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Herbal Can cer Cu res on th e Web: Non com plian ce With th e Dietary Su pplem en t Health an d Edu cation Act Robert Alan Bonakdar, MD Background and Objectives: A significant portion of the US population uses the Internet to obtain health information; nearly half of Internet users admit that this information influences decisions about their health care and medical treatments. Concurrently, approximately one third of the population uses herbal supplements; a higher percentage is noted for subgroups of cancer patients. The Dietary Supplement Health and Education Act (DSHEA) of 1994 contained regulatory standards for herbal supplements, including restricting any claims for disease prevention, treatment, or cure. This study determined the degree of compliance with the DSHEA, as applied to Internet sites focusing on the subject of herbal supplements and cancer. Methods: Internet searches were conducted using six popular search engines and three master search engines in October–December 2000 using the linked terms herb and cancer. The Internet sites identified through this search process were examined for categories of information including claims regarding prevention, treatment, or cure; commercial nature; DSHEA and physician consultation warnings; country of origin; and use of research and testimonials. Additionally, commercial sites were reviewed to identify tactics used to promote products or services. Results: Each of the six primary search engines provided between 11,730 and 58,605 matches for herb and cancer. Further cross matching with the three master search engines identified 70 non-repeating sites that appeared on all three master search engines. Of these 70 sites, nine were irrelevant matches or no longer functioning. Of the remaining 61, 34 (54%) were commercial sites (CS) and 27 (42.8%) were noncommercial sites (NCS). Of the CS surveyed, prevention, treatment, and cure were discussed 92%, 89%, and 58%, respectively. CS provided testimonials, physician consultation recommendations, and DSHEA warnings 89%, 38.8%, and 36.1% of the time, respectively. CS provided research with references 30.6% of the time versus 92.6% of the time in NCS. All international commercial sites surveyed claimed herbal cancer cures. Conclusions: Although the DSHEA was enacted and amended to decrease unlawful claims of disease prevention, treatment, and cure, the results of this study indicate that such claims are prevalent on commercial Internet sites. A majority of sites claim cancer cures through herbal supplementation with little regard for current regulations, and such claims were more common on sites operated from outside the United States. (Fam Med 2002;34(7):522-7.) Recent estimates indicate that 56% of the adult US population (104 million adults) have used the Internet. Of these, more than half use the Internet to obtain health information; a majority believe the health information to be credible. Between 47%–70% of Internet health seekers (IHS) state that information obtained from the Internet influences their decision about how to treat a medical condition, and 28% indicate that information

From the Scripps Center for Integrative Medicine, La Jolla, Calif.

from the Internet affects their decision about whether or not to visit a physician.1,2 Internet Standards Previous studies have demonstrated the unreliable nature of Internet health information. A 1997 study found that only four of 41 Internet sites on children’s fevers met accepted standards.3 A recent survey of health Web sites by Berland et al showed that 20% or less of Web sites had relevant content displayed on their first page, and less than half had clinical content that was more than minimally covered and completely accurate.4 Factors that may explain the lack of scientifically

Award-winning Papers From the AAFP 2001 Annual Scientific Assembly accurate information on many Internet sites are the lack of mandatory standards and the commercial (for profit) natures of such sites; 10% of IHS purchase medicine, herbs, or supplements on-line from these sites.1 Several organizations have attempted to construct a standard code of Internet ethics, including the American Medical Association, Hi-Ethics, Health on the Net Code, Internet HealthCare Coalition, and MedCertain. Unfortunately, these standards are voluntary, and there is no strong incentive, especially for financially lucrative sites, to abide by such standards if doing so involves changing current practices.5-10 Herbal Medicine: Reliability and Regulation The field of herbal medicine has also suffered from allegations of poor quality and reliability. Studies have documented that the potency of herbal supplements may vary considerably, and ingredients may be adulterated or diluted with materials that are found in processing or that are cheaper to produce.11-13 Additionally, claims made for herbal supplements can vary widely. The Dietary Supplement Health and Education Act (DSHEA) was established by the US Congress in 1994 to set standards for claims made about herbal and other health supplements.14 According to DSHEA, such products may still be marketed without proof of efficacy, bioavailability, or standardization, but manufacturers cannot claim that the products prevent, treat, or cure any condition. Products may only claim to have vague effects on the body’s “structure or function,” such as: “Improves urinary stream and well-being” (Saw Palmetto). Similar to the Internet, various organizations such as ConsumerLab.com, the Food and Drug Administration, and the Federal Trade Commission are attempting to provide greater reliability and standardization within the herbal medicine industry through testing and product claims enforcement.15,16 The Internet, Herbal Medicine, and Cancer Patients Although IHS are increasing in number, certain subgroups, such as cancer patients, tend to have disproportionately high levels of Internet use. This may be because cancer patients feel an increased need for information, perhaps because of a perceived lack of efficacy from conventional cancer treatments.1 Concomitantly, cancer patients have a disproportionately higher use of complementary and alternative medicine (CAM) and herbal medicines. CAM is used by up to 64% of cancer patients, with 13 studies reporting an average rate of use of 31%.17 Among the most popular treatments within CAM are dietary and herbal methods of treatment, which are used by 25%–40% of cancer patients.18 Among cancer patients, higher rates of CAM and herbal medicine use are found in younger, welleducated patients (similar demographics to IHS) who

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exhibit greater symptoms, depression, and later stage of diagnosis.18 Objectives This study examined the quality of information contained on Internet Web sites that cancer patients would potentially find when attempting to investigate herbal medicines. Because concerns have been raised about the quality of information both on the Internet and within the herbal supplement industry, it was hypothesized that poor-quality information would be particularly common when information was obtained from a combination of these two sources, ie, (1) Internet information about (2) herbal supplements. The specific objectives were to evaluate cancerrelated Internet sites that provide information about herbal supplements to determine (1) how often the sites provided claims about prevention, treatment, and cure that would violate the DSHEA, (2) whether the frequency of such claims was different on commercial (ie, for profit) and non-commercial (ie, not for profit) sites, and (3) whether the frequency of such claims differed on sites originating inside versus outside of the United States. Methods A combination of primary and master search engines were used for this study. Primary search engines (see below) were first used in this study only to assess the number of Web sites that could be found on the topics of interest. Master search engines were used next. They combine the results of multiple individual primary search engines and eliminate many irrelevant or duplicate sites. Sites identified with a master search engine represent a more-refined selection of sites, and these were selected for the actual site examination in this study. The primary search engines chosen for this study were based on popularity listings reported by Media Metrix, Inc and Se arch Engine Watc h in October 2000.19,20 The master search engines (also known as meta-search engines or metacrawlers) were selected from listings on Search Engine Watch.20 Using these resources, six primary and three master search engines were identified and used. The linked terms herb and cancer were initially entered into each of the six primary search engines, with the total number of hits identified but not searched individually. Next, the same linked phrases were entered into the three selected master search engines. These sites were analyzed for irrelevant or duplicate sites, which were discarded from the final set of matches. The sites that were found with all three master search engines were then examined using a standardized data collection form to determine if the site contained evidence of information or types of statements listed on

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Table 1

Table 2

Type of Information Sought on Review of Internet Sites

Matches for the Terms Cancer and Herb

• Statements of prevention

Primary Search Engines Hits* Lycos ................................................................................... 58,605

• Statements of treatment Hotbot .................................................................................. 53,500 • Statements of cure AllTheWeb .......................................................................... 48,232 • Commercial nature of Web site: determined by use of promotional materials used to encourage purchase of products or services • DSHEA warnings. Example: “These statements have not been evaluated by the FDA. This product is not intended to diagnose, prevent, treat, or cure any condition.”

Google ................................................................................. 46,200 Yahoo .................................................................................. 20,800 Altavista .............................................................................. 11,730

• Physician consultation warnings. Example: “It is recommended that you consult a physician when considering or discussing the treatment of a specific condition.”

Master Search Engines Hits* Sherlock ...................................................................................... 82

• Country of origin

Mama .......................................................................................... 76

• Use of research with references

IFIND ......................................................................................... 74

• Use of testimonials DSHEA—Dietary Supplement Health and Education Act

* Hits refers to the number of times each search engine identified an Internet site matching the terms cancer and herb.

Table 1. Additionally, sites were examined to identify methods, other than those mentioned in Table 1, used to encourage IHS to use or purchase products. Data Analysis Data are reported as frequencies. A two-sample t test, assuming unequal variances, was used to determine if there were statistically significant differences in the frequency of commercial and non-commercial sites that provide references to support claims made on the sites.

Table 3 Frequency of Sites That Contain Claims About Cancer Treatments and Cures Claim or Statement Cancer prevention

Results Number of Sites Identified A summary of search engine results is included in Figure 1. The six primary Web search engines yielded between 11,730 and 58,605 matches each. The three master search engines yielded 74 to 82 sites per search engine. Examination of these sites demonstrated 70 sites that were found on all three master search engines, and these 70 sites were chosen for site analysis in this study. The site names and respective number of hits from these search engines are summarized in Table 2. Of the 70 final sites, nine sites were no longer functioning at the time of this study, leaving 61 sites for review. Of those 61 sites, 34 (55.7%) were commercial sites (CS), and 27 (44.3%) were noncommercial sites (NCS).

Cancer treatment

Percentage of Web Sites Non-Commercial Sites Commercial Sites 26% 92%* 30%

89%*

1%

58%*

Patient testimonials

22%

89%

Physician consultation recommendations

60%

39%

1%

36%

Cancer cure

DSHEA warning**

DSHEA—Dietary Supplement Health and Education Act * Unlawful according to the DSHEA ** The percentage of sites containing a statement that complies with the DSHEA. An example of a DSHEA-compliant statement is “These products are not FDA approved. They have not been evaluated for the prevention, treatment, or cure of any condition.”

Award-winning Papers From the AAFP 2001 Annual Scientific Assembly Content of Sites Prevention, treatment, and cure were discussed 92%, 89%, and 58%, respectively, of the CS (Table 3) but in only 26%, 30%, and 1% of the NCS. CS provided testimonials, physician consultation recommendations, and DSHEA warnings 89%, 39%, and 36% of the time, respectively (Table 3). The corresponding percentages for NCS were 26%, 30%, and 1%. All international commercial sites (six of 34) surveyed claimed herbal cancer cures on their sites, whereas US-based sites (28 of 34) made such claims half the time (14 of 28). CS were next analyzed for whether research was cited (with references) to support statements made on the site. CS provided research with references 30.6% of the time versus 92.6% of the time in NCS (P