The debate about the safety of cyclo-oxygenase 2 (COX-2) selective inhibitor drugs reignited in February when a Spanish court rejected a lawsuit brought by the pharmaceutical company Merck, Sharpe & Dohme (MSD) against the editor and publisher of Spain's independent drug bulletin, ButlletÍ Groc.
The company sued over a July 2002 article entitled “The so-called advantages of celecoxib and rofecoxib: scientific fraud.” The article drew on previously published commentaries in BMJ (2002;324:1287-8) and The Lancet (2002;360:100-1), which slammed the organization and interpretation of 2 pivotal studies on the safety of rofecoxib (Vioxx) and celecoxib (Celebrex) in comparison with nonselective nonsteroidal anti-inflammatory drugs (NSAIDs).
Articles describing those studies — the Celecoxib Long-term Arthritis Safety Study (CLASS) (JAMA 2000;284: 1247-55) and the Vioxx Gastrointestinal Outcomes Research (VIGOR) trial (N Engl J Med 2000;343:1520-8) — were partly responsible for these drugs achieving phenomenal sales growth.
The manufacturer of rofecoxib used Spain's laws on “rectification” to ask the bulletin to print a retraction it had drafted. When the bulletin's publisher, the Catalan Institute of Pharmacology, refused, the company took legal action. In February, the Madrid court rejected this demand and ordered MSD to pay court costs.
Editor Joan-Ramon Laporte called MSD's retraction “mere propaganda” and said he is still concerned that both drugs are frequently prescribed inappropriately. He says that a meta-analysis of the CLASS and VIGOR trials, published in CMAJ (2002;167[10]: 1131-7), shows an increased incidence of serious adverse events with these drugs compared with NSAIDs.
Peter Juni, author of the original BMJ editorial, supports Laporte's editorial stance.
The bulletin's case drew messages of support from more than 700 physicians in 36 countries, as well as from the World Health Organization and the International Society of Drug Bulletins.
A spokeswoman from MSD refused to comment on whether it will pursue legal action. In a letter to BMJ the company stated that ButlletÍ Groc's criticisms of the VIGOR study were based almost entirely on The Lancet commentary published in 2002 (360:100-1), which it says carried several inaccuracies. The company also says those inaccuracies were identified in a letter sent to The Lancet's editor, but this was not published. — Colin Meek, Wester Ross, Scotland