It’s frustrating to read yet another story of the process of developing a potential new medical treatment derailed by the current infrastructure of quackery that we have in this and other countries. This is one of the unmeasurable harms that results when pseudoscience is given regulatory, academic, and professional legitimacy. The press then celebrates the nonsense that results.
The basic story is often the same, with a few variations. First, however, let me describe what should happen when someone comes up with an idea for a new medical treatment.
Background research – The first step, whether the innovator is within or without the medical community, is to familiarize oneself with existing research. Is the idea plausible, has it been investigated before, are there any similar treatments that can act as a guide to predicting how this new treatment will work?
Test basic principles – If the idea still makes sense after existing research is taken into account, then new research into the potential treatment is justified. This should start with some basic proofs of concept. Is the treatment safe, does it actually do something, what are the possible mechanisms at work. This level of research may involve in vitro studies (test tubes and petri dishes), and eventually animal research. If the treatment is something that does not have a pre-clinical model (say, for instance, a new therapy technique) then early safety and tolerability studies should be done. If there is any component of the new treatment that involves new or untested scientific principles, they should be studied before they are applied to a treatment (the human energy field and therapeutic touch come to mind).
Preliminary human trials – If the treatment still seems plausible and seems to be safe and supported by basic principles, then some preliminary early human studies are justified. These may be formal FDA phase I trials, or generic pilot studies. These usually involve few subjects, may not be blinded, and are simply intended to get some idea of the effects and safety of the treatment.
Confirmatory trials – Everything so far is simply preliminary and used to determine if large, double-blind, expensive and elaborate studies are justified. These trials are designed to answer, as definitively as possible, if the treatment has specific positive effects and what the risks and negative effects are. These trials may also compare the new treatment to existing standard treatment.
It is only after these confirmatory trials that any health claims can be reasonably justified, that patients should be charged for treatments, that the treatment should be incorporated into medical practice, and insurance companies pay for the treatments. You can make an argument for compassionate use of treatments based on preliminary evidence if there are no other options, but every effort should be made to do this as part of further research.
Press interest in the treatment should also follow this pattern. Only the technical and professional literature and news really should deal with new treatments in the introductory phase. The general lay press should not be trumpeting new treatments that are not even in the preliminary human trial phase. Reporting preliminary human trials should also be done carefully, and put into the proper context. The sensational headlines about a new treatment should be reserved for those that are well established by confirmatory research.
Everything I just described above often does happen when new treatment ideas emerge within the culture of scientific medicine and is handled properly by professionals. Every day medical scientists are sorting out what works from what doesn’t work using some version of this process, and the public usually only hears about new treatments that make it over the finish line.
Alongside this traditional, tested, science-based process there is a growing infrastructure of medical pseudoscience that follows a completely different paradigm. Their process goes something like this:
An innovator comes up with an idea for a new medical treatment (device, supplement, procedure, etc.). They immediately start using the new treatment (if they are a practitioner) or at least trying it out anecdotally on themselves or a few others. Based upon either this limited or no experience, and no actual research, they then market the new treatment directly to the public.
If a pseudoprofessional gets their hands on the treatment, then it is instantly institutionalized. The device is marketed, clinics are established, articles and books are written, and people are treated.
The lay press then give free advertising to the new treatment by writing gullible articles following a predictable narrative – a maverick innovator has come up with a “miracle cure” with dramatic anecdotes. If they developed the treatment in order to treat themselves or, better yet, a loved-one, then that, of course, is the angle. There is token mention of the nasty skeptics, but how could they deny the stunning testimonials?
These two versions of events are simply two ends of a spectrum – science vs. pseudoscience, or legitimate medicine vs. dangerous quackery. I do think that there is a bimodal distribution of new treatments based upon culture. People either function within a culture of science or a culture of pseudo and anti-science, but there is a scattering of treatment across this continuum.
Let’s see where this new treatment, the gyrostim, falls.
The GyroStim was developed by Kevin Maher, who is an engineer, not a medical scientist. He developed the device in order to help his daughter, who suffers from cerebral palsy. He and his wife were told that stimulating the vestibular system, by spinning around or doing somersaults, could help with balance and motor development. Motivated to aggressively treat his daughter to give her the best chance of improvement, they put her through “nearly 1,000 of these spinning motions per day.”
Maher decided to make this process easier by building a robotic chair in which a person can be strapped, and the chair would then spin in every axis. The chair seems to do what it is designed to do – spin a person around in every direction. If your goal is to do this a thousand times a day, this certainly seems like an advantage over doing somersaults. To that extent, the device works.
The deeper question is, however, what are the net risks and benefits of this kind of spinning therapy? But before I get into that, let me finish the story.
A GyroStim machine has apparently been sold to the Mayo Clinic for research, and another to the Air Force Academy for aerospace medical research. So far, so good.
But then Maher apparently was sucked into the rank pseudoscience of chiropractic neurology. His device was purchased by a Richard Turmel, DC, a self-described functional neurologist in Quebec. He says of the machine:
This might be the most amazing machine I’ve ever seen in medicine, and we’re only just at the beginning. I am seeing, quite frankly, new miracles almost every day with this. There are still skeptics out there in the medical community about this, but I’m sure when electricity was first invented, some people said it might be bad.
Hype, anecdotes, and dismissal of legitimate skepticism – the quack trifecta.
Another chiropractic neurologist, Ted Carrick, is also enamored of the GyroStim. I have discussed Carrick before (as has Harriet Hall), he makes many dubious claims and offers only testimonials and poorly-conceived studies as evidence.
The GyroStim is, unfortunately, now associated with the dark underbelly of medicine, the world of pseudoscience. Treatments with the GyroStim cost $2,500 – $6,000 per week, and the claims made for the treatment are expanding – concussion, cerebral palsy, and even autism (of course).
Hopefully the device will at least also go through the standard scientific evaluation. There is some plausibility for this type of treatment for vertigo. In fact, vestibular therapy is already an established and evidence-based treatment for chronic vertigo. Physical therapists develop an exercise program for patients that involve maneuvers to stimulate the vestibular system, which does tend to reduce the vertigo. This probably works through normal brain plasticity.
Vertigo can have many causes, but the common end result is that the brain is not properly integrating various sensory inputs (visual, proprioception, and vestibular) which is necessary for proper cerebellar function (balance and coordination). Forcing the brain to integrate vestibular stimulation may accelerate the process of essentially learning how to establish more normal sensory integration.
One cause of vertigo and poor balance is concussion – the brain is traumatized, which can cause diffuse damage interrupting the amount of connections that the brain makes with itself. This can interrupt sensory integration, causing vertigo. Vestibular therapy is therefore a legitimate treatment for the vertigo that results from head injuries.
The GyroStim is, essentially, automated vestibular therapy. In this regard it is nothing new. The open questions are – is it as or more effective than standard vestibular therapy, and is it cost effective? It’s very expensive, and so the cost-effectiveness question is not trivial. If it is as effective, perhaps there is a niche for it to administer vestibular therapy to patients who cannot physically comply with standard therapy.
Claims that the GyroStim can help with symptoms other than vertigo and balance, however, are not plausible. Existing evidence suggests that the benefits of these types of interventions do not extend beyond the tasks themselves. There is no global brain-training. Training in a task, for example, improves performance on the task, but not general performance.
Likewise – vestibular stimulation can plausibly help with the integration of vestibular sensory information with other sensory information and improve vestibular function, but there is no reason to suspect that it will improve any other aspect of neurological function.
The GyroStim is nothing more than automated vestibular therapy. Before it is mass produced and incorporated into medical treatment, it needs to be tested to see if it is safe, effective, and cost effective for conditions that are already treated by standard vestibular therapy.
If it is effective for vestibular therapy, then it can be studied to see if there are benefits for other conditions. I am skeptical of such benefits, however, because they lack plausibility. Only high quality confirmatory clinical research will be adequate to establish the GyroStim as a legitimate treatment for any such condition. Until then, promoting or using the GryroStim for anything other than vestibular therapy is pure quackery.