II 

109TH CONGRESS 

1ST SESSION S. 756 

To amend the Public Health Service Act to enhance public and health professional awareness and understanding of lupus and to strengthen the 

Nation’s research efforts to identify the causes and cure of lupus. 

IN THE SENATE OF THE UNITED STATES 

APRIL 11, 2005 

Mr. BENNETT (for himself, Mrs. MURRAY, Mr. SHELBY, and Mr. HATCH) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Public Health Service Act to enhance public 

and health professional awareness and understanding of 

lupus and to strengthen the Nation’s research efforts 

to identify the causes and cure of lupus. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Lupus Research, Edu5 cation, Awareness, Communication, and Healthcare 

6 Amendments of 2005’’. 

7 SEC. 2. TABLE OF CONTENTS. 

8 The table of contents for this Act is as follows: 
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Sec. 1. Short title. 

Sec. 2. Table of contents. 

Sec. 3. Findings. 

TITLE I—EXPANDING AND IMPROVING RESEARCH ON LUPUS 

Sec. 101. Expansion of lupus biomedical research. 

Sec. 102. Strengthening lupus epidemiology; lupus study. 

TITLE II—ENHANCING LUPUS AWARENESS AND EDUCATION 

Sec. 201. Increasing public awareness and improving health professional education. 

1 SEC. 3. FINDINGS. 

2 Congress makes the following findings: 

3 (1) Lupus is a serious, complex, debilitating 

4 autoimmune disease that can cause inflammation 

5 and tissue damage to virtually any organ system in 

6 the body, including the skin, joints, other connective 

7 tissue, blood and blood vessels, heart, lungs, kidney, 

8 and brain. 

9 (2) The Lupus Foundation of America, Inc. es10 timates that approximately 1,500,000 to 2,000,000 

11 Americans live with some form of lupus; lupus af12 fects women 9 times more often than men and 80 

13 percent of newly diagnosed cases of lupus develop 

14 among women of child-bearing age. 

15 (3) Lupus disproportionately affects women of 

16 color; it is 2 to 3 times more common among Afri17 can-Americans, Hispanics, Asians, and Native Amer18 icans and is generally more prevalent in minority 

19 populations, a health disparity that remains unex20 plained. According to the Centers for Disease Con-
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1 trol and Prevention, the rate of lupus mortality has 

2 increased since the late 1970s and is higher among 

3 older African-American women. 

4 (4) There have been no new drugs approved by 

5 the Food and Drug Administration specifically for 

6 lupus in nearly 40 years and while current treat7 ments for the disease can be effective, they can lead 

8 to damaging side effects. 

9 (5) The pain and fatigue associated with lupus 

10 can threaten people’s ability to live independently 

11 and make it difficult to maintain employment and 

12 lead normal lives. One in 5 people with lupus is dis13 abled by the disease, and consequently receives sup14 port from government programs, including medicare, 

15 medicaid, social security disability, and social secu16 rity supplemental income. 

17 (6) The estimated average annual cost of med18 ical treatment for an individual with lupus can range 

19 between $10,000 and $30,000; for people who have 

20 the most serious form of lupus, medical costs can 

21 greatly exceed this amount, causing a significant 

22 economic, emotional, and social burden to the entire 

23 family and to society. 

(7) More than 1 24 ⁄2 of the people with lupus suf25 fer 4 or more years and visit 3 or more physicians 
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1 before obtaining a diagnosis of lupus; early diagnosis 

2 of, and commencement of treatment for, lupus can 

3 prevent or reduce serious organ damage, disability, 

4 and death. 

5 (8) Despite the magnitude of lupus and its im6 pact on individuals and families, health professional 

7 and public understanding of lupus remains low; only 

8 1 of 5 Americans can provide even basic information 

9 about lupus, and awareness of lupus is lowest among 

10 adults ages 18 to 34, the age group most likely to 

11 develop symptoms of lupus. 

12 (9) Lupus is a significant national health issue 

13 that deserves a comprehensive and coordinated re14 sponse by Federal and State governments with the 

15 involvement of the healthcare provider, patient, and 

16 public health communities. 

17 TITLE I—EXPANDING AND IM18 PROVING RESEARCH ON 

19 LUPUS 

20 SEC. 101. EXPANSION OF LUPUS BIOMEDICAL RESEARCH. 

21 Section 441A of the Public Health Service Act (42 

22 U.S.C. 285d–6a) is amended to read as follows: 

23 ‘‘EXPANSION OF LUPUS BIOMEDICAL RESEARCH

24 ‘‘SEC. 441A. (a) IN GENERAL.—The Secretary, act25 ing through the Director of the Institute, shall expand and 
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1 intensify research and related activities of the Institute 

2 with respect to lupus. 

3 ‘‘(b) COORDINATION WITH OTHER INSTITUTES.— 

4 The Director of the Institute shall coordinate the activities 

5 of the Director under subsection (a) with similar activities 

6 conducted by the other national research institutes and 

7 agencies of the National Institutes of Health to the extent 

8 that such institutes and agencies have responsibilities that 

9 are related to lupus. 

10 ‘‘(c) PROGRAMS FOR LUPUS.—In carrying out sub11 section (a), the Director of the Institute shall conduct or 

12 support research to expand the understanding of the 

13 causes of, and to find a cure for, lupus. Activities under 

14 such subsection shall include conducting and supporting 

15 the following: 

16 ‘‘(1) Basic research to discover the pathogenesis 

17 and pathophysiology of the disease. 

18 ‘‘(2) Research to determine the reasons under19 lying the disproportionate prevalence of lupus in Af20 rican-American, Hispanic, Native American, and 

21 Asian women. 

22 ‘‘(3) Epidemiological studies to address the fre23 quency and natural history of the disease and the 

24 differences between the sexes and among racial and 

25 ethnic groups with respect to the disease. 
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1 ‘‘(4) Clinical research for the development and 

2 evaluation of new treatments, including new biologi3 cal agents. 

4 ‘‘(5) Research to validate lupus biomarkers. 

5 ‘‘(6) Research to develop improved diagnostic 

6 tests.’’. 

7 SEC. 102. STRENGTHENING LUPUS EPIDEMIOLOGY; LUPUS 

8 STUDY. 

9 Part B of title III of the Public Health Service Act 

10 (42 U.S.C. 243 et seq.) is amended by inserting after sec11 tion 318B the following: 

12 ‘‘STRENGTHENING LUPUS EPIDEMIOLOGY

13 ‘‘SEC. 318C. (a) IN GENERAL.—The Secretary, act14 ing through the Director of the Centers for Disease Con15 trol and Prevention, shall work with a consortium of lead16 ing United States academic health institutions that have 

17 expertise in the epidemiology of lupus to undertake a na18 tional scale lupus epidemiological study to determine the 

19 true prevalence and incidence of lupus in the United 

20 States. 

21 ‘‘(b) USE OF FUNDS.—The Director of the Centers 

22 for Disease Control and Prevention shall enter into a coop23 erative agreement with the consortium described in sub24 section (a) to develop, implement, and manage a system 

25 for lupus data collection and analysis, including— 
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1 ‘‘(1) the creation and use of a common data 

2 entry and management system across all study sites; 

3 and 

4 ‘‘(2) the enhancement of the 2 study sites in5 volved in the existing lupus patient registry of the 

6 Centers for Disease Control and Prevention on the 

7 day before the date of enactment of the Lupus Re8 search, Education, Awareness, Communication, and 

9 Healthcare Amendments of 2005. 

10 ‘‘(c) GEOGRAPHIC REPRESENTATION.—The Director 

11 of the Centers for Disease Control and Prevention shall 

12 ensure that the consortium described in subsection (a) 

13 represents different geographic regions of the United 

14 States that have a sufficient number of individuals of all 

15 racial and ethnic backgrounds disproportionately affected 

16 by lupus, including Hispanics, Asians, Native Americans, 

17 and African-Americans. 

18 ‘‘(d) CERTAIN ACTIVITIES.—In carrying out sub19 sections (a) and (b), the consortium described in sub20 section (a) shall capture data related to all affected popu21 lations on all forms of lupus, including lupus related dis22 orders. 

23 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

24 are authorized to be appropriated to carry out this section 
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1 $3,500,000 for each of the fiscal years 2006, 2007, 2008, 

2 and 2009. 

3 ‘‘LUPUS STUDY AND REPORT BY THE INSTITUTE OF

4 MEDICINE

5 ‘‘SEC. 318D. (a) CONTRACT.—The Secretary shall 

6 enter into a contract with the Institute of Medicine to con7 duct a study— 

8 ‘‘(1) to evaluate the Federal and State activities 

9 related to lupus research, education, and awareness 

10 programs and activities and make recommendations 

11 for ways in which these initiatives could be ex12 panded; 

13 ‘‘(2) to identify the gaps in Federal research re14 lated to— 

15 ‘‘(A) the causes of lupus; 

16 ‘‘(B) lupus detection and diagnosis; 

17 ‘‘(C) lupus treatment; and 

18 ‘‘(D) lupus quality-of-life concerns; 

19 ‘‘(3) to make recommendations for building and 

20 supporting the lupus research enterprise, including 

21 recommendations for strategies for future basic, clin22 ical, social, and behavioral research— 

23 ‘‘(A) to determine the pathophysiology and 

24 pathogenesis of the disease; and 
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1 ‘‘(B) to secure the development of new and 

2 improved lupus therapies and ways to diagnose 

3 the disease; 

4 ‘‘(4) to determine the gaps in lupus health pro5 fessional education programs and public awareness 

6 efforts and make recommendations for ways in 

7 which the Federal Government can— 

8 ‘‘(A) improve public and health profes9 sional awareness of lupus; and 

10 ‘‘(B) partner and support nonprofit vol11 untary health agencies (such as the Lupus 

12 Foundation of America, Inc.) and academic in13 stitutions and other interested stakeholders 

14 whose primary purposes are to increase public 

15 awareness of lupus and to improve the diag16 nosis and treatment of lupus; 

17 ‘‘(5) to make recommendations regarding ways 

18 to improve the quality of life for people with lupus; 

19 ‘‘(6) to summarize the clinical and biological 

20 features of lupus and the characteristics and man21 agement of major symptoms and make recommenda22 tions for disease management and measurement; and 

23 ‘‘(7) to make recommendations for epidemiolog24 ical studies in the various population groups affected 

25 by lupus in the United States. 
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1 ‘‘(b) REPORT.—Not later than 18 months after the 

2 date of enactment of the Lupus Research, Education, 

3 Awareness, Communication, and Healthcare Amendments 

4 of 2005, the Institute of Medicine shall submit to the Sec5 retary a report containing the information described in 

6 paragraphs (1) through (7) of subsection (a).’’. 

7 TITLE II—ENHANCING LUPUS 

8 AWARENESS AND EDUCATION 

9 SEC. 201. INCREASING PUBLIC AWARENESS AND IMPROV10 ING HEALTH PROFESSIONAL EDUCATION. 

11 Part B of title III of the Public Health Service Act 

12 (as amended by section 102) (42 U.S.C. 243 et seq.) is 

13 further amended by inserting after section 318D the fol14 lowing: 

15 ‘‘INCREASING PUBLIC AWARENESS OF LUPUS AND

16 IMPROVING HEALTH PROFESSIONAL EDUCATION

17 ‘‘SEC. 318E. (a) IN GENERAL.—The Secretary, act18 ing through the Director of the Office on Women’s Health 

19 and in collaboration with the Lupus Foundation of Amer20 ica, Inc. and the National Center on Minority Health and 

21 Health Disparities of the National Institutes of Health, 

22 shall conduct and support a sustained national lupus pub23 lic awareness and health professional education campaign, 

24 with an emphasis on reaching populations at highest risk 

25 for the disease. 
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1 ‘‘(b) USE OF FUNDS.—In conducting the sustained 

2 national lupus public awareness and health professional 

3 educational campaign, the Director of the Office on Wom4 en’s Health shall— 

5 ‘‘(1) promote increased awareness of early 

6 intervention and treatment so as to significantly im7 prove the diagnosis, treatment, and quality of life for 

8 people with lupus; 

9 ‘‘(2) direct communication and education ef10 forts toward minority communities that may be un11 derserved or disproportionately affected by lupus; 

12 and 

13 ‘‘(3) target at-risk women and health profes14 sionals likely to see women with lupus, including pri15 mary care physicians and specialists such as 

16 rheumatologists, nephrologists, dermatologists, and 

17 immunologists, so as to help reduce the amount of 

18 time taken to achieve a correct diagnosis of lupus. 

19 ‘‘(c) CERTAIN ACTIVITIES.—To the extent prac20 ticable and appropriate, the Secretary shall ensure that 

21 communications under subsections (a) and (b) provide the 

22 latest medically sound information related to the signs, 

23 symptoms, diagnosis, and disease management of lupus. 

24 ‘‘(d) INTEGRATION WITH OTHER PROGRAMS.—To 

25 the extent practicable and appropriate, the Secretary shall 
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1 integrate efforts under this section with other programs 

2 carried out by the Secretary. 

3 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

4 are authorized to be appropriated to carry out this section 

5 $1,000,000 for each of the fiscal years 2006 through 

6 2010.’’. 

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