U.S., French and Canadian doctors receive little or no safety information about drugs when visited in their offices by pharmaceutical sales reps for the drugs, a new study has found.
That failure to include information on harm occurred even though the United States, France and Canada all have national laws that require drug sales reps to discuss safety information about their products with doctors.
The study’s findings should concern patients. Other research has shown that sales reps greatly influence the prescribing habits of physicians (although the doctors themselves often claim that isn’t true).
For the study, researchers randomly recruited 255 family practice physicians from Sacramento, Vancouver, Montreal and Toulouse. Immediately or within a few hours of a visit from a pharmaceutical sales rep, the physicians were asked to fill out a questionnaire about what was discussed during the meeting. In all, the 255 physicians listened to 1,692 drug-specific promotions during the 13 months of the study (May 2009-June 2010).
The questionnaires revealed that in 59 percent of those meetings the sales reps failed to provide any information about common or serious side effects of the drugs they were promoting. Nor did they warn the doctors about the types of patients who should not be receiving the drugs.
In fact, serious side effects were mentioned in less than 6 percent of the visits — even though about half of the drugs being promoted were ones that carried black-box warnings, which indicates the drugs have serious or life-threatening risks.
The study found, for example, that for the diabetic drug rosiglitazone (Avandia), which in late 2010 was withdrawn from use in Europe and later significantly restricted in the United States and Canada because of an increased risk of heart attack and stroke, almost all the information provided by its reps were safety claims. Examples of the key messages the surveyed doctors said they took away from meetings with that drug’s sales reps included the following: “Avandia is safe even in patients with heart disease, as long as they don’t have heart failure” (Montreal), “Avandia is not as dangerous as the public makes it out to be” (Sacramento) and “New studies indicate safety” (Vancouver).
A lack of discussion about a drug’s potential harms didn’t stop the doctors from saying they had been provided good or excellent information by the sales reps after 54 percent of the meetings, however. And they reported being ready to prescribe the promoted drug after 64 percent of the meetings.
The surveys also revealed that in 13 percent of the meetings, the reps discussed their drug’s off-label uses — ones not approved by government regulatory agencies, including the U.S. Food and Drug Administration. Although it’s legal for U.S. doctors to prescribe drugs off-label, it’s not legal for drug companies to market their drugs for off-label purposes.
“Our results suggest a serious lack of information on harmful effects of promoted medicines,” the authors of the study conclude.
“Such omissions,” they add, “may threaten patient health.”