WASHINGTON – Sen. Chuck Grassley of Iowa sent a letter to Department of Health and Human Services Secretary Alex Azar and Food and Drug Administration Commissioner Dr. Scott Gottlieb seeking additional information about an investigation into a South Florida clinic that performed unproven stem cell treatments on patients that left them permanently blind.
A March 15, 2017 Washington Post report detailed three women in South Florida who participated in what they believed was a government-backed clinical trial to reverse the effects of macular degeneration. The stem-cell treatment they received, though not government approved, was listed on a comprehensive database of clinical trials run by the National Institutes of Health. The episode left them permanently blind. Also, in August 2017, the FDA issued a press release that noted U.S. Stem Cell Clinic tried to impede its investigation, which is a violation of federal law.
“According to a Washington Post article published in March of 2017, three women became permanently blind after undergoing unproven stem cell treatment that was touted as a clinical trial at a South Florida clinic, which was later revealed to be U.S. Stem Cell Clinic. The article raises serious concern that this clinic was able to list its study on ClinicalTrials.gov, and that at least one of the patients believed she was taking part in a government-sanctioned study,” Grassley wrote. “Despite the harm this clinic has already caused, this clinic is apparently only at risk of ‘additional enforcement action’ if it does not correct itself.”
The letter goes on to identify seven specific questions for the Department of Health and Human Services and U.S. Food and Drug Administration to respond to by April, 27, 2018.