STATEMENT SUBMITTED BY TERRIE COWLEY PRESIDENT THE TMJ ASSOCIATION
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1 STATEMENT SUBMITTED BY TERRIE COWLEY PRESIDENT THE TMJ ASSOCIATION HEARING ON THE INSTITUTE OF MEDICINE REPORT RELIEVING PAIN IN AMERICA: A BLUEPRINT FOR TRANSFORMING PREVENTION, CARE, EDUCATION, AND RESEARCH TO THE COMMITTEE ON HEALTH, EDUCATION, LABOR & PENSIONS U.S. SENATE FEBRUARY 14, 2012
2 Chairman Harkin, Ranking Minority Member Enzi and other members of the committee, you have our deepest appreciation for airing this discussion of pain and what is needed to bring relief to the millions of people in this country living in pain. Temporomandibular Disorders (TMD) are a complex condition which manifests as pain in the joint area of the face and jaw dysfunction. Twelve percent, or 36 million people in the U.S. have Temporomandibular Disorders and the majority are women in their childbearing years. Kim A TMJ Patient In the mid 1980s Kimberly, a young woman living in Florida, began to suffer symptoms of temporomandibular (jaw) disorders. She also experienced serious headaches, ear pain, pressure behind her eyes and pain in her teeth, face, neck and back, which eventually spread throughout her body. The pain was often so bad that it caused nausea and vomiting. She needed a feeding tube for sustenance. After numerous jaw surgeries and implants, including the Vitek device, (recalled by the FDA in 1990 because of the potential for the device to erode the skull and gain entry to the brain). Kim s oral surgeons told her family there was nothing wrong with her. Her husband divorced Kim and took their children. Kim not only lost her family, but she also lost her ability to make a living. Kim suffered alone in a one-bedroom apartment in isolation from her friends and family living on social security disability payments. Few people in her life believed her pain was real. Nevertheless, she carried on valiantly with her usual sunny disposition and willingness to help others. Kim s experience, though extreme, is shared by millions of TMD patients in this country and I ll explain why. 2
3 The State of Science of Temporomandibular Disorders In 1989 Enid Neidle, Scientific Director of the American Dental Association, described TMD 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 jaw 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 they are destroying peoples lives. Fast forward. In November 2010 I asked the National Institutes of Health to conduct another Technology Assessment Conference to ascertain the progress made in the science of TMJ treatments since the 1996 Technology Assessment Conference. Their response in February 2011 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 based their findings. Most of these clinical trials are of moderate to poor quality, utilizing small numbers of subjects. 3
4 The systematic reviews are notable in their consistency for finding insufficient amounts 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 the treatments most recommended to TMJ patients: surgical procedures, occlusal adjustments, stabilization splints, biofeedback, orthognathic treatment, orthodontic treatment, etc. TMJ Implant Devices On February 7, 2011 the FDA issued an order to the only 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 Staff found that 52% of TMJ devices had to be explanted within three years of surgery. While the implant manufacturers were required to collect post-market 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. Since TMJ devices are typically implanted into young women, consider what that means over a lifetime. A 30 year-old who replaces an implant every two years and lives to be 60, will have had a minimum of 15 explants/implant procedures! It is doubtful that there would be sufficient skull and jaw bone left into which a surgeon could place screws. 4
5 The Plight of the TMJ Patient & Economic Costs With no scientific guidance upon which to base a specialty focused on TMD, no scientifically based treatments, health care providers are free to treat TMD patients on the basis of what they believe is causing the problem, while assuring the patient that the proposed treatment will lead to a cure. The result has been a chaotic system of over 50 unproven treatments being recommended to TMD patients, not including drugs and surgeries. When things go wrong the patient may 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 10,000 patients in our database and the results were published in the March 2011 edition of the Clinical Journal of Pain. Excluding drugs and surgeries, of the 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 TMD 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. A Complex Disease While TMD patients continue to be treated in the manner I just described, there has been growing research interest on the nature of TMD. As though TMJ pain was not sufficiently debilitating in itself, many patients also experience comorbid painful conditions including, vulvodynia, fibromyalgia, chronic fatigue syndrome, 5
6 endometriosis, and chronic headache. Scientists now believe that Temporomandibular Disorders represent a complex disease, like hypertension, cancer or diabetes, and are influenced by genes, sex, age and environmental triggers. Dr. Lawrence Tabak, former Director of the National Institute of Dental and Craniofacial Research succinctly stated that Temporomandibular Disorders do not exist alone. They are part of a collection of disorders that are both influenced by, as well as influence, other medical conditions As a complex disease, TM disorders open the door to research 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 in understanding TMD and medical disciplines must be educated to accept responsibility for these conditions. Both professions must recognize the paradigm shift that is occurring as new studies indicate the need to broaden the scientific base for research if we are ever to understand and find effective treatments for TMD. The research methods needed to elucidate what is really happening when TMD occur, and in particular, why some people will progress to conditions of chronic pain and dysfunction and accumulate other pain conditions, must rely on a systems approach one that begins with treating the patient as a whole person with a complex history that reflects genetics and environmental factors. These conditions cry out for basic and clinical multidisciplinary teams of scientists bringing individual and collective expertise to TMD as well as increased and smart funding directed toward these conditions. The IOM report echoes The TMJ Association s call for no less than a complete transformation in the way pain is researched, understood, diagnosed, treated and prevented. 6
7 Too Late for Kim In 2010 Kim was diagnosed with cancer and underwent radiation and chemotherapy. During this time she received pain medication within hospice care. In 2011 Kim received news that she was cancer free. She was taken off hospice care and the doctors ordered a psychiatric evaluation and drug program to wean her off the pain medications for her nonexistent TMD pain. Kim was devastated by this news. In an sent to us a while back, Kim wrote I m tired. Tired of all the hurting and the pain; tired of having to "grovel" for just a little bit of gaiety in life from medications from the pain community. On October 12, 2011, at age 56 Kim took her life. Her obituary stated, Kim endures no more pain and she suffered for many years. 7
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