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Vytorin in Connecticut Crosshairs

Jan 29, 2008 | Parker Waichman LLP Connecticut can now be added to the list of states investigating Vytorin.  According to The Wall Street Journal, Connecticut Attorney General Richard Blumenthal announced that his office investigating Merck  and Schering-Plough   for claims the companies made about Vytorin.  Over the weekend, New York State Attorney General Andrew Cuomo announced a similar Vytorin investigation, and several congressional committees are also investigating the drug makers.  Vytorin has been under intense scrutiny since a study, known as ENHANCE, was released earlier this month showing  the cholesterol lowering drug was no more effective at preventing clogged arteries than a cheaper, generically available statin.  

Vytorin is a combination of cholesterol lowering Zetia and the statin Zocor.   The point of the ENHANCE study was to determine how well Vytorin prevented clogged arteries by reducing the formation of plaque.  ENHANCE focused on a group of 720 patients with a rare condition predisposing them to high cholesterol. The patients were given either Vytorin or a high dose of simvastatin, the generic form of Zocor.   Vytorin did not provide any significant benefit versus the statin drug Zocor in slowing down clogging of the arteries.  Overall, the study failed to meet its primary goal, which was to show whether Vytorin was more effective than Zocor alone in preventing progression of atherosclerosis in the carotid artery, which is in the neck.

The ENHANCE study was supposed to have been released by Merck & Schering-Plough in November 2006, but that was delayed by the companies until March 2007. Then Merck and Schering-Plough announced the release of ENHANCE would be delayed again until March 2008. The drug makers also announced that they would be changing the ENHANCE study’s endpoint – the main medical result the study was meant to measure. It is generally accepted that for a clinical trial to be effective, a study’s endpoint must be set at its beginning and remain unchanged. In December 2007, in response to the ENHANCE delays and the attempt by Merck and Schering-Plough to change the endpoint, Congress initiated an investigation of the ENHANCE study.

According to the Wall Street Journal, the Connecticut Attorney General is investigating Merck and Schering-Plough to see if “state funds were spent on false assurances about the safety and effectiveness of”  Vytorin and Zetia.  Blumenthal said Connecticut’s Medicaid program was the main public source of money spent on the medications.

The Wall Street Journal was told by a Merck spokesperson that the company hadn't been notified of an investigation by Connecticut but will cooperate.  "We stand by the safety and efficacy profiles of both Zetia and Vytorin," the spokesperson said. "We acted with integrity and good faith in connection with the clinical trial."

Many Vytorin users apparently disagree with Merck’s assertion that it acted in “good faith” in regards to Vytorin.  At least five class action lawsuits have been filed against Merck and Schering-Plough since the ENHANCE results made news, with many of them asserting that the companies’ decision to delay its release for nearly two years was an act of fraud.

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