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It is my view that we have the finest government in the world, the finest agriculture in the world and the finest medical research and drug development institutions in the world. However, these complex institutions are not working in concert to optimize health in this country. Hippocrates said in 500 BC "let food be your medicine and let your medicine be food." Our 21st Century science has brought us full circle to realize that it is no accident that 2/3 of our drugs are derived from plants or that vitamin deficiency diseases only became evident when and where mankind doesn't have a varied intake of plant products. A single orange has 170% of the recommended dietary allowance of vitamin C but it also has in its skin a fatty substance the citrus fruits developed to fight off fungi (called limonoids) which also happen to inhibit cancer cell growth. Drugs have their place and so do botanical dietary supplements. As the DSHEA law is currently being interpreted, physicians and the public cannot appreciate the full benefits of the science we are attempting to carry out on botanical dietary supplements and in some cases that science is being impeded. In the future, I hope more attention will be given to funding efforts in schools, groceries and other institutions to increase fruit and vegetable intake. Some solutions to the current dilemmas facing botanical dietary supplements include:

1) Certification of contents and inspection
2) Standardization of preparations using markers
3) Clinical Testing through our finest medical research centers
4) Labeling and Marketing Standards and
5) Post-Marketing Surveillance.

I appreciate the opportunity to testify before this committee and hope we can work together to improve the health of all Americans by implementing the full extent of the DSHEA legislation and making it possible to develop to their full potential the health benefits of fruits, vegetables, and botanical dietary supplements such as PC-SPES and Chinese Red Yeast Rice. I hope this committee will be successful in finding ways to enable the American people to continue to have access to dietary supplements and for the scientific community through the National Center For Complementary And Alternative Medicine and the Office Of Dietary Supplement Research to build the science base for what I view not only as the medicines of the past but preventive formulas for the future utilized as self-care . As the late Dr. Ernst Wynder was fond of saying : " Nobody takes better care of you than you do." Self-care is part of the health care of tomorrow.

REFERENCES

1. Fairfield KM, Fletcher RH Vitamins for Chronic Disease Prevention. JAMA 2002;287:3116-3126.
2. Heber D, Yip I, Ashley JM, Elashoff DA, Elashoff RM, and Go, VLW. Cholesterol-lowering effects of a proprietary Chinese red yeast rice dietary supplement. Am J Clin Nutrition 1999;69:231-236.
3. Wang HL, Fang SL. "Indigenous fermented foods of non-Western origin" in Hesseltine CW, Wang HL (eds) Mycologia Memoirs pp. 317-344.
4. Sung R-H. "Tien-Kung K'ai-Wu" Chinese Technology in the Seventeenth Century. Pennsylvania State University Press. 1966, pp. 292-294.
5. Tieghem Van . P. Monascus, genre nouveau de l'ordre des Ascomycetes. Bull. Soc. Fr. 1884; 31:226-231.
6. Went FAFC. Monascus purpureus le champignon de l'angquac une nouvelle thelebolee. Ann Soc Nat Bot. 1895; 8:1-17.
7. Lucas J, Schumacker J, Kunz B. Solid state fermentation of rice by Monascus Purpureus. J. Korean Society of Food Sciences. 1993;9:149-159.
8. Martinkova L, Juzlova P, Vesely D. Biological activity of polyketide pigment production by fungus Monascus. J. Appl. Bacteriology 1995;79:609-616.
9. Endo A. Monacolin K, a new hypocholesterolemic agent produced by Monascus sp. J. Antibiotics 1979;8:23-28.
10. Li C, Zhu Y, Wang Y, Zhu J-S, Chang J, Kritchevsky D. Monascus purpureus fermented rice (red yeast rice): a natural food product that lowers blood cholesterol in animal models of hypercholesterolemia. Nutrition Research 1998;18:71-78.
10. Risberg T, Lund E, Wist E, et al. Cancer patient use of nonproven therapy: 5-year follow-up study. J Clin Oncol 1998;16:6-12.
11. Eisenberg DM, Kessler RC, Foster C, et al. Unconventional medicine in the United States: prevalence, costs, and patterns of use. N Engl J Med 1993; 328: 246-252.
12. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997. JAMA 1998; 280: 1569-1575.
13. Darzynkiewicz, Z., Traganos, F., Wu, J.M et al. Chinese herbal mixture PC SPES in treatment of prostate cancer. Int. J. Oncol. 2000; 17: 729-736.
14. DiPaola, RS, Zhang, H, Lambert, GH et al. Clinical and biologic activity of an estrogenic herbal combination (PC-SPES) in prostate cancer. N. Engl. J. Med. 1998; 339: 785-791.
15. Taille A, Hayek, OR, Buttyan, R et al. Effects of a phytotherapeutic agent, PC-SPES, on prostate cancer: a preliminary investigation on human cell lines and patients. B. J. U. Int. 1999; 84: 845-850.
16. Moyad, M.A., Pienta, K.J., and Montie, J.E. Use of PC-SPES, a commercially available supplement for prostate cancer, in a patient with hormone-naive disease. Urology 1999; 54: 319-324.
17. Hsieh T, Chen, SS, Wang X et al. Regulation of androgen receptor (AR) and prostate specific antigen (PSA) expression in the androgen-responsive human prostate LNCaP cells by ethanolic extracts of the Chinese herbal preparation, PC-SPES. Biochem. Mol. Biol. Int. 1997; 42: 535-544.
18. Bonham M, Arnold H, Montgomery B, Nelson PS. Molecular effects of the herbal compound PC-SPES: Identification of activity pathways in prostate carcinoma. Cancer Research 62:3920-3924.
19. Kubota T, Hisatake J, Hisatake Y et al. PC-SPES: A unique inhibitor of proliferation of prostate cancer cells in vitro and in vivo. Prostate 2000; 42: 163-171.
20. Tiwari RK, Geliebter J, Garikapaty VP et al. Anti-tumor effects of PC-SPES, an herbal formulation in prostate cancer. Int. J. Oncol. 1999; 14: 713-719.
21. de la Taille A, Buttyan R, Hayek O et al. Herbal therapy PC-SPES: in vitro effects and evaluation of its efficacy in 69 patients with prostate cancer. J. Urol. 2000; 164: 1229-1234.
22. Small EJ, Frohlich MW, Bok R et al. Prospective trial of the herbal supplement PC-SPES in patients with progressive prostate cancer. J. Clin. Oncol. 2000; 18: 595-3603.

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