Attorneys General Begin Vytorin Investigations

ePT--the Electronic Newsletter of Pharmaceutical Technology

Connecticut Attorney General Richard Blumenthal is investigating Schering-Plough (Kenilworth, NJ) and Merck & Co. (Whitehouse Station, NJ), according to a Reuters report.

New York (Jan. 29)-Connecticut Attorney General Richard Blumenthal is investigating Schering-Plough (Kenilworth, NJ) and Merck & Co. (Whitehouse Station, NJ), according to a Reuters report. Blumenthal seeks to determine whether the companies concealed facts or made deceptive claims about their cholesterol drug “Vytorin.” Vytorin is a combination of the companies’ drug “Zetia” (ezetimibe) and the generic drug simvastatin.

Andrew M. Cuomo, attorney general of New York, served subpoenas to Merck and Schering-Plough on Jan. 26 to obtain information about Vytorin. Cuomo is investigating whether the companies deliberately concealed the negative results of their ENHANCE trial, which compared Vytorin to the generic cholesterol drug simvastatin.

Cuomo’s investigation has two components. The first component will examine Merck’s and Schering-Plough’s promotion of Vytorin as safe and effective despite the ENHANCE trial’s negative results. The companies did not release the results until nearly two years after the trial was completed.

The second component of the investigation will determine the appropriateness of company insiders’ sales of stock before the trial results were announced. It will also examine whether the companies made accurate statements to investors.

The following timeline lists the major developments to date in the Vytorin story:

Dec. 11, 2007: The US House of Representatives’s Committee on Energy and Commerce begins an investigation into the ENHANCE trial. Rep. John Dingell (D-MI), chairman of the Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), chairman of the Subcommittee on Oversight and Investigations, launched the investigation following concerns that, although the ENHANCE trial ended in April 2006, the data had not yet been released. The committee was also concerned that Merck and Schering-Plough did not register the clinical trial in a timely manner and attempted to change the study endpoints before releasing the results publicly.

Jan. 14, 2008: ENHANCE trial results are released. They show that Vytorin is no more effective than simvastatin alone. Reps. Dingell and Stupak say their investigation will continue.

Jan. 15 2008: The American College of Cardiology (ACC) and the American Heart Association (AHA) release statements saying that the ENHANCE trial alone is an insufficient basis for clinical decisions.

Jan. 16, 2008: Reps. Dingell and Stupak request information about the ENHANCE study trial from Andrew von Eschenbach, commissioner of the US Food and Drug Administration, and the CEOs of Schering-Plough and Merck.

Jan. 22, 2008: Merck and Schering-Plough stop airing direct-to-consumer (DTC) television ads for Vytorin and Zetia. The companies continue publishing print ads for the medicines, however, including an ad defending their safety.

Jan 23, 2008: Reps. Dingell and Stupak expand their investigation into DTC ads for Vytorin. Stupak asks, “Did [the companies] escalate their marketing efforts because they knew the drug did not work? Did executives sell stock based upon the study’s result?”

Jan. 24, 2008: Sen. Charles Grassley (R-IA) asks Schering-Plough and Merck when they learned about the ENHANCE trial results. Grassley also asks the AHA and the ACC to explain their policy for accepting industry funding. In addition, Grassley encourages the US Securities and Exchange Commission to consider taking action against Merck and Schering-Plough.

Jan. 25, 2008: The FDA says Merck and Schering-Plough reported preliminary results for the ENHANCE trial. The agency states it is awaiting the companies’ final report. FDA estimates it will take six months to evaluate this report. Merck and Schering-Plough say they acted in good faith in a press release today.