By now, I am sure most folks in the regenerative medical community have heard about the Federal Trade Commission (FTC) going to court and formalizing an Order that effectively shut down a physician who really was pushing the limits and engaging in blatantly false advertisement to lure patients to his clinics to pay a lot of money for getting treated with “amniotic stem cells”. I will review the case documents, the FTC’s Exhibits and provide my take on the implications for those physicians who think that the world hasn’t changed.
Let’s start with the press release from the FTC on the essential details of the case. Straight away, the FTC doesn’t mince any words by pointing out that Dr. Bryn Jarald Henderson, DO, and the two stem cell clinics he owned, Regenerative Medical Group and Telehealth Medical Group, engaged in deceptive claims, but agreed that they will no longer deceive the public about amniotic stem cell therapy for which there is no evidence of benefit:
A California-based physician and the two companies he controls have settled charges of deceptively advertising that “amniotic stem cell therapy” can treat serious diseases, including Parkinson’s disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, and heart attacks.
The settlement prohibits the defendants from making these and other health claims in the future unless the claims are true and supported by competent and reliable scientific evidence.
After reading the FTC’s press release, I didn’t think there would be much more to be gained from the legal documents, but once I started reviewing them, I couldn’t stop. The Exhibits submitted by the FTC provide us a view into Dr. Henderson’s fantasy world, which no longer is accessible—at least not when I went looking for the Regenerative Medical Group website on December 3, 2018.
Since you can’t see for yourself just how deceptive Dr. Henderson’s website(s) were, I will cover highlights from the Exhibits the FTC presented to the Court. I will start with Exhibit A, which is a reproduction of a letter Dr. Henderson made available, I think, to prospective patients. If you want to follow along, you can get the FTC case documents here.
Near the top of the letter, Dr. Henderson writes:
“Lives are being saved, the blind see, the cripple walk and patients with heart, lung, kidney and nerve diseases can alter the course of their suffering with a simple therapeutic the (sic) lasts for years and impacts their lives NOW!”
He lets us in on the miracle therapy, citing his use of “…the most advanced stem cells—Amniotic stem cells—derived from a process approved by the FDA in a FDA licensed facility in Scottsdale, AZ.”
No kidding. First off, he provides no justification in the letter or elsewhere in the Exhibits to clarify what he means by “…the most advanced stem cells…”. But I can assure you that the process used to produce the miracle cell preparations clearly is not approved by the FDA. FDA approval of a product would require Dr. Henderson or the manufacturer to have conducted a seriously expensive clinical trial (IND), which would take years to complete. Ironically, if the material had been approved by the FDA, the FTC wouldn’t have been able to cite him for some of his outlandish claims—but more about that later.
I don’t want to seem like I am piling on with the next couple of observations, but Dr. Henderson repeatedly plays fast and loose with reality by making common deceptive claims. For example, he stated the usual myth that amniotic stem cells are immune privileged. According to Diazdosc, et al. (2016), these cells most certainly are not immune privileged.
Moving down the text of the letter, Dr. Henderson made the following statement:
“There has never been any side effects reported from administering amniotic stem cells.”
This is an entirely reasonable statement for Dr. Henderson to make, since virtually nothing about treatments with amniotic fluid products has been reported in the literature. Furthermore, given how little has been published on any aspect of amniotic fluid products, including the kind with stem cells, why would a proponent of the therapy share something negative? Clearly, it is deceptive to suggest that nothing bad has been reported about magical amniotic stem cells, when in fact nothing at all has been reported in the clinical literature, as I once again found when I went looking in PubMed last week. The FTC also made a similar comment to the effect that there wasn’t any published clinical study literature available on amniotic stem cell therapy, which is the therapeutic material Dr. Henderson claimed he was using to treat his patients.
The foregoing was just a taste of the excessive claims and promises that appear in the other FTC Exhibits. I will move on to cover other choice examples of his deceptive claims from the Exhibits in the next post.