(2004; 102 pages)
4.1 Guidelines, codes and regulations for printed and broadcast material
This is by far the most commonly researched intervention.
Few studies describe regulations and guidelines about printed and broadcast promotional material and how they are monitored in different countries. Lexchin describes the situation in the UK, Australia and Canada. He suggests that in most industrialised countries the day to day control of promotion rests with voluntary national industry associations187. He examines the enforcement of the four codes (there are two in Canada) according to five critical aspects. These are mechanisms for recognising violations, the composition of monitoring committees, sanctions for violation, the quality and quantity of information in reports issued about complaints and violations, and the circulation of these reports. He argues that codes that rely on complaints are inadequate because too many violations are missed. Instead he recommends proactive monitoring of a random sample of promotional activities. Lexchin also suggests that the majority of members of committees should be from outside the industry, that sanctions should be raised so that they deter companies from misleading promotion, that offenders should be required to correct false information, and that information about the enforcement of the code should be publicly available187. His analysis is particularly clear and useful.
Herxheimer and Collier described the situation in the UK188, where the Association of the British Pharmaceutical Industry (ABPI) introduced a Code of Practice for the promotion of prescription medicines in 1958. This is administered by a code of practice committee consisting of one independent barrister, 12 representatives from member companies, and two independent doctors (and now also a representative of a patients’ organization). The ABPI secretariat examines advertisements in a random selection of journals to see if they comply with the code, and since 1985 a medical consultant also makes an independent scrutiny of a random selection of advertisements. Possible breaches of the code are pursued by informal correspondence with the company which placed the advertisements. The code of practice committee deals with cases not resolved by this informal correspondence, plus all complaints originating outside the ABPI. This process was largely secret until 1982. Herxheimer and Collier argue that the evidence suggests that the code has failed to deter promotional excesses. The ABPI's wish to secure compliance with the code seems weaker than its wish to pre-empt outside criticism and action: its self regulation seems to be a service to itself rather than to the public. They suggested that the code of practice committee should become publicly accountable, that the majority of its members should represent the health professions and the public, and that effective sanctions were needed.
Some journals also have policies about pharmaceutical advertisements. Wilkes and Kravitz184 surveyed 221 editors of medical journals in North America. Twelve per cent acknowledged occasional conflicts of interest between editorial decisions and the wishes of advertisers. Most journals published pharmaceutical advertisements (67%) and 41% of the editors of these journals reported having a great deal of control over advertisements. However only eight journals had required advertisers to make a change to an advertisement in the last five years. Forty per cent of the editors thought that journal advertisements should be subject to the same peer review process as scientific articles.
CONCLUSION: Neither the self regulatory systems that have been studied nor review by journal editors provide effective controls on drug advertising.
Many studies show that printed advertisements do not meet regulations and guidelines in force in various countries.
In the UK, Morgan et al.189 suggested in 1976 that the ABPI guidelines were “not being observed strictly”. Herxheimer and Collier188 reviewed 302 cases considered by the ABPI code of practice committee between January 1983 and December 1988, and found that the ABPI code was commonly broken. Breaches were identified in 192 of the complaints from competing companies, doctors and pharmacists. In total there were 379 breaches, of which 270 were also possible breaches of the Medicines Act. Misleading claims or comparisons, and misleading or unsubstantiated information were the most common breaches. Herxheimer and Collier argued that the code had no obvious deterrent effect. The code of practice committee had no power to require retraction or correction of misleading statements and gave no adverse publicity to those responsible for breaches. Although they required an undertaking from offenders that the breach would not be repeated, this was not always honoured. The authors noted that there was no consumer input into the code, and complainants had no opportunity to respond to defendants’ arguments.
In developing countries, frequent breaches of codes have also been found. In French-speaking West Africa, Chirac et al.190 found that 13.5% of the advertisements they studied did not meet even the most liberal interpretation of the IFPMA code. Dikshit and Dikshit191 found that the Indian issue of the Monthly Index of Medical Specialities (MIMS) did not seem to follow the code of the IFPMA, which it is covered by. Vo-Kyung and Ok Kim192 report a high level of violations of South Korean regulations on the advertising of medicines. Lal et al.193 found that only 2% of the 585 advertisements in their study cited adequate references, and therefore conformed with the WHO Ethical Criteria for Medicinal Drug Promotion. These advertisements were supplied by sales representatives to clinical departments of an Indian hospital. Both the IFPMA and the WHO Ethical Criteria for Medicinal Drug Promotion include the concept of ‘reminder’ ads, which do not need to contain full prescribing information. Tomson and Weerasuriya194 analysed advertisements in the Sri Lanka Medical Journal and found that only a quarter contained information on adverse effects and a quarter on contraindications. However they suggest that 68% would pass both the IFPMA and the WHO codes if they were classified as reminder advertisements.
In the USA, Roth195 found that 65% of the newspaper and magazine DTCA advertisements reviewed by two pharmacists presented a ‘fair balance’ of information, as required by the FDA. Stryer and Bero concluded that 42% of the 482 items received by an internal medicine residency programme, an HMO and a private internist’s office, did not meet the FDA’s requirements. Others failed to adequately meet the requirements for ‘fair balance’, or instructions for use, or included unapproved uses. However the article does not clearly outline how they operationalised the FDA requirement for ‘fair balance’. In a similar study Rothermich et al.196 suggested that 42% of the advertisements they reviewed from medical journals in 1984, 1988 and 1992 did not appear to comply with FDA requirements. In Wilkes et al.’s very thorough study197,198 advertisements were reviewed by experts in relevant fields of medicine and by clinical pharmacists, and 40% of advertisements were considered by at least two reviewers to be not balanced.
In Canada, Lexchin and Holbrook199 found problems with the methodological quality of studies referenced in drug advertisements, despite the existence of guidelines.
In Australia, Moulds et al., in a letter to the Medical Journal of Australia reported that a review by clinical pharmacologists of advertisements in Australian journals found only 53% of the advertisements to be acceptable. Technical breaches of the Australian Pharmaceutical Manufacturers’ Association Voluntary Code of Conduct were found in 22% of the advertisements200. Carandang and Moulds201 assessed 127 advertisements found in four issues of Australian medical journals against the Association’s code. Forty per cent were judged to be technical breaches, and these had increased since previous surveys. Seven per cent of the advertisements made unacceptable claims, fewer than in previous surveys, but the difference could have arisen from use of different judges rather than being the result of a real difference over time.
In New Zealand, Lexchin202, in a letter to the editor, reports that only around half of the non-reminder advertisements in four 1987 issues of the New Zealand Medical Journal contained each of the kinds of information required by the Pharmaceutical Manufacturers Association (PMA) Code of Practice. In a small study Peacock203 found that many advertisements did not comply with the voluntary code of the Researched Medicines Industry (formerly the PMA) or the Medicines Regulations.
These studies all show high levels of non-compliance with codes of practice and guidelines about promotional material, indicating that these are poor ways of controlling promotion. However they did not study the impact of changing codes or regulations, nor do they provide evidence (from different countries or different medicines) of the advantages or disadvantages of different forms of regulation. Three studies that do this are Sencan and Üstell204, Najman et al.205 and the Canadian Drugs Directorate52.
Sencan and Üstell204 examined the introduction of Turkish regulations that required advertisers to include basic information about medicines in advertisements. They found a considerable increase in the percentage of advertisements in a Turkish medical journal that contained basic information, after the introduction of the regulations. In 1990, the year before the regulations were introduced, only 41% of advertisements included adverse effects, while in 1991, 60% did. The figures for contraindications were 37% and 57%, for contraindications 26% and 51%, and for price 1% and 46%. The proportion of advertisements from foreign countries increased significantly (58% to 89%).
A particularly useful study by Najman et al.205 investigated the impact of legislative or voluntary codes of practice on advertisements in three countries. In the US, legislative requirements have been in place since 1961, while in the UK and Australia pharmaceutical manufacturers have voluntary codes of practice. Comparing advertisements in the major medical journals of those three countries for 1961, 1967, 1973 and 1977 Najman et al. found it hard to see evidence of the impact of the voluntary codes. Advertisements in the USA outlined the dangers of medicines much more than those in the UK and Australia. Fisherow206 notes that the FDA has considerable power in its interactions with companies over advertising, because it is also the regulatory body which decides whether to allow medicines onto the American market.
A Canadian report52 looked at how often magazine advertisements for nonprescription drugs complied with regulatory requirements. This is interesting because these advertisements are not subject to mandatory pre-publication clearance, and are monitored by a complaints-only system. The study found an extremely high level of non-compliance with the requirements. Of the 51 advertisements only 37% complied fully, and 39% contained major violations.
CONCLUSION: Government regulation of advertising can be more effective than voluntary regulation.