The panel based its findings on detailed evidence from a controversial study showing Vytorin worked no better than a statin drug currently being sold as a cheap generic.
Zetia was approved in 2002 and Vytorin in 2004 based on research showing that they dramatically reduce levels of LDL. High LDL levels can raise heart attack risk, however these drugs were not proven to actually save lives. Both Zetia and Vytorin are made up of a drug, ezetimibe, which blocks the absorption of bad cholesterol, LDL, in the gut. Vytorin also contains the cholesterol-lowering drug simvastatin. Statins work by blocking LDL synthesis in the liver.
The two-year trial, sponsored by the drugmakers Merck and Schering-Plough, involved 720 patients who had a severe form of inherited high cholesterol. Half were given simvastatin, also sold as Zocor, and a placebo. The rest were treated with the combo sold as Vytorin.
The drugs’ performance was evaluated by measuring fatty deposits in the carotid arteries that supply the brain and femoral arteries in the legs. Researchers found no differences between patients who took simvastatin alone and those who took Vytorin.
“There is absolutely no difference … between the two treatment groups,” said lead investigator John Kastelein of the
What makes this study particularly interesting is, in a second study published in the New England Journal, Krumholz and his co-workers scrutinzed prescribing practices in the
Furthermore, earlier studies have shown that pharmaceutical companies spend almost twice as much on marketing a drug than they spend on research and development for that same product.
So, the question is…did the drug companies know about or suspect the effectiveness of Vytorin and Zetia before they put these drugs on the market, knowing they could make a large profit before the truth caught up with them? Did they choose to put profit over consumer safety by spending more money on the marketing campaigns instead of research and development?