The omissions included drugs with the most serious, black box warnings of potential adverse effects.
Doctors often first learn of new drugs during sales meetings with pharmaceutical sales representatives, during which the representatives educate physicians about their latest offerings, provide free samples, and, according to the law, inform doctors of potential side effects associated with the medications. Manufacturers invest a considerable amount of marketing time and money into canvassing physicians’ offices in this way, and studies show that the strategy is effective; the more a product is promoted, the more prescriptions doctors write for those drugs.
However, a study published in the Journal of General Internal Medicine found that an important part of these drug pitch meetings is often missing: discussions about harmful side effects.
For the study, the researchers recruited a random sampling of 255 physicians from cities in three countries — the U.S., Canada and France — to compare the effectiveness of different strategies for regulating drug pitches. Doctors in Montreal, Vancouver, Sacramento and Toulouse filled out questionnaires immediately after sales visits detailing what was discussed during the meeting.
In 59% of the promotional meetings, sales representatives failed to provide any information about common or serious side effects for their medications. In the Canadian cities, 66% of the sales representatives did not provide harmful side effect information, and serious side effects were mentioned in only 6% of the meetings.
Even more concerning was the fact that 57% of the drugs for which side effects were not mentioned carried the highest level of warning used by a country’s regulatory agency — the “black box” for the U.S. Food and Drug Administration or a Health Canada label warning for Canada. “Laws in all three countries require sales representatives to provide information on harm as well as benefits, but no one is monitoring these visits and there are next to no sanctions for misleading or inaccurate promotion,” said lead study author Barbara Mintzes of the University of British Columbia in a statement.
One or more health benefits were talked about nearly twice as often as negative side effects and the authors report that despite the lack of information on these side effects, the doctors deemed the quality of the information provided as positive, and expressed a willingness to increase their prescriptions almost two-thirds of the time.
The findings raise serious concerns about the quality of information physicians have before making decisions to prescribe medications, given both the popularity of drug sales visits, as well as the potentially biased material they may include. In 2009, a U.S. survey reported that 85% of physicians see pharmaceutical sales representatives and these meetings are their first source of information about new drugs on the market.
While such meetings are regulated by the FDA, and drug representatives are required to follow “fair balance” provisions and provide information about both harms and benefits associated with their products, enforcement of these rules is far from adequate. In fact, the researchers initially believed that harmful effects would be mentioned more frequently during meetings in the U.S., due to these “fair balance” requirements, but information on potential dangers was equally infrequent in the meetings in Sacramento as they were in meetings occurring in the Canadian cities. Doctors in the French city of Toulouse actually reported hearing information on possible side effects more often.
In the U.S., representatives are also forbidden to discuss or promote any unapproved benefits — so-called off-label uses of their drugs for purposes other than that for which they are approved — but they may provide information about such uses to the doctor on request. (And even these restrictions may be weakening given a recent New York state appeals court decision that ruled a representative’s ability to talk about unapproved uses of medications was protected under the First Amendment.)
Canada relies on on industry self-regulation, in which the industry association Rx&D’s ethical code requires consistency with approved drug information and current medical practice. The federal regulatory agency, Health Canada, steps in to ensure the codes are being followed, although the study authors report this is fairly uncommon. France’s regulatory system, while similar to that of the U.S., is even stricter. Samples, food, gifts and invitations for study participation are prohibited and pharmaceutical sales representatives are required to provide doctors with information on the drugs’ approved uses.
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Failing to provide information about possible side effects, or promoting drugs for unapproved uses can have serious, and even fatal consequences for public health. Last July, GlaxoSmithKline LLC was forced to pay $3 billion in fines and plead guilty to marketing antidepressants for unapproved uses and failing to report drug safety information on a diabetes medication to the U.S. FDA. The agency found that the company downplayed or misrepresented side effects including increased risk of suicidality and heart problems linked to some of their popular medications, which were prescribed to millions of patients.
While it’s obvious that drug representatives are not necessarily motivated to talk about the potential adverse effects of their drugs, why aren’t doctors asking about side effects more often? One explanation given by both doctors and drug representatives is time. But, write the authors, “It seems unlikely that pharmaceutical sales representatives had too little time to provide ‘minimally adequate safety information,’ as this measure required less information than the audio portion of 60-second U.S. television ads, and most sales visits were over 5 min. Physicians frequently reported mention of listed costs, reimbursement status, cost-effectiveness, and health benefits. This strongly suggests that time was available to discuss safety.”
The results point to significant flaws in the way doctors are informed about medications that could ultimately reach millions of patients. “[The findings] raise serious concerns about the basis for such prescribing decisions, given that an understanding of a medicine’s health effects requires knowledge of both benefit and harm,” the authors write. Physicians can become more proactive in asking about side effects during the discussions, or in learning more about the drugs themselves from the FDA, and patients can do the same. Even if the law requires drug representatives to disclose such information, patients and doctors can protect themselves by becoming better informed and seeking out balanced information on the drugs they take.