The patient was not recommended for bariatric surgery, given his age and other conditions. It was unclear whether the person would have been eligible for a trial. It is also unclear whether retatrutide would work in patients who have not had success with tirzepatide.
“Something very wrong”
The public notice about expanded access is suspect because it omits much of the information that such a notice would normally include, such as conditions that might qualify a patient for such access.
“Only people who know would be able to find this (notice) using the name of the drug,” Richard Klein, who helped launch the FDA’s expanded access program in the 1980s, told Stat. “There’s something very wrong with the way this is listed because no one would know what it is or what it does.”
Stat asked both the White House and the Department of Health and Human Services whether Trump is the patient and whether he has obstructive sleep apnea and pulmonary hypertension, which were not included in the list. a note of your most recent medical evaluation. White House spokesman Kush Desai did not respond to the question and referred the matter 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 give patients with serious or life-threatening conditions access to investigational treatments when comparable or satisfactory approved therapies are not available. Each request is reviewed on a case-by-case basis based on clinical circumstances and applicable legal and regulatory requirements.
More than a dozen experts who spoke to Stat said it was highly unusual for a pharmaceutical company to grant expanded use of a drug for common conditions to a single patient rather than to a cohort of patients with a specific profile.
Lilly spokeswoman Misty Fuller did not respond to Stat’s questions, saying, “We made these decisions following all applicable regulations.” The NIH doctor who made the request, Muniyappa, also did not respond to questions.
