Is Celebrex safe or not?

Many mixed messages. The “smoking gun” was thought to be found with the study unearthed by the Public Citizen Health Research Group:

Wolfe thinks he found that second study–and it was conducted six years ago. In a letter sent to the head of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, Wolfe outlined a statistical analysis he had done of a 1999 Pfizer-funded test of Celebrex as a preventative for Alzheimer’s disease that had just been made available on an industry Web site of clinical trial results. The results had been presented at a meeting in 2000, but were never published.

The study compared 285 patients who took Celebrex with 140 who took placebo. Wolfe’s conclusion: Patients on Celebrex were 3.6 times more likely to suffer serious heart problems than those who took placebo, and they were also more likely to die. He says that both of those results are statistically significant, meaning it is unlikely they occurred by chance.

However, even the anti-Vioxx crusader, Dr. Eric Topol doubts the findings of the study:

To get those results, however, Wolfe defined “serious heart problems” much more broadly than others–including Topol–have in the past. When Topol co-authored an influential paper on Vioxx and Celebrex in 2001, he and his colleagues looked at three certain signs of cardiovascular risk: heart attack, stroke and death. Wolfe, in contrast, grouped together a smorgasbord of heart problems that are harder to diagnose, such as angina, arrhythmia and heart failure, a weakening of the heart muscle.

Bruce Psaty, a safety expert at the University of Washington, defends Wolfe’s analysis because no criteria for evaluating heart safety were specified in the study. But Topol thinks the bar was lowered too far. Moreover, when Topol had a Cleveland Clinic statistician reanalyze Wolfe’s work, the cardiovascular differences were not significant after all.

However, the cat’s already out of the bag. The headlines already are damaging enough, and certainly will be the only thing that patients will remember.