Reshma Ramachandran @reshmagar
@YaleMed Assistant Prof, @Yale_CRRIT Co-Director, @UAEM NA Board Prez, @Drsforamerica FDA Task Force Chair #access2meds #patientsbeforeprofits #openaccess New Haven, CT, United States Joined April 2010-
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The team’s all here in PGH! Great to see after months of emails and Teams meetings were just 1 sleep away from #Pharmacoequity2024! Great to share in community with our brilliant expert panelists who joined us from across the US! Still time to register! cp3.pitt.edu/events/pharmac…
Dr @reshmagar speaking on regulatory barriers & solutions to equitable clinical trial design. Our FDA practices are giving us faster drugs yes, but they are lower quality. And trial enrollment is not representative of the diversity of pts with that disease. #pharmacoequity2024
@US_FDA approvals using Real-time Oncology Review were often based on trials using surrogate markers as endpoints and lacked confirmatory trials, this study finds. @Yale_CRRIT @MaryamMooghali @jsross119 @JoshuaDWallach @TheWonkologist @reshmagar ja.ma/4bgd0to
Curbing the price of new diabetes & obesity meds @klipskaMD @reshmagar Dr Kathryn Nagel looked at drug affordability & examined the changes needed to achieve fair pricing of new diabetes & obesity drugs, creating a blueprint for policymakers @YaleMed tinyurl.com/343hu6z7
CRRIT, led by @DrMichaelMensah, @Ayman_Mohammad_, @juliaetkin, @jsross119, & @reshmagar, has submitted comments on @US_FDA's guidance on "Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products."
With 2 days left, we’re getting closer to breaking records for our 3rd Annual Pharmacoequity Conference! 😅 I’m biased as the moderator but our Policy Panel on sickle cell 💊, FDA regs, & mental health is gonna be ☄️. Register here! health.pitt.edu/news/pitt-host… #Pharmacoequity2024
No - @MaryamMooghali & colleagues found that despite most RTOR cancer drugs receiving traditional approval based on surrogate markers, @US_FDA mostly did not mandate postapproval studies, unlike with accelerated approval, leaving continued uncertainty of their clinical benefit.
New @JAMANetworkOpen study finds that 1 in 5 cancer drugs were approved through @US_FDA's Real-Time Oncology Review program (shorter review, faster approval), many of which were based on surrogate markers - Did FDA ask for confirmation of clinical benefit?jamanetwork.com/journals/jaman…
Yep, the Chair of the Senate HELP Committee and champion of enabling affordable access to medicines (not to mention, who also has the *best* staffers) will be speaking at the @drsforamerica National Leadership Conference. I'll be there - will you? doctorsforamerica.org/event/2024-nat…
Yep, the Chair of the Senate HELP Committee and champion of enabling affordable access to medicines (not to mention, who also has the *best* staffers) will be speaking at the @drsforamerica National Leadership Conference. I'll be there - will you? doctorsforamerica.org/event/2024-nat… https://t.co/3ioAAQR4L2
Very much looking forward to being part of this next week and to hear from so many inspiring speakers! cc: @uaem @drsforamerica
Very much looking forward to being part of this next week and to hear from so many inspiring speakers! cc: @uaem @drsforamerica
Spot-on letter from @SenSanders to @IFPMA & @pfizer heads urging them to stop opposing proposals in the @WHO #PandemicAccord that would enable access to drugs, vaccines, & tests during public health emergencies as an obvious lesson learned from #COVID19. sanders.senate.gov/press-releases…
The very real scenarios ignored by some on #SCOTUS: "And, in Idaho, doctors fearful of prosecution are airlifting women to neighboring states...Some Idaho doctors are recommending that their pregnant patients buy insurance that covers emergency air transportation." @drsforamerica
The very real scenarios ignored by some on #SCOTUS: "And, in Idaho, doctors fearful of prosecution are airlifting women to neighboring states...Some Idaho doctors are recommending that their pregnant patients buy insurance that covers emergency air transportation." @drsforamerica
This is the FIRST EVER study sharing detailed cost of running a clinical trial. MSF hopes to see more funders and implementors of trials revealing their trial cost to ensure transparency of cost of research and development of medicines and medical tools. #PeopleOverProfits
This is the FIRST EVER study sharing detailed cost of running a clinical trial. MSF hopes to see more funders and implementors of trials revealing their trial cost to ensure transparency of cost of research and development of medicines and medical tools. #PeopleOverProfits
Important coverage of the need for transparency at the FDA and the impact of use of surrogate endpoints (P.S. the Chair of our FDA Task Force is a co-author of the study mentioned!) @reshmagar endpts.com/researchers-se…
EMTALA is the law that allows anyone to be seen in the emergency room without being turned away. This law is being discussed in connection to an Idaho law that infringes on this federal law. This is a big deal. #EMTALA #patientsoverpolitics #ReproductiveRights #reprojustice
Kudos to @SenSanders & @HELPCmteDems team for launching this investigation based on the @JAMANetworkOpen recent study led by @mellabarb that found large discrepancies between prices charged across countries for these treatments & their costs of production: medicine.yale.edu/internal-medic…
Kudos to @SenSanders & @HELPCmteDems team for launching this investigation based on the @JAMANetworkOpen recent study led by @mellabarb that found large discrepancies between prices charged across countries for these treatments & their costs of production: medicine.yale.edu/internal-medic…
US cancer guidelines do not always inform clinicians that drugs granted accelerated approval failed to show clinical benefit in confirmatory trials. @MaryamMooghali @jsross119 @reshmagar @JoshuaDWallach @BMJMedicine bmjmedicine.bmj.com/content/3/1/e0…
Madhu Pai, MD, PhD @paimadhu
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6K Followers 5K Following Congressional Health Care Reporter @InHealthPolicy | Past: @BGOV, @CNN, @Forbes | @NABJ | ❝The people must know before they can act...❞ — Ida B. WellsNational Institute of.. @NIST
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56K Followers 1K Following The AI Now Institute produces diagnosis and actionable policy research on artificial intelligence.Meredith Whittaker @mer__edith
92K Followers 4K Following President of @signalapp, Chief Advisor to @ainowinstitute (Also on Mastodon @[email protected], also on bsky @meredithmeredith.bsky.social)Respond Crisis Transl.. @RespondCrisis
12K Followers 681 Following We mobilize around-the-clock to provide trauma-informed interpretation and translation support—and language rights advocacy. [email protected]@UREssien @seethal_jacobmd @reshmagar @IshaniG @DrJuanHC @PittCP3 @DrKMSimon @PittDeptofMed @PittGIM @PittTweet How many health services researchers can you fit into #pharmcoequity elevator? See you tomorrow for the #Pharmacoequity2024 conference. cp3.pitt.edu/events/pharmac…
The team’s all here in PGH! Great to see after months of emails and Teams meetings were just 1 sleep away from #Pharmacoequity2024! Great to share in community with our brilliant expert panelists who joined us from across the US! Still time to register! cp3.pitt.edu/events/pharmac…
Not gonna lie, that Policy Panel was 🔥. From hearing the role of the Black Panther Party in ⬆️ sickle cell disease 💊, “shenanigans” by drug companies weaponizing health equity, to the downstream effects of not ⬆️ mental health tx for all. #Pharmacoequity2024 📸: @fumikochino
We’re back from our break with our Policy Panel! 💊 Will pause on live tweeting as the moderator but so excited to learn from @seethal_jacobmd @reshmagar & @DrKMSimon. #Pharmacoequity2024
@fumikochino @seethal_jacobmd @reshmagar @DrKMSimon Closing out our morning session with our Payer Panel. Hearing from 3 pharmacists, Vanessa Campbell at UPMC, Fran Cunningham at VA & Kyle McCormick @Blueberry_Rx who shared on their strategies to improve access to 💊. There’s more after lunch. Stay tuned! #Pharmacoequity2024
@fumikochino @seethal_jacobmd @reshmagar @DrKMSimon @Blueberry_Rx Closing out an amazing day at our conference with our keynote. Lucky to have Dr. @fumikochino, an international leader on “Financial Toxicity” as our Keynote Speaker this year! Coming up with “a new term for a growing problem” is how pharmacoequity began. #Pharmacoequity2024
Dr @reshmagar speaking on regulatory barriers & solutions to equitable clinical trial design. Our FDA practices are giving us faster drugs yes, but they are lower quality. And trial enrollment is not representative of the diversity of pts with that disease. #pharmacoequity2024
Watching the campus I’m about to join in a mere 2 months in shambles is bringing up an emotion I can’t quite name.
Curbing the price of new diabetes & obesity meds @klipskaMD @reshmagar Dr Kathryn Nagel looked at drug affordability & examined the changes needed to achieve fair pricing of new diabetes & obesity drugs, creating a blueprint for policymakers @YaleMed tinyurl.com/343hu6z7
CRRIT emphasized concerns about race as a genetic proxy & the need for careful race assignment in research, stressing the importance of ensuring race-related data collection methods are appropriate + transparent to improve understanding of racial health disparities/solutions.
4. Specify the dimension and modality used to ascertain research participant race and ethnicity. 5. Connect the racial dimension to the primary outcome in an explanatory model. 6. Explicitly state what race is a proxy for, if anything, in the study's explanatory model.
2. Avoid recommending against assigning race to participants; instead, recommend following best practices established by the social sciences. 3. Add a "Middle Eastern North African" choice to the close-ended racial self-classification question.
Our comment addressed suggestions and revisions for the guidance, including... 1. @FDA refrains from suggesting that racial differences in the effects of medical products are mediated by genetics.
Our recommendations follow the newest guidance on the collection of race and ethnicity data from the Office of Management and Budget (OMB) & the newest guidance from the National Academies of Sciences, Engineering and Medicine (NASEM) to inform the collection of demographic data.
CRRIT, led by @DrMichaelMensah, @Ayman_Mohammad_, @juliaetkin, @jsross119, & @reshmagar, has submitted comments on @US_FDA's guidance on "Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products."
With 2 days left, we’re getting closer to breaking records for our 3rd Annual Pharmacoequity Conference! 😅 I’m biased as the moderator but our Policy Panel on sickle cell 💊, FDA regs, & mental health is gonna be ☄️. Register here! health.pitt.edu/news/pitt-host… #Pharmacoequity2024
🚨 It’s conference week! With over 350 registered so far, we’re close to making this our highest attended meeting yet! 😅 Can’t wait to see the all virtually or in person in Pittsburgh on Friday, 5/3! You’ll want to hear @fumikochino give her keynote! calendar.pitt.edu/event/3rd_annu…
Was just telling my kids how at Princeton in the late 90s some students occupied the President’s office for weeks, and everyone treated it as totally mundane. At Bard where I grew up it happened all the time. Heard that Guidos office at YLS was occupied too.
I feel like I'm losing my mind a little: people understand that "occupying buildings on campus" is, like, one of the most common forms of studen protest for decades and not some devious new ploy devised by professional anarchist plotters, right?
@US_FDA approvals using Real-time Oncology Review were often based on trials using surrogate markers as endpoints and lacked confirmatory trials, this study finds. @Yale_CRRIT @MaryamMooghali @jsross119 @JoshuaDWallach @TheWonkologist @reshmagar ja.ma/4bgd0to