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Flexibility Over Rigor: Stakeholder Acceptance of the Limitations of Confirmatory Studies Following Accelerated Approval

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Reposted by Joseph S. Ross, Reshma Ramachandran

Holly Fernandez Lynch @hollylynchez.bsky.social · 22d

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...

Despite the importance of postmarketing requirements (PMRs) following accelerated approval and well-recognized shortcomings in their rigor and timeliness,

academic.oup.com

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Joseph Ross @jsross119.bsky.social · Sep 10

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

Mark Gongloff @markgongloff.bsky.social · Sep 8

Climate change is an economic emergency, part 1000:

More than $1 trillion in US wages has been lost to wildfire smoke alone in the past 5 years. Gift link to my column for @opinion.bloomberg.com

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

$1 Trillion in American Wages Has Gone Up in Wildfire Smoke

The toxic haze is a nightmare for health and productivity.

$1 Trillion in American Wages Has Gone Up in Wildfire Smoke

Reposted by Joseph S. Ross

Mark Gongloff @markgongloff.bsky.social · Sep 8

The toxic haze is a nightmare for health and productivity.

FDA moves to publish drug rejection letters in real time, releases new batch including Replimune's high-profile snub

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Joseph Ross @jsross119.bsky.social · Sep 6

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@fda.gov leadership for following through on their efforts to promote transparency by posting CRLs for 2024 pending or withdrawn product applications.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-...

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...

www.fiercebiotech.com

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Joseph Ross @jsross119.bsky.social · Sep 6

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

Reposted by Shannon Vallor, Joseph S. Ross, Joe R. Feagin , and 10 more Shannon Vallor, Joseph S. Ross, Joe R. Feagin, John McLaren, Kevin Carey, Melanie C. Green, Aaron Sojourner, Andrew L. Whitehead, Erin O’Donnell, Mark Rice, Andrew Rudalevige, Nicole Guenther Discenza, Manisha Sinha

Alexandra Petri @petridishes.bsky.social · Sep 4

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.

www.theatlantic.com

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Joseph Ross @jsross119.bsky.social · Sep 4

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

Anna Edney @annaedney.bsky.social · Sep 4

In my @bloomberg.com Big Take out today I explored how Hologic pushed a medical device on breast cancer patients despite hundreds of complaints, most of which stayed buried until now

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Reposted by Joseph S. Ross

Madhu Pai, MD, PhD @madhupai.bsky.social · Sep 4

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...

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.

Trump’s Department of Energy Gets Scienced

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Reposted by Joseph S. Ross, Daniel Aaron

Anna Edney @annaedney.bsky.social · Sep 4

In my @bloomberg.com Big Take out today I explored how Hologic pushed a medical device on breast cancer patients despite hundreds of complaints, most of which stayed buried until now

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Joseph Ross @jsross119.bsky.social · Sep 3

"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...

International climate experts have extensively debunked the D.O.E.’s recent report, but will science win out?

www.newyorker.com

Reposted by Joseph S. Ross

Peer Review Congress #PRC10 @peerreviewcongress.bsky.social · Sep 1

"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

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

www.acpjournals.org

Industry payments to US neurologists related to multiple sclerosis drugs and prescribing (2015-2019): a retrospective cohort study - PubMed

Reposted by Joseph S. Ross

Aaron Mitchell @thewonkologist.bsky.social · Aug 27

“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

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...

pubmed.ncbi.nlm.nih.gov

Opinion | The Playbook Used to ‘Prove’ Vaccines Cause Autism

Joseph Ross @jsross119.bsky.social · Aug 19

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/...

Data can easily be manipulated to show a causation that doesn’t exist.

www.nytimes.com

Reposted by Joseph S. Ross

Craig Pittman @craigtimes.bsky.social · Aug 4

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

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.

www.newyorker.com

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Reposted by Joseph S. Ross

Judd Legum @juddlegum.bsky.social · Aug 4

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.

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.

popular.info

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Joseph Ross @jsross119.bsky.social · Aug 3

"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...

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

www.theguardian.com

Reposted by Joseph S. Ross, Du Toit, Jesse H. Kroll , and 1 more Joseph S. Ross, Du Toit, Jesse H. Kroll, John Fasullo

Zeke Hausfather @hausfath.bsky.social · Aug 3

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....

How the DOE and EPA used and misused my research

Elevating contrarian views while burying the actual science

www.theclimatebrink.com

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Joseph Ross @jsross119.bsky.social · Aug 1

"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 Atlantic @theatlantic.com · Jul 31

The rapid decline of American science has few precedents in history, argues @rossandersen.bsky.social. We are witnessing an unparalleled act of self-sabotage:

How Scientific Empires End

And what it means for America

How Scientific Empires End

Reposted by Joseph S. Ross

The Atlantic @theatlantic.com · Jul 31

The rapid decline of American science has few precedents in history, argues @rossandersen.bsky.social. We are witnessing an unparalleled act of self-sabotage:

And what it means for America

Breaking: Firings sweep across FDA, gutting leadership and whole offices

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Reposted by Joseph S. Ross, Linda J. Skitka, Caroline Fohlin

Neil Hillhouse (The Haunting Of) @nstenhouse.bsky.social · Jun 29

“ICE gets a bigger budget than the Marine Corps” is a simple fact that should be communicated very widely because it clearly expresses how crazy and radical this is

David Burbach 🌹 @dburbach.bsky.social · Jun 29

With this budget, ICE alone would have nearly as large a detention operation as all 50 states' prison systems combined. Bigger budget than the Marine Corps. Police-state levels of spending

Aaron Reichlin-Melnick @reichlinmelnick.bsky.social · Jun 28

If the GOP reconciliation bill passes, ICE gets through FY2029:

- $45 billion for detention, on top of the current annual budget of $3.4 billion
- $14.4 billion for transportation and removal, on top of the current annual budget of $750 million
- $8 billion for hiring/retention
- Billions more.

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Reposted by Joseph S. Ross

Zachary Brennan @zacharybrennan.bsky.social · Apr 1

Breaking: Firings sweep across FDA, gutting leadership and whole offices endpts.com/firings-swee...

Mass firings and forced resignations swept through the FDA on Tuesday, as part of thousands of planned job cuts at federal health agencies being implemented by the Trump administration.

endpts.com

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Reposted by Joseph S. Ross

JAMA @jama.com · Apr 3

Deportations and immigration restrictions could impact the US health care system by removing skilled noncitizen workers, leading to staff shortages and compromised patient care. https://ja.ma/4ci0NpS

Deporting Immigrants May Further Shrink the Health Care Workforce

This study explores the potential for health care staffing shortages in the US by estimating the number of immigrants employed in health care who could be affected by deportation or immigration restrictions.

ja.ma

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Reposted by Joseph S. Ross

Reshma Ramachandran @reshmagar.bsky.social · May 12

Anyone know what this part of the "most-favored nation" drug pricing EO means for @fda.gov given the language "maybe be unsafe, ineffective, or improperly marketed"? At worst, FDA could withdraw drugs that are thought to be, but not necessarily proven to be ineffective or unsafe? #MedSky #EpiSky

(v) the Commissioner of Food and Drugs shall review and potentially modify or revoke approvals granted for drugs, for those drugs that maybe be unsafe, ineffective, or improperly marketed; and

America could soon find itself in a new Dark Age.

Reposted by Joseph S. Ross

The Atlantic @theatlantic.com · May 27

“The Trump administration has launched a comprehensive attack on knowledge itself, a war against culture, history, and science,” @adamserwer.bsky.social writes. “If this assault is successful, it will undermine Americans’ ability to comprehend the world around us."

The Attack on Knowledge

How Health Became a Luxury Commodity

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Reposted by Joseph S. Ross

The Atlantic @theatlantic.com · May 29

Amy Larocca’s “How to Be Well” documents the ever-expanding, MAHA-adjacent wellness industry. It also reveals how health-care inequality fueled the spread of conspiracy theories, writes Sheila McClear:

A new book about American wellness reveals how health-care inequality fueled the spread of anti-science conspiracy theories.

The Men Trump Deported to a Salvadoran Prison

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Reposted by Joseph S. Ross

Charles Ornstein @charlesornstein.bsky.social · Jul 23

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

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...

projects.propublica.org

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Reposted by Joseph S. Ross, Aaron S. Kesselheim

Yale CRRIT @yalecrrit.bsky.social · Jul 21

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.