The Patient s Perspective

Transcription

1 The Patient s Perspective Terrie Cowley President & Co-founder The TMJ Association, Ltd. Milwaukee, Wisconsin The European Academy of Cranio-Mandibular Disorders

2 The TMJ Association A non-profit patient advocacy organization founded in 1986 by two patients to improve the health care and quality of life for everyone affected by Temporomandibular Disorders

3 What We Do Advocate for scientific research and health policy concerns of TMJ patients (Congress, NIH, FDA, CDC, AHRQ, etc.) Co-sponsor scientific meetings with NIH, and FASEB. Communicate with patients. Serve as a resource center for the collection and dissemination of information on research, treatment, insurance practices, patients rights, and legal and ethical issues ( Connect TMJ patients with those who can provide knowledgeable and empathetic support.

4 Who Contacts Us? Those that think they have a TMJ problem Those recently diagnosed Those in the midst of treatment and are not getting better or are getting worse Those who have had TMJ problems for many years TMJ implant patients Loved ones and friends Others dentists, social workers, attorneys, insurance companies, and media

5 The Most Frequently Asked Questions What doctor should I see? What treatments work?

6 Who should I see? How NIH answers this question. Because there is no certified specialty for TMJ disorders in either dentistry or medicine, finding the right care can be difficult.

7 What Do We Say? The TMJ Association does not provide referrals because: There is no established specialty in dentistry or medicine, hence no standards of care or of education. There are more than15 professional TMD organizations encompassing a number of disciplines, each with differing and conflicting beliefs on how to diagnose and treat TM Disorders. This reflects the chaos and controversy that the patient faces. Thus, patients have seen a broad array of professionals for diagnosis and treatment.

8 And Here They Are

9 What Do The Patients Say? It is so hard to find medical and dental professionals that have any clue of the problems we face daily. I live in fear everyday that I might not be able to obtain the assistance I need just to survive. Emma I am in search of lots of answers but it doesn t seem like anyone knows anything, especially the dentists. Patricia

10 What Treatments Work? Historical Perspective In 1989 Enid Neidle, Scientific Director to the American Dental Association, described TMJ treatments as the hottest area of unorthodoxy and outand-out quackery.

11 The 1996 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, and they are destroying peoples lives.

12 Fifteen years later, in January 2011, I asked the NIH for a report of the scientific progress underlying TMJ treatments since the 1996 TAC. Their response was: Many meta-analyses and systematic reviews were published on treatments for TMD. These analyses cover surgical procedures, occlusal adjustments, stabilization splints, biofeedback, orthognathic and orthodontic treatment, etc. Only a handful of new studies published were randomized, or close to randomized, clinical trials upon which the authors based their findings.

13 Systematic reviews were notable in their consistency for finding insufficient amount of information on which to base treatment recommendations. The majority of studies reported no difference between treatment and control, equivocal improvement, no strong influence of treatment, modest efficacy, heterogeneous results; in short, no strong conclusions. Concern was expressed that most of these clinical trials are of moderate to poor quality and had small number of patients. There was insufficiently new, high-quality information in the literature since the last TAC conference. NIH Confirmed that this information is current as of August 2012.

14 From the NIH brochure on TMD Because more studies are needed on the safety and effectiveness of most treatment for TMD, experts strongly recommend using the most conservative, reversible treatments possible. These don t invade the tissues of the face, jaw, or joint, or involve surgery. They do not cause permanent changes in the structure or position of the jaw or teeth.

15 The TMJ Association conducted a survey of our patients. The results were published in the Clinical Journal of Pain. Excluding drugs and surgeries, of 45 treatments listed, the most helpful were hot and cold packs. A most cited 1992 study estimated the annual cost of TMJ treatments to be $32 billion.

16 To summarize: Patients improve, are unaffected, or are harmed by treatments ( TMJ lotto ) Practitioners treat patients based on nonscientifically established dogmas or personal beliefs. Patients are subjected to more than 50 unproven treatments, not including surgery or drugs. It is a chaotic, uncoordinated environment in which patients are referred to a succession of many other professionals (no medical home). Professional accountability and responsibility are lacking for treatment failures or adverse events.

17 Patients are abandoned when treatments fail, produce adverse events, or if they are unable to pay ( The Money Joint ) In many cases, the patients end up physically and emotionally worse. Many become increasingly desperate and bankrupt.

18 What Do The Patients Say? I am 20 years old and have had severe TMJ for 3 years now. I ve been working with a dentist trying to improve. He is now at a stage where he doesn't believe he can help anymore. I ve spent $7,000 on treatments already, which is unbelievably hard for a 20 year old. At the moment I am in constant pain, and can open my mouth just wide enough to fit the tip of my finger in. I would rather just die then eat. No one understands how I feel. What should I do? Judy

19 What Do The Patients Say? I have had TMJ difficulties for 15 years now and have found physical therapy to be the best treatment so far. I will be getting braces (for a second time) as only my back teeth meet and I now have a huge overbite. I will also be getting orthognathic surgery, but I m concerned that there is not one method of treatment that has scientific evidence to prove its efficacy, so I feel that we re on our own to decide what treatments to pursue. John

20 Surgery/Implants 1990 Vitek implant recalled by FDA 2000 FDA approved 3 TMJ total joint devices Companies ordered to collect Postmarket data Data collected did not adequately address the timing or reasons for explantation and replacement, Most of the patients were lost to follow-up.

21 On February 7, 2011 the FDA issued an order to TMJ device manufacturers to submit clinical study protocols on their devices which had been approved a decade earlier. This order followed an analysis of MedWatch complaints from 2004 to 2010 in which 52% of the devices had to be explanted before three years. To date, protocols have not been initiated due to lack of IRBs.

22 What do the patients say? I m 35 years old and have had 26 surgeries I am now in worse condition than when I started.. I have been dealing with this for close to 40 years and spent over $400,000 in treatments, procedures, many dental surgeries and yet no one truly seems to understand the pain, discomfort and costs associated with it yet alone quality of life issues. Margie

23 Patricia, from Pittsburgh, died at the age of 41 after her 62nd jaw surgery. She received her 10 th set of TMJ implants during her final surgery.

24 What Do Patients Want? TMJA s 2012 Web survey 82% - Educating medical professionals about TMD 78% - Increasing scientific research on TMD 71% - Obtaining health insurance coverage 69% - Educating dental professionals about TMD 47% - Increasing public awareness

25 Perhaps we ve been looking for Doctor Love in all the wrong places

26 What Science Is Revealing

27 Scientific Meetings of the TMJ Association Always an emphasis on a multidisciplinary approach Moving TMJ Research into the 21 st Century 2002 Joint and Muscle Dysfunction of the Temporomandibular Joint 2004 Advancing Diagnostic Approaches for TMJ Diseases and Disorders 2006 A Systems Approach to the Understanding of TMJ as a Complex Disease

28 TM Disorders Portrait of a Complex Disease. TM Disorders A complex family of diseases and disorders influenced by genetics, gender, environmental and behavioral triggers mediating the vulnerability of patients to TMJDs and manifesting as more than dysfunction and pain of the jaw joint and muscles. TMJ Science, Vol 4, 2006

29 2008 Can Studies of Comorbidities with TMJDs Reveal Common Mechanisms of Disease? Scientific Meetings of the TMJ Association Always an emphasis on a multidisciplinary approach Moving TMJ Research into the 21 st Century 2002 Joint and Muscle Dysfunction of the Temporomandibular Joint 2004 Advancing Diagnostic Approaches for TMJ Diseases and Disorders 2006 A Systems Approach to the Understanding of TMJ as a Complex Disease

30 WHAT DID PATIENTS AND SCIENTISTS LEARN FROM EACH OTHER? TMJ Science Vol. 5, Chronic debilitating pain was the feature most shared among the comorbid conditions (TMJD, FMS, CFS, IBS, IC, vulvodynia, headache, endometriosis, others) 2. Chronic pain transcends the boundaries (silos) of biomedical research and clinical specialties. 3. Research focused on chronic pain would provide a major opportunity to fill a gap in biomedical research. 4. Opportunities for discoveries in this field have never been greater, but the complexity of the biology remains a daunting challenge.

31 2011 Scientific Meeting Can we identify common genetic and pathophysiological processes underlying these Comorbid Chronic Pain Conditions (CCPC)? PNAS, 2008 Diseases (nodes) are connected if a gene is implicated in both diseases.

32 Paradigm Shift It was concluded that there is a need to shift the focus from the isolated study of a number of chronic pain conditions each with its own set of involved organs, symptoms, clinical specialists and treatments, towards study of the mechanisms underlying nervous system dysregulation and dysfunction that may be the common basis for these conditions.

33 Research Recommendations 1. Conduct prospective population based epidemiological studies to determine the natural history of CCPC. 2. Develop a case definition and diagnosis for CCPC and redefine the case definition and diagnostics for individual chronic pain conditions. 3. Develop neurobiological profiles. 4. Create an online centralized CCPC data bank to serve as a curated repository and shared reference source and support collaborative research using this data bank.

34 Evolution of the Chronic Pain Research Alliance (CPRA) TMJ disorders vulvodynia endometriosis fibromyalgia interstitial cystitis/painful bladder syndrome irritable bowel syndrome chronic headache chronic fatigue syndrome generalized pain Patient advocates attending TMJA Scientific Meeting 2008

35 2008 The Chronic Pain Research Alliance (CPRA) The CFIDS Association of America The Endometriosis Association The TMJ Association The National Vulvodynia Association The CPRA is dedicated to alleviating the significant human suffering caused by prevalent, neglected and poorly understood chronic pain conditions that frequently co occur and disproportionately affect women, by advocating for, and supporting, innovative collaborative scientific research on these disorders.

36 Major Accomplishments 2010 Campaign to End Women s Pain 2011 Contributed to the Institute of Medicine study on PAIN. Secured US Senate report language for research in chronic pain. Trans NIH Working Group on Overlapping Conditions. NIH sponsored meeting on Overlapping Conditions, Aug 14, 2012.

37 The Future Our Hope is in Science

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39 2006 Recommendations for how academic and clinical programs could coalesce the basic and clinical expertise needed to move this field forward. Genomics ARTHRITIS PAIN CENTRAL CORE OF SHARED RESOURCES Research database of participants TMJD NIH RESEARCH GRANTS SKELETAL MUSCLE Systems modeling ALLERGY/ IMMUNITY MEDICAL AND DENTAL SCHOOL CLINICS Scientific cores: genomic sequencing, proteomics, imaging, computational biology, association studies Biobanks/Bioinformatics/Stats Collaborative pilot projects Community partnerships Educational and training programs Neurosciences /Psychiatry AFFILIATED COMMNITY HOSPITALS NIH CTSA ORAL FACIAL