Lightnews — Scholar-powered news

Holly Fernandez Lynch @hollylynchez.bsky.social · 1h

New from @pzettler.bsky.social @reshmagar.bsky.social + me in @jhppl.bsky.social.
We describe themes driving historic FDA reforms, explain how what's happening under Trump2 is different + call for principles to guide FDA reform and activity across administrations.
read.dukeupress.edu/jhppl/articl...

4 6

Reposted by Holly Fernandez Lynch

John Pfaff @johnpfaff.bsky.social · 4d

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.

“[t]he freedom of individuals verbally to oppose or challenge police action without thereby risking arrest is one of the principal characteristics by which we distinguish a free nation from a police state.”

330 4.1K 9.5K

Holly Fernandez Lynch @hollylynchez.bsky.social · 4d

"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/...

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....

www.acpjournals.org

1 1

Holly Fernandez Lynch @hollylynchez.bsky.social · 4d

“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...

How Private Equity Oversees the Ethics of Drug Research

www.nytimes.com

1 3 6

Holly Fernandez Lynch @hollylynchez.bsky.social · 4d

Had the exact same reaction.

5

Holly Fernandez Lynch @hollylynchez.bsky.social · 4d

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...

FDA approved new generic abortion pill before shutdown

The agency's decision has drawn conservative criticism.

www.politico.com

3 8

Holly Fernandez Lynch @hollylynchez.bsky.social · 4d

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

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

3 4

Holly Fernandez Lynch @hollylynchez.bsky.social · 4d

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!

Steve Joffe @stevejoffe.bsky.social · 4d

More poor framing from @chronicle.com.

Critical to recognize that memo is a sticks not carrots.

www.chronicle.com/article/the-...

4 3

Holly Fernandez Lynch @hollylynchez.bsky.social · 4d

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...

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.

www.washingtonpost.com

1 1 5

Reposted by Holly Fernandez Lynch

Kathleen Bachynski @bachynski.bsky.social · 6d

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.”

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.”

1 21 98

Reposted by Holly Fernandez Lynch

Dimitri Drekonja, MD, MS @dimitridrekonja.bsky.social · 7d

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.

Aaron Rupar @atrupar.com · 8d

Hegseth: "A few months ago I was at the White House when President Trump announced his liberation day for America's trade policy. It was a landmark day. Well, today is another liberation day. The liberation of America's warriors ... you kill people and break things for a living."

170 940 3.9K

Holly Fernandez Lynch @hollylynchez.bsky.social · 7d

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

1

Holly Fernandez Lynch @hollylynchez.bsky.social · 7d

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/

1

Holly Fernandez Lynch @hollylynchez.bsky.social · 7d

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

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...

rdcu.be

1 2

Holly Fernandez Lynch @hollylynchez.bsky.social · 9d

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

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

www.science.org

1 1

Holly Fernandez Lynch @hollylynchez.bsky.social · 9d

@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/

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...

jme.bmj.com

2 1 4

Holly Fernandez Lynch @hollylynchez.bsky.social · 9d

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/

1 2 4

Reposted by Holly Fernandez Lynch

Yale CRRIT @yalecrrit.bsky.social · 11d

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...

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 ...

news.bloomberglaw.com

1

Holly Fernandez Lynch @hollylynchez.bsky.social · 11d

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.)

8 4 99

Holly Fernandez Lynch @hollylynchez.bsky.social · 12d

"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."

2

Holly Fernandez Lynch @hollylynchez.bsky.social · 12d

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

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

1 4 11

Holly Fernandez Lynch @hollylynchez.bsky.social · 12d

"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...

democracyforward.org

1 4 5

Reposted by Holly Fernandez Lynch

Don Moynihan @donmoyn.bsky.social · 12d

This is what is happening when the cameras are running

Brad Lander @bradlander.bsky.social · 12d

I was back at 26 Federal Plaza today, where an ICE agent violently threw this bereft woman to the ground in front of her kids. She had not touched him. She did not pose any threat. She had to be taken to the hospital. (🎥: Elias Eliahu)

20 210 750

Holly Fernandez Lynch @hollylynchez.bsky.social · 13d

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...

Nominate Someone — Even Yourself — For the ASLME Board! – ASLME

aslme.org

2 2

Holly Fernandez Lynch @hollylynchez.bsky.social · 14d

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

1