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

Merck

The Enhance study revealed that the pairing of Schering-Plough’s Zetia and Merck’s Zocor, which constitutes Vytorin, to be no more effective and possibly even less effective than Zocor alone or other much cheaper, generic statins in treating arterial plaque.

But more than the disappointing results, there was the delay in making this information public. Results of the Enhance trial were completed in April 2006 but were not released until January 2008, after mounting pressure and suspicion over the delay.

Many plaintiffs, including a number of municipalities, sued Merck and Schering-Plough upon discovering that the drug makers knew the results of the Enhance trial but withheld them from the public for up to 2 years. The trial revealed Vytorin to be no more effective than cheaper generic statins in controlling cholesterol.

Nevertheless, the drug makers forged ahead with aggressive marketing campaigns for Vytorin, earning billions while allegedly knowing about the drug’s shortcomings.

Last month, Merck and Schering agreed to settle with attorneys general from 35 states who claimed the drug makers improperly marketed Vytorin and Zetia. Merck agreed to pay the states $5.4 million for costs accrued in investigating the potential violations of consumer-protection laws.

The settlement announced this week resolves all of the lawsuits seeking class-action status that were filed in New Jersey federal courts by consumers who bought and used Vytorin or Zetia. Many of the complaints sought compensation for personal injury caused by the drugs. The SEAS trial uncovered a possible link between Vytorin and higher cancer risks.

Lawsuits against the companies over securities law violations are still pending, as is the U.S. Department of Justice’s investigation into whether the drug makers’ marketing tactics led to false claims being submitted to federal healthcare programs. Moreover, congressional committees continue to inquire about the companies’ handling of the Enhance trial.

SOURCE: Vytorin Recall › Merck and Schering pay $41.5 million to settle NJ lawsuits