Written Statement of the
American Society for Pharmacology and Experimental Therapeutics

Submitted May 9, 2003

House Appropriations Subcommittee on Labor, Health and
Human Services, Education & Related Agencies

Fiscal Year 2004 Appropriations for the National Institutes of Health

 The American Society for Pharmacology and Experimental Therapeutics (ASPET) is pleased to submit written testimony in support of the National Institutes of Health FY 2004 budget.  ASPET is a 4,700 member scientific society whose members conduct basic and clinical pharmacological research in academia, industry and the government.  Our members research efforts help develop new medicines and therapeutic agents to fight existing and emerging diseases. 

ASPET members are well aware of the U.S. Congress’ support of the bipartisan doubling effort and recognition of the health and economic benefits that evolve from NIH sponsored research.  In order to maintain this robust scientific opportunity to meet serious medical needs, it is critical that Congress sustain its support of the biomedical research enterprise.  As a member of the Ad Hoc Group for Medical Research and the Federation of American Societies for Experimental Biology (FASEB), ASPET supports an appropriation of $30.06 billion for the National Institutes of Health in FY 2004.  This represents an increase of 10% above the Administration’s FY 2003 NIH budget request.

Benefits of Drug Discovery and Development

Federal investment in basic biomedical research has played a major role in developing effective drug agents and experimental therapies that aid in the treatment of many diseases and afflictions.  This link between basic research, drug discovery and clinical applications was illustrated in 1998 when three pharmacologists were awarded the 1998 Nobel Prize in Physiology or Medicine for their research on nitric oxide.  Pharmacological research provides opportunity for real therapeutic benefit to patients.  Many important drugs have been developed as a direct result of the basic knowledge gained from federally funded research, such as new therapies for breast cancer, the prevention of kidney transplant rejection, improved treatments for glaucoma, and the cholesterol lowering drugs known as statins.

Historically, our past investment in basic biological research has led to innovative medicines that have virtually eliminated diphtheria, whooping cough, measles and polio in the U.S.  Eight out of ten children now survive leukemia and death rates from heart disease and stroke have been reduced by half in 30 years.

Scientific inquiry and advancement has led to new challenges and opportunities for patients, investigators, and the general public:

• The need for increased emphasis on research and training in the area of systems and integrated/whole organ pharmacology and biology to see how drugs act not just at the molecular level but on whole animals, including human beings, to determine how such drugs impact health and disease states.  Support for such training and research on whole systems in pharmacology and other biological disciplines is crucial to continued progress in the fight against disease and suffering.
   
• The need to meet public health concerns over growing consumer use of botanical therapies and dietary supplements.  These products have unsubstantiated scientific efficacy and may adversely impact the treatment of chronic diseases, create dangerous interactions with prescription drugs, and may cause serious side effects among some users. 

Support for Whole Organ Systems and Integrative Biology

ASPET supports efforts to increase support for training and research in whole organ systems and integrative biology.  Systems and integrative biology is the study of responses in organs and organisms, including intact animals.  The decline of training and funding opportunities for integrative scientists threatens continued biomedical advances. 

The past two decades has witnessed an increase in support for cellular and molecular studies.  This support has been invaluable to science.  The recent unraveling of the human genome is in many ways the culmination of this molecular approach.  What is now needed are efforts to decipher the functions of the genes that have been identified.  Unfortunately, much of our progress in molecular areas has come at the expense of research and training in in vivo, whole organ biology.  The neglect of training and research in this important area has resulted in a lack of trained scientists capable of integrating cellular and molecular with whole systems approaches.  As a result a more thorough and comprehensive examination of new therapeutic approaches may be compromised before clinical trials begin.  The lack of highly qualified scientists in integrative approaches also negatively impacts the process of drug development.  Integrative scientists are trained to approach problems in a broad manner.  For instance, obesity is not just a metabolic disorder.  Obesity impacts many organ functions, including the heart, circulatory system, and brain.  Similarly, clinical depression should not be viewed as just a neurological disorder because depression affects multiple organs in a variety of ways.  And the discovery of drugs to treat neurodegenerative diseases such as Alzheimer’s and Parkinson’s will ultimately need to look at complex whole animal systems.

Strict reliance on studies at the cellular and molecular levels is problematic for two reasons.  First, it can lead to hypotheses that do not take into account the complexities of function and disease and second, it may lead to conclusions that misguide the development of drugs and diagnostic procedures.  The pharmaceutical industry has identified the lack of integrative scientists as a major problem for the recruitment of highly qualified, highly trained whole organ systems and integrative scientists.  What is now needed in the post-genomic era are scientists capable of doing studies of function of genes including integrative approaches. 

As senior pharmacologists classically trained in integrative biology at universities and academic health centers retire, fewer individuals remain with the expertise to teach young scientists about the complex interactions among all the organ systems in the human body. Thus, support for training and research in whole organ systems and integrative biology is critical for the training of a new generation of integrative scientists and the advancement clinical research.

To reverse the decline and adequately support training and research in whole organ systems, integrative biology, program project grants, and pre and post-doctoral training programs should be implemented that support training and research activities in whole organ and integrative biology.  Multi-disciplinary institutional and individual training and research grants on whole systems and integrative biology should be funded to investigate disease processes.  While many industrial concerns provide limited support for training and research at the post-doctoral level, their main efforts should remain focused on drug discovery and development.  It is the role of the NIH and academic institutions to provide adequate training opportunities to develop the next generation of integrative scientists. These scientists would have broad exposure to organ based, systems, and whole animal biology. ASPET also recommends that scientists with expertise in integrated systems should be adequately represented on NIH peer-review panels.  NIH should commission panels with an appropriate representation of experts competent to provide peer evaluation at the level of the whole animal.

These recommendations and support for systems and integrative biology have been affirmed in the FY 2002 U.S. Senate Labor/Health and Human Services & Related Agencies Appropriations Report (107-84).  The Senate report supports ASPET recommended language that “Increased support for research and training in whole systems pharmacology, physiology, toxicology, and other integrative biological systems that help to define the effects of therapy on disease and the overall function of the human body.”  These principles and recommendations are also affirmed in the FASEB Annual Consensus Conference Report on Federal Funding for Biomedical and Related Life Sciences Research for FY 2002.    

Support for Research on Botanicals and Herbal Therapies to Meet Public Health Needs

ASPET has for years supported peer-reviewed pharmacological examination of the mechanisms of actions of medicinal plants (H.Rpt 56-101) and is pleased that the NIH’s National Center for Complementary and Alternative Medicine (NCCAM) is beginning to study the basic biology of various botanical agents.  ASPET continues to recommend increased support to study the interaction of botanical remedies and dietary supplements with prescription medications. This support is critical to the promotion and funding of the highest quality research in botanical medicine, will help meet urgent needs of this neglected area of biological research, and will address a growing public health problem. 

The increased use of botanical and dietary supplements by consumers to treat various ailments and diseases is a major public health concern.  One national survey reported that in 1997 an estimated 15 million adults (18.4% of all prescription users) took herbal remedies concurrently with prescription medicines. Between 1990 and 1997, the use of herbal products grew by 380%.  Although there is little solid scientific evidence to support therapeutic efficacy of many botanical and dietary supplement products, the industry records over $17 billion in annual sales.  Botanical products were once regulated as drugs and the FDA had authority to prevent the sale of unproven herbal ingredients.  However, legislative reforms in 1994 eliminated the FDA’s authority to test or approve herbal products prior to marketing.  Thus, at a time when many more consumers are using more herbal products, there is little research on either their clinical efficacy or basic mechanisms of action.  The growing use of herbal products by consumers, their interactions with prescription drugs - and mechanisms of such interactions - represent a serious and growing public health problem that demands scientific attention and redress by regulatory and legislative action.

Through the NIH, research into the safety and efficacy of botanical products can be conducted in a rigorous and high quality manner.  Sound pharmacological studies will help determine the value of botanical preparations and the potential for their interactions with prescription drugs as well as chronic disease processes.  

ASPET supports continued increases in the budget of the NIH’s National Center for Complimentary and Alternative Medicine.  NCCAM’s scientific portfolio includes research on botanicals as one of its priorities.  Adequate funding for NCCAM will help the Center to expand support and encourage investigators throughout the country, through various funding mechanisms, to submit proposals that address carefully defined research questions concerning actions and toxicity of botanical drugs.  Continued support for NCCAM will also allow it to continue to leverage its limited resources and further develop partnerships with other institutes on research opportunities.  Support for highly innovative research on botanicals should be encouraged among all institutes and centers.  Such support is critical to fund the highest quality research in botanical medicine affecting many disease groups and populations.  

Little is known about the interactions or the pharmacokinetics of most botanical products.  Anecdotal evidence suggests that there may be some therapeutic benefit for some patients.  But growing consumer use of non-standardized, non-regulated drugs taken together with powerful conventional medications may pose dangerous drug interactions.  

Conclusion 

Maintaining the extraordinary scientific progress that has been made at the NIH over the past five years is the major challenge and opportunity for this Committee.  A 10% increase for the NIH in FY’04 will help NIH meet its commitment to the scientific opportunities presented above, address public health needs, and enhance the health and economic well being of the nation.  The recommended $30.06 NIH’s FY 2004 budget will prove to be one of the best investments Congress can make in addressing unmet medical needs and improving the health of Americans and others worldwide. 

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