[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.
                                 ______