FDA investigates Vytorin link to cancer risk in SEAS study

US drug majors Schering-Plough and Merck & Co's cholesterol-lowerer Vytorin (ezetimibe/simvastatin) has come under fresh scrutiny after the Food and Drug Administration announced it was investigating the results of the SEAS study, which showed an increased occurrence of cancer in trial subjects. The FDA notes, however, that it has found no definitive link between the statin and cancer thus far and most large prospective trials have reported no increased disease risk. The agency expects to receive a final SEAS study report in around three months time and to take six months to fully evaluate the data.

Separately, the Energy and Commerce Committee of the US House of Representatives, which has already investigated the drug majors over data suggesting there was no statistically-significant difference between Vytorin and simvastatin alone (Marketletter February 18), has also asked to review data from the trial. Schering-Plough, however, has refused to release the data until it has assurances it will not become public.

"Vytorin's effectiveness has been in doubt, and now its safety is questionable," said Rep Bart Stupak (Democrat, Michigan), Chairman of the Committee's Oversight and Investigations Subcommittee.