FTC Actions Against Stem Cell Clinics Making Deceptive Claims about Amniotic Fluid Products – Part Two

FTC Against False Claims

In the last post, I had introduced the sins of Dr. Henderson, who was cited by the FTC for advertising MRM—miraculous regenerative medicine. Needless to say, the FTC took exception to the outlandish and false claims Dr. Henderson made on his now-inaccessible website(s), so I will perform a public service by sharing with you my observations after reading the exhibits the FTC submitted to the court documenting his deceptive practices. I will continue my review with Exhibit B v. 1.

As shown on the first page of Exhibit B v. 1, Dr. Henderson provided a series of icons covering an expansive set of pathologies and conditions the magical amniotic stem cell preparations could treat:

Charcot Marie Tooth
COPD
Chronic Kidney Disease
Delusional Fantasies
Dementia
Depression
Diabetes
Head Injuries
Heart Attack
Liver Diseases
Macular Degeneration
Parkinson’s Disease
Stroke

Other pages from Dr. Henderson’s website contained in Exhibit B, v. 1 highlighted Cerebral Palsy and Autism.

Quite an impressive list, isn’t it? However, I have to confess that I added “Delusional Fantasies”, since that was my reaction to the absolutely untethered-to-reality approach Dr. Henderson had adopted even if he was advertising MRM. Medical experts can’t even agree about the source/cause of some of the conditions he cited as treatable. For example, autism is not a single “condition” but has a spectrum of manifestations. If the experts don’t know what biochemically is at issue in autism, I can’t imagine Dr. Henderson knowing how to cure a patient diagnosed with autism simply by treating the patient with amniotic stem cells. His approach reminds me of the old timey physicians, who would read a patient’s humors, but treat everything with bloodletting.

While I am not one to criticize someone’s website content, since I am hopelessly inept in these matters, I will note that one of the headers Dr. Henderson had in the section on Macular Degeneration is “There is Light at the end of the tunnel”. I can’t figure out if he is just playing with his desperate patients or if he really thought that the amniotic stem cells would restore vision to patients suffering from macular degeneration so that they could see the light. Unfortunately for Dr. Henderson, the light at the end of his tunnel was the FTC train bearing down on him due to his numerous false claims.

The FTC divided up some of the more outrageous and false claims from the website between Exhibit B, v. 1 and v. 2. For example, volume 2 includes “information” on Parkinson’s Disease, stroke, osteoarthritis, and refers to treating multiple sclerosis, muscular dystrophy, amyotrophic lateral sclerosis and traumatic brain injury. In some cases, Dr. Henderson claims that amniotic stem cells can make new cells in a particular pathologic site. For example, in the section on Parkinson’s Disease, Dr. Henderson states that “Stem cells make NEW cells in the substantia nigra…”. While he got the correct location of the source of pathology in Parkinson’s (substantia nigra, which loses dopamine-releasing cells causing tremors), there is absolutely no evidence that an IV infusion of amniotic stem cells results in any cells migrating through the blood brain barrier, in order to “make NEW cells” in the substantia nigra. It is an especially egregious deception, given that the only cell-based clinical studies for treating Parkinson’s I have seen involve transcranial injections. Obviously, there is a big difference between being treated IV with amniotic stem cells and having an intracranial injection of a stem cell preparation, which further highlights the audaciousness of his false claims.

There is a very curious, and completely misleading, statement made in the web content on stroke in Exhibit B, v. 2, as follows:

“Regenerative Medical Group is an excellent center that offers stroke patients the most innovative therapies. We use this unique FDA approved technology of applying activated Stem Cells previously extracted from amniotic fluids.” (p. 41)

The statement reeks of false claims, but I certainly agree with Dr. Henderson that his therapeutic preparation could have been unique, if only it truly had been approved by the FDA. Unfortunately for his patients, nothing Dr. Henderson used for therapeutic purposes was approved by the FDA. There also is the part of the quote that references “…applying activated Stem Cells”, obtained from amniotic fluids. I went through the Exhibits looking for any context that might explain what approach Dr. Henderson took to activate the stem cells found in amniotic fluids, but I couldn’t find any additional information on this point. Needless to say, while the FTC didn’t cite this as one of Dr. Henderson’s sins, the FDA certainly would have called him out on it, since activating cells causes them to exceed the standard for minimal manipulation—a regulatory no-no.

Also found in Exhibit B, v. 2, was the following statement:

“The thieves who’d prey on your hopes and fears to make a quick buck, but offer no lasting, medically-sound treatment. That’s not us.” (p. 43)

How ironic that he uses the classic con of cautioning his marks about “thieves” who would rob them blind, since what has to have been one of the biggest thieves is none other than Dr. Henderson. I don’t know if Dr. Henderson made his bucks quickly or not, but the FTC could find nothing positive to say about any of the completely unsupported and grossly false claims on his website, and instead cited him for deceptive advertising.

Before I move on in the next post to cover the FTC’s Complaint and Order on Stipulation, there is one more item that floored me when I came across it in Exhibit G:

“RMG [one of Dr. Henderson’s clinics that was cited by the FTC] is pleased to announce a Kidney guarantee – a guarantee to prevent a patient from having to go on dialysis.” (p. 54)

While this statement is yet again evidence of the false claims that were littered throughout his website, Dr. Henderson in offering up this guarantee for patients suffering from kidney pathology seems like he is treating the regenerative medical field as if it is just a commodity-based retail product, like dish soap that is guaranteed to leave your dishes sparkling clean. I have always thought that orthopedic surgeons, either fuzz ballers (mechanically-fractured fat) or SVFers (enzymatic digested fat), who touted the fact that their patients would undergo a lipoaspiration (consisting of a 30 cc or 60 cc syringe filled mostly with fluid and a few bits of tissue) were pushing the envelope, but they pale in comparison with PT Henderson.

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