for the Study of
Healthcare Organizations & Transactions
Introduction The herb pictured at the left, Aristolochia fangchi, has received attention recently because of its alleged link to kidney damage and the onset of cancer. This herb was a part of a Chinese herbal compound, used in a weight reduction treatment regimen, in Belgium, in the early 1990s. By 1993, instances of kidney failure were documented in patients who had received treatment (Depierreux, et al., 1994).
What Happened in Belgium? Greensfelder, in a short, readable article in Science (June 16, 2000), described the situation that occurred in Belgium in the early 1990s. At a weight loss clinic, between 1990 and 1992, a group of patients, who were primarily women, were prescribed a mixture of Chinese herbs and Western drugs. By 1993, instances of kidney failure were documented in the group of women patients who had received treatment (Depierreux, et al., 1994). By 1994, the first urinary tract cancers were detected among some of these same patients.
Kessler, in an editorial in The New England Journal of Medicine (June 8, 2000), discusses what investigators think happened to the herbal preparations that were used for weight loss. The preparations were supposed to contain the herbal products, Stephania tetrandra and Magnolia officinalis. However, pharmacists apparently used a derivative of the herb, Aristolochia fangchi, pictured above. The derivative, aristolochic acid, is known to be harmful to the kidneys of laboratory animals. The substitution of Aristolochia fangchi for Stephania tetrandra apparently occurred because of the similar sounding Chinese names of the two herbal products.
Nortier and colleagues described a study that was conducted on these Belgium patients and the conclusions that were drawn from it in an article published in The New England Journal of Medicine (June 8, 2000). The article itself is highly technical reading and is probably best appreciated by those who have specialized medical training. However, the short version is that, of the 105 patients who suffered from kidney disease, 43 had reached end-stage kidney failure at the time of the study. Thirty-one of the patients had already undergone successful kidney transplantation; 12 were undergoing kidney dialysis and were waiting for a kidney transplant.
Kessler, in the editorial that is mentioned above, outlines the limitations of the Nortier, et al., study. They include: the lack of a comparison group, the failure to consider other factors that may have caused the various types of cancer, and the failure to blind the pathologists to the hypothesis of the study. Because of these methodological limitations, the conclusion that is drawn by Nortier, et al., that the data suggest that aristolochia toxins "cause" kidney disease and urinary tract cancer, may be premature. There indeed may be a connection between this substance and kidney disease as well as cancer. However, because of the limitations of the study by Nortier, et al., it is difficult to agree that "cause" has been established.
Has Anything Similar Occurred in the United States? There has been no such tragedy in the United States. But what happened in Belgium has raised serious concerns about the safety and efficacy of herbal products and dietary supplements.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements may bear "structure/function" claims without prior Food and Drug Administration (FDA) review. These are merely claims that the products affect the structure or function of the body. However, dietary supplements may not bear a claim that they can prevent, treat, cure, mitigate or diagnose disease without prior FDA review. (Click on our page, Labeling Drugs and Herbal Remedies, to read more about the 1994 Act and the January, 2000 rules affecting labeling.)
As a result of this Act, most herbal products are now sold in a food category designated "dietary supplements." The legislative intent of DSHEA was to guarantee availability of herbal products, to allow scientific information, that is truthful and appropriately qualified, to be used in conjunction with the sale of these products, as well as to give consumers some information about the products' benefits, and to provide appropriate cautions about their use. The Act also places the burden of proof that an herb product is adulterated or unsafe on the government. The result is, as Kessler (2000) points out, that, for the most part, dietary supplements need not undergo rigorous FDA review for safety or effectiveness before they are marketed.
What Should be Done? Kessler, in his June 8, 2000 editorial, suggests that the debate could move in any one of several directions.
First, proponents of herbals and their use might argue that other substances that the patients in Belgium used were the probable cause of the kidney disease and cancer and not necessarily the herbal compound. Given the limitations of the Belgium study, this is certainly a plausible argument.
Second, opponents of herbal products and dietary supplements might use this opportunity to advocate a ban on all herbs and supplements.
Third, those like Kessler argue that Congress should require that more testing of herbals and dietary supplements be conducted before they are allowed on the market. This would probably entail more company-sponsored premarket testing and more rigorous FDA regulation and oversight.
Finally, those like Dr. Varro Tyler, a retired dean of the School of Pharmacy at Purdue University and author of many books on herbs and their use, consider premarket company-sponsored testing to be unrealistic. The reasons are simple: such testing costs the companies too much. Rather, Dr. Tyler suggests that the FDA convene an expert committee, perhaps similar to the German E Commission. (Click on our page, A Guide to Popular Herbs, to read more about the German E Commission's work.) He argues that experts already know a great deal about the safety and effectiveness of herbal products. This information should be reviewed and compiled; then, information about unsafe herbal products should be given to both consumers and manufacturers. Dr. Tyler seems to believe that after this information is provided to a company that markets herbals and dietary supplements, it would not market unsafe products because of the potential for legal action.
Who is Right? One thing is certain: The debate over the use and regulation of herbals and supplements is only beginning. The Institute for the Future (Palo Alto, CA, 1999) has predicted that by 2005 "new consumers" -- people who are actively involved in making choices about the health care that they receive (or purchase for others) -- will become a majority. And, as individuals become disenchanted with mainstream medicine and the practice of medicine, the use of herbals and dietary supplements may increase. Individuals may decide that they are able to get better results using herbal products.
Should Congress require more premarket company-sponsored testing? Should we rely on an expert commission to review the existing evidence and tell consumers what is safe and effective? Are there other alternatives? These are important open questions.
The photograph was adapted from Science (June 16, 2000) page 1946.
Depierreux, M., Van Damme, B., Vanden Houte, K., Vanherweghem, J-L. (1994). Pathologic aspects of a newly described nephropathy related to the prolonged use of Chinese herbs. The American Journal of Kidney Disease, 24: 172-180.
Greensfelder, L. (June 16, 2000). Herbal product linked to cancer. Science, 288: 1946.
Kessler, D.A. (June 8, 2000). Cancer and herbs. The New England Journal of Medicine, 342, 23: 1742-3.
Mittman, R. & Cain, M. (January, 1999). The Future of the Internet in Health Care. Written for the California HealthCare Foundation (Online) http://www.chcf.org.
Nortier, J.L., Muniz Martinez, M-C., Schmeiser, H.H., et al., (June 8, 2000). Urothelial carcinoma associated with the use of a Chinese herb (Aristolochia Fangchi). The New England Journal of Medicine, 342, 23: 1686-1692.
Lucy Canter Kihlstrom, PhD
Copyright © 2000 Institute for the Study of Healthcare Organizations & Transactions. All rights reserved.
Revised: April 08, 2010 .