FDA Advisers Urge Curbs On Some Asthma Drugs

MICHELE NORRIS, host:

There is news today for people who take asthma drugs. An advisory committee to the Food and Drug Administration gave mixed reviews to a popular class of those drugs. The committee says that two of the four drugs should not be used to treat asthma. Two others, the committee says, are OK to use. NPR's Joanne Silberner is here to explain this, and, Joanne, let's start with the drugs themselves. Which drugs are we talking about?

JOANNE SILBERNER: There are four drugs. They are known as long-acting-beta-agonists, and they are called Serevent, Foradil, Symbicort, and Advair. They're meant only for serious cases when other drugs just aren't enough, but they are very widely used. Advair is the most popular one, and that's used by four million people.

NORRIS: So, why do the committee say that two of the drugs are OK and that two aren't?

SILBERNER: Well, they work in different ways. The first two drugs, Serevent and Foradil, they act - they just do one thing. They relax the muscles around the airways and the lungs, and that's one of things that happens during asthma - those muscles seize up. The other two drugs, Advair and Symbicort, they have a second drug in them that does a second thing. It reduces inflammation, which is also bad in an asthma attack.

Now, a number of studies show that when you use the two drugs at once, it's much better, so if you are using one of the single drugs, then the suggestion is you had a second drug that does that second thing of reducing inflammation. And a lot of people on the committee thought, you know, what let's - its better for people to take it on one than, you know, that they get that second drug.

NORRIS: A lot of questions have been raised in the course of this process. What are the real issues here?

SILBERNER: Whether they cause more asthma exacerbations and hospitalizations and deaths. There were some studies of the single-acting drugs that suggested that there could be more hospitalizations and deaths with them. And, of course, that is not something that you want in a drug that you are using to treat asthma.

Studies of the other two drugs are pretty clear that they are beneficial, and, you know, one of the issues was those first two drugs being used alone. The (unintelligible) anecdotes to people dying holding those drugs in their hands because they were thinking that they were fast-acting drugs. They were not, actually. They're long-acting drugs that need to be taken daily.

NORRIS: It sounds like it's really hard to figure out whether these drugs are helpful or harmful. Why is it so complicated?

SILBERNER: Because asthma is a really complicated disease. What you really need to do to do a clean study that's clear is to have a lot of people with the disease. And from person to person, asthma can vary. Within one person, it can get worse; it can get better.

And then what you do is, you take this clean group of people and give half of them one drug and see how it works. People with asthma are often on other drugs, or they may not be on other drugs when they should be on other drugs. It's hard to tell what they are taking. Sometimes they don't take daily medicine because they are feeling fine, so it gets very messy.

And the numbers are low. The numbers of problems are low, which makes statistics very difficult, and one study, for example, that did show deaths in the group was 13 deaths among 13,000 people. It's a pretty low number.

Another issue is, how we do drug studies in this country, that, for most part, they are done by the drug companies, and a lot of people would like to see them done by the government or someone else, so that the results are very clear and that the studies are done comparatively.

NORRIS: The two drugs that were approved today, is this going to mark the end of all the safety questions attached to these drugs?

SILBERNER: No, the committee's asking for more research. They were especially worried that a lot of research hadn't been done on kids. It used to be that research was always on adults. They have just started recently in the last few years looking at kids, and a lot of kids have asthma. So it's especially important to get those studies done.

NORRIS: That's NPR's Joanne Silberner. Joanne, thanks so much.

SILBERNER: Thank you. Transcript provided by NPR, Copyright NPR.