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The influence of pharmaceutical companies on guidelines - two examples from Germany

Date and Location

Session: 

O1.04.4

Date

Friday 20 September 2013 - 10:30 - 12:00

Location

Presenting author and contact person

Presenting author

Gisela Schott

Contact person

Gisela Schott
Abstract text
Background: Recommendations in clinical guidelines are based on study results and the opinion of experts. Objectives: The influence of pharmaceutical companies on these two factors will be examined using two examples from Germany. Methods: Court records have shown that the marketing authorization holder of gabapentin manipulated the publicly available data. Therefore, gabapentin was chosen as an example to examine if German guideline recommendations are based on manipulated data. The guidelines published by the German Association of Scientific Medical Societies (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF) were searched for demonstrably false publications about gabapentin. The potential impact of financial connections between guideline authors and pharmaceutical companies was investigated by comparing the recommendations of the German S3 guideline for the treatment of psoriasis using efalizumab with guideline recommendations created by authors without conflicts of interest. This example was chosen because one of the authors noticed a difference in the prescribing practice of dermatologists, with prescribers of efalizumab referring to the S3 guideline. Results: Recommendations for the prescription of gabapentin in guidelines published by the AWMF were based on data manipulated by the marketing authorization holder. Compared to the NICE-Guideline, efalizumab and its application were favorably assessed in the S3 guideline, i.e. the quality of the evidence was considered to be good, the use of efalizumab for induction and combination therapy in psoriasis vulgaris was advocated and the improvements in health-related quality of life were highlighted. Conclusions: Public access to all trial data must be ensured. Responsibility for the development of guidelines should lie with authors and organizations that are free from conflicts of interest. This requires more public funding, as does the implementation of industry-independent drug research. The research will be published in detail: Schott G et al.: Dtsch Arztebl Int 2013; 110: in print.