Monday, November 22, 2010

Pharmalot Nails Oxford University Doctors' "Misleading" Vytorin® Study Pre-Presser

Well -- file this under "isn't it DOUBLY ironic". On last Tuesday morning, in Chicago at the AHA Science Sessions -- Oxford (and these same researchers!) won the role as the principal investigators (or PIs, for short), on a massive new Merck cholesterol management study, involving hundreds of millions of dollars of reallocable expense burns, 30,000 patient, multi-center, multi-continent, eight year study -- called "REVEAL" -- to evaluate the efficacy of Merck's CETP inhibitor candidate, Anacetrapib. One has to wonder whether the below is how they "won the business" -- perhaps worth as much as $50 million in revenue-net-of-expenses, to Oxford -- over all the otherwise "well-qualified" universities around the globe.

Ed Silverman, writing at Pharmalot has done a great job of collecting the SHARP Vytorin® history here -- do go review it, top to bottom -- but here is a bit:

. . . .Ironically, it was Merck (and Schering-Plough, its former Vytorin partner that is now owned by Merck) that was hammered for distortions when the scandal first erupted. Now, the Oxford researchers stand accused of questionable conduct. “The ‘breathless’ Oxford press release sent to media in advance of the presentation was highly misleading and resulted in many news stories that distorted the benefits of this therapy and minimized its risks,” Steve Nissen of the Cleveland Clinic Foundation writes us, adding that, among Vytorin patients, there was higher all cause mortality (24.6 percent versus 24.1 percent), more hemorrhagic strokes (45 vs. 37), and more cancer deaths (150 vs. 128). As CardioBrief puts it: "It’s a model of a press release that tries to manipulate the reader to adopt its view of the trial and ruthlessly suppresses all information and perspective that doesn’t support its view. . . ."

Nonetheless, the upside [to Merck] is likely to be modest, given that Vytorin was damaged by the scandal and faces a big challenge next year when generic Lipitor debuts. Even the results of Merck’s Improve-It trial, which directly compares Vytorin to simvastatin in patients with acute coronary syndrome, may not make much difference because the outcomes won’t be known until 2013, writes Deutsche Bank’s Barbara Ryan. . . .

Recall also that Dr. James Stein, an independent University of Wisconsin cardiologist, believes that most, if not all, of the SHARP result may be the work of simple. cheap. generic. statins. Indeed. Spin away, ye Brits!

We'll keep you posted -- as ever. [Do go back and read Yale University's Dr. Harlan Krumholz (another independent's voice), on the Anacetrapib DEFINE results -- in view of the above (alleged) shenanigans. Makes sense to me -- when the rest of the story has outed.]

1 comment:

Anonymous said...

The Oxford "trialists" are shameless and conflicted. They stand to reap hundreds of millions of dollars for the conduct of the NEXT Merck trial (outcomes with anacetrapib). The conflict to spin this dog (SHARP) in such a positive way invalidates the Oxford group's role as self-annointed pre-eminent trialists. Rather they should stand impassive next to the data, describe what they found, and leave the rampant over-speculation to others. In sum, Oxford is a joke. The very modest numbers speak for themselves in SHARP- the results are wildly over-represented. I don't believe anything the Oxford group does.