Prominent cardiologist: Schering-Plough could have known the result of Vytorin trial before unblinding data.

One important aspect of the "who knew what and when" story related to Schering-Plough executives selling massive amounts of SP stock in 2007 is that while the treatment arms of the Vytorin trial were blinded, the treatment effect on the primary end point—change in mean carotid intima-media thickness (CIMT) after two years—was similar in the Zocor (simvastatin-alone) and Vytorin (ezetimibe/simvastatin-combination) groups.

Some cardiologists believe that unblinding the results would have been unnecessary to know the treatment effect was neutral:

Chart courtesy of PharmaGossip.

"Somebody had looked at the end-point examination, the IMT results, and, irrespective of group assignment, could know that a groupwise comparison of CIMT changes showed no statistically significant difference," Dr Allen Taylor (Walter Reed Army Medical Center, Washington, DC) told heartwire. "In my view, once that is known, the trial is functionally unblinded."

Taylor, a researcher involved in numerous clinical trials, including his role as the lead investigator of the Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol (ARBITER-2) CIMT study, stressed that he has no inside knowledge of when the end-point analysis was completed and does not know whether company officials looked at the blinded data, although he believes it that remains open to speculation.

He said it would be difficult to look across all the data without assigning patients to treatment groups and make any sense of presumed outliers. He added that the 18-month gap after the trial was completed and the reporting of the results leaves the companies wide open to question, especially Merck/Schering Plough's contention that they sought to address quality issues with the images.

"Their sequence of actions to rehabilitate the data is in many ways a signal of distress," said Taylor. "What was fueling that? I can see some may readily speculate that it seems highly implausible that 18 months were spent working on the data without there being a reason related to the overall trial results being known to be negative."

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I can see some may readily speculate that it seems highly implausible that 18 months were spent working on the data without there being a reason related to the overall trial results being known to be negative.

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