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

The study, which monitored the progress of 1,873 subjects, found that 37 of the subjects taking Vytorin died of cancer, compared to 20 subjects who died of cancer while receiving a placebo. The data is rightfully alarming, but the study’s leaders maintain that it is a fluke. To support their claim, they point to two larger studies still in progress – SHARP and IMPROVE-IT. Numbers from those studies combined still show a higher rate of cancer among Zetia users, but only enough to be statistically irrelevant or at least inconclusive.

However, some professionals who are following the study, including a panel of doctors from The New England Journal of Medicine, argue that there is indeed a legitimate cause for concern, not the least of which that all three trials revealed more cancer in Zetia users. They also point out that Zetia “interferes with the gastrointestinal absorption not only of cholesterol but also of other molecular entities that could conceivably affect the growth of cancer cells.”

The other “molecular entities” include the tumor-fighting and cholesterol-busting superhero: plant-derived sterols. People ingest sterols every time they eat fruits and vegetables. Because Vytorin interferes with the body’s absorption of sterols, then it may, in theory, promote cancer.

The FDA expects to receive a final SEAS report in about 12 weeks. The agency anticipates it will take another 6 months to review and evaluate the study data, after which it will issue its conclusions and recommendations. In the meantime, the FDA has advised health care professionals to monitor their patients on Vytorin and to report side effects to the agency.

SOURCE: Vytorin Recall › SEAS study may link Vytorin, cancer

Merck and Schering-Plough teamed up to create Vytorin, a new cholesterol-fighting drug that combined the power of statins with Zetia, a drug that reduces absorption of cholesterol in the intestine. In this way, the battle against cholesterol would occur on both genetic and dietary fronts.

Data from the ENHANCE study, however, revealed that Vytorin was largely a flop. While it lowered LDL cholesterol, it did nothing to actually reduce plaque in the carotid arteries as promised.

Dr. Harlan Krumholz, a Yale University cardiologist, told the Associated Press that “people need to turn back to statins. We know that statins are good drugs. We know they reduce risks.”

Dr. Roger Blumenthal, a Johns Hopkins University cardiologist and spokesman for the American Heart Association, likewise advised against prescribing Vytorin, at least as the first line of treatment. “A lot of us thought that there would be some glimmer of benefit,” he told the AP, adding that doctors should first prescribe more traditional, proven cholesterol lowering drugs before turning to Vytorin.

Dr. John Kastelein, a Dutch scientist and the primary investigator for the ENHANCE trial, sounded the harshest criticism. The AP report quotes him as saying that Vytorin showed “no result . Zilch. In no subgroup, in no segment, was there any added benefit” in patients seeking to reduce plaque buildup.

Studies of Vytorin continue. IMPROVE-IT, an ongoing trial slated to end in 2012, will compare and measure the primary effects of Vytorin and simvastatin alone in approximately 18,000 patients with acute coronary syndrome. Another trial, SHARP is monitoring the results of Vytorin and placebo in kidney patients.

SOURCE: Vytorin Recall › Doctors say stay with statins