Lawsuit Claims Execs Knew Vytorin Study Wouldn’t Be Favorable

A lawsuit alleges that marketing executives at Schering-Plough, one of the makers of <"">Vytorin, knew long before it was released that the ENHANCE study would not be favorable.

Vytorin is a combination of Zetia and the statin Zocor that is marketed jointly by Merck & Co. and Schering-Plough. It has been under the microscope since the ENHANCE study was released, showing it was no better at preventing clogged arteries than a cheaper statin. ENHANCE raised serious questions about the effectiveness of both Vytorin and Zetia.

The ENHANCE debacle spawned scores of lawsuits against Merck and Schering-Plough. Many accused the companies of marketing Vytorin and Zetia in a misleading fashion and failing to disclose the results of ENHANCE in a timely manner. In August, the drug makers agreed to pay $41.5 million to settle class-action lawsuits filed by consumers who used Vytorin and Zetia.

Rumors have swirled ever since the ENHANCE release that Merck and Schering-Plough had known that the study would be disappointing long before the release. For example, in February 2008, we reported that Congressional investigators were looking into some incriminating comments posted on by anonymous pharmaceutical sales reps that indicated prior knowledge of the ENHANCE findings. The author of one March 2007 comment claimed to have a “buddy” at Schering-Plough. “He says that the study is a bust,” the post stated. Another post in 2007 stated, “Heard it crashed and burned!” A third, detailed post about the study stated, “Adding Zetia to high dose generic statin provides no real benefit.”

Now, Fierce Pharma is reporting that a lawsuit filed on behalf of pension plan investors has been amended to include more detailed allegations that Schering-Plough executives had prior knowledge of ENHANCE. The lawsuit claims to name those executives.

According to the complaint, a “confidential informant” claims that named members of Schering-Plough’s “Brand Team” charged with marketing Vytorin received regular updates about ENHANCE, though the study was supposed to be blinded. The lawsuit also states that the drug maker’s principle investigator suspected that Vytorin would show no benefit as early as 2005, and claims that the marketing team knew by 2006 that ENHANCE would not be favorable. Despite this, Schering-Plough continued to promote Vytorin’s supposed benefits in its marketing campaign.

The lawsuit claims that withholding the ENHANCE results artificially inflated Schering-Plough’s stock price, and that investors depended on the firm’s positive statements about Vytorin. Investors suffered when ENHANCE was finally published in 2008, and Schering-Plough’s stock fell 55 percent from its high in 2007.

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