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Ex-Merck researcher's e-mails show Vioxx concerns

Posted on: Wednesday, 21 September 2005, 13:56 CDT

By Jon Hurdle

ATLANTIC CITY, New Jersey (Reuters) - The former head of research at Merck & Co Inc. expressed concerns five years ago about the safety of the company's painkiller Vioxx, according to video testimony played for jurors on Wednesday.

In a video deposition, ex-Merck research chief Edward Scolnick was asked by a lawyer for plaintiff Frederick Humeston, a Vioxx user who blames the painkiller for his 2001 heart attack, about e-mails he wrote confessing his concerns about the drug's safety.

"My worry quotient is high," he wrote in an April 2000 e-mail. "I am actually in minor agony."

But Scolnick later promised colleagues he would not agree to a U.S. Food and Drug Administration warning label about cardiovascular risks related to Vioxx.

"I assure you that I will not sign off on any label that had a cardiac warning," Scolnick wrote in a November 2001 e-mail.

Humeston's lawyers, who contend the company hid the heart attack risks linked to the popular painkiller, displayed the e-mails to jurors on a screen in the Atlantic City courtroom.

In the first Vioxx trial in Texas this summer, e-mails from Scolnick were considered a key factor in the jury's decision to find Merck liable in the death of a man who had taken the painkiller.

Whitehouse Station, New Jersey-based Merck pulled the drug from the market in September 2004 after its own research showed increased risk of heart attack and stroke in some patients who took it for at least 18 months. The company, which says it acted responsibly by withdrawing the drug, faces about 5,000 Vioxx lawsuits and has vowed to fight them one by one.

Scolnick, in his deposition played for jurors on Wednesday, said he had initial doubts about the safety of Vioxx and wanted to conduct a larger trial than had previously been done, but later concluded that the drug was safe.

A trial covering 8,000 people whose results were published in March 2003 found that 20 out of 4,000 patients taking Vioxx suffered heart attacks, compared with 4 out of 4,000 who were taking naproxen, another painkiller.

Scolnick also described his anger when the FDA sought to warn Vioxx users that the drug carried heart attack risks.

Scolnick said the FDA's proposal was "ugly cubed" and that he told senior colleagues at Merck he would fight the agency's plan. In an e-mail, he called personnel at the FDA division that evaluates the safety of drugs "grade D high school students."

He proposed that Merck take a confrontational approach to the FDA.

"I have never seen being nice to the FDA, except on rare occasions, pay off," he wrote in another e-mail.

Scolnick's video deposition lasted about two hours. In his testimony, he said he regretted the language he had used to attack the FDA's proposal, but that he had been in an emotional state at the time.

Source: REUTERS

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