Treatment of rheumatic diseases has certainly been revolutionized by the development of the biologic response modifying medications (BRMs), and additional developments are expected in the near future. Although the initial experience with the BRMs has been mainly positive, the rheumatology community has also had to endure controversy and retrenchment in regard to the development and use of COXIBs.

The recent experience with both the BRMs and COXIBs drugs has brought the issue of drug safety in rheumatic disease therapy to the forefront. In this issue of Arthritis Care & Research, we present summaries of drug approval and safety monitoring in the United States, Canada, and the European Union (1–3). Although the similarities are greater than the differences between these 3 jurisdictions, the differences that do exist are nevertheless noteworthy. In particular, Marra and colleagues (2) note that the longer time for drug approval in Canada (when compared with the United States and the United Kingdom) is accompanied by a lower rate of discontinuation (although one should intrepret this correlation with caution). San Miguel and colleagues (3) observe that in the European Union, there is increased emphasis on comparisons between new and existing agents, while in the United States, most comparisons are between a new agent and placebo.

We are certain that there are positives and negatives in each system. Our hope is that by taking the best from each system, we can maximize the benefits to patients with rheumatic diseases, but to do that, we must understand how each system works.


  1. Top of page
  2. References