December 23, 1999
The Health Unit is a partnership with
the Henry J. Kaiser Family Foundation.
RAY SUAREZ: Over the last two decades, the rate of asthma has more than doubled in the United States. An estimated 17 million Americans suffer from asthma today. That includes nearly 5 million children, making it the most common chronic childhood disease. Asthma is responsible for 5,500 deaths annually.
For years, steroids have been a standard treatment, but they also pose
side effects over time. Now a study in today's issue of the New England
Journal of Medicine finds that a new, experimental drug may provide
treatment with fewer side effects.
Dr. Milgrom, this is good news, I guess, but what keeps us something short of declaring victory and going home?
|Small patient group did well on new drug|
DR. HENRY MILGROM: Well, what keeps us short of declaring victory is that this is a preliminary kind of study which will need to be expanded upon. We have been very gratified by the results. The patients that we treated all did very well on the drug. They were able to reduce their corticosteroids over a fairly short period of time and continued to do well clinically in spite of the reduction of corticosteroids -- in fact, continued to improve clinically both in symptoms and in pulmonary function studies. The reason why we cannot declare a victory just yet is because this was a relatively small group of patients. And they were not studied for a very long period of time.
RAY SUAREZ: Wasn't there also a subsection of the population in general that it turns out that this is better treatment for -- something that doesn't cover everybody from pediatric to geriatric cases?
DR. HENRY MILGROM: Well, we selected patients who had documented allergies. I think that in pediatrics, you can safely say that virtually all the children with asthma are allergic and a majority or great majority of the adults with asthma are also allergic. So we did not really limit the population that much, but I think that perhaps what we need to do is to determine which groups of the population actually are most likely to benefit from this.
You know, asthma is probably not a single disease but rather a group of diseases which behave similarly in some ways but maybe respond to treatment differently. So without a doubt, there will be patients with asthma who are particularly well suited for this kind of therapy and there will be others for whom this therapy may be unnecessary or may be less effective even than existing therapies.
RAY SUAREZ: Dr. Kaliner, a lot of attention is being paid to the fact that this is a non-steroid treatment. What are the shortcomings of steroids as a longitudinal or a permanent answer for asthma sufferers?
DR. MICHAEL KALINER: We would first recommend inhaled steroids as the first-line therapy for nearly all asthmatics, everybody who wheezes more than occasionally should be on an inhaled steroid. And so let's not scare the 17 million people who have asthma. The inhaled steroid preparations we use today are by and large extremely safe and over the long haul within reasonable dose ranges are perfectly safe. And so there are potential problems from them because steroids have deleterious side effects at high dose that -- and we've only used them for 20 some years now by inhalation -- but by and large these are extremely safe products or else I wouldn't be recommending them to all my patients as I do.
RAY SUAREZ: So they're not the best of a bad bunch. They're actually on the whole safe and certainly safer than not getting the best respiration possible.
DR. MICHAEL KALINER: Well, they are -- they're wonderful products. You have to take this into perspective. I've been treating asthma for 30 years now. And we can treat asthma so much better today than we've ever been able to do in the past. So we have wonderful tools to treat asthma. Now, this is a new way -- with the anti-IGE -- is a new way to treat asthma. And it will find its way into the scheme of things but we already are so far ahead of what we were just five years ago.
RAY SUAREZ: In reading some of the results, Dr. Milgrom, I saw that your placebo group did quite a bit better, but you have some ideas as to why.
DR. HENRY MILGROM: Right. Well, as Dr. Kaliner pointed out, inhaled steroids are very good, a very good treatment of asthma. And the patients who received placebo were not receiving placebo alone; they were receiving placebo and the kind of therapy that is currently recommended for patients. And they were receiving it under close supervision, and they were receiving encouragement to take their medication correctly. So, in point of fact, you know, it's a common finding that patients who enter studies improve regardless, whether they're on therapy or whether they're on control therapy. And so let me just make one point clear: There were three groups in this study. One group -- each group received what we considered to be optimal care, and then one group received high-dose of the study drug. One group received low-dose of the study drug and the third group received placebo in addition to the, you know, correct management for asthma.
So from this point, the reason why everybody improved a little bit probably is that their therapy was perhaps more correct or more compulsively taken than it had been prior to the initiation of the study. What happens with asthma very frequently is that once patients get better, they can tolerate less therapy. So it takes more medicine to make patients well than it takes to maintain them in good control. So, once these patients were better, they were able to tolerate some reduction of drugs, and their symptom scores were improved by reason of that therapy. I don't think it's because the placebo made them better. It's because the underlying treatment made them better.
So the important thing in the study is that, you know, the study patients continued to do well and continued to improve in spite of the fact that their corticosteroids were being reduced, and they did it throughout the study. We only had eight weeks during which to reduce the corticosteroids. And we were reducing these corticosteroids until the final visit. What this basically means is that if the steroid reduction phase had been longer, the steroid dose could have probably been reduced further.
|Asthma cases increasing|
RAY SUAREZ: Are we any closer to understanding, Dr. Kaliner, why there has been this tremendous run-up in the number of cases and why so many people are dying from something that we have a good treatment for?
DR. MICHAEL KALINER: Well, there are two different questions. Let me answer them separately. There's a parallel increase in the incidence of allergy. And that probably accounts why there's such an increase in asthma. So they're both doubling over this past period of two decades. So, I think that accounts for the asthma. It is not pollution. That's a misunderstanding. Pollution in the United States is getting much better. So pollution levels are going down, and asthma is going up. I don't think that pollution plays any role in the increasing problem with asthma. Cigarette smoking still does. The death rate is very different. The death rate is largely in underserved portions of the American population particularly inner-city minority groups. Blacks and Hispanics are getting very bad medical care. That's why they're dying.
RAY SUAREZ: Dr. Milgrom, in that case, can anti-IGE drugs -- as they're called -- be an answer for what is a medically underserved population. This is something that is administered by IV, not the easiest way to take your medicine?
DR. HENRY MILGROM: Well, the study results that we report were obtained in an IV protocol. But the drug can now be administered subcutaneously, and it only needs to be administered once every four weeks. So, you know, this is not the ideal way to serve people who are not well served, but it does offer an opportunity to offer injections to these people that could be administered once a month, and even if this is not sufficient treatment for their asthma, this may provide a safety net for them. But this is probably the way to improve the care of asthma for the indigent people -- is not going to be solved by medications because the medications that we have now probably are equal to the task. So it's going to be solved by improved care and by improved self-management by patients.
RAY SUAREZ: And Dr. Kaliner, aren't these drugs still pretty expensive?
DR. MICHAEL KALINER: I don't know the cost, but I anticipate it will be very expensive certainly in the initial phases of it. The issue is one not just of looking at the best medicine but the best delivery of medicine. I think that's what Dr. Milgrom was implying. We have to figure out how we can provide good medical care to the underserved population and then asthma can be addressed as a part of that -- the way that we present medicine to those people.
RAY SUAREZ: So Dr. Milgrom, what is the next study you have to do to take the next step?
DR. HENRY MILGROM: Well, I think as far as use of anti-IGE what we need to do is to seek out which groups of patients are most likely to benefit from it. We need to determine how long the drug needs to be used, whether it should be used in combination with other drugs, whether it should be used in combination with existing immunotherapy. There are a lot of questions that remain unanswered. I think what we know is that we have watched the development and not merely the development but also the application of a new drug, a very, very ingeniously conceived drug which will treat allergic disease other than asthma as well as asthma, and will treat immunological disease in a way that is unique in that the anti-body that is being given to these patients is effective regardless of the specificity of the patient's allergy.
So whereas at the present time if somebody is giving immunotherapy to a patient, he has to know pretty well what the patient is allergic to. This may be a way to do it without having to know exactly what the patient is allergic to. And this is a difficult thing to define. But we certainly have a lot to learn about the best ways to apply this drug, and it's clear to me that the patients who require a great deal of medical care, who are frequently in the hospital, who are frequently in the emergency room, are either not responding to their corticosteroids or are not taking their corticosteroids. And for this group of patients who are actually very big users of the dollars assigned to medical care for asthma, this drug is bound to be cost-effective.
RAY SUAREZ: Dr. Milgrom, Dr. Kaliner, thanks to you both.