Celebrex Increases Heart Attack Risk, Too

With all the attention at yesterday's American College of Cardiology meeting in Chicago focused on the Merck/Schering-Plough Vytorin fiasco (Sen. Charles Grassley, R-IA, yesterday demanded more documents on the companies' withholding data), reporters largely ignored another damning study on Pfizer's Celebrex.

A pooled analysis of clinical trials of the last Cox-2 inhibitor on the market showed that patients already at risk of heart disease who take high doses of Celebrex tripled their risk of potentially lethal heart attacks and strokes. Even at the more common dose of 200 milligrams twice a day for chronic arthritis pain, the risk nearly doubled, from 6.9 events among 1,000 patients not taking the drug over the course of a year to 10.8 events for every 1,000 patients taking the drug for a year.

The statistical meta-analysis, conducted on a National Cancer Institute grant by researchers led by Scott D. Solomon of the Harvard Medical School, suffered from the trials it had to work with: all the trials used a placebo as the comparison and used fairly high doses of Celebrex. Had it used a drug like naproxen (sold over-the-counter as Aleve or Naprocyn) as the comparator, the results might have been similar to the Vioxx-naproxen trial that doomed that drug. And the high doses used in the pooled trials allowed Pfizer to dismiss the new analysis as not typical because it exceeds the labeled use, which already carries a black box warning about the heart attack risk at high doses.

But are people prescribed this painkiller heeding the warnings on the label? According to Pfizer's latest Securities and Exchange Commission filings, sales of its anti-arthritis medications rose to $2.9 billion in 2007 from $2.7 the previous year and $2.4 billion in 2005, the first year after the black box warning got slapped on the drug. How could sales of this drug be rising? Between April and July of last year, the company launched a massive direct-to-consumer advertising campaign to "clarify misperceptions among arthritis sufferers." It was so successful, they reprised the campaign starting in November.

On the American Heart Association website, where the trial got major billing, past AHA president Ray Gibbons suggested physicians pay close attention to their patients' underlying cardiovascular risk when considering using the drug. "Patients at the highest risk should be the most cautious," he said.

Yes, but when serious arthritis or back pain hits, or an aging Baby Boomer is about to go out and play 18 holes of golf, they're likely to grab a couple of those 200-milligram pills; and they'll take a few more when they get home. And if they do that repeatedly and they're already at risk of a coronary (overweight? diabetic? got a family history?), this latest analysis suggests they've unwittingly put themselves at much greater risk.