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Maine and 30 Other States Share $58 Million in a Record Breaking Settlement with Merck Pharmaceutical Resolving a Three Year Investigation
May 20, 2008
Attorney General Steven Rowe today filed a stipulated judgment with Merck and Company, Inc. resolving a three-year investigation by 30 states concerning the company's deceptive promotion of the anti-inflammatory "Cox-2" drug Vioxx. In addition to a $58 million payment to the participating states, with Maine's share being $1.1 million the judgment filed in the Kennebec County Superior Court will restrict Merck's ability to deceptively promote other Merck products.
"This is the largest money settlement that states have received in a consumer protection case against a pharmaceutical company. We are pleased with the monetary amount of the settlement as well as with the advertising restrictions that Merck has agreed to," Attorney General Rowe 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 FDA to delay DTC advertising for new Merck pain relieving drugs. The states’ 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.
For example, prior to Merck's withdrawal of Vioxx from the market in 2004 (following release of a study that found a higher rate of heart attacks and strokes in patients taking the drug than in those on a placebo), the drug had been aggressively marketed in more than 80 countries worldwide. The drug had been marketed with DTC ads featuring personalities such as Olympic gold medalists Dorothy Hamill and Bruce Jenner.
"Merck's aggressive and deceptive 'direct-to-consumer' promotion of Vioxx drove hundreds of thousands of consumers to seek prescriptions before the product's risks were fully understood," Attorney General Rowe said. "This settlement requires Merck to submit television advertisements for its new pain drugs to the FDA and to modify them consistent with FDA comments before running the ads."
Other concerns of the states are either prohibited or curtailed in the judgment including:
- deceptive use of scientific data when marketing to doctors,
- "ghost writing" of articles and studies
- failing to adequately disclose the conflict of interest of Merck promotional speakers when these speakers present in supposedly "independent" Continuing Medical Education
- Conflicts of interest in Merck sponsored Data Safety Monitoring Boards
The following form is available for download in PDF format. You will need the free Adobe Reader to view and print.
Download the Complaint and Consent Judgment (PDF)
May 20, 2008 David Loughran, (207) 626-8577