Eye injections causing blindness? FDA’s stem cell clinic crackdown readies for action
Beginning next week, the FDA will officially start a long-awaited crackdown on stem cell clinics hawking unproven treatments that have no intention of going through the official process of testing their products in clinical trials.
More than 1,000 of these direct-to-consumer stem cell clinics have popped up across the country in recent years, promising help for conditions with limited to no treatment options, like Alzheimer’s, ALS, autism or even Covid-19, and no clinical evidence to back their pricey products.
“Obviously, it can’t be that on June 1 we’re going to shut everything down, because we don’t have the bandwidth,” FDA’s top biologics head Peter Marks told Endpoints News in an interview. “But we’re going to make very clear that we are serious about putting an end to products that should be under investigational new drug applications or biologic license applications.”
The FDA has provided these clinics with plenty of leeway in the intervening years (although any safety events must be reported to the agency by law) — offering more than 3 years of enforcement discretion while providing rapid responses to any inquiries from stem clinics that wanted to get up to speed on what they need to submit to the FDA.
“People deserve to have medical products that work. It’s quite an irony that people who are paying out of pocket are often getting products that have zero efficacy or even worse, they could be harmful,” Marks added.
Indeed, the FDA has documented such serious adverse events over the years, including at least one patient becoming blind due to an injection of stem cells into the eye, and another receiving a spinal cord injection that caused the growth of a tumor.
Back in 2017, US Marshals, at the request of FDA, also seized five vials of a smallpox vaccine containing live cow pox virus that were discovered during an inspection of a San Diego-based stem cell clinic purporting to specialize in “immune-oncology.”
“Even if stem cells are your own cells, there are still safety risks,” FDA explains, noting that the manipulation of such cells after removal can lead to contamination.
And while the FDA can continue to issue warnings and untitled letters, as it has over the years, Marks also made clear that the agency can take tougher action to close businesses that are acting egregiously.