Cox-2 Concerns Affecting Medical Research, Experts Say

Mounting concerns over the safety of Cox-2 inhibitors is having a negative impact on medical research, including large studies on the prevention and treatment of cancer, rheumatoid arthritis and osteoarthritis, dementia, and other diseases, industry experts warn.

Scientific and medical researchers believe Cox-2 inhibitors, part of a class of nonsteroidal anti-inflammatory drugs (NSAIDs), could help in battling certain diseases. However, some clinical studies involving the drug class have been disrupted or shut down as a result of mounting public concern that Cox-2s could cause heart attacks or have other cardiovascular risks.

The FDA issued a public health advisory Dec. 23, 2004, stating that Cox-2 selective agents, including Vioxx (rofecoxib), Celebrex (celecoxib) and Bextra (valdecoxib), may be associated with an increased risk of serious cardiovascular events.

Although the study results that prompted the advisory are "preliminary and conflict with other study data," the FDA nonetheless said physicians should reconsider prescribing Celebrex and Bextra, both Pfizer drugs, to their patients. Vioxx was recalled from the market by Merck last September.

Prior research indicated, however, that Cox-2 inhibitors may be effective in fighting certain diseases. This dichotomy of negative and positive results has put many medical experts in a difficult position — they understand the public fear engulfing the anti-inflammatory class of drugs; however, they worry that beneficial research could be lost in an effort to quell the public's fear and save the federal government's reputation, which has been tarnished by accusations that it has formed too close a relationship with the drug industry.

Source :
http://www.fdanews.com/dailies/drugdaily/2_18/news/34962-1.html