I
107TH CONGRESS
1ST SESSION
H. R. 1297
To amend the Public Health Service Act to provide for the expansion, inten-
sification, and coordination of the activities of the National Heart, Lung,
and Blood Institute with respect to research on pulmonary hypertension.
IN THE HOUSE OF REPRESENTATIVES
MARCH 29, 2001
Mr. BRADY of Texas introduced the following bill; which was referred to the
Committee on Energy and Commerce
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 Insti-
tute with respect to research on pulmonary hypertension.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Pulmonary Hyper-
tension Research Act of 2001’’.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) In order to take full advantage of the tre-
mendous potential for finding a cure or effective
treatment, the Federal investment in pulmonary hy-
pertension must be expanded, and coordination
among the national research institutes of the Na-
tional Institutes of Health must be strengthened.
(2) Primary, or unexplained, pulmonary hyper-
tension (‘‘PPH’’) is a rare lung disorder which oc-
curs for no apparent reason. It has been historically
chronic and incurable with a poor survival rate.
(3) In the United States it has been estimated
that 300 new cases of PPH are diagnosed each year,
or about two persons per million population per
year; the greatest number are reported in women be-
tween 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 chil-
dren to elderly people, can develop PPH. It also af-
fects people of all racial and ethnic origins equally.
(4) The low prevalence of PPH makes learning
more about the disease extremely difficult. Studies
of PPH also have been difficult because a good ani-
mal model of the disease has not been available.
(5) In about 6 to 10 percent of cases, PPH is
familial.
(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.
(8) In 1981, the National Heart, Lung, and
Blood Institute established the first PPH-patient
registry in the world. The registry followed 194 peo-
ple 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) 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 iden-
tifying factors that cause growth of smooth muscle
and formation of scar tissue in the vessel walls.
(10) During the period January 1996 through
December 1997 almost 6,000,000 Americans took
anorexic drugs, which can cause PPH in some peo-
ple. Thousands now have PPH and are in terminal
stages or have already succumbed to the disease. It
is anticipated that many more cases of PPH from
diet drugs will be diagnosed within the coming years.
(11) 
Secondary 
pulmonary 
hypertension
(‘‘SPH’’) means the cause is known. Common
causes of SPH are the breathing disorders emphy-
sema 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 con-
genital heart diseases that cause shunting of extra
blood through the lungs like ventricular and atrial
septal defects, chronic pulmonary thromboembolism,
HIV infection, liver disease and certain diet drugs.
SEC. 3. EXPANSION, INTENSIFICATION, AND COORDINA-
TION OF ACTIVITIES OF NATIONAL HEART,
LUNG, AND BLOOD INSTITUTE WITH RESPECT
TO 
RESEARCH 
ON 
PULMONARY 
HYPER-
TENSION.
Subpart 2 of part C of title IV of the Public Health
Service Act (42 U.S.C. 285b et seq.) is amended by insert-
ing 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 coordi-
nate the activities of the Institute with respect to re-
search on pulmonary hypertension.
‘‘(2) 
COORDINATION
WITH
OTHER
INSTI-
TUTES.—The Director of the Institute shall coordi-
nate the activities of the Director under paragraph
(1) with similar activities conducted by other na-
tional research institutes and agencies of the Na-
tional 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 hyper-
tension.
‘‘(2) RESEARCH, TRAINING, AND INFORMATION
AND EDUCATION.—
‘‘(A) IN GENERAL.—With respect to pul-
monary hypertension, each center assisted
under paragraph (1) shall—
‘‘(i) conduct basic and clinical re-
search into the cause, diagnosis, early de-
tection, prevention, control, and treatment
of such disease;
‘‘(ii) conduct training programs for
scientists and health professionals;
‘‘(iii) conduct programs to provide in-
formation and continuing education to
health professionals; and
‘‘(iv) conduct programs for the dis-
semination of information to the public.
‘‘(B) STIPENDS FOR TRAINING OF HEALTH
PROFESSIONALS.—A center under paragraph
(1) may use funds under such paragraph to
provide stipends for scientists and health pro-
fessionals enrolled in 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 cen-
ter 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 SUP-
PORT.—The Director shall, subject to the extent of
amounts made available in appropriations Acts, pro-
vide for the establishment of not less than three cen-
ters under paragraph (1). Support of such a center
may be for a period not exceeding 5 years. Such pe-
riod may be extended for one or more additional pe-
riods not exceeding 5 years if the operations of such
center have been reviewed by an appropriate tech-
nical and scientific peer review group established by
the Director and if such group has recommended to
the Director that such period should be extended.
‘‘(c) DATA SYSTEM; CLEARINGHOUSE.—
‘‘(1) DATA SYSTEM.—The Director of the Insti-
tute shall establish a data system for the collection,
storage, analysis, retrieval, and dissemination of
data derived from patient populations with pul-
monary 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 dis-
semination of information, knowledge and under-
standing of pulmonary hypertension by health pro-
fessionals, 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 Na-
tional Institutes of Health with respect to primary hyper-
tension and through which the Director can receive com-
ments from the public regarding such programs and ac-
tivities.
‘‘(e) REPORTS.—The Director of the Institute shall
prepare biennial reports on the activities conducted and
supported under this section, and shall include such re-