US congressional committee widens Vytorin investigation

Under existing rules of the US House of Representatives, the Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations are looking at US drug majors Schering-Plough and Merck and Co's cholesterol-lowerer Vytorin (ezetimibe/simvastatin) and the ENHANCE trial. They say that they are concerned about the delay in releasing the study results and the fact that medical representatives of the firms had access to these from anonymous postings on web sites.

The ENHANCE findings, comparing Vytorin to simvastatin alone, showed that the combination drug had failed to produce the desired effects (Marketletter January 21), and there was no statistically-significant difference between treatment groups on the study's primary endpoints.

The chairmen of the two committees have written to US Food and Drug Administration Commissioner Andrew von Eschenbach requesting all records relating to protocols for the ENHANCE trial and to any and all amendments to these. They have called for similar information from both S-P and Merck, as well as the operator of and web-master for Cafepharma Inc.