The lowdown: The decision to add a warning and not to remove the drugs from the market will provide some relief for drug companies. These drugs have been under increased scrutiny since a Congressional hearing on Vioxx (rofecoxib; Merck) last year when FDA's David Graham expressed concerns about the safety of Serevent. Advair and Serevent already contain boxed warnings about the risk of asthma exacerbations, after preliminary results from the SMART study showed a small, but significant, risk of asthma-related deaths or life-threatening episodes in patients taking Serevent. Despite no conclusive evidence of risk associated with Foradil, lumping the drug together with Advair and Serevent suggests the effect could be shared by all treatments containing a long-acting β2-agonist. It is still not clear how drugs designed to relieve asthma symptoms can, in some instances, make them worse. Also unexplained is whether there is a possible race effect, as the SMART study found that African-Americans had a higher risk of exacerbations. Efforts to uncover the underlying mechanisms by collecting DNA in all drug trials, for example, should be something that companies and regulatory bodies actively pursue.
The lowdown: Gilead, which developed the drug, has accused Roche, which has exclusive marketing rights to the drug, of not fulfilling its side of the bargain. Roche allegedly has not done enough to manufacture Tamiflu (thereby creating supply shortages), has not began promotion of the drug in 43 of the 64 countries in which it is approved, and owes more than US$18 million in underpaid royalties from sales. Roche says it is surprised by the claims, but if a settlement isn't reached within 90 days, the dispute will go to arbitration, which could take a further 18 months to resolve. Fears that the dispute could affect the supply and stockpiling of Tamiflu to defend against a potential pandemic outbreak of avian flu have been rejected by Gilead and public-health experts.
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