[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2084 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 2084

To increase awareness of and research on autoimmune diseases, which are 
    a major women's health problem, affect as many as 23.5 million 
 Americans, and encompass more than 100 interrelated diseases, such as 
 lupus, multiple sclerosis, rheumatoid arthritis, Sjogren's syndrome, 
 polymyositis, pemphigus, myasthenia gravis, Wegener's granulomatosis, 
psoriasis, celiac disease, autoimmune platelet disorders, scleroderma, 
alopecia areata, vitiligo, autoimmune thyroid disease, and sarcoidosis, 
                        and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 23, 2009

Mr. Kennedy (for himself, Mr. Stearns, and Mr. McGovern) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
To increase awareness of and research on autoimmune diseases, which are 
    a major women's health problem, affect as many as 23.5 million 
 Americans, and encompass more than 100 interrelated diseases, such as 
 lupus, multiple sclerosis, rheumatoid arthritis, Sjogren's syndrome, 
 polymyositis, pemphigus, myasthenia gravis, Wegener's granulomatosis, 
psoriasis, celiac disease, autoimmune platelet disorders, scleroderma, 
alopecia areata, vitiligo, autoimmune thyroid disease, and sarcoidosis, 
                        and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Prevention, Awareness, and Research 
of Autoimmune Diseases Act of 2009''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) The National Institutes of Health estimates that 
        between 14 and 23.5 million Americans have an autoimmune 
        disease and the prevalence is rising. Seventy-five percent of 
        those afflicted are women with most cases occurring during the 
        childbearing years.
            (2) Researchers have identified more than 100 autoimmune 
        diseases and suspect at least 40 additional disorders of having 
        an autoimmune basis.
            (3) Autoimmune diseases are chronic and can be life-
        threatening, ranking in the top 10 causes of death in children 
        and women in all age groups up to 64 years of age.
            (4) Early diagnosis of and commencement of treatment for 
        autoimmune diseases can prevent or reduce serious organ damage, 
        disability, and death. According to a study conducted by the 
        American Autoimmune Related Diseases Association, more than 
        half of those with an autoimmune disease suffered for 4 years 
        and visited 4 doctors before obtaining a diagnosis, and 44.6 
        percent of women were told they were chronic complainers or too 
        concerned with their health prior to being diagnosed.
            (5) A close genetic relationship exists among autoimmune 
        diseases, explaining clustering in individuals and families as 
        well as common pathways for disease development.
            (6) The rapidly evolving field of epigenetics has shown 
        that environmental factors can cause genes to be ``turned on'' 
        or ``turned off''. Differing exposures to environmental factors 
        can result in differing patterns of autoimmune expression.
            (7) Frequently used immunosuppressant treatments lead to 
        devastating long-term side effects. Those with autoimmune 
        diseases lack effective treatments.
            (8) The Institute of Medicine reports that the United 
        States is behind other countries in research into immune system 
        self-recognition, the process involved in autoimmune diseases.
            (9) Understanding how to modulate immune system activity 
        will benefit transplant recipients, cancer patients, AIDS 
        patients, and infectious disease patients.
            (10) The National Institutes of Health estimates that 
        annual direct health care costs for autoimmune disease are in 
        the range of $100,000,000,000.
            (11) Lack of awareness on the part of the public and health 
        care professionals contributes to patients' extreme difficulty 
        in obtaining a correct diagnosis, and lack of effective 
        treatments. Despite the prevalence of autoimmune diseases, 
        public awareness remains low. According to a Roper study, only 
        5.5 percent of Americans can even name an autoimmune disease 
        and 29 percent incorrectly identify AIDS as an autoimmune 
        disease. Awareness is lowest among adults ages 18 to 34, the 
        age group most likely to develop an autoimmune disease.
            (12) Examples of autoimmune diseases include lupus, 
        multiple sclerosis, rheumatoid arthritis, Sjogren's syndrome, 
        polymyositis, pemphigus, myasthenia gravis, Wegener's 
        granulomatosis, psoriasis, celiac disease, autoimmune platelet 
        disorders, scleroderma, alopecia areata, vitiligo, autoimmune 
        thyroid disease, and sarcoidosis.
            (13) Lupus can affect many parts of the body, including 
        joints, skin, kidneys, heart, lungs, blood vessels, and brain. 
        At least 1,500,000 Americans have a form of lupus, 9 out of 10 
        of these Americans are women, and 80 percent of all newly 
        diagnosed cases of lupus are among women of childbearing age. 
        According to a Lupus Foundation of America survey, more than 
        half of the people with lupus suffered for 4 or more years and 
        visited 3 or more doctors before obtaining a diagnosis of 
        lupus. About 1 out of 5 lupus sufferers receives disability 
        payments, costing the Government several billion dollars each 
        year for Social Security disability benefits, lost taxes, and 
        medical care provided through Medicare and Medicaid. The 
        average annual cost of medical treatment for an individual with 
        lupus is $6,000 to $10,000; for some people, medical costs may 
        exceed several thousand dollars every month. Early diagnosis of 
        and commencement of treatment for lupus can prevent or reduce 
        serious organ damage, disability, and death.
            (14) In multiple sclerosis (MS), the immune system attacks 
        the protective coating around the nerves. The damage affects 
        the brain or spinal cord and interferes with the nerve 
        pathways, causing muscular weakness, loss of coordination, and 
        visual and speech problem. Multiple sclerosis is a chronic and 
        often disabling disease of the central nervous system which 
        often first appears in people who are 20 to 50 years of age, 
        with lifelong physical and emotional effects. Multiple 
        sclerosis is twice as common in women as in men. An estimated 
        400,000 individuals have multiple sclerosis nationally. 
        According to the Multiple Sclerosis Society, the average annual 
        cost of multiple sclerosis to each affected individual is 
        approximately $57,000, and the total cost can exceed $3,000,000 
        over an individual's lifetime. The annual cost of treating all 
        people who suffer from multiple sclerosis in the United States 
        is approximately $20,000,000,000.
            (15) Four million Americans suffer from Sjogren's syndrome, 
        a serious autoimmune disease. Ninety percent of those with 
        Sjogren's syndrome are women. Sjogren's affects all races and 
        ethnic groups. Hallmark symptoms of Sjogren's include dry eyes 
        and dry mouth, which can lead to corneal abrasions and 
        blindness and loss of teeth if not recognized and treated and 
        affect a persons' ability to eat, swallow, and digest food. 
        Sjogren's syndrome is a systemic disease that can affect any 
        body organ or system, cause extreme fatigue and pain, and lead 
        to development of non-Hodgkin's B-cell lymphoma and heart block 
        in babies born to mothers with Sjogren's syndrome. Sjogren's 
        syndrome is frequently misdiagnosed because of lack of 
        recognition and physician education. According to the Sjogren's 
        Syndrome Foundation, the average time for those who do obtain a 
        correct diagnosis is 6.3 years after the onset of symptoms and 
        active attempt to obtain a diagnosis.
            (16) In rheumatoid arthritis, the immune system attacks the 
        linings of the joints resulting in joint pain, stiffness, 
        swelling, and destruction. Among the 2,100,000 people with 
        rheumatoid arthritis in the United States, women outnumber men 
        3 to 1. According to the Arthritis Foundation, total direct 
        costs of rheumatoid arthritis, including money spent on 
        treatments, hospitalizations, medications, transportation, and 
        specialist aids, are approximately $1,200,000,000 each year. 
        The average medical care expenditures over the course of a 
        rheumatoid arthritis patient's lifetime is $225,000 to 
        $370,000.
            (17) Systemic sclerosis affects approximately 240 
        individuals per million, and an estimated 300,000 are affected 
        by all forms of scleroderma in the United States. Scleroderma 
        strikes more women than men, with an overall ratio of 
        approximately 4 to 1. Scleroderma is a chronic, often 
        progressive autoimmune disease. The disease, which literally 
        means ``hard skin'', can cause thickening and tightening of the 
        skin, as well as fibrosis of the internal organs, including the 
        lungs, heart, kidneys, and gastrointestinal tract. Scleroderma 
        can be life threatening. The Scleroderma Foundation estimates 
        the direct and indirect costs of systematic sclerosis in the 
        United States to be $1,500,000,000, the value of lifetime 
        earnings lost to be $300,000 per systemic sclerosis death, and 
        direct costs at $4,731 per patient annually.
            (18) Myasthenia gravis is an autoimmune neuromuscular 
        disease which affects the skeletal muscles and is characterized 
        by muscular weakness which is the result of a disturbance of 
        the neuromuscular transmission. Certain muscles are more 
        frequently involved, and these include the muscles that control 
        eye movement, eyelids, chewing, swallowing, coughing, and 
        facial expression. Muscles that control breathing and movement 
        of the arms and legs may also be affected. Approximately 40 to 
        50 percent of individuals with myasthenia gravis experience 
        vision problems at the time of diagnosis, and up to 90 percent 
        experience such problems in the disease's lifetime. About 40 to 
        50 percent of patients experience generalized myasthenia gravis 
        affecting the muscles of the trunk or limbs, which may result 
        in impaired breathing. The prevalence of myasthenia gravis in 
        the Untied States is estimated at approximately 36,000 cases. 
        However, myasthenia gravis is probably underdiagnosed, and the 
        prevalence is probably higher. Previous studies have shown that 
        women are more often affected than men; however, now it seems 
        that males over 50 are more often affected. The most common age 
        at onset is before age 40 in women and after age 50 in men. 
        Treatment for myasthenia gravis can cost up to $524 per month 
        per prescription. Various surgeries can cost up to $6,000.
            (19) Wegener's granulomatosis (WG) strikes 1 in every 
        20,000 to 30,000 people. The disease can occur at any age, 
        although peak occurrence is in the 4th or 5th decade of life. 
        Males and females are affected equally. Wegener's 
        granulomatosis is a rare form of vasculitis, a disease 
        characterized by inflammation of blood vessel walls which can 
        damage vital organs by restricting blood flow. Wegener's 
        granulomatosis primarily affects the respiratory tract (sinus, 
        nose, trachea, and lungs) and the kidneys and may involve the 
        joints, eyes, and skin. According to the Wegener's 
        Granulomatosus Association, patients experience a 26 percent 
        reduction in income within the first year of diagnosis, or 
        $9,700,000 per year in lost income total for all Wegener's 
        patients. A 1998 survey of Wegener's patients showed costs of 
        $33,517 per patient per year.
            (20) In immune thrombocytopenic purpura (ITP), the body 
        mounts an autoimmune attack against platelets, particles in the 
        blood essential for clotting. People with immune 
        thrombocytopenic purpura are prone to spontaneous hemorrhages, 
        potentially in the brain and other vital organs. According to 
        the Platelet Disorders Support Association, treating immune 
        thrombocytopenic purpura costs from several thousand to 
        hundreds of thousands of dollars per year, depending on the 
        severity of the case and response to treatments. Immune 
        thrombocytopenic purpura is a diagnosis of exclusion. Many 
        other diseases and conditions present with low platelets and 
        can be confused with immune thrombocytopenic purpura.
            (21) According to the National Alopecia Areata Foundation, 
        over 4,500,000 Americans have alopecia areata, alopecia 
        totalis, or alopecia universalis, or 1.7 percent of any given 
        population. While children are affected most frequently, 
        alopecia areata occurs in all ages and ethnicities and in males 
        and females. Alopecia areata results in hair loss, with many 
        people losing all hair over their entire body, including 
        eyebrows and eyelashes and the hair on their head. This leads 
        to loss of self-esteem and filtering protection from the 
        elements and cold. Denting and stripping of nails can also 
        occur along with complete nail loss. Since no approved 
        treatments exist for alopecia areata, insurance companies fail 
        to recognize its seriousness and do not cover treatments that 
        could affect the disease's course. Treatments are often paid 
        for by patients or not administered. Diagnosis is difficult 
        because of lack of knowledge, especially among pediatricians 
        and general practitioners who would refer patients to 
        specialists. The International Pemphigus Foundation estimates 
        the incidence of pemphigus and pemphigoid as between 1 and 5 
        people per hundred thousand. These diseases affect all races 
        and ethnic groups. Pemphigus and pemphigoid are a group of 
        chronic, rare autoimmune blistering diseases of the skin or 
        mucous membranes. They are characterized by painful, burn-like 
        blisters or lesions covering much of the body that do not heal, 
        and they can cause serious infection, difficulty swallowing, 
        and, with cicatricial pemphigoid (CP), blindness. If untreated, 
        pemphigus is usually fatal.
            (22) Polymyositis is an autoimmune disease that causes 
        inflammation of the small and medium-sized arteries and leads 
        to problems in the muscles, joints, intestines, nerves, kidney, 
        and skin. Myositis is a neuromuscular autoimmune disease 
        affecting about 50,000 Americans. Because it is rare and not 
        easily detectable, individuals with myositis are often 
        misdiagnosed. It is common for those with myositis to go either 
        undiagnosed or misdiagnosed for several years before getting a 
        correct diagnosis. The efficacy of treatment is diminished by 
        delayed diagnoses and the resulting medications required and 
        costs incurred are substantially higher.
            (23) More than 5,000,000 people in the United States have 
        been diagnosed with psoriasis or psoriatic arthritis, including 
        children. Psoriasis is a lifelong skin disease that occurs when 
        faulty signals in the immune system cause skin cells to 
        regenerate too quickly. Extra skin cells build up on the skin's 
        surface forming red, flaky, scaly lesions that can itch, crack, 
        bleed, and be extremely painful. Psoriasis generally appears on 
        the joints, limbs, and scalp, but it can appear anywhere, 
        covering some people from head to toe. The National Psoriasis 
        Foundation estimates the cost of psoriasis care in the United 
        States ranges from $650,000,000 a year to $4,300,000,000 a 
        year. A recent study estimates that Americans with psoriasis 
        lose about 56 million hours of work and spend $2 to $3 billion 
        to treat the disease each year.
            (24) Sarcoidosis results in small growths of blood vessels, 
        cells, and connective tissue and leads to problems in the skin, 
        lungs, eyes, joints, and muscles. Sarcoidosis is a disease due 
        to inflammation that can attack any organ in the body in any 
        location. The disease is characterized by the presence of 
        granulomas, small areas of inflamed cells. They can be either 
        inside the body or on the body's exterior, appearing as sores 
        on the face or shins. Sarcoidosis is most frequently found in 
        the lungs. There are about 25,000 cases of sarcoidosis in the 
        United States. African-Americans have a higher risk for 
        sarcoidosis than do other Americans. However, the disease 
        occurs in every race in the United States and throughout the 
        world, including in individuals of European ancestry. 
        Sarcoidosis occurs predominantly between the ages of 20 and 40 
        years of age.
            (25) Vitiligo affects 1 to 2 percent of the population, or 
        about 3 to 6 million Americans, and affects every nationality, 
        race, and gender equally. Vitiligo is an autoimmune disease in 
        which the immune system mistakenly attacks the pigment cells in 
        the skin. It appears as milky white patches and can occur 
        anywhere on the body. Usually progressive, it can have a 
        devastating impact on a patient's mental state, especially in 
        those with darker skin. Cost varies by treatment. Treatment can 
        cost up to $150 a month for topical medications, $2,000 to 
        $3,000 for a home unit for phototherapy, and up to $30 per 
        doctor's office visit 2 to 3 times per week. Laser treatments 
        can cost $100 to $200 per treatment per area. Diagnosis can be 
        extremely difficult, as loss of pigment occurs in several other 
        conditions, and physician education is lacking. It can take 
        several months or trips to several different dermatologists for 
        a definitive diagnosis.

SEC. 3. RESEARCH ON ENVIRONMENTAL TRIGGERS OF AUTOIMMUNE DISEASES.

    Subpart 12 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285l et seq.) is amended by adding at the end the following:

``SEC. 463C. RESEARCH ON ENVIRONMENTAL TRIGGERS OF AUTOIMMUNE DISEASES.

    ``(a) Authority.--The Secretary, acting through the Director of the 
Institute and in collaboration with the directors of such other 
national research institutes as the Secretary deems appropriate, shall 
award not less than 2 grants to eligible entities for the conduct or 
support of research on environmental triggers, such as heavy metals, 
fluorescent  lighting, phthalates, post traumatic stress, and 
pharmaceuticals, that can cause the initiation of autoimmune diseases 
in genetically predisposed individuals.
    ``(b) Grant Period.--Each grant under this section shall be for a 
period of 5 years.
    ``(c) Definition.--In this section, the term `eligible entity' 
means--
            ``(1) a nonprofit organization;
            ``(2) an institution of higher education (as defined in 
        section 101 of the Higher Education Act of 1965); or
            ``(3) a Federal, State, or local agency.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $10,000,000 for each of fiscal 
years 2010 and 2011.''.

SEC. 4. GRANTS TO INCREASE AWARENESS OF AUTOIMMUNE DISEASES.

    (a) Purpose.--The purpose of this section is to increase awareness 
of autoimmune diseases in order to provide to the public a more 
complete understanding of these diseases, which affect 5 to 10 percent 
of the people in the United States.
    (b) Amendments.--Title III of the Public Health Service Act (42 
U.S.C. 241 et seq.) is amended by inserting after section 317T the 
following:

``SEC. 317U. GRANTS TO INCREASE AWARENESS OF AUTOIMMUNE DISEASES.

    ``(a) Grants.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall award grants to 
eligible entities to conduct public and professional awareness 
activities regarding autoimmune diseases.
    ``(b) Use of Funds.--In conducting public and professional 
awareness activities with a grant under this section, an eligible 
entity may do any of the following:
            ``(1) Promote increased awareness of early intervention and 
        treatment so as to significantly improve the quality of life 
        for people with autoimmune diseases.
            ``(2) Target minority communities that may be underserved 
        or disproportionately affected by autoimmune diseases.
            ``(3) Target women (who are disproportionately affected by 
        autoimmune diseases) so as to help reduce the amount of time 
        taken for correct diagnosis of such diseases, which often takes 
        more than 1 year.
    ``(c) Eligible Entity.--For purposes of this section, the term 
`eligible entity' means a nonprofit organization, an institution of 
higher education (as defined in section 101 of the Higher Education Act 
of 1965), a Federal, State, or local governmental agency, or a media 
organization.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $18,000,000 for each of fiscal 
years 2010 and 2011.''.

SEC. 5. GRANTS FOR EDUCATION ON RELATIONSHIP BETWEEN AUTOIMMUNE 
              DISEASES AND MENTAL ILLNESSES.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.), 
as amended by section 4, is amended by inserting after section 317U the 
following:

``SEC. 317V. GRANTS FOR EDUCATION ON RELATIONSHIP BETWEEN AUTOIMMUNE 
              DISEASES AND MENTAL ILLNESSES.

    ``(a) Grants.--The Secretary, acting through the Administrator of 
the Health Resources and Services Administration, shall award grants to 
eligible entities for the education of health care providers on 
potential links between autoimmune diseases and cognitive and mood 
disorders, such as depression.
    ``(b) Eligible Entity.--For purposes of this section, the term 
`eligible entity' means a nonprofit organization, an institution of 
higher education (as defined in section 101 of the Higher Education Act 
of 1965), a Federal, State, or local governmental agency, or a media 
organization.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $5,000,000 for each of fiscal 
years 2010 and 2011.''.

SEC. 6. LOAN REPAYMENT PROGRAM REGARDING PHYSICIAN RESEARCH ON 
              AUTOIMMUNE DISEASES.

    Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) 
is amended--
            (1) by redesignating the second section 487F as section 
        487G; and
            (2) by inserting after section 487G (as so redesignated) 
        the following:

``SEC. 487H. LOAN REPAYMENT PROGRAM REGARDING PHYSICIAN RESEARCH ON 
              AUTOIMMUNE DISEASES.

    ``(a) Establishment.--To the extent and in the amounts provided in 
advance in appropriations Acts, the Secretary, acting through the 
Administrator of the Health Resources and Services Administration, 
shall establish a program to enter into contracts with qualified 
physicians under which such qualified physicians agree to conduct 
research for a period of at least 3 years regarding autoimmune diseases 
in consideration of the Federal Government agreeing to repay, for each 
year of service conducting such research, not more than $35,000 of the 
principal and interest of the educational loans of such qualified 
physicians.
    ``(b) Application of Provisions.--Except as inconsistent with this 
section, the provisions of sections 338B, 338C, and 338E shall apply to 
the program established under this section to the same extent and in 
the same manner as such provisions apply to the National Health Service 
Corps Loan Repayment Program established in subpart III of part D of 
title III.
    ``(c) Qualified Physician.--For purposes of this section, the term 
`qualified physician' means an individual who has received, or will 
have received by the time of the research to be conducted under this 
section, a degree of doctor of medicine or its equivalent and is 
licensed to practice medicine in the United States.''.

SEC. 7. RESEARCH AND DATABASE ON BIOMARKERS OF AUTOIMMUNE DISEASES.

    Subpart 4 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285d et seq.) is amended by adding at the end the following:

``SEC. 442B. BIOMARKERS OF AUTOIMMUNE DISEASES.

    ``(a) Research.--The Director of the Institute shall conduct or 
support research on biomarkers of autoimmune diseases for the purpose 
of--
            ``(1) preventing such diseases; and
            ``(2) making dramatic improvements in the diagnosis, 
        treatment, and monitoring of such diseases.
    ``(b) Database.--The Director of the Institute shall establish and 
maintain a database on biomarkers of autoimmune diseases for the 
purpose of facilitating research on, and understanding of, the 
relationship between such biomarkers and the development and severity 
of autoimmune diseases.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $10,000,000 for each of fiscal 
years 2010 and 2011.''.
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