Now that Merck has removed its arthritis painkiller Vioxx from the market after tests found that it increased the risk of heart attacks and strokes, its rival Pfizer is taking a surprising stance. Pfizer says it is looking into whether its somewhat similar drug, Celebrex, may actually help prevent heart attacks.
Yet there have been at least a few studies on animals suggesting that Celebrex could be harmful to the cardiovascular system. And a US Food and Drug Administration reviewer expressed concern over cases of elevated blood pressure and edema, or swelling, in a clinical trial of the similar drug Bextra as a painkiller in patients undergoing coronary bypass surgery, according to agency files obtained in a lawsuit by the advocacy group Public Citizen.
"We're not running away from cardiology," Mitch Gandelman, a Pfizer vice president, said last Friday, adding that a couple of studies on a very small scale suggested that Celebrex could be good for cardiovascular health. "We are actually looking into cardiology."
Gandelman acknowledged that evidence for this is scant and inconclusive. But it is part of Pfizer's effort to distance itself from Merck's problems and provide an answer to what has become a central question: Is it a class effect? Do all the drugs in the widely prescribed group known as COX-2 inhibitors carry the same risks as Vioxx?
Millions of patients and billions of dollars in sales could be affected by the answer. Spurred by heavy advertising, COX-2 inhibitors took off faster than any other group of drugs after Celebrex and Vioxx went on sale in 1999. Sales of the two medications, plus those of Pfizer's newer Bextra, exceeded $6 billion worldwide last year.
Patients discontinuing Vioxx can now decide whether to switch to one of the other COX-2 inhibitors on the market.
And it is possible that safety concerns could delay approval of two other drugs that are now in advanced development, Merck's Arcoxia and Prexige from Novartis, as well as others.
Merck said last week that it would no longer sell Vioxx because a study showed a higher risk of heart attacks and strokes among patients who had taken it for longer than 18 months. The reason for the greater risk is not known.
Many experts say that Celebrex, the oldest and biggest seller in the category, is somewhat different chemically from Vioxx and has not shown signs of increasing cardiovascular risk in clinical trials or in studies examining medical records of people who have taken that drug.
Daniel Solomon, a rheumatologist and epidemiologist at Brigham and Women's Hospital in Boston, said, "I feel comfortable as a clinician, as someone prescribing these drugs, that it has a clean bill of health." By contrast, he and others said, several studies dating to 2000 pointed to a risk for Vioxx.
But Eric Topol, cardiovascular chairman at the Cleveland Clinic, said the drugs had not been tested adequately in people with heart disease, even though such people use the drugs. "The real answer is we don't know," he said.
Gandelman said that the results of animal studies using Celebrex varied and that, in any case, such studies did not always reflect what happens with people. As for the Bextra study, he said, "It's a finding in a narrow type of surgery, and it's a use we would not recommend."
Pfizer issued a statement on Friday saying that three trials involving a total of 6,000 patients that had been under way for several years had not shown any significant safety issues. The tests are designed to determine whether Celebrex can help prevent colon cancer or prevent or slow Alzheimer's disease.
For the moment, investors seem to think that Pfizer's sales will rise as a result of the withdrawal of Vioxx. Pfizer's shares, which had recently been battered, rose 42 cents on Thursday, the day Merck said it would withdraw its drug, and 37 cents more on Friday, closing at US$30.97.
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