The patient was not recommended for bariatric surgery, given their age and other conditions. It was unclear whether the person would have been eligible for a trial. It’s also unclear if retatrutide would work in patients who have failed to see success with tirzepatide.
“Something very wrong”
The public notice of the expanded access is suspicious, omitting much of the information that such a notice would normally include, such as the conditions that might qualify a patient for such access.
“Only people in the know would be able to find this [notice], using the drug name,” Richard Klein, who helped launch the FDA’s expanded access program in the 1980s, told Stat. “There is something very wrong with the way this is listed because no one would know what it is from the listing, or what it’s for.”
Stat asked both the White House and the Department of Health and Human Services if Trump is the patient, and if he has obstructive sleep apnea and pulmonary hypertension, which were not included in a memo of his most recent medical evaluation. White House spokesperson Kush Desai did not answer the question and deferred to the health department. HHS spokesperson Emily Hilliard also did not directly deny that Trump is the patient.
She provided a statement saying:
The FDA supports expanded access programs that can provide patients with serious or life-threatening conditions access to investigational treatments when no comparable or satisfying approved therapies are available. Each request is reviewed on a case-by-case basis based on the clinical circumstances and applicable statutory and regulatory requirements.
Over a dozen experts who spoke to Stat said it was highly unusual for a drug company to grant expanded use of a drug for common conditions to a single patient rather than a cohort of patients with a specified profile.
Lilly spokesperson Misty Fuller did not answer Stat’s questions, saying, “We make these decisions following all applicable regulations.” The NIH clinician who made the request, Muniyappa, also did not respond to questions.
