Merck To Pay $58 Million in Vioxx Settlement

Drug maker Merck & Co. Inc., will pay $58 million to Massachusetts, 28 other states, and the District of Columbia, to settle lawsuits that claim Merck allegedly used deceptive marketing to promote its popular painkiller <"">Vioxx.  Merck employs over 150 people at a research facility in Boston’s Longwood area.

Vioxx is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) and works by reducing substances that cause inflammation, pain, and fever.  A three-year study aimed at showing that Vioxx—at a 25 milligram dose—prevents recurrence of polyps in the colon and rectum was ceased when Merck discovered a higher heart risk compared to patients taking placebos.  Prior to the Vioxx withdrawal, the Food and Drug Administration (FDA) announced that patients taking Vioxx had a 50 percent greater chance of heart attack and sudden cardiac death and patients taking the highest recommended daily dosage of Vioxx had three times the risk of heart attack and sudden cardiac death as those not taking standard painkillers.  Merck pulled Vioxx from the market on September 30, 2004 after acknowledging that Vioxx could significantly increase the risk of heart attacks.

After a few years of litigation, a comprehensive settlement was proposed in November.  Under the settlement plan, Merck agreed to compensate plaintiffs who can show, under certain conditions, that taking the drug was connected to their having suffered a heart attack or stroke.

Massachusetts Attorney General Martha Coakley called the settlement the “largest consumer protection settlement to date” regarding the promotion of a prescription drug.   Coakley said under the settlement, Massachusetts will receive $1.64 million of the overall payment.  Of that amount, $500,000 goes to the Attorney General’s Local Consumer Aid Fund and $1 million goes into a fund to help low-income, disabled, or elderly consumers who take prescription drugs or to educate consumers about drug price differences.  The remainder pays for legal costs and attorneys fees.

The consent judgment against Merck, filed in Suffolk Superior Court, prevents New Jersey-based Merck from misleading consumers in future advertising and mandates full disclosure of all known risks of Merck drugs.  The judgment bans the deceptive use of scientific data when marketing doctors and “ghost writing” articles and studies and addresses conflict of interest issues.  Also, Merck must obtain FDA approval for direct to consumer television drug advertisements and must comply with regulatory recommendations if the FDA calls for a delay in such advertising.  In 2000, Merck spent $160.8 million on direct to consumer Vioxx marketing.

In a statement released by Merck, its general counsel said Merck “remains committed to communications that help patients and their physicians choose medicines based on accurate, fair, and balanced information.  Today’s agreement enables Merck to put this matter behind us and focus on what Merck does best, developing new medicines.”

In April, two reports published in the Journal of the American Medical Association (JAMA) found that two Merck-funded studies investigating the benefits of Vioxx for Alzheimer’s disease patients had minimized death rates for people taking the now-recalled drug.  The reports also revealed that Merck hired outside firms to write Vioxx studies, paying prominent researchers to list their names as authors of the research.

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