Vytorin and cancer
Bad news continues to pile up for the Merck & Co. and Schering-Plough drug Vytorin, which has recently been linked to an increase in cancer.
Already beleaguered by reports of dangerous side effects like liver damage, followed by a study that indicates the drug is not effective in its stated mission of reducing cholesterol or plaque buildup in artieres, Vytorin took another hit Aug. 21 when the FDA announced a possible link between the drug and increased risk of cancer[1].
A MedWatch alert[2] released by the FDA informed healthcare professionals that it is investigating results of the SEAS (Simvastatin and Ezetimibe in Aoritc Stenosis) trial, which indicate a possible link between Vytorin use and increased incidence of cancer. Vytorin combines simvastatin (Zocor) and ezetimibe (Zetia).
According to the FDA, the SEAS clinical trial showed a larger percentage of cancer diagnosis and cancer death in patients taking Vytorin versus those taking a placebo, based on a 5-year study.
Reports immediately following the news downplayed the cancer connection, saying that the FDA is still waiting on the final report from the SEAS study, with three more months of analysis before its completion. As a result, the FDA said it would not recommend patients stop taking Vytorin, as the link to cancer is not clear, but it would recommend patients consult with their physician.
The FDA says its review and evaluation of the SEAS clinical trial data could take an additional 6 months after receipt of the final report.
SEAS results statistically significant
A report by Forbes.com [3]about 5 days after the initial FDA announcement says concerns about the link were too easily dismissed. It reports that the SEAS study found 50 percent more cancers – of varying types – among patients who took Vytorin versus those that received a placebo.
Beyond that, Forbes reports, 10 of the 16 medical experts surveyed by the news agency thought there was “at least some possibility” that Vytorin increases the risk of death for patients who have cancer. That is “highly statistically significant,” experts say.
Congressional inquiry spurs Vytorin warning
Pharmaceutical Online says that the FDA warning and announcement of its timeline to study the Vytorin-cancer link came only after pressure from Congress. Representatives John D. Dingell (D-Mich.) and Bart Stupak (D-Mich.) pressed for the results of the SEAS study following the news in January that Vytorin does not actually reduce plaque in the carotid arteries as promised.[4]
Dingell is chair of the Committee on Energy and Commerce, while Stupak chairs the Oversight and Investigations Subcommittee. According to the Pharmaceutical Online story, the representatives sent letters to drug manufacturers Merck & Co. and Schering-Plough demanding data about cancer risks of Vytorin. After receiving the letters, the FDA statement confirmed the investigation of the link between Vytorin and cancer.
According to the news report, the inquiry came after the congressmen became suspicious about differing sets of data supplied by the drug companies.
Merck and Schering-Plough executives have said the link between Vytoin and cancer is “an anomaly that will be dispelled once full analysis of the study has been completed,” according to the report.
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