In From our Director, News & Blog, SCI Research

Want to get me riled up? Just show me unscrupulous claims made by so-called overseas clinics offering unproven or even disproven “treatments” that supposedly cure or improve function of people with spinal cord injury.  This is likely not a surprise – it’s no secret that I am strong opponent of purveyors of such false hope, predators that put people at risk for their own financial gain.

It’s also not a surprise to see these predatory clinics offering and marketing the latest interesting developments in research as legitimate treatments, despite a lack of evidence for their safety and efficacy. So I wasn’t overly surprised to receive an email this morning from Unique Access Medical*, a clinic in Bangkok, Thailand that is offering epidural stimulation treatment (in combination with stem cells and physical rehabilitation), asking me to let SCI BC’s members know about their “treatment.” No, I wasn’t surprised. But I was riled up. Riled up enough to write this blog post.

Spinal schematic for FRONTIERS 11292013The latest addition to the SCI “treatment” repertoire of many overseas clinics is epidural stimulation. Readers of the Spin magazine will be aware of the latest developments in this newly emerging area of research. Early and unexpected findings by the research teams of Drs. Susan Harkema, Claudia Angeli, and Reggie Edgerton have led to efforts to fund a much larger study on the potential effects of epidural stimulation on restoring motor and autonomic function for people with spinal cord injuries. You can read about these studies in the Summer 2014 issue of the Spin, and you can find out more about the next steps for the research on the Christopher and Dana Reeve Foundation’s The Big Idea website.

I hesitate to provide the website address for the Bangkok clinic, but do so to draw attention to a trick they and many other such clinics use. View it here, but please don’t believe the claims on the site. Note how similar the Bangkok clinic’s website looks to the Reeve Foundation’s? I’m guessing that’s no coincidence. If it looks the same, it must be officially connected to the legitimate research.

It’s not.

What is offered by Unique Access Medical in Bangkok is a combination of procedures that have not yet been validated through the clinical research process, meaning they have not been proven to be safe or to work. Curiously, under the “Research” tab on their website, they summarize Drs Harkema’s research and even bold the following:

“This suggests that these interventions could be a viable clinical approach for functional recovery after severe paralysis.” 

This is an accurate statement – note the “could be a viable clinical approach.” They seem to acknowledge that it isn’t yet a viable clinical approach, but they are nonetheless willing to overlook this and take your money for performing the treatment, anyway. This is wrong.

Contrast this to what is stated on the Christopher & Dana Reeve Foundation’s The Big Idea website (which, to be clear, is part of a campaign to generate funding for the next phase of research into epidural stimulation):

Is it a cure? Not yet. The next step is to fund a new study with 36 additional participants – men and women of a range of ages and diverse backgrounds – to prove beyond a doubt that this therapy is viable. This will allow us to expedite epidural stimulation to the clinic.

To drive home the point, the Christopher and Dana Reeve’s Foundation has created a section on its sight to clarify that the “treatments” offered by oversees clinics are not the same as the research they are funding They state:

The Christopher & Dana Reeve Foundation is aware that there are companies and clinics in other parts of the world that offer epidural stimulation alone or in combination with other interventions (i.e. stem cell transplants). Narratives, advertisements and patient testimonials on their websites and in their social media suggest that their “therapies” are the equivalent of the epidural stimulation studies being done at the University of Louisville, funded in part by the Reeve Foundation, and reported extensively in peer reviewed academic journals. These medical treatments are not the same.

The Reeve Foundation’s epidural stimulation clinical research initiative (The Big Idea) will have US Food and Drug Administration (FDA) approval for a very specific research protocol and patient population. The study builds on several decades of basic science discoveries and will extend those findings through a rigorous and rationally designed human trial. It will follow the FDA-approved protocol in order to meet the safety and effectiveness requirements needed to gain FDA approval for epidural stimulation as a therapy for spinal cord injury.

This statement is intended to clarify what may be confusing or misleading information in the public domain. The Reeve Foundation is committed to conveying accurate information to our community, donors and all interested parties and to ensuring their safety and well-being.

It is “best practice” (yes, that’s sarcastic) for unscrupulous and illegitimate clinics to share compelling “treatment” success stories. The Bangkok clinic is no different. They share 2. While I sincerely hope all of those that who forked over however many thousands of dollars for the procedure did experience some benefit beyond what they would have naturally regained or regained through physical rehab alone, we just can’t determine what lead to their improvements (if they actually improved at all). Was it spontaneous recovery? The stem cells? The epidural stimulation? The rehab? Placebo? False or incomplete reporting? We just don’t know because the procedures did not follow a clinical trials protocol and the claims are not supported by acceptable, peer-reviewed evidence.

It is noteworthy that the Bangkok clinic is offering a combination of unproven therapies. Stem cells are still a hot item and the epidural stimulation is the new hot topic. The pre-clinical evidence for stem cells in the treatment of SCI has created intrigue and hope (but is it really strong enough to move to human trials?) and epidural stimulation has showed unexpected (and as yet unexplained) results in very early clinical research, so what better than to combine them? Surely, the combination research evidence for the two together must create a case that overcomes the lack of demonstrated treatment efficacy for either one on their own.

While a combination of interventions for functional recovery after SCI will most likely be required for the success of validated therapies sometime in the distant future, they haven’t been shown to be effective now, and most likely won’t be in the near future.  As Body of Evidence’s Jonathan Jarry explains in his video, Gauntlet, very few early research findings survive the gauntlet from bench science to human clinical trials. Not because of lack of interest or funding, but because what can be shown to work in a petri dish may not work in a rat, or, if it does work in a rat, may not work in humans. Very few experimental treatments make it to the next stage.

As Jarry explains in the description of the video, “Biomedical research has devised an amazing gauntlet to reduce the risk that an early research finding will turn out to be a dud. Of course, the charlatans simply bypass this system.” Just as Unique Access Medical and so many other charlatans running overseas clinics have.

With every high-profile advance in SCI research will come a new, unproven treatment provided by predatory clinics looking to make a tidy profit off of people who are understandably desperate enough to believe the false hope on offer. For spinal cord injury, this has been going on for well over the past 25 years (anyone remember embryonic shark cell implantation at the International Spinal Cord Regeneration Center in Tijuana, Mexico?). It will continue. Which means we must remain vigilant and critical of those offering risky, expensive treatments that have no evidence to support their validity.

This is, after all, not a principled academic argument. Real people are being taken advantage of. Real people are being preyed upon.

* Note that I have singled out Unique Access Medical in this blog but there are many, many others offering similar “treatments.” I focused on Unique Access Medical because they emailed me directly to help market their clinic to SCI BC members. This was a mistake on their part – they obviously hadn’t done their research into my position on overseas cure treatments. But I guess research isn’t really their strong point.

For more information on how what to think about before participating in a trial or treatment, you might want to have a look at these and other resources:

ICCP and ICORD’s Clinical Trials Guidelines and what you should know if you are considering participation in a clinical trial:

Body of Evidence’s videos

Christopher and Dana Reeve Foundation’s position statement on off-shore epidural stimulation treatments:

Canadian Stem Cell Foundation

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Showing 2 comments
  • Stewart Midwinter

    Well yes, Chris, those are all great points and I certainly agree with them. There’s just one thing however: all around the world, there is promising research being done, showing some interesting and encouraging results, and none of it actually leads anywhere. Where are the clinical trials transitioning to general availability? Researchers are interested in research, not in commercializing new products. Researchers are motivated to keep on researching endlessly. That’s their livelihood! Unless we have some people willing to push the envelope, I fear we will never get to any treatments you can actually sign up for and buy.

    • Chris McBride

      Stewart, thanks for your comments. You are right that there is a lot of research going on and that a lot of it seemingly goes no where. In fact much of it does go no where, but this is not for lack of desire. Often experiments that work in one model simply don’t work when translated to either animal models or humans. The other thing is that we tend to overestimate our understanding of our very complex biology. So much more research has to be done at very basic levels before translated to humans, especially for something as complex as spinal cord injury. I think Jonathan Jarry does a nice job describing this in his Gauntlet video .

      I totally get the frustration of waiting for science to catch up with the needs it hopes to address.I also agree that researchers are motivated to keep researching endlessly – they love to learn and discover and this is a really good thing! But they also love research for the positive impact it can have for people. Having spent almost 20 years of my life in the world of SCI research, I can say that pretty much researcher I knew and know was and is genuinely motivated to advance research to the point where a meaningful clinical intervention, an assistive device, community service, and/or, policy change was realized for the the benefit of people with SCI. They really want this to happen, which is why they work so hard (I’m not sure that the general public realizes just how much time and energy researchers spend doing their research). The pace is frustratingly slow for everyone, albeit more so for people with SCI and their families. However, researchers know they must follow the rigours of the scientific process to make sure the advances they claim to make are real and valid, and later to show that they are safe and effective.

      They also know that rushing to clinical translation can lead to failure – not just from a safety perspective, but from a lack of efficacy. There is precious little money out there for expensive translation projects and if too many studies fail (because not enough work was done in the early stages of the transnational research project – particularly demonstrating the replication of results), investors will turn their attention elsewhere. For so many reasons, spending the time and resources on getting right early on is so critical. It adds time, yes, but it ultimately will lead to better results.

      The good news is that there is more and more research being done on things that can be achieved in shorter timeframes and that will have direct benefits sooner that later. This is particularly true for assistive devices and other technologies that are not or less reliant on a full understanding of our complex biology. They don’t represent cures, but the do represent ways to achieve greater independence and quality of life. Hopefully, these are interim solutions that will someday in the distant future be superseded by various forms of a cure.

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