (or rejection) decisions are too complex and high stakes to be left in the hands of individual FDA office or center directors. 1/
rdcu.be/eIEN7

Ethicists flirt with AI to review human research Large language models could help reduce backlog of study proposals, but critics are wary of entrusting ethics to machines

I was pleased to see this coverage by Science: www.science.org/content/arti.... I'm not as skeptical as I come across in the story (probably no more skeptical than the authors of the original paper). Lots of good is possible here. But lots of danger zones, too, and some worrisome incentives. 3/3

Chat-IRB? How application-specific language models can enhance research ethics review Institutional review boards (IRBs) play a crucial role in ensuring the ethical conduct of human subjects research, but face challenges including inconsistency, delays, and inefficiencies. We propose t...

@briandavidearp.bsky.social
and friends (including AEREO member, Joel Seah) do a phenomenal, nuanced job highlighting the possibilities in their new Journal of Medical Ethics paper: jme.bmj.com/content/earl... 2/

I don't want AI making ethics decisions about research, that's what human IRBs are and should be for. But there's a lot that AI could improve in the IRB space, from better protocol submissions to helping reviewers incorporate the research ethics literature and prior decisions. 1/

Trump Tylenol Warning Kicks Off Label Change Drugmaker May Fight Details of the FDA’s plan to modify Tylenol’s label to say it may be associated with a risk of autism in children will be crucial in determining when and how the painkiller’s manufacturer can dispute ...

Dr. Ramachandran said, “This is backwards. They’re announcing this process for making this change, and then they have the president and secretary go on national television and warn people to not take Tylenol.” (3/3)

🔗 news.bloomberglaw.com/health-law-a...

Everything is still on fire but rescuing a new puppy helps a lot. (As does our older rescue pup but it turns out 2 are better than 1.)

"Research is compromised when it is informed by bias or is designed to reach a predetermined conclusion. Compromised research should not be considered when approving and regulating medications, including mifepristone."

Here's what the experts have to say on the matter.

www.acog.org/news/news-re...

"HHS--through the FDA--is conducting its own review of the evidence" re: mifepristone's safety + effectiveness.
Signed by RFK and Makary.

Given what we just saw w/ tylenol + leucovorin, I'm sure this will be done to the absolute highest scientific standards.

democracyforward.org/wp-content/u...

This is what is happening when the cameras are running

Please consider submitting an application - or nominating great candidates - to join the American Society of Law, Medicine, and Ethics Board of Directors. Our organization is in an exciting time of transition and creativity. Join us in shaping ASLME's future.

aslme.org/nominate-som...

Heartened by the expert takes on the embargoed data, as reported here: www.statnews.com/2025/09/24/h...

No publication yet but this looks to be amazing news.

DJT: I am using the state to punish criticism and extort people
WH: this business decision was driven by
DJT: No I am using the state to punish criticism and extort people
WH: Unitary executive theory implies that
DJT: I SAID I AM USING THE STATE TO PUNISH CRITICISM AND EXTORT PEOPLE FOR MONEY

This is what the administration would have done if they really wanted the answers.

Agreed. But this should be done *before* FDA approval. Obviously.

F.D.A.’s Approval of a Drug for Autism Upends Review Process

“I think this is a dangerous kind of subversion of what F.D.A. approval is supposed to be"

www.nytimes.com/2025/09/23/h...

FDA’s leucovorin approval could be a boon for supplement makers Parents may flock to a dietary supplement with the same key ingredient as leucovorin, which the FDA just approved for children with autism. But there are drawbacks.

New: RFK Jr. and aides touted leucovorin as a treatment for autism, despite limited evidence. Now, makers of a related supplement, available without a prescription, could try to cash in.

Via @tarabannow.bsky.social

www.statnews.com/2025/09/23/l...