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Dietary supplement or drug? The case for Cholestin

UCLA Center for Human Nutrition 900 Veteran Avenue Room 13-146 Warren Hall Los Angeles, CA 90095-1742 E-mail: dheber{at}med1.medsch.ucla.edu

Dear Sir:

In his editorial about our recent article, "Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement" (1), Havel (2) focuses on the issue of whether Cholestin (Pharmanex, Simi Valley, CA) is a drug or dietary supplement, citing the position of the Food and Drug Administration, rather than on the merits of our recent double-blind clinical trial of a standardized, commercial dietary supplement. In addition, he takes issue with 2 important facts. First, he states that the dietary supplement Cholestin actually differs from the traditional red yeast used as a dietary staple in Asia, which is prepared by fermenting yeast on rice. His sole argument for this position is that Cholestin "is manufactured by growing a single strain of M. purpureus on rice under carefully controlled conditions that increase the statin content, which is monitored during production." This is incorrect. The strain is selected as one that produces a family of monacolins, one of which is lovastatin (monacolin K). The actual composition of a Cholestin capsule is only yeast and the rice on which the yeast was fermented. Of course, when one produces a food, it is usual to monitor the product for the content of marker substances to ensure the constancy of production methods. However, there was no attempt to increase the production of the monacolins during fermentation. Selecting a yeast strain is no different from selecting a particular strain of tomato to grow for sale as a food on the basis of its red color (or perhaps someday its lycopene content). This is an essential point for dietary supplements at the growing edge of nutrition. Supplements are not unpurified drugs, but are natural substances. Drugs are produced by crystallization and purification from plant sources; a significant proportion of all drugs are derived from plants. The effect on public health of affordable and safe dietary supplementation cannot be underestimated.

Havel's second factual misinterpretation is that the statin content of the supplement is 10 mg. In fact, the appropriate comparison is between monacolin K and lovastatin, of which there is only 5 mg per tablet. Therefore, the comparison of the cholesterol-lowering effects of the dietary supplement with those of 10 mg lovastatin, which was tested in a multicenter trial by Havel et al (3), is inappropriate. As a dietary supplement, this yeast contains ten monacolins (1), which may have significant cholesterol-lowering activity, and differs from lovastatin. The activity of these other substances, and this needs to be tested. Because this dietary supplement is based on a traditional Asian food, it is reasonable to assume that it is safe; and the Dietary Supplement Health and Education Act was specifically written to protect dietary supplement manufacturers from being required to conduct the expensive trials required of manufacturers of purified drugs (4). One reason costs are high in the US health care system is because drug testing is expensive. In fact, only small numbers of individuals in this country are currently taking cholesterol-lowering drugs—even individuals with cholesterol concentrations >6.2 mmol/L (240 mg/dL).

The need for an alternative to prescription drugs for the tens of millions of Americans with cholesterol concentrations between 5.2 and 6.2 mmol/L (200 and 240 mg/dL) is clear to me. As a physician, I am frequently faced with the dilemma of which treatment option is best for patients who have changed their diets and lifestyles optimally, but who still have undesirably high cholesterol concentrations. My only choice, other than natural remedies (5), is to prescribe drugs for my patients who have cholesterol concentrations below values for which these drugs are approved. Since the publication of Havel's editorial, the Federal District Court has ruled against the Food and Drug Administration, finding that Cholestin is a dietary supplement. I urge all nutritionists to become informed about the entwined scientific, public health, and legal issues concerned with dietary supplements so we can fulfill our important mission.

REFERENCES

1. Heber D, Yip I, Ashley JM, Elashoff DA, Elashoff RM, Go VLW. Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement. Am J Clin Nutr 1999;69:231–6.[Abstract/Free Full Text]
2. Havel R. Dietary supplement or drug? The case of Cholestin. Am J Clin Nutr 1999;69:175–6 (editorial).[Free Full Text]
3. Havel RJ, Hunninghake DB, Illingworth DR, et al. Lovastatin (mevinolin) in the treatment of heterozygous familial hypercholesterolemia. A multicenter study. Ann Intern Med 1987;107:609–15.
4. Dietary Supplement Health and Education Act of 1994. Public law 103-417. 1994.
5. Heber D. Natural remedies for a healthy heart. Garden City, NY: Avery Books, 1999.

This Article Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Heber, D. Search for Related Content PubMed PubMed Citation Articles by Heber, D. Agricola Articles by Heber, D.