Merck to pay $58m in settlement over rofecoxib advertising

BMJ 2008; 336 doi: (Published 29 May 2008) Cite this as: BMJ 2008;336:1208
  1. Fred Charatan
  1. 1Florida

    Merck & Company has agreed to pay $58m (£29m; €37m) to settle allegations that advertising for its analgesic rofecoxib (Vioxx) played down potential health risks.

    The civil settlement ends investigations by 29 US states and the District of Columbia into Merck’s previous advertising practices for the drug. Tom Corbett, attorney general of Pennsylvania, said that the agreement is the largest in a multi-state consumer protection case involving drugs.

    Mr Corbett said that in 1999 Merck had launched “an aggressive and deceptive advertising campaign which misrepresented the safety and improperly concealed the increased risks associated with Vioxx.” Hundreds of thousands of consumers demanded prescriptions for the drug before doctors had a chance to understand the side effects, he added.

    “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. “This settlement addresses all of our concerns and will restrict Merck’s ability to deceptively promote any of their products.”

    The agreement requires Merck to submit all new television advertisements for its drugs to the Food and Drug Administration for review for the next seven years. The company is also prohibited from engaging in “ghost writing,” after allegations that people working for the company or otherwise connected with it wrote positive articles and papers about rofecoxib.

    “Some of these articles looked as though they were being published by an independent doctor or organisation, but they were allegedly written by people who worked for, or had some interest in, Merck,” said Mr Corbett.

    In a statement published this week Merck acknowledged that it had reached civil settlements “to resolve previously disclosed investigations under state consumer protection laws related to past activities for Vioxx.” The company said that it had “acted in good faith and that the company’s activities in support of Vioxx were intended to fully comply with relevant regulations.”

    Bruce Kuhlik, executive vice president and general counsel to Merck, said in the statement, “Merck remains committed to communications that help patients and their physicians choose medicines based on accurate, fair, and balanced information.” He added, “Today’s agreement enables Merck to put this matter behind us and focus on what Merck does best, developing new medicines.”

    Merck withdrew rofecoxib in September 2004, after studies linked it to an increased risk of heart attack and stroke. The company agreed six months ago to pay $4.9bn to settle about 26 000 lawsuits (BMJ 2008;336:580-1, 15 Mar doi: 10.1136/bmj.39513.541296.DB).

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