WHO CRITERIA FOR OTC DRUG ADVERTISING HAS HAD "LITTLE INFLUENCE"

WHO CRITERIA FOR OTC DRUG ADVERTISING HAS HAD "LITTLE INFLUENCE" on national policies, the International Organisation of Consumers Unions concludes in a recent study of OTC drug print ads from 11 countries, including the U.S. As a result, the IOCU report points out that the World Health Organization's Ethical Criteria on the Promotion of Medicinal Products has not had "much impact" on manufacturers' advertising of health products.

In light of the study findings, IOCU recommended that "steps be taken" to promote the Ethical Criteria and to "actively encourage manufacturers to voluntarily adopt" the practices outlined in that document. The WHO criteria are voluntary standards which "governments and manufacturers are free to adopt," the study notes.

IOCU, a worldwide federation of consumer organizations, conducted the study by examining 183 advertisements from 11 countries to verify that the ads complied with two international standards, the WHO Ethical Criteria and the European Union Directive on Advertising of Medicinal Products. IOCU determined compliance by comparing both the texts and the pictorial aspects of the ads to a "checklist" of 25 items that are either required or prohibited by the two international guidelines. The study only considered ads for registered drugs or ads making medicinal claims for a product.

The print ads analyzed in the study were from Australia, Denmark, Finland, Germany, Israel, the Netherlands, New Zealand, Sweden, Switzerland, the U.K. and the U.S.

The study acknowledges that the sample of ads used in the analysis was collected in November/December 1992, prior to the Jan. 1, 1993 effective date of the EU Directive on advertising. Also, only four of the 11 countries involved in the study are members of the EU. IOCU said it aimed "to evaluate the situation in a variety of countries before the implementation of the EU Directive with the intention of repeating the study at a suitable date after implementation" as a way of measuring the effectiveness of the legislation.

The study found that only three of the 183 ads "complied entirely with all the criteria" set forth in the two standards. The average number of breaches per advertisement was 4.6, according to the study. "Particularly notable," the study declares, "is the absence of the required information on contraindications, side effects and warnings." Almost 92% of the ads studied omitted these items.

Other items that were often missing from the ads, according to the study, were information on use of the drug (116 ads), the name of the substance in the product (80 ads) and the identity of the promoted product, i.e. drug, food or cosmetic (53 ads). The IOCU said that many of the ads included the use of a "prohibited" item such as a reference to scientific research "without accompanying scientific literature or reference source" or a comparison to a similar product. The study found that breaches occurred more often in ads for non-registered drugs making medicinal claims than in ads for registered drugs.

The study points out that the rules of both the EU and WHO standards "are sometimes contrary to national rules." For example, the study notes that the U.S. allows direct-to-consumer ads for Rx drugs and comparative ads. Of the 11 ads from the U.S. included in the IOCU survey, seven were for registered drugs (two Rx drugs and presumably five OTCs), one was for a food product, one was for a cosmetic and one was for a vitamin product. Only eight of the U.S. ads were analyzed against an EU/WHO checklist. The report discusses only three of the U.S. ads: the two Rx drug ads, which were included in the study results despite meeting FDA requirements for direct-to-consumer ads; and a comparative ad for Whitehall's Advil.

The study found that while the WHO Criteria and the EU Directive "cover most elements in advertising, they do not cover all eventualities." Because some potentially misleading areas for OTC ads are not covered explicitly in the EU and WHO standards, IOCU suggested developing new criteria for future study that "might be useful" in detecting misleading advertising.

Examples of problem areas cited by IOCU include the potential for consumers to make a "causal connection" between the "naturalness" of a product and its "safety" even though advertising for the product does not make such a connection. The study also questioned the promotion of antioxidant vitamins that "exploits existing consumer attitudes" by "the inference that free radicals could have a causative role" in cancer and that antioxidants, therefore, can prevent the development of cancer. The report also criticized implied comparative ads that use such terms as "the only one that..." or "the best." According to IOCU, "these pretensions of uniqueness are almost always misleading, because it is impossible for the advertiser (and, of course, the consumer) to verify such a claim."

IOCU recommended that a larger, "more rigorous" quantitative study be undertaken on a multi-country basis now that the EU Directive has been implemented. In addition, IOCU called for the development of a background paper on the differences between national laws in order to determine whether country-by-country variations are a result of legislative or cultural differences. IOCU recommended that future studies analyze ads for compliance with national standards first and then cross-analyze the ads using international standards.

The consumer group also suggested that a background paper "on the basis for allegation of 'misleadingness' in advertising" be prepared to examine "how far cultural preferences play a part in any variation between countries in their approach to the question of misleading advertising."