When Johnson & Johnson launched its latest advertising campaign for birth control patch Ortho Evra, the industry cheered the spots for featuring a gynecologist answering common patient questions.
The campaign was pegged as a turning point in drug company marketing, where there would be as much emphasis on risk information as on benefits.
Yet here we are a year later. J&J is facing lawsuits from dozens of women or their families who blame the patch for causing (in some cases fatal) blood clots.
Critics are also pegging the "aggressive" marketing of the patch for driving up prescription rates.
When these lawsuits reach a jury, plaintiffs will find a highly sympathetic audience. Most of the victims were in their teens and twenties, and were not at risk for cardiovascular disease.
Moreover, there is a high expectation of safety for contraceptives; in most cases, they are prescribed to young, healthy women – and if the first rule of medicine is do no harm, there is a greater onus on doctors to make sure that the benefits outweigh the risks.
While many doctors still prescribe the patch, others will not.
Clearly the highly acclaimed marketing efforts could not prevent damage to the company's reputation or the Ortho Evra brand.
J&J's ads gave equal time to risk/benefit information – that's not under debate. The point of contention is whether the company was irresponsible for not telling women that they are exposed to 60% more estrogen (which has been linked to blood clots) on the patch than on a pill.
The Food and Drug Administration has recently required a warning on the patch.
The questions of what did J&J know and when did they know it are for juries and regulators to consider. But the case once again reveals the limitations of mass direct-to-consumer marketing efforts.
In healthcare uniquely, the more people exposed to a message – and the more individuals who act on it – the greater the risk to the company's reputation. As the number of people using a drug increases, so too do the number (and types) of complications reported.
Talking openly about risks means talking about unknowns: the possibility that pre-approval clinical trials do not always present a complete picture of a drug's safety profile.
But no company wants to draw attention to the fact that drugs could contain hidden side effects. Instead, when questions arise, they often point to the relatively small numbers of patient enrolled in clinical trials to reassure patients and the medical community.
For these reasons, self-imposed moratoria on advertising as well as grassroots and targeted outreach have a real and important advantage in the first few years after a product is approved.
Companies are, of course, under great financial pressure to show a return on their investment in research and development. There is also great enthusiasm and momentum immediately after a product receives Food and Drug Administration approval.
But with the stakes so high for the industry, slow and steady product launches will ultimately win the marketing race.