Celebrex new ad, with questionable claims.(medication)

After a two-year hiatus, Pfizer is again advertising its pain reliever celecoxib (Celebrex) with a direct-to-consumer TV ad. The company had voluntarily suspended such advertising of Celebrex in December 2004 after evidence suggested that the drug, like its previously withdrawn cousin rofecoxib (Vioxx), might increase heart attack or stroke risk.

The ad suggests that the medication is no riskier for the heart than other prescription nonsteroidal anti-inflammatory drugs (NSAIDs), such as naproxen (Naprosyn and generic), and is possibly easier on the gut. We think that the claims, which also appear at www.celebrex.com, don't tell the whole story.

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For our analysis, we asked Gail Cawkwell, M.D., Ph.D., Pfizer's senior medical director for Celebrex, to provide supporting evidence for the claim. Then we commissioned experts on communicating medical information to review that and other evidence on the medication. We also combed the medical literature and asked drug-safety experts, specialists in heart and joint diseases, and the Food and Drug Administration to weigh in. Here's what we found:

The claim. All prescription NSAIDs--not just celecoxib--may increase the chance of heart attack or stroke.

CR's take. Since April 2005 all prescription NSAIDs have carried the same FDA-approved black-box warning, the most serious label alert, about increased cardiovascular risk. But that's largely because the FDA didn't have enough data to rank the drugs for safety. There's more evidence now that at least one prescription pain reliever, naproxen, might pose less heart risk than celecoxib.

Although the evidence is mixed, some meta-analyses, which assess the combined data from many clinical trials, have linked celecoxib at moderate to high doses to an increased likelihood of heart attack compared with either a placebo or naproxen. Similarly, some analyses and other studies suggest that naproxen might not threaten the heart. A September 2006 report ...