You might have wondered why in yesterday’s blog I would be so concerned about chiropractors, naturopaths, and acupuncturists entering into the field of stem cell therapy. After all, if you read this blog, you know that I’m a huge fan of chiropractors, naturopaths, acupuncturists, and other alternative-health practitioners. I’ve even called out my own profession as ignorant because of new research showing that certain alternative therapies have a real basis for working and new research showing efficacy. So what evidence do I have that alternative-health practitioners in orthopedic stem cell therapy will damage the field? Look no further than the ad for an upcoming documentary by Jeff Hayes entitled, “The Healing Miracle: The Truth About Stem Cells.” Let me explain.
I Love Alternative-Health Practitioners
There are days when I see how my own medical profession can be the worst type of proverbial bull in the china shop of the body. It’s on these days that I can’t stand my colleagues. When I see how a long spinal fusion has permanently ruined a life. When I observe botched joint replacements or patients on their 10th knee surgery, I’m incensed. On the other hand, living in Boulder, Colorado, the alternative-health capital of the earth, I get to see some crazy stuff, but I also see patients who aren’t maimed and who are generally happy with their results.
Having said that, I also realize that some alternative practitioners live in an alternate universe of hyperbole. As an example, I will never forget spending time with a chiropractor in a mini-externship when I was a resident physician. This was an unusual request that freaked out Baylor College of Medicine, so I did it over a couple vacation days. While I learned much about chiropractic, one thing disturbed me. While we had been taught to never bias a patient result by suggesting anything about whether our therapy was effective, the chiropractor said to every single patient as they got off the adjusting table, “Now tell me how good you feel.” That was when I learned that some alternative-health practitioners viewed patient outcome in a more hyperbolic and subjective fashion. I’ve also since come to understand that this is much less common among younger chiros and more common with older chiros. In fact, chiro colleges have been trying to adopt more and more medical approaches for the last one to two decades.
The Jeff Hayes Film “The Healing Miracle: The Truth About Stem Cells”
So why is it that I’m so concerned about alternative-health practitioners entering into orthopedic stem cell therapy? One only need look as far as the new ad for the film “The Healing Miracle: The Truth About Stem Cells.” We’ve known about this Stem Cell Institute of America (SCIA) sponsored film series since earlier this year when the company took out full-page ads in chiropractic magazines to announce that the film would be “distributed to millions of consumers.” They also claimed that chiropractors needed to join the SCIA network now because the films would generate massive patient interest in SCIA stem cell treatments. To see the ad I’m talking about, see about 1:28 in the video below (this is the investigative video I posted yesterday and not the Jeff Hayes film):
At that time, the Jeff Hayes film looks like it had a different title (“Stem Cells Revealed”) and it was to be released in October of 2017, which came and went.
The Ad for the New Film Is a Prime Example of Why I’m VERY Concerned
As I said yesterday, the single thing keeping stem cells out of everyday clinical use is credibility. That extends from the idea of “street cred” to the more stringent “academic cred.” That credibility increases when physicians publish more data, find out who is and isn’t a candidate for this therapy, and underpromise and overdeliver. In fact, it’s this last part that the ad and film really violates.
One need go no further than the name of the film. The word “miracle,” while likely fine in how patients describe some therapies, is a huge problem in medicine. All therapies have a success and failure rate, and stem cells are no different. Referring to stem cell treatment as a miracle is irresponsible. Why? Because it’s not a miracle for those patients that don’t respond or who partially respond. It’s also not a miracle for those who have complications. More importantly, suggesting that stem cells are a miracle cure reduces the credibility of the field.
Next up we have this ridiculous image:
On the left, we see a patient with moderate to several lateral compartment arthritis with severe valgus deformity. The X-ray film on the right purports to show that cartilage has been restored. Even the deformity (the angle of the knees) has resolved. What’s interesting here is that I have asked every orthopedic stem cell expert I know whether they have ever seen a patient with moderate to severe knee arthritis get complete cartilage restoration or any significant restoration for that matter. Despite my expert panel (which includes myself) never having seen this happen using any number of different technologies (including those used by SCIA), we have the hyperbole above.
So how did this happen in the images above? First, what’s not shown is interesting. We don’t ever see an MRI image, despite there being about 12,000 MRI scanners in the U.S. Why? Second, the image seems to show an increase in joint-space width, but anyone can create or delete the appearance of joint space width simply by changing the angle of the X-ray beam relative to the joint. For example, see my images below where I tilted the beam an imperceptible five degrees and created the false appearance of a bigger joint space in the process:
Finally, the dead-giveaway clue about what happened with these knees is found in the dramatic change in angle of joint. If the knee has loose ligaments, the patient could literally create both images without any change in cartilage simply by standing a different way. Finally, despite the fact that you can’t see cartilage on an X-ray and no MRI is shown (that can see cartilage), the caption of the image states that the cartilage has been restored.
More Irresponsible Statements
How about these humdingers?
“…the cure for what will someday surely kill you is already available, already in…you.
…the “fountain of youth” was REAL? (ok, not the fountain of youth, but at least a few drops from it….)”
We have no evidence that using your body’s own stem cells or dead amniotic tissue will cure fatal diseases and allow you to live a longer life. This statement is so badly worded that it includes all diseases that could kill us, which is quite a wide list. I’m not even going to comment on the fountain of youth gaffe.
Getting into the Trailer
The lalapalooza of crazy statements not supported by any clinical research or even responsible observation continues. I know a few people in the film and was very concerned to see Neil Riordon say that in tens of thousands of stem cell procedures, there have been no serious adverse events (SAE). While Neil is one of the only “experts” featured in this trailer who has any clinical publications, I can find no safety paper published by Neil that supports that statement. Neil may not understand that the NIH/HHS definition of SAE is any complication that requires significant medical care to remediate it. We’ve actually published the world’s largest safety paper in stem cell therapy with 2,372 patients, and while there were no serious complications related to the therapies we use, there were SAEs.
Regrettably, the vast majority of those quoted in the trailer and claimed to be experts, aren’t experts. Most are chiropractors who have no publications in this area. Given that the definition of “expert” in medicine is someone who has published in the peer-reviewed medical literature or who would be invited to speak on the podium of a medical conference because of his or her experience and expertise, these are what I call “faux insta-experts.” For example, due to lack of actual expertise, none of these “experts” would be invited to speak at an academic orthopedic stem cell conference.
In this “stem cell” documentary, we also continue to see patients treated with amniotic-tissue products, which you’ve now learned don’t have any live and viable stem cells (see the video above). So the bait and switch exposed in the investigative film above continue to happen in the Healing Miracle film.
We also see a blind injection without guidance, a “no-no” if you read this blog (at 1:08), using improper sterile technique (no drapes). In addition, that blind injection is medial patellofemoral, which has a much higher blind miss rate for being in the joint (due to the large medial PF fat pad). Meaning there was a significant chance that this knee injection never made it into the joint. It’s 2017 folks—there is no rationale for not using ultrasound or fluoroscopic guidance in a knee injection.
We also see Kristin Comella, who is with US Stem Cell, where three patients were blinded by stem cell injections into their eyes. She and the company also just received a warning letter from the FDA and were called out by the new FDA commissioner, Scott Gottlieb, as “bad actors” (not in the film sense). Mark Berman is also there, also called out by Gottlieb as a bad actor after his Rancho Mirage office was raided by the FBI for the possession of a smallpox vaccine being used to transfect stem cells used to treat cancer. He also recently received a 483 inspection report from FDA stating that his office was producing a cell drug without FDA approval. Both US Stem Cell and Berman were called out for not meeting drug manufacturing standards.
I also know others in the documentary who are well-meaning patient activists, and my guess is that they had no idea that they were being asked to participate in a sales piece for SCIA. How do I know this is an SCIA-sponsored piece? One bit of evidence is that that’s what it says in the SCIA advertisement. The second is found in an e-mail sent by a colleague who turned down being involved in this film.
The E-mail That Shows This Is an SCIA Ad
A while back I was told by a colleague who is a stem cell expert that he was asked to participate in this film. He turned them down as he had concerns about the e-mail and the film itself. Who sent the e-mail? No other than the president of Stem Cell Institute of America, Brent Detelich (a convicted felon—see video above). Brent was recruiting for people to be in the documentary. Note that while the e-mail was cc’d to Jeff Hayes and a production assistant, it was from Detelich.
The upshot? Now you see why I’m concerned about chiropractors entering this space. Orthopedic stem cell therapy has serious work to do to hit the mainstream, and documentaries like this and advertising like that used by this film and SCIA move that credibility matrix backward and not forward. In addition, this film looks to me to squarely fit into the category of “bad actors” described by the new FDA commissioner. Hence, my concern is that rather than the FDA allowing orthopedic stem cell therapy to find its own way and gain needed street cred with the medical community at large, my opinion is that this film will force the FDA’s hand to get rid of all physician-centered therapies in orthopedics. Basically, the approach will change from allowing orthopedic therapies to continue while targeting the out-of-control miracle-cure clinics offering therapy for every known incurable disease to “throw the baby out with the bathwater.”