109th Congress

Lupus Research, Education, Awareness, Communication, and Healthcare Amendments of 2005

H.R. 3307, S. 756

Background

Lupus is one of many disorders of the immune system known as autoimmune diseases. In autoimmune diseases, the immune system attacks parts of the body it is designed to protect, leading to inflammation of and damage to various body tissues. Lupus can affect the joints, skin, kidneys, heart, lungs, blood vessels, and brain. Although this disorder affects people of all races, African American women are three times more likely to have lupus than White women and are more likely to die from it. Lupus is also more common in women of Hispanic, Asian, and Native American descent. At present, there is no cure for lupus; however, it can be effectively treated with drugs, and most people with the disease lead active, healthy lives.

Intense lupus research efforts are underway, and scientists funded by the National Institutes of Health (NIH) are making great strides in understanding the disease. The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the lead NIH Institute conducting research in this area, is continuing to enhance its research activities relating to lupus through a number of efforts. For example, NIAMS leads the Lupus Federal Working Group, which comprises representatives from all relevant U.S. Department of Health and Human Services agencies and other Federal departments with an interest in lupus. NIAMS also supports a large lupus registry and repository designed to accelerate the search for lupus susceptibility genes. Researchers supported by NIAMS analyze DNA samples from families for the presence of genetic markers. About one-third of the families involved in the study are African American; Mexican American and Puerto Rican families are also represented.

Most recently, researchers supported by NIAMS, in collaboration with the National Institute of Allergy and Infectious Diseases, National Center on Minority Health and Health Disparities, and Office of Research on Women's Health, have discovered a genetic "signature" present in some lupus patients who develop life-threatening complications such as blood disorders, central nervous system damage, and kidney failure. These findings provide strong support for developing new therapies to block the affected pathways in patients with severe lupus and for identifying the patients most likely to benefit from these new therapies. Other NIAMS-supported researchers have found different genetic regions linked to lupus in African Americans and European Americans. This genetic linkage study may help to explain why more African Americans die of lupus as well as develop more serious complications, such as nephritis (kidney failure), compared with people of European descent. NIAMS-supported researchers have also found that people diagnosed with lupus have autoantibodies (proteins that attach to the body's healthy tissues by mistake) in their blood years before the symptoms of lupus appear. The early detection of autoantibodies may help identify individuals who will develop the disease and allow physicians to begin monitoring them before any symptoms occur.

NIAMS is actively supporting research to identify and validate biomarkers for lupus. For example, it supports the Autoimmune Biomarkers Collaborative Network, which uses cutting-edge technologies, such as gene expression profiling with DNA microarrays, to develop lupus biomarkers. These new technologies may assist in the diagnosis of lupus, help physicians better guide and manage therapy, and provide information on the course of the disease. NIAMS also leads the Lupus Biomarkers Working Group, which is exploring how to establish new strategies for developing and validating lupus biomarkers.

In the 106th Congress, Senator Robert Bennett (R-UT) and Representative Carrie Meek (D-FL) sponsored the Lupus Research and Care Amendments, which was incorporated into the Public Health Service Amendments of 2000 (P.L. 106-505, enacted November 13, 2000). P.L. 106-505 added a new section to the Public Health Service Act to require the Director of NIAMS to expand research related to lupus, coordinate with other Institutes and Centers involved in lupus research, develop improved screening techniques, increase basic and clinical research, and create information and education programs for health care professionals. The legislation authorized such sums as may have been necessary for fiscal years 2001-2003. The current legislation would amend this new section of the Public Health Service Act.

Provisions of the Legislation/Impact on NIH

H.R. 3307 and S. 756 would amend Section 441A of the Public Health Service Act to:

• Require the Director of NIAMS to act through the Secretary of Health and Human Services to increase lupus research at the Institute
• Delete the requirement that NIAMS must conduct and support research to determine the reasons underlying the elevated prevalence of lupus in women, including African American women
• Clarify that NIAMS would have to conduct and support basic research to discover the pathogenesis and pathophysiology of lupus
• Expand the number of racial categories that NIAMS would have to study to determine the reasons for the higher prevalence of lupus in these populations
• Delete the requirement that NIAMS conduct information and education programs for health care professionals and the public
• Add a requirement that NIAMS conduct and support research to validate lupus biomarkers and develop improved diagnostic tests
• Delete the authorization of appropriations section

Status and Outlook

H.R. 3307, a companion bill to S. 756, was introduced by Representative Ileana Ros-Lehtinen (R-FL) on July 14, 2005, and was referred to the House Committee on Energy and Commerce. No further action has occurred on this legislation.

S. 756, a companion bill to H.R. 3307, was introduced by Senator Bennett on April 11, 2005, and was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action has occurred on this legislation.