Mike Mitka Analyzes Latest FDA Word -- on Vytorin -- in JAMA, Today

[But first, thanks go to Marilyn Mann for pointing this one out to me. Excellent find!]

JAMA is today carrying a rather exhaustive run-down on what the latest FDA announcement, released in January 2009 really means for Vytorin (post-ENHANCE). This is what much of the Schering defense lawyers' back and forth, and the plaintiffs' lawyers cogent replies, have been about, of late, in the ENHANCE-related would-be class actions -- but JAMA Senior Staff Writer Mitka clarifies, rather than obscures (as the Schering lawyers are often wont). Moreover, Mitka reminds us that FDA will very-likely have a similar announcement, but related to SEAS (the Vytorin study that arguably yielded a cancer-signal) -- as early as May 2009.

Do go read all of Mitka's carefully-constructed analysis-by-article ($$ subscription req'd), but I'll quote a very-illuminating snippet, here:

. . . .“Since LDL-C is a validated surrogate for cardiovascular disease, some would argue that an outcomes study is not necessary for a LDL-lowering drug [before or anytime after approval],” [FDA's] Colman said. “Others would argue that there may be some uncertainty about whether an LDL-lowering drug -- particularly if it is a first-in-class compound -- does what it is intended to do, so an outcomes trial should be done, at least following the drug’s approval.”

In the case of ezetimibe/simvastatin, starting an outcomes study as soon as possible after approval “would be ideal,” Colman added. But no such trial was initiated. . . .

Indeed, as the JAMA piece makes plain, IMPROVE-IT, the comprehensive Schering/Vytorin "outcomes" trial data will now likely not be available until late-2012. In the mean time, doctors -- and their patients -- will be left to wonder whether taking this very-pricey combination pill will yield any additional protection from cardiac events, as compared to simply taking a generic statin (and at 1/20th the price!), alone. The data on statins is clear -- it does help improve outcomes.