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

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

If Vytorin ad campaigns and promotional media were based on a false or misleading premise, and the drug isn’t all its manufacturers publicized it to be (as the drug trials suggest), then government programs spent millions of dollars on reimbursement for a drug that is ineffective, possibly dangerous, and much more expensive than generic cholesterol medications.

Additionally, 35 attorneys general are investigating to see if any state consumer protection laws were violated by the marketing.

Connecticut Attorney General Richard Blumenthal is one of the state attorneys investigating the matter. “We believe that there are very real and serious issues that may have affected consumer pocketbooks, if not their health, and we intend to pursue these issues vigorously,” he told the Wall Street Journal.

Merck and Schering-Plough, both New Jersey based corporations, said they were cooperating with the investigations and jointly responding to the inquiries.

Earlier this year, the House Energy and Commerce Committee launched an investigations into the safety of Vytorin and the ways in which the drug was marketed.

It is widely believed that Merck and Schering Plough concealed unfavorable trial results for up to two years in an effort to protect the drug’s stellar sales. Both companies deny the accusation that trial data were withheld.

Vytorin is already the subject of a number of lawsuits seeking class action status. Approximately 140 such suits have been filed across the country.

SOURCE: Vytorin Recall › Investigations of Vytorin marketing intensifying