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NIH: Hydroxyurea Is Underused for Sickle Cell Disease

BETHESDA, Md -- February 28, 2008 -- An independent panel convened this week by the National Institutes of Health concluded that more adolescents and adults should use hydroxyurea for sickle cell disease. Although it was approved by the US Food and Drug Administration for adults with sickle cell anaemia in 1998, concerns by providers and patients about side effects have hindered its use, depriving many patients of its proven benefits. Research has shown that patients with sickle cell taking hydroxyurea have fewer pain crises and hospital admissions, and the panel has therefore advocated increased use of this drug with appropriate monitoring. Additionally, the panel concluded that the risks of serious side effects of hydroxyurea appear to be lower than previously thought -- and these risks are acceptable when compared with the risks of untreated sickle cell disease in adolescents and adults.

"The compelling benefits of hydroxyurea warrant increased adoption of this drug as a frontline therapy in adults with sickle cell disease," reported Otis Brawley, MD, conference panel chair, Professor of Hematology, Oncology, Medicine, and Epidemiology, Emory University, Atlanta, and Chief Medical Officer of the American Cancer Society.

For younger patients, data on safety and efficacy are limited but still supportive of hydroxyurea treatment. Although the panel was unable to definitively recommend broad paediatric use of the drug at this time, results from ongoing clinical trials may help to resolve any remaining questions about use in adolescents.

The panel also called for Medicare or Medicaid coverage of sickle cell patients of all ages. Surveys indicate that a large proportion of patients with sickle cell disease are ethnic minorities, poor, and from underserved communities. For many, limited resources and lack of culturally competent clinicians set the stage for suboptimal care. Recurring pain crises associated with the disease can severely limit individuals' ability to sustain employment or educational efforts, aggravating problems with insurance coverage and subsequent healthcare costs.

"This disease illuminates the limitations of our current healthcare system," Dr. Brawley noted. "The best way to achieve optimal care for patients with sickle cell disease is for them to be treated in clinics specialising in the care of this disease." The panel recognised that many patients lack a single healthcare provider to direct their sickle cell management. Instead, there is heavy reliance on emergency and acute care facilities to treat pain. Dr. Brawley added that "all sickle cell patients should have a principal healthcare provider, and that provider, if not a haematologist, should be in frequent consultation with one." Additionally, patients often "fall through the cracks" when transitioning from paediatric to adult care. Contributing to this problem is a lack of providers armed with the knowledge, skills, and experience to effectively manage adults with sickle cell disease.

The conference was sponsored by the NIH Office of Medical Applications of Research (OMAR) and the National Heart, Lung, and Blood Institute, along with other NIH and Department of Health and Human Services components. It was conducted under the NIH Consensus Development Program, which convenes conferences to assess the available scientific evidence and develop objective statements on controversial medical issues.


SOURCE: National Institutes of Health

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