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As you have heard we are facing a national and international epidemic of obesity, heart disease diabetes and common forms of cancer. Increasing fruit and vegetable intake will help to correct an imbalance of our genes and environment which has resulted from our great success in raising grains efficiently. Modern humans evolved about 50,000 years ago in Africa in a veritable Garden of Eden where our genes were in equilibrium with a varied and colorful diet of plant foods as well as many minor species of herbs and spices that enriched our diet and provided health benefits. One result of our modernization of food production has been the loss of this diversity. Existing Hunter-Gatherers in the outback of Australia who live in equilibrium with nature eat over 800 varieties of colorful fruits, vegetables and other plant foods. The USDA spends only 4.5% of its budget promoting fruit and vegetable intake but recommends that fruits and vegetables make up 33% of the American diet. This discrepancy should be corrected, but the plant world has much more to offer us in terms of health that we have yet to discover. Botanical dietary supplements are at the growing edge of nutrition science, and represent the restoration of even greater diversity than can be accomplished with increased servings of fruits and vegetables. Spices such as garlic and curcumin have been known since ancient times to have health benefits. At UCLA, I directed the first U.S. clinical trial showing that Chinese Red Yeast Rice can be as effective as prescription drugs for lowering cholesterol (2). This ancient spice is a distant relative of the red spice on Peking Duck and Pork Spare Ribs available at your local Chinese restaurant. The difference between that spice and the traditional spice is that modern spice is made by liquid fermentation and does not have the same phytochemicals contained in yeast fermented by the traditional Chinese method on a bed of premium rice. Red yeast rice made this way is a traditional food consumed throughout Asia for its food and medicinal value for over a thousand years with the first written documentation in 800 A.D.(3,4). The fungus Monascus isolated from red yeast rice first became known in Western society through the work of Dutch scientists who noted its use by local populations in Java as reported by Van Tieghem et al. in 1884 (5). A species isolated from red Koji or Honqu (as red rice yeast is known in East Asia) was named Monascus Purpureus Went in 1895 recognizing the purple coloration (6). Today there are more than 30 Monascus strains on deposit with the American Type Culture Collection (Bethesda, MD) and it was declared a food product by the USDA in the 1920's. The traditional method of making red yeast rice is to ferment the yeast naturally on a bed of cooked non-glutinous whole rice kernels (7), and this method was industrialized in China to produce a dietary supplement which was imported and marketed in the United States until a Federal Appeals Court decision in favor of the FDA declared this an unapproved drug rather than a dietary supplement. The supplement contains only the rice and the Monascus fungus and the yeast in a capsule. There are a number of constituents in the natural product including pigments, fatty acids, and polyketides (monacolins) (8). The production of monacolins including Monacolin K by 124 strains of the genus Monascus including many strains of Monascus Purpureus was reported by Endo (9), and these substances are believed to account for the majority of the cholesterol-lowering activity of the yeast. In animals fed diets designed to induce hypercholesterolemia, Chinese Red Yeast Rice has been shown to lower cholesterol (10). We believe that during the fermentation process chemicals on the rice surface send a signal to the yeast resulting in the production naturally of a family of compounds called Monacolins first discovered in the 1970's by Dr. Endo in Japan and now known to occur in 39 species of yeast and fungi including the oyster mushroom sold in the produce section of your local market. One of these compounds called Monacolin K was isolated by a drug manufacturer from a different species of fungus and purified and crystallized to purity. The drug, Mevacor (Merck) initiated a generation of medical research that has developed many drugs in the category called statins through novel chemical modifications. These drugs have been shown to reduce mortality from heart disease and may someday have benefits for bone disease and cancer. The key difference between drugs and herbs is that herbs are a combination of multiple compounds while drugs consist of a single purified crystallized compound. Our research shows that only 5 mg of Monacolin K in the matrix of this yeast has the same cholesterol-lowering effect as 20 mg of Mevacor demonstrating that the entire family of compounds has an effect not just the one species which became a drug. Furthermore in animals, the yeast has no side effects at 500 times the normal human dose, while it is well-known that some statins have muscle and liver toxicities. There are 57 million Americans with high cholesterol and only 13 million take prescription drugs for cholesterol lowering. Mevacor at 20 mg to 40 mg per day has been shown to reduce heart disease deaths and heart attacks by 30% over 5 years in individuals with modestly high cholesterol levels. I suspect that Chinese Red Yeast Rice would have the same public health benefit at lower cost, but the Federal Appeals Court decision has made this an unapproved drug based on its containing a substance previously approved as a drug. This phrase is included in the DSHEA law as a protection against companies simply marketing impure fractions of drugs, a situation that is not in my view pertinent here. I have an IND pending before FDA currently to allow me to study the differences in metabolism between mevacor and Chinese Red Yeast Rice, but there can be no large phase III trial of Red Yeast Rice in this country until we find a way to solve the procedural and legal barriers to its marketing. As it stands, Red Yeast Rice is sold legally in every country but the United States. The use of botanical dietary supplements in the prevention and treatment of common forms of cancer has been dramatically rising in recent years in the United States (11-13), and our NIH-funded laboratories at UCLA have been studying such herbal products as green tea extract, Chinese Red Yeast Rice, and PC-SPES for their potent anti-cancer effects. PC-SPES was until recently being used by thousands of individuals with prostate cancer (14-17) . It contains a partially extracted mixture of eight different herbs: Dendrantherma morifolium, Tzvel; Ganoderma Lucidium, Karst; Glycyrrhiza glabra L; Isatis indigotica, Fort; Panax pseudo-ginseng, Wall; Robdosia rubescens; Scutellaria baicalensis, Georgi and Serenoa repens (15-19). In previous studies, we and others showed that PC-SPES mediated an antiproliferative effect on prostate cancer cells in vivo and in vitro (16-21). In addition, recent clinical studies showed that PC-SPES reduced prostate specific antigen (PSA) levels in more than 80 % of individuals with prostate cancer (22,23). CapCure, the Association for the Cure of Prostate Cancer, a non-profit foundation established by Michael Milken which has raised nearly 200 million dollars for prostate cancer research supported much of the basic research on PC-SPES including a clinical trial conducted at Harvard University and UCSF. This trial comparing PC-SPES to DES, a hormonal treatment for prostate cancer was stopped when one laboratory in Boston found trace amounts of a hormone DES in one lot of PC-SPES. The preliminary results demonstrated a significant 50% response to PC-SPES at the time the trial was stopped. In another study (18), conducted at the University of Washington the actions of PC-SPES in terms of gene activation in prostate cancer were shown to be entirely different than DES. Subsequently the California equivalent of the FDA found trace amounts of warfarin in several lots of PC-SPES imported from China and PC-SPES was withdrawn from the market. The manufacturer has since gone out of business, and there are deliberations planned in the next month which will determine the future of research with this herbal mixture including an NIH-funded study at Johns Hopkins University. These eight herbs are well-known and we have the facilities at UCLA and other institutions to proceed to investigate this mixture. The strategies and details for manufacturing enough material for the ongoing scientific studies and clinical trials in a properly controlled manufacturing environment are being actively developed. Dr. Phillip Koeffler, who has directed several studies in collaboration with me at UCLA and is Chief of Medical Oncology at Cedars-Sinai Medical Center in Los Angeles is convinced that there is much more to PC-SPES than can be explained by any of the reported contaminants based on our findings of substances in these herbs that inhibit cancer cell growth in several forms of cancer. I share his view on this matter. |
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