Indianapolis-based Eli Lilly and Company gave an unidentified 79-year-old man exclusive access to its experimental obesity and diabetes drug, according to reporting by the life sciences media organization STAT.
The practice was so abnormal, according to the clinicians, bioethics experts and current and former government health officials STAT interviewed, that the publication asked the White House if the sole individual who had received the coveted drug was President Donald Trump. At the time the drug was requested — April — Trump was 79 and had previously told the New York Times that he “probably should” take GLP-1 drugs.
But after not directly answering STAT’s question, the White House is now denying that the application for special access to the pharmaceutical was for the president.
A spokesperson for Eli Lilly said it does not answer questions about individual applications.
“In rare situations, when individuals can’t join a clinical trial and have run out of treatment options, Lilly may provide an investigational medicine in coordination with a requesting physician,” said Michael Jamison, Lilly’s communications director for litigation and special products. “We make these decisions following all applicable regulations.”
Here’s what we know.
What is the drug?
Eli Lilly’s new drug, retratrutide, is a triple hormone receptor agonist currently in Phase 3 of clinical trials to treat a variety of diseases, including obesity, type 2 diabetes and obstructive sleep apnea.
In other words, it’s a more powerful version of the GLP-1 drugs like Wegovy or Ozempic that have revolutionized weight loss and are expected to create a $100 billion market by 2030.
Weight loss results from the most recent phase of clinical trials for retratrutide show the drug has a level of effectiveness comparable to bariatric surgery. The breakthrough has led to the creation of a black market for the drug, which has not yet been approved by the Food and Drug Administration.
How did the individual get access?
The drug was requested through the FDA’s “compassionate use” program, according to STAT, a process by which patients with life-threatening conditions can access medicine before it hits the market.
STAT reported that the drug was requested for an individual with refractory obesity with obstructive sleep apnea and pulmonary hypertension by a senior clinician at the National Institutes of Health.
Experts interviewed by STAT said it was unusual that Eli Lilly would offer exclusive access to an obesity drug, which could help millions of people, to just one person. STAT’s reporting also suggested that the individual who received the drug was well-connected, particularly since the one public posting of the compassionate use program for the drug provided no information about which patients or conditions might qualify.
Spokespeople for the White House and Health and Human Services Department did not answer STAT’s questions about the patient’s identity but pointed the publication to Trump’s most recent physical from May, which describes Trump as being in “excellent health.”
While Trump has indicated interest in weight loss drugs in the past, he told the New York Times in January that he had never taken one. The anonymous patient, however, had been treated with a different Lilly obesity drug for a year, according to sources who spoke to STAT.
The speculation around Trump and the mystery drug application comes as the president enjoys a close relationship with Eli Lilly CEO David Ricks.
For example, Trump dined with Ricks at Mar a Lago and has praised his chops as CEO. The president also purchased $680,000 in Lilly stock earlier this year, and his administration has pushed for initiatives that the company has benefitted from.
How common is it to get exclusive access?
Lilly offers three main avenues for patients in dire need of accessing experimental drugs, according to its website: participation in clinical trials, cohort expanded access or individual patient expanded access.
Lilly offers expanded access, another term for compassionate use, under a certain set of conditions:
Expanded access is sometimes offered for a specific group of people when the company learns enough about the new drug’s capabilities. But individual access is much more rare, according to Lilly’s website.
“In the absence of a Cohort Expanded Access Program and in rare cases, Lilly may still decide – in response to a physician request – to provide investigational medicine access to an individual patient, where it is allowed by local regulations and when it meets our company’s expanded access criteria,” the website’s expanded use policy reads.
Contact breaking politics reporter Marissa Meador at mmeador@indystar.com or find her on X at @marissa_meador.
This article originally appeared on Indianapolis Star: Fact check: Who did Eli Lilly give access to its obesity drug? White House says not Trump
Reporting by Marissa Meador, Indianapolis Star / Indianapolis Star
USA TODAY Network via Reuters Connect
By Marissa Meador, Indianapolis Star | USA TODAY Network
