First-Person: Vytorin ENHANCE Study and its Implications

The ENHANCE trial for the cholesterol lowering drug Vytorin was completed in 2006, yet the release of the results was delayed by nearly one and a half years, with the results only being shown to the medical establishment and the public yesterday, January 14, 2008. Why the delay? The heart disease moderator at About.Com believes that it is possible that the delay gave the manufacturer time to manipulate the study results to make them appear more positive.

Vytorin is a combination of two expensive and high selling drugs made by Merck/Schering Plough, a large pharmaceuticals company, these drugs being Zetia and Zocor. Significantly, Zocor's patent protection ended in 2006, just around the time the new combination drug Vytorin hit the market. Pharmaceutical makers are well known for repackaging no longer patented drugs in an attempt to continue to make large sums of money from them.

The study is disturbing, in that the results showed that while Vytorin does significantly lower LDL (or BAD) cholesterol, it appears that patients taking the drug had more heart attacks and other problems related to high cholesterol, and that the patients in the study also had MORE plaque in their arteries after the study was concluded than at its onset. In fact, one doctor states unequivocally that Vytorin should be used only as a therapy of last resort when nothing else appears to be working. These results are frightening to those of us taking Vytorin.

Forbes.Com states that perhaps it is time for the outside researchers doing these drug studies to have the control over the databases created for the analysis of study results. I could not agree more, as this will help to prevent the future manipulation and delay of data reaching the health consumers whose very lives depend on the medications being studied.