Heart docs pan Vytorin
Vytorin and Zetia risk being relegated to second- or third-line therapies after taking a drubbing at last weekend's annual meeting of the American College of Cardiology.
Merck and Schering-Plough had pinned their hopes for a turnaround in perceptions of the drug on the conference, where they felt a reasoned discussion of the full results of the Enhance trial might mitigate the damage done. But analysts and attendees saw little of note that was new in the full results, published in the New England Journal of Medicine, and panelists slammed the combo drug.
Saturday featured a discussion of the Enhance results by Cleveland Clinic's Dr. Steven Nissen and Duke's Dr. Robert Califf. “The Saturday discussion by Nissen was expected,” wrote Bernstein analyst Tim Anderson in a note, “negative on Vytorin, which was in line with his original position. Dr. Califf tried to offer at least some degree of balance, but Nissen stole the show.” A panel discussion on the results the following day “was a mess, to put it bluntly,” said Anderson, applying scare quotes to the term “panel.” “It was essentially not a panel discussion at all, but rather a monologue by Dr. Harlan Krumholz, who was very negative on Vytorin. The other panelists did not speak.”
To top it all off, the New England Journal of Medicine issued an editorial calling the results “a red flag but not a black box,” nonetheless urging physicians to first try statins plus niacin and fibrates, then try Zetia in patients for whom that doesn't work.
"We were surprised that the scientific forum that we were waiting for didn't occur," Schering-Plough CEO Fred Hassan told the Wall Street Journal, adding that "the panel was selected based on some credentials that we don't understand, and secondly, the way the panel proceeded was something that we would not call a scientific forum. ... It was basically a statement and basically there was no participation by the audience."
Hassan told the Journal that while Schering-Plough has no immediate plans for a shakeup in response to the drugs' travails, "If revenues are going to be permanently impaired, then we would need to size the company to line up with that size."