An influential consumer group in the USA has attacked Pfizer’s new television advert for its painkiller Celebrex, saying that the claims made in it are “dangerous and misleading.”
The advert, which was first aired last week, and can also be viewed on www.celebrex.com, lasts for an unusually long two-and-a-half minutes and features. It is an animated piece and has a voiceover which compares the COX-2 inhibitor Celebrex (celecoxib) with other painkillers and discusses the risks associated with its use. The advert, which was approved by the US Food and Drug Administration, comes three years after Pfizer pulled Celebrex ads after a request by the agency at a time when Merck & Co’s COX-2 inhibitor Vioxx (rofecoxib) and Pfizer’s own Bextra (valdecoxib) were withdrawn from the market.
However, the advert has not gone down well with the US consumer group Public Citizen Sincerely, and Sidney Wolfe, director of its Health Research Group, has written to FDA Commissioner Andrew Von Eschenbach to “immediately stop its dangerous, misleading” advertisement. Dr Wolfe says that the overall purpose of the ad is to make it appear, “contrary to scientific evidence, that the cardiovascular dangers of Celebrex are not greater than those of any of the other non-steroidal anti-inflammatory drugs painkillers,” such as ibuprofen and naproxen. “Further,” he claims, “it asserts that certain gastrointestinal problems are, if anything, less frequent with Celebrex than with two popular over-the-counter painkillers.”
Claims of false statements
Dr Wolfe goes on to state that 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.”
He also notes that the American Heart Association recently stated that important differences exist between treatments in terms of risk of major thrombotic events, and because of these differences, Dr Wolfe claims that “naproxen is the preferred choice among NSAIDs, but the AHA recommendation is that the COX-2 drugs be the last choice, to be used for those people who fail to respond to the older NSAIDs or other drugs.” He concludes by saying that although Pfizer has stated that the advert is the result of long-term consultation with the FDA, “it is clear that the final version of the ad was not seen by the agency until very shortly before it started to air last week. 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.”
In response, Pfizer’s senior medical director, Gail Cawkwell, told The New York Times that “we do feel that this ad is a very responsible approach to talking about a medicine, and clearly a medicine that is an important thing for many, many patients to be thinking about and talking to their doctors about.”
Dr Cawkwell added that the allegations by Public Citizen were wrong in several respects, notably when the letter suggested that the ad compared Celebrex to OTC medications, but it never does. She also said that the advert clearly stated the gastrointestinal risks of Celebrex, while Dr Wolfe suggests that those risks are played down.
