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By MIKE SCHWARTZ / The Press-Enterprise

December 18, 2004 - For the second time within three months, a top-selling prescription drug used to treat arthritis pain has been impugned by research findings as risky for patients predisposed to heart attacks. First it was Vioxx, recalled by Merck & Co. 11 weeks ago. Yesterday it was Celebrex, which long-term National Cancer Institute data shows more than doubles a user's risk of a heart attack

The difference is that drug-maker Pfizer Inc. still stands by Celebrex, insisting the NCI results conflict with many other studies showing the drug is safe and effective. Pfizer intends to keep the painkiller on the market until researchers can prove conclusively it's dangerous. Even so, the revelation startled Inland family caregivers and patients racked with pain and inflammation from arthritis and other ailments. They said the findings slash an already shrinking list of options.

"I'm really surprised to hear this," said Arlo Gard, 79, of Riverside who suffers from osteoarthritis. "I was on Vioxx but went to Naprosyn until it caused intestinal problems. So I switched to Celebrex eight months ago. It's worked really fine." Gard said he intends to check with his doctor. "But unless I can find something else, I'll continue with Celebrex ... especially since my heart is in good shape," he said.

Ray Mastalish, deputy director of senior programs at the Riverside County Office on Aging has an 89-year-old mother with "terrible arthritis," he said. "She's had to contend with medicine that's caused stomach problems. Adding questions about Celebrex to the equation now may limit her options."

Still, Mastalish said he is glad Pfizer came out publicly with the finding. "If there are problems, let's get the word out right away rather than covering it up," he said. Local physicians said the latest findings prompt safety concerns about medications in this class, known as COX-2. The class includes Bextra, whose safety also has been debated. Dr. Gary Huffaker, assistant medical director of Kaiser Permanente Medical Center, Riverside, said some colleagues have told him they still use Celebrex and others say they don't.

"It's still not completely clear. There are so many variables. So it's hard to make a blanket statement," Huffaker said. Short of indisputable evidence that Celebrex is risky, Dr. Lawrence R. Walker, an orthopedic surgeon, would still feel comfortable prescribing it - except to patients with a known history of heart trouble. "There can be risks associated with any medicine you take," said Walker, chief of staff at St. Bernardine Medical Center, San Bernardino. "But with Celebrex, the benefits still outweigh the risks."

Walker said other ongoing studies show there is no increased risk of heart trouble from Celebrex, which may even be "a bit cardio-protective" compared with Vioxx and Bextra, as well as aspirin, ibuprofen and other anti-inflammatory drugs. Celebrex also seems to reduce colon polyps and protect against cancer, he said. Dr. Keith K. Colburn, chief of rheumatology at Loma Linda University Medical Center, points out that COX-2 drugs were developed to eliminate the gastrointestinal side effects of older drugs such as Motrin and Naprosyn.

"After all the negative hype has worn off, they still will have a place," Colburn said. They are as safe - or safer - than many other medicines, he said. "If aspirin had come along today it probably wouldn't have gotten past the FDA because of its gastric side effects," quipped Colburn. Another benefit: Celebrex and related drugs don't affect blood platelets. This means they can be used right up until surgery without worrying about bleeding.

Colburn advises patients uncomfortable about taking Celebrex to consider switching back to older drugs, along with a proton pump inhibitor such as Prilosec to help prevent gastric upset. But don't make an abrupt decision, cautions Huffaker. "Talk to your doctor and, ultimately, consider the evidence, he said.

Shares of Pfizer plunged $3.23, or 11.15 percent, to $25.75 in late afternoon trading on the New York Stock Exchange. The decline wiped out almost $25 billion of Pfizer's market value.

Reach Mike Schwartz at (951)368-9591 or mschwartz@pe.com
The Associated Press contributed to this story.

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