Lowering Regulatory Standards Encourages Unproven Stem Cell Therapies
​​[Posted on: Thursday, April 19, 2018]

There is a general perception that FDA regulations are overly burdensome, FDA takes long time to approve new treatments, and patients can benefit from treatments based on anecdotal data. This led to some laws passed at the state level solely intended to undermine FDA’s oversight. But these states and patients may soon face buyer’s remorse. Laws that allow stem cell clinics offering treatments to patients outside of FDA approval and oversight are such laws. Last year the states of Texas and California passed laws allowing most stem cell clinics to provide treatments not approved by FDA to patients without fear of prosecution by state authorities. Several other states are debating similar laws. A recent investigation showed that these laws are encouraging deceitful companies to operate in these states. Although the laws contain checks to verify credible stem cell therapies, there are many loopholes for non-credible providers to stay in business deceiving patients and state regulators alike. The investigation found operators who till recently had to move their business to Mexico and other places with lax regulations, now contemplating bringing these clinics back to the US while maintaining risky practices. The investigation also found that the investigated stem cell clinics likely did not have any serious intentions to conduct robust product testing or evaluating the accuracy of the safety and efficacy claims they make. Even if one assumes that these clinics offer lower risk autologous therapies where the patient’s own cells are implanted back into the same patient, these so-called treatments use improperly tested products of unreliable potency and cost thousands of dollars out of pocket by the patients. And since the patients are told that these “treatments” are not approved by FDA, not covered by insurance, and require the patients to sign consents to get these therapies at their own risk, the patients have few legal and financial options should they not get the promised benefit from the same. While these laws have good intent, the outcome is likely not in the interest of most patients. But we can’t blame the states to take action when FDA won’t. FDA has repeatedly declared such stem cell clinics to be illegal but not attempted to take serious enforcement actions against most clinics. FDA has also mostly ignored reasonable arguments to allow at least some of the low risk treatment options so such clinics can at least register with FDA and come under FDA’s oversight. FDA has taken a very conservative stand on paper while mostly turning a blind eye to the enforcement of its own laws. This party at the wrong end of this debate is the patients who may soon find that the laws designed to protect them or provide them more options, actually did the opposite. These laws create higher risk for patients and provide unreliable, at best, and dangerous, at worst treatment options. Lowering the bar on regulations, does not help patients but does on the contrary.