Drug company sales reps rarely provide even minimal safety information about the pills theyre promoting, even when the medicines carry black box warnings, the gravest of all drug alerts, a Canadian-led international study suggests.
The study, which involved family doctors from Canada, the U.S. and France, found that serious risks were mentioned in only six per cent of drug promotions. More than half 57 per cent of the sales pitches were for drugs that carry boxed warnings from American or Canadian drug regulators or were subject to recent safety advisories.
Our results suggest a serious lack of information on harmful effects of promoted medicines, the University of British Columbia-led research team wrote in the Journal of General Internal Medicine.
Such omissions may threaten patient health.
For their study, researchers had doctors in Montreal, Vancouver, Sacramento, Calif., and Toulouse, France complete questionnaires after consecutive visits from drug reps. Doctors were asked to fill out the questionnaires either immediately after each office visit or later the same day.
Physicians were randomly recruited from the three countries from May 2009 to June 2010 to see whether differences in rules governing drug promotions made a difference to the information being provided.
Laws in all three countries require sales representatives to provide information on harm as well as on benefits, lead author Barbara Mintzes, an assistant professor at the B.C. universitys School of Population and Public Health, said in a statement released with the study.
But no one is monitoring these visits and there are next to no sanctions for misleading or inaccurate promotion.
In all, 255 doctors reported on 1,692 drug specific promotions.
The researchers were looking at how often reps provided even a minimal basket of safety information, Mintzes said in an interview. That includes mention of at least one serious risk of the medicine, at least one common side effect and at least one contraindication, meaning situations under which the drug should not be used less information than the U.S. Food and Drug Administration requires in a 60-second TV ad, she said.
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Drug reps rarely inform doctors about serious side-effects of medicines, Canadian-led study shows
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