Confirming the Hypothesis at any Cost?
The question of conflicts of interest in the context of guidelines is an important one. Accusations of influenceability and the effects this has on a guideline should, however, be brought only with the utmost degree of caution. Unfortunately, the article by Schott et al. on the topic of competing interests (1) is subject to serious flaws.
The charge that efalizumab was judged more favorably in the S3 guideline than etanercept is easily countered by looking at the different strengths of recommendation for efalizumab (↑) and etanercept (↑↑), which Schott et al. do not mention anywhere in their article. If any influence had existed then the medication would certainly not have received the weakest strength of recommendation of all the biologicals.
The UK’s Health Technology Assessment (HTA) based guidance from the National Institute for Health and Clinical Excellence (NICE) was compared with a German S3 guideline. Differences in methodology were ignored. NICE guidelines correspond to legal directives and are far more strict than German guidelines, which intentionally often leave extra scope for making decisions. To base accusations of influenceability on a unilateral comparison of publications that are not comparable does not constitute good scientific practice.
Positive mentions of efalizumab in other HTAs/guidelines (German Institute of Medical Documentation and Information, Deutsches Institut für Medizinische Dokumentation und Information [DIMDI]): “rapid onset of effectiveness”, in the British Association of Dermatologists’ guideline (“For patients with latent tuberculosis demyelinating disease, efalizumab should be considered the treatment of choice”) are not mentioned in the discussion (2, 3). Negative statements regarding efalizumab in the German guideline (for example, the risk of rebound) that have no corresponding elements in the NICE guidance are not listed at all.
The statement in the discussion, that the authors of the NICE guideline had “no conflicts of interest,” is incorrect (J Baker/C E M Griffiths: numerous conflicts of interest) (4). The conflicts of interest of the British experts should have also been systematically checked out, not only those of the German experts.
Why did the authors not contact the guideline group in advance to ask for a position statement? It would have been easy to explain the reasons for the putative differences to the NICE guideline. Science grows through discourse. This should, however, be based on careful research.
We are ready and would be happy to convince Schott et al. in a personal discussion that their hypotheses do not hold.
On behalf of the German psoriasis guideline group 2006:
PD Dr. med. Alexander Nast
AWMF-Leitlinienberater, Leiter der Division of Evidence Based Medicine, Klinik für Dermatologie, Venerologie und Allergologie, Charité – Universitätsmedizin Berlin
Prof. Dr. med. Berthold Rzany SC.M.
AWMF-Leitlinienberater, RZANY & HUND, Privatpraxis für Dermatologie und Ästhetische Medizin, Berlin
Conflict of interest statement
PD Dr Nast is the first author of the psoriasis guideline. At the time when the guideline was published he had no conflicts of interest to declare.
Since the guideline was published he has received contract honoraria from Pfizer, the current manufacturers of etanercept, and study support from Wyeth (now Pfizer).
Furthermore he is a member of the working group on conflicts of interest of the AWMF (the Association of Scientific Medical Societies in Germany [Arbeitsgemeinschaft der wissenschaftlichen medizinischen Fachgesellschaften]) .
Professor Rzany is a coauthor of the psoriasis guideline. At the time the guideline was published in 2006 he acted as a consultant to Serono and Wyeth (now Pfizer).
He declares that currently no conflict of interest exists.
|1.||Schott G, Dünnweber C, Mühlbauer B, Niebling W, Pachl H, Ludwig WD: Does the pharmaceutical industry influence guidelines? Two examples from Germany. Dtsch Arztebl Int 2013; 110(35–36): 575–83. VOLLTEXT|
|2.||Claes C, Kulp W, Greiner W, Graf von der Schulenburg JM, Werfel T: Therapie der mittelschweren und schweren Psoriasis. HTA-Bericht 34. http://portal.dimdi.de/de/hta/hta_berichte/hta129_bericht_de.pdf (last accessed on 27 September 2013).|
|3.||Smith CH, Anstey AV, Barker JN, et al.: British Association of Dermatologists guidelines for use of biological interventions in psoriasis 2005. Br J Dermatol 2005; 153: 486–97. CrossRef MEDLINE|
|4.||National Institute for Health and Care Excellence: Appraisals Committee Meeting: Minutes. http://guidance.nice.org.uk/TA103 (last accessed on 27 September 2013).|