The SEAS study sought to test Vytorin’s effectiveness as an alternative to surgery in reducing arterial clogging caused by high cholesterol. The results, which were announced in a July 2008 press conference, did not favor the drug. Not only did researchers find that Vytorin worked no better than cheaper, generic statins, they also discovered that patients taking Vytorin experienced 50 percent more new cancer cases and cancer deaths than the subjects who took placebos.

Merck and some of the researchers connected to the SEAS study dismissed the results as a “fluke,” while many physicians and medical researchers not connected to the drug company remained skeptical and cautioned consumers to stick with traditional statins to control cholesterol levels. For instance, Merck’s Zocor, taken alone, was shown to be more effective than Vytorin and cost about one-third as much because it had become available as a generic drug.

That research promoted many municipalities that had included Vytorin in their health plans to file lawsuits against Merck, essentially asking for their money back. Vytorin and its sister drug Zetia, made by Schering-Plough, brought in sales of more than $5 billion at their peak. The sales have fallen but continue to earn $4 billion annually.

Vytorin is a hybrid drug which combines Merck’s Zocor with Schering-Plough’s Zetia to combat both dietary and hereditary cholesterol. The FDA said that ample evidence exists showing Zocor to be safe, but insufficient evidence exists on Zetia to “rule out a cancer risk at this time.”

Two additional Vytorin studies known by the acronyms SHARP and IMPROVE-IT are ongoing and scheduled to end in 2010 and 2012.

SOURCE: Vytorin Recall › FDA says it finds no Vytorin-cancer link, but unsure

Vytorin

If lowering LDL or “bad” cholesterol is the doctor’s sole intention when prescribing Vytorin to patients, then the drug does a great job. However, as previous studies have shown, lower levels of LDL cholesterol don’t automatically translate to cleaner arteries and lower incidences of cardiac arrest. While Vytorin worked better than statins combined with time-release Niacin to lower LDL cholesterol in 200 patients, its performance was inferior in reducing artery clogging deposits.

In fact, five of Vytorin group patients suffered five fatal heart attacks – a rate significantly and statistically higher than the niacin group, in which just one fatal heart attack occurred. The key to understanding the difference may lie in “good” HDL cholesterol, which pulls LDL buildup from artery walls. While niacin is known to raise HDL levels, Vytorin actually lowers levels of good cholesterol.

Higher rates of cardiac arrest, lower levels of good cholesterol – these are beside the point, Merck seems to say in defending Vytorin, which earns the pharmaceutical giant $4 billion annually. The company says that lowering LDL cholesterol is the “well established” and “primary target” of therapy.

“Zetia and Vytorin, when used as a supplement to a healthy diet, are effective in reducing LDL cholesterol,” said Peter S. Kim, President of Merck Research Laboratories, in a statement.

However, if Vytorin doesn’t reduce the risk of adverse cardiac events or strokes, then what good is it possibly doing?

Approximately 9 million Americans are currently taking Vytorin and Zetia.

Source: NPR

SOURCE: Vytorin Recall › New study shows vytorin and zetia less effective than niacin