The majority of promotional material is not screened by an independent body before publication. Responsible companies, however, usually screen material in-house. The APMA has established a monitoring subcommittee that monitors promotional material retrospectively. In August 1996, this committee monitored 31 advertisements concerning central nervous system drugs which had been published between February and April that same year. Monitoring revealed that 26 (84%) were in accord with the Code, one (3%) was considered a technical breach of the Code and 4 (13%) were considered potential breaches of the Code.
The main means for ensuring that promotional claims are in accord with the Code's standards is through a complaints mechanism. Health professionals, pharmaceutical companies and other interested parties are encouraged to lodge complaints with the APMA when they perceive promotional practice to be inappropriate.
Complaints have to be in writing and include 'the nature of the practice being complained about and a simple explanation of the reason(s) for the objection'. Once lodged, complaints are heard by the Code of Conduct Subcommittee. This is chaired by a lawyer with experience in trade practice and includes medical, industry and consumer representatives. In the year 1 July 1997 to 30 June 1998, the APMA Code of Conduct Subcommittee evaluated 39 complaints, of which 32 were found to breach the Code.3
An example of a complaint lodged in 1997 is that concerning a promotional brochure that stated 'New [fluvoxamine]. It's the difference that matters'. The complainant suggested that some claims in this brochure were misleading and implied fluvoxamine was superior to other selective serotonin reuptake inhibitors (SSRIs) with regard to sexual dysfunction, adverse effects and drug interactions. It was found that 'statements inferring [fluvoxamine's] superiority over other SSRIs for drug interactions were incorrect and unsubstantiated', that 'figures quoted in the data implying [fluvoxamine's] superiority over other SSRIs regarding sexual dysfunction were inaccurate' and that 'the clinical relevance of the study used was unknown'.3
Deciding if a piece of promotion is misleading can be difficult, particularly if you are hearing about a new product for the first time. However, there are some common causes of misleading claims. These include claims based on poorly-designed studies, obsolete data, information outside of approved product information and the use of animal or in vitro data to support clinical claims.