Notice is hereby given of the National Institutes of Health (NIH) “NIH Consensus Development Conference: Hydroxyurea Treatment for Sickle Cell Disease” to be held February 25-27, 2008, in the NIH Natcher Conference Center, 45 Center Drive, Bethesda, Maryland 20892. The conference will begin at 8:30 a.m. on February 25 and 26, at 9 a.m. on February 27, and will be open to the public.
Sickle cell disease is an inherited blood disorder that affects between 50,000 and 75,000 people in the United States. It is most common among people whose ancestors come from sub-Saharan Africa, South and Central America, the Middle East, India, and the Mediterranean basin. Sickle cell disease occurs when an infant inherits the gene for sickle hemoglobin from both parents (Hb SS, or sickle cell anemia) or the gene for sickle hemoglobin from one parent and another abnormal hemoglobin gene from the other parent. Each year, approximately 2,000 babies with sickle cell disease are born in the United States. The condition is chronic and lifelong and is associated with a decreased lifespan. In addition, approximately 2 million Americans carry the sickle cell trait, which increases the public health burden as this disorder is passed on to future generations.
The red blood cells in people with sickle cell disease become deoxygenated (or depleted of oxygen) and crescent-shaped or “sickled.” The cells become sticky and adhere to blood vessel walls, thereby blocking blood flow within limbs and organs. These changes lead to acute painful episodes, chronic pain, and chronic damage to the brain, heart, lungs, kidneys, liver, and spleen. Infections and lung disease are leading causes of death.
Pain crises are responsible for most emergency room visits and hospitalizations of people with sickle cell disease. Standard treatments for acute pain crises include painkilling medications, fluid replacement, and oxygen. In the mid-1990s, researchers began investigating the potential of hydroxyurea to reduce the number and severity of pain crises in sickle cell patients. Hydroxyurea is in a class of anticancer drugs and it acts to increase the overall percentage of normally structured red blood cells in the circulation. By diluting the number of cells that “sickle,” it may, if taken on a daily basis, reduce their damaging effects. Hydroxyurea was approved by the Food and Drug Administration for use in adults with sickle cell anemia in 1998. However, there are a number of unresolved issues about the use of hydroxyurea, including a lack of knowledgeable providers who treat sickle cell disease, and patient and practitioner questions about safety and effectiveness, including concerns regarding potential long-term carcinogenesis.
In order to take a closer look at this important topic, the National Heart, Lung, and Blood Institute and the Office of Medical Applications of Research of Start Printed Page 65971the NIH will convene a Consensus Development Conference from February 25-27, 2008, to assess the available scientific evidence related to the following questions:
- What is the efficacy (results from clinical studies) of hydroxyurea treatment for patients who have sickle cell disease in three groups: Infants, preadolescents, and adolescents/adults?
- What is the effectiveness (in everyday practice) of hydroxyurea treatment for patients who have sickle cell disease?
- What are the short- and long-term harms of hydroxyurea treatment?
- What are the barriers to hydroxyurea treatment (i.e., health care system factors and patient-related factors) for patients who have sickle cell disease and what are the potential solutions?
- What are the future research needs?
An impartial, independent panel will be charged with reviewing the available published literature in advance of the conference, including a systematic literature review commissioned through the Agency for Healthcare Research and Quality. The first day and a half of the conference will consist of presentations by expert researchers and practitioners and open public discussions. On Wednesday, February 27, the panel will present a statement of its collective assessment of the evidence to answer each of the questions above. The panel will also hold a press conference to address questions from the media. The draft statement will be published online later that day, and the final version will be released approximately six weeks later. The primary sponsors of this meeting are the NIH National Heart, Lung, and Blood Institute and the NIH Office of Medical Applications of Research.
Advance information about the conference and conference registration materials may be obtained from American Institutes for Research of Silver Spring, Maryland, by calling 888-644-2667 or by sending e-mail to email@example.com. American Institutes for Research's mailing address is 10720 Columbia Pike, Silver Spring, MD 20901. Registration information is also available on the NIH Consensus Development Program Web site at http://consensus.nih.gov.
The NIH has instituted security measures to ensure the safety of NIH employees and property. All visitors must be prepared to show a photo ID upon request. Visitors may be required to pass through a metal detector and have bags, backpacks, or purses inspected or x-rayed as they enter NIH buildings. For more information about the new security measures at NIH, please visit the Web site at http://www.nih.gov/about/visitorsecurity.htm.Start Signature
Dated: November 14, 2007.
Raynard S. Kington,
Deputy Director, National Institutes of Health.
[FR Doc. E7-22907 Filed 11-23-07; 8:45 am]
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