In the previous three posts (Part One, Part Two, Part Three), I have been reviewing aspects of the FTC’s recent court case against Dr. Henderson, who was charged by the FTC with false advertising by making clinically-unsupported claims about the therapeutic power of amniotic stem cells. Dr. Henderson acknowledged engaging in false advertising and making false claims to patients and potential patients. I also speculated on the role the FTC might play in aiding the FDA to reign in rogue clinics and “bad actors” that have made regenerative medicine a free-for-all. I will cover additional implications of the Order the FTC obtained in their case against Dr. Henderson in this post.
With the relatively quick takedown of Dr. Henderson’s operations, the FDA probably is going to let the FTC continue the whack-a-mole exercise on non-compliant, fantasy-based physicians and clinics, since it seems the false advertising and deceptive claims approach is straight forward. However, there are important considerations and warnings for physicians based on the language the FTC used in their Stipulation and Complaint against Dr. Henderson. In an easy to follow recitation, the FTC set the bar for making public claims of therapeutic benefit (e.g., on a website) dependent on a physician knowing of and providing clinical evidence that can be obtained only through Level 1 (placebo-controlled, double-blinded) clinical studies, just the kind of clinical studies that are required by the FDA in traditional IND programs to gain approval of drugs. If that is the standard by which a physician needs to establish the validity of their claims (“greatest therapy ever”, “miraculous therapy”), I suspect no physician currently advertising the use of materials including cord blood, amniotic stem cells, Wharton’s Jelly stem cells, umbilical cord cells, SVF, fuzz balls (i.e., mechanically fractured fat) or some of the hybrid compositions in use will be able to withstand an FTC complaint for fraudulent practices.
Detailed definition of the standards the FTC is going to enforce are explained in Section 1 of the Order, in which the FTC laid out for the defendants what they would be required to do if they wanted to make “Health-related Claims” concerning amniotic stem cells. To wit, in order for a medical therapy to be advertised as equivalent to or superior to conventional therapies, a physician will need to provide clinical support meeting the following criteria:
- The claims are made by a physician who is non-misleading in presenting the claims.
- Non-misleading means that the physician knows of “…competent and reliable scientific evidence that is sufficient in quality and quantity…[as to be] accepted by experts in the relevant disease…”.
- Competent and reliable scientific evidence is obtained from studies performed by experts in the particular disease or condition.
- The protocols of the studies are thought by experts “…to yield accurate and reliable results…”.
- Clinical protocols used in the studies will consist of “…randomized, double-blind, and placebo-controlled human clinical testing of the Covered Product or Covered Service…”.
Clearly, none of these conditions have been met by the hawkers of amniotic stem cells, or the physicians using these magical preparations.
While it seems to me the FTC’s rules for advertising a clinic’s regenerative medical program are pretty straight forward, I suspect there are physicians who are thinking that if they aren’t quite as blatant as Dr. Henderson was on making public claims they can get away with advertising their use of the magical goop du jour and not run the risk of triggering an FTC investigation. However, the FTC has stated that if a physician wants to advertise, and who doesn’t want to advertise after going to all of the trouble of creating and maintaining a website, any claim needs to be backed up with Level 1 clinical data. And not just from anyone, but from recognized experts in the particular pathology being treated. Frankly, the structure of the legal case made against Dr. Henderson by the FTC leaves physicians without much to advertise compared to the good old days when they were dancing to their own beat selling miraculous regenerative medicine on their websites.
My only disappointment in the FTC’s use of false advertising complaints is that most likely none of the physicians or owners of the offending stem cell clinics will end up doing time in the big house. Even so, there will be those physicians who will continue to skirt the rules in the regenerative medical field, especially with the ready availability of “off-the-shelf” products like amniotic stem cells, but at long last, it has become more legally perilous for physicians to deceive their patients with unsupported regenerative medical practices and deceptive claims.
Just as I am the other kind of doc—a PhD—and don’t tell physicians how to practice medicine, I also am not an attorney, so my advice on how I think a physician might avoid the FTC hammer shouldn’t be considered as a stay out of jail free card, so to speak. However, I believe a physician can advertise the offering of regenerative medical therapies as long as they avoid extravagant statements that suggest that the therapy will cure the patient, or a therapy has been shown to be equivalent to or superior to conventional treatments.
Dr. Henderson seemed completely unconcerned with the need to provide clinically-supported evidence about the amniotic stem cells he was offering, so if you don’t make claims for something like PRP and BMC, it means you probably won’t need to sign a Stipulation Agreement at the behest of the FTC. In any event, consult competent legal experts if you want to push the FTC’s limits, especially with unproven, FDA non-compliant, therapeutic preparations like Wharton’s Jelly stem cells that are gaining traction in the regenerative medical community right now.