I analysed the results of a randomised controlled trial that had just been completed by some of my colleagues. The trial compared an oxygen radical scavenger with a placebo in patients with acute myocardial infarction. One of the major outcome measures included infarct size,as measured by nuclear imaging. My analysis showed that there was no significant difference between groups for either of these parameters, but statisticians from the pharmaceutical company involved concluded that the treatment provided significant clinical benefit. The main difference was that they had performed within-group analyses,which showed a significant reduction in infarct size in the treatment group. The study had already been presented at conventions using this analysis. I maintained that the within-group analysis was not only inappropriate,but misleading,and even unethical. I suggested that because of the small sample size (around 60 patients), they should be happy that the results leant towards a benefit for treatment, and what they really needed was a larger trial. Unfortunately, the study contract forbade publication without the drug manufacturer’s permission. I contented myself with the thought that I had prevented the publication of wrongful claims, and we continued to lecture that there was insuf?cient evidence for the use of this drug in coronary artery disease. To date, the drug continues to be a best seller. The story then hit the headlines, when it was published in a journal. The concession to its publication had been the inclusion of some statements pointing out that the conclusion was based on within-group analysis. I was appalled. How could they purposely publish a misleading claim, and ignore all references to alternative analyses? The problem is compounded by the following: The principal instigator is a senior cardiologist,professor emeritus in our college,and a leading figure in heart associations. He sits on many committees that approve funding for projects (some of which are mine). He has lectured far and wide that the drug is actually effective. The editor is a good friend of his. What should I do?
This is not within COPE’s remit as the case was not submitted by an editor. Suggest that the complainant submit a letter to the editor of the journal concerned. A systematic review of published studies would expose the flaws.