FDA Discussing Whether Vioxx should Return

posted on:
August 9, 2005

author:
Staff

 Drug maker Merck & Co. is considering whether to put Vioxx back on the market, the former company president said in a recorded deposition shown Tuesday to jurors hearing the nation’s first lawsuit over the once-popular painkiller. 

“I mean, we haven’t made any decisions about that, but we are in discussions with the FDA at this time as to whether or not the drug should be brought back and under what circumstances it should be brought back,” Raymond Gilmartin told lawyers in the videotaped deposition.

Gilmartin’s video testimony was shown during the fifth week of Carol Ernst’s lawsuit against the giant drug manufacturer. She claims Vioxx killed her 59-year-old husband, Robert Ernst, in 2001.

Ernst’s is the first of 4,300 Vioxx-related lawsuits across the nation to go to trial.

Merck attorneys contend Vioxx could not have killed Robert Ernst because he died of an arrhythmia, and no studies showed that Vioxx caused an increased risk of arrhythmia. They also contend that Ernst took the drug for less than eight months, too short a time to be harmed by it.

In his video testimony, Gilmartin said Merck began selling Vioxx in 1999 after tests involving 10,000 patients. The drug was important, he said, because it eased inflammation and pain without causing the stomach problems of similar drugs.

When a study in 2000 showed patients taking Vioxx had four or five times as many heart-related problems as those taking the older painkiller naproxen, Merck researchers thought it was because of the heart-protective qualities of the older drug, not problems with Vioxx, he said.

Merck continued to sell Vioxx and added information from the naproxen study to its label in 2002.

A phone call from a researcher on Sept. 24, 2004, changed all that, Gilmartin said.

Outside investigators studying Vioxx in the treatment of colon polyps “recommended that we discontinue the trial because they had seen an increased rate of cardiovascular events in the trial,” he said.

After studying the data, Merck researchers decided that Vioxx showed no difference in cardiovascular risk when compared to a placebo for the first 18 months of use, he said. By 30 months of use, however, there was a statistically significant difference in risk between the drug and the placebo, he said.

Although some recommended keeping the drug on the market by adding warnings to the label, Gilmartin said he decided to pull the painkiller.

Since then, he said, a U.S. Food and Drug Administration advisory panel has determined that other drugs in the same class as Vioxx also have increased heart risks and that Vioxx could be put back on the market with appropriate label warnings.

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