We have a big problem with clinics in the U.S. selling unproven and non-FDA approved stem cell “treatments” to patients and part of the reason in my view why we have this mess today with upwards of 700 such businesses from coast to coast is that regulators including both the FDA and state medical boards haven’t realized the scope of the clinic industry and/or taken proportionate action accordingly. There are signs that this lack of the needed scope of regulatory oversight may be changing for the better at the federal level (we’ll see how that plays out with the FDA), but will state medical boards step up to the plate to tackle this problem that poses serious risks to patients?
I’m more hopeful at this point.
One potentially encouraging development is that the Federal of State Medical Boards (FSMB) formed a working group to develop a report on stem cells and regenerative medicine including the problem of direct-to-consumer clinics. This group, called the “Workgroup to Study Regenerative and Stem Cell Therapy Practices” is due to issue a final report in May. The big questions are (1) whether this report will be bold enough considering the magnitude of the problem and (2) even if the report is appropriately strong, will the medical boards actually take concrete actions on the ground to rein in risky clinics and the care providers at them?
How do we read the tea leaves here? The FSMB stem cell working group issued a draft report in December that I found mostly very encouraging. For instance, it lists 10 good, proposed expectations for boards and physicians in this area of medicine (see my summary image above of the 10 major recommendations; this summary is just my impressions and of course I don’t speak for FSMB).
The key is going to be finding the sweet spot where medical boards respond with more appropriate scaled action to the major risks in his area, while maintaining respect for patients. We don’t want medical boards landing in some safe spot of political correctness that leads to little action. It seems like the working group gets this:
“In regulating this evolving area of medical practice, state medical boards will need to strive to achieve an appropriate balance between respecting the autonomy of patients as they seek viable and reasonable treatment options, and adequately safeguarding them against the risks presented by novel, but often unproven and potentially dangerous, interventions.”
I also received the following information from Joe Knickrehm Director of Communications and Public Affairs at FSMB:
“The Workgroup to Study Regenerative and Stem Cell Therapy Practices has created a draft report of recommendations that is currently making its way through our editing process and will be discussed further at FSMB’s Annual Meeting being held in Charlotte, NC in late April. At the meeting, members of the nation’s state medical boards will have the opportunity to make further edits and suggestions to the draft report before it is voted on by our House of Delegates. If adopted, it will become official FSMB policy and made public.
In completing its charge, the Workgroup drafted its report in the form of a guidance document, with recommendations that address the regulation of the provision of stem cell and regenerative therapies, as well as their promotion and communication to patients, and documentation of treatments provided. The recommendations do not address which uses are appropriate or for specific conditions or symptoms, as this area of medicine continues to be dynamic and subject to change. Rather, the recommendations focus on sensible and necessary principles of patient safety, autonomy, and non-exploitation.”
Let’s see how the final report turns out.
One of the concerns in the longer run has been that my impression in the past was that the collective track record of state medical boards was fairly minimal in regards to actions on stem cell clinics in their various states. For instance, I was aware of only a couple of actions here (e.g. here and here) in California by the state medical board, which effectively seems like a drop in the bucket considering the magnitude of the direct-to-consumer industry here. However, in the draft working group report a substantially higher level of medical board activity is referenced:
“Results from a 2017 survey of its member boards conducted by the FSMB indicate that a third (n = 17) of the 51 responding boards have investigated complaints against physicians related to regenerative medicine or stem cell therapy, and that eight of those boards have taken disciplinary action against physicians for issues relating to regenerative medicine or stem cell therapy.”
That’s much more action than most of us were aware of who follow this area. Still, with hundreds of clinics out there selling non-FDA approved stem cell offerings that often lack data to back them up, I believe that much more medical board action is needed.
Will the final FSMB working group report released in May spark more concrete action or changes in clinic practices to be more responsible? Again, I’m encouraged by the draft report. There’s no easy fix at the state or federal levels for the stem cell clinic industry problems, but more action by the FDA and medical boards can have major positive impact.
2. Written informed consent is already required for medical and surgical procedures
3. State medical boards are already supposed to be doing this
4. State medical boards shouldn’t be spending state resources enforcing federal FDA regulations. For example, it will be pretty ironic if California starts enforcing federal stem cell regulations in light of its refusal to support federal immigration law and its refusal to enforce federal drug laws with regards to marijuana.
5. This doesn’t apply to all areas of practice now. It should apply to all doctors or none, regardless of “stem cell therapy”
7. They are already supposed to be policing this
8. In which states are judges issuing gag orders to patients?
9. Doctors already cannot make unsubstantiated claims
10. State medical boards cannot and should not dictate to doctors, clinics or hospitals how much to charge. If they are going to do it, then they need to dictate all prices to all doctors, clinics and hospitals. Something tells me that’s not legal.