Reshma Ramachandran

@YaleMed Assistant Prof, @Yale_CRRIT Co-Director, @Drsforamerica Board of Directors #patientsbeforeprofits *Views here are my own*

[Reshma Ramachandran @reshmagar]

While this paper focuses on FAERS (FDA's passive drug safety surveillance system), the limitations also apply to VAERS for vaccines. Current FDA leadership is using VAERS to make conclusions despite its many limitations & with no transparency of how the reports were investigated.

[Yale CRRIT @Yale_CRRIT]

Now out in @NEJM is a new Perspective piece from the CRRIT team on the potential consequences of @US_FDA’s recent announcement to release daily drug adverse event reports from FDA’s Adverse Event Reporting System (FAERS) https://t.co/U5th7nE5rA (1/10)

[Sarah Karlin-Smith @SarahKarlin]

For its own employees Cigna will end GLP-1 weight-loss drug coverage arguing "as availability has increased and new options ​have emerged..." but story says its covering OLD options rarely due poor safety, effectiveness.

https://t.co/OH6bfvibFs

[Adam Gaffney @awgaffney]

Extraordinary study in JAMA IM confirms what many of us have warned against: "pay-for-performance" incentives in medicine reward "teaching to the test" with potentially harmful results

In this quasi-experimental study, incentivizing doctors to control blood pressure (BP)...

1/X

[Max Bayer @maxonwifi]

Some scoopy details in our Replimune coverage: The FDA investigated how the RP1 submissions were handled and found that processes were followed accordingly in both reviews. But, there were mixed opinions across the agency about whether to grant approval.

https://t.co/xbWWbwc5Ew

[National Breast Cancer Coalition @NBCCStopBC]

Attending the @drsforamerica Conference on June 5th? Don't miss NBCC's @MichelleTregear on a panel of experts, including @reshmagar & more, discussing the state of the FDA's drug approvals system. Learn more about the event here: https://t.co/WUyaHtqBWW

[Lauren Gardner @Gardner_LM]

NEW: Former FDA Commissioner Marty Makary's signature program to speed up reviews for certain drug applications will continue for now. But "commissioner" is dropping from the title and the pilot will be reassessed after a public mtg next month. For Pros: https://t.co/rwBclycvE4

[Reshma Ramachandran @reshmagar]

"Nearly all the appointees hold senior leadership positions in health care organizations that are invested in making money off the U.S. health system, suggesting they may be more committed to serving the bottom lines of groups that profit from the U.S.’s broken health care..."

[Sarah Karlin-Smith @SarahKarlin]

If you're covering the first meeting of CMS's new Healthcare Advisory Committee today, I dug into the backgrounds of the members.

https://t.co/awf25R7jXS

[Reshma Ramachandran @reshmagar]

Here's our study, mentioned in the article (thanks Ed!) led by Tobias Liu: "A recent analysis published in @JAMANetworkOpen found that pharma companies that were penalized for kickbacks paid only 2.2% of their U.S. revenue generated by selling drugs..." https://t.co/P7sZtHk7lc

[pharmalot @pharmalot]

Takeda will pay $13.6 million to settle allegations it paid kickbacks to doctors... https://t.co/XpAldKX0Mc #pharma #kickbacks #bribes #Takeda #doctors #meals #speaker $TAK

[ProPublica @propublica]

NEW: We just launched a new podcast! It’s called “Paper Trail,” and for our first episode, we’re taking you behind the scenes of a Pulitzer finalist investigation.

This is what the FDA won’t tell you about the generic drugs in your medicine cabinet: https://t.co/kyW1yTgwyr

[Lauren Gardner @Gardner_LM]

SCOOP: Makary is out as FDA commissioner, Kyle Diamantas to serve as acting. From @davidalim et moi:

https://t.co/qkgoFJBiNX

[Reshma Ramachandran @reshmagar]

Link: https://t.co/DhyhjegCM3

[Reshma Ramachandran @reshmagar]

🎯from @NicholasFlorko in @TheAtlantic: They show how, time & again, [FDA Commissioner Makary] put his or his bosses’ preferences first. These decisions may end his career as commissioner, but they’ve already set a dangerous precedent for political interference at the agency.

[Reshma Ramachandran @reshmagar]

A must-read piece. Makary has claimed that he'll hire 3000 (up from his prior goal of 1000, which hasn't panned out) new staff after the mass firing (#DOGE) & exit of doctors, scientists, & technical experts at FDA who play a critical role in protecting patients & public health.

[Lizzy Lawrence @LizzyLaw_]

NEW: The FDA has started to rehire after losing thousands of employees last year. But it will be difficult to replace what was lost. Read our profile of six of the folks who left, featuring video portraits filmed by @HoganAlex:
https://t.co/2q0pWIm5C4

[Reshma Ramachandran @reshmagar]

@GregTHR @bylenasun I saw this & hope WSJ releases Makary's memo as well - nevertheless, interference from a political appointee (Makary) & the White House (who is also politically invested in this decision) on what should be an independent, scientific process from a regulator is still not good.

[Reshma Ramachandran @reshmagar]

@thoughtsmoke_ https://t.co/NLkBxgaMKe

[Reshma Ramachandran @reshmagar]

@GregTHR @bylenasun I saw this & hope WSJ releases Makary's memo as well - nevertheless, interference from a political appointee (Makary) & the White House (who is also politically invested in this decision) on what should be an independent, scientific process from a regulator is still not good.

[Reshma Ramachandran @reshmagar]

This is bad, very bad. Instead of FDA making regulatory decisions independently & with scientific integrity, the White House seems to have politically pressured the agency here. By doing so, Trump/RFK Jr/HHS have set a dangerous precedent, inviting doubt on future FDA decisions.

[LenaSun @bylenasun]

NEW: In a first, FDA authorizes fruit-flavored vapes for adults. Approval marks shift after FDA for years worked aggressively to regulate flavored vapes. It came after President Trump reportedly pressed FDA chief to approve the product. @Rachel_Roubein https://t.co/sFLWDCOXN3

[Lizzy Lawrence @LizzyLaw_]

SCOOP: Sanofi has asked the FDA to pull its type 1 diabetes drug, Tzield, out of the Commissioner's drug review voucher program. The move comes after acting CDER director Tracy Beth Høeg disagreed with a staff decision to approve the drug.
https://t.co/ebTZSIy3tO

[Reshma Ramachandran @reshmagar]

@GregTHR @bylenasun this decision mean for future regulatory decisions around these products? Will the White House exert pressure for their preferred decision despite what internal reviewers might determine? This time, White House may have aligned with career staff, but what happens when it's not?

[Reshma Ramachandran @reshmagar]

@GregTHR @bylenasun This is why there is a dispute resolution process at the agency. Consider other areas where the White House is invested - peptides, psychedelics, vaccines - we're seeing announcements indicating a willingness to ignore FDA's scientific review process almost daily. What does...

[Charles Ornstein @charlesornstein]

IMPORTANT AND HEART BREAKING STORY: Babies Are Bleeding to Death as Parents Reject a Vitamin Shot Given at Birth
https://t.co/27DV09IIsl @deldeib