Healthy Skepticism Library item: 12564

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Merck, Schering speak out on Vytorin flap
CNN Money.com 2008 Jan 25
http://money.cnn.com/2008/01/25/news/companies/bc.apfn.schering.plough.merck.ap/index.htm?source=yahoo_quote

Abstract:

Companies, facing lawsuits for allegedly misleading consumers over cholesterol drug’s effectiveness, say they acted ‘with integrity and good faith.’

Full text:

Merck and Schering-Plough said Friday that they object to mischaracterizations of a recent study that raised questions about the effectiveness of cholesterol drug Vytorin.

The companies are being sued in several states over allegations they misled consumers into thinking that Vytorin and the drug Zetia were more effective than generics. In a statement Friday, the companies defended their actions, saying they acted “with integrity and good faith.”

Last week, Merck (MRK, Fortune 500) and Schering-Plough (SGP, Fortune 500) released partial data from the controversial ENHANCE study, which ended in April 2006. The study results revealed cholesterol drug Vytorin is no more effective than a high dose of one of its components, Zocor, which is available generically at a third of the cost. Vytorin, developed by Merck and Schering-Plough, is a combination of Zetia and Merck’s Zocor, which lost patent protection in 2006.

The study of 720 patients was meant to show how well Vytorin reduced plaque buildup in neck arteries in people whose genes gave them stratospheric cholesterol. Instead, it showed $100-a-month Vytorin was no more effective and perhaps a bit worse than Zocor alone.

The companies’ stocks tumbled on the results, with Schering-Plough shares setting new 52-week lows. A congressional committee began probing the companies’ delay in releasing clinical results and doctor critics accused the companies of first trying to change how the results were analyzed, then foot-dragging because the drugs bring in several billion dollars a year.

“While the ENHANCE trial was time-consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith in connection with the trial. We took numerous actions to assure the quality of the reading of the ultrasound images,” said Thomas Koestler, president of the Schering-Plough Research Institute, in a statement Friday.

Clinical studies conducted to date have showed Vytorin and Zetia “significantly decrease” LDL cholesterol, also known as “bad” cholesterol, in patients with elevated cholesterol, along with a healthy diet, the companies said.

But unlike some statins, or cholesterol-lowering drugs, Zetia has not been shown to prevent heart disease or heart attacks, the companies said. Vytorin also has not been shown to reduce heart attacks or strokes more than the generic, simvastatin, alone, the companies added.