I

107TH CONGRESS

1ST SESSION H. R. 1297

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.

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 Institute with respect to research on pulmonary hypertension.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Pulmonary Hyper5 tension Research Act of 2001’’.

6 SEC. 2. FINDINGS.

7 The Congress finds as follows:
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1 (1) In order to take full advantage of the tre2 mendous potential for finding a cure or effective

3 treatment, the Federal investment in pulmonary hy4 pertension must be expanded, and coordination

5 among the national research institutes of the Na6 tional Institutes of Health must be strengthened.

7 (2) Primary, or unexplained, pulmonary hyper8 tension (‘‘PPH’’) is a rare lung disorder which oc9 curs for no apparent reason. It has been historically

10 chronic and incurable with a poor survival rate.

11 (3) In the United States it has been estimated

12 that 300 new cases of PPH are diagnosed each year,

13 or about two persons per million population per

14 year; the greatest number are reported in women be15 tween the ages of 21 and 40. While at one time the

16 disease was thought to occur among young women

17 almost exclusively; we now know, however, that men

18 and women in all age ranges, from very young chil19 dren to elderly people, can develop PPH. It also af20 fects people of all racial and ethnic origins equally.

21 (4) The low prevalence of PPH makes learning

22 more about the disease extremely difficult. Studies

23 of PPH also have been difficult because a good ani24 mal model of the disease has not been available.
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1 (5) In about 6 to 10 percent of cases, PPH is

2 familial.

3 (6) In the more advanced stages of PPH, the

4 patient is able to perform only minimal activity and

5 has symptoms even when resting. The disease may

6 worsen to the point where the patient is completely

7 bedridden.

8 (7) PPH remains a diagnosis of exclusion and

9 is rarely picked up in a routine medical examination.

10 Even in its later stages, the signs of the disease can

11 be confused with other conditions affecting the heart

12 and lungs.

13 (8) In 1981, the National Heart, Lung, and

14 Blood Institute established the first PPH-patient

15 registry in the world. The registry followed 194 peo16 ple with PPH over a period of at least 1 year and,

17 in some cases, for as long as 7.5 years. Much of

18 what we know about the illness today stems from

19 this study.

20 (9) Because we still do not understand the

21 cause or have a cure for PPH, basic research studies

22 are focusing on the possible involvement of

23 immunologic and genetic factors in the cause and

24 progression of PPH, looking at agents that cause

25 narrowing of the pulmonary blood vessels, and iden-
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1 tifying factors that cause growth of smooth muscle

2 and formation of scar tissue in the vessel walls.

3 (10) During the period January 1996 through

4 December 1997 almost 6,000,000 Americans took

5 anorexic drugs, which can cause PPH in some peo6 ple. Thousands now have PPH and are in terminal

7 stages or have already succumbed to the disease. It

8 is anticipated that many more cases of PPH from

9 diet drugs will be diagnosed within the coming years.

10 (11) Secondary pulmonary hypertension

11 (‘‘SPH’’) means the cause is known. Common

12 causes of SPH are the breathing disorders emphy13 sema and bronchitis. Other less frequent causes are

14 the inflammatory or collagen vascular diseases such

15 as scleroderma, CREST syndrome or systemic lupus

16 erythematosus (‘‘SLE’’). Other causes include con17 genital heart diseases that cause shunting of extra

18 blood through the lungs like ventricular and atrial

19 septal defects, chronic pulmonary thromboembolism,

20 HIV infection, liver disease and certain diet drugs.
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1 SEC. 3. EXPANSION, INTENSIFICATION, AND COORDINA2 TION OF ACTIVITIES OF NATIONAL HEART,

3 LUNG, AND BLOOD INSTITUTE WITH RESPECT

4 TO RESEARCH ON PULMONARY HYPER5 TENSION.

6 Subpart 2 of part C of title IV of the Public Health

7 Service Act (42 U.S.C. 285b et seq.) is amended by insert8 ing after section 424B the following section:

9 ‘‘PULMONARY HYPERTENSION

10 ‘‘SEC. 424C. (a) IN GENERAL.—

11 ‘‘(1) EXPANSION OF ACTIVITIES.—The Director

12 of the Institute shall expand, intensify, and coordi13 nate the activities of the Institute with respect to re14 search on pulmonary hypertension.

15 ‘‘(2) COORDINATION WITH OTHER INSTI16 TUTES.—The Director of the Institute shall coordi17 nate the activities of the Director under paragraph

18 (1) with similar activities conducted by other na19 tional research institutes and agencies of the Na20 tional Institutes of Health to the extent that such

21 Institutes and agencies have responsibilities that are

22 related to pulmonary hypertension.

23 ‘‘(b) CENTERS OF EXCELLENCE.—

24 ‘‘(1) IN GENERAL.—In carrying out subsection

25 (a), the Director of the Institute shall make grants

26 to, or enter into contracts with, public or nonprofit
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1 private entities for the development and operation of

2 centers to conduct research on pulmonary hyper3 tension.

4 ‘‘(2) RESEARCH, TRAINING, AND INFORMATION

5 AND EDUCATION.—

6 ‘‘(A) IN GENERAL.—With respect to pul7 monary hypertension, each center assisted

8 under paragraph (1) shall—

9 ‘‘(i) conduct basic and clinical re10 search into the cause, diagnosis, early de11 tection, prevention, control, and treatment

12 of such disease;

13 ‘‘(ii) conduct training programs for

14 scientists and health professionals;

15 ‘‘(iii) conduct programs to provide in16 formation and continuing education to

17 health professionals; and

18 ‘‘(iv) conduct programs for the dis19 semination of information to the public.

20 ‘‘(B) STIPENDS FOR TRAINING OF HEALTH

21 PROFESSIONALS.—A center under paragraph

22 (1) may use funds under such paragraph to

23 provide stipends for scientists and health pro24 fessionals enrolled in programs described in

25 subparagraph (A)(ii).
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1 ‘‘(3) COORDINATION OF CENTERS; REPORTS.—

2 The Director shall, as appropriate, provide for the

3 coordination of information among centers under

4 paragraph (1) and ensure regular communication

5 between such centers, and may require the periodic

6 preparation of reports on the activities of the centers

7 and the submission of the reports to the Director.

8 ‘‘(4) ORGANIZATION OF CENTERS.—Each cen9 ter under paragraph (1) shall use the facilities of a

10 single institution, or be formed from a consortium of

11 cooperating institutions, meeting such requirements

12 as may be prescribed by the Director.

13 ‘‘(5) NUMBER OF CENTERS; DURATION OF SUP14 PORT.—The Director shall, subject to the extent of

15 amounts made available in appropriations Acts, pro16 vide for the establishment of not less than three cen17 ters under paragraph (1). Support of such a center

18 may be for a period not exceeding 5 years. Such pe19 riod may be extended for one or more additional pe20 riods not exceeding 5 years if the operations of such

21 center have been reviewed by an appropriate tech22 nical and scientific peer review group established by

23 the Director and if such group has recommended to

24 the Director that such period should be extended.

25 ‘‘(c) DATA SYSTEM; CLEARINGHOUSE.—
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1 ‘‘(1) DATA SYSTEM.—The Director of the Insti2 tute shall establish a data system for the collection,

3 storage, analysis, retrieval, and dissemination of

4 data derived from patient populations with pul5 monary hypertension, including where possible, data

6 involving general populations for the purpose of

7 identifying individuals at risk of developing such

8 condition.

9 ‘‘(2) CLEARINGHOUSE.—The Director of the

10 Institute shall establish an information clearinghouse

11 to facilitate and enhance, through the effective dis12 semination of information, knowledge and under13 standing of pulmonary hypertension by health pro14 fessionals, patients, industry, and the public.

15 ‘‘(d) PUBLIC INPUT.—In carrying out subsection (a),

16 the Director of the Institute shall provide for means

17 through which the public can obtain information on the

18 existing and planned programs and activities of the Na19 tional Institutes of Health with respect to primary hyper20 tension and through which the Director can receive com21 ments from the public regarding such programs and ac22 tivities.

23 ‘‘(e) REPORTS.—The Director of the Institute shall

24 prepare biennial reports on the activities conducted and

25 supported under this section, and shall include such re-
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1 ports in the biennial reports prepared by the Director

2 under section 407.

3 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the

4 purpose of carrying out this section, there are authorized

5 to be appropriated such sums as may be necessary up to

6 $25,000,000 for each of the fiscal years 2002 through

7 2006. Such authorizations of appropriations are in addi8 tion to any other authorization of appropriations that is

9 available for such purpose.’’.

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