FDA cracks down on clinics selling unproven stem cell therapies

The US Food and Drug Administration (FDA) yesterday targeted a booming national market for suspect medical treatments, announcing actions against clinics offering questionable stem-cell treatments for cancer and other diseases.

The FDA moved against California Stem Cell Treatment Centers in Beverly Hills and Rancho Mirage; StemImmune Inc of San Diego; and the US Stem Cell Clinic of Sunrise, Florida.

In what it termed as ''decisive action'' to protect patients, the FDA on Friday dispatched US marshals to the California clinics and seized close to 500 doses of smallpox vaccine supplied by StemImmune. The vaccine was to be mixed with stem cells taken from patients' body fat, for direct injection into patients' malignant tumors.

According to the FDA's statement issued Monday, this is ''an unapproved and potentially dangerous treatment for cancer.''

Of the five vials of vaccine, one had been opened and was ''partially used,'' the FDA said.

According to the agency, the seizure of the smallpox vaccine was necessary ''to prevent the use of a potentially dangerous and unproven treatment.''

The FDA said it would investigate how StemImmune Inc came to be in possession of the smallpox vaccine, which is not commercially available and is normally reserved for people who are at risk of exposure to smallpox, such as military personnel and healthcare workers.

Meanwhile, the FDA said in a press release, "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.

''Speaking as a cancer survivour, 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, MD.

''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 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 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.''