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"Informant" Names Schering Execs Who Allegedly Knew Vytorin/Enhance Trial Was a Bust, Suit Claims

By Jim Edwards | Oct 12, 2009

An amended lawsuit filed over the Schering-Plough pension plan alleges that executives at the company suspected as early as 2005 that the “Enhance” Vytorin trial was a bust. Citing a “confidential informant,” it also names names.

The company did not reveal the full results — which showed that Vytorin had no effect on reducing blocked arteries — thus leaving SGP’s stock price artificially inflated. The pension plan suffered as a result when the results came out in 2008, and SGP fell 55 percent from its 2007 high. The suit states:

Defendants had intimate knowledge of, or an active role in, improper business activities that allowed Schering-Plough to artificially inflate and manipulate the Company’s earnings.

The amended complaint, filed Oct. 1, 2009, rehashes all the claims about anonymous CafePharma commenters correctly predicting that Enhance was a dud. But it adds a tantalizing new ingredient: A “confidential informant” who has told lawyers in a related securities action who knew what and when inside Schering. The informant is one of “Schering-Plough’s senior medical personnel”:

According to that confidential source, even though the ENHANCE trial was purportedly blinded, updates regarding the trial were shared in quarterly meetings of Schering-Plough’s Brand Team (the “Brand Team”), that included Sean McNicholas, Ray Russo (“Russo”), Michael McCann, Michael Matin, Eric Cox, Steven Morales and Denise Foy.

… Further, according to that confidential source, by the Spring or Summer of 2006, it was clear that the results of the ENHANCE trial would be problematic for the Company.

Still further, according to that confidential source, the individuals at Schering-Plough who were familiar with the Company’s cholesterol franchise (including Defendants [CEO Fred] Hassan and [CFO Robert] Bertolini who were regularly briefed on the details of the ENHANCE trial) were aware of this information.

Schering’s principle investigator had suspected since 2005 that the drug would show no benefit, the suit also claims. An extended discussion can be found at Shearlings Got Plowed. Schering has yet to respond to the new complaint. More generally, it denies the allegations.

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

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