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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
Competing interests:
No competing interests
27 June 2007
Knut A Holtedahl
Professor
Eivind Meland
Institute of Community Medicine, University of Tromsø, 9037 Tromsø, Norway
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
Competing interests: No competing interests