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anyelo robles
4 years ago
Merck Scrapped Vioxx Study. Drug maker Merck & Co. scrapped a planned study of the cardiac safety of Vioxx once it knew U.S. regulators were going to tone down their warning about heart risks for patients taking the painkiller, a plaintiff’s lawyer argued Friday in a product liability trial. But Merck’s former head of U.S. […]
Merck Scrapped Vioxx Study. Drug maker Merck & Co. scrapped a planned study of the cardiac safety of Vioxx once it knew U.S. regulators were going to tone down their warning about heart risks for patients taking the painkiller, a plaintiff’s lawyer argued Friday in a product liability trial.
But Merck’s former head of U.S. marketing, David Anstice, testified it was coincidence that the study was canceled in March 2002 as Food and Drug Administration regulators and Merck officials settled on putting a notice about Vioxx cardiac risks in the precautions section of the drug’s label the fine-print package insert rather than in the higher-profile warnings section.
“I do not know of any connection between the discussions that were going on around the labeling issue and decisions that were taken on this study,” Anstice said.
Vioxx, once a $2.5 billion-a-year blockbuster for Whitehouse Station-based Merck, was pulled from the market in September 2004 after Merck said other research showed Vioxx doubled risk of heart attacks and strokes with long-term use.
The company now faces more than 13,000 Vioxx-related lawsuits and has vowed to fight them one by one. Merck has lost three trials so far, with juries awarding multimillion-dollar verdicts in each. The company plans to appeal those losses.
In the latest Atlantic City case, plaintiff Elaine Doherty, a 68-year-old Lawrenceville homemaker, is suing Merck, blaming Vioxx for the heart attack she suffered in January 2004 after taking the drug for arthritis for 2 1/2 years.
One of her lawyers, showed the jury a letter by Merck’s head of regulatory affairs indicating the company was content with the FDA’s decision on the warning, then a memo written the next day by a Merck research scientist telling outside doctors that the heart safety trial, about to begin, was being canceled.
Her lawyer also showed jurors a series of Merck documents indicating the company set up teams to “neutralize” 36 prominent doctors who publicly voiced concerns about risks of using Vioxx or who preferred prescribing competing painkillers.
Later documents stated many of the doctors had been “neutralized” by methods such as Merck indirectly paying them for serving on advisory boards, giving favorable speeches or participating in Merck research studies.
“There were a lot of people involved in getting data to physicians” to give them a “balanced” view of Vioxx, Anstice responded; he denied any improper payments.
The jury also was shown a comical Merck training video depicting the “V Squad” Vioxx sales representatives dressed in superhero costumes learning to battle sales obstacles, meaning doctors’ concerns about the drug’s safety or preferences for prescribing other drugs.
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