You guessed it right . . . we're talking about the study that is infamous before it's even been presented.
The lead researcher of this long-delayed drug study says he regrets not standing up to Merck & Co. and Schering-Plough Corp. when they first told him last month that they planned to alter the statistical analysis of their jointly sponsored trial.
Under mounting criticism, the companies last week reversed the earlier decision to change the primary measure to evaluate the drug. The study, called Enhance, tested 720 people to determine whether a combination of Schering-Plough's Zetia and Merck's now off-patent cholesterol fighter Zocor works better than Zocor alone.
The WSJ has the story.
Peter Rost, M.D., is a former Pfizer Marketing Vice President providing services as a medical device and drug expert witness and pharmaceutical marketing expert. Judge Sanders: "The court agrees with defendants' view that Dr. Rost is a very adept and seasoned expert witness." He is also the author of Emergency Surgery, The Whistleblower and Killer Drug. You can reach him on rostpeter (insert symbol) hotmail.com. Follow on https://twitter.com/peterrost
Tuesday, December 18, 2007
Quote of the day: "It's never, ever right to change the primary endpoint of a study, especially after all the data are in"
Posted by Peter Rost at 8:36 AM
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