Just one week after Pfizer launched a new television ad for its pain killer Celebrex, consumer group Public Citizen has come out attacking the spot, calling on the FDA to order Pfizer to stop airing it.
In a letter sent to FDA commissioner Andrew von Eschenbach on Monday, Public Citizen’s director of health research Sidney Wolfe called Pfizer’s new Celebrex ad “dangerous” and “misleading” to consumers.
“The ad violates FDA law and regulations because it contains several false or misleading statements that will lead many viewers to underestimate the cardiovascular and gastrointestinal risks of Celebrex and use it in preference to equally effective, safer alternatives such as OTC naproxen,” Wolfe wrote.
The letter further states: “Given that this ad is seen by millions of people a day, there is a special urgency to order Pfizer to stop running it before more people are misled into asking their doctors for Celebrex because of the deceptive nature of this ad.”
A Pfizer spokesman was not immediately available to comment on the Public Citizen letter.
Dr. Steven Romano, VP, Pfizer medical affairs, said in a statement last week, “With this advertising, Pfizer took a different approach to address this confusion head-on and clearly communicate the potential for cardiovascular risks of Celebrex and other NSAID therapies.”
Pfizer last Monday resumed its DTC television advertising for Celebrex with a two-and-a-half-minute spot airing on network and cable.
The ad, created by Kaplan Thaler, bucks notions of traditional prescription drug TV ads by presenting its warning information up front, noting that that Celebrex, and rivals ibuprofen and naproxen, all may cause heart attack, stroke and death. Celebrex’s benefits are stated afterward.
Pfizer pulled TV advertising for Celebrex in the wake of the 2004 withdrawal of Merck’s Vioxx.
An FDA panel later said that painkillers similar to Vioxx, known as COX- 2 inhibitors, also carried the same risks of heart attack and stroke. As a result, Pfizer withdrew its COX-2 Bextra from the market in April 2005. Celebrex, however, remained available to consumers.
Even without a major TV ad campaign behind the brand, global sales of Celebrex jumped 18% in 2006, exceeding $2 billion.