Lessons for asthma drug makers in the COX-2 fiasco

A new NIH study, published in today’s New England Journal of Medicine suggests that patients with mild asthma don’t need to take inhaled steroids daily. They can do just as well by taking their medications only when they have flare-ups, and avoid possible complications from chronic use.

The Wall Street Journal (Rethinking Asthma Treatment) cites study co-leader Dr. Homer Boushey’s estimate that shifting from daily to intermittent use could reduce drug costs by $2 billion. But later in the article, a spokesman for inhaled steroid maker AstraZeneca says he doesn’t “anticipate any impact on our business or change in our strategy as a result of this study.”

There is a parallel to the COX-2 situation here. Vioxx, Celebrex, and Bextra –all of which are very useful drugs for some people– were over-promoted. Some patients who didn’t need the drugs ended up taking them and suffering disease or death as a result. Risks and benefits weren’t properly balanced by industry, and the FDA eventually stepped in with a heavy hand. (See my previous post on the Bextra withdrawal.) A similar situation may be brewing here. It’s likely that risks of daily use outweigh benefits for mild asthmatics. If so AstraZeneca and the other major steroid maker, GlaxoSmithKline should tread carefully in continuing to promote daily use for such patients.

The study also shows the usefulness of NIH funded research. It would be unlikely for a drug company to sponsor a study to challenge a daily dosing guideline with intermittent dosing.

April 14, 2005

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