November 2 Update: CardioBrief has learned from a reliable source that ARBITER-6 and accompanying editorials will in fact be published in the New England Journal of Medicine.
October 29: Wall Street analysts, in a growing chorus, are confidently predicting that niacin will enjoy a decisive victory over ezetimibe in ARBITER 6, the much discussed trial headed by Allen Taylor that is scheduled to be presented next month at the AHA.
In addition, one analyst, Tim Anderson of Sanford Bernstein, said that he expects the trial to be published concurrently in “a major medical journal” along with– note the plural form– “some interesting editorials.”
In addition, the CNBC pharmaceuticals reporter, Mike Huckman, wrote in his blog that Anderson says the journal will be the New England Journal of Medicine and “one of the opinion pieces will be ‘pretty scathing by a well-known critic.’ Any guesses? Hmm, lemme think.” To state what others are whispering and hinting, Huckman and Anderson appear to be referring to Steve Nissen.
All the Wall Street analysts admit they are working on sheer speculation regarding the trial results, but their confidence is stunning. The analysts have hired statisticians and other consultants in an attempt to foresee the outcome. The Cowen analyst writes that “a Zetia victory appears unfathomable.” Larry Biegelsen, the Wells Fargo analyst, speculates that the trial may show “a regression in plaque with Niaspan and a progression in plaque with Zetia.”
Anderson goes one step further and raises the possibility that “there may have been an imbalance in events between the two arms of ARBITER 6, meaning more heart attacks and other adverse cardiovascular outcomes in the Zetia arm compared to the Niaspan arm. While the numbers would likely be small and non-statistically significant, this would be a damaging finding nonetheless.” Anderson speculates that the outcome may prompt some critics to “go so far as to call for Zetia/Vytorin to be removed from the market (recall that this happened in 2008).”
Despite his dour view of ARBITER 6 and its likely outcome, Anderson writes that “we continue to defend the merits of Zetia/Vytorin and feel that the products were maligned to a degree substantially out of line with the true scientific teachings of ENHANCE and SEAS.” In fact, Anderson writes that “we still like the longer-term prospects” of Merck and Schering-Plough.
Despite this rosy perspective, CNBC’s Huckman wrote that, on the day of an exceptionally strong rally on Wall Street, the stocks of the two companies declined on the basis of Anderson’s report.
Click here to read the design and rationale of the ARBITER 6 Trial (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol)-6-HDL and LDL Treatment Strategies in Atherosclerosis (HALTS).