Regen Med Has a Medical Education Risk Problem

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gulf coast biologics

I tend to write about what I experience every day. These past few weeks I’ve seen what IMHO are some really irresponsible course offerings that ultimately place the whole field at risk. Let me explain.

Why Would I Care?

Way back in 2005 when I injected the first bone marrow concentrate and culture-expanded stem cells into things like knee joints and low back discs, there was no feild of regenerative orthopedics or interventional orthobiologics. My partner John Schultz and I were also taking great personal risk, so much so that we used a peer IRB just to be safe. Since then, the field of regenerative orthopedics and spine care has exploded. However, the problem with a massive rise in physician interest is that the risk of bad things happening increases and must be carefully managed if the field is going to mature and become standard of care.

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What Happens When the Risks and Expectations of a New Technology Go Unmanaged?

The medical field is filled with promising technologies that ended up in the dustbin of history because the risk and training of how to properly use that technology were poorly managed. Let’s take three quick examples: early prolotherapy, chemonucleolysis, and IDETC.

Back in the 1930s and 40s, prolotherapy, or the injection of ligaments with substances that caused a brief inflammatory healing cycle, was growing in popularity. There was even a prescription drug that was injected. However, because of poor injection training, some knucklehead injected prolotherapy solution into a spinal cord and caused paralysis. As a result, prolotherapy died off and wasn’t revived until decades later in the 1980s.

Chemonucleolysis using chymopapain injected to dissolve a disc herniation was growing in popularity in the 1970s. Then it was determined that 1% of people had an allergic reaction to the procedure and that the doctors performing these procedures weren’t well trained enough to handle or identify what was happening. Ultimateley, several people died and the procedure was relegated to the dustbin of history.

Finally, IntraDiscal ElectroThermal Cautery (IDETC) was a technology to help patients with disc pain by inserting a catheter into a low back disc that was then heated up to ablate the painful nerves. It seemed to work well, but the proponents did little to manage the expectations that this was a cure for everyone with disc pain. Hence, once in the hands of doctors who were often poorly trained in the technique, the results were poor. Hence, the technology withered away, despite the fact that in the right hands and the right patients it could be helpful.

An Example of the Problem: Gulf Coast Biologics

This is a hard part of the blog for me to write as I really like the company behind Gulf Coast Biologics (Emcyte). I also like many of the people associated with Emcyte and have referred many doctors who aren’t ready for a more advanced on-site lab to this company to buy their kits and centrifuges. However, right now they’re a good example of the lack of managed risk which is so prevalent in regen med education.

A few weeks back, I noticed a bone marrow aspiration posted by Gulf Coast that was blind, meaning that there was no guidance. This was confusing as this was below the existing standard of care for that procedure. I commented on it and moved on, thinking it was an oversight by the company.

Then Gulf Coast put out a course offering on injecting penises and vaginas (P and O-Shots). Huh? While there may be some legit uses of these types of procedures for medical conditions like erectile dysfunction, there is scant data that this works and some of the providers offering them are advertising the injections for sexual enhancement. Meaning that this was very concerning. I commented on the linked post and moved on.

Then came a post this weekend on a spine course. Given the other two prior posts, I looked at the agenda. What did I see? A course that pushed the envelope of what can be safely accomplished in spine injection training.

Proper Spine Injection Training

Injecting the spine using imaging guidance is hard to learn. Why? Each spine is slightly different and injecting the wrong spot in the wrong way can result in everything from permanent paralysis to death. Hence, the existing spinal education players like SIS (Spine Intervention Society) and ASIPP (American Society of Interventional Pain Physicians) have a strict policy about who can take these courses and how they are managed to reduce risk.

How does this work? You start with learning simple fluoroscopy-guided lumbar injections like facet joints, SI joints, and epidurals. Then you get to go back to your practice and implement what you have learned, preferably with a proctor (an experienced doctor who can observe and tweak your technique). Once that’s done, then you qualify to take the next level course and repeat. By the time you’re learning how to stick a needle in a lumbar disc, you already have dozens of hours of actual experience. By the time you’re injecting a cervical disc, you have hundreds. Why? If not done correctly, these last two procedures could result in serious harm to the patient.

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The Gulf Coast Biologics Spine Course

My concern with the Gulf Coast Biologics spine course is that in the same course we see the basic stuff like lumbar epidural, facet, and SI injections and then more advanced and dangerous procedures like lumbar and cervical intradiscal procedures (the disc injections I mention above). In my clinical education experience, you will invariably get physicians who won’t self-govern. They will believe that they have the qualifications to perform procedures that are more advanced than their current training level. While an instructor may try to limit this behavior, that places an immense burden on the physician instructor. Almost always, people get taught something they shouldn’t yet be doing. Ultimately, the way you manage this is to not offer advanced procedures to providers who have no business performing them. Meaning you offer a beginning and advanced course or several levels and strictly enforce entry requirements. This is to help protect patients, instructors, and the malpractice policies of the physicians learning the procedures.

What Could Go Wrong?

Many years ago I was asked by a defense attorney to look at a cervical facet injection gone bad. He wanted to know if I would be an expert for his side. I reviewed the images and the provider’s education for performing this procedure and was deeply concerned. First, the provider had not been properly trained. Second, the provider had inadvertently documented himself injecting the patient’s spinal cord based on the fluoro images provided. Meaning the provider was so clueless as to what he was doing that he didn’t know that the images he handed his malpractice attorney were proof of his own incompetence. Suffice it to say that I told the attorney that couldn’t defend the provider.

Another example is a neurosurgeon who wanted to take the advanced spine course at IOF, way back when when I was the acting president of the organization. I had in place a questionnaire that would filter out unqualified providers from taking the course, which the neurosurgeon didn’t pass because he had no spinal injection training. I spoke to the surgeon on the phone who then asked, “How hard could this be”? That was all I needed to make sure that this surgeon was not allowed to take that course. I instructed him to get basic training and get back to us.

Reaching Out to Gulf Coast Biologics

I tried through several channels to reach out to Gulf Coast Biologics for comment. That included messaging their CSO Peter Everts. I never heard back, but would be happy to include their comments if I get a response.

Ways to Fix this Issue

This is not a problem specific just to Gulf Coast Biologics. In fact, regenerative medical education is a mess right now. Another player I’ve called out in the past is A4M. The big issue is that strict protocols need to be in place as to who can be educated and what they can be taught and when. This is the only way to protect patients and the field.

The upshot? Welcome to the wild west of regenerative medical education. While I really like the company involved with Gulf Coast (Emcycte), we must all also look after the integrity of our field. If we want to see it all go mainstream, we need to police ourselves and make sure that medical education is focused on protecting patients.

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

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