Merck Scientist Testifies Vioxx Caused More Heart Attacks Than AleveJun 30, 2006 | www.nctimes.com
People who took part in a clinical trial of the pain reliever Vioxx had heart attacks at a rate four times higher than those taking an older painkiller, a health data analyst for Merck and Co. testified today.
Deborah Shapiro, director of clinical biostatistics for Merck and Co. which marketed Vioxx from 1999 to 2004 said in a videotaped deposition shown to a jury that half of the 8,000 patients in the study took Vioxx and the other half naproxen, known by the brand name Aleve.
"The data was unfavorable to Vioxx, and of course that was a matter of concern," Shapiro testified.
The clinical trial, called Vioxx Gastrointestinal Outcomes Research, took place in 1999, Shapiro said.
Shapiro's videotaped deposition, which is being used in place of courtroom testimony, was shown on the third day of the trial of Stewart Grossberg's products liability lawsuit against Merck.
The retired Northridge construction manager's case in Los Angeles Superior Court case is the first against Vioxx and its manufacturer to go before a California jury.
Grossberg was 66 when he had a non-fatal heart attack in September 2001, more than two years after he began taking Vioxx, according to his court papers. He and his attorneys allege the heart attack was substantially related to his use of Vioxx.
Jurors were shown a copy of a December 1999 memo Shapiro co-signed and gave to Dr. Alise Reicin, a VIGOR study author and a top Merck scientist who had long defended Vioxx's safety. In the memo, Shapiro and another Merck researcher stated there were "serious vascular adverse experiences in the Vioxx program."
Shapiro said she does not know what Reicin did with the memo.
"I don't know who she shared the letter with," Shapiro said.
Shapiro testified that although she told various Merck officials about her concerns, she did not try and influence them with her feelings.
"I tried to avoid giving my opinion because it was their opinion that ruled the day," Shapiro said.
However, one Merck scientist asked her to "do additional analysis to explore the data because the trends were disconcerting," Shapiro testified.
Merck's attorneys have said there is little evidence that Vioxx caused heart attacks in Grossberg or plaintiffs in other cases.
The company's scientists have said the results of the VIGOR study can be explained by the success of naproxen in preventing heart attacks in those patients who took the drug.