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NEWS: Jeanne Lenzer Nigeria files criminal charges against Pfizer BMJ 2007; 334: 1181 [Full text]

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Time for independent quality check before doctors participate in recruiting patients for pharmaceutical industry projects

Knut A Holtedahl, Eivind Meland   (27 June 2007)

Time for independent quality check before doctors participate in recruiting patients for pharmaceutical industry projects 27 June 2007
Knut A Holtedahl, Professor Institute of Community Medicine, University of Tromsø, 9037 Tromsø, Norway, Eivind Meland Send response to journal: Re: Time for independent quality check before doctors participate in recruiting patients for pharmaceutical industry projects	Dear Editor In your edition of 9 June it is told that Nigeria files criminal charges against Pfizer. The company is accused of favouring its own drug in a randomised controlled study by using a low dose of the control group drug. We know this only from your BMJ article and do not wish to give any opinion on this concrete case. However, in Norway, through our work in a “General Practice Research Committee” under the Norwegian Medical Association, we have been involved in a voluntary arrangement with pharmaceutical companies where we evaluate research projects initiated by the industry and recruiting general practitioners to find patients. Our committee makes recommendations to Norwegian GPs about whether a project is a real research project rather than marketing camouflaged as research. Patients and doctors should not participate in research where the prime objective is to improve marketing. However, after we criticised some projects in 2001, this arrangement has been largely boycotted by the industry. One objection in one particular project was that the protocol favoured the company’s own drug. We also maintained that exaggerated demands for statistical power led to a grossly overestimated number of people participating. Research ethics should safeguard that type 2 error is prevented, but statistical power beyond reasonable limits (95% or greater power), leads to research where almost any difference becomes statistically significant. According to our view, this also represents a violation of ethical demands in research. Apparently, it is not evident that research committees have expertise that takes such considerations into account. In a correspondence in 2001 with the National Research Ethics Committee in Norway (NEM), we recommended that ethics committees routinely should ask and require a positive answer to these two questions: 1. Is the project design a priori neutral and without favouring one or the other of intervention and control drugs? 2. Are power calculations reasonable and realistic, so that neither too few nor unnecessarily many patients are recruited? Research projects initiated by the pharmaceutical companies, being very common in all countries and recruiting patients through doctors either in hospitals or in general practice, should be critically examined in order to safeguard scientific relevance and quality. “The General Practice Research Committee” under the Norwegian Medical Association has a check list for quality assurance of multi centre drug research in general practice. All questions require a positive answer. The most important demands for approval are: 1. Is the objective of the study important and relevant for general practice? 2. Are financial support and coverage clarified and openly communicated? 3. Are methods and criteria for inclusion and exclusion specified? 4. Is the size of the study groups sufficient and not exaggerated? 5. Does the protocol safeguard that all participants and their outcomes will be registered and accounted for? 6. Has the research committee behind the study full access to data and the entitlement to publish the results? 7. Is external validity safeguarded and are possible causal interpretations plausible? 8. Are the recommendations in the Helsinki Declaration satisfied? Knut A Holtedahl Professor, University of Tromsø, Norway Eivind Meland Professor, University of Bergen, Norway Competing interests: None declared