Ragging Battles and Rigged Panels

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The following section are excerpts from an article of a highly regarded personal mentor of mine, Dr. Robert Jankelson, published in the book titled, Neuromuscular Dentistry – The Next Millennium, Anthology Volume V, 1999.

Fighting for Scientific Truth in the Neuromuscular Dental Arena

Since the early 1970’s battles have been ragging among our profession regarding occlusion and the neuromuscular concepts. Scientific facts rather than opinions was Dr. Bernard Jankelson basis for his further investigative studies as a trained prosthodontist who practiced in the state of Washington. His son Robert Jankelson, also a practicing prosthodontist and gnathologically trained, who is often in the background of today’s political agendas has been so kind to share with me his knowledge and beliefs of neuromuscular dentistry. Without doctors like Bob Janekelson, Jim Garry, Gary Wolford, Mike Mazzacco and others, I would not be able to present this information to you. It is out of respect to all who are interested in learning the other views that I share these facts as an historical record of what has gone before.

“In 1986, the American Dental Association Council on Scientific Affairs granted the Seal of Recognition to Myotronic’s neuromuscular instrumentation. The instrumentation that I use to date includes windows based computerized mandibular scanning (jaw tracking) instrumentation, electromyographic (EMG), electrosonography (SONO) and TENS (Myomonitor). It is through the help of this instrumentation that scientific break throughs have made it possible to understand more clearly the points we have been discussing regarding occlusion, muscle physiology and its relationship to mandibular movement, bite relationships and position.

Becker and Seldon wrote: “There has been a very long historical battle to disprove the methodology and credibility of this neuromuscular approach and use of this technology. “In the past, character flaws couldn’t wholly prevent the recognition of scientific truths. Both sides of a controversy would fight with equal vehemence, and the one with better evidence would usually win sooner or later. In the past four decades, however, changes in the structure of scientific institutions have produced a situation so heavily weighted in favor of the establishment that it impedes progress in health care and prevents truly new ideas from getting a fair hearing in almost all circumstances. The present system in effect is a dogmatic religion with a self perpetuating priesthood dedicated only to preserving the current orthodoxies.”

Through the years since the early 1970’s there has been a resistance of anti-instrumentation critics when the present methodologies were challenged with scientific credibility. Although the CR concepts has been the gold standard it has been unsupported with scientific evidence. In 1988 the political battlefield shifted from occlusion to TMD. A small group identified with the gnathological occlusal paradigm joined a small group from the American Association of Orofacial Pain (AAOP), to exert political pressure upon the ADA to rescind the Scientific Council Seal of Recognition for neuromuscular measuring devices. Dr. Norman Mohl was retained by the ADA to review the scientific safety and efficacy of these devices as aids in diagnosis and treatment of TMD. The draft Report concluded that “Expert for devices have been developed for electromyographic biofeedback, none of the other devices intended for treatment of TMD have the scientific evidence required for their recommendations.”

Scientific Evidence Exposing the Mohl Report
These devices included jaw tracking, surface electromyography, thermography, sonography, Doppler ultrasound, and muscle stimulators. It appeared that the anti-instrumentation Luddites were strategically placed politically within the American Dental Association. Disciples of the neuromuscular paradigm were armed only with facts and conviction.  The 1989 ADA Mohl Draft Status Report rejecting the safety and efficacy of transcutaneous electrical neural stimulation (TENS), jaw tracking, and electromyography, and electrosonography became the manifesto of the anti-instrumentation Luddites. Ultimately it could not hold back the tide of scientific evidence that exposed the Mohl Report as a adhominem politial diatribe, not a reasoned scientific document. Myotronics submitted a voluminous review of the scientific literature supporting the efficacy of surface EMG, jaw tracking and low frequency TENS for diagnosis and treatment of TMD to the ADA Council on Scientific Affairs. After unprecedented scientific scrutiny these devices were ultimately awarded the ADA Council on Scientific Affairs Seal of Acceptance.

“Manuscripts submitted to scientific journals are reviewed for validity in the same way as granted requests. And who is better qualified to judge an article than those same eminent experts with their laurels to guard?”

Despite being marked Draft Only, Not to be Referenced, and despite its rejection by the Council on Scientific Affairs the Mohl Draft Status Report appeared in over twenty refereed journals in the next six years. Many years after its rejection by the ADA Council on Scientific Affairs, the pigeon droppings from original Draft Report trace a scatologic trail through the mainstream dental literature.

Rigging the 1994 FDA Dental Advisory Panel
Failing to achieve their political agenda through the American Dental Association, the anti-instrumentation Luddites resorted to improper and illegal distortion of the regulatory process, culminating in “rigging” of the October 1994 FDA Dental Advisory Panel convened to classify muscle monitoring devices. An Orwellian nightmare for the manufacturing of neuromuscular instrumentation began in 1991 when an anti-instrumentation cabal subverted certain FDA employees to bring the full wrath of the FDA regulatory process upon them. The 1994 FDA Dental Advisory Panel was designed to be the death knell of neuromuscular instrumentation and ideas.

Dickenson’s FDA Review in an article entitled, “Perverted’FDA: exposed the deceitful rigging of the panel by placing three well known opponents of the Myotronics technology, who had earlier fought unsuccessfully to get the American Dental Association to rescind its approval seals for the firms’ products.

For two years the investigative trail of the FDA Special Investigators, the U.S. House Commerce Oversight Committee and the U.S. Department of Health and Human Services Inspector General exposed Machiavellian machinations by an anti-instrumentation group subverting FDA employees to destroy the manufacturers of neuromuscular instrumentation.

The next three years was a David versus Goliath battle to re-instate the legitimacy of neuromuscular instrumentation and to expose the egregious misuse of the governmental regulatory process by a small group of anti-instrumentation foes. With only conviction and facts on their side, a few neuromuscular disciples took on the AAOP academic establishment and the governmental FDA Goliath. Few could have predicted the outcome. Few will ever appreciate the price paid by the neuromuscular advocates.

The Battle and Its Outcome
“The battle and its outcome was chronicled in the Medical Devices and Diagnostic Industry (MDDI) Reports: “An investigation was begun by the FDA Office of the Chief Mediator in conjunction with the FDA Omsbudsman’s Office in response to a 33 page letter of complaint filed in January 1995 by the Washington D.C. law firm of Hyman, Phelps & McNamara on behalf of Myotronics. In July 1995 Myotronics President Roland Jankelson testified at a hearing before Rep. Barton’s House Commerce Oversight Subcommittee on allegations of FDA retaliation that the FDA’s Office of Internal Affairs planned to conduct its own inquiry.

The House oversight Committee found Roland Jankelson’s testimony so compelling, the credibility of then FDA Commissioner David Kessler’s testimony to the Committee regarding the Myotronic’s issues so lacking and the evidence of FDA cover up so powerful that the criminal investigation was transferred to the Inspector General, Department of Health and Human Services. The two year investigation concluded “In 1994 the Dental Products Advisory Panel of the Center for Devices and Radiologic Health (CDRH) assessing a Myotronics Inc. dental measuring device was indeed rigged.” The probed resulted in discipline and dismissal of certain FDA employees, including the author of the 1988 ADA Draft Status Report.

Dr. James Garry, past President of ICCMO, Dr. Barry Cooper, President of ICCMO, Dr. Larry Tilley, President of the TMD Alliance, and my brother Roland Jankelson who possessed all the courage and tenacity of our father, and countless others gave their time and energies to overcome seemingly insurmountable adversaries. Yet, time after time the disciples of Dr. J have prevailed and the pigeons of Zeus retreat, only to reappear. Their venues change, but their agendas remain the same. The neuromuscular devices have the ADA Seal of Acceptance. The neuromuscular devices, after reconvening the Dental Advisory Panel, now have the lowest priority classification, which they should have been granted in 1994, and are recognized as safe and effective by the FDA.

In the face of overwhelming evidence of misbehavior and regulatory abuse by the FDA employees, eight years after Norman Mohl submitted his anti-instrumentation Draft Status Report to the ADA, FDA informed Mohl that his FDA consultantship would not be renewed. Further, the FDA accepted the voluntary resignation of Charles Bertolami, Chairman of the discredited 1994 Dental Products Panel. Other FDA employees were disciplined. The FDA admonished the 1994 panel Secretary Carolyn Tylenda by inserting a confession of inappropriate conduct into her record. She had previously left the Agency. The FDA verbally admonished General and Restorative Device reviewer Dr. Gregory Singleton. Singleton left the Agency on August 1, 1997. An article in the Gray Sheet, an industry trade journal, reported that “Singleton was dismissed from the Agency in a quick and discreet manner, FDA says …”

It is only recently that a small group from the Academy of Orofacial Pain have denied occlusal causality for TMD. In its place they have attempted to posture TMD as a psychosocial disease caused by emotional stressors. The 1996 National Institute of Dental Research Consensus Conference clearly defined the biomechanical versus the psychosocial paradigm schism. This the next field fertilized by the pigeons of Zeus.

The neuromuscular dentist will be well served by technological advances in the next few years. Computer interface modules, faster hardware, easier to use software, EMG spectral analysis to give newer insights into muscle fatigue states will make clinical procedures even better. However, as long as there are “pigeons of Zeus covering new ideas with their droppings” and anti-instrumentation Luddites with adhominem diatrabe there will be more political battles and more victories to win for “Dr., J” and our patients.”

Clayton A. Chan, D.D.S.
Originally posted November 1, 2005

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