At Vioxx Trial, a Discrepancy Appears to Undercut Merck's Defense

By ALEX BERENSON Published: July 20, 2005

In the letter, Merck reported that patients taking Vioxx in the largest clinical trial of the drug ever, only 0.5 percent had incurred "cardiovascular events," or heart and circulation problems. That would mean only about 20 patients among the more than 4,000 who took Vioxx during the study.

But in fact, 14.6 percent of the Vioxx patients - or 590 people - had cardiovascular troubles while taking the drug, according to Merck's own report on the study to federal regulators. And 2.5 percent, or 101 people, had serious problems, like heart attacks.

Merck sent the letter to thousands of doctors, including in April 2001 to Dr. Brent Wallace, who had prescribed Vioxx to Robert Ernst. Mr. Ernst, who was 59, died suddenly in May 2001 after taking Vioxx for eight months, and his family is suing Merck, claiming the drug caused his death.

Merck lied to Dr. Wallace, said W. Mark Lanier, a lawyer for the Ernst family. ...

Merck denies that Vioxx was responsible for Mr. Ernst's death, which according to the autopsy report was the result of arrhythmia, or an irregular heartbeat. Vioxx has never been proved to cause arrhythmia, the company says. The discrepancy between Merck's letter and its analysis of the study's data was the crucial point in Mr. Lanier's day of questioning Dr. Santanello, who first took the stand Monday afternoon. Mr. Lanier upbraided Dr. Santanello dozens of times for not answering his questions, saying in one typical instance, "I asked you to quit dodging and focus on my questions please." Gerry Lowry, a lawyer for Merck, complained repeatedly to Judge Ben Hardin that Mr. Lanier was making speeches to the jury instead of simply asking questions. Near the end of the day, the judge twice asked Mr. Lanier to give Dr. Santanello time to answer. Mr. Lanier also played Merck's television advertisements for Vioxx, which did not mention the drug's possible heart risks. Later, he showed the jury e-mail messages between two top Merck executives in which they complained about the Food and Drug Administration's proposed label for Vioxx. In one message, Dr. Edward M. Scolnick, Merck's top scientist, referred to the F.D.A. officials as "bastards."