By Anne Belli of The Houston Chronicle
A doctor who has analyzed the effects of Vioxx on the heart denied today that four studies that he says showed the link in low-dose use were statistically insignificant.
On cross-examination by an attorney for drug marker Merck, Wayne Ray, director of the Pharmaco-Epidemiology department of Vanderbilt University School of Medicine, stuck to his earlier testimony that the once blockbuster drug caused cardiac events in patients who took just 25mg a day.
That’s how much Florida seafood salesman Richard “Dicky” Irvin Jr. was taking when he had a heart attack and died in May 2001. Irvin, 53, died after taking Vioxx for 22 days for back pain. His widow, Evelyn Irvin Plunkett, is suing Merck for unspecified damages.
“However you slice the date, Vioxx is always coming up higher,” Ray said.
Later he added that one of the studies, released in the spring of 200, was a “huge red flag” that the drug leads to heart attacks and strokes.
Ray’s testimony came on the fourth day of the nation’s first federal trial involving the drug.
On Thursday, Alan Nies, former senior vice president of clinical research at Merck, said the drug maker did not specifically test Vioxx’s effects on the heart before marketing it, even though scientists from around the world had concerns that it might contribute to heart attacks.
Nies acknowledged that some researchers in the late 1990s questioned whether Vioxx caused various so-called cardiac events, including clots and strokes. Jurors were also shown letters, memos and other internal company documents related to those concerns.
When asked by plaintiff’s lawyer Jere Beasley if those concerns represented “warnings” to Merck, he said they did not. “We weren’t going to do them because they really weren’t helpful to us in terms of patient safety,” he said about testing.
Merck pulled Vioxx from the market in September 2004 after a study found that Vioxx users had double the risk of heart attacks and strokes when they took it for 18 months or longer.
Easier on the stomach
Nies said Thursday that this was the first time company officials has any evidence that the drug, which was approved for sale in 1999 and had annual sales of more thatn $2.5 billion a year, may be linked to cardiac disease.
Beasley suggested that promise of such robust sales causes Nies and other Merck officials to turn a blind eye to the cardiac concerns because they were in a tight competition with Pfizer to develop a painkiller that would be eaiser on the stomach than such drugs as naproxen and Alleve.
Beasley showed jurors the company’s own development plan for Vioxx, which stated that there was “considerable pressure to market” the drug and that clinical programs would need to be “compressed and accelerated.”
But as jurors took notes and listened intently, Nies denied that that meant the company was cutting corners. Rather, it had planned to shorten the traditional down time between studies, he said.
On cross-examination by Merck lawyer, Nies said that every one of the nearly 60 clinical trials conducted by Merck involving 10,000 patients was reviewed by the U.S. Food & Drug Administration, which in 1999 found it safe and effective.
Further, he disputed assertions that a 2000 study – in which Vioxx uses had five times the incidence of cardiac events compared to patients who took naproxen – meant that Vioxx was the reason for the increase.
To this day, Nies said, he believed that reason for those results is the naproxen actually causes a decrease in heart attacks.
Beasley jumped on that contention, asking why then the makers of naproxen hadn’t been marketing that drug for that use if it had such powerful effects in these days of aggressive advertising by the pharmaceutical industry.
“They have never done studies to show that,” Nies said.
U.S. District Judge Eldon Fallon has said he wants to wrap up testimony in the case within two weeks.
The case was originally to be tried in New Orleans but it was moved to Houston after Hurricane Katrina damaged the courthouse there.