Just how did Merck and Schering-Plough get themselves into hot water with the ENHANCE trial, which compared Zetia and Vytorin to a generic cholesterol drug? Maybe by excluding their lead investigator from key discussions.
John Kastelein, that investigator, wasn't present when the companies decided to change the trial's endpoint after the data was already in--a big no-no in scientific circles, because tailoring a goal to the data can make results seem better than they are. Even Congress knows that; a House committee confronted the companies with "apparent manipulation of trial data." No wonder Kastelein sighed with relief when the companies backtracked, returning to the trial's original goals.
Schering confirms that Kastelein wasn't present, but says an "independent expert panel" made the controversial choice. Forbes says the group included experts on studying arterial plaque with imaging technology, a key element of the trial; it also included a former FDA official. Schering and Merck say that the imaging techniques used in ENHANCE are difficult to handle, unlike typical cholesterol-drug trials that use simple blood tests to see whether lipid levels are changing. Their attempt to change the endpoint was made with good intentions, they say.
- read the article in Forbes