"When drugs show health risks after they are approved, consumers are correct to ask: Are we being used as guinea pigs to serve the profit motive of the pharmaceutical industry?"

Cardiovascular Risk More Than Double

The study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped because analysis by an independent Data Safety and Monitoring Board (DSMB) showed a 2.5-fold increased risk of major fatal and non-fatal cardiovascular events for participants taking the drug compared to those on a placebo. Trial participants will remain under observation for the planned remainder of the study.

Celebrex is approved for use in the United States for the treatment of arthritis and pain, at recommended doses of 100mg to 200mg daily for osteoarthritis and 200mg to 400mg a day for rheumatoid arthritis. It is also approved for a rare condition called familial adenomatous polyposis in doses up to 800mg per day. The APC cancer trial was studied Celebrex at doses of 400mg to 800mg per day.

Same Drug Class as Vioxx

Celebrex is a COX-2 inhibitor -- the same class of drug as Vioxx, which was recalled from the market by its manufacturer, Merck, following a September 2004 report that it caused a two-fold increased risk of cardiovascular toxicities.

"Data from the report on rofecoxib (Vioxx) informed us of the need to focus on specific cardiovascular issues, and our Institutes brought in the experts to do so," said Elias A. Zerhouni, M.D., NIH Director.

"Our overwhelming commitment is to advance the health and to protect the safety of participants in clinical trials. We are examining the use of these agents in all NIH-sponsored clinical studies. In addition, we are working closely with our colleagues at FDA to ensure that the public has the information they need to make informed decisions about the use of this class of drug," Zerhouni said.

'Full Review' Requested

NIH sponsors over 40 studies using celecoxib for the prevention and treatment of cancer, dementia and other diseases. In light of these new findings, NIH Director Zerhouni requested a full review of all NIH-supported studies involving this class of drug.

Pfizer noted that the Data Safety and Monitoring Board also reported that a second trial (the PreSAP cancer trial) revealed no greater cardiovascular risk for participants using Celebrex than for those taking a placebo. In the PreSAP cancer trial the Celebrex dose was 400mg per day.

"These clinical trial results are new. The cardiovascular findings in one of the studies (APC) are unexpected and not consistent with the reported findings in the second study (PreSAP). Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world," said Hank McKinnell, Pfizer chairman and chief executive officer.

Pfizer Advises Discussion with Doctor

"Celebrex is an important medicine that provides necessary pain relief to many patients," said Dr. Joseph Feczko, president of worldwide development for Pfizer. "Patients being treated with Celebrex should discuss appropriate treatment options with their healthcare professionals. Physicians should factor this new information, as well as ulcer risks and gastrointestinal bleeding seen with traditional NSAIDs, into their prescribing decision."

Pfizer has not indicated that it plans to withdraw Celebrex from the market.

Consumer Lawyer Calls for Reform

In the wake of the news about heart attack risks with Celebrex, consumer attorney Guerry R. Thornton, Jr., an Atlanta lawyer who handles Vioxx cases, called for regulatory reforms.

"The pace of drug safety issues raises more concern about the effectiveness of the FDA," he says. "When drugs show health risks after they are approved, consumers are correct to ask: Are we being used as guinea pigs to serve the profit motive of the pharmaceutical industry?"

The risk of heart attacks has long been a concern related to Cox-2 inhibitors like Celebrex and Vioxx, according to Thornton. "The trial bar acted quickly in the Vioxx controversy and should use its influence to help bring about reform," he says. "Certain senators favor protection for FDA approved drugs. Such laws should not provide a safe haven for negligent drug companies."

In 2004, 19.8 million prescriptions were filled for Celebrex. Pfizer's sales have reached over $2 billion per year, according to Thornton.