In the last post, I reviewed some of the issues and lessons from the Shapiro, et al. papers, as they related to doing higher level clinical studies with BMC. However, even their study didn’t meet the newly minted standard set by the FTC in the court Order issued last October. In that court Order, the FTC clearly defined the requirement in order for anyone—manufacturer, health care provider or clinic—to make health-related claims for regenerative medical therapeutics. Namely, you can only rely on data from Level 1 clinical studies performed by recognized experts in the pathology to satisfy the FTC, and presumably, the FDA. I will cover what I think will be serious challenges to doing a Level 1 clinical study for BMC intraosseous treatments in this post, and will suggest an alternative that won’t meet the FTC’s requirements but will assist physicians in refining their practice of regenerative medicine.
The following statements were made in the FTC court filings:
- Henderson, the target of the FTC legal action, was cited in the Complaint for knowingly making deceptive claims and engaging in false advertisement.
- He was cited as being deceptive when he spoke to patients about the therapeutic benefit of amniotic stem cells
- He and his clinics also engaged in false advertisements and making deceptive claims when potential patients could read on the clinics’ websites outrageous, and completely unsupported, claims about the therapeutic potential of amniotic stem cells
- The Order mandated that Dr. Henderson not support in any way, shape or form making health-related claims about amniotic stem cells with patients or to aid others in seeking patients to receive treatment
- The only way for Dr. Henderson to get back in the regenerative medical market was to rely on Level 1 clinical studies
During a panel discussion on regulatory matters at the recently concluded IOF Conference (Broomfield, CO), I pointed out that the FTC had cited the claims Dr. Henderson made during his interactions with patients as part of his sins, indicating that a physician making claims one-on-one with a patient in the absence of Level 1 clinical evidence might be in violation of the court Order. My co-panelist, Andrew Ittleman, a highly-respected attorney in regulatory matters, didn’t think that the FTC would try to intervene in the dialog physicians have with their patients.
It is a reasonable position, and probably right. Nonetheless, the FTC has said that if a clinician doesn’t have Level 1 clinical study data to support their regenerative medicine therapeutic material of choice, and the clinician is recommending the material to patients, that the clinicians are engaging in making fraudulent claims, based on statements made in the court Order. So, while physicians might not need to fear the FTC paying them a visit, there might be some vulnerability to claims of civil fraud made by law firms specializing in class-action lawsuits. I am not saying that physicians will be subject to class-action lawsuits if they provide something like amniotic stem cells as a treatment, but there is no denying the thrust of the Federal court Order against Dr. Henderson indicating he had engaged in fraudulent practices while touting the miracle cures of amniotic stem cells.
Given the potential implications of the FTC court Order, what is a clinician to do in order to avoid being accused of making fraudulent health-related claims with respect to treating knee OA with an intraosseous BMC protocol? What kind of clinical study format might pass muster with the FTC and the FDA? Good questions. Clearly, the traditional Level 1 framework works well for comparing an experimental drug taken orally with a placebo pill also taken orally. Or, you might have two versions of surgical anchors and one group of patients gets the cleared anchor and the other group gets the experimental anchor. But what if you want to do intraosseous injections?
If you go strictly by the traditional Level 1 framework, your control patients not only would be required to undergo a bone marrow aspiration, which would be thrown away, but they would need to receive a placebo delivered intraossesously into the femoral condyle and the tibial plateau. Not going to happen, since that type of delivery usually requires more than conscious sedation and has a potential for serious complications, not to mention that it would incur the cost of an operating room. Perhaps the FDA would be willing to consider as a control group those patients receiving an intraossesous hit of bone cement, but this type of treatment usually is performed to treat localized bony defects and isn’t associated with treating adjacent tissue osteoarthritis.
There are some hybrid approaches that might be considered, including not doing a sham intraosseous injection, in which case you just compare a BMC-treatment cohort with a so-called active control cohort receiving an established treatment, like viscosupplementation. Or you could do a format in which patients are their own controls, in which case I would urge you to reconsider, in light of the Shapiro, et al. findings. On the other hand, you could skip the drama and difficulty of Level 1 formats with intraosseous treatments and go with Level 4—a case series format.
I will review in the next post some of the features of a Level 4 clinical study format that a physician might consider in order to bring a little more rigor and respectability to the case series clinical outcomes.