Merck’s $58M settlement puts clamp on ads

HARRISBURG, Pa. – Drugmaker Merck & Co. last week agreed to a $58 million settlement with the District of Columbia and 29 states, including Massachusetts and Connecticut but not Rhode Island, to end investigations into whether the company knowingly downplayed the risks of Vioxx in direct-to-consumer ads for years.
Merck voluntarily withdrew Vioxx, a painkiller known as a Cox-2 inhibitor, in 2004 after published studies linked it to a doubled risk of heart attack and stroke. The company last year agreed to a $4.85 billion settlement, which is still pending, to end most of a slew of lawsuits from consumers.
More than 25,000 lawsuits have been filed against Merck in connection with the drug, which was aggressively marketed directly to consumers, leading to hundreds of thousands of prescriptions.
One of the most troubling aspects of the Vioxx case, however, in many people’s view is that the cardiovascular risk associated with the drug had been known to some extent for years. The states’ investigation focused on whether Merck had deceptively downplayed the risks in ads going back to 1999.
As part of the settlement, which was announced by Pennsylvania Attorney General Tom Corbett, Merck agreed to submit new TV commercials for its drugs to the U.S. Food and Drug Administration for review, and to comply with any FDA recommendations for 10 years to delay TV ads for newly approved pain medications.
“Consumers need clear information about the risks associated with prescription drugs so that they can make well-informed decisions about their health care,” Corbett said in a news release. “This settlement addresses all of our concerns and will restrict Merck’s ability to deceptively promote any of their products.”
Also as part of the settlement, Merck agreed to end a practice known as “medical ghostwriting,” in which Merck staff and people associated with the company wrote articles about the company’s drugs that were then published in journals under the names of doctors and scientists.
Last April, the Journal of the American Medical Association published a report showing that 16 of 20 early studies of Vioxx had listed the lead author as an academic researcher even though internal documents showed a Merck employee had been the author of the first draft.
“Ghostwriting can be a particularly deceptive practice,” Corbett said. “Some of these articles looked as though they were being published by an independent doctor or organization, but they were allegedly written by people who worked for, or had some sort of interest, in Merck.”
The settlement also requires Merck to refrain from using scientific data deceptively when marketing to doctors.
Merck did not admit any wrongdoing under the settlement and defended its marketing of Vioxx in a statement.
“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.
Most of the settlement cost will be covered by a $55 million pretax charge that Merck said it took in the first quarter. The money will be paid to the states, but Pennsylvania officials last week did not immediately say how the payout would be broken down.
Along with Pennsylvania, Connecticut and Massachusetts, the settlement includes Arkansas, Arizona, California, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Maine, Maryland, Michigan, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Vermont, Washington, Wisconsin and the District of Columbia.