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The Plight of the TMJ Patient

Terrie Cowley President & Co-founder The TMJ Association, Ltd.

Presented at: American Academy of Orofacial Pain 35th Scientific Meeting Orofacial Pain: Periphery to Cortex and Back Las Vegas, NV April 29 - May1, 2011

In order to be a patient advocate one must be a bit schizophrenic. We act humble when asking Congress to address the needs of the patients, tenacious in presenting the patients' needs to government agencies and firm in demanding scientific evidence from the practitioners. But most of all, providing support, credible information and advocating for the needs of the TMJ patients are our top priorities. As much as I was heartened by the great scientific talks presented yesterday, the distance between the science and the real world the patients live in crashed over me each time I'd take a few minutes to read an e-mail from a patient on my blackberry. The potential scientific opportunities vs. the reality of how patients are being treated can be striking. In 1989 Enid Neidle, Scientific Director to the American Dental Association, described TMJ treatments as the hottest area of unorthodoxy and out-and-out quackery. In 1996 the National Institutes of Health Technology Assessment Conference on Management of Temporomandibular disorders concluded that: Professionals don't know what TMJ pain signifies, don't know what to call it, don't know who should treat it, don't know what works because they haven't done clinical trials and they are destroying peoples' lives. Fast forward 15 years. In January of this year I asked the NIH what progress has there been in the science in support of TMJ treatments since the 1996 Technology Assessment Conference. Their response included the following statements. There have been multiple meta-analyses and systematic reviews published on treatments for TMDs. These found: Insufficiently new, high-quality information in the literature since the last conference was convened [1996]. While there are new studies that have been published, only a handful of these are randomized trials upon which the authors base their findings.

Most of these clinical trials are of moderate to poor quality, utilizing small numbers of subjects. The systematic reviews are notable in their consistency for finding insufficient amount of information on which to base treatment recommendations. The reviews also express concerns about the quality of the available evidence. The majority of the studies report no difference between treatment and control, equivocal improvement, no strong influence of treatment, modest efficacy, heterogeneous results; in short, no strong conclusions. These analyses cover surgical procedures, occlusal adjustments, stabilization splints, biofeedback, orthognathic treatment, orthodontic treatment, etc. Following a change of regime at the FDA and participating in several conference calls with the Director of the Center for Devices and Radiological Health, I met with Director Shurin July of last year. Among many questions I had for him was what happens to all of the MedWatch Reports that are filed on TMJ devices? I explained that with a patient's permission we file reports and we knew of many patients that filed their own reports. He said he would investigate. On February 7th of this year he called to tell me that that morning the FDA issued an order to the three TMJ device manufacturers to submit post-market surveillance clinical study protocols on their devices, which were approved approximately10 years ago. FDA's order followed an analysis of complaints compiled in their voluntary reporting system, MedWatch, from 2004 to 2010. Staff found that 52% of TMJ devices had to be explanted within three years of surgery. Considering that the devices are being implanted into young women, think ­ if a 30 year old has an implant every two years and they live to be 60, they will

have had a minimum of 15 explants/implant procedures! Who has that much skull and mandible in which to drill screw holes? While the implant manufacturers were required to collect postmarket data on their implants as part of the initial approval process, the data collected did not adequately address either the timing or the reasons for replacement, and many of the enrolled patients in their studies were lost to follow-up. The lack of evidence of the safety and efficacy for all treatments for Temporomandibular Disorders is directly related to the plight of the TMJ patient. With no scientific guidance upon which to base a specialty focused on TMDs, and extremely limited pre-doctoral training in the neuroscience of pain, health care providers are free to treat TMD patients on the basis of what they believe is causing the problem, at the same time assuring the patient that the proposed treatment will lead to a cure. The result has been a chaotic system of over 50 unproven treatments, not including drugs and surgeries. When things go wrong the patient may very well be abandoned by the provider, suffer worse pain and dysfunction and become impoverished by the costs of treatment, because the lack of scientific evidence for treatment may also mean the lack of insurance coverage. The TMJ Association conducted a survey of the patients in our database and the results were recently published in the Clinical Journal of Pain. Excluding drugs and surgeries, of 45 treatments listed, the most helpful to the patients were hot or cold packs. A recent survey conducted by the Wealthy Dentist found that 78% of dentists treat Temporomandibular Disorders with multiple treatments. A 1993 study found that 33 billion dollars was spent annually on TMJ treatments. In short, some TMD patients get better on their own or in spite of treatments, others are unaffected by treatments - except financially - and some are made worse

physically, psychologically and financially. This is simply TMJ LOTTO. It is harmful and unethical. While TMJ patients continue to be treated in the manner I just described, there has been growing research interest on the nature of TMD. Scientists now believe that TM disorders represent a complex disease ­ like hypertension, cancer or diabetes ­ influenced by genes, sex, age and environmental triggers. Moreover TM disorders, particularly in patients where symptoms are chronic and severe, are not alone. They usually co-exist with one or another of a collection of disorders being influenced by, as well as influencing other medical conditions such as chronic fatigue syndrome, fibromyalgia, vulvodynia, endometriosis, cardiovascular disorders, hearing problems such as tinnitus, digestive and gastrointestinal and sleep disorders. Clearly, as a complex disease, TM disorders open the door to considerations far removed from a concentration on structures of the face and head. Attributing every patient's orofacial pain to tooth and jaw problems, when the etiology may be elsewhere, may not only be ineffective, but harmful. As such, dentistry must admit to its limitations on TMD and medical disciplines must be educated regarding their responsibility to these conditions. Both must recognize the paradigm shift that is occurring as new research indicates the need to incorporate more scientific and medical disciplines into this complex disease. The research methods necessary to elucidate what is really happening when TMDs occur and why some people will progress to conditions of chronic pain and dysfunction will rely on a systems approach--one that begins with treating the patient as a whole person with a complex history that reflects genetics, epigentics, and environmental factors. Until new research yields greater understanding of

Temporomandibular disorders and treatments that help and don't harm, I have three suggestions. Your patients are suffering. Be compassionate. Educate everyone about the state-of-science and the limitations in treating these conditions. Educate the patients, and especially their loved ones. Be careful not to stigmatize the patients further by citing psychological etiology. When you refer a patient to a medical professional, educate that professional about the relationship of the patient's condition to their specialty. Lastly, heed the admonishment of the National Institutes of Health ­ Less is best when it comes to treating TM Disorders. I thank the Academy for this opportunity to tell you about the plight of the TMJ patients and the thousands of patients that share not just their TMJ experiences but their life experiences with us ­ to the Agencies of the NIH for their grant support of our scientific meetings to advance this field and to Joan Wilentz, Deanne Clare and Laurie Friedrich for their help with this presentation.

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