A US congressional committee is investigating whether the makers of Vytorin knew about the negative results of a key study showing that their expensive drug is no more effective than a cheaper generic.

Vtyorin, a cholesterol drug made by Merck and Schering-Plough Pharmaceuticals is a combination of ezetimibe (Zetia) and the generic drug simvastatin. The results of the ENHANCE trial, announced last month, showed no benefit of the combination of these two drugs over simvastatin alone. The ENHANCE trial was dogged with controversy for several months prior to the release of its results. The controversy surrounded allegations on delayed reporting of results and issues about the design of the study.

The congressional committee’s investigation was sparked by anonymous entries in an online forum designed for pharmaceutical representatives called Cafepharma. According to lawmakers, one March 2007 anonymous entry on Cafepharma said “have a buddy at (Schering-Plough Research Institute). He says that the study is a bust. Adding Zetia to already maxed out statin is useless.” Another from June 2007 said “heard it crashed and burned!” These entries, in addition to several others like them, were posted on Cafepharma months before the results of the ENHANCE trial were released. Cafepharma has told investigators that they do not collect information on anonymous users and that none of the comments in question came from registered members.

Regardless of the outcome of the congressional investigation, this story highlights the need for pharmaceutical companies to maintain transparency regarding the results of their trials. Today, it’s become very difficult to control the flow of information. Honesty is, therefore, the best policy.

More information: ENHANCE trial, Cafepharma

Filed under: Pharma/Biotech