Is Advair the next Vioxx?

Now growing evidence suggests that a small percentage of patients–perhaps 4,000 people a year, by one doctor’s estimate–may be dying because of Advair or its Serevent component. This highlights a tough dilemma in drug safety: what to do about drugs that help many but harm a few. It could mark the start of the next great drug-liability war, and already the drama seems all too familiar: scared patients, contradictory studies, a company that calls the evidence “inconclusive” and is accused of skewing clinical data–and lawyers looking at whether there’s enough damage here to cash in. responds to this article:

The bias of the story is evident from the characterization of Glaxo having “deemed statistically insignificant” a difference in a study. A statistical result either is or isn’t statistically significant at a certain level. There is no subjective component of “deeming” to the mathematical calculation, unless the story is trying to improperly impugn sinister motives to one who performs basic science.

At a minimum, an editor at Forbes should have questioned the story’s asking readers to infer that a Glaxo denial of a problem is evidence of wrongdoing. How precisely is an accused company supposed to defend itself?

The story was especially disappointing coming from Forbes, which usually debunks self-serving claims of plaintiffs’ lawyers like Beasley Allen, rather than acts as a publicity agent for those claims.

The bottom-line recommendations from UptoDate:

If adherence is acceptable, prescribing other controller medications (eg, a leukotriene receptor antagonist or theophylline) instead or in addition to the long-acting beta agonist should be considered. Patients receiving long-acting beta agonists should be advised of the reported increased risk noted in a small number of patients, monitored closely, and advised to seek medical care if their symptoms persist or worsen.

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