Were Vytorin Results Circulating Under Our Noses?
8 CommentsBy Ed Silverman // January 30th, 2008 // 5:32 pm
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
SPRI
This is absolutely incredible! Peter Rost is doing the investigative work for all of the agencies (FDA, OIG, SEC, OAG) and groups (House, Senate) that want to look into this entire ENHANCE fiasco. If Schering-Plough employees, who are in the field outside of Kenilworth HQ, were posting information they had heard about ENHANCE months and months ago, how in the world is anyone ever going to believe that the top executives, who are located in the hallowed ground of the company, knew nothing at all about the results of ENHANCE prior to the press release on January 14! If some investigators, friends of investigators, and physicians knew that ENHANCE was a disaster, then how will anyone ever believe that Fred Hassan, Carrie Cox, C. Ron Cheeley, Brent Saunders, Tom Sabatino and their cronies had no knowledge of the results.
One writer speculates that SP was searching for alternative endpoints and attempting to develop a counter-strategy. Another notes that ENHANCE failed for the primary endpoint and there were more liver problems with Vytorin. This is very detailed information about a study for which the results were unknown until early January of this year. More evidence that Schering-Plough and its top executives are lying through their teeth and need to be dealt with by the appropriate legal authorities! I certainly hope that they act soon!
BDM
Absolutely shocking!!!!!
Peter Rost
Thanks Ed, I was actually rather shaken when I realized how every dot matched up with what later happened, revealed six to nine months earlier on CP . . . If these were simply random guesses, one would have expected to find the opposite as well; rosy forecasts about the trial results. I didn’t find that.
BP MD
It appears there will be even more difficult fires to put out at Schering-Plough in Kenilworth! This is tremendous information added to the pile of evidence that seem to indicate huge ethical problems at the heart of this very suspect company. There’s lies, d&$%n lies and Big Pharma lies, with the latter being the worst kind!
ol cranky
Even more interesting is the fact that Cafe Pharma isn’t a site most clinical development personnel, the ones who are knee-deep in the data, even know about let alone visit. That means the top-line results had bubbled up and over for a leak to get to someone in sales that would frequent the site.
"Phil"
Shameful and pitiful. The exact reason I got out of big pharma.
PRSP
The people hurt in this case come from two sources: the poor stockholders who hung onto their shares while the big shots sold off huge blocks and the poor employees who have large amounts of stock in their 401K plans who now have much less. The garden-variety investor went unprotected while the executives with inside information raked in millions. These actions are unethical, illegal and disgusting! I really hope that the SEC is successful with its’ ionvestigation and subsequent prosecution.
BP Watch
I wonder when the FDA, OIG, OAG, SEC and Congress will get around to conducting their investigations into this fiasco? It can’t come soon enough!