This week, Pfizer ran television ads promoting their controversial arthritis drug, Celebrex, for the first time in more than two years. The move came following protracted negotiations between Pfizer and the U.S. Food and Drug Administration (FDA), who had asked Pfizer to voluntarily suspend its television marketing of Celebrex in December of 2004 a time when the safety of the drug was under close scrutiny.
The ads take a new tack: They stress the significant risks associated with the drug early on, comparing them with the risks of rival painkillers naproxen and ibuprofen. Only later on in the ads do they mention the drugs benefits.
The hullabaloo around Celebrex came in the wake of the Vioxx situation. Merck's Vioxx was pulled from the market in 2004 due to an increased risk of heart attacks. Vioxx is a type of non-steroidal anti-inflammatory drug (NSAID) known as a COX-2 inhibitor the same class as Celebrex. However, the FDA eventually ruled that Celebrex benefits outweighed its risks and allowed it to remain on the market. Shortly after the Vioxx uproar, the FDA instituted its strictest black-box warning on all NSAIDs, including Celebrex, alerting consumers to the risk of blood clots, heart attacks, stroke, and stomach problems.
Significantly, the new ads don't specifically mention two recent clinical trials, according to Reuters: The first study showed that the risk of stomach ulcers was roughly the same for Celebrex users as it was for naproxen and ibuprofen users. The second trial, conducted to determine whether the drug was effective in fighting colon polyps, found an increased risk of heart attacks and strokes when compared to a placebo. The FDA is currently monitoring an ongoing clinical trial about Celebrex risks.
In 2005, as health-care professionals and consumers questioned the drugs safety and Pfizer pulled its advertising, sales of Celebrex declined nearly 50 percent, but they rebounded sharply last year in part because Vioxx was no longer an option. Still, the reason Pfizer attempted to get the ads back on television is that roughly 40 percent of consumers had mistakenly believed the drug was off the market.