Senator Grassley reveals Vytorin researcher's secret e-mails to Schering-Plough.
Senator Grassley in a letter today reveals explosive communication between the lead investigator of the Vytorin ENHANCE study, Dr. John Kastelein, and two senior Schering-Plough executives:
Grassley writes (link to letter): "I am troubled to learn that after careful analysis of the ENHANCE results, medical experts are now calling Vytorin the cholesterol fighter of last resort. According to reports today on CNBC, at least one prominent cardiologist is now referring to Vytorin as an "expensive placebo." Medical professionals should have had the facts about Vytorin much earlier so they could make informed decisions about the care that they provide to patients."
Then comes the bomb shell:
Senator Grassley writes, "I am not the only one troubled by the delay in the release of ENHANCE. During their review of documents submitted by M/SP, my Committee staff found emails between Schering Plough employees and Dr. John Kastelein, the primary investigator of the ENHANCE trial. Those emails are seminal in documenting Dr. Kastelein's concerns about M/SP's delay in releasing the results of ENHANCE."
On July 6, 2007, Dr. Kastelein wrote to Dr. John Strony, who is a cardiologist and study director at Schering-Plough, with cc to Dr. Enrico Veltri, Vice President, Clinical Research and Medical & Safety Services and head of cardiovascular clinical research for Schering-Plough:
Is it correct that SP has decided not to present at AHA, but to await the two other,
completely unvalidated, endpoints, which analysis is going to take us straight into 2008??!!??
If this is true, SP must have taken this decision without even the semblance of decency to consult me as PI of the study. I can tell you that if this is the case, our collaboration is over…This starts smelling like extending the publication for no other [than] political reasons and I cannot live with that.
That next day, Dr. Kastelein wrote again to Dr. John Strony:
I have been travelling half the globe in the last 6 months to a number of large and important meetings at the strong wish of Merck to chair them or to present ezetimibe data. At every single one of them I was cleared to say that ENHANCE would be presented at AHA. There is no reason whatsoever to include femorals; you will be seen as a company that tries to hide something and I will be perceived as being in bed with you!
Grassley also writes, "it was reported in the media that M/SP launched an ongoing Public Relations blitz called the "49 plan," designed to wine and dine doctors and convince them to prescribe Vytorin. 5 In recent days, I have learned that M/SP budgeted at least $3.5 million for the "49 plan." This seems like a great deal of money for free lunches and dinners."
And he asks for detailed accounting of these expenses.