As early as last spring, there was scuttlebutt about the controversial Vytorin data - the bet-the-franchise study that failed to find any statistical advantage over the much cheaper Zocor in reducing arterial plaque. The results were delayed for nearly two years while the primary endpoint was changed.
Meanwhile, Vytorin and Zetia (which, along with Zocor comprise the Vytorin combo therapy) were heavily promoted. And concerns that Schering-Plough execs sold lots of stock last year have sparked investigations by Congress and two state attorneys general. This has all led to the 'Who knew what and when?' line of skepticism toward Schering-Plough and Merck, its Vytorin joint venture partner.
Schering-Plough has repeatedly argued its execs knew nothing of the results until early this month, going so far as to release a chronology (a Merck spokeswoman tells Pharmalot that ceo Dick Clark was told of the results on the evening of Jan. 8, two days before Schering-Plough ceo Fred Hassan was told). But skepticism remains that the results were rumbling around months ago among untold numbers of people in and out of the drugmakers' buildings.
To underscore the point, BrandweekNRX has spent time on Cafe Pharma, the site where detailers love to dish, and found several posts containing info some interesting remarks. Okay, we know - the site is seen as a disreputable electronic bathroom wall by many people. And anonymous remarks amount to hearsay. But as we've said before, interesting and informative nuggets can be found if one looks hard enough. BrandweekNRX blogger Peter Rost did so and noticed that several remarks match what we now know about the results, raising questions about info that was circulating...
For instance, click on the chart at right. Rost compares that with the Schering-Plough press release, which says: "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 Vytorin (2.8 percent) as compared to 8 out of 360 for Zocor (2.2 percent). " [This means there were higher rates of liver problems for Vytorin than Zocor, as stated six months ago, he writes].
Then, he compared a July 24 comment in which someone describes how Schering-Plough will find another study endpoint, and attempt to discredit the trial. Of course, Schering-Plough and Merck did, briefly, change the endpoint. And at the Morgan Stanley investor conference, Schering-Plough ceo Fred Hassan maintained the study involved a "narrow population" of patients.
Of course, as Rost points out, none of this proves that any Schering-Plough or Merck exec knew the study results prematurely or anything untoward did occur. However, the argument that the results were kept under lock and key wears thin when the information on such sites turns out to mirror certain details and explanations that are later offered for the record.
Hat tip to BrandweekNRX