How many and from which offices? The filing with the Securities and Exchange Commission doesn’t specify. We asked a Schering-Plough spokeswoman for clarity, but until we receive a reply, we are left to wonder whether this involves a securities matter, healthcare reimbursement or, perhaps, both.
To an extent, this is not surprising. As Schering-Plough notes in [...]

Last Friday, Genzyme and Isis Pharmaceuticals disclosed that the FDA wants them to gather more data in order to win approval for a novel cholesterol drug. Specifically, the agency indicated that lowering cholesterol is an “acceptable surrogate endpoint” for using their mipomersen in patients with a rare, inherited form of high cholesterol. But an outcomes trial [...]

Wondering just what managed care and pharmacy benefit managers may be thinking about Vytorin and Zetia? A survey of 71 execs taken during the week immediately following the American College of Cardiology meeting finds that 67 percent felt there would be “no immediate change” to their coverage plans, according to Cognet-X, a healthcare research firm.
The [...]

The line is growing ever longer. First, the House Energy and Commerce Committee and the Senate Finance Committee opened investigations into the controversial Vytorin trial, known as Enhance. Then, the New York and Connecticut Attorneys General begin their own probes into the handling of study data and the marketing of the expensive cholesterol med. Earlier [...]

So says Jim Stein, the University of Wisconsin cardiology professor who participated in an expert panel convened last year to examine the infamous Enhance trial data. Stein was the expert whose review of a hastily composed summary of the meeting last November was released last Friday by the House Energy and Commerce Committee (look here). [...]

On January 22, Schering-Plough and Merck announced they would briefly suspend Vytorin ads after the uproar over the disclosure the previous week of the Enhance trial. A spokesman blamed “mischaracterization and misinterpretation” of the study results, which found Vytorin failed to show any benefit over the much cheaper Zocor in reducing plaque in the carotid [...]

Here’s another nugget from the leaked Vytorin documents released today by the House Energy and Commerce Committee. Last September 14, John Kastelein, the primary investigator for the infamous Enhance trial, writes an e-mail to Soren Christiansen, the general manager for the endocrine franchise at Merck, which jointly markets Vytorin with Schering-Plough. Kastelein is upset that [...]

Last November 16, an expert panel meeting was held at the Omni Shoreham Hotel in Washington, DC, to review the results of the infamous Enhance trial that was designed to boost the prospects of the Vytorin cholesterol pill jointly marketed by Schering-Plough and Merck. The panel consisted of five outside experts and 11 employees of [...]

Not us. A survey of 101 primary care docs conducted by Deutsche Bank analyst Barbara Ryan has predictably bad news for Schering-Plough and Merck - the results suggest “both additional abrupt and sustained declines for Vytorin and Zetia, and increased utilization of other statins, especially Crestor,” she writes in an investor note this morning. [...]

So you thought there was no true panel discussion about the famous Enhance trial at the American College of Cardiology? Well, you were wrong. Peeved that Yale University’s Harlan Krumholz dominated the official session held to review the study, Schering-Plough and Merck did the next best thing - they hosted their own. And it featured [...]