State Attorneys General have recently filed actions against stem cell clinics whose outsized claims for their treatments far outstripped the evidence. Today we’ll look at several of these cases and see how the states are helping fill the gap caused by the lack of effective regulation for these relatively new therapies.
Stem cell clinics are ubiquitous in the U.S. and, unfortunately, too many make claims of effectiveness that are not backed by sufficient evidence for any number of conditions, including Parkinson’s disease, ALS, stroke, traumatic brain injury, and spinal cord injuries. In addition to overstating the success of their treatments, some clinics enroll patients in what are essentially fake clinical trials, charging thousands of dollars to participate. Both financial and physical harms (for example, blindness) from worthless stem cell treatments have resulted.
Because stem cell therapies are relatively new, regulation is playing catch up. Some therapies are considered drugs or biological products by the FDA and are therefore regulated as such. Others are not. Where to draw the line between the two is a point of contention between stem cell clinics and the FDA.
The Federal Trade Commission (FTC), with its jurisdiction over “unfair or deceptive acts or practices in or affecting commerce”, including advertising claims, can also serve as a means of regulating stem cell clinics, although unfortunately after-the-fact. Rather than haggling over whether or not a therapy...
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