Evidence-Based Promotion

To the Editor: I am writing regarding the article by Mark S. Bauer, M.D., and Landis Mitchner, M.D., regarding mood stabilizers (1). This is an excellent article, mentioning some of the difficulties in an “evidence-based” review, e.g., there may be more studies available involving older drugs (because they are older), and publication bias against negative results. I think, however, that two other issues should be mentioned. One is the fact that a majority of studies are now funded by pharmaceutical companies, resulting in a preponderance of “evidence” concerning patented medications that the companies are actively marketing, while little “evidence” regarding efficacy is being pursued regarding drugs that are off patent. For example, carbamazepine was previously actively studied for bipolar disorder, but this stopped, for the most part, when its patent expired and the drug company was no longer motivated to conduct studies. Thus, “evidence-based medicine” as good as it might initially sound, is strongly biased toward drugs for which pharmaceutical companies are actively pursuing evidence of efficacy and against generic drugs. One potential solution, especially since the government is increasingly involved in paying for medications, is that the government, perhaps through the National Institute for Mental Health, could fund studies of drugs that are off patent to determine if they might be as good as the newer (much more expensive) drugs. Theoretically, insurance companies might also be motivated to assist in funding such research.

One approach to minimize publication bias is to require any article based on a study funded by a drug company to include a discussion of all relevant studies funded by the company, both positive and negative, whether previously published or not (some journals are now pursuing this approach). The company could not restrict publication to positive studies. Companies would probably be opposed since they would have to open their files to present data from negative studies, but this would not be an unreasonable position for journals to take to ensure a balanced presentation. Pharmaceutical companies already have, perhaps, excessive influence over educational events and publications. I think it’s important that physicians ensure that “evidence-based” reviews should not become simply another way for pharmaceutical companies to promote their newer, more profitable products. Of note, attempts to reduce the influence of marketing and promotion may be ultimately beneficial for pharmaceutical companies as well as patients, since it will motivate the companies to produce better medications rather than relying on marketing to promote new drugs that may not be substantially better than older drugs.