[Federal Register Volume 72, Number 226 (Monday, November 26, 2007)]
[Notices]
[Pages 65970-65971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22907]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


NIH Consensus Development Conference: Hydroxyurea Treatment for 
Sickle Cell Disease; Notice

    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

[[Page 65971]]

the 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 protected]. 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.

    Please Note: 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.


    Dated: November 14, 2007.
Raynard S. Kington,
Deputy Director, National Institutes of Health.
 [FR Doc. E7-22907 Filed 11-23-07; 8:45 am]
BILLING CODE 4140-01-P