[Congressional Record Volume 145, Number 148 (Wednesday, October 27, 1999)]
[Senate]
[Pages S13273-S13275]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KENNEDY (for himself, Mr. Frist, Mr. Jeffords, Ms. 
        Mikulski, Mrs. Murray, Mr. Durbin, and Mr. Cochran):
  S. 1813. A bill to expand the Public Health Service Act to provide 
additional support for and to expand clinical research programs, and 
for other purposes; to the Committee on Health, Education, Labor, and 
Pensions.


             the clinical research enhancement act of 1999

  Mr. KENNEDY. Mr. President, today I join with my colleagues, Senator 
Frist, Senator Jeffords, Senator Mikulski, Senator Murray, Senator 
Durbin, and Senator Cochran to introduce the ``Clinical Research 
Enhancement Act of 1999''.
  Our goal is to enhance support for clinical research, which is 
central to biomedical research. Major advances in basic biological 
research are opening doors to new insights into all aspects of 
medicine. As a result, extraordinary opportunities exist for cutting-
edge clinical research to bring breakthroughs in the laboratory to the 
bedside of the patient. Clinical research is essential for the 
advancement of scientific knowledge and the development of cures and 
treatments for disease. In addition, the results of clinical research 
are incorporated by industry and used to develop new drugs, vaccines, 
and health care products. These advances in turn strengthen the economy 
and create jobs.
  Unfortunately, the number of physicians choosing careers in clinical 
research is in serious decline. Between 1994 and 1998, the number of 
physicians applying for first-time NIH grants decreased by 21 percent. 
Studies by the Institute of Medicine, the National Research Council, 
the National Academy of Sciences, and the National Institutes of Health 
have all highlighted the significant problems faced by clinical 
researchers, including lack of grant support, lack of training 
opportunities, and the heavy debt burden from medical school.
  The legislation we are introducing today seeks to enhance clinical 
research by addressing these issues. Our bill will provide research 
support and training opportunities for clinical researchers at all 
stages of their careers, as well as the necessary infrastructure to 
conduct clinical research.
  The bill establishes several research grant awards. The Mentored 
Patient-Oriented Research Career Development Awards will support 
clinical investigators in the early phases of their independent careers 
by providing salary and other support for a period of supervised study. 
The Mid-Career Investigator Awards in Patient-Oriented Research will 
provide support for mid-career clinicians, to give them time for 
clinical research and to act as mentors for beginning investigators.
  To encourage the training of clinical investigators at various stages 
in their careers, the bill establishes several programs. The NIH will 
support intramural and extramural training programs for medical and 
dental students. For students who want to pursue an advanced degree in 
clinical research, the bill provides support for both students and 
institutions to create training programs. For post-graduate education, 
NIH will support continuing education in such research.
  Our legislation also creates a clinical research tuition loan 
repayment program to encourage recruitment of new investigators. 
Student debt is a major barrier to clinical research. Young physicians 
graduate from medical school with an average debt of $86,000. Because 
of the limited financial opportunities in clinical research to repay 
their large debts, many young physicians are under great pressure to 
choose more lucrative fields of medical practice. NIH has acknowledged 
this problem, and has established an intramural loan repayment program 
to encourage the recruitment of clinical researchers to NIH. Our 
legislation expands the current program, so that researchers throughout 
the country will be eligible.

  A solid infrastructure is essential to any research program. In 
clinical research, that infrastructure is provided, in part, by the 
general clinical research centers at academic health centers throughout 
the country. Our bill provides statutory authority for those clinical 
research centers.
  In the past, support for these centers was once provided largely by 
academic health centers. However, academic health centers today are 
confronted with heavy competition from non-teaching institutions and 
are increasingly emphasizing patient care over research to minimize 
costs. In the face of these changes, clinical researchers have become 
much more dependent on NIH for infrastructure support.
  I look forward to working with my colleagues to move this important 
legislation through Congress. Our bill is supported by over 70 
biomedical associations and organizations. I commend the American 
Federation for Medical Research for its support of this legislation. 
Mr. President, I ask unanimous consent that a copy of the bill, the 
American Federation for Medical Research's letter of support, and a 
list of supporters be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                S. 1813

       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 ``Clinical Research 
     Enhancement Act of 1999''.

      SEC. 2. FINDINGS AND PURPOSE.

       (a) Findings.--Congress makes the following findings:
       (1) Clinical research is critical to the advancement of 
     scientific knowledge and to the development of cures and 
     improved treatment for disease.
       (2) Tremendous advances in biology are opening doors to new 
     insights into human physiology, pathophysiology and disease, 
     creating extraordinary opportunities for clinical research.
       (3) Clinical research includes translational research which 
     is an integral part of the research process leading to 
     general human applications. It is the bridge between the 
     laboratory and new methods of diagnosis, treatment, and 
     prevention and is thus essential to progress against cancer 
     and other diseases.
       (4) The United States will spend more than 
     $1,200,000,000,000 on health care in 1999, but the Federal 
     budget for health research at the National Institutes of 
     Health was $15,600,000,000 only 1 percent of that total.
       (5) Studies at the Institute of Medicine, the National 
     Research Council, and the National Academy of Sciences have 
     all addressed the current problems in clinical research.
       (6) The Director of the National Institutes of Health has 
     recognized the current problems in clinical research and 
     appointed a special panel, which recommended expanded support 
     for existing National Institutes of Health clinical research 
     programs and the creation of new initiatives to recruit and 
     retain clinical investigators.
       (7) The current level of training and support for health 
     professionals in clinical research is fragmented, 
     undervalued, and underfunded.
       (8) Young investigators are not only apprentices for future 
     positions but a crucial source of energy, enthusiasm, and 
     ideas in the day-to-day research that constitutes the 
     scientific enterprise. Serious questions about the future of 
     life-science research are raised by the following:
       (A) The number of young investigators applying for grants 
     dropped by 54 percent between 1985 and 1993.
       (B) The number of physicians applying for first-time 
     National Institutes of Health research project grants fell 
     from 1226 in 1994 to 963 in 1998, a 21 percent reduction.

[[Page S13274]]

       (C) Newly independent life-scientists are expected to raise 
     funds to support their new research programs and a 
     substantial proportion of their own salaries.
       (9) The following have been cited as reasons for the 
     decline in the number of active clinical researchers, and 
     those choosing this career path:
       (A) A medical school graduate incurs an average debt of 
     $85,619, as reported in the Medical School Graduation 
     Questionnaire by the Association of American Medical Colleges 
     (AAMC).
       (B) The prolonged period of clinical training required 
     increases the accumulated debt burden.
       (C) The decreasing number of mentors and role models.
       (D) The perceived instability of funding from the National 
     Institutes of Health and other Federal agencies.
       (E) The almost complete absence of clinical research 
     training in the curriculum of training grant awardees.
       (F) Academic Medical Centers are experiencing difficulties 
     in maintaining a proper environment for research in a highly 
     competitive health care marketplace, which are compounded by 
     the decreased willingness of third party payers to cover 
     health care costs for patients engaged in research studies 
     and research procedures.
       (10) In 1960, general clinical research centers were 
     established under the Office of the Director of the National 
     Institutes of Health with an initial appropriation of 
     $3,000,000.
       (11) Appropriations for general clinical research centers 
     in fiscal year 1999 equaled $200,500,000.
       Since the late 1960s, spending for general clinical 
     research centers has declined from approximately 3 percent to 
     1 percent of the National Institutes of Health budget.
       (12) In fiscal year 1999, there were 77 general clinical 
     research centers in operation, supplying patients in the 
     areas in which such centers operate with access to the most 
     modern clinical research and clinical research facilities and 
     technologies.
       (b) Purpose.--It is the purpose of this Act to provide 
     additional support for and to expand clinical research 
     programs.

     SEC. 3. INCREASING THE INVOLVEMENT OF THE NATIONAL INSTITUTES 
                   OF HEALTH IN CLINICAL RESEARCH.

       Part B of title IV of the Public Health Service Act (42 
     U.S.C. 284 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 409C. CLINICAL RESEARCH.

       ``(a) In General.--The Director of National Institutes of 
     Health shall undertake activities to support and expand the 
     involvement of the National Institutes of Health in clinical 
     research.
       ``(b) Requirements.--In carrying out subsection (a), the 
     Director of National Institutes of Health shall--
       ``(1) consider the recommendations of the Division of 
     Research Grants Clinical Research Study Group and other 
     recommendations for enhancing clinical research; and
       ``(2) establish intramural and extramural clinical research 
     fellowship programs directed specifically at medical and 
     dental students and a continuing education clinical research 
     training program at the National Institutes of Health.
       ``(c) Support for the Diverse Needs of Clinical Research.--
     The Director of National Institutes of Health, in cooperation 
     with the Directors of the Institutes, Centers, and Divisions 
     of the National Institutes of Health, shall support and 
     expand the resources available for the diverse needs of the 
     clinical research community, including inpatient, outpatient, 
     and critical care clinical research.
       ``(d) Peer Review.--The Director of National Institutes of 
     Health shall establish peer review mechanisms to evaluate 
     applications for the awards and fellowships provided for in 
     subsection (b)(2) and section 409D. Such review mechanisms 
     shall include individuals who are exceptionally qualified to 
     appraise the merits of potential clinical research training 
     and research grant proposals.''.

     SEC. 4. GENERAL CLINICAL RESEARCH CENTERS.

       (a) Grants.--Subpart 1 of part B of title IV of the Public 
     Health Service Act (42 U.S.C. 287 et seq.) is amended by 
     adding at the end the following:

     ``SEC. 481C. GENERAL CLINICAL RESEARCH CENTERS.

       ``(a) Grants.--The Director of the National Center for 
     Research Resources shall award grants for the establishment 
     of general clinical research centers to provide the 
     infrastructure for clinical research including clinical 
     research training and career enhancement. Such centers shall 
     support clinical studies and career development in all 
     settings of the hospital or academic medical center involved.
       ``(b) Activities.--In carrying out subsection (a), the 
     Director of National Institutes of Health shall expand the 
     activities of the general clinical research centers through 
     the increased use of telecommunications and telemedicine 
     initiatives.
       ``(c) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated such sums as may be necessary for each fiscal 
     year.''.
       (b) Enhancement Awards.--Part B of title IV of the Public 
     Health Service Act (42 U.S.C. 284 et seq.), as amended by 
     section 3, is further amended by adding at the end the 
     following:

     ``SEC. 409D. ENHANCEMENT AWARDS.

       ``(a) Mentored Patient-Oriented Research Career Development 
     Awards.--
       ``(1) Grants.--
       ``(A) In general.--The Director of the National Institutes 
     of Health shall make grants (to be referred to as `Mentored 
     Patient-Oriented Research Career Development Awards') to 
     support individual careers in clinical research at general 
     clinical research centers or at other institutions that have 
     the infrastructure and resources deemed appropriate for 
     conducting patient-oriented clinical research.
       ``(B) Use.--Grants under subparagraph (A) shall be used to 
     support clinical investigators in the early phases of their 
     independent careers by providing salary and such other 
     support for a period of supervised study.
       ``(2) Applications.--An application for a grant under this 
     subsection shall be submitted by an individual scientist at 
     such time as the Director may require.
       ``(3) Authorization of appropriations.--For the purpose of 
     carrying out this subsection, there are authorized to be 
     appropriated such sums as may be necessary for each fiscal 
     year.
       ``(b) Mid-Career Investigator Awards in Patient-Oriented 
     Research.--
       ``(1) Grants.--
       ``(A) In general.--The Director of the National Institutes 
     of Health shall make grants (to be referred to as `Mid-Career 
     Investigator Awards in Patient-Oriented Research') to support 
     individual clinical research projects at general clinical 
     research centers or at other institutions that have the 
     infrastructure and resources deemed appropriate for 
     conducting patient-oriented clinical research.
       ``(B) Use.--Grants under subparagraph (A) shall be used to 
     provide support for mid-career level clinicians to allow such 
     clinicians to devote time to clinical research and to act as 
     mentors for beginning clinical investigators.
       ``(2) Applications.--An application for a grant under this 
     subsection shall be submitted by an individual scientist at 
     such time as the Director requires.
       ``(3) Authorization of appropriations.--For the purpose of 
     carrying out this subsection, there are authorized to be 
     appropriated such sums as may be necessary for each fiscal 
     year.
       ``(c) Graduate Training in Clinical Investigation Award.--
       ``(1) In general.--The Director of the National Institutes 
     of Health shall make grants (to be referred to as `Graduate 
     Training in Clinical Investigation Awards') to support 
     individuals pursuing master's or doctoral degrees in clinical 
     investigation.
       `` (2) Applications.--An application for a grant under this 
     subsection shall be submitted by an individual scientist at 
     such time as the Director may require.
       `` (3) Limitations.--Grants under this subsection shall be 
     for terms of 2 years or more and shall provide stipend, 
     tuition, and institutional support for individual advanced 
     degree programs in clinical investigation.
       ``(4) Definition.--As used in this subsection, the term 
     `advanced degree programs in clinical investigation' means 
     programs that award a master's or Ph.D. degree in clinical 
     investigation after 2 or more years of training in areas such 
     as the following:
       ``(A) Analytical methods, biostatistics, and study design.
       ``(B) Principles of clinical pharmacology and 
     pharmacokinetics.
       ``(C) Clinical epidemiology.
       ``(D) Computer data management and medical informatics.
       ``(E) Ethical and regulatory issues.
       ``(F) Biomedical writing.
       ``(5) Authorization of appropriations.--For the purpose of 
     carrying out this subsection, there are authorized to be 
     appropriated such sums as may be necessary for each fiscal 
     year.
       ``(d) Clinical Research Curriculum Awards.--
       ``(1) In general.--The Director of the National Institutes 
     of Health shall make grants (to be referred to as `Clinical 
     Research Curriculum Awards') to institutions for the 
     development and support of programs of core curricula for 
     training clinical investigators, including medical students. 
     Such core curricula may include training in areas such as the 
     following:
       ``(A) Analytical methods, biostatistics, and study design.
       ``(B) Principles of clinical pharmacology and 
     pharmacokinetics.
       ``(C) Clinical epidemiology.
       ``(D) Computer data management and medical informatics.
       ``(E) Ethical and regulatory issues.
       ``(F) Biomedical writing.
       ``(2) Applications.--An application for a grant under this 
     subsection shall be submitted by an individual institution or 
     a consortium of institutions at such time as the Director may 
     require. An institution may submit only 1 such application.
       ``(3) Limitations.--Grants under this subsection shall be 
     for terms of up to 5 years and may be renewable.
       ``(4) Authorization of appropriations.--For the purpose of 
     carrying out this subsection, there are authorized to be 
     appropriated such sums as may be necessary for each fiscal 
     year.''.

     SEC. 5. LOAN REPAYMENT PROGRAM REGARDING CLINICAL 
                   RESEARCHERS.

       Part G of title IV of the Public Health Service Act is 
     amended by inserting after section 487E (42 U.S.C. 288-5) the 
     following:

[[Page S13275]]

     ``SEC. 487F. LOAN REPAYMENT PROGRAM REGARDING CLINICAL 
                   RESEARCHERS.

       ``(a) In General.--The Secretary, acting through the 
     Director of the National Institutes of Health, shall 
     establish a program to enter into contracts with qualified 
     health professionals under which such health professionals 
     agree to conduct clinical research, in consideration of the 
     Federal Government agreeing to repay, for each year of 
     service conducting such research, not more than $35,000 of 
     the principal and interest of the educational loans of such 
     health professionals.
       ``(b) Application of Provisions.--The provisions of 
     sections 338B, 338C, and 338E shall, except as inconsistent 
     with subsection (a) of this section, apply to the program 
     established under subsection (a) to the same extent and in 
     the same manner as such provisions apply to the National 
     Health Service Corps Loan Repayment Program established in 
     subpart III of part D of title III.
       ``(c) Funding.--
       ``(1) Authorization of appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated such sums as may be necessary for each fiscal 
     year.
       ``(2) Availability.--Amounts appropriated for carrying out 
     this section shall remain available until the expiration of 
     the second fiscal year beginning after the fiscal year for 
     which the amounts were made available.''.

     SEC. 6. DEFINITION.

       Section 409 of the Public Health Service Act (42 U.S.C. 
     284d) is amended--
       (1) by striking ``For purposes'' and inserting ``(a) Health 
     Service Research.--For purposes''; and
       (2) by adding at the end the following:
       ``(b) Clinical Research.--As used in this title, the term 
     `clinical research' means patient oriented clinical research 
     conducted with human subjects, or research on the causes and 
     consequences of disease in human populations involving 
     material of human origin (such as tissue specimens and 
     cognitive phenomena) for which an investigator or colleague 
     directly interacts with human subjects in an outpatient or 
     inpatient setting to clarify a problem in human physiology, 
     pathophysiology or disease, or epidemiologic or behavioral 
     studies, outcomes research or health services research, or 
     developing new technologies, therapeutic interventions, or 
     clinical trials.''.

     SEC. 7. OVERSIGHT BY GENERAL ACCOUNTING OFFICE.

       Not later than 18 months after the date of enactment of 
     this Act, the Comptroller General of the United States shall 
     submit to the Congress a reporting describing the extent to 
     which the National Institutes of Health has complied with the 
     amendments made by this Act.
                                  ____

                                               American Federation


                                         for Medical Research,

                                  Washington, DC, October 27, 1999
     Hon. Edward Kennedy,
     U.S. Senate, Washington, DC.
       Dear Senator Kennedy: I write to thank you for your 
     continued support of the need to enhance clinical research 
     programs at the National Institutes of Health by 
     reintroducing the Clinical Research Enhancement Act. The 
     American Federation for Medical Research, a national 
     organization of over 5,000 physician-scientists who are 
     involved in basic, translational, clinical and health 
     services research, is committed to the improvement of human 
     health through the translation of basic scientific 
     discoveries to treatments and cures for disease.
       For many years, academic medical centers have been able to 
     provide institutional support to young physician-scientists 
     who are interested in pursuing careers in biomedical 
     research. However, as the health care marketplace has become 
     increasingly competitive, academic centers have all but 
     eliminated internal subsidies for clinical research or the 
     training of clinical investigators. In fact, the Association 
     of American Medical Colleges has estimated that these 
     institutions have lost approximately $800 million in annual 
     ``purchasing power'' for research and research training 
     within their institutions.
       Unfortunately, young investigators and medical students 
     have suffered as a result of the loss of these funds from the 
     system. The AMA has reported that the number of medical 
     school graduates indicating an interest in a research career 
     has fallen steadily in the 1990's. In addition, the number of 
     first time physician applicants to the National Institutes of 
     Health for research support has fallen by at least 20 percent 
     between 1994 and 1997. It is important that these downward 
     trends are stopped. These lost physician scientists represent 
     the next generation who will move basic science discoveries 
     to patients. We thank you for introducing the Clinical 
     Research Enhancement Act, an extremely modest investment in a 
     much-needed program to reinvigorate our nation's clinical 
     research capabilities.
       There is a strong consensus among the 70 scientific and 
     consumer organizations that have endorsed this legislation 
     that Congress must stop the deterioration of the U.S. 
     clinical research capacity. In addition, we must assure that 
     the American people and the American economy benefit from the 
     translation of basic science breakthroughs to improved 
     clinical care and new medical products. The American 
     Federation for Medical Research is pleased to have the 
     opportunity to express its strong support for this important 
     piece of legislation.
           Sincerely,
                                               William Lowe, M.D.,
     President.
                                  ____


       Supporters of the Senate Clinical Research Enhancement Act

       Academy of Radiology Research, Alliance for Aging Research, 
     Alzheimer's Association, Ambulatory Pediatric Association, 
     American Academy of Child and Adolescent Psychiatry, American 
     Academy of Neurology, American Academy of Pediatrics, 
     American Academy of Physical Medicine and Rehabilitation, 
     American Academy of Optometry, American Academy of Orthopedic 
     Surgeons, American Academy of Otolaryngology-Head and Neck 
     Surgery, American Academy of Pediatrics, American Association 
     for Cancer Research, American Association for Dental 
     Research, American Association for the Study of Liver 
     Disease, American Association of Dental Schools, American 
     College of Cardiology, American College of 
     Neuropsychopharmacology, American College of Physicians--
     American Society of Internal Medicine, American College of 
     Preventive Medicine.
       American Federation for Medical Research, American Heart 
     Association, American Kidney Fund, American Pediatric 
     Society, American Podiatric Medical Association, American 
     Professors of Dermatology, American Society for Clinical 
     Pharmacology and Therapeutics, American Society for Clinical 
     Nutrition, American Society for Investigative Pathology, 
     American Society for Reproductive Medicine, American Society 
     for Addiction Medicine, American Society for Hematology, 
     American Urological Association, Arthritis Foundation, 
     Association for Research in Vision and Ophthalmology, 
     Association of Academic Health Centers, Association of 
     American Cancer Institutes, Association of Departments of 
     Family Medicine, Association of Medical Schools Pediatric 
     Department Chairs, Association of Pathology Chairs.
       Association of University Professors of Ophthalmology, 
     Citizens for Public Action, Coalition for American Trauma 
     Care, Coalition of Patient Advocates for Skin Disease 
     Research, College on Problems of Drug Dependence, Cooley's 
     Anemia Foundation, Cystic Fibrosis Foundation, East Carolina 
     University School of Medicine, Epilepsy Foundation, 
     Federation of Behavioral, Psychological & Cognitive Sciences, 
     Friends of the National Institute of Dental Research, General 
     Clinical Research Centers Program Directors Association, 
     Jeffrey Modell Foundation, Medical Dermatology Society, 
     National Alopecia Areata Foundation.
       National Caucus of Basic Biomedical Science Chairs, 
     National Health Council, National Hemophilia Foundation, 
     National Organization for Rare Disorders, National 
     Osteoporosis Foundation, New York University School of 
     Medicine, Research! America, Research Society on Alcoholism, 
     RESOLVE, The National Infertility Association, St. Jude 
     Children's Research Hospital, Scleroderma Foundation--Central 
     New Jersey Chapter, Sjogren's Syndrome Foundation, Society 
     for Investigative Dermatology, Society for Maternal--Fetal 
     Medicine, Society for Pediatric Research, Society for Women's 
     Health Research, University of Washington--Department of 
     Ophthalmology.
                                 ______