The Food and Drug Administration admitted to seizing five vials of smallpox vaccine from a clinic in San Diego. Allegedly, this clinic had used the vaccine without approval from the government agency—and without any proof of efficacy—for the treatment of cancer patients.
In a statement, the agency said, “The U.S. 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, and although one vial was partially used, four of the vials were intact.”
The vaccine uses a live small pox virus, of course, which means it is volatile and requires tight controls. This is why you need approval and permission (and proof) to use such a medicine, regardless of the treatment. Misuse or mishandling, obviously, could be tragic.
The company, StemImmune Inc., had administered the vaccine to patients under care at the California Stem Cell Treatment Centers, which is located in Rancho Mirage and Beverly Hills, according to the FDA.
The FDA statement continues, “As the vaccine is not commercially available, the FDA has serious concerns about how StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment. The FDA is actively investigating the circumstances by which StemImmune came to possess the vaccine.”
Still, the agency has not reported as to whether or not any persons were harmed as a result of the unapproved treatments.
FDA Commissioner Scott Gottlieb, MD makes sure to advise: “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.”
In addition to his caution, Gottlieb adds, “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.”