Enlarge / FDA Commissioner Scott Gottlieb had vowed to crackdown on the dubious clinics. (credit: Getty | Zach Gibson)
Two stem cell clinics will “vigorously defend” their dubious treatments against civil suits levied this week by the Department of Justice at the request of the Food and Drug Administration.
The two clinics are no stranger to federal officials’ bad sides; they have both received warnings and wrist-slaps in the past. In August of last year, the FDA sent a warning letter to US Stem Cell Clinic of Sunrise, Florida and its chief scientific officer Kristin Comella for “significant deviations” from good practices. That was shortly after researchers determined that three women had permanently lost their vision after the clinic posed as a legitimate research facility conducting a clinical trial and injected an unproven concoction of cells directly into their eyeballs. The women reported paying $ 5,000 for the procedure, and the clinic’s supposed clinical trial never took place.
The other clinic, California Stem Cell Treatment Center Inc. of Rancho Mirage and Beverly Hills, California, and affiliates—including StemImmune Inc. and Cell Surgical Network—were likewise chided by the FDA for inappropriately obtaining vials of smallpox vaccine from the Centers for Disease Control and Prevention. (The CDC maintains a stash of vaccines against the eradicated virus for research and emergency military purposes.) The clinic was mixing the vaccine into unproven, unapproved cell treatments for cancer and injecting it directly into patients’ tumors.
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