Evidence has just surfaced that Schering-Plough insiders may have known as early as March 13, 2007 that the ENHANCE trial would not show any statistically significant difference between Vytorin and generic Zocor.
What Schering employees knew--and when--is important, since there have been questions about Schering-Plough President Carrie Cox's sales of $28 million of SP stock in April and May 2007 as well as the fact that Thomas Sabatino, Executive Vice President and General Counsel, Brent Saunders, Senior Vice President and President, Consumer Health Care, C. Ron Cheeley, Senior Vice President, Global Human Resources also sold millions of dollars of SP stock at the same time.
Schering responded to these questions with an SEC filing which detailed not only the date when the Vytorin data was unblinded, a few weeks ago, but also the actual time of the day when various SP executives learned of the unblinded data. The underlying assumption was that no one knew anything until the data was unblinded.
A survey of Schering Plough's message board on Cafe Pharma has now crushed that assumption.
Every entry on the Cafe Pharma message board is date and time stamped. The message board is mostly frequented by sales reps, but also by others. We don't know who posted, but we do know what was written, and often the language makes it highly probable that these individuals were indeed insiders.
As early as March 13, 2007, there is a detailed record on Schering-Plough's message board of the outcome of the ENHANCE trial, information that was officially available only a few weeks ago. And here's the proof:
SPRI is an abbreviation used by Schering-Plough employees for the Schering-Plough Research Institute, which is the research and development arm of Schering-Plough Corporation.
Let's compare the statement above with SP's January 14, 2008 press release:
"There was no statistically significant difference between treatment groups on the primary endpoint. "
"The incidence of consecutive elevations of serum transaminases (greater than or equal to 3x ULN) was 10 out of 356 for ezetimibe/simvastatin (2.8 percent) as compared to 8 out of 360 for simvastatin (2.2 percent). " [This means there were higher rates of liver problems for Vytorin as stated six months earlier by someone on SP's message board.]
Now let's look at the next post, dated July 24, 2007 (below), in which someone describes how Schering-Plough will: 1. Find some other endpoint, 2. Spin and discredit the trial.
We know this is exactly what happened, because on November 20, 2007 (four months later), the New York Times wrote, "Merck and Schering-Plough said yesterday that they had changed the trial's ''primary endpoint'' -- the main medical result being measured."
Then on January 4, 2008 Reuters reported that Fred Hassan has started discrediting the ENHANCE trial at a Morgan Stanley investor conference: "The chief executive of Schering-Plough Corp on Thursday said poor quality of ultrasound images hobbled a closely watched trial of its Vytorin cholesterol fighter, and stressed that the controversial study involved a "narrow population" of patients. "
Of course, none of the above is proof about what any individual executive at Schering-Plough may have known.
But there is simply a bit too much smoke, and too detailed information, for this not to look like a highly suspicious fire somewhere.
For any of the regular media or Congressional investigators who want to continue to look into this, here are the links for the images above: