Dingell, Stupak Look Into Vytorin DTC Ads

Two high-ranking members of Congress are investigating whether Merck and Schering-Plough continued to run advertisements for Vytorin while company officials knew the drug did not provide a significant benefit compared with a generic alternative.

The companies recently released results from the long-awaited ENHANCE clinical trial that showed Vytorin, which combines Merck’s Zocor (simvastatin) with Merck and Schering-Plough’s Zetia (ezetimibe), was no more effective than Zocor in treating people genetically disposed to having high cholesterol. 

House Energy and Commerce Committee Chairman John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chairman Bart Stupak (D-Mich.) wrote to FDA Commissioner Andrew von Eschenbach, Schering-Plough CEO Fred Hassan and Merck CEO Richard Clark requesting documents related to direct-to-consumer (DTC) advertisements for the drug.

In their letter to von Eschenbach, the lawmakers say company officials may have continued the “massive” Vytorin DTC advertisement campaign even though they had the ENHANCE study results showing the drug was not more effective than Zocor alone. 

In the letter to the Merck and Schering-Plough CEOs, the lawmakers say they were “dismayed at the pace of the release of the ENHANCE study results.” Patients should have learned of its lack of benefits earlier than January, they add. “This situation raises concerns that the drug companies and their advertisement agencies profited at the significant expense of patients’ health,” the letter says.

The letters can be seen at energycommerce.house.gov/Press_110/110-ltr.011608.ScheringPloughMerck.pdf and energycommerce.house.gov/Press_110/110-ltr.011608.FDA.pdf.