AFTER 10 years collecting data, la revue Prescrire's Representatives Monitoring Network has concluded that medical representatives in France continue to mislead prescribers about drug safety and efficacy. Numerous Government attempts to regulate representatives' visits have done little to remedy the situation, the group says. The Network has involved hundreds of doctors and pharmacists throughout France in completing Prescrire's questionnaires that analyse a representative's visit for misleading information. (see Essential Drugs Monitor 17 and 24).
Continued vigilance needed
During the period March 2000/2001 the main trends reported by observers concerned more frequent promotion of off-label indications. In total only 68% of indications promoted conformed to the summary of product characteristics, compared to 79% in 1997. Warnings about risks were included in only 10% of cases against 17% the year before. Drug interactions were mentioned in 8% of visits, while in 6% they were denied, and adverse effects were stated in just 10% of cases and denied in 9% (up from 4% the previous year).
During the year representatives were less likely to offer documents on the drugs they were promoting - only 17% of cases. Just a few gave out copies of the statement from France's Transparency Commission that compares a drug with others in the same class. It is a legal requirement for medical representatives to supply this document, which uses a scoring system to assess a drug's benefit and cost-effectiveness. The statement was only used in 2% of cases.
Prescrire's Network believes the findings are particularly alarming given that drug manufacturers say visits by medical representatives remain the most effective way of persuading physicians to prescribe their products. Regulations, industrial ethical codes and international recommendations have had no significant effect so far, according to la revue Prescrire, which will continue to monitor the situation.
Source: Prescrire International, vol.10, No.55, October 2001.