Healthy Skepticism Library item: 2196
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
News of Prescrire's Reps Monitoring Network: Pretences and off-label claims
Prescrire 2001 Oct 01
http://www.ncbi.nlm.nih.gov/pubmed/11824429
Full text:
Information increasingly unrelated to the summary of product characteristics (SPC).
The annual report by Prescrire’s Medical Representatives Monitoring Network sometimes provokes strong reactions, especially from the pharmaceutical industry (1,2). Yet the trends observed by this strict sentinel network are so distinct that they can hardly be due to chance alone (3,4).
During the period spanning March 2000-March 2001, the questionnaires collected by the network’s observers showed a global deterioration in the quality of medical visits.
More frequent promotion of off-label indications.
Prelaunch visits presenting drugs that have not yet been marketed were less frequent than in previous years: 4% of observed visits, compared to 5% the year before and 1 1 % the year before that. We assume that this is because prelaunch campaigns are increasingly aimed at hospital physicians and the general public (even prescription-only drugs), rather than at primary care physicians.
In all, 55% of visits focused on newly marketed preparations and 45% on older drugs. There was a trend towards promotion of off-label (i.e. not recommended in the SPC) indications and dose regimens for older preparations.
Only 68% of indications promoted by the reps conformed to the corresponding SPC (compared to 79% in 1997, with a gradual decline). As regards the recommended doses stated by the reps, 86% conformed to the SPC, 1 1 % were slightly different and 3% were totally different.
Risks increasingly overlooked.
The reps stated contraindications in only 10% of cases (against 17% the year before); and warnings in only 10% (against 14% the year before,). Drug interactions were stated in only 8% of cases and were denied in 6% of cases. As for adverse effects, they were stated in only 10% of cases and denied in 9% of cases (against 4% the previous year).
Some reps seem to think that prescribers should know the risks associated with older drugs, and that these do not need to be restated (2). This is not the opinion of the network observers, who considered this year that, in 86% of cases in which risks were not mentioned, they should have been stated.
Official documents not presented.
Medical reps were less likely this year to offer documents (including brochures) on the drugs they were promoting (only 17% of cases). A very small number of observers received the statement from the Transparency Commission that places the drug in context with other members of its class. In France this statement is based on a scoring system assessing improvement in the “medical service rendered” (cost effectiveness). It was presented in only 2% of cases in 2000-2001, while in previous years this percentage had been increasing (albeit remaining below 10%). Some reps even appeared to be unaware that the statement existed, while others said they did not have a copy to hand or that the document was “ unavailable “. Some offered to send it, but never did. [Note that it is a legal obligation for medical reps to supply this document in France.]
Fewer gifts?
As regards the small gifts given by many medical reps, members of the Network continued to receive very few: in 11 % of visits in 2000-2001 doctors were offered paperweights and other gadgets,bottles of wine, invitations to dinners or social programmes, and a few were offered proposals of paid studies. The fact that this percentage is lower than in previous years does not mean that visits are becoming more serious and more informative. Rather, visits to members of the Network are probably unrepresentative: Network observers are often listed as “Prescrire readers” or even worse “Outstanding readers of Prescrire Readers’test”, meaning that they tend to ask technical questions, disdain gifts, and reject invitations. The reps simply adapt their presentation to the type of audience.
Enough is enough!
The mean global score for reps’ visits (attributed by the Network observers using a visual scale) was no more than 5/10. The worst mean score (1 /10) was for Pfizer reps touting fluconazole powder for oral suspension, mainly because reps claimed off-label indications (complications of antibiotic therapy, denture use, steroid inhalation, dry mouth etc.), and emphasised the orange flavour. This is one of the examples that most annoyed the observers, especially as this is a drug that must be used with caution.
