Last week, Pfizer began airing its controversial two-and-a-half-minute commercial promoting the painkiller Celebrex, which is in the same class of drugs as the discredited (and discontinued) Vioxx. For Celebrex, a type of non-steroidal anti-inflammatory drug (NSAID) known as a COX-2 inhibitor, it was a return to television marketing for the first time in more than two years. However, Pfizer may now be forced to pull the ad in the face of mounting criticism that the spot is misleading.

Today, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, sent a letter to Andrew Von Eschenbach, commissioner of the U.S. Food and Drug Administration (FDA), to raise his concerns. Calling the ad “misleading” and “dangerous,” Wolfe wants the FDA to order Pfizer to immediately pull the commercial from the airwaves.

“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 NSAID painkillers,” Wolfe writes. “Further, it asserts that certain gastrointestinal problems are, if anything, less frequent with Celebrex than with two popular over-the-counter (OTC) painkillers.

“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 takes Pfizer to task specifically for three potentially false and misleading claims. The first controversial claim made in the spot points to the cardiovascular risks of Celebrex competitors like ibuprofen and naproxen. But as Wolfe states, “In a thorough review of all randomized controlled trials of older NSAIDs such as ibuprofen and naproxen, as well as the newer COX-2 NSAIDs such as Vioxx and Celebrex, published almost one year ago, the authors concluded that the COX-2 drugs, including Celebrex, did have an increased cardiovascular risk, seen most clearly with heart attacks (myocardial infarctions).” He also notes that naproxen was not associated with increased cardiovascular risk in that review.

Secondly, Pfizer says in their ad that Celebrex has the same FDA-mandated cardiovascular warning as the other NSAID drugs. While this is true for prescription drugs, OTC NSAIDs such as naproxen and ibuprofen are not required to have the same black-box warning. According to the FDA, short-term use of low-dose OTC NSAIDs is not associated with any increased cardiovascular risk. Wolfe also points out that, according to the American Heart Association (AHA), “important differences exist between these agents in terms of risk of major thrombotic events.”

“Following the withdrawal of both Vioxx and Bextra,” Wolfe explains, “in each case involving increased cardiac risks of these COX-2 drugs, the FDA issued a statement requiring boxed warnings of increased cardiovascular risk on the prescription versions of all older (non-selective) NSAIDs and the remaining COX-2 drug, Celebrex. The FDA also explained, however, why the over-the-counter NSAIDs such as naproxen and ibuprofen would be available without such a boxed warning.”

The third point of contention in the ad relates to the issue of gastrointestinal damage and Pfizer’s claim that “a lower percentage of patients on Celebrex reported indigestion, abdominal pain, and nausea versus prescription ibuprofen and naproxen.” While it’s true that all NSAIDs carry a warning of stomach or intestinal problems, Wolfe says, this statement does not account for “more serious problems, ulcers or bleeding, [which] occur equally with all NSAIDs.”

This entry was posted on Monday, April 9th, 2007 at 3:57 pm and is filed under Health Concerns.