Is Advair, the Ultra-Popular Asthma Drug, Really Safe? - Daily Beast

by Jeff Gerth, ProPublica

Advair is one of the biggest blockbusters in pharmaceutical history.

The asthma drug has generated more than $80 billion in global revenues for its maker, GlaxoSmithKline, since its U.S. approval in 2000. With its distinctive purple inhaler, Advair has helped legions of asthma sufferers achieve control of their symptoms.

But recent federal research suggests that a significant percentage of asthma patients begin using Advair inappropriately, taking on what the drug’s label describes as an increased “risk of asthma-related death” from one of its two ingredients.

Concerns about that ingredient—salmeterol—emerged in a 1993 study, and more troubling results became known in early 2003. But it took the Food and Drug Administration seven more years to require Glaxo and makers of drugs similar to Advair to launch studies big enough to assess the risks.

Results aren’t due until 2017. Meantime, millions of patients on the drugs—a class long dominated by Advair—remain exposed.

Portions of Advair’s story have been told before , but a ProPublica examination, based on previously undisclosed or overlooked documents, shows that the traditional guardians of U.S. drug safety—manufacturers, regulators, doctors and the courts—have repeatedly failed to stop misuse of Advair or unlock its secrets.

Before Advair’s approval, a Glaxo scientist told the FDA that it wasn’t appropriate for patients with mild asthma. The agency agreed, a Glaxo document states, but it took five years to make that clear on the drug’s label.

When a handful of state Medicaid agencies moved to limit access to Advair, based on concerns about misuse, Glaxo lobbied aggressively to stop what was viewed internally as an “infestation” of such policies.

And Glaxo has faced scores of lawsuits and claims brought by people whose relatives have died while taking Advair, quietly settling some when pushed to the brink of...


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