Outrage of the Month: Illegal Stem Cell Treatments Endanger Vulnerable Patients
by: Michael Carome, M.D., Contributor
Over the past decade, an unscrupulous stem cell industry that preys on vulnerable patients by offering modern-day snake oil has flourished. The number of clinics in the U.S. that peddle unproven stem cell “treatments” directly to consumers exploded from a handful in 2010 to as many as 570 in 2016.
Typically operated by for-profit companies, these clinics market stem cell injections for dozens of conditions, including Alzheimer’s disease, spinal cord injuries, autism, cerebral palsy, joint damage and heart disease. Some clinics even offer stem cell injections for cosmetic applications, such as facelifts and breast augmentation.
However, the vast majority of these potentially dangerous stem cell therapies have never been shown to be safe or effective in well-designed clinical trials. Moreover, the stem cells used by these clinics — which often are extracted from a patient’s own fat tissue — are considered to be drugs and biologic products under Food and Drug Administration (FDA) regulations, but the purveyors of these stem cell products, with few exceptions, have not obtained FDA approval to market them.
The FDA’s years-long failure to enforce regulations governing stem cell therapies emboldened for-profit stem cell clinics and fostered a regulatory environment characterized by some observers as a “Wild West” and a “Cowboy Culture.” But in late August, the FDA signaled that it finally may be willing to clamp down on the marketing of illegal stem cell treatments.
On August 28, 2017, the FDA called public attention to one of the most disturbing examples to date of stem cell clinics running amok: According to the agency, the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California had injected vulnerable cancer patients with a “potentially dangerous and unproven” stem cell product that combined fat-tissue-derived stem cells with smallpox vaccine….
Source: Huffington Post