Merck & Co., Schering-Plough defend actions over Vytorin study

Merck & Co. and Schering-Plough stated that the companies "strongly object to mischaracterisations" about the ENHANCE trial, which showed that cholesterol drug Vytorin was no better than Zocor at slowing atherosclerosis in certain patients. The move comes amidst concerns from US lawmakers and some doctors about the two-year delay in presenting the study findings.

Thomas Koestler, president of the Schering-Plough Research Institute, stated that "while the ENHANCE trial was time-consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith…We took numerous actions to assure the quality of the reading of the ultrasound images." Although the study ended in 2006, the drugmakers said the trial remained blinded until December 31, 2007, and that company officials were only made aware of the results in January.

In response to reports that some senior executives at Schering-Plough sold company shares based on non-public information prior to the release of the ENHANCE results, the drugmaker said that several high-level officials didn't learn of the "top-line" results until January 10 of this year "as part of a pre-determined process." According to regulatory filings, the head of Schering-Plough's pharmaceutical unit, Carrie Smith Cox, sold $28 million worth of stock in 2007. The company maintains that federal securities laws were not broken by executives.

"We stand behind Vytorin and Zetia and stand behind our science," added Peter Kim, president of Merck Research Laboratories. Meanwhile, Goldman Sachs' James Kelly recently noted that "the importance of the ENHANCE trial has snowballed through the feedback loop of media attention." The analyst added that "the trial data were not positive, but the reaction to the data has been disproportionate to its significance. The controversy has created its own realities and prescription trends will be affected.''

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