Introduction

Although pharmaceutical companies provide products designed to prevent or cure disease, they are money-making enterprises. The employees at the intersection of aid and profit are pharmaceutical sales representatives (PSRs). There is no question that their job is first and foremost to push their product, but at what cost to the patient?

Background

The FDA requires that PSRs take a “fair balance” approach to promotional meetings by reasonably covering both benefits and risks of a new drug. However, a recently published study conducted in France, Canada, and the United States found that only 4 out of 255 physicians reported being informed about both the benefits and serious adverse events (SAE) of a particular drug. The recent Avandia controversy was highlighted in the study as well. Physicians reported that key messages from PSRs stressed safety while minimizing or even omitting the potential for risk. Despite the unbalanced coverage, nearly two-thirds of physicians still said they trusted the presentation and would be more likely to prescribe a promoted drug after a meeting.

Issue

Are pharmaceutical representatives inadequately conveying adverse event (AE) information in promotional meetings at the expense of patients who will eventually receive these drugs?

Rule

PSRs are inadequately conveying AEs if:

1)   They are not meeting minimum safety requirements during the promotional meetings

AND

2)   Their visits have a significant impact on physicians’ prescribing habits

Analysis

Minimum Safety Requirements

Necessary Information

The FDA requires that PSRs take a fair and balanced approach to marketing their medicines, being sure to cover positive and negative aspects of the drug. The current guidelines aren’t explicit and even suggest that the same amount of time need not be spent on risks and benefits if the PSR judges that equal time isn’t warranted. To help with analysis, a 2013 British Columbia study defined exactly what they considered “fair balance” (called “minimally adequate safety information”) and determined that it took less than 1 minute to cover.

Rate of Adherence to Fair Balance Approach

Overall, safety is mentioned nearly twice as much in meetings as adverse events, and only 4-6% of visits have any mention of SAEs, despite nearly half of drugs being promoted carrying a black box label. The vague guidelines that currently exist make it very difficult to assess whether PSRs are deliberately downplaying adverse events to increase sales or genuinely believe that the AEs aren’t important. Regardless, these promotional meetings are not meeting the minimum safety requirements and are unfairly promoting the safety of drugs at the expense of adequate cautionary information.

Impact on Physicians’ Prescribing Habits

Possibly more worrying than this inadequate coverage is that physicians still considered the imbalanced presentations “very good” and did not intend to conduct further research of their own into risks. Studies have already proven that one-on-one promotional meetings are more likely to result in changed prescription habits. To help control for this, federal strictures have been imposed on the PSR-physician relationship to limit the extravagant gifts and grants designed to increase sales, but no truly explicit regulations are imposed on the information presented in the meeting as long as the PSR can argue that, per their interpretation, they presented balanced  information. If even truly balanced exposure to the risks and benefits of a drug can change a physician’s prescribing habits, then the effect of a report that unfairly emphasizes benefits while downplaying or ignoring AEs can only skew the prescription increase further in the company’s favor.

Conclusion

Since promotional meetings have been proven to have a measurable effect on physician’s prescribing habits and recent studies have shown a lack of fair and balanced drug portrayals in one-on-one promotional meetings, PSRs are inadequately conveying adverse information to physicians and increasing risk for patients.

For more information on this issue, contact the Kulkarni Law Firm.