US seizes smallpox vaccine from stem cell company

By Barry Eitel

SAN FRANCISCO (AA) - The Food and Drug Administration (FDA) said Monday it has confiscated several vials of smallpox vaccine from a California company that was using it as a cancer treatment.

San Diego-based StemImmune was injecting the vaccine into cancerous tumors of patients as part of an unproven treatment regimen.

The FDA is investigating how StemImmune acquired the vaccine, which is not available commercially and is reserved for those who have a high risk for smallpox exposure, such as some members of the military. Fortunately, the vaccine is not made of the smallpox virus and cannot infect patients with smallpox.

Authorities raided StemImmune’s offices on August 25 and seized five vials of the vaccine, with each vial containing 100 doses, according to the FDA. Four vials were sealed and one was partially used.

“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 Scott Gottlieb said in a statement. “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.

FDA inspectors learned StemImmune was using the vaccine to create an unapproved stem cell mixture that was administered to cancer patients with compromised immune systems, a treatment the FDA said could be fatally dangerous.

“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,” Gottlieb said.

"StemImmune, a biopharmaceutical company engaged in cutting edge R&D of adult human stem-cell based therapies for the treatment of cancer, is fully cooperating with the FDA about the development of its stem cell-based investigational cancer therapy," said StemImmune spokesman Ulrike Szalay. "We look forward to continuing our dialogue with the FDA as we seek to bring this important cancer therapy to cancer patients."

The company did not clarify how many doses it had used or how many patients were using the vaccine, but it has been in operation since 2014.