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Psoriasis and Psoriatic Arthritis Research, Cure, and Care Act of 2007
H.R. 1188 and S. 1459
February 27, 2007
Psoriasis Cure Now applauds introduction of psoriasis bill in Congress
Psoriasis Cure Now, a nonprofit patient advocacy group, today applauded the introduction of H.R. 1188, the Psoriasis and Psoriatic Arthritis Research, Cure, and Care Act of 2007. The bill was introduced by Congressmen David Wu of Oregon and Jim Gerlach of Pennsylvania.
“Congressmen David Wu and Jim Gerlach and the National Psoriasis Foundation have done a tremendous job in developing this historic psoriasis legislation,” said Michael Paranzino, president of Psoriasis Cure Now. “For more than a decade, psoriasis research has been underfunded by the federal government. This legislation could help reverse that.”
Psoriasis Cure Now has released a plain-language, section-by-section analysis of the legislation, to help psoriasis patients understand the bill more fully. The review also proposes improvements that would strengthen the bill as it winds its way through Congress. [That analysis is below.]
“As we continue to meet with Congressional offices to educate them about the seriousness of psoriasis, we will urge them to co-sponsor this bill and adopt our proposed changes to strengthen it,” Paranzino added. “We hope it becomes law.”
Congressman Gerlach was a Psoriasis Cure Now Health Care Advocate of the Year winner in 2006.
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H.R. 1188 [and S. 1459 (sponsored by Senator Robert Menendez of New Jersey)] – “Psoriasis and Psoriatic Arthritis Research, Cure, and Care Act of 2007”
Key points:
• Congressmen David Wu and Jim Gerlach and the National Psoriasis Foundation have done a tremendous job in developing this historic psoriasis legislation, and we should all hope to see it passed by Congress and signed into law by the President.
• The most important section of the bill is Section Four, Expansion of Biomedical Research. Psoriasis research has been underfunded for more than a decade, and this must change.
• Unfortunately, the bill does not authorize specific, increased funding levels for psoriasis research, something that we will seek to have changed as the bill winds its way through Congress. Given the poor funding of psoriasis research in the past, Congress should speak clearly on appropriate funding levels. While psoriasis research funding has been between $5 and $8 million annually for more than a decade, we believe this bill should authorize $20 million annually for psoriasis research at the National Institutes of Health (NIH).
• The bill appropriately focuses on work at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), and mentions coordination with other institutes, but we believe it should explicitly mention the National Institute of Allergy and Infectious Diseases (NIAID) and the National Human Genome Research Institute (NHGRI), institutes with budgets that dwarf the size of NIAMS and that study the immune system and the genome, respectively, both highly relevant to psoriasis, an immune system disease impacted by several genes.
• If only one section of this bill can make it into law, it should be Section Four, the section on increasing psoriasis research at NIH.
Please take a moment right now to write your lawmakers in Washington to urge increased research on psoriasis and psoriatic arthritis and to ask that they cosponsor this bill:
Section by Section analysis of H.R. 1188, the Psoriasis and Psoriatic Arthritis Research, Cure, and Care Act of 2007
[Note: this bill has been proposed by Members of Congress, but would not become law, and would have no legal effect, unless and until it is passed by both the U.S. House of Representatives and the United States Senate, and is signed into law by the President.]
Section One states the title of the bill.
Section Two is a Table of Contents.
Section Three is called “Findings.” Findings are statements of fact that Congress wants to draw attention to. The Findings have no legal impact, but it would still be helpful to have Congress pass and the President sign into law statements like “Psoriasis and psoriatic arthritis are autoimmune-mediated, chronic, inflammatory, painful, disfiguring, and life-altering diseases that require life-long sophisticated medical intervention and care and have no cure” and “Psoriasis and psoriatic arthritis constitute a significant national health issue”.
Section Four is the most important section of the bill: Expansion of Biomedical Research. This section would essentially order the National Institutes of Health (NIH), through the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), to “expand and intensify research and related activities of the Institutes with respect to psoriasis and psoriatic arthritis.” The section then lists 11 areas of promising research that should receive more attention, and it directs NIAMS to coordinate its work with any other parts of NIH that may be doing work on psoriasis and psoriatic arthritis.
Psoriasis patients need more and better treatment options and a cure, and it will take significant investments in biomedical research to get there. Psoriasis research has been woefully underfunded by the federal government for more than a decade. For the decade ending in 2005, research funded by NIH on other diseases doubled, while research on psoriasis fell by one-fifth. In 2006, psoriasis research finally increased, from $6.6 million to $8 million. But psoriasis research at NIH remains more than $30 million short of what would have been invested in psoriasis research had its funding merely kept pace with NIH’s growth over the last decade. In addition, NIH is currently projecting that in 2007, psoriasis research funding will dip back down again, to $7 million.
Unfortunately, this bill does not authorize specific, increased funding levels for psoriasis research, something that we will seek to have changed as the bill winds its way through Congress. Given the poor funding of psoriasis research in the past, Congress should speak clearly on appropriate funding levels. We believe this bill should authorize $20 million annually for psoriasis and psoriatic arthritis research at the National Institutes of Health. ($8 million is the most ever invested in psoriasis research in one year.) We should note that a Congressional “authorization” is no guarantee that money will actually be spent on something. An authorization still requires a Congressional “appropriation” to fund something.
Many other disease-specific bills authorize specific amounts by which they propose to increase research funding, including two other bills introduced on February 16, the day this psoriasis bill was introduced. H.R. 1157, the Breast Cancer and Environmental Research Act of 2007, includes an authorization for an additional $40 million annually for five years for research on environmental factors that may cause breast cancer. (Breast cancer research currently receives more than $700 million annually in NIH funding.) And H.R. 1113, the Inflammatory Bowel Disease Research Enhancement Act, includes an authorization for $270 million in research over three years. (Inflammatory bowel disease research currently receives about $70 million annually in NIH funding.)
Similarly, in December 2006, Congress passed and the President signed into law the Combating Autism Act. That law includes an authorization that would increase autism research funding at NIH from about $110 million to about $130 million annually. Clearly then, specific authorizations are a common and effective method used by Congress to increase funding on diseases it wants prioritized. We will seek revisions to this bill to lock in long-overdue increases in psoriasis research funding.
This section also directs NIAMS to coordinate all of NIH’s psoriasis work. We believe this section would be strengthened by specifically citing the National Institute of Allergy and Infectious Diseases (NIAID) and the National Human Genome Research Institute (NHGRI). The core research of these institutes is precisely the kind of work needed in the psoriasis field, specifically studies of the immune system underpinnings of psoriasis, and identification of all the genes that make people susceptible to psoriasis. In addition, the NIAID annual budget of roughly $4.4 billion dwarfs the budget of NIAMS, which, like the budget of NHGRI, is about $500 million annually. Even if psoriasis only captured a tiny sliver of the budgets of the nearly $5 billion spent annually by NIAID and NHGRI, it would dramatically expand the work that can be done on psoriasis, which as stated above has totaled between just $5 and $8 million annually for the past 15 years.
Section Five would establish a national psoriasis and psoriatic arthritis patient registry, by having the Centers for Disease Control and Prevention (CDC) contract with the National Psoriasis Foundation (the Foundation is not named but the section’s language is crafted to apply only to that organization, which is based in the Oregon Congressional District of the bill’s sponsor). The section authorizes up to $3 million in federal funds for the CDC/NPF collaboration over five years. We believe a properly-focused patient registry could be helpful, and are happy to see it specifically mentions including children and older Americans, a shortcoming in prior studies that we challenged in 2005. In fact, we have been asking lawmakers to create a long-term registry for psoriasis patients at CDC to track the impact and side effects of their psoriasis treatments over the decades that most patients must treat their disease.
But the section is not without problems. The section is very vague about what the registry would do. Aside from requiring that longitudinal data be collected (monitoring certain people for a long time--a good idea), the section is otherwise silent on the purposes of the registry. Compare this section to the registry proposed in H.R. 1113, the Inflammatory Bowel Disease (IBD) Research Enhancement Act mentioned above, which includes a specific section detailing the purposes of its registry:
“PURPOSES OF REGISTRY- The National Pediatric IBD Registry--
`(A) shall include a population-based registry of cases of pediatric IBD in the United States;
`(B) shall be used to gather data concerning--
`(i) pediatric IBD, including the incidence and prevalence of pediatric IBD in the United States;
`(ii) the genetic and environmental factors that may be associated with pediatric IBD;
`(iii) the age, race or ethnicity, gender, and family history of individuals who are diagnosed with pediatric IBD;
`(iv) treatment approaches and outcomes; and
`(v) other matters as recommended by the Advisory Committee established under subsection (b); and
`(C) shall be used to establish a secure method to put patients in contact with scientists studying the environmental and genetic causes of pediatric IBD or conducting clinical trials on pediatric IBD.”
We will seek to have a clear purposes section added to this section of the psoriasis bill, to ensure that the registry is focused on collecting the most valuable data.
Our other concern is that sometimes disease-specific bills like this psoriasis bill are chopped up, with parts of them cobbled together into one big multi-disease bill that is then passed by Congress and signed into law by the President. The other parts do not become law, and Congress then is highly unlikely to pass additional legislation about those diseases for several years. So you get one shot to get it right. If Congressional leaders decide to take a portion of the psoriasis bill and add it to a health care bill that will become law, they might drop the essential NIH research funding provision (Section Four) that will speed a cure, and instead select the much smaller (just $3 million spread over five years) registry section. We want it clear moving forward that a strong Section Four, providing an increase in psoriasis research funding, is the vital core of this legislation.
Section Six would convene a national summit of those interested in psoriasis and psoriatic arthritis both in and out of government to study the government’s involvement in key psoriasis issues (most notably psoriasis research) and then issue a report to Congress on the summit’s findings. This summit would be an excellent opportunity to educate the media about the seriousness of psoriasis, and the report would serve as a roadmap for what the federal government should do on behalf of the psoriasis patient community in the years ahead. The National Psoriasis Foundation and Psoriasis Cure Now jointly sought an NIH report in 2006 to address the psoriasis research funding shortfall; we continue to believe a report (and a summit) is a worthwhile idea.
Section Seven would create a study and report by the Institute of Medicine (IOM) about issues psoriasis patients face with insurers concerning access to treatments. Some insurance companies put roadblocks in place before they will cover psoriasis treatments and others simply deny treatment outright. An IOM study would help draw both Congressional and media attention to some of the unfair tactics being used by some insurers to deny psoriasis patients appropriate coverage.
In summary, this is a strong bill that would help those with psoriasis and psoriatic arthritis in several ways. Most importantly, if signed into law, it would lead to increased funding of psoriasis research, the single most valuable way the federal government can advance the search for a cure for psoriasis and psoriatic arthritis. We commend Congressmen Wu and Gerlach, and the National Psoriasis Foundation, for this important legislation. We will urge all lawmakers to cosponsor this bill as we also seek to strengthen the bill as outlined above.
Click here to read Psoriasis Cure Now’s 2005 testimony to Congress.
FULL TEXT OF LEGISLATION:
Psoriasis and Psoriatic Arthritis Research, Cure, and Care Act of 2007 (Introduced in House)
HR 1188
110th CONGRESS
1st Session
H. R. 1188
To strengthen the Nation's research efforts to identify the causes and cure of psoriasis and psoriatic arthritis, expand psoriasis and psoriatic arthritis data collection, study access to and quality of care for people with psoriasis and psoriatic arthritis, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
February 16, 2007
Mr. WU (for himself, Mr. GERLACH, Ms. WASSERMAN SCHULTZ, and Mr. LYNCH) introduced the following bill; which was referred to the Committee on Energy and Commerce
A BILL
To strengthen the Nation's research efforts to identify the causes and cure of psoriasis and psoriatic arthritis, expand psoriasis and psoriatic arthritis data collection, study access to and quality of care for people with psoriasis and psoriatic arthritis, 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 `Psoriasis and Psoriatic Arthritis Research, Cure, and Care Act of 2007'.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Findings.
Sec. 4. Expansion of biomedical research.
Sec. 5. National patient registry.
Sec. 6. National summit.
Sec. 7. Study and report by the Institute of Medicine.
SEC. 3. FINDINGS.
The Congress finds as follows:
(1) Psoriasis and psoriatic arthritis are autoimmune-mediated, chronic, inflammatory, painful, disfiguring, and life-altering diseases that require life-long sophisticated medical intervention and care and have no cure.
(2) Psoriasis and psoriatic arthritis affect as many as 7.5 million men, women, and children of all ages and have an adverse impact on the quality of life for virtually all affected.
(3) Psoriasis often is overlooked or dismissed because it does not cause death. Psoriasis is commonly and incorrectly considered by insurers, employers, policymakers, and the public as a mere annoyance, a superficial problem, mistakenly thought to be contagious and due to poor hygiene. Treatment for psoriasis often is categorized, wrongly, as `life-style' and not `medically necessary'.
(4) Psoriasis goes hand-in-hand with a myriad of co-morbidities such as Crohn's disease, diabetes, metabolic syndrome, obesity, hypertension, heart attack, cardiovascular disease, liver disease, and psoriatic arthritis, which occurs in 10 to 30 percent of people with psoriasis.
(5) The National Institute of Mental Health funded a study that found that psoriasis may cause as much physical and mental disability as other major diseases, including cancer, arthritis, hypertension, heart disease, diabetes, and depression.
(6) Psoriasis is associated with elevated rates of depression and suicidal ideation.
(7) Each year the people of the United States lose approximately 56 million hours of work and spend $2 billion to $3 billion to treat psoriasis.
(8) Early diagnosis and treatment of psoriatic arthritis may help prevent irreversible joint damage.
(9) Treating psoriasis and psoriatic arthritis presents a challenge for patients and their health care providers because no one treatment works for everyone, some treatments lose effectiveness over time, many treatments are used in combination with other treatments, and all treatments may cause a unique set of side effects.
(10) Although new and more effective treatments finally are becoming available, too many people do not yet have access to the types of therapies that may make a significant difference in the quality of their lives.
(11) Psoriasis and psoriatic arthritis constitute a significant national health issue that deserves a comprehensive and coordinated response by State and Federal governments with involvement of the health care provider, patient, and public health communities.
SEC. 4. EXPANSION OF BIOMEDICAL RESEARCH.
(a) In General- The Secretary of Health and Human Services (in this Act referred to as the `Secretary'), acting through the Director of the National Institutes of Health, shall expand and intensify research and related activities of the Institutes with respect to psoriasis and psoriatic arthritis.
(b) Research by NIAMS-
(1) IN GENERAL- The Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases shall conduct or support research to expand understanding of the causes of, and to find a cure for, psoriasis and psoriatic arthritis. Such research shall include the following:
(A) Basic research to discover the pathogenesis and pathophysiology of the disease.
(B) Expansion of molecular genetics and immunology studies, including additional animal models.
(C) Global association mapping with single nucleotide polymorphisms.
(D) Identification of environmental triggers and autoantigens in psoriasis.
(E) Elucidation of specific immune receptor cells and their products involved.
(F) Pharmcogenetic studies to understand the molecular basis for varying patient response to treatment.
(G) Identification of genetic markers of psoriatic arthritis susceptibility.
(H) Research to increase understanding of joint inflammation and destruction in psoriatic arthritis.
(I) Clinical research for the development and evaluation of new treatments, including new biological agents.
(J) Research to develop improved diagnostic tests.
(K) Research to increase understanding of co-morbidities and psoriasis, including shared molecular pathways.
(2) COORDINATION WITH OTHER INSTITUTES- In carrying out paragraph (1), the Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases shall coordinate the activities of the Institute with the activities of other national research institutes and other agencies and offices of the National Institutes of Health relating to psoriasis or psoriatic arthritis.
SEC. 5. NATIONAL PATIENT REGISTRY.
(a) In General- The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in collaboration with an eligible national organization, shall establish a national psoriasis and psoriatic arthritis patient registry.
(b) Cooperative Agreements- In carrying out subsection (a), the Secretary shall enter into cooperative agreements with an eligible national organization and appropriate academic health institutions to develop, implement, and manage a system for psoriasis and psoriatic arthritis patient data collection and analysis, including the creation and use of a common data entry and management system.
(c) Longitudinal Data- In carrying out subsection (a), the Secretary shall ensure the collection and analysis of longitudinal data related to individuals of all ages with psoriasis and psoriatic arthritis, including infants, young children, adolescents, and adults of all ages including older Americans.
(d) Eligible National Organization- In this section, the term `eligible national organization' means a national organization that--
(1) has expertise in the epidemiology of psoriasis and psoriatic arthritis; and
(2) maintains an established patient registry or biobank.
(e) Authorization of Appropriations- To carry out this section, there are authorized to be appropriated $1,000,000 for fiscal year 2008 and $500,000 for each of fiscal years 2009 through 2012.
SEC. 6. NATIONAL SUMMIT.
(a) In General- Not later than one year after the date of enactment of this Act, the Secretary shall convene a summit on the current activities of the Federal Government to conduct or support research, treatment, education, and quality-of-life activities with respect to psoriasis and psoriatic arthritis, including psoriasis and psoriatic arthritis related co-morbidities. The summit shall include researchers, public health professionals, representatives of voluntary health agencies and patient advocacy organizations, representatives of academic institutions, and Federal and State policymakers.
(b) Focus- The summit convened under this section shall focus on--
(1) a broad range of research activities relating to biomedical, epidemiological, psychosocial, and rehabilitative issues;
(2) clinical research for the development and evaluation of new treatments, including new biological agents;
(3) translational research;
(4) information and education programs for health care professionals and the public;
(5) priorities among the programs and activities of the various Federal agencies involved in psoriasis and psoriatic arthritis and psoriasis and psoriatic arthritis related co-morbidities; and
(6) challenges and opportunities for scientists, clinicians, patients, and voluntary organizations.
(c) Report to Congress- Not later than 180 days after the first day of the summit convened under this section, the Secretary shall submit to the Congress and make publicly available a report that includes a description of--
(1) the proceedings at the summit; and
(2) the research, treatment, education, and quality-of-life activities conducted or supported by the Federal Government with respect to psoriasis and psoriatic arthritis, including psoriasis and psoriatic arthritis related co-morbidities.
(d) Authorization of Appropriations- To carry out this section, there are authorized such sums as may be necessary for each of fiscal years 2008 through 2010.
SEC. 7. STUDY AND REPORT BY THE INSTITUTE OF MEDICINE.
(a) In General- The Secretary shall enter into an agreement with the Institute of Medicine to conduct a study on the following:
(1) The extent to which public and private insurers cover prescription medications and other treatments for psoriasis and psoriatic arthritis.
(2) The payment structures, such as deductibles and co-payments, and the amounts and duration of coverage under health plans and their adequacy to cover the costs of providing ongoing care to patients with psoriasis and psoriatic arthritis.
(3) Health plan and insurer coverage policies and practices and their impact on the access of such patients to the best regimen and most appropriate care for their particular disease state.
(b) Report- The agreement entered into under subsection (a) shall provide for the Institute of Medicine to submit to the Secretary of Health and Human Services and the Congress, not later than 18 months after the date of the enactment of this Act, a report containing a description of the results of the study conducted under this section and the conclusions and recommendations of the Institutes of Medicine regarding each of the issues described in paragraphs (1) through (3) of subsection (a).
[END]
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