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Merck exec testifies about battle over Vioxx warning label
Tuesday, September 27, 2005
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ATLANTIC CITY, N.J. -- Fearing a warning about Vioxx's cardiac risks would hurt the painkiller's sales, Merck & Co. battled with federal regulators for two years to keep the information out of the "warnings" section of the package insert, the company's top marketing official testified Monday.

Under questioning by plaintiff's attorney Chris Seeger, David W. Anstice acknowledged Merck forecast a $500 million drop in sales for the $2.5 billion-a-year blockbuster drug if Merck lost its bid to instead put information about heart attack risks in the insert's less-urgent "precautions" section.
It was during those negotiations between Merck and the U.S. Food and Drug Administration that Frederick "Mike" Humeston suffered a heart attack, two months after he began taking Vioxx, said Seeger.

Merck prevailed on the label issue, but withdrew the drug from the market last September.
Humeston, 60, a postal worker in Boise, Idaho, is suing Merck in the second product liability trial over Vioxx, which he blames for his Sept. 18, 2001, heart attack. Merck, which is facing 5,000 such lawsuits, says the painkiller wasn't to blame.

Anstice, who headed Merck's business division during Vioxx's development and sale, spent a third day on the witness stand Monday. Humeston's lawyers have been grilling him about Merck's marketing and promotion of Vioxx amid signs it could cause heart attacks and strokes in some users.
A patient study in 2000 showed Vioxx users suffered five times as many heart attacks as those taking the older, cheaper painkiller naproxen. Anstice testified that Merck asked the FDA to put that risk information in the "clinical studies" and "precautions" sections of the detailed package insert, or label, not in the more-serious "warnings" section.

In the meantime, Merck stuck to its policy of not letting its sales representatives talk to physicians about any potential risks not yet listed on the Vioxx label, Anstice said.

Seeger said if Merck was concerned about the safety of Vioxx users, salespeople could have been told to discuss the study.

Seeger again showed jurors e-mail messages written by Edward Scolnick, Merck's former head research scientist, in which Scolnick ripped the FDA's proposed label as "ugly" and called FDA officials "bastards."

Scolnick, who testified earlier in the trial that he had lingering fears about Vioxx's safety, told Merck colleagues in a Feb. 25, 2002, e-mail it would be a miracle if FDA agreed to put the warning in the "precautions" section.

"To all: If you get this label, it will be an Al Michaels quote: Do you believe in miracles?" Scolnick wrote, alluding to the sportcaster's call when the U.S. hockey team defeated the Soviet Union in the 1980 Olympics.

Humeston's lawyers are expected to wrap up their case this week, after which Merck is to present its witnesses to the seven-woman, three-man jury. Humeston is expected to testify.

The trial comes after a Texas jury awarded $253 million to the widow of a Vioxx user. That amount will be slashed because of Texas law limiting punitive damages.

On the Net: http://www.merck.com
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