For the first time, the Federal Trade Commission has cracked down on stem cell clinics for overzealous marketing claims, filing a complaint against two California clinics that promoted their treatments for everything from autism to Parkinson’s despite a lack of evidence.
As part of a proposed settlement announced Thursday, the FTC is requiring the clinics — Regenerative Medical Group and Telehealth Medical Group — and their owner, Dr. Bryn Jarald Henderson, to stop making such claims and to inform past and current patients about the settlement.
In the complaint, the FTC accused Henderson and his clinics of implying or directly saying that their treatments could help patients with a range of diseases even though there was no indication that was the case. The agency also cited the companies for describing their treatments as comparable to or better than approved or studied treatments.
The clinics, both in Orange, Calif., touted the “miracles” made possible by the amniotic stem cells they used. Ads and promotional materials claimed the cells could “reverse autism symptoms” and enabled a “101 year old Lady once blind for 7 years” to see again. The clinics also claimed the cells could treat cerebral palsy, Parkinson’s disease, and chronic kidney disease.
“Until recently, it was believed that damaged brain tissue is a permanent condition,” read one piece of marketing tied to treatment for stroke recovery. “Nowadays the re-growth of brain cells and improvements of neurological function has been documented. Stem Cell treatment acts as a form of medical time machine, reversing the damage that has already been made.”
As the FTC complaint states: “There are no human clinical studies in the scientific literature showing that amniotic stem cell therapy cures, treats, or mitigates diseases or health conditions in humans.” It also says that Henderson did not conduct any studies to show his therapies could do what he claimed.
As part of the proposed settlement, the defendants were ordered to pay $3.31 million — the amount the clinics generated in sales from 2014 to 2017 — but the FTC said that penalty will be suspended once Henderson pays $525,000 to the agency.
The clinics charged from $9,500 to $15,000 for the first round of treatments, according to the complaint, with follow-up “boosters” costing patients $5,000 to $8,000.
The complaint marks the first the FTC has announced, but hundreds of stem cell clinics have popped up around the country in recent years; experts and public health advocates warn many clinics are taking advantage of desperate patients with unfounded claims of miracle cures.
Even regulators have indicated that because of limited resources and the proliferation of the clinics, they have to focus their efforts on the worst actors in the industry.
In May, for example, the Food and Drug Administration and the Justice Department moved to stop two clinics from providing stem cell treatments to patients, alleging that they were endangering patient safety. But the clinics — one in Florida and one in California — were by then widely known by critics of the industry. A 2015 procedure at the Florida clinic led to three women going legally blind, and the California clinic was involved in making an experimental cancer treatment from a smallpox vaccine that is not commercially available.
https://www.statnews.com/2018/10/18/feds-crack-down-on-stem-cell-clinics-that-touted-autism-treatments-blindness-cures/
No comments:
Post a Comment