[Federal Register: November 26, 2007 (Volume 72, Number 226)]
[Notices]
[Page 65970-65971]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no07-50]
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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 consensus@mail.nih.gov. 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