By Len Monheit
Yesterday, the NationalCenter for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements (ODS) announced funding of botanical research initiatives at five centers across the United States as some $30 million was allocated over the next five years, into projects which include metabolic syndrome, age-related diseases, women's health, immunomodulation and botanical lipids.
For those that haven't read the release and subsequent articles providing details of the funding, here goes:
MSKCC ResearchCenter for Botanical Immunomodulators
Co-Principal Investigators: Barrie Cassileth, Ph.D., and Philip Livingston, M.D.
MemorialSloan-KetteringCancerCenter is to study whether cancer and infectious disease might be treated with botanicals including echinacea, astralagus, turmeric and maitake which some people say can affect the immune system. The project will include collaboration with the Institute of Chinese Medicine and the ChineseUniversity in Hong Kong, and with Weill Medical College of Cornell University and The Rockefeller University.
Botanicals and Metabolic Syndrome
Principal Investigator: William Cefalu, M.D.
The Pennington Biomedical Research Center is to get $7.5 million over the next five years and will work with scientists at Rutgers University's Center of Agriculture and the Environment and at the LSU Agricultural Center, investigating extracts of Russian tarragon, Shilianhua and grape seed to see how these products might influence processes associated with metabolic syndrome, which includes a group of diseases and conditions including obesity, insulin resistance, type 2 diabetes, and cardiovascular disease.
Botanical Dietary Supplements for Women's Health
Principal Investigator: Norman Farnsworth, Ph.D.
The University of Illinois at Chicago, with $5 million over five years, will investigate women's health. Specifically, according to the release, the facility will continue studies on black cohosh and red clover for relief of menopausal symptoms as well as ongoing pharmacognosy training, but will also be examining botanical standardization, toxicity and metabolism. According to an Associated Press article, (http://www.belleville.com/mld/belleville/news/11337919.htm ) studies will also involve hops and chaste berry.
Wake Forest and HarvardCenter for Botanical Lipids
Principal Investigator: Floyd Chilton, Ph.D.
WakeForestUniversitySchool of Medicine will receive $7.5 million over five years, and working in collaboration with HarvardMedicalCenter will open a research center to be called the WakeForest and HarvardCenter for Botanical Lipids. The center will look at mechanisms and clinical applications of polyunsaturated fatty acids from plants such as flaxseed, echium and borage, in studies focused on inflammation and the ability of these botanical oils to prevent and treat inflammation-related diseases and conditions such as atherosclerosis and asthma.
Botanical Center for Age-Related Diseases
Principal Investigator: Connie Weaver, Ph.D.
Purdue University is to receive $6 million over the next five years and working in collaboration with the University of Alabama at Birmingham and Rutgers University, will examine the effects of polyphenols and their ability to prevent and treat conditions associated with aging, including osteoporosis, cognitive decline, and cataracts. According to an article in the Indianapolis Star (http://www.indystar.com/articles/8/235273-6168-009.html ), current studies on soy protein, green tea and supplement regulation will continue and polyphenols from kudzu will also potentially be studied.
Calls for dollars answered...
Calls for increased funding to further research the safety and efficacy of botanicals have been increasing in recent years. More attention to drug:herb interactions, observations of the use of sub-efficacious dose in commercial products, quality issues and concerns, and a perception of a non-research-based platform have all undermined sector credibility. Frequently, even when the research is performed, the results have been neutral, the hypothesis has been flawed, media distortion or lack of attention has reduced the result to insignificant, or marketers have trumpeted the science in forms that have been absolutely unrecognizable.
The current funding bonanza represents excellent opportunities to get top level projects initiated. And the areas of research are at least in line with where industry pundits tell us some of the commercial opportunities lie - so there should be some correlation between the science and the market opportunity and application of the science.
So industry gets some of what it wants - more funds for research, and into presumably, reasonable areas of study. But as we certainly know with science, it's extremely dangerous to have the outcome pre-determined or to anticipate the hypothesis to be proven with certainty. To expect automatic credibility just because efficacy is established in the study is unrealistic. A positive result should not automatically translate to validation of all commercial products in the category. If that's our expectation as an industry, we will certainly be disappointed. And if the results are negative or neutral, we must prepare for that too. There is the possibility that even with a well-defined study, the products investigated will not prove efficacious, or, possibly even more likely, will show efficacy but through an unknown mechanism of action. As an industry, we have to handle these outcomes maturely and professionally.
We wished for money and emphasis on science, we've got some of that. The adage 'Be careful what you wish for' does come to mind.
Putting this all in context, the next research stage, for those products which demonstrate efficacy, must involve health care cost impact assessment. This is part of what industry must be anticipating and putting keeping wheels in motion on an ongoing basis.