Vol. 20 •Issue 6 • Page 27
Storm Rages Over Long-Acting Beta-Agonists
There is a storm brewing in the asthma world. The storm swirls around the use of common asthma drugs, and the related issues may end in litigation, certainly need clarification and probably require additional research. The issue absolutely cannot be ignored.
In June 2006, The Annals of Internal Medicine published a study, “Meta-Analysis: Effect of Long-Acting Beta-Agonists on Severe Asthma Exacerbations and Asthma-Related Deaths.” The study pooled data involving 33,826 patients from 19 clinical trials published between 1966 and December 2005. The researchers wanted to assess whether or not there was a risk for severe, life-threatening or fatal asthma exacerbations associated with the use of long-acting beta-agonists.
They admitted the small number of deaths reported by the trials limited the reliability of their assessing this risk and that all the trials allowed the use of short-acting beta-agonists as needed. Researchers noted the definition varied as to what constituted an exacerbation (some studies included clinical symptoms and decreases in peak flows in asymptomatic patients, others did not) and that several studies did not report information on the outcomes of interest which also limited their findings.
Nonetheless, they concluded: “Long-acting beta-agonists have been shown to increase severe and life-threatening asthma exacerbations as well as asthma-related deaths.”
On the professional side, there have been several criticisms. The first is that using studies which date back to 1966 before the advent of long-acting beta-agonists is comparing apples and oranges. Others noted that several pivotal trials evaluating the benefit of long-acting beta-agonists used with inhaled corticosteroids were not included in the analysis. Still others have publicly noted the limitation reported by the authors and expounded on them.
Drugs in the Press
Several of these concerns have been published in various peer-reviewed journals. The real problem, however, is that while the physicians are slugging it out in academia, the study has been widely covered in the popular media with varying degrees of accuracy about the actual findings.
Headline news stories have warned asthma patients of impending death if they use beta-agonists or just asthma medications in general. Some of these stories have made little or no distinction between short-acting beta-agonists and long-acting beta-agonists. Others clarified the distinction a few paragraphs down.
Many have asked, “Who is Dr. Shelley Saltpeter?” Some news stories list her as a professor at Stanford University; others just refer to her as being “of Stanford University.” A search of Stanford University’s faculty and the Stanford University School of Medicine does not come up with her name, and this has created confusion.
Digging a little deeper, you find her listed at Santa Clara Valley Medical Center, in San Jose, Calif., as assistant chief of Primary Care, director of Medicine Consults and clinical professor of Medicine, Stanford. So the news stories didn’t get it wrong; they just didn’t get it completely right.
She is part of the clinical faculty at San Jose, but patients don’t understand this distinction. They just know she isn’t listed on the Stanford Web sites. If you look at the other co-authors, you find Thomas Ormiston, MD, is a physician at Santa Clara Valley Medical Center in San Jose; Nicholas Buckley, a student at Sequoia High School in Redwood City, Calif., is Shelley Salpeter’s son; and the other Dr. Salpeter listed in the article is Shelley Salpeter’s father, Edwin E. Salpeter, PhD, an astrophysicist and professor emeritus at Cornell University.
If you search for a physician named E. Salpeter from Cornell, he doesn’t exist. So, at least on the surface, this allows people to question the overall validity of the study.
The bottom line here is this: Whether we as practitioners accept the analysis or not has yet to be determined. What is clear is news reporters have grabbed the story and run with it.
I have heard patients say they stopped taking their asthma medications because they read in the paper or saw on television that it would kill them. That is dangerous! As practitioners, we need to be aware of this potential and be proactive in asking all of our patients whether they are regularly taking their medicines or not and discuss any fears and concerns they may have.
The controversy over asthma medications is not going to go away overnight. But, sadly, an untreated asthma or COPD patient could be harmed in the process.
Salpeter SR, Buckley NS, Ormiston TM, Salpeter EE. Meta-analysis: effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths. Ann Intern Med. (2006 June 20;144, 12: 904-12).
Margaret Clark is a Georgia practitioner.