Pharma Sales Reps Withholding Vital Safety Information
Drug company reps are withholding relevant safety information during sales visits with physicians, according to a recent study by the University of British Colombia. Despite the scant detail provided on related side effects, doctors are still prescribing these drugs to patients.
The findings of the international study involving Canadian, U.S. and French physicians were published online Wednesday (10thApril 2013) in the Journal of General Internal Medicine. Researchers recruited a random selection of 255 physicians from cities in the three countries to compare different strategies for regulating drug pitches. Following 1,692 drug promotions that took place between May 2009 and June 2010, participating doctors filled out questionnaires immediately after these sales visits detailing what was discussed during the meeting.
Sales meetings with pharma sales reps are often the first introduction doctors will have to new drugs, where the representative will educate the physician about their latest offerings and provide free samples. Considering the importance of the role, instructing the last line of defense that separates patient and drug, it is not only a legal obligation, but also a moral obligation of the pharma rep to inform doctors of potential side effects associated with these medications.
But this latest study reveals that in almost 60 per cent of the promotional meetings, sales reps failed to provide any information about common or serious side effects for their products. And serious side effects were only mentioned in a mere 6 per cent of the visits, even though over half of the medications involved in these visits came with the strongest drug warnings – US Food and Drug Administration (FDA) “black box” or Health Canada boxed warnings.
Bad Pharma
The results of the study come at a tough time for the pharmaceutical industry. While Big Pharma is recognised as being vital to the global healthcare system, developing crucial medicines that have saved countless lives; these successes and breakthroughs have been marred by a substantial amount of shady dealings in recent years. Since 2007, eight of the biggest international drug companies have agreed to pay millions, if not billions, of dollars to settle charges of misconduct. Currently operating under “corporate integrity agreements” — basically, promises not to be ‘Bad Pharma’ again – some of these firms have already dishonoured earlier agreements multiple times, albeit at a hefty price.
Last July, GlaxoSmithKline (GSK) pleaded guilty to marketing two anti-depressants in the US for unapproved uses, Paxil and Wellbutrin, and failing to report drug safety information on a diabetes medication. The FDA found that the company downplayed the severe side effects (i.e. increased risk of suicide and heart problems) linked to some of their most popular medications and GSK were forced to pay $3 billion in fines.
At the time, the US Deputy Attorney General, James Cole, said the settlement was “unprecedented in both size and scope”, and should serve as a warning to other pharmaceutical and drug companies to the consequences of engaging in such malpractices. But, according to Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients author, Ben Goldacre, in an interview with Time magazine earlier this year, basic lessons have still to be learned. “Overall, for the treatments that we currently use today, the chances of a trial being published are around 50 per cent. The trials with positive results are about twice [as likely] to be published as trials with negative results. So, we’re missing half of the evidence that we’re supposed to be using to make informed decisions. [And] we’re not just missing any old half; we’re selectively missing the unflattering half.”
A model in disrepair
Apart from avoiding heavy fines, pharmaceutical companies should be acting fairly in order to re-establish trust with the US and global consumer. In order to achieve this, a monitored policy structure must be enforced from company board level to field sales rep, ensuring sales are based on the communication of sound and transparent clinical information. Whether or not the rep themselves should be held legally accountable for essential information that is not shared in these meetings is another debate but there are indications in the market that the sales approaches and attitudes adopted by some firms are perhaps beginning to change for the better.
At the same time, however, doctors should be more vigilant as regards enquiries into the side effects of any new drug. And time constraint complaints don’t hold too much water. According to the authors of the study, “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.”