[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1774 Introduced in Senate (IS)]








109th CONGRESS
  1st Session
                                S. 1774

 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 SENATE OF THE UNITED STATES

                           September 27, 2005

  Mr. Cornyn (for himself and Ms. Mikulski) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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.

    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.
            (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.''.
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