Maybe before the American College of Cardiology meeting in late March?
The bottom-line results, of course, were released on Jan. 14, and set off a firestorm - the pricey cholesterol med failed to show any benefit over the much cheaper Zocor in reducing plaque in the carotid artery, and even showed a statistically insignificant buildup, even though the pill did a better job of lowering LDL. Then there was the way Schering-Plough and Merck, which jointly market Vytorin, handled the trial.
The results of the study, known as Enhance, were delayed nearly two years; the primary endpoint was briefly changed without consulting the lead investigator, and an independent panel tapped to review the data wasn't really independent - three members have financial ties to the drugmakers but nobody knew this because the drugmakers refused to reveal their names. Then came allegations of insider stock sales by Schering-Plough execs.
Since last month, prescriptions for Vytorin and Zetia (which along with Zocor comprises the Vytorin combo pill) have plunged. The drugmakers, therefore, would love to get the full data out there lickety-split to give their sales reps ammunition for influencing docs. Last week, Merck ceo Dick Clark suggested during a teleconference with analysts that this is possible: "We're working with the lead investigator who will submit the enhanced study for publication and make sure that is done as soon as we can, and so that is being certainly studied," he said. (see page 13).
As Larry Biegelsen, a Wachovia Securities analyst, notes, the American College of Cardiology hasn't listed the Enhance study among its late-breakers during its upcoming annual meeting, most likely because the drugmakers already released some info. For this reason, Sanford Bernstein analyst Tim Anderson thinks a plenary session will be held instead. "I do think they want a wide venue at ACC in any event," he tells us. "They really need to get full results out ASAP so that they can address some of the concerns in the marketplace."
A Merck spokeswoman would only say that "it would be inappropriate to draw conclusions or speculate about a specific publication date. We still intend to present the data at ACC." A Schering-Plough spokesman suggested we contact the lead investigator, John Kastelein, who declined comment.
1 Comment
Don't count on ENHANCE appearing in print anytime soon. If the results of the study were positive, there would have been a rush to publish. Given the failure of the study, we may see it appear by the end of 2008. Even that may be stertching it. There will be innumerable post-hoc analyses in an attempt to "weave a silk purse out of a sow's ear." As we have seen noted many times in the past several weeks, Big Pharma hates the idea of publishing negative studies!