@YaleMed Assistant Prof, @Yale_CRRIT Co-Director, @Drsforamerica Board of Directors #patientsbeforeprofits *Views here are my own*
New Haven, CT, United States
Joined April 2010
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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.
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) nejm.org/doi/full/10.1056/NE… (1/10)
in their recommendation to not allow for legal compounding of these peptides (in addition to pointing to decades of evidence showing no demonstrated efficacy or safety nor there being established quality standards for these products): healthaffairs.org/content/fo…
For an administration that is so concerned about fraud, waste, and abuse, opening the doors to unproven peptides only creates more of these problems for patients. Plus stripping health insurance from millions means they won't be able to see a doctor who can provide independent...
Requiring compounders to report adverse events for peptides where there is no evidence of efficacy, safety, and quality is basically putting a bandaid on a bullet hole. Here are the many reasons why this is an awful idea that will fail to protect patients:
New: Top officials at HHS and FDA have been working to balance Health Secretary Robert F. Kennedy Jr.’s push to expand access to buzzy peptides with safety concerns raised by agency scientists. A peek behind the curtain with new details on the path ahead w/ the dream team @rileyraygriffin @g0ingmad @nyahphengsitthy
🎁: bloomberg.com/news/articles/…
overstating benefits or not disclosing/underplaying risks to attract patients and then having little to no clinical oversight of the prescription process, providing care that is centered around a prescription and not the patient: jamanetwork.com/journals/jam…
as we've found, despite arguments from the peptide industry that patients will be safe with clinician providing oversight, that is not what happens in practice. These platforms effectively act as a pill mill using misleading marketing including... jamanetwork.com/journals/jam…
FDA deal with this patchwork of state policies to ensure compliance and enforcement? 5. Telehealth platforms like Hims&Hers and others are waiting for FDA/RFK to turn on the switch for peptides to start widely marketing and prescribing to patients but... fiercehealthcare.com/health-…
4. Under current law, these pharmacies are also not required to be registered with the FDA so the agency will have to rely on state regulators to find these pharmacies and ensure ongoing reporting. But state regulations are highly variable including around inspections! How will..
3. Under this administration, FDA has lost almost a quarter of its technical capacity through DOGE and others leaving the agency. So who is left to take on this monumental task of monitoring these pharmacies selling unprovem peptides? statnews.com/2026/09/17/fda-…
this primary relies on insurance claims data and electronic health records. These studies of reported adverse events are necessary for FDA to take timely regulatory action like shutting down a compounding pharmacy that is selling harmful products. jamanetwork.com/journals/jam…
system to investigate these signals which leads me to point 2. As these peptides will be available outside of insurance and traditional healthcare (ie, telehealth, medspas), FDA will not be able to use its active surveillance system, Sentinel to investigate these signals as...
and would also necessitate FDA to investigate the safety signals to see if the effects are indeed due to the peptides themselves. Not to mention how such passive reporting is often gamed by manufacturers including to dissuade competitors. FDA could use its active surveillance...
1. Even for drugs that undergo FDA regulatory review, passive reporting like this has several limitations as we @Yale_CRRIT have detailed: nejm.org/doi/abs/10.1056/NEJ…. There would be no reliable denominator of how many people are taking peptides to gauge the extent of the safety...
Reshma Ramachandran retweeted
Our latest @CBSNews investigation - We bought and tested what was sold as an experimental weight loss drug. The lab results were "pretty terrifying."
MORE HERE: cbsnews.com/news/tested-expe…
@adamyamaguchi @ByDanielGilbert @mattmosk @CBSMornings
The weight loss drug, Retatrutide, is not FDA approved and still in clinical trials, but is being advertised all over the internet.
CBS News’ @AdamYamaguchi shows just how surprisingly easy it is to buy and tests what's really in it. cbsnews.com/news/tested-expe…
Thanks for speaking with me for this segment (I'm in this!). This is incredible investigative reporting from CBS/@adamyamaguchi who bought retatrutide (not yet FDA approved) way too easily, finding via testing the drugs bought weren't what was claimed or had harmful contaminants.
Weight-loss drug retatrutide is in development and not FDA approved — but across the internet and in American corner stores, vials and shipments labeled as “reta” are readily available, a CBS News investigation found.
But what is in those bootleg drugs? @adamyamaguchi had copycat products from multiple sources tested.
Reshma Ramachandran retweeted
Reminder that this event is TOMORROW! Please join! Free and open to all (with registration)!
Event at @nyulaw @nyuengelberg with @realtahiramin & @reshmagar!
Monday, October 19, 6 pm!
We'll discuss Tahir's new book, Pharma Monopoly: The Battle for the Future of Medicines, co-authored with Rohit Malpani.
Free! Open to all! Join us!
Reshma Ramachandran retweeted
Doctors for America Urges White House to Reject FDA's "Interim Access Policy" for Unapproved Peptides
doctorsforamerica.org/news/s…
As we've written, this is a mistake that could harm patients. FDA leadership should listen to their own scientific experts, not the companies who'll profit, before opening the back door to peptides of unknown benefit, unknown safety, and unknown quality. washingtonpost.com/health/20…
Here's our @Yale_CRRIT piece in @Health_Affairs Forefront on the lack of evidence for efficacy, safety, and quality for peptides and our research finding little to no clinician oversight from telehealth platforms selling peptides directly to patients: healthaffairs.org/content/fo…