US: Merck Agrees to Settlement Over Vioxx Ads

Publisher Name: 
The New York Times

HARRISBURG, Pa. - The drug maker, Merck & Company, has agreed to pay $58 million as part of a multistate settlement of accusations that its ads for the once-popular painkiller Vioxx deceptively played down the health risks.

The agreement announced Tuesday also calls for Merck to submit all new TV commercials for its drugs to the Food and Drug Administration for review.

The
civil settlement ends investigations by 29 states and the District of
Columbia into Merck's advertising practices involving Vioxx,
Pennsylvania Attorney General Tom Corbett said.

Vioxx was taken
off the market in 2004 after research showed it doubled the risk of
heart attacks and strokes. That triggered thousands of lawsuits against
Merck, which is based in Whitehouse Station, N.J. A pending $4.85
billion settlement would end the bulk of those personal injury suits.

Thanks
to 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, Mr. Corbett said.

"Consumers need clear information
about the risks associated with prescription drugs so that they can
make well-informed decisions about their health care," Mr. Corbett said.

An F.D.A. spokeswoman did not immediately return a telephone message seeking comment Tuesday.

The
agreement calls for Merck to submit all new TV commercials for its
drugs to the agency for review and follow through with any changes the
agency recommends before airing them for seven years. Additionally, for
a 10-year period Merck must comply with any F.D.A. recommendations to
delay television advertising for newly approved pain medications.

Merck
is also prohibited from "ghostwriting," a practice in which people who
worked for the company or were otherwise connected to it allegedly
wrote positive articles and studies about Vioxx, Mr. Corbett said.

Merck is not admitting any wrongdoing under the settlement and defended its marketing of Vioxx in a statement Tuesday.

"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.

A Corbett spokesman, Kevin Harley, said the settlement does not require court approval.

Most of the settlement cost will be covered by a $55 million pretax charge that Merck said it took in the first quarter.

Pennsylvania officials could not immediately provide a breakdown of how the $58 million will be divided.

In
February, Merck agreed to pay $671 million to settle claims it
overcharged the government for Vioxx and three other popular drugs and
bribed doctors to prescribe its drugs. The announcement by federal
prosecutors was one of the biggest U.S. health care fraud settlements
ever.

In addition to Pennsylvania, the states included in
Tuesday's settlement are Arkansas, Arizona, California, Connecticut,
Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Maine, Maryland,
Massachusetts, Michigan, Nebraska, Nevada, New Jersey, North Carolina,
North Dakota, Ohio, Oregon, South Carolina, South Dakota, Tennessee,
Texas, Vermont, Washington, Wisconsin.

AMP Section Name:Pharmaceuticals
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