Is This the End of the Chiro “Stem Cell” Clinic Business Plan?
One of the hardest things to watch in the stem cell wild west has been chiropractic clinics pretend that they have any idea of which end is up when it comes to delivering orthobiologics. In fact, as I’ve spoken to various chiropractic boards and chiros around the country, it turns out that most boards don’t like what they see happening as well. Hence, a recent board case brought against a Florida chiro should come as no surprise but should be read by every chiropractor offering stem cell services around the country. Let’s dig in.
The New Florida Chiropractic Case involving Stem Cell Fraud
As I have shown many times on this blog, claiming to a patient that an umbilical cord product contains millions of live and viable stem cells is fraud. Why? Because we now have many top-notch labs around the world that have tested these products and found them to have no live and functional mesenchymal stem cells (MSCs). In fact, our latest data on this topic has been accepted for publication and will be out soon. In that investigation, we had a university lab test six different umbilical cord products whose manufacturers all claimed live stem cells. None had any live and functional MSCs. To learn more, see my video below:
So when a chiropractor named Charles Popa in St. Petersburg offered patients stem cell treatments that were derived from umbilical cord tissue, IMHO, he was committing fraud. Recently the Florida Chiropractic Board looked at this case and had several conclusions. This first charge against Dr. Popa is interesting and worth exploring: “It is outside the scope of practice for a chiropractor to recommend specific stem cell treatments to a patient.”
Practicing Outside Your Scope
The Florida board’s complaint and charges against Dr. Popa begin with an obvious one, but one that should send shivers down the spines of every chiropractor in the country who runs a fake stem cell clinic by offering umbilical cord tissue to patients. It’s beyond the scope of chiropractic practice to consult with a patient and then based on that consultation, offer stem cell treatment.
First, you need to know that all alternative health practitioners have practice acts that clearly define what they can and can’t do. Only MD’s/DOs have the extensive training to be licensed to offer the full gamut of medical care. Chiropractors are usually licensed very differently, in this case, with a practice scope that includes them prescribing things they can offer like manipulation, x-rays, devices, or exercise.
However, what happens when a chiropractor is the one determining whether you need things that he or she isn’t licensed to deliver? Taken to the extreme, this is the same as a chiropractor being the one that decides that you need brain surgery and then hiring a brain surgeon to come into his or her office and perform the procedure. We would all hopefully conclude that a chiropractor has no place in deciding whether a procedure that could kill you happened or not. The training needed to weigh the risks and benefits of that procedure isn’t there.
Now if we substitute the phrase “stem cell treatment” for “brain surgery”, we still have the same problem. The chiropractor isn’t licensed to perform stem cell treatment, hence he or she has no business being the one to recommend and facilitate that treatment. The Florida chiropractic board agrees.
Who Is the Treating Provider?
Based on the complaint, it turns out that Dr. Popa, who hails from Ohio, was an employee of this St. Petersburg chiropractic clinic. Based on what I read, he seems to be a “patient recruiter” who is having mostly telephone consultations with patients and then recommending treatment. By doing this, he becomes the patient’s treating provider, but also never identifies himself as such in the records, which is another problem in the state of Florida:
“Rule 64B2-L7.0065(5), Florida Administrative Code, provides in pertinent part, “The treating physician must be readily identifiable either by signature, initials, or printed name on the record.”
Respondent failed to identify himself as the treating physician in the records for Patients T.W., A.W.-1, and/or A.W.-2.”
This should also greatly concern chiro stem cell clinics as I have seen this many times. A patient recruiter is hired by the clinic to meet with patients and get them signed up. It looks like if you try this in Florida, that you have a problem.
In Dr. Popa’s case, the patients paid for their treatment upfront, to the tune of thousands to tens of thousands. Turns out, in the state of Florida, as a chiropractor, you can only collect a maximum of $1,500 upfront. Hence, the complaint goes on to charge Dr. Popa with additional violations of the state board rules.
The Florida chiropractic board also charges Dr. Popa with performing human experimentation without consent. Whenever a medical provider uses a new treatment that isn’t standard of care, there are a few rules.
First, the patient needs to know that the care being delivered is new or experimental. They need an informed consent document that explains this issue and the risks of the therapy. A registry should be used to track outcomes and complications and then report those online or in the medical literature. Depending on how new or how risky the therapy is, using an IRB may also be wise.
For example, at Regenexx, we perform expanded informed consent when using orthobiologics. We have also had a registry in place since our first patient was treated way back when in 2005. In addition, back then, we had a local peer IRB oversee our care while it was clearly in the experimental phase. Since then, other IRBs have overseen our work.
Why These Actions by the Florida Chiropractic Board Are a Big Deal
Some of these charges brought against Dr. Popa could easily be brought against many chiros in the state of Florida who are offering dead cells in a vial as a cure-all for every medical condition. One of the biggest game-changers here is the clear statements in the complaint that it is beyond the scope of a chiropractor to recommend stem cell treatment. Why is this such a big deal?
First, most of these clinics hire mid-level providers like PA’s and NPs to come in and perform injections. Some will hire physicians to do the same. However, that creates a problem. The patients at these clinics don’t know these providers as they come and go, so the chiropractors are usually the ones determining if a patient needs a procedure.
It should be noted that being the one who determines you need a procedure is VERY different than referring to a qualified professional who will then determine what you need. In the former case, you’re prescribing invasive care, in the latter, you’re using the expertise of another professional to see what care is needed.
The upshot? In my opinion, this is the beginning of the end of the chiro stem cell clinic. Why? Once state medical boards begin cracking down on this business plan, this house of cards is coming down.