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Pfizer Celebrex Lawsuits - 1500 and Counting

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Message Evelyn Pringle
Patients in the trial who were taking 400 mg of Celebrex twice a day were found to have a 3.4 times greater risk of cardiovascular events compared to patients taking a placebo and patients taking the 200 mg dose had a risk that was 2.5 times greater.

The news of this study came a mere 10 weeks after Merck's recall of Vioxx, when a study found that Vioxx doubled the risk of heart attack and stroke among patients taking the drug to prevent colon polyps.

In fact, on September 30, 2004, in response to Merck's announcement, Pfizer issued a press release bragging that over 27 million patients in the US had been prescribed Celebrex since it was approved and said people should use it instead of Vioxx.

"Because of its outstanding long-term safety profile and broad indication base including osteoarthritis, rheumatoid arthritis and acute pain, Celebrex is an appropriate treatment alternative," said Dr Joe Feczko, Pfizer's president of worldwide development.

The press release claimed that a recent FDA sponsored study of 1.4 million patients, found that those patients who received Celebrex demonstrated no increased risk of cardiac events. "Pfizer is confident in the long-term cardiovascular safety of Celebrex," Dr Joe Feczko stated.

Well, that glory was short-lived because in January 2005, following a sharp decline in new prescriptions for Celebrex after the December 2004 study was revealed, Pfizer investors filed a federal class action lawsuit against Pfizer in Connecticut alleging that the company misled investors about the safety of Celebrex.

A former Vice President of Pfizer turned whistleblower, Peter Rost, says shareholders were rightfully upset and estimates that the fiasco probably cost Pfizer $3-4 billion.

As for the potential damages to the company from all the lawsuits filed, Mr Rost states companies like Pfizer usually carry some insurance but says, "Most comes out of shareholders pockets."

He predicts that more hidden studies and documents will pop up during litigation.

And that too seems likely being Pfizer has been forced to acknowledge that a study that was testing Celebrex as a treatment for Alzheimer's disease between 1997 to 1999, showed patients taking Celebrex quadrupled their risk for a heart attack compared to those patients taking a placebo.

The study found patients on Celebrex had a 3.6 times greater occurrence of a serious heart event compared to those on a placebo, according to an analysis of the data by the patient advocacy group, Public Citizen.

On January 24, 2005, Public Citizen petitioned the FDA to immediately remove Celebrex from the market and a week later on January 31, 2005, Citizen accused Pfizer of burying the study. Sidney Wolfe, director of Public Citizen's Health Research Group, said "there is no excuse for this study not being made more public."

Critics say this study proves that the drug makers knew that Celebrex was a total fraud before the drug even hit the shelves.

According to Merrill Goozner, author of the $800 Million Dollar Pill, the only legitimate selling point for the Cox-2 inhibitors was the claim that they would eliminate the ulcers and deaths that on rare occasions resulted from the prolonged use of generic painkillers.

"Yet the FDA didn't allow them to claim that in their advertising or literature," he points out, "since the clinical trials failed to turn up evidence that the new drugs were safer than NSAIDs."

"The package insert, which goes out with every prescription," he notes, "contained the same warning label as all the other NSAIDs."

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.
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