News
News from and about Tomed.Interesting to know
3. Commercial insight: questionable practices of sleep dentists against Tomed
Our prefabricated oral appliances SomnoGuard, SomnoGuard 2.0 and SomnoGuard AP are many times cheaper than the custom-made appliances, but not necessarily less effective. Due to the tremendous price differences between our prefabricated and the major brands of custom-made oral appliances for the treatment of primary snoring and mild to moderate obstructive sleep apnoea in adult patients some few sleep dentists have been combatting us for years. Thus, we have decided to disclose some of the available facts to our customers and other interested parties to enable them to draw their own conclusions and make up their mind about the seriousness of those experts.
3.1 Publication from the authors Vanderveken, Braem, Marklund et al. at AJRCCM 2008, 178, 197-202
Providing misleading press releases like "Prefabricated thermoplastic oral appliances for mandibular advancement are not effective for treating mild sleep apnea, and clinicians should use custom-made devices instead, new research suggests" (click) is intended to manipulate medical experts' and public opinion to favour extremely expensive custom-made oral appliances rather than the cheaper prefabricated devices for obvious monetary reasons.
The following are documented facts to counteract that type of propaganda campaign:
It is apparent that a few orthodontists and sleep dentists want to ban inexpensive prefabricated oral appliances from the market just to maintain their extremely high profit margins for the fabrication of the custom-made oral appliances. For the aforementioned reasons the 2008 publication from Vanderveken, Braem, Marklund et al. is considered scientifically irrelevant and worthless.
3.2 Litigation in German courts against board members of the German Society of Dental Sleep Medicine (DGZS)
There has been litigation in the German courts against the German Society of Dental Sleep Medicine (DGZS - Deutsche Gesellschaft Zahnärztliche Schlafmedizin) represented by the leading figures Dr. Susanne Schwarting (president, orthodontist) and Dr. Ulrich Huebers (vice-president, orthodontist). The DGZS has a similar background of untrue statements for the sole purpose of removing inexpensive prefabricated oral appliances from the market and thus strenghten the market position of the very expensive custom-made oral devices such as TAP, SomnoDent, Silencer Professional and the German IST devices. The leading major brands of custom made devices are priced in Germany at about € 800 to € 1800.
As an example, in March 2006 Huebers lectured in a sleep medicine educational course in front of an audience of more than 100 otolayrngologists that
The court has no doubt at all that the DGZS tries to push back the commercial SomnoGuard for apparent economic reasons to support the economical interests of their members. To achieve this goal, the accused DGZS is using alarming and questionable methods. They pretend to be objective and neutral, but disregard and ignore voluntarily that there is available at the market a much lower priced product, which meets the medical requirements for the majority of patients. It is proven clearly by the submitted clinical trials, that these requirements are met. Primary focus should finally be the patients'medical needs. ...
Our prefabricated oral appliances SomnoGuard, SomnoGuard 2.0 and SomnoGuard AP are many times cheaper than the custom-made appliances, but not necessarily less effective. Due to the tremendous price differences between our prefabricated and the major brands of custom-made oral appliances for the treatment of primary snoring and mild to moderate obstructive sleep apnoea in adult patients some few sleep dentists have been combatting us for years. Thus, we have decided to disclose some of the available facts to our customers and other interested parties to enable them to draw their own conclusions and make up their mind about the seriousness of those experts.
3.1 Publication from the authors Vanderveken, Braem, Marklund et al. at AJRCCM 2008, 178, 197-202
Providing misleading press releases like "Prefabricated thermoplastic oral appliances for mandibular advancement are not effective for treating mild sleep apnea, and clinicians should use custom-made devices instead, new research suggests" (click) is intended to manipulate medical experts' and public opinion to favour extremely expensive custom-made oral appliances rather than the cheaper prefabricated devices for obvious monetary reasons.
The following are documented facts to counteract that type of propaganda campaign:
- The authors of the study publication,
cited in the above press release, Vanderveken,
Braem, Marklund et al., compared only one custom-made oral appliance
from the Swedish co-author Marklund against just one former
prefabricated product from Tomed that was a non-validated research and development
project, which has never been available in any market. There had been
significant design differences ( please click) between the never marketed former
development project and the commercial 1-part SomnoGuard. Development of
that prefabricated oral device project ceased in 2004. Four years
before the results of the study were published, the authors were
informed in 2004 about the abandonment of the development project at a
very early stage of their comparative cross-over trial. The global
approach of their conclusions is inappropriate and misleading, since
there are many one-part and two-part prefabricated oral appliances
available in the market, e.g., 1part: the classic SomnoGuard, Snorban,
the so-called IST test device from Prof. Rolf Hinz (Germany) mentioned below and
2part: SomnoGuard AP, Respironics Silencer, TheraSnore, Norad etc., which
were not considered at all in the study.
The facts and conclusions of any such scientific study should be precise, not misleading, and refer only to the specifically examined appliances. The conclusions of the Vanderveken study expressed in the press releases definitely state that all types and brands of prefabricated oral appliances for the treatment of snoring and obstructive sleep apnea are not effective. Extrapolating data in this way infringes the principles of serious scientific and ethical research work and disqualify investigators themselves. In view of the fact that previous clinicical research outcome data with the commercial 1-part SomnoGuard had been very positive (i.e. JT Maurer et al. 2007, OM Vanderveken et al. themselves in 2004), serious investigators would have questioned such research outcome data resulting from a never-marketed development project which had been abandoned at the rather beginning of the trial and four years (!) prior to the publication of the study results. It is most funny that Vanderveken, Marklund, Braem et al. had used a non-validated development appliance instead of the commercial 1-part SomnoGuard characterised by a number of very positive clinical trials which had even partially been performed by themselves (somnoguard_clinical_trials.php).
- The co-author Marklund, an orthodontist from Umea university in
Sweden, invented and is marketing her custom-made appliance described
in this publication. There is no declaration of this vested interest in
the study. Nevertheless she had been involved in the study both as an
investigator and author, whereas Tomed were not asked to be involved in
the study to such an extent. Tomed funded part of the study but
withheld payment when it learnt of Marklund's involvement.
- The authors stated that there were no previous studies comparing
the efficacy of custom-made and prefabricated devices. This statement
is clearly untrue. In 2006 Tomed made available to Vanderveken, Braem
and Van de Heyning a publication from the authors Wigand et al.
describing the strongly correlating clinical trial outcome of a
custom-made and a prefabricated device. These devices are manufactured
by the German orthodontist Prof. Rolf Hinz. (reference: Wigand T,
Verlaan S, Niemann A, Konermann M, Prädiktoren der Wirksamkeit
endgültiger Schnarchtherapiegeräte, SomnoJournal 2005, 1: 10
- 12). A copy of this publication is available from Tomed.
There are many clinical trials referring to the efficacy of prefabricated commercial oral appliances for the treatment of snoring and sleep apnea in adult patients. Some very positive clinical trial outcome data just regarding the commercial FDA approved series of oral appliances are referred to under somnoguard_clinical_trials.php and somnoguard ap clinical_trials.php.
- Apart from a previous positive publication in 2004 on a pilot study enrolling 20 patients (click)
Vanderveken and colleagues failed to disclose in their recent
publication their own very positive clinical trial outcome data on a
total of 36 patients using the commercial one-part SomnoGuard which
Vanderveken presented to the "7th World Congress on Sleep Apnea" in
Helsinki on 2 July 2003 (click).
- Because of the tremendous price differences between prefabricated
and custom-made oral appliances financial interest appears to be the
only credible reason why Vanderveken, Braem and Marklund used for their
cross-over study a non-validated development product from Tomed instead
of the commercial one-part SomnoGuard with its track record of proven
efficacy.
It is apparent that a few orthodontists and sleep dentists want to ban inexpensive prefabricated oral appliances from the market just to maintain their extremely high profit margins for the fabrication of the custom-made oral appliances. For the aforementioned reasons the 2008 publication from Vanderveken, Braem, Marklund et al. is considered scientifically irrelevant and worthless.
3.2 Litigation in German courts against board members of the German Society of Dental Sleep Medicine (DGZS)
There has been litigation in the German courts against the German Society of Dental Sleep Medicine (DGZS - Deutsche Gesellschaft Zahnärztliche Schlafmedizin) represented by the leading figures Dr. Susanne Schwarting (president, orthodontist) and Dr. Ulrich Huebers (vice-president, orthodontist). The DGZS has a similar background of untrue statements for the sole purpose of removing inexpensive prefabricated oral appliances from the market and thus strenghten the market position of the very expensive custom-made oral devices such as TAP, SomnoDent, Silencer Professional and the German IST devices. The leading major brands of custom made devices are priced in Germany at about € 800 to € 1800.
As an example, in March 2006 Huebers lectured in a sleep medicine educational course in front of an audience of more than 100 otolayrngologists that
- the 1part prefabricated oral
appliance SomnoGuard would be banned from distribution in the U.S.
(Note: we had just received the U.S. FDA marketing approval in
Sept. 2006 and had not had any activities in the U.S. before) and
- the appliance could cause occlusal bite changes supporting this
statement with a faked photograph. The case as well as the essential parts of the court's
verdict can be downloaded in German language (case click 1, verdict click 2, faked photograph click 3). Huebers had to accept a declaration of discontinuance with a penalty clause as it is unclosed in the verdict.
The court has no doubt at all that the DGZS tries to push back the commercial SomnoGuard for apparent economic reasons to support the economical interests of their members. To achieve this goal, the accused DGZS is using alarming and questionable methods. They pretend to be objective and neutral, but disregard and ignore voluntarily that there is available at the market a much lower priced product, which meets the medical requirements for the majority of patients. It is proven clearly by the submitted clinical trials, that these requirements are met. Primary focus should finally be the patients'medical needs. ...