Applied pharmacoeconomics. When can publication be legitimately withheld?

Pharmacoeconomic studies can help decision-makers choose the most efficient drug treatments in our internationally cost-constrained healthcare environment. However, perceptions of bias about the nature of many economic evaluations limit the usefulness of pharmacoeconomic data to decision-makers. In an effort to increase the credibility of pharmacoeconomic studies, several groups have developed methodological guidelines, and one has developed ethical guidelines for these evaluations. In this article, we evaluate issues related to the publication of the results of pharmacoeconomic studies. Pharmacoeconomics is a true science (and should be so treated), rather than a form of marketing. Pharmacoeconomic studies must undergo the same peer review process and be published in serious research journals, as are other types of scientific investigations. Investigators should attempt to publish the results of pharmacoeconomic studies, even (and, perhaps, especially) when the results are not favourable to the sponsor. However, there are acceptable reasons to withhold publication of 'negative' results. For example, when methodological problems plague a study, or when the study addresses an investigational drug not likely to be approved, then researchers are justified in giving up on publication, if they so choose. Similarly, feasibility studies to test methods of data collection or analyses conducted very early in the drug development process need not always be published. Nonetheless, access to all important investigations--regardless of whether the results are positive or negative--will become more important as healthcare becomes more evidence-based, as decisions have impact on large populations of people, and as those in charge of formularies actually begin to use cost-effectiveness analysis to help make choices among competing drugs.