Merck to Pay $58 Million In Settlement for Vioxx Ads

Merck agreed to pay $58 million as part of a multistate settlement of allegations that its ads for the painkiller Vioxx deceptively played down the health risks.

The agreement announced yesterday also calls for Merck to submit all new TV commercials for its drugs to the Food and Drug Administration for review before they can be aired.

Another provision of the settlement bars the company from "ghostwriting," a practice in which scientists are paid to take credit for positive research articles prepared by company-hired medical writers.

The civil settlement ends a joint three-year investigation by 29 states and the District into Merck's advertising practices involving Vioxx, Pennsylvania Attorney General Tom Corbett said.

Vioxx was taken off the market in 2004 after research showed that it doubled the risk of heart attacks and strokes. That triggered thousands of lawsuits against Merck. A pending $4.85 billion settlement would end most of those claims.

Because of aggressive marketing that began in 1999, hundreds of thousands of consumers demanded Vioxx prescriptions before doctors had a chance to understand the side effects, Corbett said.

The FDA does not require drug companies to submit advertisements for approval except in cases in which it has pursued enforcement actions over false and misleading claims, agency spokeswoman Rita Chappelle said.

For a seven-year period, Merck agreed to submit all new TV ads for its drugs to the FDA for review and to follow through with any changes the agency recommends before airing them. Additionally, for a 10-year period, Merck must comply with any FDA recommendations to delay television commercials for newly approved pain medications.

Two studies published in April in the Journal of the American Medical Association mentioned alleged ghostwriting by Merck and contended that the company tried to minimize deaths in two studies that showed Vioxx didn't 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 panel.

Merck is not admitting 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 general counsel.