REASONS TO OPPOSE ESTABLISHMENT OF
A NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE

e Demonstrated Scientific Potential--In order for an entity to be elevated to institute or
center status, the scientific potential of the field should already be sufficiently
demonstrated so that the new institute or center can support a thriving intramural and
extramural research program. Such potential has not yet been demonstrated or
documented in the field of complementary and alternative medicine.

In 1984, the Institute of Medicine developed a report entitled, “Responding to Health
Needs and Scientific Opportunity: The Organizational Structure of the National Institutes
of Health.” In its report the IOM concluded that, before creating a new institute or other
major organizational entity, “the research area to be emphasized must have a potential for
growth, both in terms of the underlying science and in the number of scientists whose
efforts could profitably be directed toward the area.”

The current NIH Office of Alternative Medicine was established administratively by NIH
in 1991 in response to a recognized need for a focus for this discipline and a
Congressional mandate for a study in this area was contained in the FY 1992 NIH
Appropriations Bill Report. Subsequently, the Congress established the OAM in statute
in the NIH Revitalization Act of 1993. The relatively new field of research in
complementary and alternative medicine has only recently begun to develop a research
base, and the potential for growth must be further explored before proceeding with the
creation of anew Center. In these early years, the role of the OAM would be served best
by concentrating on stimulating, coordinating, and monitoring the NIH activities in
alternative medicine research.

If each proposal for an institute or center were to be adopted, it would cause significant
negative outcomes for NIH and its research programs. Before creating a new entity, it
would be prudent to examine in a deliberative manner the need and anticipated value of _
such actions. A hasty move to create an AIDS institute, rather than the Office of AIDS
Research for example, would have divorced the science from the institute expertise, and
would have had a detrimental effect on the developing science in this area.

° Need for Integration of Research on Complementary and Alternative Medicine
Within Each Institute--In order to fully realize the scientific potential of complementary
and alternative medicine, this research must be integrated into the NIH Institutes and
Centers. The majority of NIH Institutes and Centers are established around scientific
disciplines. Developing plans and methodologies around categorical diseases, such as
cancer, heart disease, and diabetes, provides a focused, targeted approach to research,
capitalizing on the scientific expertise of experts in the field, as well as on the knowledge
base on related diseases and conditions. Complementary and alternative medicine,
however, does not lend itself to this model. It now is, and should continue to be,
integrated into mainstream medical research across a number of disease areas. The
majority of complementary and alternative medicine research is performed and/or
supported by the 24 NIH institutes and centers, and is an integral part of the research
missions and activities of these components. This breadth of research is reflected in the
fact that the NIH institutes and centers supported approximately $43 million in research
in these areas in FY 1996, of which $7.4 million was provided by the OAM in the form
of supplemental grants. The scientists and researchers who are responsible for broad
areas of science are most effective when they are able to integrate complementary and
alternative medicine into their research portfolio. It is through just such an integrated
approach that strides in research on AIDS, nutrition, prevention, women’s health, and
minority health have been realized. Similar benefits to research in complementary and
alternative medicine are likely to accrue through this approach.

The OAM already has broad authority sufficient to allow the Office to carry out the
purposes of Senator Harkin’s proposal within its current structure, working through the
NIH research institutes. The OAM provides a central focus for research germane to all
NIH components and provides for a multi-disciplinary approach to the conduct and
support of research on alternative and complementary therapies. The current
arrangement, whereby the OAM identifies promising leads that are then carried through
by the NIH institutes and centers ensures that NIH scientists are able to integrate the
alternative medicine research into the various institute/center missions. Divorcing work
in complementary and alternative medicine from its current scientific locus within the
mainstream research of each institute would result in fragmentation of research and delay
obtaining data needed to address the many questions regarding the efficacy of these
therapies. The October 1984 IOM report concluded that “a proposed change in the NIH
organizational structure should, on balance, improve communication, management,
priority setting, and accountability.” The proposed structural change for the Office of
Alternative Medicine would work at cross purposes with these objectives.

The following two examples best illustrate the ongoing collaboration that is presently
occurring between the OAM and NIH Institutes and demonstrates the need for this
research to be integrated within the Institutes:

1) The OAM, the National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS), and the National Institute of Child Health and Human
Development (NICHD), are collaborating to fund research to determine the
efficacy and effectiveness of chiropractic care for musculoskeletal disorders,
including chronic pain. Scientific administration is being provided by an NIAMS
program administrator who is an orthopedic surgeon.

2) The OAM, the National Institute of Mental Health (NIMH), and the Office of
Dietary Supplements (ODS) are collaborating to fund research to determine the
potential benefits and risks of Hypericum perforatum, commonly known as “‘St.
John’s Wort”, for the treatment of depression. The scientific management of this
clinical trial will be provided by NIMH staff. (The OAM is funding the study
during its first year. NIMH has made a commitment to fund future years.)
° Additional Administrative Costs--Establishing the Center would require additional,
continuing administrative costs. The new Center would require numerous FTEs,
including a Center Director, Deputy Director, administrative/management/clerical
personnel, and a larger staff to administer both an intramural and extramural program and
to develop the discipline. The costs of travel, supplies, rent, and equipment also would
comprise a significant part of the cost of operation of the Center.

These costs would be at the expense of existing NIH research programs, thus reducing
NIH research efforts in these areas, including ongoing research in complementary and
alternative medicine. Even if new monies were provided to cover these initial start-up
costs, funding for these administrative costs in subsequent years would have an impact on
research funding because they would have to be built into the funding base; yet, any new
monies would best be utilized in the conduct and support of research.

This increased administrative cost would be in conflict with current ongoing NIH
streamlining initiatives and would come at a time when the Congress is insisting that NIH
hold its research management and support (RM&S) budget constant.

Conclusion

With the focus now on making each research dollar count, a proposal to create a new
administrative entity, without demonstrated benefit, runs counter to what appropriators
have been trying to achieve with the NIH budget. Consolidation and coordination, not
proliferation, is the current theme. As with AIDS research, the OAM provides a broad
perspective and a coordinating function, and it serves to stimulate research, while
utilizing the expertise of the institutes and centers to carry out the research. Similarly,
both the Office of Research on Women’s Health and the Office of Research on Minority
Health provide the stimulus for institute efforts in these research areas, which some
argued were underserved and in need of focus and action at the OD level. Thus, the
coordination/stimulation role was appropriately placed within OD, while maintaining the
role of research design and scientific endeavor within the institutes where the expertise
resides. In an ideal world, the role of the OAM to stimulate the science base for
complementary and alternative medicine would diminish as this area of research becomes
more developed and integrated into the research programs of the institutes.

September 16, 1997.