MCDANIEL ANNOUNCES MERCK SETTLEMENT RESOLVING A THREE-YEAR INVESTIGATION INTO THE COMPANYS MARKETING OF VIOXX

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May 20, 2008

Arkansas and 29 other states share in $58 million settlement

LITTLE ROCK-Attorney General Dustin McDaniel today announced that his office, along with 29 other states, reached a settlement with Merck and Company, Inc. resolving a three-year investigation by 30 states concerning the company's deceptive promotion of the "Cox-2" drug Vioxx. COX-2 drugs like Vioxx are a type of non-steroidal anti-inflammatory drug (NSAID) that acts to relieve pain and inflammation. In addition to a $58 million payment to the participating states, the judgment filed in the Pulaski Circuit Court will restrict Merck's ability to deceptively promote any Merck product. Arkansas's share of the settlement is $1,283,974.90.
"In addition to the monetary recovery, the significant injunctive relief addresses the problems we uncovered during the last three years of investigation," McDaniel said.
Today's judgment requires Merck to submit all "direct to consumer" (DTC) television drug advertisements to the Food and Drug Administration (FDA), wait for approval and comply with FDA comments before running the advertisement. Merck must also comply with any recommendation by the FDA to delay DTC advertising for new Merck pain relieving drugs. The State Attorneys General expressed concerns regarding the negative effect of DTC advertising that commences immediately with the release of a new drug before doctors have a chance to gain experience with the drug and understand its potential side effects.
"Merck's aggressive early DTC promotion of Vioxx drove many consumers to seek prescriptions before Vioxx's risks were fully understood," AG McDaniel said. "This action gives the FDA clear discretion and authority to make just such an assessment on all new Merck pain drugs and requires Merck to submit television ads to the FDA for suggested revisions and acceptance of the final product before running the ads."
Other business practices that will be restricted by the settlement include the following:
• Merck's deceptive use of scientific data when marketing to doctors;
• "Ghost writing" of articles and studies. These occur when Merck authors an article or study but professionally credits it to a medical doctor;
•  Failing to adequately disclose the conflicts of interest of Merck's promotional speakers when those speakers make presentations in supposedly "independent" Continuing Medical Education seminars or other educational events; and
• Conflicts of interest in Merck sponsored Data Safety Monitoring Boards which purport to provide oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data.

Consumers wanting more information about this settlement may call the Office of the Attorney General, Consumer Protection Division at (501) 682-2007.
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