FDA Seeks Court Orders To Stop Firms From Providing Unproven Stem Cell Treatments
The lawsuits target Stem Cell Treatment Center, with two locations in Southern California, and U.S. Stem Cell Clinic of Sunrise, Fla. The clinics remove fat from patients’ bellies by liposuction and then inject an extract of it into various parts of the body like knees or the spinal cord.
The New York Times:
F.D.A. Moves To Stop Rogue Clinics From Using Unapproved Stem Cell Therapies
The Food and Drug Administration said on Wednesday that it was seeking court orders to stop two clinics from using unapproved stem cell treatments that in some cases have seriously harmed patients. The clinics remove fat from patients’ bellies by liposuction and then inject an extract of it into various parts of the body like knees or the spinal cord, on the theory that the extract contains stem cells that can provide replacement cells that will repair the damage from injury or illness. (Grady and Kaplan, 5/9)
The Associated Press:
Feds Sue To Close Stem Cell Clinics In California, Florida
The Justice Department says in court filings Wednesday that the firms put consumers at risk by promising benefits from treatments never approved by the Food and Drug Administration. The complaints involve treatments derived from cells taken from patients’ own fat tissue. The lawsuits target Southern California’s Stem Cell Treatment Center and U.S. Stem Cell Clinic of Sunrise, Florida. Mark Berman, director of the California clinics, says he stands by his treatments and looks forward to fighting the lawsuit. (Weber, 5/9)
The Washington Post:
FDA Seeks Injunction To Stop Two Stem Cell Companies After Patients Blinded
Hundreds of such clinics have popped up across the country in recent years, many promoting treatments for conditions including Parkinson’s disease, autism and multiple sclerosis. Federal regulators have not approved any of their procedures, and critics liken the facilities to modern-day snake-oil salesmen. Many stem cell researchers and former patients have long urged the FDA to take stronger action against the clinics. Current and former agency officials have acknowledged the need for greater regulation of the booming industry, citing limited resources for the lack of aggressive action in the past. (Wan and McGinley, 5/9)
Stat:
FDA Seeking To Stop Procedures At Two Unregulated Stem Cell Clinics
In separate statements, both US Stem Cell and the California clinic and its affiliates said they intended to fight the lawsuits. They argued that the FDA’s efforts interfered in the doctor-patient relationship and that these clinical decisions should be made without meddling from the government. (Joseph, 5/9)
