Safety claims of new arthritis drugs may be misleading

Popular arthritis drugs, known as selective COX 2 inhibitors, may not be superior to traditional non-steroidal anti-inflammatory drugs, conclude researchers in this week’s BMJ.

A study published in September 2000 concluded that the COX 2 inhibitor, celecoxib, was associated with a lower rate of stomach and intestinal ulcers than two older drugs for arthritis. However, only data for the first six months of the study were published. When all the data were considered, the published results appeared to be clearly flawed.

Two issues cause concern, say the researchers. The authors’ explanations for these serious irregularities were inadequate, and the flawed findings published in the original article appear to be widely distributed and believed by many physicians.

They believe that an “industry independent” analysis of all trials of selective COX 2 inhibitors must be performed to include both published and unpublished data. They also call for the wide dissemination of the misleading results of the trial has to be counterbalanced by the equally wide dissemination of the findings of the reanalysis according to the original protocol.

“If this is not done, the pharmaceutical industry will feel no need to put the record straight in this or any future instances,” they conclude.

The failure of this study may have more to do with the design of the trial than with inadequacies of COX 2 inhibitors, suggest researchers at Queen’s Medical Centre, Nottingham in a second editorial. “Although it is extremely important to highlight distortion of information, it is equally important to recognise that the more information there is the more issues can arise, and a lack of information can easily nurture as many illusions as partial publication.”