The wider role of regulatory scientists

In 1990, a research scientist at the US Food and Drug Administration wrote in a letter to the New England Journal of Medicine (NEJM), “I review many clinical-trial protocols. The results of some of these trials subsequently appear in the medical literature. On occasion, the published description of the study may differ from the prospective protocol in important aspects of study design or statistical analysis—eg, study size, clinical end-points, and statistical tests used. The potential for misuse … is tremendous.”1

These comments were eerily prophetic: subsequent years brought the scandals of rofecoxib,23 celecoxib,4 paroxetine,56 and oseltamivir.7 The comments also suggest that each of these scandals could have largely been averted if journals had taken better account of what regulators—particularly the FDA—had to say about the relevant trials. We agree. Long before NEJM issued an expression of concern about data on harms missing from its report of the VIGOR trial of rofecoxib, those same data were available on the FDA’s website.2JAMA reported CLASS as a six month trial …