Aug. 28 (UPI) — U.S. Marshals on behalf of the FDA seized five vials of the Vaccinia Virus Vaccine (Live), for use only in smallpox, from stem cell centers in California Friday.
The seizure was made because the virus is being used as an unproven and potentially dangerous treatment from StemImmune Inc., and has been administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills.
The Vaccinia Virus Vaccine is reserved for people at high risk for smallpox such as some members of the military. The vaccine is not approved by the FDA for commercial use and has caused serious concerns in relation to how StemImmune obtained the vaccine for use as part of an unapproved and potentially dangerous stem cell treatment.
“Speaking as a cancer survivor, I know all too well the fear and anxiety the diagnosis of cancer can have on a patient and their loved ones and how tempting it can be to believe the audacious but ultimately hollow claims made by these kinds of unscrupulous clinics or others selling so-called cures,” FDA Commissioner Dr. Scott Gottlieb, said in a press release.
“The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work. I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.”
The agency found through inspections that StemImmune Inc., and the California Stem Cell Treatment Centers was using the vaccine to create an unapproved stem cell product, a combination of excess amounts of vaccine and stromal vascular fraction, which are stem cells derived from body fat.
The unapproved stem cell product was then given to cancer patients with potentially compromised immune systems, although the vaccine presents potential harm — including inflammation of the heart and heart tissue. The treatment was injected intravenously and directed into patients’ tumors.
“I’ve directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk,” Gottlieb said. “I also urge health care providers, patients and consumers to report these kinds of activities or any adverse events associated with these unproven treatments to the agency through MedWatch.”