Ads for Pfizer's Celebrex arthritis drug are set to splash across U.S. television screens on Monday after more than a two-year hiatus, with an unusual upfront focus on its risks rather than its benefits.
The ads will stress that the risks from Celebrex are similar to those of rival treatments such as ibuprofen and naproxen.
Pfizer halted its direct-to-consumer TV ads for Celebrex in December 2004, several months after Merck & Co. withdrew its similar Vioxx medicine due to elevated risk of heart attack in long-term users.
"The Food and Drug Administration had asked us to voluntarily stop all direct-to-consumer ads at a time when there were concerns about the safety of all non-steroidal anti-inflammatory drugs (NSAIDs)," including Celebrex, ibuprofen and naproxen, said Steven Romano, a senior Pfizer executive.
Since then, the FDA has required all NSAIDs to carry prominent "black-box" warnings that they may pose risks of causing serious blood clots, heart attacks and stroke.
The new Celebrex ad is slated to air Monday evening on ABC Evening News and cable TV outlets, and print versions of the ad will begin appearing in Time Magazine, U.S. News & World Report and a variety of health magazines.
In an unconventional twist, the TV ad immediately launches into the risks of Celebrex. Its overriding message is that the risks are similar to those of other NSAIDS, but it notes that Celebrex, unlike Vioxx, has never been taken off the market.
Can Lead to Death
"Any prescription NSAID, including Celebrex, may increase the chance of heart attack or stroke, which can lead to death," the narrator warns in the opening moments of the ad.
Similarly, the narrator notes that all such drugs increase the chance of bleeding and ulcers, and may also cause death.
Not until halfway into the advertisement does the ad specify reasons to take Celebrex, including the fact that a lower percentage of patients taking it in clinical trials reported indigestion, abdominal pain and nausea than those taking ibuprofen and naproxen.
It also notes that Celebrex provides 24-hour relief for arthritis pain, stiffness and inflammation.
The ad fails to mention, however, that patients taking Celebrex in a large clinical trial had a frequency of ulcers not significantly better than those taking ibuprofen and naproxen and that the Pfizer drug thereby failed the primary goal of the study.
Nor does the ad mention that there was a significantly higher incidence of death, heart attack and stroke among patients taking Celebrex in another trial, which was designed to see if the medicine could prevent colon polyps, than those receiving placebos. In a similar colon polyp trial, however, no such higher risk was seen.
Romano said the ad accurately portrays the overall risks of Celebrex, even though the unfavorable ulcer data and worrisome safety trends in the colon-polyp trial are not mentioned.
"We didn't have 15 minutes to talk about all the data" from various trials.
"In our new add, we wanted to come with an appropriate way of characterizing the risk of Celebrex and NSAIDs so patients with arthritis could have the information. By addressing the risks right upfront, it is unprecedented," Romano said.
Sales of Celebrex plunged after the September 2004 withdrawal of Vioxx due to concerns that both medicines work the same way, by blocking the so-called COX-2 protein which is linked to inflammation.
Pfizer in April 2005 withdrew its newer COX-2 inhibitor, called Bextra, after the $1.3 billion-a-year drug was linked to a rare but dangerous skin disorder.
However, it kept Celebrex on the market after FDA advisers determined the drug's benefits outweighed its risks.
With safety concerns swirling and no direct-to-consumer ads to prop up Celebrex, sales of Pfizer's COX-2 franchise fell more than 50% 2005 to $2.4 billion.
Celebrex sales began rebounding last year, helped by a return of print advertisements in April 2006 and greater awareness by consumers that rival drugs -- including far cheaper prescription and over-the-counter forms of ibuprofen and naproxen -- also carry serious safety risks.