It looks like Merck find themselves in court once again.  On January 17, Merck and Schering-Plough are listed as defendants in a class action suit which charges them with fraud and misrepresentation for withholding a study that could be damaging to their drug – Vytorin.

Vytorin (Simvastatin and Ezetimibe), a cholesterol lowering agent, is a joint venture between the two companies, with Merck contributing the drug simvastatin and Schering-Plough contributing Ezetimibe. 

The clinical trial in question is called the ENHANCE study.  The trial began in June of 2002 and looked at 720 patient who has a genetic disorder which gave them high blood cholesterols.  This population is different from the majority of people who are high blood cholesterol who may have a genetic disposition to have high cholesterol, but are more of a result of age and diet. 

It was recently discovered that the ENHANCE trial showed that Vytorin did not decrease blood cholesterol more effectively than simvastatin alone and additionally, Vytorin may cause MORE atherosclerotic plaque build-up in the blood vessel than through using simvastatin alone.  The rub about this information is that the first part is shown to be statistically significant and the latter point has not shown to be statistically significant (p=0.28).

The ENHANCE trial was first expected to be release in November of 2006 but the companies delay the release until March of 2007 and then again until March of 2008 and at which point the company tried to change the original endpoint of the study and when the FDA took up the investigation.

The companies had foretold that if this research gets out, it would undermine the sale of Vytorin.  I personally, don’t think the plaintiffs in this case will be victorious unless they fall into this small population of patients whose high blood cholesterol is caused by their genetics.  But through the poor handling of this situation and the public reading poor interpretations of the ENHANCE trial, their reputation and the reputation of Vytorin will be significantly smeared. 

I do not recommend that anybody stop taking their prescribed therapy until speaking with their primary care physician. 

Stocks of both companies fell today after the news.

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