RANCHO MIRAGE, Calif. - The U.S. Food and Drug Administration have taken action and seized a potentially harmful vaccine administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and San Diego.
U.S. Marshalls seized five vials of the Vaccinia Virus Vaccine, which is reserved only for people at high risk of smallpox. Each of the vials originally contained 100 doses of the vaccine, one vial was partially used, four of the vials were intact.
The vials belong to the biotech company named StemImmune Inc. Investigators say there is no proof of the vaccine being effective, and could be potentially dangerous.
“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,” said FDA Commissioner Scott Gottlieb, M.D. “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 seizure comes after recent FDA inspections at StemImmune Inc. and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product (a combination of excess amounts of vaccine and stromal vascular fraction – stem cells derived from body fat), which was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including myocarditis and pericarditis (inflammation and swelling of the heart and surrounding tissues). The unproven and potentially dangerous treatment was being injected into patients’ tumors.
The vaccine can be life-threatening for unvaccinated people who are accidentally infected with the vaccinia virus by being in close contact with someone who has recently received the vaccine.
Unvaccinated people who are pregnant, or have problems with their heart or immune system, or have skin problems like eczema, dermatitis, psoriasis and have close contact with a vaccine recipient are at an increased risk for inflammation and swelling of the heart and surrounding tissues if they become infected with the vaccine virus, either by being vaccinated or by being in close contact with a person who was vaccinated.
“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 added. “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.”
Health care professionals and consumers should report adverse effects related to treatments received at California Stem Cell Treatment Center to the FDA’s MedWatch Adverse Event Reporting program.
To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.
The U.S. Department of Justice filed the seizure complaint, on behalf of the FDA, in the U.S. District Court for the Central District of California.
Noticias en español: Telemundo 15