Over a dozen medical journal editors have warned that the might refuse to publish drug studies which do not adhere to their disclosure demands. Leading the list is Dr. Jeffrey Drazen, editor of the prestigious New England Journal of Medicine and one-time paid consultant for a pharmaceutical manufacturer. The editors suspect that drug companies may be exerting more influence over so-called independent academic investigators they hire to conduct drug trials than previously believed. For example, of 107 medical school research centers surveyed half would permit drug company sponsors to draft the manuscripts of medical journal articles reporting trial results while limiting revisions by the investigators themselves. About a quarter of the research centers surveyed would even allow the sponsoring company to supply the trial results. Dr. Drazen is has also been critical of the practice by companies of suppressing negative information concerning drug trials.
Until recently, medical journals were wary of directly criticizing drug companies for a number of reasons. The journals rely on the companies for substantial advertising revenue as well as subscriptions. In addition, the journals are always interested in being the first to publish new findings which may come out of the trials. Now, however, “converts” like Dr. Drazen see their sole mission as being to “help physicians do their jobs better and help patients get better information.”
Although an industry spokesperson claimed that the criticisms were “unfair,” drug (and medical device) manufacturers have only hurt themselves recently with revelations concerning their suppression and intentional withholding of negative, unflattering, or damaging information about their products. (Consider the revelations with respect to Vioxx, Bextra, the safety of COX-2 inhibitors in general, the Guidant internal defibrillator, as well as highly publicized examples of misleading direct-to-consumer advertising.) There is also the fact that certain drug manufacturers have not provided the NIH database with information necessary to conduct meaningful data searches. The journal editors have warned that they will not continue to publish articles on studies and trials which are not registered with this publicly-available database (www.clinicaltrials.gov) before the first patient was enrolled.