FDA Needs Nine More Months To Study Vytorin, Cancer Link
Questions have arisen over the past several months as to the efficacy and safety of the popular cholesterol-lowering prescription drug, Vytorin, which is a combination of ezetimibe and simvastatin. The US Food and Drug Administration (FDA) issued a timeline for the study of the Vytorin/cancer link after repeated contact from two Michigan congressmen demanding answers.
Representatives John D. Dingell and Bart Stupak, both Democrats from Michigan, asked the FDA two weeks ago to reveal its data on Vytorin and any risks of cancer associated with it. The FDA did not furnish the requested data.
Dingell serves as chairman of the Committee on Energy and Commerce. Stupak chairs the Oversight and Investigations Subcommittee. They have been requesting information from the drug's manufacturers since January, with no results. Their requests follow the disclosure made in January that Vytorin does not reduce the burden of plaque in carotid arteries as well as do drugs containing only simvastatin.
Earlier today, the representatives sent letters of demand to the chief executive officers (CEOs) of both Merck and Schering-Plough, co-developers of Vytorin. The letters demanded information on potential cancer risks associated with the drug.
Within hours of the pharmaceutical executives' receipt of the congressmen's letters, the FDA issued a statement that confirms their investigation of the cancer link associated with Vytorin. The federal agency also offered a timeline for when their investigation is expected to be complete.
The FDA is said to be awaiting the final safety report from the five-year-long Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study, delivery of which is expected in about three months. Preliminary data revealed a rate of all types of cancer and death from cancer that was significantly higher in patients taking Vytorin than in patients taking placebo instead.
Once the FDA receives the final data from the pharmaceutical manufacturers' study, it anticipates a six-month evaluation period, with a conclusion expected about nine months from now. The agency urges the medical community to continue monitoring patients taking Vytorin in the meantime and to report all side effects associated with the drug.
The congressmen say their demand for information stems from differing sets of data supplied by the drug companies and their biostatistician, Richard Peto, PhD, Oxford, whose analysis seems to suggest there is no increased risk of cancer associated with the drug. Although his work is said to be independent, Peto is currently conducting another study of Vytorin, the Study of Heart and Renal Protection (SHARP), funded by one or both of the drug companies.
Peto has already submitted a copy of his final report directly to the FDA on July 21, a situation the congressmen find questionable.
The Schering-Plough/Merck executives released a statement today saying they planned to issue a timely response to the congressmen's requests for data. They say Peto is scheduled to present the findings of the SEAS study to the European Society of Cardiology at its annual meeting in early September.
The executives also suggest the increased risk of cancer associated with Vytorin is more likely an anomaly that will be dispelled once full analysis of the study has been completed. They are standing behind Vytorin as a safe and effective means of lowering cholesteroland feel that no changes should be made to the way the drug is being prescribed at this time.
SOURCE: MedHeadlines