[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6214 Introduced in House (IH)]
109th CONGRESS
2d Session
H. R. 6214
To increase awareness of and research on autoimmune diseases, which are
a major women's health problem, affect as many as 22 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, sarcoidosis, and
fibromyalgia, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 27, 2006
Mr. Kennedy of Rhode Island 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 22 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, sarcoidosis, and
fibromyalgia, 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 Disease Act of 2006''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) The National Institutes of Health estimates that
between 14 and 22 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) Frequently used immunosuppressant treatments lead to
devastating long-term side effects. Those with autoimmune
diseases lack effective treatments.
(7) 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.
(8) Understanding how to modulate immune system activity
will benefit transplant recipients, cancer patients, AIDS
patients, and infectious disease patients.
(9) The National Institutes of Health estimates that annual
direct health care costs for autoimmune disease are in the
range of $100,000,000,000.
(10) 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.
(11) 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, sarcoidosis, and fibromyalgia.
(12) 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.
(13) 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
250,000 to 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 $50,000, 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.
(14) 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.
(15) 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.
(16) 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.
(17) Fibromyalgia is believed to affect approximately
3,700,000 people (approximately 2 percent of the United States
population) and occurs more commonly in women than men. Current
research supports a high correlation of those diagnosed with
fibromyalgia also diagnosed with an autoimmune disease.
Symptoms usually occur first between the ages of 20 to 40 years
old. Fibromyalgia is widespread pain and tenderness, fatigue,
and exhaustion after minimal effort. Fibromyalgia is a lifelong
disorder, with more than 90 percent of patients remaining
symptomatic. Nearly 30 percent of patients claim they cannot
hold steady employment due to their condition. The total yearly
drain on the United States economy is estimated to be over
$20,000,000,000. About 16.2 percent of fibromyalgia patients
draw Social Security disability payments. The average health
care cost per patient per year is close to $2,300.
(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 underbefore 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. GRANTS TO INCREASE AWARENESS OF AUTOIMMUNE DISEASES.
(a) Purpose.--The purpose of this section is to increase awareness
of autoimmune diseases, such as lupus, multiple sclerosis, rheumatoid
arthritis, and fibromyalgia, 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 317S the
following:
``Sec. 317T. (a) Grants to Increase Awareness of Autoimmune
Diseases.--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, such as lupus, multiple sclerosis,
rheumatoid arthritis, and fibromyalgia.
``(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, such as lupus, multiple
sclerosis, rheumatoid arthritis, and fibromyalgia.
``(2) Target minority communities that may be underserved
or disproportionately affected by autoimmune diseases, such as
lupus, multiple sclerosis, rheumatoid arthritis, and
fibromyalgia.
``(3) Target women (who are disproportionately affected by
autoimmune diseases, such as lupus, multiple sclerosis,
rheumatoid arthritis, and fibromyalgia) 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, a consumer group, 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 2007 and 2008.''.
SEC. 4. 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 3, is amended by inserting after section 317T the
following:
``Sec. 317U. (a) Grants for Education on Relationship Between
Autoimmune Diseases and Mental Illnesses.--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, such as lupus, multiple sclerosis, rheumatoid
arthritis, and fibromyalgia, and cognitive and mood disorders, such as
depression.
``(b) Eligible Entity.--For purposes of this section, the term
`eligible entity' means a nonprofit organization, a consumer group, 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 2007 and 2008.''.
SEC. 5. 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, such as lupus, multiple sclerosis, rheumatoid arthritis, and
fibromyalgia, 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 any 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.
``(d) Funding.--
``(1) Authorization of appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for 2007 and each
subsequent fiscal year.
``(2) Availability.--Amounts appropriated for carrying out
this section shall remain available until the expiration of the
second fiscal year beginning after the fiscal year for which
the amounts were made available.''.
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