[Congressional Record Volume 143, Number 158 (Monday, November 10, 1997)]
[Extensions of Remarks]
[Pages E2317-E2318]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




     INTRODUCTION OF THE CLINICAL RESEARCH ENHANCEMENT ACT OF 1997

                                 ______
                                 

                           HON. NITA M. LOWEY

                              of new york

                    in the house of representatives

                        Sunday, November 9, 1997

  Mrs. LOWEY. Mr. Speaker, I am pleased to introduce today the Clinical 
Research Enhancement Act of 1997. This legislation will better enable 
us to translate basic science discoveries into improvements in medical 
treatment. I am pleased to be joined by Congresswoman Nancy Johnson as 
the primary cosponsor of this important legislation.
  The difficulties faced by clinical researchers and their patients 
threaten progress in medicine and our country's international 
competitive edge in biomedical science. We are losing a generation of 
physician scientists because of limited research funding, medical 
tuition indebtedness, and obstacles created by our increasingly 
competitive health care system. While the Clinical Research Enhancement 
Act of 1997 cannot address all these problems, it can help us to 
recruit and retain talented clinical investigators to insure that 
advances in basic biomedical science are more readily translated into 
improvements in patient care.
  In 1994, the Institute of Medicine [IOM] issued a groundbreaking 
report outlining the crisis facing clinical research. The IOM report 
found that numerous obstacles confront clinical researchers at various 
points in their careers. Furthermore, the IOM concluded that we simply 
are not training the number of clinical scientists necessary to address 
the rapid discoveries occurring in basic biomedicine. Studies by the 
National Research Council, National Academy of Sciences, and the 
National Institutes of Health have also highlighted the problems facing 
clinical research.
  The Clinical Research Enhancement Act of 1997 will improve Federal 
support of clinical research by:
  Improving the peer review process for clinical research grants and 
establishing innovative science awards that will be reviewed by 
scientists who are particularly knowledgeable about clinical research;
  Strengthening the general clinical research centers [GCRC's] which 
now serve as the hub of NIH-supported extramural clinical research 
activity;
  Enhancing the career development of clinical scientists by creating 
new awards that will be similar to existing NIH career awards but 
focused on clinical investigators who pursue initial research projects 
with a mentor prior to independent pursuit of research;
  Creating innovative medical science awards for more established 
researchers in order to improve funding for projects involving 
potential clinical applications of a basic discovery which are tested 
on a small number of patients;
  Providing support for scientists seeking advanced degrees in clinical 
investigation in order to address the need for structured, academic 
training in clinical investigation; and
  Expanding the existing loan repayment program available to clinical 
researchers who are based at the NIH campus to make it available to 
NIH-supported clinical scientists at centers around the country.
  The Clinical Research Enhancement Act of 1997 has the support of over 
100 medical, scientific, and academic organizations. I want to 
especially commend the American Federation for Medical Research for 
their leadership on this important issue.
  I urge my colleagues to cosponsor this legislation which will help to 
ensure that our Federal investment in basic biomedical science is 
translated into improvements in medical care.
  I request that the accompanying materials be included in the Record.

       As a coalition of organizations concerned about improving 
     the quality of health care,

[[Page E2318]]

     the National Health Council strongly supports the Clinical 
     Research Enhancement Act. As you know, it has been more than 
     three years since the Institute of Medicine (IOM) documented 
     the major challenges confronting clinical research in our 
     country. Your bill would implement a number of the IOM 
     recommendations for addressing these problems. It is 
     critically important that the NIH move forward as rapidly as 
     possible with these initiatives.
       The NIH is the major funding source in the United States 
     for basic biomedical research. However, the major dividends 
     from this investment are discoveries that improve our ability 
     to prevent, effectively treat, and cure disease and 
     disability. The NIH must foster not only the basic research 
     that begins this process but also the translational research 
     through which a basic science discovery is applied to a 
     medical problem. There is generous industry support for 
     clinical research and clinical trials aimed at the 
     development of new products. However, private funding is 
     extremely limited for initial translational research that may 
     have little or no commercial product potential. Examples of 
     such research include studies of nutritional therapies, new 
     approaches to disease prevention, transplantation techniques, 
     behavioral interventions, and studies of off-label uses of 
     approved drugs. In the past, such research was often 
     subsidized from patient care revenues to academic medical 
     centers. However, competition in the health care marketplace 
     has begun to erode this source of funding; therefore, NIH 
     must play an expanded role in providing support for this 
     research. The Clinical Research Enhancement Act would foster 
     NIH funding opportunities for this type of research through 
     the establishment of ``innovative medical science awards.'' 
     Such studies will focus on translating basic research 
     discoveries into tools that health care professionals can use 
     to cure disease and relieve suffering.
       In addition, we support provisions of the bill that would 
     foster opportunities for physicians to pursue careers in 
     clinical research. There is ample evidence that American 
     physicians are opting out of careers in science for a variety 
     of reasons. Steps must be taken to rebuild our nation's 
     supply of well-trained physician scientists if the United 
     States is to continue its leadership of the world in medical 
     science.
       Finally, the bill would direct the NIH to improve the peer 
     review of patient-oriented research. Studies have documented 
     the fact that clinical research proposals are at a 
     disadvantage when reviewed by NIH study sections because of 
     NIH's primary focus on basic biomedical research. This must 
     be changed, as proposed in your bill, so that scientific 
     opportunities to improve medical care are not lost.
       The undersigned organizations are extremely grateful for 
     your leadership in addressing the problems confronting 
     clinical research. We support your initiative to assure that 
     the NIH invests in the translational research that holds the 
     key for patients around the country who are waiting for a 
     cure. We are pleased to endorse the Clinical Research 
     Enhancement Act.
       Alzheimer's Association, American Autoimmune Related 
     Diseases Association, American Diabetes Association, American 
     Kidney Fund, American Paralysis Association, Digestive 
     Diseases National Coalition, Epilepsy Foundation of America, 
     Foundation Fighting Blindness, Juvenile Diabetes Foundation 
     International.
       Glaucoma Research Foundation, Myasthenia Gravis Foundation, 
     National Alopecia Areata Foundation, National Multiple 
     Sclerosis Society, National Osteoporosis Foundation, National 
     Tuberous Sclerosis Association, Paget Foundation, Sjogren's 
     Syndrome Foundation, Tourette Syndrome Association.


     
                                                                    ____
                                           American Federation for


                                             Medical Research,

                                 Washington, DC, November 7, 1997.
     Hon. Nancy Johnson,
     Hon. Nita Lowey,
     U.S. House of Representatives, Washington, DC.
       Dear Representatives Johnson and Lowey: I write to express 
     the strong support of the American Federation for Medical 
     Research for the legislation you will introduce to enhance 
     clinical research programs at the National Institutes of 
     Health. The AFMR is a national organization of 6,000 
     physician scientists engaged in basic, clinical, and health 
     services research. Most of our members receive NIH support 
     for their basic research but are finding it increasingly 
     difficult to obtain public or private funding for 
     translational or clinical research--studies through which 
     basic science discoveries are translated to the care of 
     patients. In the past, academic medical centers provided 
     institutional support for this research through revenues 
     generated by patient care activities. However, as the health 
     care marketplace has become increasingly competitive, 
     academic centers have all but eliminated internal subsidies, 
     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. In this context, 
     the $60 million in spending entailed in your legislation 
     (representing less than one-half of one percent of the NIH 
     budget) would seem an extremely modest investment in a much-
     needed program to reinvigorate our nation's clinical research 
     capabilities.
       The Clinical Research Enhancement Act is a conservative 
     approach to a severe problem. The Institute of Medicine (IOM) 
     expressed alarm about the challenges confronting clinical 
     research in a 1994 report, and your bill is based on the 
     initiatives recommended by the IOM:
       The IOM recommended that the General Clinical Research 
     Centers program be strengthened. Your bill would codify this 
     program, which has existed since the late 1950's, so that the 
     Congress will have greater discretion over GCRC funding.
       The IOM recommended enhanced career development in clinical 
     investigation, and your bill proposes such awards.
       The IOM noted problems with the NIH peer review of clinical 
     research. Your bill directs the NIH to improve the peer 
     review process for such research and establishes ``innovative 
     science awards'' that will be reviewed by scientists 
     knowledgeable in clinical investigation.
       The IOM recommended programs to relieve the tuition debt of 
     physicians pursuing clinical research careers. Your bill 
     would expand an existing NIH intramural program for this 
     purpose to the extramural community.
       The IOM recommended structured, didactic training in 
     clinical investigation. Your bill authorizes funding for 
     advanced degree (master's and Ph.D) training in clinical 
     research as successfully initiated at several institutions 
     around the country.
       The list of almost 150 organizations that support the 
     Clinical Research Enhancement Act indicates the consensus of 
     scientific, medical, consumer, and patient organizations that 
     steps must be taken as soon as possible to stop the 
     deterioration of the U.S. clinical research capacity, to 
     reinvigorate the clinical research programs of academic 
     medical centers, and to 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 your legislation.
           Sincerely,
                                               Jeffrey Kern, M.D.,
                                                        President.

     

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