Merck used U-Haul to deliver Vioxx research to FDA

Ann Knef Mar. 15, 2007, 2:01am

Vioxx was tested on more people and for longer periods of time than required by the Food and Drug Administration, explained Merck's vice president of research Briggs Morrison on the witness stand all day in Madison County Court Wednesday.

He said that before the arthritis pain relieving drug went on the market, research showed that Vioxx posed no increased risk of cardio vascular effects.

"I thought it was a wonderful drug," Morrison said. Vioxx sales began May 20, 1999. Merck took the drug off the market in September 2004.

Merck attorney Norman Kleinberg also asked Morrison about the results of a 1997 "Fitzgerald" study suggesting that COX-2 inhibiting drugs, like Vioxx, increased the risk of cardiovascular problems.

Fitzgerald's theory stated that COX-2 inhibitors block the production of a substance called prostacyclin, which leads to blood vessel constriction and clotting.

Morrison said he was surprised at Fitzgerald's results.

He said studies were also conducted on dogs and rabbits to test theories about heart and kidney risks, resulting in data that was not consistent with Fitzgerald's hypothesis.

Outside experts were consulted about Fitzgerald's findings, but a board of scientific advisors recommended that there was a strong mandate for introduction of Vioxx, he testified.

Morrison, a defense expert who was later cross examined by plaintiff's attorney Andy Birchfield, said 10,000 patients participated in 58 clinical trials. A total of 5,435 people actually took the drug in trials when only 1,500 are required by the FDA.

Morrison said Merck used a U-Haul rental truck to deliver the raw data and summaries collected on Vioxx research to the FDA.

"It was a lot of information," Morrison said.

Several skirmishes between opposing counsel broke out during cross examination.

Defense attorney Dan Ball objected several times to Birchfield's line of questioning, arguing that introducing an email from a retired Merck research president regarding the company's "culture," went "way, way beyond the scope of redirect" and was unfairly prejudicial.

After jurors were excused Birchfield told Judge Daniel Stack that the document goes directly to Merck's rush to market Vioxx and that under the leadership of Merck CEO Raymond Gilmartin, marketing took precedence over science.

Stack sustained defense objections.

When jurors returned Birchfield attempted to trip Morrison up on previous testimony. He asked Morrison twice, "Is it your position Vioxx did not cause one single heart attack?"

Morrison said, "The way you phrase that I cannot answer."

Morrison explained that data in its entirety did not show Vioxx posed increased risks of cardiovascular problems.

More News