Executive points to 2000 study that Supported Vioxx

posted on:
December 7, 2005

author:
Staff

Two Merck executives involved in the development of the blockbuster drug Vioxx testified Tuesday there was no clinical evidence it could cause heart attacks and strokes when it was approved for sale five years ago.

Further, one of the officials said that a study concluded in 2000 had been widely misinterpreted to link the drug to serious cardiac events. And she pointed to internal company documents showing several outside experts had agreed with the company’s position.

“It was quite comforting,” Dr. Alise Reicin said of an e-mail she received from a Utah doctor who had monitored the company’s so- called VIGOR trial and concurred Vioxx hadn’t caused adverse heart events in patients.

Reicin and Dr. Briggs Morrison, both vice presidents of research at Merck, were among the first defense witnesses in the nation’s first federal trial over the painkiller.

Evelyn Irvin Plunkett is suing the drug giant over the May 2001 death of her husband, 53-year-old Richard “Dicky” Irvin, a former college football player and Florida seafood salesman who died of a heart attack 22 days after he began taking Vioxx for back pain.

Merck pulled the drug, which had $2.5 billion in annual sales, from the market in September 2004 after a study showed it doubled the risk of heart attacks and strokes in cancer patients who took it for 18 months or longer.

It now faces roughly 7,000 lawsuits, and analysts have predicted its overall litigation costs to run in excess of $20 billion.

Merck scored a victory last month in its home state of New Jersey when a jury there exonerated it of any wrongdoing in the non-fatal heart attack of an Idaho postal worker. In August, however, a Brazoria County jury awarded the widow of a former marathon runner $253 million in damages in connection with his fatal heart attack.

Merck contends in the current case that Irvin suffered from pre- existing heart disease and that Vioxx had nothing to do with his death. Plunkett says the drug caused a fatal blood clot in her husband’s heart, even though he took a relatively low dose of 25 mg a day and for under a month.

Reicin told the jury that she was the Merck scientist who designed the now-famous VIGOR trial – which touched off a national scientific debate on the drug’s safety that continues today – to see if Vioxx was easier on the stomach than the older painkiller naproxen.

Like others at the company, she said she was “quite concerned” about the cardiovascular results in the arthritis patients studied. Those results showed that Vioxx users had five times as many heart attacks and strokes as those who took naproxen.

But she said she was no longer concerned after she reviewed not only the VIGOR data, but also results from other trials and two on- going studies of Alzheimer’s patients. After doing so, she and other scientists concluded Vioxx hadn’t caused the heart problems, but naproxen had prevented them.

“I will tell you it was very, very comforting data,” Reicin said, adding that the company reported the data to the U.S. Food & Drug Administration two weeks after receiving it.

She also countered testimony from several plaintiffs’ witnesses last week that there was no medical evidence supporting the so- called naproxen theory, saying there had been “some literature” on the topic.

Morrison also testified that he believed that naproxen, sold under the brand name of Aleve, was “cardioprotective.”

But during his cross-examination, plaintiffs attorney Jere Beasley handed him a package of Aleve and asked him to show the jury where drug maker Bayer had touted its heart protection benefits.

Morrison said no such advertising existed, prompting Beasley to ask, “Don’t you believe that if they thought Aleve was cardioprotective that would be one of their leading advertisements?”

Morrison responded that he doubted Bayer had even tested the theory because aspirin is already widely used for that reason.

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