John Kastelein looks back and wishes he stood up to Merck and Schering-Plough when the drugmakers last month told him that they planned to change the statistical analysis of a long-delayed clinical trial of their jointly marketed Vytorin cholesterol med.
You may recall that last week the two drugmakers changed their mind, but not before encountering blistering criticism for changing study endpoints and refusing to reveal the members of a panel convened to review the data. The negative publicity prompted the House Energy and Commerce committee to begin an investigation into withholding clinical trial data.
"It's never, ever right to change the primary endpoint of a study," especially after all the data are in, he tells The Wall Street Journal. "It is statistically not good and it gives the wrong impression to the outside world."
A cardiologist at the Academic Medical Center and the study's principal investigator, Kastelein says he initially went along with the plan but now regrets not firmly resisting it from the outset. The episode, he tells the paper, was the culmination of a long-running battle over the conduct of the trial and the companies' worries that some deficiencies in the data would jeopardize a good result. He says the concerns were unnecessary, and so he breathed a "sigh of relief" when the companies told him last week they were reversing course.
Perhaps this episode will prove instructive - for drugmakers, they may want to think twice about the negative publicity such behavior can cause, and for researchers, they may now be emboldened to ensure the integrity of their research is the highest priority, not a sponsor's concerns.
The study, called Enhance, was designed to determine whether Vytorin -a combination of Zocor and Zetia - outperforms Zocor in slowing or reducing the accumulation of fatty deposits in the carotid or neck arteries that carry blood to the brain. Such deposits are considered a strong predictor for heart attacks and strokes, the Journal notes. The results are supposed to be presented in March, more than a year later than first expected.
2 Comments
All,
I'll bet Dr. Kastelein deeply regrets the day he ever got hooked up with Schering-Plough and Merck for the ENHANCE study. Here's a well-respected investigator with a solid global reputation who has his integrity dragged through the mud by a couple of money-hungry, self-serving comapnies. Thee firms simply can't accept that the value for their $4 billion could decrease and are determined to do anything they can to prevent it from happening. In the sloppy delay, they've already made an additional $2 - 4 billion on a premium-priced product without any meaningful justification. Where is the FDA and the OIG in this travesty? probably hiding behind their desks so that the corporate-loving administartion won't fire them. Isn't US healthcare wonderful?
At this point will not there always be serious questions about this study.