To the Editor: Dr Als-Nielsen and colleagues1 found that trials funded by for-profit organizations favored the active drug more commonly than placebo. The authors concluded that this may have been due to biased interpretation of trial results. However, an association between funding and study conclusions is not surprising.
A major reason for this, which the authors alluded to briefly, is the "violation of the uncertainty principle," an unfortunate phrase, as it implies error or some nefarious or underhanded activity. There really is no reason to expect that "half of all [published] trials should favor the control intervention." While equipoise may be present in at least some trials sponsored by nonprofit organizations, it is unrealistic to think that there is anything like equipoise in studies sponsored by industry. It is not the business of pharmaceutical companies to do such studies; they are in the business of confirming efficacy. No pharmaceutical company would perform an expensive phase 3 study if it thought the probability of a positive outcome was only 50%. After a positive phase 2 program, one expects a considerably higher probability of success. So it is not surprising that such studies "have a higher likelihood of favoring the experimental drug." In addition, I believe that studies from for-profit organizations, conducted under the watchful eyes of regulatory agencies, are more likely to be better studies (ie, to have adequate double blinding), which would explain the association between double blinding and recommending the experimental drug.
Had the authors included the purpose of the study as a covariate in the analysis (eg, phase 3 study for drug approval), such a factor would be likely to be even more highly correlated with conclusions than sponsorship, although it might be difficult to find many such studies performed by nonprofit institutions.
Financial Disclosure: Dr Palmer is employed by Forest Laboratories Inc and was previously employed by GlaxoSmithKline.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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