Why Aren’t We Mad?

Abstract & Commentary

Synopsis: Labels on the 10 most frequently used herbs failed to adequately describe the ingredients, provide the correct dose of the herb, or were not interpretable by professional pharmacists.

Source: Garrard J, et al. Arch Intern Med. 2003;163:2290-2295.

In 2000, the sales of herbs and dietary supplements were more than $15 billion. There are numerous reports of herbal products having serious interactions with other drugs, and more recent analysis has shown that the products do not always contain the ingredients listed on the labels and may contain ingredients other than those advertised or listed.1,2

Patients who report use of herbs to their physician are usually not able to describe the ingredients of the herbs they are taking and may not be taking an appropriate dose. The purpose of this study by Garrard and colleagues was to describe the variations in the label information of the 10 most commonly purchased herbs.

Products of each of 10 herbs were surveyed in samples from 20 retail stores in a large metropolitan area. Herbs were those with the greatest sales volumes in 1998: Echinacea, St. John’s wort, Ginkgo biloba, garlic, saw palmetto, ginseng, goldenseal, Siberian ginseng, aloe, and valerian.

Each herb studied had a large range of label ingredients and of recommended daily dose (RDD) across available products. Strengths were not directly comparable because of ingredient variability. (In the absence of federal standard for ingredients or dose recommendations, the benchmarks for RDD and for recommended content were taken from the Professional’s Handbook of Complementary and Alternative Medicines.4) Among 880 products, 43% were consistent with a benchmark in ingredients and recommended daily dose, 20% in ingredients only, and 37% were either not consistent or label information was insufficient. Price per RDD was a predictor of consistency with the benchmark, but store type was not.

Garrard et al concluded that persons self-medicating with an herb might be ingesting ingredients substantially different from those recommended by a benchmark. Higher price was the best predictor of consistency with a benchmark. This study demonstrates that health providers and consumers need to closely examine label ingredients of presumably the same or similar herbal products.

Comment by Ralph R. Hall, MD, FACP

Garrard et al’s conclusions were perplexing. They concluded that higher cost was a predictor of content and quality, while their findings demonstrated that for valerian, St. John’s wort, Ginkgo biloba, and aloe, a lower cost was associated with consistency with the benchmark. If your product contains the correct ingredients or correct dose only 60-75% of the time using such criteria, why would you want to buy it?

In the discussion, Garrard et al state that many of the products had label descriptions of ingredients and products that were so vague professional pharmacists were unable to interpret them. How then is the consumer going to interpret the label? One must further be aware that even though the product labels are explicit, the product may be missing the key ingredient or, in the case of some weight-control herbs, they may contain an ingredient that is not listed such as ephedra or a related product. Studies reported by consumerlab.com have shown that many products do not contain any of the listed ingredients or at best only a trace. A report from consumerlab.com in 2000 found that 25% of Ginkgo biloba-labeled products did not contain significant amounts of the herb. Even though they did not pass testing, all bore labels claiming standardization for the product.2

This study examines only 1 aspect of the difficult health problems that are rife in the dispensing of herbal products. A recent report showed that 50% of the liver-transplant patients at a large academic center had used potentially hepato-toxic herbal and dietary supplements.3 In a group of 105 patients who took weight-reducing pills containing Aristolochia fangchi, 43 developed end-stage renal disease.4 While preparing an editorial regarding A fangchi, David Kessler, former head of the FDA, was able to easily purchase the herb.

This herb has also been associated with a significant incidence of carcinoma of the urogenital system.5

Even when the FDA is able to act against these agents, how is it to know which products contain the toxic ingredient? How are they to know which agent sells them? Kessler notes that "Congress has put the FDA in the position of being able to act only after the fact and after substantial harm has occurred."

The root of this problem was fueled by passage of the Dietary Supplement Health and Education Act of 1994, (sometimes called the "Hatch Act," after Senator Oren Hatch of Utah, who introduced this bill and who currently chairs the committee that would be involved in any change of this act). The act deregulated the industry by limiting the role of the FDA.

The Office of the Inspector General report noted that the FDA currently receives reports of less than 1% of all adverse events associated with dietary supplements; that "data on these adverse events are characterized by limited medical information, limited product information, limited manufacturer information, limited information on affected consumers, and limited ability to analyze trends of adverse event reports."6

If the large pharmaceutical companies market a drug in which there are even a minimal amount of data suggesting that it is not effective or unsafe, there is a public outcry. Where is the outcry regarding the disasters and deception of the herbal medicine and dietary supplement industry?

Dr. Hall, Emeritus Professor of Medicine, University of Missouri-Kansas City School of Medicine, is Associate Editor of Internal Medicine Alert.

References

1. Kessler DA. N Engl J Med. 2000;342:1742-1743.

2. www.consumerlab.com. Product Review— Ginkgo Biloba. Accessed 12/01/03.

3. Estes JD. Arch of Surg. 2003;138:852-858.

4. Nortier JL, et al. N Engl J Med. 2000;342:1686-1692

5. Cosyns JP, et al. Am J Kidney Dis. 1999;25:694-700.

6. Office of the Inspector General, Department of Health and Human Services, 2001. Available at http://oig.hhs.gov/oei/reports/oei-01-00-00180.pdf. Accessed 12/01/03.