Dr. Jekyll and Mr. Hyde: Pharmaceutical Companies Contend with Drug Benefit and Risk Communications
The art and science of pharmaceutical industry marketing has undergone profound changes over the past two decades, largely in response to patients becoming active, well-educated health consumers (versus end users), involved in pursuing the treatment options that enable them to live longer and healthier lives. The public's influence on brand choice has increased substantially, and pharma companies are appealing directly to this new audience. This change presents a new predicament for marketers: with greater brand awareness comes increased sensitivity to shifts in public opinion, consumer confidence, and corporate credibility.
The recall of the prescription anti-inflammatory Vioxx (rofecoxib), a COX-2 inhibitor manufactured by Merck & Co., on September 30, 2004, altered the professional and the public community's comfort level with pharmaceutical use. Shareholders felt the effects too, as Vioxx represented 11% of Merck's $22.49-billion in revenue in 2003. On February 18, a committee advising the FDA ruled that COX-2 inhibitors Celebrex, Vioxx, and Bextra should remain in the marketplace, but prescribed with caution and the benefits and risks weighed carefully by patients.
The recall, prompted by a study from the FDA's office of drug safety, was a catalyst of change unprecedented within the health sector, casting doubt on the benefits of much-needed discoveries and eroding faith in the credibility of science. With pharmaceutical company stocks reeling from recent crises (not just Merck's Vioxx recall), the challenge will be accurately defining and effectively communicating prescription drug benefits and risks in ways that establish or renew public confidence and reduce public scrutiny.
Despite the hype, a recent poll conducted by the Associated Press and Ipsos Public Affairs confirms that the American public--including those who have used COX-2 inhibitors, including Vioxx prior to its recall--generally has confidence in the safety of prescription drugs. The more highly educated the respondent, the more likely they are to be confident in the safety of the drugs they take given the understood trade-off between benefits and risks.
Surprisingly, adults in the U.S. are more confident in the safety of prescription drugs (85%) than they are in the ability of the FDA to ensure safety with use (77%). Confidence in prescription drugs is closely tied to the FDA's reputation. Nearly all those who have confidence in the FDA also trust that prescription drugs are safe (94%). People who lack confidence in the FDA, by contrast, are divided on drug safety (51% confident, 47% not). Of adults who have taken prescription drugs in the past year, people who took any one of the three leading COX-2 inhibitors [Celebrex (11%), Vioxx (10%), or Bextra (5%)] have nearly as much confidence in the FDA (71%) and overall drug safety (83%) as the public at large.
This suggests that consumers acknowledge the inherent risks in pharmaceutical drugs, but want the risks and benefits to be clearly communicated and effectively scrutinized by the agency approving the drugs that come to market. Ironically, it seems that the party whose reputation was most injured by the Vioxx recall is the agency that instigated the events by warning the public of health issues associated with use of the drug in their report.
Nevertheless, pharmaceutical manufacturers should respond quickly and address the public's safety concerns and information demands. A key vehicle is communicating risks and benefits with physicians. Six out of ten patients rely heavily on their doctor's advice to get the best possible treatments and understand the benefit to risk ratio or profile with each drug consumed. Public relations departments also need to kick into high gear to reinforce credibility in the drug development process and, more importantly, the investment required to bring new discoveries to market.