Zelnorm Recall
April 2, 2007Zelnorm profits depended on ad blitz, CEO says
According to a recent article in Forbes magazine, sales of the irritable bowel syndrome (IBS) drug Zelnorm increased by more than one-third thanks to a series of television advertisements promoting the drug. Zelnorm was recently withdrawn by its manufacturer, Novartis, after it was linked with an increased risk of heart attack, stroke and other cardiovascular side effects. Officials from the Food and Drug Administration say that Novartis is planning to issue a Zelnorm recall, although no date has been announced.Novartis began airing a series of ads for Zelnorm over the past few years that showed two groups of women with messages written on their stomachs. The first group of women, purportedly suffering from the symptoms of IBS, had messages written on their stomachs such as “bloated” or “I want to feel better,” indicating the abdominal problems they were experiencing. The second group, with messages like “I asked my doctor,” “I’m feeling better” and “Yes, there is help,” represented women who had used Zelnorm to treat their IBS symptoms.
According to Forbes, sales of Zelnorm rose by 36% to $556 million in the year after these ads began to air. Novartis’ CEO, Thomas Ebeling, says that the success or failure of Zelnorm to generate profits lies in the company’s ad campaign for the drug. “The weeks we go off the air, the growth flattens. When we restart, you see the growth accelerate again,” he says.
But Novartis’ advertising campaign for Zelnorm has not been without its share of problems. In June 2003, the company was forced to pull its earlier Zelnorm ad campaign from the airwaves by the FDA. The agency said that the ads, which talked about a “treatment from Novartis” that is “beating IBS” (without mentioning Zelnorm by name), deceived patients into thinking that the drug was more effective at relieving constipation from IBS than it is. According to statistics from the FDA, after three months Zelnorm is only 6% more effective than a placebo at relieving symptoms.
The FDA’s reaction to Novartis’ Zelnorm ads is typical of a backlash against the advertising blitz that drug companies have unleashed on the airways. Congress is currently considering a bill that would bar the pharmaceutical industry from advertising new drugs for two years after they are approved by the FDA. Officials say that this would prevent drugs—such as Zelnorm—whose dangers are only understood after they have been used by thousands of patients from being mass-marketed to unaware consumers.