Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Remember those Vytorin commercials with the split screen, comparing people to food? Aunt Barbara on the left and some tacos on the right? Mildly entertaining though they were, those ads underscore a big problem with the promotion of new pharmaceuticals. Evidence suggests that Vytorin’s manufacturers, Merck and Schering-Plough, promoted and sold the anti-cholesterol drug for nearly 2 years despite known clinical trial results that strongly suggested Vytorin to be no more effective than cheap, generic statin drugs.

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Many Americans assume that the Food and Drug Administration adequately tests new drugs for safety before they go on the market and become available to the general population. If your doctor prescribes a new drug to help you lower your cholesterol or help you quit smoking, then that drug must be safe, right?

The answer is a surprising, and disconcerting, NO.

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Merck news release Jan 14 2008 On January 14, 2008, Merck issued a press release reporting that there was no significant difference found between Vytorin and simvastatin alone in the amount of atherosclerotic plaque in the inner walls of the carotid (neck) arteries, despite greater lowering of bad cholesterol (LDL).

FDA early communication Jan 25 2008 On January 25, 2008, the FDA issued an Early Communication announcing that it will conduct a review of Merck/Schering Plough’s recently completed ENHANCE study on Vytorin (ezetimibe/simvastatin) once the agency receives the final results. This Early Communication is based on information that FDA has not yet fully evaluated.

On July 18, 2008, the Merck released the publication Merck Q & A: Making Sense of Vytorin Concerns, July 18 2008, featuring Dr. Robert Temple, Director of the Office of Medical Policy in the Food and Drug Administration’s Center for Drug Evaluation and Research. The piece, titled Making Sense of Vytorin Concerns, addressed questions raised by the ENHANCE study.

An FDA Alert, Aug 8 2008 notified the public of the risk of a rare condition of muscle injury called rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone.

On August 21, 2008, the FDA investigates report from SEAS trial, (Simvastatin and Ezetimibe in Aortic Stenosis) of a possible association between the use of Vytorin (a combination of simvastatin plus ezetimibe) and a potentially increased incidence of cancer.

Today in Munich, Germany, researchers presented all of the data from the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study to the European Society of Cardiology. The SEAS study roused concern back in July when researchers revealed a possible link between cancer and the Zetia half of Vytorin.

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