Making Interventional Orthobiologics Standard of Care Requires Policing

Published on Mar 24, 2022

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A blog reader who is a physician in Florida recently asked many colleagues what to do about a local chiropractic clinic that is aggressively advertising that their midlevel treats spine with stem cell therapy. My response was that her most effective move would be bringing this issue to the attention of the chiropractic board. Why did I say that? What would that complaint be like? Let’s dig in.

The Interventional Orthobiologics Police?

Interventional orthobiologics (IO) means the use of precise image guidance to place substances that can help the orthopedic system heal or mitigate pain without destroying tissue. This is a nascent field that I and many others have had a hand in creating because it makes sense for patients. Based on what I’ve observed and am now studying with an academic medical center, switching patients from orthopedic surgeries to this type of intervention can dramatically lower medical care costs and reduce patient morbidity.

However, IO is still nascent. Meaning it’s in that fragile time at the start of a medical specialty where things frankly could go either way. Meaning today’s young physicians can either take this torch and create a world where these procedures become the prevailing standard of care of the 2030s and 2040s and beyond, or the whole field could get relegated to the dustbin of medical history. The difference will be how IO policies itself.

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Real Medical Specialities Police Themselves

I’ve recently reviewed the IO midlevel problem. Meaning the situation where business-minded clinics hire lesser trained non-physician Physician Assistants and Nurse Practitioners because they’re cheaper than hiring specialists. While these providers can legally do anything from brain surgery to orthopedic surgery, neither of these medical specialties tolerates that behavior. Why? First, the lack of training for a mid-level would put patients at serious risk of harm. Second, the medical specialties for these organizations police themselves. Any Physician’s Assistant that is trying to perform arthroscopic surgery in their office would find themselves the brunt of many different board complaints and legal challenges.

An Example Where the Local Provider Needs to Step In

I get sent all sorts of stuff for story ideas. Sometimes one or more a day. This past week, I got this from a colleague:

“Good morning
Would you know the correct person to report a Chiro office doing “stem cell” by an NP who admitted doing spine with donated cells?
I had contacted _____ but he didn’t have a great answer.
Thank you”

I asked for the name of the clinic so I could take a look and this is from their website:

“Doctors at ________ can even use regenerative medicine and stem cell therapy to slow the progression of degenerative conditions and lessen the pain and discomfort of chronic conditions like arthritis.”

OK, this is a bit dodgy. As I have blogged, when it comes to PRP, we do finally have some evidence that this injection could slow the progression of knee osteoarthritis, but that statement needs to be qualified that there are studies on both sides of that fence. Then there’s this:

“Because regenerative medicine involves rebuilding tissues, everyone’s healing process may be different. For some it might take a few weeks, while others it may take a few months for you to notice improvement. New cells continue to replace damaged bone and soft tissue cells over time, essentially regenerating your ligaments, muscles, and joints to diminish or alleviate pain, increase function, and restore your mobility.”

This is worse. While it’s true that these positive changes can be observed in the right patients with the right clinical scenarios, this statement makes it seem like every patient ends up with new ligaments, muscles, and joints.

Digging Deeper

This is a chiropractic clinic that has a nurse practitioner working there, as discussed by my colleague. They have a “medical director”, but a search under that doctor’s name shows that he works at 6 different clinics in the area, including the local QC Kinetix, so he’s clearly a medical director for hire. For example, his Linkedin profile and online search states he lives in the Orlando area but covers clinics as far south as Miami. Growing up in Florida, that’s a 4 hour’s drive. So there’s no way that he commutes 8 hours there and back every day.

So what’s happening here? We have a classic chiropractic office integrative setup. The nurse practitioner (NP) sees the patients and if the medical director shows up at all, it would be infrequently at best.

Above my colleague is complaining that the NP is out of her practice depth by injecting the spine and claiming that she is using “stem cells” from an off-the-shelf vial. So assuming that’s the case, how do we as IO physicians police this?

My Experience with Board Complaints

I advised my colleague above that in my experience, complaining to the nursing board is unlikely to help. Why? After several complaints being totally ignored here in Colorado and elsewhere, my take is that the nursing board is trying to continually expand the scope of practice for NPs. Hence, any complaint about an NP who is going beyond that scope, even if it’s dangerous, will be unlikely to initiate an investigation and sanction.

However, where I have had more success is with submitting a complaint to the chiropractic board on the details of why the care being delivered is fraudulent (i.e. injecting birth tissues that are dead and calling that “stem cell therapy”) or how the care being delivered in that office is dangerous. Why? That’s an interesting one.

There’s a bit of a civil war within the chiropractic profession. Most chiropractors don’t own nor will they contemplate this type of integrative practice where a mid-level and medical director is hired. They simply don’t believe that this is responsible chiropractic care. In addition, chiropractors have long fought an uphill battle to be taken seriously by the medical profession. While providers like myself have long worked with good chiropractors and appreciated how they can help patients, some physicians still won’t go there. Hence, the chiropractic profession has learned the hard way that policing itself is the path to acceptance by mainstream medicine. Hence, when I have submitted well-written complaints to the chiropractic board they are usually taken seriously.

What Should the Complaint Say?

Here’s what I believe the Florida chiropractic board would pay close attention to:

Fraud-Claiming to be injecting “stem cells” when dead tissue is being injected. The data is very clear on this one with our recent paper in the American Journal of Sports Medicine being yet another study that shows this is a fraudulent claim.
Over Reaching on Claims-The language on the publically available website above makes it seem like this office can regrow older people young new joints. That’s also a type of fraud.
Lack of Medical Direction-How often does this medical director who is employed at 6 different places actually show up in the clinic? A simple call to this office could find that out.
A Nurse Doing Dangerous Things-Is this nurse sticking a needle into the spine blind? If so, how? Are there any bad outcomes that were due to poor training?
Misrepresentation-If you call this clinic and want your disc injected with stem cells, will they tell you a nurse can do this with ultrasound? Meaning is a bait and switch happening?

Putting It All Together

If our field of Interventional Orthobiologics is to become standard of care, we must begin policing what qualifies under that umbrella and what doesn’t. That includes things like ethical standards, basic qualifications to be trained, standardizing procedures, and policing. That last item is a critical part of the equation. So please take some time as an IO physician to call things out you know aren’t right. That’s when you know people are receiving substandard or dangerous care and being charged an arm and a leg.

The upshot? We need to police ourselves if we want to become the standard of care. It’s really that simple.