Should FDA Be Going After Chiro Stem Cell Consultants Like Drug Dealers?
Last year I blogged on David Singer, a chiropractic consultant who was telling chiropractors how they could make big bucks by adding “stem cell” injections to their practice. You would think that after being called on the proverbial carpet for misleading people about what he was selling that he would have changed his ways. Nope, if anything he has doubled down. So let’s explore whether David Singer now meets the definition of a drug dealer.
If you’re a patient or a physician, you likely have no idea who David Singer is at this point. If you’re a chiropractor, you know the name well. David is a Scientologist business consultant who has been aggressively marketing his services to the chiropractic community for decades. Those services used to be ways to improve your practice and income by being a better chiropractor, creating a better organization, or learning sales techniques. However, in the past few years, David has opened up a new business line in his consulting business-adding “stem cells” to chiropractic practices.
I blogged on David and his stem cell courses in 2019. I pointed out how David was teaching chiropractors how to mislead the public by having them offer dead birth tissues advertised as live stem cell injections. I frankly figured that once I exposed that very clear fraud that David would at least change his tune.Request a Regenexx Appointment
Umbilical Cord “Stem Cell” Scams
One of the biggest healthcare frauds of the nascent 21 century is that birth tissues like the umbilical cord products being sold by vendors to providers contain live and functional mesenchymal stem cells. Why? Because multiple labs have tested these products and found that there are no live stem cells in these vials (1-3). Despite this data, an army of shady sales reps, clinic salespeople, and unscrupulous healthcare providers continue to claim the opposite.
Is David Singer a Drug Dealer?
Webster defines the term “drug dealer” as:
So does David Singer sell illegal drugs?
David Singer’s Regenerative Medicine Materials
Recently a colleague signed up for and attended one of David’s “Regenerative Medicine” webinars. He was intrigued after seeing this statement on his website:
“Recently he has devoted his efforts to not only opening stem cell clinics in partnership with other doctors, but also helping doctors to successfully integrate regenerative medicine into their private practices.”
After he attended the webinar, he was sent this presentation:
The materials state, “Our current focus is on products derived from perinatal tissue.”
Since the last time that I checked in on David Singer, this FDA Consumer Alert was issued:
So with that document in mind, let’s look at David’s presentation:
“The FDA’s position is that if you are going to use these types of tissues, they must be minimally manipulated.”
That’s about all David says about the FDA, but then he writes the following:
“The tissue is found with many different beneficial components. There are stem cells called MSCs, growth factors, cytokines, chemokines, and other components that enhance the body’s healing.
The tissue we use is derived from Wharton’s jelly…and is concentrated with Mesenchymal Stem Cells, also called MSCs…
MSCs are multipotent stromal cells that can differentiate into a variety of cells types, making them ideal for procedures ranging from:
- Sports injuries
- Orthopedic conditions
- Sexual health
- And more”
So David is claiming that the products he uses have MSCs and that they can be used to treat everything from orthopedic injuries to sexual health to anti-aging. The problem? The FDA Consumer Alert above says:
“Anyone considering the use of anything purported to be a regenerative medicine product, including stem cell products, exosome products, or other widely promoted products such as products derived from adipose tissue (this product is also known as stromal vascular fraction), human umbilical cord blood, Wharton’s Jelly, or amniotic fluid should know:
- None of these products have been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain.”
In addition, David tells you in the presentation that he will sell you this Wharton’s Jelly “stem cell” product.
IMHO David Singer is a Drug Dealer
David classifies his Wharton Jelly product as having stem cells and provides clinical indications from orthopedics to sexual health to anti-aging. Hence, based on my reading of the FDA Warnings, Untitled Letters, and Consumer Alerts, David is selling an illegal drug product. Hence, IMHO David fits the Webster definition of a drug dealer.
Drug dealers often gloss over the possible side effects of using their illegal drugs. Let’s see if David does the same. From the presentation:
“Since MSCs do not trigger an immune response and are tolerated by the immune system…”
All umbilical cord products are HLA matched to the recipient (4). What does that mean? All cells have ID information on them that ties them to one group of people. When cells are transplanted between one person and the next, they need to be matched to make sure they’re in the same HLA type or group (5). If they aren’t matched, then the patient is at risk of Graft Verus Host Disease (GVHD) a serious medical condition that can lead to rashes, organ failure, or death (6).
Dr. Singer would have us believe that MSCs are immune privileged. Well, that’s half right. As I have blogged before, we now know that someone else’s live and unmatched stem cells can provoke an immune response because while they can evade someone else’s immune system, they aren’t actually immune privileged (8.9). So if you have live and unmatched stem cells from someone else injected into your body, you won’t get GVHD, but they will get gobbled up by your killer T cell system.
What happens if those stem cells are dead? Well, that’s a very big problem. Live stem cells can evade the immune system of the host for a while. Dead stem cells just cause an immune reaction. Hence, injecting dead stem cells into patients can be very dangerous.
In addition, what Dr. Singer didn’t get the memo on is that Wharton’s Jelly contains other cells that can’t evade the immune system (7). Hence, any and all of them can provoke an immune response.
If you really want to dive deep on these issues, please check out my lecture below:
What, Me Worry?
If you’re a chiropractor thinking of signing up for one of these courses given by consultants such as David Singer, please take note of this recent FDA and FTC Warning letter sent to a chiropractor:
This chiro in California is using umbilical cord “stem cells” to treat many of the things that Singer teaches. However, now he has to deal with three departments in the FDA and the FTC. So that added million a year he was earning selling fake stem cell treatments will now be used for a legal defense.
The upshot? IMHO David Singer now clearly meets the definition of a drug dealer. I hope regulatory agencies start realizing that in my opinion, taking down one David Singer is equal to getting rid of hundreds of clinics offering fake stem cell therapies.
(1) Berger D, Lyons N, Steinmetz, N. In Vitro Evaluation of Injectable, Placental Tissue-Derived Products for Interventional Orthopedics. Interventional Orthopedics Foundation Annual Meeting. Denver, 2015. https://interventionalorthopedics.org/wp-content/uploads/2017/08/AmnioProducts-Poster.pdf
(2) Becktell L, Matuska A, Hon S, Delco M, Cole B, Fortier L. Proteomic analysis and cell viability of nine amnion-derived biologics. Orthopedic Research Society Annual Meeting, New Orleans, 2018. https://app.box.com/s/vcx7uw17gupg9ki06i57lno1tbjmzwaf
(3) Panero, A, Hirahara, A., Andersen, W, Rothenberg J, Fierro, F. Are Amniotic Fluid Products Stem Cell Therapies? A Study of Amniotic Fluid Preparations for Mesenchymal Stem Cells With Bone Marrow Comparison. The American Journal of Sports Medicine, 2019 47(5), 1230–1235. https://doi.org/10.1177/0363546519829034
(4) Eapen, Mary et al. Mismatched Related and Unrelated Donors for Allogeneic Hematopoietic Cell Transplantation for Adults with Hematologic Malignancies. Biology of Blood and Marrow Transplantation, Volume 20, Issue 10, 1485 – 1492. https://www.ncbi.nlm.nih.gov/pubmed/24862638
(5) Flomenberg N, Baxter-Lowe LA, Confer D, et al. Impact of HLA class I and class II high-resolution matching on outcomes of unrelated donor bone marrow transplantation: HLA-C mismatching is associated with a strong adverse effect on transplantation outcome. Blood. 2004;104(7):1923–1930. https://www.ncbi.nlm.nih.gov/pubmed/15191952
(6) Holtan SG, Pasquini M, Weisdorf DJ. Acute graft-versus-host disease: a bench-to-bedside update. Blood Jul 2014, 124 (3) 363-373; DOI: 10.1182/blood-2014-01-514786
(7) Stefańska K, Ożegowska K, Hutchings G, et al. Human Wharton’s Jelly-Cellular Specificity, Stemness Potency, Animal Models, and Current Application in Human Clinical Trials. J Clin Med. 2020;9(4):1102. Published 2020 Apr 12. doi:10.3390/jcm9041102
(8) Ankrum, J., Ong, J. & Karp, J. Mesenchymal stem cells: immune evasive, not immune privileged. Nat Biotechnol 32, 252–260 (2014). https://doi.org/10.1038/nbt.2816
(9) Rowland, A.L., Xu, J.J., Joswig, A.J. et al. In vitro MSC function is related to clinical reaction in vivo. Stem Cell Res Ther 9, 295 (2018). https://doi.org/10.1186/s13287-018-1037-4