Pharma Sales Reps Lie About Side Effects: Study

Pharma Sales Reps Lie About Side Effects: Study

April 12th, 2013 // 2:48 pm @

Exclusive cGMP and FDA Compliance News

There is little, if any debate that pharmaceutical sales reps are hired to sell. The operative word in the job title, after all, is ‘sales.’ But a new study raises concern that the promotional push is crowding out some of the most important medical information that physicians need – most family doctors are not being told of the potentially harmful consequences of medications that are being pitched.

The study, which surveyed 255 doctors in Montreal, Vancouver, Sacramento and Toulouse, France, found that, from 59 percent to 66 percent of the time – depending upon location – sales reps failed to provide any information about serious adverse events, common side effects, contraindications, unqualified safety claims, unapproved indications or patients who should not use a particular drug.

cGMP Quality Tips for Senior Managers

Moreover, serious adverse events were mentioned in only 6 percent of the interactions between reps and physicians, even though 57 percent of the medications being pitched during these visits sported Black Box warnings from the FDA or Health Canada. But as one study researcher notes, laws in all three countries require reps to provide information on potential harms, not just benefits (here is the abstract).

“It’s concerning, because patient safety may be compromised,” Barbara Mintzes, assistant professor at the School of Population and Public Health at the University of British Columbia. Even more so, she says, because the study also found that 51 percent of the promotions were deemed good or excellent and 64 percent of the physicians expressed a willingness to prescribe after their interactions with sales reps.

May 1 – Avoiding Warning Letter Disasters With a Strong Contractor Quality Agreement

One example cited involve the Avandia diabetes pill that, for instance, was restricted in the US after links were established to heart attacks and strokes. Most of the key messages given to physicians emphasized safety. In Sacramento, a doctor reported being told that “Avandia is not as dangerous as the public makes it out to be.” And in Vancouver, a rep reportedly told a doctor that “new studies indicate safety.”

The study, which was published in the Journal of General Internal Medicine, compiled survey results from 255 physicians and information on 1,692 different interactions they had with sales reps between May 2009 and June 2010. The primary outcome measure was described as minimally adequate safety information (here is the abstract).

The upshot: patients may need to adopt a buyer beware attitude when receiving prescriptions. In other words, the promotional process leaves them vulnerable if sales reps are going to de-emphasize potential harms and physicians fail to actively inquire about these issues.

“Unfortunately, nobody is monitoring this,” Mintzes tells us. “But doctors can seek out independent sources of information about medicines. It’s always an individual choice to see sales reps. And when they are interacting with sales reps, they can certainly push and insist on a minimum of information about serious adverse events associated with the use of medicines.”

Upcoming Expertbriefings.com Webinars


Subscribe Now

Featured Partner