110th Congress

Lupus Research, Education, Awareness, Communication, and Healthcare Amendments of 2007

H.R. 1192, S. 1359

Background

Lupus (systemic lupus erythematosus) is a serious and potentially fatal autoimmune disease that mainly affects young women. (Onset is often between the ages of 15 and 44.) The manifestations of lupus are diverse: it can affect many parts of the body, including the joints, skin, kidneys, heart, lungs, blood vessels, and brain. People of all races can develop lupus; however, African American women have a three times higher incidence rate than White women. African American women also tend to develop the disease at a younger age than White women and to develop more serious complications. Nine times more women than men have lupus, and it is more common in women of Hispanic, Asian, and Native American descent.

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 related 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. The working group brings together key players from across the lupus research community in order to facilitate communication and coordination. In order to further advance lupus research and continue to improve patient care, NIAMS is leading the development of a 5-year plan for lupus research at NIH. The plan describes the state of the science and areas of research with the greatest need and most promising scientific opportunity regarding the causes of lupus, mechanisms of disease, epidemiology and special populations, and diagnosis and treatment. The final plan will be available in mid-2007.

Researchers supported by NIAMS, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), National Center on Minority Health and Health Disparities (NCMHD), and Office of Research on Women’s Health (ORWH), 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 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 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 also supports a large lupus registry and repository designed to accelerate the search for lupus susceptibility genes. Researchers are analyzing 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. In addition, NIAMS provides support for the Research Registry for Neonatal Lupus, which provides material for basic research on the causes of the disease, tracks important epidemiological data such as incidence, and facilitates family counseling. Data from both registries, as well as other ongoing genetics studies, will facilitate the development of improved methods of diagnosis, prevention, and treatment.

Epstein-Barr virus (EBV) has often been suspected as a trigger for lupus, but recent research has yielded a more direct association and may suggest strategies for disease prevention. Using serial blood samples, researchers were able to identify when people with lupus began to make the self-destructive autoantibodies that target and damage tissues. In many patients, the antibodies were first produced in response to EBV infection (as evidenced by antibodies to the virus). In genetically predisposed people, antibodies targeting the EBV protein cross-reacted with a normal protein fragment in the body called Ro. These autoantibodies mistakenly attacked the patient’s own body. These results provide insights into how the disease begins and have implications for how to treat or even prevent the disease by retraining the body not to attack its own tissues. Support for this research was provided by several NIH components, including NIAMS, NIAID, NCMHD, ORWH, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Center for Research Resources, demonstrating the interest in and commitment to lupus research across NIH.

Currently, the only way to determine whether a patient has renal disease is by taking a biopsy of the kidney. This involves inserting a needle into the kidney and removing a sample of tissue for analysis, sometimes repeatedly, in order to determine the exact kind and severity of the disease and the appropriate treatment. NIAMS-supported researchers analyzed urine samples from patients with lupus just before they underwent kidney biopsies, using two-dimensional electrophoresis. The process identified several proteins associated with specific forms of end-stage renal disease and indicated the severity of the disease, as well as the level of kidney damage. Such biomarkers could form the basis of clinical tests that could help doctors establish an effective treatment plan for these patients without the need for repeated kidney biopsies.

NIAMS has recently developed a new funding mechanism specifically designed to bring together basic and clinical research in a way that helps translate basic discoveries into new drugs, treatments, and diagnostics. Lupus is the focus of one of the first Center of Research Translation (CORT) awards. Researchers will study the role of different cell types in lupus pathogenesis, develop markers of disease activity and severity, and look for new targets for treatment. The multifaceted approach promoted through the CORT mechanism will likely yield some of the most significant advances yet in understanding and treating lupus.

Through advances in medical research, we have a much better understanding of the many factors, both genetic and environmental, that cause lupus; improved diagnostic abilities to identify lupus far earlier in the disease process before tissue damage has occurred; and targeted, less toxic therapies. Building on these advances, the future for patients diagnosed with lupus is significantly brighter, with genuine hope for improved quality of life.

During the 106th Congress, Senator Robert Bennett (R-UT) and Representative Carrie Meek (D-FL) sponsored the Lupus Research and Care Amendments, which were 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. In the 109th Congress, Representative Ileana Ros-Lehtinen (R-FL) and Senator Bennett introduced legislation identical to the bills introduced in the 110th Congress by Representative Kendrick B. Meek (D-FL) and Senator Patty Murray (D-WA) to amend this new section of the Public Health Service Act.

Provisions of the Legislation/Impact on NIH

H.R. 1192 would require the Secretary of Health and Human Services, acting through NIAMS, to conduct or support research to expand the understanding of the causes of lupus, including:

• Basic research to discover the pathogenesis and pathophysiology of lupus
• Research to determine the underlying reasons for the elevated prevalence of lupus in women, including African American, Hispanic, Native American, and Asian women
• Epidemiological studies to examine the differences between the sexes and among racial and ethnic groups regarding lupus
• Clinical research focused on new treatments, including biological agents
• Research to validate lupus biomarkers and develop improved diagnostic tests

Status and Outlook

H.R. 1192 was introduced by Representative Meek on February 27, 2007, and was referred to the House Committee on Energy and Commerce. No further action has occurred on this legislation.

S. 1359 was introduced by Senator Murray on May 10, 2007, and was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action has occurred on this legislation.