FOIAengine: Multiple News Outlets Sought Details on “Compassionate Use”
Within days of a Stat News report describing a highly unusual government decision to grant a 79-year-old patient early access to Eli Lilly’s experimental obesity drug retatrutide, some of the nation’s largest news organizations quietly launched their own investigations.
The Stat story opened with a provocative question: “Eli Lilly gave extraordinary obesity drug access to a 79-year-old patient. Who was it? Sources point to a single instance in which experimental therapy retatrutide was provided for ‘compassionate use’”.
An obvious question loomed: Was the privileged patient none other than Donald Trump, a 79 year old when the exception was made?
The Washington Post, the Wall Street Journal, Politico, Forbes and Wired all jumped in, filing federal Freedom of Information Act requests seeking different pieces of the same puzzle: Who approved the request? Why was it approved? And did the application receive unusual attention inside the Food and Drug Administration or the Department of Health and Human Services? CBS News asked for adverse-event reports.
The requests were among 54 filed with the FDA by media organizations last month. All the requests can be found in PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows.
The flurry of requests about the retatrutide exception – submitted within days of each other late last month – provides a rare glimpse into how health reporters pursue a developing story long before the underlying government records become public. Rather than focusing on a question that was likely to be shot down on privacy grounds – who was the patient? – the media requests targeted FDA communications, internal deliberations, calendars, approval documents, and correspondence that could reveal how a single expanded-access application moved through the federal government.
All the FOIA requests except CBS’s came immediately after Stat’s June 23 report that flagged the FDA’s approval of the one-person clinical trial.
Stat’s reporting left unanswered exactly how and why the unidentified 79-year-old man had been granted access to retatrutide through the FDA’s Expanded Access program. According to Stat, the request for the patient’s special treatment was submitted by Dr. Ranganath Muniyappa, a senior NIH endocrinologist whose research focuses on obesity and metabolic disease. Muniyappa and the FDA did not respond to our emailed questions. Lilly also didn’t respond to our questions that were emailed and posted to the company’s media-inquiry portal.
The mystery that the media’s FOIA requests sought to solve ran deep. Muniyappa’s name wasn’t part of the official record posted on the official government website, ClinicalTrials.gov, nor was the patient’s age or gender. In fact, the public record revealed nothing about the requesting physician, the patient, or the “compassionate-need” circumstances surrounding the request. The FDA’s clinical trials website merely sketched out what’s known in agency parlance as an “individual-patient expanded-access application” – essentially, a clinical trial comprised of a single patient – that was sponsored by Eli Lilly. The few added details came from Stat’s reporting, not from the public registry.
Retatrutide is one of Eli Lilly’s most closely watched pipeline products and already has the makings of a blockbuster. The investigational drug, which activates three metabolic hormone pathways, has produced striking weight-loss results in late-stage clinical studies, far exceeding those of Lilly’s other GLP-1 drugs. Retatrutide is currently being evaluated in Lilly’s global Phase 3 development program, involving thousands of participants across multiple studies. Lilly says it intends to seek FDA approval after completing the Phase 3 program.
Given the scope and promise of Lilly’s large Phase 3 trial for retatrutide, Stat’s report raised another question. Since patients typically obtain investigational drugs like retatrutide by enrolling in clinical trials, why didn’t the 79 year old just join one of the trials? The answer could lie in the randomized nature of drug trials: Participation in a randomized Phase 3 study does not necessarily guarantee receipt of the investigational medicine. Instead, eligible participants may be assigned to receive a placebo or might be routed into another study arm, depending on the trial design. “Expanded access,” by contrast, guarantees direct access to the investigational drug once the physician, manufacturer and FDA all agree that the statutory urgent-need criteria have been met.
There is no public evidence that the unidentified patient was eligible – or ineligible – for one of Lilly’s Phase 3 trials, and so far there is no basis to conclude why expanded access was pursued instead. Nevertheless, one of the questions that could be answered by the pending FOIA requests is whether trial participation was considered before the physician sought the individual-patient expanded-access authorization.
Because the patient was 79 years old when the application was submitted – and because Trump was also 79 at the time – Stat asked the White House whether the patient was Trump. The White House responded with an unusually forceful denial, insisting that Trump was not the recipient and criticizing the reporting in unusually personal terms.
Responding to the Stat reporter, spokesman Steven Cheung posted on X: “You thought this was your big shot, but in reality, you’re just a big idiot. . . . Good job, loser. You’ll never make it.”
The White House denials did little to quiet the questions.
Within two days, Sen. Maggie Hassan (D-N.H.) demanded answers from HHS Secretary Robert F. Kennedy Jr., asking whether the administration had bent the rules of the expanded-access program to benefit a politically connected individual. Hassan also sought information about who approved the request, whether the drug had been provided free of charge, and whether the recipient was the president or someone connected to him. We asked Hassan’s office whether she’d received answers, or intended to follow up with the FDA or HHS; we didn’t hear back.
The media FOIA requests, however, suggest that reporters were looking well beyond political speculation.
Several sought FDA routing records and internal communications concerning the application itself. Others requested FDA correspondence with Eli Lilly, approval memoranda, calendars, meeting records and related documents that could show how the request was evaluated and whether it followed the agency’s ordinary expanded-access process. CBS News took a different approach, requesting adverse-event reports associated with specified retatrutide case numbers.
FDA’s June closed FOIA log shows that the CBS request was processed and closed with records released. Because that request sought adverse-event reports rather than records documenting the expanded-access decision itself, it is unlikely to resolve the central questions surrounding the application. The remaining requests appear still to be pending.
As readers of this space know, FOIA requests to the federal government can be an important early warning of bad publicity, litigation to come, or uncertainties to be hedged and gamed out. In this case, the FOIA requests show something else: how multiple newsrooms quickly, and independently, converged on the same set of issues. The media FOIA requests sought the identity of the reviewing officials, communications with Eli Lilly, the physician’s application, and the path the request followed through the FDA. Reporters believed the story lay not simply in who received the drug, but in how the government handled an exceptional request.
Expanded access is generally intended for patients with serious or immediately life-threatening diseases who lack satisfactory treatment alternatives and cannot appropriately obtain the investigational therapy through a clinical trial. Bioethicists and expanded-access experts interviewed by Stat described the retatrutide request as unusual because obesity drugs have rarely been made available through this pathway, and because approved GLP-1 therapies already exist for many patients.
The identity of the patient may ultimately prove less significant than the process itself.
The pending FOIA requests could establish who reviewed the application inside FDA, whether HHS political leadership became involved, how quickly the request moved through the agency, what communications occurred with Eli Lilly, and whether the application received treatment different from other expanded-access requests.
Until those records are released, the most revealing fact may not be the identity of the mystery patient, but the unusual convergence of journalistic interest. In the space of a few days, major news organizations independently concluded that a single expanded-access application for an experimental obesity drug warranted an investigation into how the federal government reached one of its most closely scrutinized medical decisions of the year.
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John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. He is the author of The Partisan: The Life of William Rehnquist. His latest book is Summer of ’71: Five Months That Changed America, about the fateful year before Watergate. Click here to watch the official book trailer. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at JAJ@PoliScio.com.