Merck settles case over ads for Vioxx
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HARRISBURG, Pennsylvania: Merck has agreed to pay $58 million as part of a multistate civil settlement of charges that its ads for the painkiller Vioxx deceptively played down the health risks.
The agreement, announced Tuesday, also calls for Merck to submit all new television commercials for its drugs to the U.S. Food and Drug Administration for review before they can be broadcast.
Another provision of the settlement bars the company from "ghostwriting," a practice in which academic scientists were supposedly paid to take credit for positive research articles prepared by company-hired medical writers.
The settlement ends a joint three-year investigation by 29 states and the District of Columbia into Merck's advertising for Vioxx, said Pennsylvania's attorney general, Tom Corbett.
Vioxx was taken off the market in 2004 after research showed that it doubled the risk of heart attacks and strokes. Then thousands of lawsuits were filed against Merck, which is based in Whitehouse Station, New Jersey. A pending $4.85 billion settlement would end the bulk of those lawsuits.
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Because of aggressive marketing through direct-to-consumer television ads begun in 1999, hundreds of thousands of consumers demanded Vioxx prescriptions before doctors had a chance to understand the side effects, Corbett said.
The drug agency does not require drug companies to submit advertisements for advance approval except in cases where it has pursued enforcement actions over false and misleading claims, said an agency spokeswoman, Rita Chappelle.
Merck is required to submit all new TV commercials for its drugs to the agency for review and follow through with any changes that the agency recommends before broadcasting them for seven years.
For a 10-year period Merck must also comply with any agency recommendations to delay television advertising for newly approved pain medications.
Two studies published in April in The Journal of the American Medical Association mentioned supposed ghostwriting by Merck and contended that the company tried to minimize deaths in two studies that showed that Vioxx did not work at treating or preventing Alzheimer's disease.
Merck called the reports biased because five writers of the articles were paid consultants for people who sued Merck over Vioxx's heart and stroke risks, and a sixth testified about Merck and Vioxx's heart risks before a Senate committee.
In a statement issued Tuesday, Merck did not admit any wrongdoing under the settlement and defended its marketing of Vioxx. "Today's agreement enables Merck to put this matter behind us and focus on what Merck does best, developing new medicines," said Bruce Kuhlik, Merck's executive vice president and general counsel.
The settlement does not require approval by any court, said Corbett's spokesman, Kevin Harley.
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