These past few years have seen an explosion in chiropractic and alternative medicine clinics who are offering "stem cell" therapies. In fact, while most medical doctors wouldn't recognize the term "chiropractor stem cell" as words that go together, I would estimate about half of all patients these days get exposed to what they believe is a stem cell therapy at a chiropractor's office rather than their local M.D. or D.O. This morning I'd like to go over how a chiropractor can legitimately offer this type of care versus what's a public health risk. Let's dig into this controversial topic.
Before We Get Started…
Two of my best friends are chiropractors. I was honored when both of them called me an honorary chiropractor because of my "total body" approach to care. I routinely refer back and forth to chiros for dynamic imaging, chiropractic care, curve restoration, etc… All of the chiros I know and work with would no more add "stem cell therapy" to their practices then they would renounce their chiropractic licenses. They all believe that this would be as out of their area of expertise as it would be for me to begin manipulating spines.
The History of the Chiropractor Stem Cell Explosion
How did we get here? Approximately a 1-2 decades ago, a handful of chiropractic clinics began to add simple non-chiropractic services. These included things like physical therapy or massage. That then morphed into simple medical services like medical weight loss and hormone therapy. The good news? These are all low-risk services. Meaning, it's hard to harm or kill anyone with PT, massage, a diet, or by prescribing hormones. To accomplish these last two medical services, chiro clinics began hiring mostly physician assistants and nurse practitioners. These were far cheaper providers to hire than an actual M.D. or D.O. and for these lower level services, the risk of using lesser trained providers was minimal.
However, a few years back, a new phenomenon began. We started to see chiro clinics offering "stem cell" therapies. This generally happened because most of these clinics that added medical services had an existing relationship with one of the many chiropractic management companies out there. These companies, having made as much as they could by charging chiros fees to add simple medical services were looking for their next "big thing". This was "stem cells". However, we now had clinics offering services (mostly using non-physicians) that had a higher risk matrix. To understand the last part, let me walk you through some medical records I recently reviewed. First, to get up to snuff on why the birth tissues (like amniotic and umbilical cord "stem cell" injections) are really dead tissue, watch my video below:
What Could Go Wrong?
As an expert in orthopedic stem cell use who has published quite a bit in this area, I am asked sometimes to review medical records where things may have gone horribly wrong. In this case, medical records were sent my way where we had a chiropractor offering "stem cell" therapy by hiring a non-physician mid-level (like a physician's assistant or nurse practitioner) to evaluate patients with spinal pain for "stem cell" therapy. The therapy was, of course, a scam, as what was being injected was a dead stem cell product that used umbilical cord blood, so it was very unlikely that any patient was getting any live stem cells. However, the key fact here is that the chiropractor and a mid-level made the decision to have the umbilical cord blood injected into the epidural space, facet joints, and discs of three patients. The only time an actual licensed medical physician was brought in was to perform the procedures. So to review, we have a chiropractor with a 4-year degree and a non-physician making the decision to take the risk of injecting umbilical cord blood into the spine.
First, what the chiro and mid-level didn't grasp is that there is no safety data on injecting this stuff into these places. Nor is there any published efficacy data. Meaning, that we have no idea whether any of this would work. They just conflated the idea that the product had "stem cells" (not having the education to understand why this was a dead cell product) with the idea that stem cells may help these areas heal.
Second, all three patients reported that the chiro was present in the operating room telling the physician specialist where to place the umbilical cord blood. In addition, some of these patients got IV umbilical cord blood as well. Why? Your guess is as good as mine, but it clearly demonstrated that the chiro was sticking his nose into areas of medicine where he had neither the training nor experience to understand the risks and benefits.
The result? This umbilical cord blood was bacterially contaminated and all of these patients got very, very sick. It wasn't enough that some had abscesses in their spine from the injections, but some also had an even higher risk IV injection of this nasty stuff, making sure that those patients got even sicker by distributing the bacteria all over their bodies. It's unsure if any of these patients will ever be made whole again.
Unpacking What Happened and Why Chiro Stem Cell Clinics are a Serious Public Health Risk
The problems and risks here can be broken down as follows:
1. We had a chiropractor with the equivalent of a 4-year degree in charge of which patients got a high-risk therapy.
2. Neither the chiro (nor the mid-level) had any idea of the risk-benefit of these procedures, as they were not trained in what those potential complications might be. For example, stratifying the risk of these procedures in light of bacterial contamination would be: IV is the riskiest, inside the disc is next and a close second, injecting epidural is almost as risky as the disc, and finally the safest (but not by much) would be inside the facet joint. Meaning, it would have been better to avoid all of these places to inject umbilical cord blood and instead try a muscle trigger point injection (safest). If there was still a desire to perform these procedures, given the lack of existing evidence, that would only have been appropriate as part of an IRB approved study where the patients understood the risk.
3. The specialist physicians, who should have known better, were not in charge of the medicine. They were simply hired consultants to perform a procedure. The chiro and mid-level would likely argue that the MD performed his or her own evaluation and that he or she green-lighted the procedure. However, if so, I found no documentation that this happened. Even if it did, this places the MD in the place of being "the bad guy" in having to cancel a procedure that the patient already paid for and is planning on receiving. Meaning that practically, giving the MD the right to cancel the procedure is not often going to result in a canceled procedure.
4. The chiro didn't have the educational background (nor did the non-physician mid-level) to understand that what was being offered (umbilical cord blood distributed frozen to the surgery center) was not an actual stem cell therapy, but was dead tissue, and that there was no research on whether what was being offered was safe and effective.
As you can see, the problems stem from the chiropractor and mid-level running the show. How often does this happen even when there is an MD or DO physician in the mix? Often in my experience. Why? the chiro is often more charismatic and sells the procedure.
In fact, in some local cases, we've seen medical assistants selling the procedures in seminars and then determining candidacy in the clinic. Meaning, in almost all instances, the physician is practically removed from almost all aspects of the candidacy process, which is not clinical, but sales oriented. Hence, just about every person willing to pay is a candidate for the therapy.
A Second Case?
Last year, a west coast colleague informed me of a patient who was given an injection of umbilical cord blood "stem cells" and ended up in the ICU. Near as anybody could tell, the case likely happened due to the endotoxins in the cord blood. Basically, dead cells can release nasty stuff. In addition, while stem cells are immune privileged, other cells in cord blood may not be and in some cases, may cause an immune response in the host. This immune response can be deadly. Again, this was a chiro clinic.
Compare this to a call I had from a company wanting to sell me cord blood to inject into my orthopedic patients. The first question I asked was where was the data showing that it was safe to inject into joints? I instantly understood that the research the company sent was on isolated and culture expanded stem cells and not the cord blood nucleated cells they wanted to sell me. Why? Because I had the base trainming to know the difference. In fact, when pressed, the company had zero orthopedic safety data on what it was selling. A chiropractor or a mid-level would not have asked these questions, see above.
What Medical Doctors Do Everyday to Reduce Risk
The difference between a chiropractor hiring an outside consultant to perform an injection and a physician-run and lead clinic will always be risk mitigation. As an example, when physicians are in total control of the clinic, they make a hundred conscious decisions each day to reduce patient risk. For example, should I use this medication or that one, how should I inject this to reduce the likelihood of damaging a nerve or a blood vessel, or should I even do this procedure in this patient? These decisions are informed by years of clinical experience both during and after training.
Having a chiropractor or mid-level in the loop here blunts that risk mitigation, as shown above. At the end of the day, chiropractors have no training in medicine or procedural based care like surgery or image-guided injections. In the first case, the chiropractor likely had no idea that placing anything inside a human spinal disc has about a 1 in 100-200 chance of a serious infection called discitis. Nor would a mid-level have that knowledge nor experience. For example, most reputable training organizations won't allow mid-levels to even be trained to inject anything inside a spinal disc. The risks are simply too great to allow this procedure to be performed by anyone less trained than a physician with double to triple the training hours of a mid-level.
Breaking Chiro Stem Cell Clinics Down by Risk
I'll break chiro clinics now into three types, two are a public health risk and one is clearly not. Here goes:
Type 1- The Chiro-Mid-Level Two Step-These are clinics that have a chiro plus a nurse practitioner or physician's assistant (mid-levels). There may or may not be a medical supervisor as required by law in some states, but he or she is almost always a figurehead and may have never even stepped foot into the clinic. Why is this a problem? Let me explain.
Mid-level providers were developed to help physicians extend their time (this is why they're often called "physician extenders") and to help reduce the physician shortage in rural areas. Since they have far less training and experience than the average doctor, they were never meant to replace physicians in settings where there is no medical supervision. So in hospital systems, mid-levels may see patients and act quasi-independently, but they are surrounded by more experienced physicians with whom they can staff difficult cases and learn. However, take a mid-level out of that environment and dump them into a chiro clinic without any real medical supervision or help and you have a prescription for disaster.
Why would a chiro clinic do this instead of hiring a real physician? Cost is the main factor. Mid-levels generally run about half or less as much as hiring a physician. In addition, there are laws in many states that make hiring a physician by a non-physician problematic (corporate practice of medicine).
Type 2-The Chiro Mid-Level/Physician Consultant Bait and Switch-As you can see, the disaster case above was actually a level above the chiro mid-level two-step. In this case, the chiro hired an actual specialist physician to perform the procedure. In this set-up, you have two levels of risk:
Type 2a-Incompetent physician
Type 2b-Competent physician
First, when I say competent or incompetent above, I mean concerning the subject matter of an image-guided injection and how best to use orthobiologics. I don't mean that the doctor is medically incompetent. As an example, most physicians who work in chiro owned clinics tend to have subject matter issues. For example, I've highlighted a neurosurgeon with a drug problem in another blog. Or an elderly sports medicine doctor who was trained decades before ultrasound guided injections were a thing. Why? The best doctors out there, generally don't want to work for chiropractic owned clinics, they very reasonably, want to be in an atmosphere where other physicians are plentiful.
The first type of chiro clinic that employs a physician (Type 2a) is when the doctor hired is the lowest dollar provider and is incompetent in the subject matter. Meaning he or she may have no idea how to treat the orthopedic system or the spine or how to perform precise image-guided injections. However, those physicians who do understand these things (like an experienced interventional spine physician to inject the low back) are often twice the price of a general family doctor or internist.
This subject matter incompetence adds risk, as the doctor hired isn't really a trained specialist in how to use orthobiologics through precise injections and may have no idea which end is up. Another way risk is added is by using mid-levels in the equation. The doctor may be a consultant or work full time, but the mid-levels are generally used to perform the evaluations because this maximizes profit.
The second type (Type 2b) is actually less risky, but as I illustrated above, was the one that caused the first disaster I used as an example. In this case, a highly trained provider is hired as a consultant to perform the procedure. however, because the provider was letting the chiro and mid-level "drive the bus", a real calamity ensued. Hence, the risk of this type of arrangement is directly related to how much control the consultant maintains. The problem, however, is practical. The chiro doesn't want to pay the big bucks it would take to hire the specialist physician to be the one seeing patients in the clinic and making the decisions about who should or shouldn't be injected.
As discussed above, the physician is often put in the position of having to cancel the patient's injection if he or she believes it was inappropriately scheduled. However, this is practically difficult to do when the patient has already been told that he or she is a candidate for the procedure, has paid for the injection, has taken time off work, brought in a friend or loved one to drive, etc… Hence, the specialist is under immense pressure to perform the procedure, regardless of whether he or she would have made that decision from the start.
Type 3-An Ethical Chiro Owned Physician Model-Finally, there is one type of chiro owned clinic that poses no additional risks to the public, but it's prohibitively expensive, so very few chiros choose this model. In fact, I only know of a handful of chiros who have done this right. Let's review.
In this model, the chiro is merely a business owner and has no control nor input into the medical care in the clinic. In fact, he or she doesn't even practice. Mid-levels are not used to replace physicians. In addition, specialist physicians are hired full-time and are the ones that make all the decisions about which patients get which procedures.
The problem here is cost. Specialist physicians who understand how to perform precise, image-guided ultrasound and x-ray guided procedures and who understand orthopedic injuries are expensive. For example, hiring a family doctor who has no idea how to do any of this stuff on a consultant basis just to perform procedures (Type 2a above) would run about 50K a year. Hiring a specialist full time who understands this stuff runs typically 350-600K a year. See the stark difference?
As an example, I'll highlight Norm Deitch, who owns several Regenexx clinics in California. Norm is a chiropractor by training who only acts as a business owner. He employs 4 full-time physicians superspecialists through a management services agreement and has no clinical input into their care decisions. These are physicians qualified enough to be added to our network and who have had hundreds of hours of additional training each. In fact, Norm spends tens of thousands of dollars annually to bring his whole crew out to the Interventional Orthopedics Foundation meeting, demonstrating that quality and safety trumps profit.
The upshot? Chiro clinics offering stem cells are a significant public health risk. Having said that, there are ways that a chiropractor can do this right, but that's the rare exception rather than the rule. In the meantime, I will continue to do my part to mitigate the public health risk by calling out chiro clinics that are placing patients at risk just to make a quick buck.