Attorneys General Settle Major Prescription Drug Investigation of Vioxx Medication
Des Moines. Attorney General Tom Miller announced today that Iowa and 29 other states have obtained court orders against Merck & Co., Inc., settling a three-year investigation concerning the company’s allegedly deceptive promotion of the drug Vioxx. The Iowa Consent Judgment against Merck was signed today in Des Moines by Judge Richard G. Blane II for the Iowa District Court for Polk County.
Miller said that the case revolved around Merck’s aggressive marketing of Vioxx to consumers and health care professionals as a safe and effective treatment of pain for arthritis sufferers and failure to pull the product and cease making the claims after learning of study results concluding that taking the medication increased the risk of heart attack and other adverse cardiovascular events. Miller’s lawsuit, also filed today in Polk County District Court, alleged that for the entire time Vioxx was on the market, Merck’s advertisements and promotional activities misrepresented Vioxx’s cardiovascular safety.
Miller said the most important aspect of the settlement is that the judgment imposes strong restrictions on Merck’s ability to deceptively promote any Merck product. “The comprehensive injunctive relief obtained is outstanding and addresses all concerns identified over the last three years of investigation,” Miller said.
The judgment requires Merck to submit all “direct to consumer” television drug advertisements to the Food and Drug Administration (FDA), wait for approval and comply with FDA comments before broadcasting the advertisement. Merck must also comply with any recommendation by the FDA to delay the advertising for new Merck pain relieving drugs.
The Attorneys General expressed concerns regarding the negative effect of “direct to consumer” advertising that begins with the release of a new drug before doctors have a chance to gain experience with the drug and understand its potential side effects. “We allege Merck’s aggressive early ‘direct to consumer’ promotion of Vioxx drove hundreds of thousands of consumers to seek prescriptions of Vioxx before its risks were fully understood,” Miller said. “This action gives the FDA clear discretion and authority to make a full assessment of risks 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 of the states’ concerns about Merck's alleged past practices that are either prohibited or curtailed in the judgment include:
- deceptive use of scientific data when marketing to doctors;
- “ghost writing” of articles and studies that fail to adequately disclose the conflict of interest of Merck promotional speakers when these speakers present in supposedly “independent” Continuing Medical Education; and,
- conflicts of interest in Merck sponsored Data Safety Monitoring Boards.
In addition to strictly regulating future Merck advertising to ensure it is not misleading, the settlement was the largest monetary settlement ever in a multistate pharmaceutical case in that it requires Merck to pay the joining states $58 million. Iowa’s share of that sum is just in excess of $1.3 million and may be used by the Attorney General’s office for consumer litigation and education purposes. Miller noted that individual consumers with claims for damages from Merck relating to Vioxx were included in a nationwide private settlement and suggested consumers check Merck’s website, www.merck.com, for further details.
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