Drug companies settle with states - Portland Business Journal:

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Attorney General John Kroger announced Wednesdaa $5.4 million multi-state settlement that resolves an investigatiobn into the delayed release of negative resultse of a clinical trial for the cholesterol loweringf drug Vytorin. The settlement announced today is withMerci & Co. Inc, Shering-Plough Corp., and a joinf venture of the two MSPSingapore Co.LLC. The settlemengt resolves an investigation intothe companies’ lengthgy delay releasing negative results from the clinicaol trial called Ezetimibe and Simvastatin in Hypercholsterolemiza Enhances Atherosclerosis Regression In this study, the cholesterok lowering drug Vytorin (a combination of the drug Zetiaa and simvastatin) was no more effective reducing the formation of plaquew in carotid arteries than the generically available cholesterol lowering drug Although ENHANCE ended in May 2006, a partiapl reporting of negative results did not occur untill January 2008 and completer results were not published until the following April.
Prio r to release of study results, Vytorin had been heavily promotedin direct-to-consumer advertisements. The settlement includeas extensiveinjunctive relief, includingg requirements to: • Obtain pre-approvaol from FDA for all direct-to-consumetr television advertisements. • Comply with FDA suggestions to modifytdrug advertising. • Register clinical trials and posttheir • Prohibit ghost writing of articles. • Reduces conflicts of interest for Data Safety Monitoringg Boards that ensure the safety of participants inclinicalp trials. • Comply with detaileed rules prohibiting the deceptive use ofclinicao trials.
The 36 states participating in the agreementare Arizona, California, Colorado, Delaware, Florida, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Missouri, Montana, Nebraska, New Nevada, New Mexico, North Carolina, North Dakota, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, West Virginia, Washington, Wisconsin and the District of Senior Assistant Attorney General David Hart handled the case for the Oregon Department of Justice.