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The patient was not approved for bariatric surgery, due to their age and other factors. It was not known if the man would be fit to stand trial. It is also unclear whether retatrutide will work in patients who have had poor vision with tirzepatide.
Public knowledge of increased access is questionable, leaving out much of what this information might include, such as the conditions that would predispose a patient to such access.
“Only knowledgeable people can find this (information), using the drug’s name,” Richard Klein, who helped establish the FDA’s supplemental program in the 1980s, told Stat. “There is something very wrong with the way this is written because no one will know what is on the list, or what it is.”
Stat asked both the White House and the Department of Health and Human Services whether Mr. Trump is sick, and whether he has insomnia and high blood pressure, which were not included. and memo about his recent medical examination. White House spokesman Kush Desai did not answer the question and referred it to the Department of Health. HHS spokeswoman Emily Hilliard did not directly deny that Trump was the patient.
He wrote:
The FDA supports additional programs that would provide patients with serious or life-threatening conditions access to investigational treatments when no comparable or satisfactory approved treatment options are available. Each request is evaluated on a case-by-case basis based on medical conditions and legal requirements.
More than a dozen experts who spoke to Stat said it is highly unusual for a pharmaceutical company to expand the use of the drug to one patient rather than to a group of patients with a specific history.
Lilly spokeswoman Misty Fuller did not respond to Stat’s questions, saying, “We make these decisions in compliance with all applicable laws.” The NIH doctor who made the request, Muniyappa, also did not respond to questions.