Drug Promotion - What We Know, What We Have Yet to Learn - Reviews of Materials in the WHO/HAI Database on Drug Promotion - EDM Research Series No. 032
(2004; 102 pages) View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentExecutive summary
Open this folder and view contentsIntroduction
Open this folder and view contentsReview 1. What attitudes do professional and lay people have to promotion?
Open this folder and view contentsReview 2. What impact does pharmaceutical promotion have on attitudes and knowledge?
Open this folder and view contentsReview 3. What impact does pharmaceutical promotion have on behaviour?
Close this folderReview 4. What interventions have been tried to counter promotional activities, and with what results?
View the document4.1 Guidelines, codes and regulations for printed and broadcast material
View the document4.2. The ‘Fair Balance’ requirement
View the document4.3 Guidelines for sales representatives
View the document4.4 Guidelines for post-marketing surveillance
View the document4.5 Guidelines on conflict of interest in research
View the document4.6 Guidelines for package inserts and compendia
View the document4.7 Guidelines about gifts
View the document4.8 Guidelines for trainee doctors and for hospitals
View the document4.9 Knowledge of these guidelines and their effect on attitudes
View the document4.10 Education about promotion
View the document4.11 Monitoring/countering promotion
View the document4.12 Research as an intervention
View the documentSummary of conclusions
View the documentDirections for future research
View the documentFinal conclusions
View the documentReferences
 

4.5 Guidelines on conflict of interest in research

The previous review described a number of studies that showed that published studies that are funded by manufacturers are likely to support the manufacturers’ drugs. Published work does not always disclose relationships between manufacturers and researchers. Two studies have looked at research institutions’ policies about conflict of interest.

Lo et al.222 looked at 10 medical schools that received the largest amounts of National Institutes of Health funding in the US. They found wide variation and significant limitations in policies about conflict of interest in clinical trials. Five universities required disclosure of all possibly conflicting financial interests, independent of value. Universities varied in whether their policies covered non-faculty research staff. The authors recommend that university-based investigators and research staff be prohibited from holding stock, stock options, or decision-making positions in a company that may reasonably appear to be affected by the results of their clinical research.

McCrary et al.223 surveyed medical schools and other research institutions that received over US$5 million annually from the National Institutes of Health or the National Science Foundation, 48 journals and 17 federal agencies. They found five medical schools and 10 other research institutions had no policy on conflicts of interest. There was marked variation amongst the rest. Less than half of the journals (43%) had policies requiring disclosure of conflict of interest. The management of conflicts and penalties for non-disclosure were almost always totally discretionary. Only three institutions required financial interests to be disclosed to research subjects.

Many authors have called for researchers to explain clearly sponsoring company involvement in clinical trials149. There have also been calls for a prospective register of all trials to be set up, before the results are known. This would reduce the problems of bias in published findings. Stern and Simes point out that this should not be difficult in countries where ethical approval is required for trials, because the register could be added on to this process158.

CONCLUSION: many organizations, including many medical schools, research institutions and medical journals lack adequate policies for dealing with conflicts of interest. There is a strong case for all trials to be listed on a public register at the time they are set up.

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