Joseph Ross

Postmarket Safety Actions for Novel Oncology Drugs Granted Accelerated Approval This cross-sectional study examines postmarket safety actions for novel oncology drugs that received accelerated Food and Drug Administration (FDA) approval.

New study in @jamanetworkopen.com this week: frequency of post-market safety issues for cancer drugs with accelerated approval.

Happy to collaborate on this study with Dr. Mooghali, @reshmagar.bsky.social @jsross119.bsky.social

jamanetwork.com/journals/jam...

Well worth the read ... subsidy cuts will be felt hardest in states that did not expand Medicaid as part of the ACA

Postmarket Safety Events Among Therapeutics Approved by the FDA This study describes withdrawals, boxed warnings, and safety communications affecting pharmaceuticals and biologics approved by the US Food and Drug Administration between 2001 and 2010, and associati...

Thanks @arnoldventures.bsky.social for supporting @yalecrrit.bsky.social - study builds on work nearly a decade ago published in @jama.com (jamanetwork.com/journals/jam...) - flagging for @alecgaffney.bsky.social @zacharybrennan.bsky.social @sarahkarlin-smith.bsky.social @lizzylawrence.bsky.social

Postmarket Drug Safety−Related Actions Before and After the FDA Amendments Act This cross-sectional analysis assesses whether the US Food and Drug Administration Amendments Act was associated with differences in time to first postmarket drug safety−related action and whether the...

Lots more detail in the paper (jamanetwork.com/journals/jam...), but our findings provide the first evaluation of FDAAA and its enhanced safety-related regulatory authorities, and its impact on drug safety and public health, and informs current PDUFA VII negotiations! @reshmagar.bsky.social (5/5)

... among therapeutics with postmarket safety-related actions within 5 years of approval, median time to first action was 1.3 years shorter post-FDAAA implementation, perhaps a consequence of FDAAA's conferring FDA new PMR authority and defined timelines for label changes (4/5)

Among these, FDA took postmarket safety-related actions for 23%, including actions within 5 years of approval for 21% approved pre-FDAAA and 14% approved post-FDAAA (p=.06). While FDAAA was not associated with differences in time to first postmarket safety-related action ... (3/5)

We wanted to understand whether FDAAA was associated with changes in FDA postmarket drug safety−related actions, and what characteristics were associated with a greater or lower likelihood of actions. To do this, we studied all 560 new drugs and biologics approved by FDA from 2001-2017 (2/5)

New paper from @yalecrrit.bsky.social out today in @jamainternalmed.com - The 2007 US Food and Drug Administration (FDA) Amendments Act (FDAAA) expanded the agency's safety-related regulatory authorities, including enhanced postmarketing safety surveillance and new clinical study requirements (1/5)

Flexibility Over Rigor: Stakeholder Acceptance of the Limitations of Confirmatory Studies Following Accelerated Approval Despite the importance of postmarketing requirements (PMRs) following accelerated approval and well-recognized shortcomings in their rigor and timeliness,

Here's our new article reporting findings from stakeholder interviews in which we hoped to learn what it takes to successfully complete rigorous confirmatory studies after accelerated approval. Instead, we mostly heard willingness to trade rigor for feasibility. 1/
academic.oup.com/healthaffair...

Trends in the Proportion of US and International Medical Graduates at the County Level This study assesses temporal trends in US medical graduates’ and international medical graduates’ relative contributions to the total physician workforce from 2010 to 2022, by rurality and across medi...

See recent articles in @jama.com, such as jamanetwork.com/journals/jam..., jamanetwork.com/journals/jam..., and jamanetwork.com/journals/jam... @lisamjarvis.bsky.social

Trump Shapes Gilded Age of US Immigration With $100,000 H-1B Fee President Donald Trump took his most extensive step yet toward overhauling the US legal migration system, with a pair of proclamations that explicitly favor the wealthiest of the world’s prospective e...

Most early attention on the H-1B EO imposing a $100k fee is focused on the tech industry (i.e., good story by @joshwingrovebbg.bsky.social and Spencer Soper) www.bloomberg.com/news/article.... However, this policy will have a huge impact on healthcare delivery systems and research enterprise (1/2)

"Climate change is no longer a problem for our grandchildren but is inflicting profound economic and health damage right now.” @markgongloff.bsky.social

FDA moves to publish drug rejection letters in real time, releases new batch including Replimune's high-profile snub The FDA today announced a plan to p | The Food and Drug Administration today announced a plan to publicly release complete response letters at the same time they are issued to sponsoring companies, pa...

Kudos to @fda.gov leadership for following through on their efforts to promote transparency by posting CRLs for 2024 pending or withdrawn product applications. There is a lot that scientists, industry and clinicians can learn when FDA does not approve a product www.fiercebiotech.com/biotech/fda-...

Great reporting on RFK "going wild" by sabotaging the @altcdc.altgov.info @dhruvkhullar.bsky.social www.newyorker.com/magazine/202...

Florida Decided There Were Too Many Children The state’s elimination of vaccine mandates is a courageous first step toward decluttering itself of any excess kids.

Florida Decided There Were Too Many Children

Florida Made a Vaccine Mistake. Now, It’s Everyone’s Problem. State efforts to protect access to shots are welcome, but they can’t compensate for others’ anti-science policies and a dysfunctional CDC.

Florida Made a Vaccine Mistake. Now, It’s Everyone’s Problem.

Agree with @lisamjarvis.bsky.social, viruses don’t give a damn for state lines

www.bloomberg.com/opinion/arti...

Great story by @annaedney.bsky.social ... reminds me of what happened with Essure, as patients complaints went unheeded for years

Trump’s Department of Energy Gets Scienced International climate experts have extensively debunked the D.O.E.’s recent report, but will science win out?

"The American scientific enterprise is being unravelled before our eyes—research grants are being cut off, satellites disconnected, reports cooked up [by] particular industries and ideologies ... but in the end, the truth will [win] out." @billmckibben.bsky.social www.newyorker.com/news/the-led...

Industry payments to US neurologists related to multiple sclerosis drugs and prescribing (2015-2019): a retrospective cohort study - PubMed Nearly 80% of neurologists prescribing MS drugs received at least one industry payment, with higher volume prescribers being more likely to receive payments. Physicians receiving payments were more li...

“Physicians receiving payments were more likely to prescribe the company's drugs, with a stronger association for payments that were larger, sustained and recent.”

New work on bribes to Rx multiple sclerosis drugs by Sayed, @reshmagar.bsky.social @jsross119.bsky.social

On a Slow Boat to Publication: Rethinking How We Disseminate Medical Research | Annals of Internal Medicine

"In a world accustomed to receiving real-time information, the process of publishing medical research remains trapped in a system designed for a slower era,” per @jsross119.bsky.social & colleagues from @utoronto.ca Med in @annalsofim.bsky.social
www.acpjournals.org/doi/10.7326/...
#peerreview

Opinion | The Playbook Used to ‘Prove’ Vaccines Cause Autism Data can easily be manipulated to show a causation that doesn’t exist.

Amazing data visualization illustrating how Grier family manipulated science to ‘prove’ vaccines cause autism. Key take-home: "those who claim to champion people with autism are denying them real research while undermining one of public health’s greatest achievements" www.nytimes.com/interactive/...

The E.P.A.’s Disastrous Plan to End the Regulation of Greenhouse Gases With a new proposal, the Trump Administration, which has already laid waste to dozens of programs aimed at limiting climate change, has managed to outdo itself.

The EPA's disastrous plan to end the regulation of greenhouse gases & just let climate change run rampant. www.newyorker.com/news/the-led... via @elizkolbert.bsky.social

Days after $5 million donation to MAGA Inc., Trump freezes Medicare waste crackdown Trump pledged to root out "waste, fraud and abuse." Then a big contribution to his Super PAC came in.

1. On February 24, Extremity Care LLC, a company that sells very expensive bandages made from placentas, donated $5 MILLION TO TRUMP'S SUPER PAC

Days later, Trump froze a pending rule that would BAR MEDICARE FROM COVERING EXTREMITY CARE'S PRODUCTS, which are overpriced & not backed by science.

Scientists slam Trump administration climate report as a ‘farce’ full of misinformation Experts say the report being used to justify the mass rollback of climate regulations has many claims based on long-debunked research

"The esteemed climate scientist Michael Mann said the report was akin to the result he would expect “if you took a chatbot and you trained it on the top 10 fossil fuel industry-funded climate denier websites”."
www.theguardian.com/us-news/2025...

How the DOE and EPA used and misused my research Elevating contrarian views while burying the actual science

I have a new post over at The Climate Brink on how the recent DOE report on climate science and the EPA's proposed overturning of the endangerment finding used and misused my research: www.theclimatebrink....

"If the US is no longer the world’s technoscientific superpower, it will almost certainly suffer for the change. America’s technology sector might lose its creativity. But science itself, in the global sense, will be fine. The deep human curiosities that drive it do not belong to any nation-state."

The Men Trump Deported to a Salvadoran Prison On March 15, President Donald Trump’s administration sent more than 230 Venezuelan immigrants to a maximum-security prison in El Salvador. Last week, the men were released as suddenly as they’d been t...

A singular achievement in reporting and storytelling: The Men Trump Deported to a Salvadoran Prison, by @propublica.org and partners.

High brand-name drug prices fall once a generic enters the market. In a new @journalgim.bsky.social article, Ravi Gupta, CRRIT Co-Director @jsross119.bsky.social, and colleagues from @portalresearch.org assess associations between patents, revenue, and generic competition.

Musk’s Neuralink falsified federal forms, claims to qualify for racial diversity program The company, owned by the world's wealthiest man, says it is a "small disadvantaged business"

You cannot make this stuff up! @muskwatch.bsky.social reports that Musk's $9b neurotechnology company self-certified as a "small disadvantaged business", despite his >$400b net worth, and federal regs precluding designation to individuals with a net worth >$850k www.muskwatch.com/p/musks-neur...

Demand for 988 Continues to Grow at Third Anniversary | KFF This policy watch examines 988 on its third anniversary, drawing from the latest Lifeline data available through May 2025 and suicide death data from CDC WONDER for the period 2013 to 2023. 988 receiv...

988 contacts continue to grow; however, significant legislative changes to Medicaid are expected to result in less coverage and funding with implications for access to broader mental health services. www.kff.org/policy-watch...