Clinical Trials Does Not Support Your Treatment? Really?

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(The following is a communication with an individual (KR) who makes her living doing research funded by grants with the NIH – National Institute of  Health)
She stated the following as part of a long discussion:

“…a million individual case studies don’t stack up against a single randomized, controlled clinical trial. Sorry, those our my standards and the standards for scientific evidence. You are welcome to use other standards, should you wish, but we are then operating on different planes regarding what we consider ‘evidence.’ ”

 

KR: Clayton A. Chan, There is a big difference between the FDA approving a device for measuring what it says it measures (at a particular point in time) and for changes over time to be informative clinically. It’s a question of within-subject reliability, which study after study has found to be problematic in EMG . I’m not arguing at all about the general value of EMG (which is what the studies you cite are mostly about) and, as I wrote earlier, I think it is important in understanding some of the causes of TMJ pain. However, to infer that a particular treatment is effective BECAUSE EMG changes from one point in time to another point in time many months later is altogether different issue and huge, unsupported leap. The authors/studies you cite do NOT support those kinds of conclusions. Studies supporting this philosophical approach to TMJ treatment are uncontrolled, so uninterpretable. I’ve read the long FDA reports specifically related to these devices and they say NOTHING whatsoever about how to interpret changes in these measures. Yes, electrodiagnostic instrumentation, particularly because it is minimal risk to the patient and was ‘substantially equivalent’ to existing devices was given FDA approval.. . In fact, if you go onto the FDA’s website you can see a 2012 letter from the FDA to the manufacturer of these devices censuring them, in a warning letter, for making unsubstantiated claims that were not evaluated or cleared by the FDA. Note also an NIH Technology assessment conference in 1996 (yup, I was there) that concluded, ” “Therapies that permanently alter the patient’s occlusion cannot be recommended on the basic of current data.” There were no controlled clinical trials then, and there still aren’t now.

Clayton A . Chan Response:
Yes, I agree EMGs as a stand alone diagnostic aid is not enough. It is pertinent information that most in the clinical arena fail to properly recognize as a powerful aid in recognizing masticatory muscle dysfunction and impairment problems. I understand why most don’t understand EMGs and why they don’t think in their minds it is reliable. Because of their lack of comprehending the physiologic rest concept as well as an inability to compare asymptomatic cases from symptomatic groups as they relate to the multi faceted musculoskeletal occlusal signs and symptoms, certainly it can be overwhelming and confusing…thus most of the literature is confused and biased.

Treatment effectiveness can be measured and quantified when using all the proper diagnostic measuring tools including CMS (computeraized mandibular scanning, jaw tracking) combined with TENS, EMGs and ESG. To use only one measuring aid will certainly lead to false positives and inclusive results as you have noted. Most of those who have written and published on these matters have not used all in a complete manner nor have they received the proper training and education in these technologies, so we naturally found that we cannot rely on them as a credible resource when it comes to clinical treatment of TMD issues and the literature they have produce. In fact, most of those who write papers really have not been properly trained or schooled in occlusion nor the use of these technologies, but make comments with no clear standing as to their experience in the use of these technologies when it comes to patient treatment. It is actually entertaining to many of us dentists who use these devices on a regular basis to read their writings with intrigue.

The wet fingered clinicians who treat TMD patients cannot rely on the NIH information as reliable source since they are not involved in the actual patient care business. We are practical and in the business of caring and resolving patient health problems…getting results is what patients desire and want!

NIH have not given any clear answers to what is the cause of TMD and how best to remedy the problem. But rather leaves our who community of TMD patients in a state of confusion believing it is a multi-disciplinary approach with no real answers accept a psychosocial agenda to perpetuate “orofacial pain management”…. we in the community of dentist who use these technologies see it from a whole different perspective and do not allow biased literature to sway or clinical convictions, observations, and patients experiences as to what has worked and what has not for them.

The ADA and FDA have accepted these tools as useful and valid aids for us dentists to use and help support what we do from a diagnostic perspective.

It is interesting that the NIH sure seems to disparage electronic objective measuring instrumentation, yet they still fail to arrive an any definitive answers about TMD after years of so called cohort cochran studies. If they have no clear answers, as treating dentists, we can stand around and wait for these entities to come up with nothing… so we dentists do what we logically and intuitively do – identify the problem, objectively, quantify mandibular impairments/dysfunctions before, mid and after, quantify and measure muscle activity before, mid and after, as well as locate physiologic jaw relationships and position as to where best to relate the upper to lower teeth, especially if there is joint derangementproblems, prior to any treatment, keeping things conservative and reversible, until our patients teeth, muscles, joints and CNS are stable before we conclude a definitive mode of phase 2 treatment.

I don’t think most folks see anything wrong with that approach.

I am confident what you saw on the 2012 FDA website is now corrected and updated by the manufacturers and is in compliance to their standards since Myotronics abides by and follows their guidelines to maintain FDA recognition status as well as 510K status for these technologies.

KR: It has been DEMONSTRATED to be unreliable with DATA.

KR: I actually wanted to do a study lòoking at emg changes. These are interesting hypotheses. I was told by expert after expert that the technoology won’t allow for meaningful within-person interpretation. I have no bias. The research data show clearly that within-person changes are not interpretable.

Clayton A . Chan Response:

Not So! We teach on these matters and educate our doctors how to properly interpret the data correctly….lol

The so called experts you reference most likely are not so expert in this field compared to many of us and my colleagues who routinely use these technologies daily in our TMD occlusal treatments.

KR what you say “it has been DEMONSTRATED to be unrealiable with DATA” is DEFINITELY NOT TRUE! Those who have tried to make such statements have been proven to be biased and have FALSELY misrepresented the facts of the matter. These so called experts have been exposed! This is a very old argument that has been exposed years ago. Those who have perpetuated these myths are bitter because they could not disprove the credibility of the Myotronics technology, and were exposed years ago in Congressional hearings in Washington, DC.

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.”

KR: “Wow. I didn’t realize that i was conversing with a neuromuscular dentist. You have a lot to lose, should clinical trials not support your treatment model. Models are great but they need to be evaluated with controlled clinical trials. If blogs are sufficiently persuasive for you, fine. As a scientist, i look to data. After more than 20 years when such a need was formallly identified,, still no data.”

KR: “I will not argue religion with you here. End of this dialogue for me. I offered this group my knowledge base as a long-funded research scientist. That offer stands. I am concerned that Patients have access to high-level research findings and will point out where no such evidence has been published.”

Clayton A. Chan’s Response:
I don’t  identify myself as a “neuromuscular” dentist. I am a dentist to treats patients comprehensively. Your bias is now really showing! Clinical trails? We have been waiting for them to begin for over 15 years….nothing has happened….TMD patients on these forums can’t stand around waiting for academics to come up with answers….academia have been given more than plenty of grant money and time to come up with something reasonable and effective…but NOTHING has come up as useful!

These Fb forum blogs all know it! That is why we all are on these forums discussing the issues. Most of us got over the referencing of “peer” reviewed literature…it doesn’t seem to stick here…since many on these forums are comprised also of professionals and lay folks of all walks of live. We are looking for real practical answers…not more academics.

I am a clinical wet fingered dentist who treats real TMD patients, not paper and literature studies that only research other papers to make further conclusions of conclusions.

I research and study real patients with real issues with real problems that must be solved today! Not yesterday. Most of us dentist couldn’t stand around waiting for secondary data and literature to be published…so we go about gathering our own live patient data, compare it, share it and discuss our findings internationally amongst those who actually objectively measure and treat cases. We realized the NIH has let us down as well as the TMD community of patients…this is the reason why there are many FB TMD and TMJ/TMD discussion groups of lay patients around the world talking and wondering why there are no real answers. They hare find better answers from dentists who measure and quantify their findings in real time.

This is how we learn and educate ourselves.

Further comment:

Now KR you accuse what we are discussion “religion”? Come on… I am use to that accusation for years… what part of what I do and advocate is of any “religious mindset”. I am not that religious….I live in Las Vegas, NV. We aren’t too religious out here.

The evidence is overwhelming in favor of instrumentation and objective measurements. The rigged and biased entity you and your colleagues engage yourself with an anti-instrumentation agenda was exposed long ago in the “TCB Department of Health and Human Services Public Health Services Food and Drug Administration – Dental Products Panel Meeting Open Session Volume 1”, report on Tuesday, August 4, 1998. Our “NM colleagues even offered to help participate in research with your colleagues, but time and time again it has been declined. One has to wonder why?

For further review to read the whole report meetings minuets:http://webcache.googleusercontent.com/search…

Clayton Dentistry
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Clinical Trials Does Not Support Your Treatment? Really?