Lawmakers Ask FDA for Study Linking Vytorin to Cancer
Two prominent congressmen have asked the FDA to release what they say are a new trial’s data linking Merck and Schering-Plough’s controversial cholesterol drug Vytorin to cancer.
Reps. John Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, and Bart Stupak (D-Mich.), chairman of its Oversight and Investigations Subcommittee, have asked FDA Commissioner Andrew von Eschenbach to release a report on Vytorin (ezetimibe/simvastatin) by Sir Richard Peto of the University of Oxford Clinical Trial Service Unit by Aug. 14.
“We have received the letter and are working on a response,” FDA spokeswoman Felicia Stewart said.
The committee has been investigating Vytorin for several months. In a letter sent in January to the Merck and Schering-Plough CEOs, the lawmakers said they were dismayed at the slow release of the results of the ENHANCE study, which showed that Vytorin was no more effective than Merck’s Zocor (simvastatin) alone in treating people genetically disposed to having high cholesterol.
Patients and healthcare providers should have learned as soon as possible that Vytorin did not have a benefit over a cheaper generic alternative, the congressmen said.The SEAS trial tested Vytorin’s effect on lowering LDL cholesterol in patients with aortic stenosis. The drug did not meet its primary endpoint of reducing cardiovascular events and 158 of 1,873 patients had serious adverse events involving cancer.