Merck official says study prompted drug's removal

By Steve Gonzalez | Mar 9, 2007

Mikal Watts

Norman Kleinberg

Merck's executive director of epidemiology was grilled for nearly six hours Thursday by plaintiff's attorney Mikal Watts in Madison County's Vioxx trial.

Nancy Santanello told jurors she did not know that Vioxx could cause a heart attack until after results of a study known as "APPROVe" were released. The study prompted Merck to remove Vioxx from the market in September 2004.

Considered an adverse witness for plaintiff Frank Schwaller of Granite City, whose 52-year-old wife Patricia Schwaller died after taking Vioxx, Santanello at times frustrated Watts with her answers.

He asked her how many morbidly obese people had taken the arthritis pain-relieving drug before it was approved by the Food and Drug Administration.

"It would be wrong for Merck to sell a drug to drug to morbidly obese people without testing it on morbidly obese people, right?" Watts asked.

Santanello did not provide a direct answer, prompting Watts to walk through details of various clinical tests conducted on Vioxx.

She conceded that patients weighing more than 280 pounds would need a waiver to get in the clinical studies, and told Watts that patients in that weight range would be considered morbidly obese.

Patricia Schwaller, who had a family history of heart disease, and suffered from diabetes, high blood pressure and a sedentary lifestyle, weighed approximately 280 pounds and was five-feet, two-inches tall.

Watts asked Santanello if Merck made the right decision in recalling Vioxx.

"The decision Merck made was the right decision at the time," she said.

Watts was expected to continue his questioning of Santanello on Friday. Defense attorney Norman Kleinberg of Hughes, Hubbard & Reed in New York will interview Santanello later in the day.

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