Pressing for Transparency
Democratic lawmakers are urging the Trump administration to reveal who received special access to Eli Lilly’s investigational obesity drug retatrutide.
Senator’s Inquiry
Sen. Maggie Hassan (D-N.H.) sent a letter to HHS Secretary Robert F. Kennedy Jr. asking to identify the individual who was granted compassionate use in April for a 79-year-old man with refractory obesity, obstructive sleep apnea, and pulmonary hypertension.
Questions About Access
Hassan’s letter queried whether this individual was President Trump, a senior Administration official, a political donor, or someone closely connected to the Administration. She also inquired if the drug was dispensed at no cost and who at HHS sanctioned the request.
Implications of Drug Access
During a press briefing, Rep. Ted Lieu (D-Calif.) speculated that President Trump may have experienced “side effects” from the drug, further questioning the circumstances surrounding the special access to retatrutide.
FDA’s Compassionate Use Programs
The FDA describes expanded access programs as a means to allow early access to investigational drugs for life-threatening conditions when no satisfactory alternative therapy is available. Recent approvals include programs for investigational drugs such as daraxonrasib for pancreatic cancer.
Discussion of Patient Eligibility
According to reports from STAT, the application for compassionate use was filed by a senior clinician at NIH for a patient with refractory obesity, indicating that the patient had only moderate weight loss on another medication.
Denials from the Administration
Although initial responses from the White House were vague, after the story broke, they firmly denied that President Trump was the patient in question. White House spokesperson Kush Desai accused a reporter of sensationalism, emphasizing that the application was not for the President.
Previous Use of Compassionate Use Pathway
Trump had previously utilized the FDA’s compassionate use pathway when he received a monoclonal antibody treatment from Regeneron during his COVID-19 illness in October 2020.
Disclaimer: This content is intended for informational purposes only and should not be considered medical advice. Please consult a healthcare professional for personalized guidance.
Fuente: https://www.medpagetoday.com/washington-watch/washington-watch/121932
Join the doctors who get the most relevant medical news, curated by specialty, every week — no spam, unsubscribe anytime.
