In addition to enforcement action, the agency also will also create a working group to pursue unscrupulous stem cell clinics.
Now, the Food and Drug Administration has acted to seize smallpox vaccine given to cancer patients during an unapproved and potentially dangerous treatment program from a San Diego stem cell company.
Five vials of the vaccine were seized from StemImmune by the U.S. Marshals Service on behalf of the FDA. The vials, one partially used and four intact, originally contained 100 doses each of vaccine.
The action and an FDA warning given to a Florida stem cell clinic were welcomed by researchers who had warned for years of dangers from a proliferation of unregulated stem cell clinics.
The vaccine contains live vaccinia virus, related to cowpox and smallpox. It’s safe when given to healthy people. But since vaccination eradicated smallpox in nature decades ago, the vaccine is no longer used except for those at risk to exposure to bioweapons.
Furthermore, while the vaccine is safe for healthy people with functional immune systems, the health of cancer patients is usually not optimum. Using any vaccine with a live virus — especially one as potentially dangerous as smallpox — is “contraindicated.” Typically, these vaccines are reserved for personnel determined to have a real potential risk at being exposed to the now-eradicated disease (e.g., military personnel who may face bio-weapons.)
The FDA indicates that this is the first of many enforcement actions.
The FDA announced the move on the same day it posted a warning letter to a Florida stem cell company and issued a statement from commissioner Scott Gottlieb saying the agency is stepping up enforcement against “dishonest actors” in the growing stem cell treatment industry.
Gottlieb is quoted as saying, “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.”
Many stem cell scientists have for years been calling for tougher action against companies selling expensive and unproven treatments.
The agency will also create a working group to pursue unscrupulous clinics offering questionable stem cell treatments.
“The prospect of clinical tissue repair strategies is a tangible reality,” Gottlieb said in a statement. However, some businesses have seized on that promise and made “deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products.”
Known as regenerative medicine, the practice uses human cells or tissues that are engineered or taken from donors. The market stretches from small companies developing treatments to individual clinics where doctors offer procedures often involving patients’ own stem cells or tissues.
Over the next several months, the FDA plans to clarify which treatments will fall under its oversight, and tell providers of the therapies what they need to do to get regulators’ approval.
For example, some individualized treatments where doctors at a clinic remove a patient’s stem cells and put them back in with minimal manipulation likely won’t be subject to FDA review, Gottlieb said. However, when the cells are manufactured on a larger scale, the FDA would police the product, he said.
This wonderful TED-Ed summarizes this history of smallpox and its eradication (featuring ancient Egypt!), for those of you interested in the background of this deadly pathogen.DONATE
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