Healthy Skepticism Library item: 9063

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Japsen B.
Pfizer, FDA talks could bring ads for Celebrex back to television
Chicago Tribune 2007 Mar 29
http://www.chicagotribune.com/business/chi-0703280672mar29,0,7139704.story?coll=chi-business-hed

Full text:

The controversial arthritis pain pill Celebrex could return to television in new ads by this summer pending negotiations under way between the drug’s maker, Pfizer Inc., and the Food and Drug Administration.

Pfizer agreed to pull ads for Celebrex in the wake of the Vioxx imbroglio and just before of an FDA advisory panel said the drug and similar painkillers, known as Cox-2 inhibitors, increased the risk of heart attacks and strokes. Rival Cox-2 drug Vioxx was pulled by its maker, Merck & Co., in September 2004 and Pfizer ceased ads in December of that year after studies linked Celebrex to heart risks as well.

At that time critics including physician advisers to the FDA and consumer groups said Celebrex ads led to patients getting the drug who did not need it. Critics also said the ads did not provide enough information about potential risks, including heart problems, so Pfizer pulled the ads under mounting pressure.

In one widely used Celebrex ad, active elderly people doing tai chi in a park surrounded by a backdrop of trees were featured. It’s unclear what the new ads will feature because neither Pfizer nor the FDA would provide specifics.

“We plan to launch new consumer advertising sometime in the second quarter based on the outcome of discussions with the FDA,” Pfizer spokesman Jack Cox said.

Although Pfizer will not discuss its Celebrex ads, they are likely to provide prominent information about the drug’s safety risks, given the company’s stated pledge in regard to consumer ads. The New York-based pharmaceutical giant is one of several drugmakers that two years ago pledged to be more accountable and serious when they advertise their brand-name prescription medicines to consumers, a measure critics have said is a move to regulate themselves before the government takes action.

Through the Pharmaceutical Research and Manufacturers of America, the lobbying arm of major companies such as Pfizer, Merck and North Chicago-based Abbott Laboratories, the firms would submit their ads to the FDA for screening before they are broadcast. The companies also said they would put more information about potential safety risks in their commercials.

In the case of Celebrex the drug’s risks are serious. The FDA panel’s hearing two years ago led to the agency’s most stringent warning, a “black box,” which warns of the drug’s risk to the heart.

Worldwide sales of Celebrex, which was developed by the now-shuttered G.D. Searle & Co. in Skokie, jumped 18 percent last year, exceeding $2 billion.

Its growth trend is in sharp contrast to the huge loss in sales that the pain-relief prescription sector experienced in 2005. Celebrex sales plummeted 48 percent that year, to $1.73 billion, compared with 2004.