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The Food and Drug Administration is tackling a tough case involving the safety of medication. It is looking into drugs used for severe asthma. Many doctors and professional groups say the drugs are lifesavers. The agency is considering whether the drugs may make asthma worse, or even prove fatal. NPR's Joanne Silberner reports.
JOANNE SILBERNER: The drugs are called long-acting beta agonists. They relax the airways in people with asthma. Several years ago, a study suggested that one of the drugs, Serevent, could worsen asthma, or even in rare cases cause death. That was enough to prompt the Food and Drug Administration to put a warning on Serevent and later the labels of other long-acting beta agonists. And it was enough to make lung specialist Gregory Diette of Johns Hopkins University start telling his patients about the study.
Dr. GREGORY DIETTE (Associate Professor, Johns Hopkins Bloomberg School of Public Health): I try to give them some idea of what the magnitude of the risk is. In that study, there were three people out of 13,000 who had an asthma-related death in the placebo group, and 13 out of 13,000 in the active treatment group. And so it was about an extra 10 people per 10,000.
SILBERNER: Most of his patients who were taking the drug at the time came off it. Now, with new patients, most opt to take it.
Dr. DIETTE: I think for some people, you know, the risk is too great. And for some people, it's not very much at all. And it's a very personal decision.
SILBERNER: There's already that warning on the drugs - not just Serevent, but also Advair, Foradil, and Symbicort. Most lung specialists say that warning is enough. A few outright critics of the drug say those doctors are just saying that because the drug companies pay them to speak or do research. Most asthma experts, in fact - including all the ones in this story - have taken money from pharmaceutical companies, which finance most of the research on these drugs.
The asthma doctors' professional organization and the American Academy of Pediatrics support the use of long-acting beta agonists. The National Institutes of Health issued guidelines last year saying that the drugs are worth the risk, so long as the drugs are used correctly — only in children and adults with serious asthma and only in conjunction with inhaled steroids. William Busse was one of the authors of the guidelines.
Dr. WILLIAM BUSSE (Chair, Department of Medicine, University of Wisconsin): You get greater improvement in lung function, you get less asthma attacks and less need for rescue medications.
SILBERNER: He's basing that on multiple studies that show an overall benefit. But four FDA staffers have done a new analysis combining many studies. They conclude the drugs are too risky for use in children under 18. On adult usage, they say two of the four drugs should not be used for asthma, though the group splits on the other two drugs in the class.
One thing everyone agrees on: The various studies of the drugs all have problems. Some studies are too small, and some researchers didn't collect information on how sick the patients were to begin with or what other drugs they were taking. And whenever you let scientists evaluate a lot of insufficient studies, you get a lot of different opinions. Busse, an author of the NIH guideline, says he thinks the analyses that say the drugs do more good than harm are right.
Dr. BUSSE: If these medications were really unsafe, epidemiologically we would have seen a change in asthma morbidity and asthma hospitalization. And we're not seeing this at the present time.
SILBERNER: But he's glad the FDA is airing the issue. So is Stephen Teach of Children's National Medical Center, who runs an asthma program for inner-city children. Teach doesn't want to see a complete ban on the long-acting drugs.
Dr. STEPHEN TEACH (Children's National Medical Center): My overarching concern here is that banning completely would force doctors and patients to rely on other drugs which may be less affective and potentially even less safe.
SILBERNER: The FDA will hear today from three advisory committees on whether the agency should beef up the warnings, ban the drugs for asthma, or just leave things alone. The FDA usually, but does not always, follow the advice of its committees. Joanne Silberner, NPR News, Washington.