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Should FDA Be Going After Chiro Stem Cell Consultants Like Drug Dealers?

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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.

David Singer

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.

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.”

FDA Issues

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
  • Anti-aging
  • 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.

Rejection Issues

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.

_____________________________________

References:

(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

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7 thoughts on “Should FDA Be Going After Chiro Stem Cell Consultants Like Drug Dealers?

  1. Brad

    Chiros frequently give the illusion they perform these procedures themselves.

    I recognize the importance of chiropractic in certain circumstances – I have a problem though when they make themselves out to be something they are not and deceive patients and others. There’s an entire industry of chiro clinics calling themselves “physical medicine” clinics inappropriately and deceptively. Some of them hire a midlevel to perform injections – which is another part of (and compounds) the problem (many of them don’t know what they don’t know).

  2. Dr. Dean Raffelock

    I’ve had the dubious pleasure of being introduced to David Singer in about 1979-1980. He wanted to meet because I had the most high profile “holistic chiropractic” practice in the West Los Angeles area. At the time David was aggressively hawking his “practice management” business which if I remember clearly was based upon L. Ron Hubbard’s Scientology model. Whatever it was, his high pressure tactics were a big turnoff and I remember wondering why he felt that I needed his help and feeling like I needed a shower after the meeting. After that, every once in a while David’s name would re-surface and he’d be into something else equally suspect. He is one of those guys who is smart enough to make a genuine contribution and an honest living but just seems to lack the moral compass to earn money by actually working hard to learn how to help people.

    I would have to say about Brad’s comment though, that I find that many physiatrists, orthopedists, and anesthesiologists also don’t know what they don’t know. Many of them do highly inaccurate muscle testing yielding false information and then develop expensive treatment programs based upon their faulty diagnostic information. No one has all the answers and there are some truly egregiously dishonest physical medicine physicians and anesthesiologists taking advantage of people. So better I think to not cast dispersions on whole professions. There is a reason that many of the starting players on the 1997 and 1998 Super Bowl winning Denver Broncos team paid me high off-hour fees to fix their problems when the Broncos orthopedists, physical therapists and trainers didn’t have a clue how to diagnose their injuries let alone get them back on the field. I couldn’t inject the ones who needed it but didn’t hesitate to refer to either Chris or John when it was needed. I retired in 2013 and enjoy a satisfying second career formulating top quality utraceutical products for a few ethical companies that do everything right.

    So yes David Singer has a tweaked moral compass. And yes, we all don’t know what we don’t know.

    DR

    1. Chris Centeno, MD Post author

      Dean, I work with countless chiros who are a fantastic resource. Hence, no issues with the profession, just “integrated” practices that venture into areas that they know little about and then fleece patients. That’s a bit like me adding chiropractic to my practice, which I would never do because I know little about how to make that work.

  3. Phillip Yoo

    Dear Dean and Dr Centeno :

    I actually appreciate the mention of our integrated MD/DC Medical Corporation in your blog and I’ll have to admit it was a very fair and unbiased assessment of our warning letter, in which we are marking the requested appropriate corrections.
    Just to clarify I serve as the President of the medical corporation and our Medical Director who is an Orthopedic Surgeon does the regenerative medical procedures.

    1. Chris Centeno, MD Post author

      Phillip, thanks for the clarification. I don’t think the FDA had concerns about who was doing the injections, but the claims being made about umbilical cord tissue and exosomes that couldn’t be substantiated. For example, that you were injecting live and young stem cells, which is not consistent with the published and presented literature on umbilical cord products. Or that you could inject these stem cells and that these would have some sort of effect on preventing COVID-19.

    2. Chris Centeno, MD Post author

      Here’s an example: ““The type of stem cells we use, from the umbilical cord… we’re using the adult, mature, umbilical cord because the baby is already out and healthy and born…It can be given to the recipient to regenerate their immunity or joints or pain. Wharton’s jelly, that’s what was used in the China study, is the highest count in stem cells and growth factors.” [www.youtube.com/watch?v=kfUp6LSsKZ8]”. The China study you’re referring to used culture-expanded MSCs that were living and the product you offered to patients had no living MSCs.

    3. Chris Centeno, MD Post author

      Here we have you stating that you will send a nurse to someone’s home to inject stem cells and then misstating that the products you use have been approved by FDA to treat COVID, “If you are afraid to leave your home, we can deliver the treatments to you. We can send a doctor or nurse to come if you need stem cells. We could do it in your home, heck, we’ll even do it in your car in the parking lot if you’re afraid to have guests in your home…There’s a lot of rapid approvals that the FDA has approved for umbilical cord stem cells, exosome therapy, natural killer cell therapy to kill the COVID virus.” So if you have a medical director overseeing this, then he or she, IMHO, should lose a medical license.

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