Michael S. Sinha | Lightnews

Michael Sinha @drsinhaesq.bsky.social · 1d

Now published in @uchilegalforum.bsky.social --

Vaccines for Pandemics: Lessons from COVID-19 for H5N1 and Beyond (with Alison McCarthy, SLU LAW '25)
legal-forum.uchicago.edu/sites/defaul...

cc: @slulaw.bsky.social @sluhealthlaw.bsky.social @ciclslulaw.bsky.social

JAMA @jama.com · 2d

💬 Viewpoint: Combination-only approvals for new #HIV drugs limit generic substitution and sustain high antiretroviral prices, even after key patents expire.

ja.ma/4jw2Dqz

A JAMA article titled "Combination-Only Approvals as a Barrier to Affordable HIV Care" by S. Sean Tu, et al. Published online December 1, 2025. The article discusses prescription drug costs and HIV treatment access.

Michael Sinha @drsinhaesq.bsky.social · 4d

Check out our article, "Combination-Only Approvals as a Barrier to Affordable HIV Care," in this week's issue of @jama.com: jamanetwork.com/journals/jam...

cc: @sluhealthlaw.bsky.social @slulaw.bsky.social @portalresearch.org @dartmouthchem.bsky.social

Michael Sinha @drsinhaesq.bsky.social · 4d

Now in print in this week's issue of @jama.com!

JAMA @jama.com · Dec 1

💬 Viewpoint: Combination-only approvals for new #HIV drugs limit generic substitution and sustain high antiretroviral prices, even after key patents expire.

#WorldAIDSDay2025

ja.ma/4pwRTKi

A page from JAMA (Journal of the American Medical Association) titled "Combination-Only Approvals as a Barrier to Affordable HIV Care" by S. Sean Tu et al. It discusses prescription drug costs and HIV treatment access.

Petrie-Flom Center @petrieflomcenter.bsky.social · 4d

New @jama.com article written by @medlawdan.bsky.social, @drsinhaesq.bsky.social, and I. Glenn Cohen examines the FDA’s plan to approve leucovorin for some patients with autism using evidence that departs from traditional regulatory standards jamanetwork.com/journals/jam...

Michael Sinha @drsinhaesq.bsky.social · 14d

A lot has happened at FDA since we wrote this piece in @jama.com, but leucovorin was a harbinger of things to come.

Daniel G. Aaron, MD, JD @medlawdan.bsky.social · 19d

NEW: Paper in @jama.com (me, Glenn Cohen, & @drsinhaesq.bsky.social) discusses FDA plan to approve leucovorin for new indication based on "case reports" and "mechanistic data"

1. Departure from FDA's evidentiary standards

2. May harm patients and set bad precedent

jamanetwork.com/journals/jam...

Michael Sinha @drsinhaesq.bsky.social · 19d

Also my life right now. #Torts

Michael Sinha @drsinhaesq.bsky.social · 19d

cc: @petrieflomcenter.bsky.social @slulaw.bsky.social @sluhealthlaw.bsky.social @sjquinney.bsky.social

Daniel G. Aaron, MD, JD @medlawdan.bsky.social · 19d

NEW: Paper in @jama.com (me, Glenn Cohen, & @drsinhaesq.bsky.social) discusses FDA plan to approve leucovorin for new indication based on "case reports" and "mechanistic data"

1. Departure from FDA's evidentiary standards

2. May harm patients and set bad precedent

jamanetwork.com/journals/jam...

JAMA @jama.com · 19d

💬 Viewpoint: Approval of leucovorin for cerebral folate deficiency based on limited evidence raises concerns about weakening FDA drug approval standards and public trust.

ja.ma/4asLxYh

A JAMA viewpoint article titled "The FDA's Leucovorin Approval—A Departure From Evidentiary Standards" by Daniel G. Aaron et al. It discusses the FDA's intent to approve Wellcovorin for autism based on limited evidence.

Michael Sinha @drsinhaesq.bsky.social · 24d

Nice review of my AJLM article with Joseph DaVault (@slulaw.bsky.social '24) on lab grown meat www.theregreview.org/2025/12/17/a... via @theregreview.bsky.social

cc: @sluhealthlaw.bsky.social

Regulating Cultivated Meat | The Regulatory Review

Scholars discuss challenges and opportunities in lab-grown meat regulation.

www.theregreview.org

Michael Sinha @drsinhaesq.bsky.social · Dec 9

Officially out in UC Irvine Law Review: Unpatenting Product Hops! escholarship.org/uc/item/0kg3...

Bittersweet, as it shares an issue with the legendary @ucirvinelaw.bsky.social Prof. Dan Burk's final article (published posthumously).

cc: @sluhealthlaw.bsky.social @slulaw.bsky.social

University of Utah S.J. Quinney College of Law @sjquinney.bsky.social · Dec 4

Professor @jcontreras.bsky.social coauthored an article in @nature.com with @realjlo.bsky.social, Christopher R. Donohue, @jonathanmoreno.bsky.social, Ana Santos Rutschman, Joshua Sarnoff, @drsinhaesq.bsky.social + Thomas Stoeger about 23andMe + its database.

www.nature.com/articles/s41...

Jonathan LoTempio @realjlo.bsky.social · Dec 4

New out in @natgenet.nature.com - The bankruptcy of #23andMe put #human #genetic #data at risk of #enclosure. Under the new #23andMeResearchInstitute, data remain available. Read me, @jonathanmoreno.bsky.social et al on lessons for next time: www.nature.com/articles/s41... @ucirvine.bsky.social

Impact of the 23andMe bankruptcy on preserving the public benefit of scientific data - Nature Genetics

The bankruptcy of 23andMe was an inflection point for the direct-to-consumer genetics market. Although the privacy of consumer data has been highlighted by many as a concern, we discuss another key te...

www.nature.com

Michael Sinha @drsinhaesq.bsky.social · Dec 1

cc: @slulaw.bsky.social @sluhealthlaw.bsky.social

JAMA @jama.com · Dec 1

💬 Viewpoint: Combination-only approvals for new #HIV drugs limit generic substitution and sustain high antiretroviral prices, even after key patents expire.

#WorldAIDSDay2025

ja.ma/4pwRTKi

Michael Sinha @drsinhaesq.bsky.social · Dec 1

cc: @sluhealthlaw.bsky.social @slulaw.bsky.social @slu-official.bsky.social @portalresearch.org @dartmouthchem.bsky.social

Michael Sinha @drsinhaesq.bsky.social · Dec 1

🚨NEW🚨 in @jama.com: Combination-Only Approvals as a Barrier to Affordable #HIV Care jamanetwork.com/journals/jam...

Glad to see it published on #WorldAIDSDay! An important reminder of the work that still needs to be done.

Combination-Only Approvals as a Barrier to Affordable HIV Care

This Viewpoint discusses the barrier that combination-only antiretroviral therapy drugs have been to access of affordable HIV care.

jamanetwork.com

Michael Sinha @drsinhaesq.bsky.social · Dec 1

Product liability, perhaps (but it feels like a stretch)

JAMA @jama.com · Dec 1

💬 Viewpoint: Combination-only approvals for new #HIV drugs limit generic substitution and sustain high antiretroviral prices, even after key patents expire.

#WorldAIDSDay2025

ja.ma/4pwRTKi

Michael Sinha @drsinhaesq.bsky.social · Nov 29

Just finished a terrific semester of Health Equity, Policy & Advocacy at @slulaw.bsky.social, an experiential law school class focused on the preparation of white papers and other deliverables for the City of St. Louis Department of Health and the St. Louis County Department of Public Health.

Michael Sinha @drsinhaesq.bsky.social · Nov 29

After a busy semester teaching 1L Torts (for the first time) to 81 (!!!) students, I remain optimistic about the future of the legal profession! "class photo" via Gemini, complete with Simon the pug and the arm sling I was using last week. Best of luck with finals!

Michael Sinha @drsinhaesq.bsky.social · Nov 10

Hooray!

Michael Sinha @drsinhaesq.bsky.social · Nov 4

Understood, just wanted to reiterate what's at stake.

Michael Sinha @drsinhaesq.bsky.social · Nov 4

Calling it a "clown show" or a "soap opera" seems to imply that there is no real-world impact. That it's just a performance.

To be clear: these "theatrics" will have devastating consequences to FDA and its stakeholders that may take decades to overcome.

Matthew Herper @matthewherper.bsky.social · Nov 4

Experts worry FDA’s credibility is being shredded by scandal and 'embarassing' ‘soap opera’ 'clown show' www.statnews.com/2025/11/04/f...

Experts worry FDA’s credibility is being shredded by scandal and 'soap opera'

Experts worry that the FDA’s credibility is being shredded by scandal and "soap opera."

www.statnews.com

Matthew Herper @matthewherper.bsky.social · Nov 4

Experts worry FDA’s credibility is being shredded by scandal and 'embarassing' ‘soap opera’ 'clown show' www.statnews.com/2025/11/04/f...

Experts worry FDA’s credibility is being shredded by scandal and 'soap opera'

Experts worry that the FDA’s credibility is being shredded by scandal and "soap opera."

www.statnews.com

Michael Sinha @drsinhaesq.bsky.social · Oct 13

I took ~10 pictures, and this one seemed to capture the moment best!

"Is that a comment or a question?"

Michael Sinha @drsinhaesq.bsky.social · Oct 13

Thought-provoking talk today by @umichlaw.bsky.social Professor @sbagen.bsky.social on his experiences in public service and his ideas for "Reconstructing the Public Health State"

On behalf of @slulaw.bsky.social and @sluhealthlaw.bsky.social, thank you for joining us!

Michael Sinha @drsinhaesq.bsky.social · Oct 13

Happening today at noon: @sbagen.bsky.social @umichlaw.bsky.social will present "Reconstructing the Public Health State" as part of the @sluhealthlaw.bsky.social Distinguished Speaker Series!

Daniel G. Aaron, MD, JD @medlawdan.bsky.social · Oct 10

Thrilled that my new piece with @drsinhaesq.bsky.social is out. We review different funding models for research and stress the importance of public funding for two reasons: (1) It can support non-profit-driven research, and (2) It can serve as a bulwark against corporate influence over science.

Michael Sinha @drsinhaesq.bsky.social · Oct 10

NEW with @medlawdan.bsky.social @sjquinney.bsky.social in Health Affairs Forefront:

As An Alternative To Federal Research Funding, Private Investment Brings Significant Risks www.healthaffairs.org/content/fore...

cc: @slulaw.bsky.social @sluhealthlaw.bsky.social

As An Alternative To Federal Research Funding, Private Investment Brings Significant Risks | Health Affairs Forefront

Researchers and physician scientists who accept private funding from profit-motivated actors must take affirmative steps to ensure it does not compromise the integrity of their work.

www.healthaffairs.org