The fall-out from the controversial clinical trial of Merck & Co and Schering-Plough’s combination cholesterol treatment Vytorin continues to hurt the firms with the news that New York’s Attorney General is demanding documents to check if disappointing data had been concealed.
The results of the ENHANCE trial were finally released a couple of weeks ago following a good deal of speculation over possible data manipulation and a U-turn on the study’s primary endpoint. The results showed that Vytorin (10mg ezetimibe + 80mg simvastatin) was no more effective at slowing the progression of atherosclerosis than 80mg simvastatin (the now genericised Zocor) alone.
Now Attorney General Andrew Cuomo has subpoenaed Merck and S-P and is demanding documents concerning the firms’ marketing of Vytorin. His investigation comes at a time when the Senate Finance Committee and the House Energy & Commerce Committee are also investigating the controversy.
As for the companies, they have issued a statement noting that they “strongly object to mischaracterisations” about the ENHANCE trial. Thomas Koestler, president of the Schering-Plough Research Institute, stated that while the study 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 firms said that it remained blinded until December 31 last year.
“We stand behind Vytorin and Zetia and stand behind our science,” added Peter Kim, president of Merck Research Laboratories.
