We have a real problem. We have hundreds of physicians, chiropractors, and alternative-health practitioners who have been lying to patients about injecting them with millions of young stem cells from amniotic fluid and/or umbilical cord tissue. On its face, since there are no living mesenchymal stem cells in these commercial products, that’s consumer fraud. However, do these physicians and healthcare providers have a responsibility to know that these are dead tissues, or can they claim ignorance and blame the companies who sold them the tissue? Should these healthcare providers be legally liable for their actions? Let’s explore that issue this morning.
With the publication of the consensus document on amniotic and umbilical cord products being dead tissue and calling out the medical providers who are scamming patients by claiming that these are live stem cell treatments, “the gig is up.” Meaning, given the research that was reviewed for that document and now new research out of UC Irvine, there is enough “out there,” for anyone who wants to look, to discover that any company claiming to sell live stem cell products derived from birth tissues is more likely than not, perpetuating a scam.
As a physician, there isn’t a week that goes by that you don’t get pitched by some sales rep for something. Any reasonable person knows that a third-party seller, such as a sales rep, has a greater responsibility to the manufacturer than to the buyer. In fact, this is called an “arm’s length relationship,” which is defined as below:
“Arm’s length…a relationship between two parties who are unrelated or strangers; thus each owes no special obligation to the other party. The term is commonly applied…describing parties who carry out a particular transaction, each acting in self-interest….”
Hence, it’s the responsibility of the buyer to educate himself or herself about the product. This is the origin of the phrase “buyer beware.” What complicates this in the world of birth tissue sales and clinics is that the medical provider “buyer” of these products then turns around and becomes a seller of the product to patients. Hence, there is a tendency for whatever lies the seller told the physician buyer to be passed on to the patient. In fact, the only way that transmission of misinformation can be prevented is if the physician acts as a gatekeeper of information.
Think about this for a second. Physicians are the broadest and deepest trained of any of the health care professionals. Nurses, pharmacists, nurse practitioners, physician assistants, and medical assistants all have less training. Doctors must graduate at the top of their college classes just to be considered for medical school. Then they have to go through four grueling years of postgraduate education in medical school. Add in an internship and, these days, at least three years of residency and then often a fellowship, and they are the top dogs on the medical educational ladder.
Hence, it’s because of this both broad and deep training that society at large trusts doctors to scientifically vet all of their treatment. Therefore, as a physician, you have the training or can get the training to be smart enough to thoroughly vet the sales pitches thrown your way by pharma, device, and other companies. You are the one that should be asking the tough questions, or if you can’t ask them, you are the one who should be seeking the information to be able to ask them.
For many of the things a physician can use on a day-to-day basis, there is a rigorous FDA approval process. Hence, the doctor can at least rely on the science behind that approval. He or she may still question whether that science applies to a unique patient, but there is at least a strong safety and efficacy background to back the doctor up.
However, things get much murkier when the doctor moves from FDA-approved drugs to FDA-cleared devices or FDA-registered tissues. In these latter categories, the FDA has often made no statement about the science behind safety and efficacy. For example, for an FDA 510K cleared device, the only thing the FDA has stated is that this device is substantially similar to some other device. Often these predicate devices are grandfathered and also have no clinical data to support their use.
For FDA-registered tissues, matters get still worse. Unlike a 510K cleared device, where the FDA has at least looked at how the device is manufactured and that it’s similar to something else, for 361-registered tissues the agency has reviewed nothing at all. The tissue is merely registered on a free online form. While at some point the agency might inspect the site where that tissue is processed for sterility, that’s the extent of the FDA’s involvement.
This lack of FDA oversight becomes a critical issue in the use of birth tissues, such as amniotic fluid and umbilical cord products, as these are only registered with the agency. Meaning that the FDA does not vet the birth tissue science for you. This is a big problem in this industry, as it’s rife with manufacturer and sales reps claims that often include the idea that the tissue has many live, young, and functional mesenchymal stem cells. The companies often produce white papers to support these claims that look very scientific.
Given that the main claim driving sales for many amniotic and umbilical cord products is that they contain mesenchymal stem cells (MSCs), a physician has a responsibility to vet this claim. What does he or she need to know? That part is pretty simple. How does one define and confirm the presence of an MSC?
If we run that Google search—”identification of mesenchymal stem cell”—this is the paper that comes up as the number 1 hit: Mesenchymal stem cells: Identification, phenotypic characterization, biological properties and potential for regenerative medicine through biomaterial micro-engineering of their niche. There is ample information in this paper to allow the physician to dig deeper on what data to expect when identifying mesenchymal stem cells. It’s a short jump from there to realizing that the data being offered by birth tissue vendors is insufficient to confirm the presence or absence of MSCs in these products. Hence, if the physician was acting in his or her role as an information gatekeeper, this would keep any physician from claiming that these products had MSCs, despite the claims of tissue manufacturers.
So what happens to doctors who just believe the reps that these products have loads of young and viable MSCs? Especially when they pass that lie on to patients who then pay them big bucks to be injected with millions of stem cells? Do these patients have cause for consumer or malpractice legal action against these doctors? While I’m no attorney, I would argue that they clearly do have a legal case. The doctor failed them in his or her role as an information gatekeeper and then defrauded them.
The upshot? It’s time to end the charade that you can buy amniotic or umbilical cord products with millions of live mesenchymal stem cells. More importantly, I would argue that for companies and physicians who keep up this game of consumer fraud, there should be real legal consequences.
*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.
Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.
About the Author
Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…