Senator Grassley goes after Schering Plough and Merck with new letter, based on BrandweekNRX information.
BrandweekNRX is clearly creating some turmoil over at Schering-Plough and Merck.
Not only were we first reporting on suspicious insider trading, we also dug up the information on CafeParma that led to a letter yesterday from the House Energy & Commerce Committee to SGP, MRK and CafePharma.
And now Senator Grassley, Ranking Member of the Senate Finanance Committee, is using another BrandweekNRX first, the information in our article on January 31, "Prominent cardiologist: Schering-Plough could have known the result of Vytorin trial before unblinding data."
Senator Grassley just wrote to Schering-Plough and Merck: "It has come to my attention that Schering Plough and Merck would not need to unblind the data to understand that Vytorin performed no better than generic simvastatin. The ENHANCE trial is a non-inferiority study. These studies try to detect a statistically significant difference between treatment groups on the primary endpoint. Once the results are recorded, the study is then unblinded to determine which drug is the better performer. However, if the drugs performed the same, meaning there is no statistically significant difference in the treatments, then this information is apparent before the study has been unblinded."
He adds: According to your own press release on the ENHANCE results, “There was no statistically significant difference between treatment groups on the primary endpoint.”
Senator Grassley is in his letter asking Schering-Plough for the names of all employees who had access to the ENHANCE data during or after completion of the trial. He also wants names of all statisticians at the Schering-Plough Institute.
BrandweekNRX only has one comment: YO MAN, GO, Senator Grassley!




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dan
Posted by: Dan Emerson | March 03, 2008 at 10:24 AM