Written Response of the American Society for Pharmacology and Experimental Therapeutics 
to the Strategic Plan of the National Center for Complementary and Alternative Medicine 

Submitted to the 
National Center for Complementary and Alternative Medicine 
June 19, 2000

June 19, 2000 


Stephen E. Straus, M.D. 
Director 
National Center for Complementary 
and Alternative Medicine 
National Institutes of Health 
Building 31, Room 5B41 
31 Center Drive, MSC 2182 
Bethesda, MD 20892 

Dear Dr. Straus: 

The American Society for Pharmacology and Experimental Therapeutics (ASPET), a professional society representing 4500 pharmacologists, is pleased to submit the following comments in response to the draft five-year Strategic Plan of the National Center for Complementary and Alternative Medicine (NCCAM). These comments have been developed and approved in consultation with the ASPET Council and Committee on Public Affairs. 

ASPET has particular interest in a neglected area of biomedical research, namely botanicals and herbal medicine. We are very supportive of your efforts to raise the level of scientific tradition at NCCAM and to insist on sound evidence-based research as its cornerstone. Critical to the success of this goal is NCCAM’s Advisory Council and Cancer Advisory Panel. We strongly recommend that additional appointments be made to represent the areas of pharmacology and toxicology. ASPET is pleased that the draft Strategic Plan focuses attention on basic and clinical research with botanicals. We hope the finalized plan will recognize the need to offer more balance between clinical studies of efficacy and those directed to examination of basic mechanisms of action and will state more explicitly those public health concerns that must be addressed on behalf of a U.S. public which uses non-standardized, unregulated herbal remedies that may harm rather than heal. 

As development and implementation of the Strategic Plan advances, ASPET looks forward to continued dialogue with you and your staff. 

Strategic area 1: Investing in research 

Goal 1: Stimulate submission of high-quality applications in CAM priority areas 

ASPET supports the need for studies on basic mechanisms of action and toxicity and for investigator-initiated research. Toward this end we recommend that NCCAM employ the RFA and other mechanisms with dedicated funding, to support and encourage investigators to submit grant proposals that address carefully defined research questions concerning actions and toxicity of botanicals. New investigators would be encouraged to pursue research if they recognized the availability of funds for meritorious grant proposals. Also, investigator-initiated research into botanicals needs to be expanded to promote our understanding of both prescription drug-herbal and herbal-herbal interactions. To stimulate new grant submissions on botanicals - and to address the scientific needs of a growing public health issue - we believe it is important for NCCAM to state explicitly to the biomedical research community that it supports high quality, basic research submissions. NCCAM might also consider use of R21 grants and Supplemental grants to attract established investigators with specialized research expertise to areas that interest them, but in which they may not have realized funding opportunities existed. Such steps are entirely consistent with on-going developments in NIH review procedures and reorganization of Study Sections. 

Goal 2: Expand the scope of the NCCAM extramural research portfolio and subject participation 

Encouraging high-quality, basic science oriented grant proposals in botanical research is critical to our understanding of herbal mechanisms and drug-herbal interactions. Therefore, ASPET would suggest clarification and rephrasing of the statement contained under the Basic Research subheading: “In addition, randomized clinical trials will be designed not only to test treatments, but also, to the extent possible, to determine underlying mechanisms of their action….”. ASPET believes that basic and clinical research in botanicals can be conducted concurrently, and that the above statement (…”to the extent possible…”) unintentionally undermines support within NCCAM for basic research. With respect to botanicals, the lack of standardization and the fact that herbals are not single agents but mixtures of many compounds makes our understanding of the underlying mechanisms of action of carefully standardized herbal preparations all the more critical. 

Goal 3: Create an NCCAM intramural research program 

A strong intramural program in CAM modalities will help to establish a benchmark for opportunities in botanical research. ASPET recommends that, given the orientation of NCCAM on clinical research in the extramural community, that intramural research on botanicals be more appropriately balanced between basic and clinical research projects with herbals. In the intramural program, NCCAM can take a leading position on the development of some standardization with respect to select herbal agents. Additionally, NCCAM can establish an intramural training program for botanical research. 

ASPET suggests that NCCAM take the lead in supporting development, perhaps with input from the herbal and pharmaceutical industries, of "voucher" (defined and standardized) samples of the most widely used herbal preparations. Such samples could be made available to interested basic science and clinical researchers. 

Goal 4: Establish a global NCCAM research enterprise 

ASPET cautions against collaborations with international and indigenous health practices unless sufficient measures are taken to make certain that international research efforts meet the same high scientific standard of rigor NCCAM is demanding. 

Strategic Area 2: Training CAM Researchers 

Goal: Increase the number, quality, and diversity of CAM investigators. 

ASPET offers no specific comment to this goal. A number of these issues are addressed throughout our comments. 

Strategic Area 3: Expanding Outreach 

Goal 1: Establish an effective dialogue with CAM stakeholders 

The Strategic Plan makes an obvious commitment to sound scientific method and insistence on the highest quality research. As a professional organization representing Pharmacologists, ASPET is one representative of the biomedical research community. Our meetings with you and interactions with NCCAM staff have been productive and informative: we look forward to continuing and expanding this relationship in the future. In communication with all CAM stakeholders, NCCAM must insist that strict adherence to sound scientific principle be maintained. 

Goal 2: Make reliable scientific information readily available to the public 

Given the wide consumer use of botanicals and the paucity of credible scientific data on their benefits or dangers, NCCAM can play an influential role as spokesperson for alerting the public to potential dangers of drug-herbal interactions. By increasing extramural support for the study of botanicals,
NCCAM also raises the level of consumer scientific awareness when significant studies are reported from laboratories across the nation. 

Strategic Area 4: Facilitating Integration 

Goal 1: Facilitate development of health education curricula that respect and incorporate insights and opportunities afforded by validated CAM and conventional practices 

The Strategic Plan makes clear the need for sound evidence based science for CAM modalities. Demonstrated federal support for botanical research coupled with consumer demand for answers to their medical needs will generate more and improved sources of education for both caretaker and patient. Proving what is useful and what is useless ultimately will help teachers and their students at universities, medical schools, academic health centers, and schools of public health and nursing, develop appropriate educational curricula. The teaching of herbal interactions with prescription drugs
will become the responsibility of all health care institutions. 

Goal 2: Facilitate coupling of effective CAM and conventional practices within a coordinated, interdisciplinary healthcare delivery system 

ASPET believes that those CAM modalities proven to be effective will be integrated into conventional medicine. Those that are proved to be ineffective will not. Market forces will allow conventional medical practice and patients to demand what works and reject what does not, facilitating integration. 

Strategic Area 5: Practicing Responsible Stewardship 

ASPET is supportive of NCCAM’s goals outlined in this area of the Strategic Plan but offers no specific comments. 

On behalf of the ASPET Council, thank you for the opportunity to offer public comment to the NCCAM Strategic Plan. 

With best personal regards, 

Norman Gillis, Ph.D. 
Professor Emeritus, Yale University School of Medicine 
Chair, Herbal Medicine Interest Group 
American Society for Pharmacology and Experimental Therapeutics