[Congressional Record Volume 151, Number 122 (Tuesday, September 27, 2005)]
[Senate]
[Pages S10515-S10516]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. CORNYN (for himself and Ms. Mikulski):
S. 1774. A bill to amend the Public Health Service Act to provide for
the expansion, intensification, and coordination of the activities of
the National Heart, Lung, and Blood Institute with respect to research
on pulmonary hypertension; to the Committee on Health, Education,
Labor, and Pensions.
Mr. CORNYN. Mr. President, I ask unanimous consent that the text of
the bill be printed in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 1774
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 ``Pulmonary Hypertension
Research Act of 2005''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) In order to take full advantage of the tremendous
potential for finding a cure or effective treatment, the
Federal investment in pulmonary hypertension must be
expanded, and coordination among the national research
institutes of the National Institutes of Health must be
strengthened.
(2) Pulmonary hypertension (``PH'') is a serious and often
fatal condition where the blood pressure in the lungs rises
to dangerously high levels. In PH patients, the walls of the
arteries that take blood from the right side of the heart to
the lungs thicken and constrict. As a result, the right side
of the heart has to pump harder to move blood into the lungs,
causing it to enlarge and ultimately fail.
(3) In the United States it has been estimated that 300 new
cases of PPH are diagnosed each year, or about 2 persons per
million population per year; the greatest number are reported
in women between the ages of 21 and 40. While at one time the
disease was thought to occur among young women almost
exclusively, we now know, however, that men and women in all
age ranges, from very young children to elderly people, can
develop PPH. It also affects people of all racial and ethnic
origins, with African Americans suffering from a mortality
rate twice as high as that affecting Caucasians.
(4) The low prevalence of PPH makes learning more about the
disease extremely difficult. Studies of PPH also have been
difficult because a good animal model of the disease has not
been available.
(5) In about 6 to 10 percent of cases, PPH is familial. The
familial PPH gene is located on chromosome 2 and was
discovered in July 2000. This discovery provided new insights
for determining the molecular basis of PPH and opened new
avenues of study for understanding the fundamental nature of
the disease.
(6) In the more advanced stages of PPH, the patient is able
to perform only minimal activity and has symptoms even when
resting. The disease may worsen to the point where the
patient is completely bedridden.
(7) PPH remains a diagnosis of exclusion and is rarely
picked up in a routine medical examination. Even in its later
stages, the signs of the disease can be confused with other
conditions affecting the heart and lungs. The use of new
diagnostic standards has been positively related to the rates
of diagnosis.
[[Page S10516]]
(8) In 1981, the National Heart, Lung, and Blood Institute
established the first PPH-patient registry in the world. The
registry followed 194 people with PPH over a period of at
least 1 year and, in some cases, for as long as 7.5 years.
Much of what we know about the illness today stems from this
study.
(9) As research progresses, so do treatments for PH.
Currently, there are 4 FDA-approved medications for PH and 3
more in trials. However, all medications are not effective on
all patients. Lung transplantation is often considered a
treatment of last resort for PH.
(10) Because we still do not understand the cause or have a
cure for PPH, basic research studies are focusing on the
possible involvement of immunologic and genetic factors in
the cause and progression of PPH, looking at agents that
cause narrowing of the pulmonary blood vessels, and
identifying factors that cause growth of smooth muscle and
formation of scar tissue in the vessel walls.
(11) Secondary pulmonary hypertension (``SPH'') means the
cause is known. Common causes of SPH are the breathing
disorders emphysema and bronchitis. Other less frequent
causes are the inflammatory or collagen vascular diseases
such as scleroderma, CREST syndrome, or systemic lupus
erythematosus (``SLE''). Other causes include congenital
heart diseases that cause shunting of extra blood through the
lungs like ventricular and atrial septal defects, chronic
pulmonary thromboembolism, HIV infection, and liver disease.
Sickle cell anemia is also linked to SPH, with preliminary
studies suggesting that approximately one third of sickle
cell patients develop SPH.
SEC. 3. EXPANSION, INTENSIFICATION, AND COORDINATION OF
ACTIVITIES OF NATIONAL HEART, LUNG, AND BLOOD
INSTITUTE WITH RESPECT TO RESEARCH ON PULMONARY
HYPERTENSION.
Subpart 2 of part C of title IV of the Public Health
Service Act (42 U.S.C. 285b et seq.) is amended by inserting
after section 424B the following section:
``PULMONARY HYPERTENSION
``Sec. 424C. (a) In General.--
``(1) Expansion of activities.--The Director of the
Institute shall expand, intensify, and coordinate the
activities of the Institute with respect to research on
pulmonary hypertension.
``(2) Coordination with other institutes.--The Director of
the Institute shall coordinate the activities of the Director
under paragraph (1) with similar activities conducted by
other national research institutes and agencies of the
National Institutes of Health to the extent that such
Institutes and agencies have responsibilities that are
related to pulmonary hypertension.
``(b) Centers of Excellence.--
``(1) In general.--In carrying out subsection (a), the
Director of the Institute shall make grants to, or enter into
contracts with, public or nonprofit private entities for the
development and operation of centers to conduct research on
pulmonary hypertension.
``(2) Research, training, and information and education.--
``(A) In general.--With respect to pulmonary hypertension,
each center assisted under paragraph (1) shall--
``(i) conduct basic and clinical research into the cause,
diagnosis, early detection, prevention, control, and
treatment of such disease;
``(ii) conduct training programs for scientists and health
professionals;
``(iii) conduct programs to provide information and
continuing education to health professionals; and
``(iv) conduct programs for the dissemination of
information to the public.
``(B) Stipends for training of health professionals.--A
center under paragraph (1) may use funds provided under such
paragraph to provide stipends for scientists and health
professionals enrolled in the programs described in
subparagraph (A)(ii).
``(3) Coordination of centers; reports.--The Director
shall, as appropriate, provide for the coordination of
information among centers under paragraph (1) and ensure
regular communication between such centers, and may require
the periodic preparation of reports on the activities of the
centers and the submission of the reports to the Director.
``(4) Organization of centers.--Each center under paragraph
(1) shall use the facilities of a single institution, or be
formed from a consortium of cooperating institutions, meeting
such requirements as may be prescribed by the Director.
``(5) Number of centers; duration of support.--The Director
shall, subject to the extent of amounts made available in
appropriations Acts, provide for the establishment of not
less than 3 centers under paragraph (1). Support of such a
center may be for a period not exceeding 5 years. Such period
may be extended for 1 or more additional periods not
exceeding 5 years if--
``(A) the operations of such center have been reviewed by
an appropriate technical and scientific peer review group
established by the Director; and
``(B) such group has recommended to the Director that such
period should be extended.
``(c) Data System; Clearinghouse.--
``(1) Data system.--The Director of the Institute shall
establish a data system for the collection, storage,
analysis, retrieval, and dissemination of data derived from
patient populations with pulmonary hypertension, including,
where possible, data involving general populations for the
purpose of identifying individuals at risk of developing such
condition.
``(2) Clearinghouse.--The Director of the Institute shall
establish an information clearinghouse to facilitate and
enhance, through the effective dissemination of information,
knowledge and understanding of pulmonary hypertension by
health professionals, patients, industry, and the public.
``(d) Public Input.--In carrying out subsection (a), the
Director of the Institute shall provide for means through
which the public can obtain information on the existing and
planned programs and activities of the National Institutes of
Health with respect to primary hypertension and through which
the Director can receive comments from the public regarding
such programs and activities.
``(e) Reports.--The Director of the Institute shall prepare
biennial reports on the activities conducted and supported
under this section, and shall include such reports in the
biennial reports prepared by the Director under section 407.
``(f) Authorization of Appropriations.--For the purpose of
carrying out this section, there is authorized to be
appropriated $50,000,000 for each of the fiscal years 2006
through 2010.''.
Ms. MIKULSKI. Mr. President, I rise today with Senator Cornyn to
introduce the ``Pulmonary Hypertension Research Act of 2005.'' This
important legislation increases funding for medical research dedicated
to finding treatments and possibly a cure for Pulmonary Hypertension
(PH), and would establish Centers of Excellence that would be charged
with educating health professionals and the public about the disease.
PH is a serious, often fatal condition. It is estimated that more
than 100,000 Americans suffer from pulmonary hypertension. It does not
discriminate based on race, gender or age. However, women are more than
twice as likely as men to develop the condition. PH is characterized by
dangerously high blood pressure in the lungs. In PH patients, the walls
of the arteries that take blood from the right side of the heart to the
lungs thicken so much that they restrict the flow of blood.
The Pulmonary Hypertension Research Act would do three things: First,
it expands PH research at the National Heart, Lung and Blood Institute
at the NIH, authorizing $250 million over five years to fund PH
research. Additional funding would help researchers further understand
PH and develop new treatment options for the illness.
Second, the legislation would establish ``Centers of Excellence''
which would focus on PH research and education efforts for both health
professionals and the general public. One of the greatest tragedies of
PH is that it often goes undiagnosed. Most Americans have never heard
of PH and do not know that symptoms such as shortness of breath,
fatigue, and dizziness are common indicators of the illness. Lastly,
the legislation establishes a data system and clearinghouse at the
National Heart, Lung and Blood Institute that would disseminate
information on PH to the general public in order to facilitate more
accurate and timely diagnosis.
Since my first days in Congress, I have been fighting to make sure
women don't get left out or left behind when it comes to their health.
From women's inclusion in clinical trials to quality standards for
mammograms, I have led the way to make sure women's health needs are
treated fairly and taken seriously. This legislation builds on these
past successes to address this silent disease among young American
women. I look forward to working with my colleagues to get this bill
signed into law.
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