Back when Merck and Schering-Plough finally released the results of their star-crossed cholesterol drug study Enhance in early 2008, industry observers wondered just how much the companies themselves knew about the study data. Had company officials held off on publicizing the data because they knew it wouldn't favor the partnership's pricey drug Vytorin? Both companies denied any foreknowledge, saying the data remained blinded until just before its release.
But some insiders claimed--anonymously--that word on Enhance had leaked out. And now, a lawsuit filed by pension-plan investors has been amended with more detailed allegations that execs at that company knew something was up. Preliminary checks of data from early study enrollees in late 2005 indicated that an outcome favorable to Vytorin would be tough to get, the suit alleges. A company informant--called "CW 1" in the suit--updated Schering Vytorin/Zetia brand team daily, and said that those marketing folks knew by Summer 2006 that Enhance wouldn't be good.
Meanwhile, though, Schering officials were still touting their meds, saying "the science" favored them, the suit claims. And that well-known food-and-family ad campaign for Vytorin continued apace. The suit alleges that those who invested in Schering stock were relying on the company's positive statements about Vytorin, knowing how important the cholesterol franchise was to the drugmaker. All that time, the suit claims, the stock was artificially inflated, and investors suffered from the executives' dishonesty.
Schering hasn't filed a response to the new allegations yet. But the company has denied any wrongdoing in previous court filings. We'll see how they answer this latest round.