Helping share the news earlier this year about three women who had been blinded by a fraudulent stem cell procedure was sobering and somewhat surprising for me. The women had undergone procedures at a clinic in Florida. Surely, I thought, things like this shouldn’t happen in the United States (or anywhere!).
Others thought the same: Jeffrey Goldberg, MD, PhD, chair of ophthalmology at Stanford, called the publication of the cases in The New England Journal of Medicine a “call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research.”
It appears the U.S. Food and Drug Administration took notice. This week it censured, albeit for violations unrelated to the eye “therapies,” the Florida clinic where the procedures took place.
In a statement, FDA Commissioner Scott Gottlieb, MD, had strong words for rogue operators:
Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk. As the FDA takes new steps to advance an efficient, modern approach to the regulation of cell based regenerative medicine, at the same time we will be stepping up our enforcement actions against clinics that abuse the trust of patients and, more important, endanger their health with unsanitary conditions or by purporting to have treatments which may not provide any benefit.
Goldberg lauded the FDA’s move in an email: “The FDA’s vigilance and willingness to respond to protect patients from predatory clinics should help both with patient safety and with maintaining progress on appropriate stem cell research programs.”
The company is disputing the FDA’s findings, which stem from a recent inspection. A statement on its website reads: “We believe that we have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards.”
It is admittedly challenging for patients and families to discern which stem cell treatments are safe and have proven efficacy. (The three patients who were blinded thought they were participating in a clinical trial for macular degeneration.) In general, patients should be wary of clinical trials that charge patients for admission (each of the women had to pay $5,000) and should feel more confident if the trial has ties to an academic medical center, Goldberg says. He also recommends that patients considering a stem cell treatment should consult a website, A Closer Look at Stem Cells, maintained by the International Society for Stem Cell Research.