Researcher Claims “No Credible Evidence” of Vytorin Cancer Side Effects

In response to concerns about a potential link between Vytorin and cancer, the FDA has initiated a safety review and members of Congress have requested additional information about the potential side effect. However, a prominent researcher released a letter this week in response to the congressional probe indicating that there is “no credible evidence” that Vytorin is linked to an increased risk of cancer.

Vytorin is a combination cholesterol drug jointly marketed by Merck & Co and Schering-Plough Corp. It contains Zetia (ezetmibe) and simvastatin, which is also known by its brand name Zocor. Vytorin is prescribed to treat high levels of cholesterol in the blood, but recently studies have raised questions about whether the drug provides any medical benefits over cheaper generic medications.

Concerns emerged about potential Vytorin cancer side effects in July 2008, when data was released from the SEAS study (Simvastatin and Ezetimibe in Aortic Stenosis). The medical community was surprised by data that indicated a higher incidence of cancer among users of Vytorin when compared to those taking a placebo.

Although the findings did not rise to the level of statistical significance, an editorial released earlier this month by the New England Journal of Medicine indicated that it is too early to dismiss the potential Vytorin cancer risks. The authors concluded that longer duration studies were needed to fully evaluate the potential link, and that it should not be assumed that the increased incidence of cancer was due only to chance.

In a letter dated September 16, 2008, Sir Richard Peto, a prominent statistics expert from Oxford University, dismissed the connection between Vytorin and cancer. The sharply worded letter suggests that “any competent trial statistician” would endorse his conclusion that there is no credible evidence to support this link.

The FDA released an early communication on August 21, 2008, confirming that they are investigating the potential association between cancer and Vytorin, Zetia and Zocor. The regulators have estimated that it will take about nine months to complete their safety review into the potential Vytorin cancer side effects and to make any decisions about whether regulatory actions are warranted.