2.1 THE BOTANICAL RESEARCH CENTERS PROGRAM, 1999 – 2010 AND BEYOND
In 1999, Congress attached language to the appropriation for ODS that “calls on ODS to establish a botanical research initiative with major research institutions in the United States”. The then-Office of Alternative Medicine, also at NIH and predecessor to NCCAM, found this to be of considerable interest to them and joined ODS in publishing the first Request for Applications (RFA) for two multidisciplinary Centers that were funded at the end of 1999. Shortly thereafter, a second RFA released by ODS and NCCAM led to the addition of three more Centers. Both the National Institute of General Medical Sciences (NIGMS) and the Office of Research on Women’s Health (ORWH) at NIH participated in funding these Centers. A sixth Center was added in 2002 with support from the National Institute of Environmental Health Sciences (NIEHS). The Centers were called upon to conduct the full range of studies from botany to the clinic, create training opportunities, and perform public outreach. An evaluation of the program at the end of this first funding period led to a more focused RFA in 2004, with an emphasis on basic, pre-clinical, and early clinical studies. This decision was based on the realization that major clinical studies were beyond the scope of what could be reasonably accomplished in a five-year funding period and that other NIH mechanisms existed to fill this need. Furthermore, it was recognized that much work needed to be done at the earlier phases of investigation before full-scale clinical trials of botanical extracts would be appropriate. Training, while a valuable component of a Center’s activities, could also be funded in other ways and Centers were encouraged to take advantage of other mechanisms at the NIH (e.g., pre- and post-doctoral training awards) to meet this goal.
Over the first two rounds of the BRCP, the NIH has invested a total of approximately $90 million. The Program has been a sound investment for NIH and has been responsible for significant contributions to the field of research on botanical dietary supplements [3
2.2 OTHER ODS AND NCCAM SUPPORT FOR RESEARCH ON BOTANICALS
In addition to the NIH BRCP, NCCAM has developed a robust portfolio of investigator-initiated research on botanical extracts and compounds. Many of the research grants funded by NCCAM in this area are supported with co-funding from ODS. NCCAM’s botanical research portfolio also includes Small Business Innovation Research (SBIR) projects, as well as mentored training and fellowship grants to support projects of young investigators in training. The research scope of NCCAM-funded botanical research includes both basic and mechanistic studies, as well as early-phase clinical work.
In considering what data are required prior to implementing clinical research on a given botanical, NCCAM encourages investigators to focus on critical gaps in the understanding of product biology before embarking on human trials. Such gaps typically include data on absorption, distribution, metabolism, and excretion, as well as toxicity. Data on appropriate dosing or dose frequency are also frequently lacking. Although markers of biologic effect, and efficacy, are also scarce, it is important that such markers be sought for a specific botanical of interest. An understanding of appropriate study outcome measures and target population are similarly important for ultimately planning a large clinical trial of a botanical product.
It is also important to recognize that other Institutes at the NIH support botanical research, including NIEHS; the National Cancer Institute (NCI); the National Heart, Lung and Blood Institute (NHLBI); the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); and the National Institute on Aging (NIA). In view of the broad research scope funded across the NIH, and their strong interest and commitment to funding outstanding botanical research, both NCCAM and ODS work with staff from other NIH Institutes to organize and support scientific meetings on botanical research, and co-fund many projects that are supported primarily by other NIH Institutes.