(Mis)communicating Cox-2 Clinical Trial Risks; Did Pharma Drop The Ball At FDA Cox-2 Hearings?

By Mark Hochhauser and Norman M. Goldfarb. The FDA has approved Cox-2 NSAID drugs to treat short-term acute pain and for long-term treatment of rheumatoid arthritis and osteoarthritis. These benefits, however, appear to come at the price of higher risks for heart attacks (cardiovascular events) and strokes (cerebrovascular events). What the public discussion has not, however, made clear are the risk/benefit trade-offs. At a recent FDA meeting to consider these risks, negative risk framing and related presentation problems influenced perceptions of Cox-2 NSAID drug risks. As a result, Cox-2 risks and benefits are probably not clearly understood by federal regulators, the media, physicians or their patients. The risks appear to be serious, but these drugs may be worth taking by patients unable to achieve relief with other drugs. Depriving patients of an accurate understanding of the risks is like depriving them of the drugs themselves, or, in other circumstances, forcing the drugs upon them. The pharmaceutical industry is often accused of promoting an overly-positive perspective on the benefits of its products. For some reason, even the industry speakers at this meeting presented the risks of their Cox-2 products in a negative light.