Congress: M/S-P sat on bad news

The Vytorin onslaught continues, with Congressional committees circling and secret emails surfacing. And Merck and Schering-Plough, looking to minimize the damage, are criticizing the American College of Cardiology panel convened to discuss the controversial Enhance study and readying a sales-and-marketing push to counteract the negative publicity [1].

First, Congress. The Senate Finance Committee and House Energy and Commerce Committee have been on the Vytorin/Zetia case for months [2], probing everything from the reasons behind the delay in presenting study results to the DTC marketing that went on while the Enhance data was under review. Now, the Senate is asking for more information on the study's delay. And Sen. Charles Grassley has released evidence that the companies might have known long ago [3]that Vytorin wasn't any more effective than Zocor alone, but kept mum to avoid deflating sales. Among that evidence: Emails from the study's lead investigator John Kastelein, who was left out of the loop when Merck and Schering Plough considered changing the study's primary endpoint. "[T]his starts smelling like extending the publication for no other (than) political reasons," one message read. Another said, "You will be seen as a company that tries to hide something and I will be perceived as being in bed with you!"

Schering says those emails were taken out of context and that Kastelein's complaints were resolved long ago. Merck says the study was delayed because of difficulties interpreting complex data. But the House committee has cited evidence from an Internet site where sales reps posted back in March 2007 that "the study is a bust."

Meanwhile, Merck and Schering-Plough are doing damage control as they watch their stocks drop, 15 percent in Merck's case and 26 percent in Schering's. Among their strategies: a letter for doctors that presents the companies' view of Enhance, covering a copy of the entire study. "Our sales force and medical-affairs group have been well prepared about what this study is and how to talk about it." The companies also plan to aggressively defend Vytorin and Zetia to managed care plans and pharmacy benefits managers--and are considering when and whether to resume DTC ads.

- see Senate Finance's press release [4], including Grassley's letters (.pdf)
- read the Washington Post story [5]
- check out the NYT's coverage [6] of Congressional accusations
- get more on the emails [7] from the WSJ Health Blog
- see Merck and Schering's defensive plans [8] in the WSJ
- find more [9] on Grassley's letters, also in the WSJ

ALSO: Silver lining in the Enhance cloud? Maybe, for Merck's awaiting-approval cholesterol med Cordaptive and Abbott Laboratories' niacin-based meds Niaspan and SimCor and fibrate TriCor. Niacins and fibrates were both recommended by the New England Journal of Medicine as backups for when first-line statins have failed. The NEJM said Vytorin and Zetia should be last resorts. Report [10] | Report [11]

Related Articles:
ACC panel unleashes Vytorin whirlwind. Report [1]
Companies saw Vytorin threat in 2005. Report [3]
Congress: Were Enhance results secret? Report [2]
Congress promises Vytorin hearings. Report [12]
Merck, Schering defend embattled Vytorin. Report [13]
Merck, Schering's Vytorin fails trial. Report [14]