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FDA halts unproved stem-cell cancer treatments administered to California patients, which was derived from a commercially unavailable military-grade vaccine.
FDA said on August 28, 2017 that it took action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune (San Diego, CA) and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, CA. On behalf of FDA, on Aug. 25, 2017, the US Marshals Service seized five vials of Vaccinia Virus Vaccine (live)-a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine. One vial was partially used, and four of the vials were intact.
The US Department of Justice filed the seizure complaint, on behalf of FDA, in the US District Court for the Central District of California. Because the vaccine is not commercially available, FDA is concerned with the means by which StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment and is actively investigating these circumstances.
The seizure comes after recent FDA inspections at StemImmune and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product. The product is a combination of excess amounts of vaccine and stromal vascular fraction-stem cells derived from body fat. The product was 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 treatment was being injected intravenously and directly into patients’ tumors.
Serious health problems, including those that are life-threatening, can also occur in unvaccinated people who are accidentally infected with the vaccinia virus by being in close contact with someone who has recently received the vaccine. In particular, unvaccinated people who are pregnant, or have problems with their heart or immune system, or have skin problems such as eczema, dermatitis, and psoriasis and who have close contact with a vaccine recipient are at an increased risk of myocarditis and pericarditis if they become infected with the vaccine virus, either by being vaccinated or by being in close contact with a person who was vaccinated.
“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,” said FDA Commissioner Scott Gottlieb, MD, in an agency press release.
“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,” Dr. Gottlieb said in the release. “I also urge healthcare providers, patients, and consumers to report these kinds of activities or any adverse events associated with these unproven treatments to the agency through MedWatch.”