A STUDY OF MANUFACTURER-SUPPORTED TRIALS OF NONSTEROIDAL ANTIINFLAMMATORY DRUGS IN THE TREATMENT OF ARTHRITIS

Background: To study the relation between reported drug performance in published trials and support of the trials by the manufacturer of the drug under evaluation, we studied a sample of trials of nonsteroidal anti-inflammatory drugs (NSAIDs) used in the treatment of arthritis. M ethods: All randomized control vials of NSAIDs published between Septe mber 1987 and May 1990 identified by MEDLINE were reviewed. If an arti cle met the following criteria (n=61), it was selected: trials involvi ng adult patients with osteoarthritis or rheumatoid arthritis (n=180), use of nonsalicylate NSAIDs marketed in the United States (n=101), ra ndomized control trial (n=81), duration of the trial 4 or more days (n =78), and use of an efficacy outcome measure (n=61). Reviewers, ''blin ded'' to manufacturer status, evaluated the narrative interpretation o f results and extracted numeric data on efficacy and toxicity. Manufac turer-associated trials were defined as those that acknowledged an ass ociation with a pharmaceutical manufacturer. Because of the scarcity o f non-manufacturer-associated trials (n=9), we report only on the manu facturer-associated articles. Results: Fifty-two publications (85.2%) representing 56 trials were associated with a manufacturer. The manufa cturer-associated drug was reported as comparable with (71.4%) or supe rior to (28.6%) the comparison drug in all 56 trials. These narrative claims of superiority were usually justified with trial data. Of the t rials identifying one drug as less toxic (n=22), the manufacturer-asso ciated drug's safety was reported as superior to the comparison drug i n 86.4% of cases. Justification for the narrative interpretation of th e trial findings regarding less toxicity was provided in only 12 (54.5 %) of 22 trials. Conclusion: The manufacturer-associated NSAID is almo st always reported as being equal or superior in efficacy and toxicity to the comparison drug. These claims of superiority, especially in re gard to side effect profiles, are often not supported by trial data. T hese data raise concerns about selective publication or biased interpr etation of results in manufacturer-associated trials.