[Congressional Record Volume 142, Number 11 (Friday, January 26, 1996)]
[Senate]
[Pages S502-S505]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

             By Mr. HATFIELD (for himself and Mr. Kennedy):

  S. 1534. A bill to amend the Public Health Service Act to provide 
additional support for and to expand clinical research programs, and 
for other purposes; to the Commission on Labor and Human Resources.


             THE CLINICAL RESEARCH ENHANCEMENT ACT OF 1996

 Mr. HATFIELD. Mr. President, the proud tradition of American 
leadership in science and health care has been an important factor in 
our international stature and our domestic quality of life. This 
tradition is however vulnerable and may wither if not nurtured. The CBO 
predicts that national expenditures for health will reach the 
astonishing sum of $1,613 billion by the year 2000. This an 
astronomical sum for a nation who seemingly can meet its health care 
needs. Investments in biomedical research offer the only reasonable 
hope of reducing not only monetary costs, but, more importantly, human 
suffering.
  Biomedical research is commonly thought of as existing in two 
spheres. The first is ``basic'' research in which fundamental 
biological principles are studied primarily in laboratories using 
molecules, cells or animals. The second is ``clinical'' or patient 
oriented research [POR], in which the scientific principles discovered 
in the lab are applied to patients with disease. To determine which of 
several medicines is most effective in curing a cancer, careful 
comparison of these drugs is necessary in large groups of real people. 
To understand which of several different types of treatment: medical, 
surgical, or nutritional is best in helping patients not merely for the 
short run but over time, the various treatment 

[[Page S503]]
options must be tried systematically on real people. The emphasis is on 
people. We must use the knowledge gained by biomedical research to help 
people get better.
  Both aspects of biomedical research are essential because they depend 
upon each other--without the foundation of basic research, clinical 
research would be impossible. For example the current successful 
treatment of sickle cell Anemia which so cruelly strikes young people, 
had its origins in basic research from the development of chicken 
embryos. Medications which modified chicken embryonic cells were found 
to also enable monkeys to manufacture certain types of hemoglobin, 
hemoglobin a component of blood cells necessary to combat thalassemia 
and sickle cell disease. The studies moved from basic research in 
chickens to monkeys and finally to clinical research in humans leading 
to a successful therapy for a previously terrible disorder.
  Yet despite their mutual importance clinical research has failed to 
receive the support necessary to permit us to fully benefit from the 
advances of basic research. The proposal for a national fund for health 
research which Senator Harkin and I have introduced goes a long way to 
prevent the possibility of robbing funds from Peter to pay Paul. We 
need more money in the system, but we also will have a better balance 
between basic and clinical research.
  The Institute of Medicine has recently published an exhaustive report 
which concludes that clinical research is in a state of crisis. A state 
which if not addressed will result in: a serious deficiency of clinical 
expertise; a paucity of effective clinical interventions; an increase 
in human suffering and disability; and ultimately an increase in the 
cost of medical care.
  Historically clinical research has resulted in marked improvements in 
care and costs. A $1.2 million investment in neonatal screening for 
subnormal thyroid has saved $206 million in treatment costs annually. A 
$679,000 investment in developing a treatment for recurring renal 
stones has resulted in an estimated savings of $300 million annually. A 
multicenter clinical trial of interventions in stroke prevention cost 
approximately $4.6 million. Its results could prevent 20 to 30,000 
strokes per year with an annual savings of $200 million. All of these 
and many other achievements have occurred because of the ability of 
clinical research to take knowledge derived from basic research to the 
bedside, bridging the gap between the laboratory and the patient.
  Yet despite its clear societal and economic benefits, clinical 
research is in crisis. The amount and proportion of personnel and 
fiscal resources devoted to clinical research, particularly at the NIH 
has fallen to levels which place our Nation at a severe disadvantage. 
Unable to capitalize on new discoveries, the quality of life of our 
patients slowly falls as ironically our costs continue to rise. The 
nature of this crisis is threefold a relative lack of: people involved 
in clinical research; an infrastructure to adequately select and 
support the best clinical research; and declining fiscal investment in 
biomedical research overall.


                                 PEOPLE

  While the United States continues to train large numbers of excellent 
young physicians the proportion of those choosing careers in clinical 
research becomes ever smaller. The Association of American Medical 
Colleges [AAMC] survey of 1994 medical graduates found that only 10 
percent of these young physicians intended to enter research careers. 
Students enrolled in public medical schools were much less likely to 
choose research careers than those attending private institutions.
  America's teaching hospitals have of necessity increased the 
proportion of their income derived from service from 12.2 percent 
1971-- to 38.5 percent--1988. As a result the proportion of physicians 
in those institutions who are active in research has fallen from 40 to 
25 percent. This leaves fewer clinicians available for instruction of 
students and fewer investigators for clinical research.


                              INSTITUTIONS

  Our medical schools need to increase their focus on the training of 
students for clinical research careers. Fully 58 percent of 1994 
graduates reported inadequate instruction in research techniques. 
Unlike the situation in Ph.D. programs for basic research, there is no 
clear academic pathway into a clinical research career. Only 11 percent 
of physicians in clinical departments are principle investigators of 
NIH grants. This compares unfavorably to 27 percent rate for Ph.D.'s. 
As a result there are relatively fewer role models for young clinical 
researchers.
  Our ability to fund new research ideas has not been able to keep pace 
with the development of new initiatives. It is extremely difficult for 
young clinical investigators to even obtain research funding. Only 55 
percent of all applicants for NIH grants are ever funded. The overall 
number of research grant applications has increased by 42 percent from 
14,142 in 1980 to 20,154 in 1990. The number of new grant applications 
funded has actually fallen by 15 percent from 5,400 in 1989 to 4,600 in 
1990. This is complicated by the fact that the greatest proportion of 
research grants goes to continue funding previously granted awards, 70 
percent. So that ever increasing number of new projects compete with an 
ever smaller pool of resources.
  The emphasis is so heavily weighted toward basic research that the 
NIH has difficulty determining just what proportion of funded studies 
are directed at patients. The Institute of Medicine estimates that only 
10.4 percent of all NIH funded research is clinical research. Only 20 
percent of grant reviewers are physicians, therefore the expertise 
necessary to critically review clinical research applications is 
considerably less than that for basic research. With the proportion of 
funded proposals falling to approximately 25 percent of submissions the 
odds of gaining grant funding are now low enough that young 
investigators are turning away from clinical research careers. The NIH 
has recognized these deficiencies and has made recommendations to 
reverse this trend. Implementation however requires more resources.
  Implementation also requires cooperation from the community of health 
care providers. Many insurance companies and managed care plans 
discourage or prevent persons from participating in clinical studies. 
This limits access to potentially helpful therapies for patients, and 
inhibits the ability of researchers to find patients to work with and 
hence make new discoveries. Insurers who eventually benefit from new 
treatments which by alleviating illness lowers costs, must contribute 
to the process by encouraging rather than discouraging patient 
participation.


                                FUNDING

  The level of support for biomedical research, particularly for the 75 
general clinical research centers, has been relatively flat over the 
past 5 years, just barely keeping up with inflation.
  The resulting increased competition by more investigators for a piece 
of an ever smaller pie results in a stagnation and atmosphere where 
innovation and clinical research is sublimated for short term 
laboratory based projects which produce publishable results quickly.
  The legislation I and my colleague Senator Kennedy are introducing 
today, the Clinical Research Enhancement Act, will rectify these 
problems by: First, establishing a President's Research Advisory Panel 
within the Office of Science and Technology Policy, [OSTP]. This panel 
will regularly evaluate the status of clinical research in the United 
States so that we are continually aware of our progress. It will make 
recommendations for any necessary improvements in clinical research and 
monitor them to ensure that we reach our goals.
  Second, we will increase the involvement of the NIH in clinical 
research. The Director of NIH will establish intramural clinical 
research fellowship programs to train clinical researchers. There will 
be increases in the number of FIRST Grants for young investigators, and 
by implementing the recommendations of the NIH's own Clinical Research 
Study Group improve the merit review process for evaluating 
applications.
  Third, we will stabilize the funding of general clinical research 
centers. It is within these centers that much of the training of young 
investigators as well as actual clinical research is done.
  Fourth, we will create new opportunities for career development in 
clinical research. This through the development of clinical research 
career enhancement awards, and expansion of 

[[Page S504]]
the Loan Repayment Program for Clinical Researchers.
  Fifth, we will establish innovative medial service awards to 
stimulate the development of new and creative clinical research 
proposals.
  Rectifying the disparagement between support of basic and clinical 
research will serve to more effectively promote the types of 
discoveries that we have all come to expect. It is my hope that this 
proposal for clinical research enhancement is not seen as simply 
another cost of health care, but as a way, really the only way to 
eventually reduce costs both in terms of dollars and human life.
  I urge my colleagues to join us in supporting legislation to enhance 
the pipeline for clinical researchers.
  Mr. President, I ask unanimous consent that additional material be 
printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

   The Clinical Research Enhancement Act of 1996--Section-by-Section 
                                Summary

       Section 1--Short Title: The Clinical Research Enhancement 
     Act of 1996
       Section 2--Findings and Purposes: Clinical research, 
     patient-oriented research requiring the participation of a 
     human subject, is in decline. Independent studies at the 
     National Research Council, the National Institute of Medicare 
     and the National Academy of Sciences have all addressed the 
     current problems in clinical research. The decline in young 
     clinical investigators is attributed to a heavy debt burden, 
     lack of a federal support system, and lack of a formal 
     training regime. It is the purpose of this Act to provide for 
     a mechanism to address these problems and a stimulus for 
     physicians to enter clinical research.
       Section 3--President's Clinical Research Panel: The 
     President shall establish within the Office of Science and 
     Technology Policy, a panel, to evaluate the status of the 
     national clinical research environment, and prepare periodic 
     progress reports to the President. It will be composed of 
     representatives from clinical research, insurance and 
     pharmaceutical companies, health maintenance organizations, 
     accreditation and certification organizations, academic 
     research administrators and patients. Its members will be 
     nominated by the President of the Institute of Medicine.
       Section 4--NIH Director's Advisory Committee on Clinical 
     Research: The Secretary of Health and Human Services shall 
     designate the advisory committee established by the Director 
     of NIH. This committee will report to the Director and the 
     President's Panel. It will review the status of clinical 
     research within NIH and implement changes as necessary.
       Section 5--Study Section Review: The President's Clinical 
     Research Panel shall direct the Office for Science and 
     Technology to review study section activities of all federal 
     agencies conducting or funding clinical research.
       Section 6--Increase the Involvement of the National 
     Institutes of Health in Clinical Research: The Director of 
     NIH shall:
       1. Increase the number of FIRST grants.
       2. Design test pilot projects.
       3. Establish an intramural clinical research fellowship 
     program at NIH.
       4. Support and expand resources available for the clinical 
     research community.
       5. Establish peer review mechanisms to evaluate 
     applications: for Instramural Fellowships; Clinical Research 
     Career Enhancement Awards; & Innovative Medical Science 
     Awards.
       Section 7--General Clinical Research Centers: The Director 
     shall award grants for General Clinical Research Centers to 
     provide the infrastructure for clinical research, training 
     and enhancement. Expand the activities of the centers through 
     increased use of telecommunications and telemedicine. 
     Establish grant programs at the centers. The Director of the 
     National Center for research Resources shall establish: 
     Clinical Career Enhancement Awards; and Innovative Medical 
     Science Awards.
       Section 8--Clinical Research Assistance: Expand the current 
     Loan Repayment Program Regarding Clinical Researchers from 
     Disadvantaged Backgrounds to include students with heavy debt 
     burdens. Increase the numbers of awards from 50 to 100. 
     Establish a minority set-aside of 50%.
       Section 9--Insurance coverage of investigational 
     treatments: A health plan shall allow individuals when 
     medically appropriate to participate in investigational 
     therapy.
       Section 10--Definition: Define ``clinical research'' as 
     ``patient oriented clinical research requiring the 
     participation of a human subject, or research on the causes 
     and consequences of disease in human populations.''
                                                                    ____


           Supporters of Hatfield Clinical Research Bill (79)

       Academy of Radiology Research.
       Alzheimer's Association.
       American Academy of Child and Adolescent Psychiatry.
       American Academy of Dermatology.
       American Academy of Neurology.
       American Academy of Ophthalmology.
       American Academy of Otolaryngology--Head and Neck Surgery.
       American Association of Anatomists.
       American College of Clinical Pharmacology.
       American College of Medical Genetics.
       American Diabetes Association.
       American Federation for Clinical Research.
       American Geriatrics Society.
       American Gastroenterological Association.
       American Neurological Association.
       American Nurses Association.
       American Orthopaedic Association.
       American Podiatric Medical Association.
       American Society for bone and Mineral Research.
       American Society for Clinical Pharmacology and 
     Therapeutics.
       American Society for Therapeutic Radiology and Oncology.
       American Society for Addiction Medicine.
       American Society of Hematology.
       American Society of Human Genetics.
       American Society of Nephrology.
       American Veterinary Medical Association.
       Arthritis Foundation.
       Association for Behavioral Sciences and Medical Education.
       Association of Anatomy, Cell Biology and Neurobiology 
     Chairs.
       Association of Behavioral Sciences and Medical Education 
     Association.
       Association of Academic Health Centers.
       Association of American Cancer Institutes.
       Association of Medical and Graduate Departments of 
     Biochemistry.
       Association of Pathology Chairs.
       Association of Professors of Dermatology.
       Association of Program Directors in Internal Medicine.
       Association of Schools of Public Health.
       Association of Subspecialty Professors.
       Association of Teachers of Preventive Medicine.
       Association of University Professors of Ophthalmology.
       Association of University Radiologists.
       Central Society for Clinical Research.
       Citizens for Public Action on Blood Pressure and 
     Cholesterol, Inc.
       Coalition for American Trauma Care.
       Cystic Fibrosis Foundation.
       Department of Orthopaedics/Rehabilitation at the University 
     of New Mexico.
       Department of Pathology and Laboratory Medicine at the 
     University of Southern California.
       Department of Physiology at the University of Florida 
     College of Medicine.
       Dystrophic Epidermolysis Bullosa Research Association of 
     America.
       The Epilepsy Foundation of America.
       Federation of Behavioral/Psychological and Cognitive 
     Sciences.
       Foundation for Ichthyosis and Related Skin Types.
       General Clinical Research Center Program Directors' 
     Association.
       General Clinical Research Center at the University of 
     Alabama at Birmingham.
       Joint Council of Allergy, Asthma and Immunology.
       Lupus Foundation of America, Inc.
       National Alopecia Areata Foundation.
       National Caucus of Basic Biomedical Science Chairs.
       National Committee to Preserve Social Security and 
     Medicare.
       National Foundation for Ectodermal Dysplasias.
       National Marfan Foundation.
       National Osteoporosis Foundation.
       National Organizations for Rare Disorders, Inc.
       National Perinatal Association.
       National Psoriasis Foundation.
       National Tuberous Sclerosis Association.
       The Orton Dyslexia Society.
       Scleroderma Research Foundation.
       Society for Academic Emergency Medicine.
       Society for Investigative Dermatology.
       Society for Neuroscience.
       Society for the Advancement of Women's Health Research.
       Society of Medical College Director of Continuing Medical 
     Education.
       Society of University Urologists.
       St. Jude Children's Research Hospital.
       The Endocrine Society.
       Tourette Syndrome Association.
       United Scleraderma Foundation.
       University of Alabama at Birmingham.
                                                                    ____

                                           American Federation for


                                            Clinical Research,

                                                 January 25, 1996.
     Hon. Mark Hatfield,
     Chairman, Committee on Appropriations,
     U.S. Senate, Washington, DC.
       Dear Senator Hatfield: On behalf of the American Federation 
     for Clinical Research, I write in strong support of the 
     ``Clinical Research Enhancement Act.'' The legislation you 
     are introducing today addresses critical problems facing our 
     country: the loss of a generation of young physician 
     scientists because of medical school tuition debts and 
     limited funding opportunities, the loss of our international 
     competitiveness in medicine as scientists in other nations 
     move ahead to capitalize on basic science discoveries with 
     new therapies and products, and the increasing difficulties 
     confronting patients who wish to participate in clinical 
     research but are limited by the unwillingness of insurance 
     companies to cover any investigational therapies.
       The Clinical Research Enhancement Act addresses these 
     problems through the creation of new career development and 
     research programs, the expansion of existing 

[[Page S505]]
     NIH loan repayment opportunities for physician scientist, and mandates 
     on insurance companies to expand coverage of investigational 
     treatments. Further, the creation of a Presidential 
     commission on clinical research will bring to the attention 
     of our nation's leaders critical obstacles to the advancement 
     of medical science.
       The 11,000 members of the American Federation for Clinical 
     Research are in strong support of this legislation and call 
     on the Congress to pass the Clinical Research Enhancement Act 
     before adjourning in the fall. America has led the world in 
     medical science. The bill you introduce today will help to 
     assure that we maintain that leadership.
           Sincerely,
                                          Veronica Catanese, M.D.,

                                                President.

                                 ______