The Wall Street Journal-20080128-Vytorin Makers Get Subpoenas As Handling of Trial Is Probed

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Vytorin Makers Get Subpoenas As Handling of Trial Is Probed

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New York Attorney General Andrew Cuomo launched an investigation into Merck & Co. and Schering-Plough Corp.'s handling of a controversial study of their cholesterol drug Vytorin.

Mr. Cuomo has served the companies with subpoenas as part of a probe into whether the companies "deliberately concealed" negative results from the study, called Enhance, his office said Saturday.

The companies co-market Vytorin and its sister drug, Zetia, as a joint venture.

Both companies said they received the subpoenas and will cooperate. Merck spokesman Chris Garland said the company stands behind the efficacy and safety of Vytorin and Zetia, and "acted with integrity and good faith in connection with the clinical trial." Schering-Plough spokesman Lee Davies said, "We stand behind our medications and our clinical trials."

One prong of the investigation focuses on the "aggressive marketing" of Vytorin to patients and doctors, the attorney general's office said. The other involves sales of the companies' shares before the study's unflattering results were disclosed, probing whether certain insiders' stock sales were appropriate and whether the companies' statements to investors were accurate.

The subpoenas seek, among other things, Vytorin-related documents that pertain to marketing and advertising and to communications with drug representatives, investors and analysts, as well as information about insiders' sales of the companies' stock or exercise of options.

Mr. Cuomo's office says that over the past two years, New York state's Medicaid program spent about $21 million on Vytorin.

The Enhance clinical trial cast doubt about whether Vytorin is better than a cheaper generic drug in slowing the progression of cardiovascular disease, even though Vytorin was more effective in reducing LDL, the so-called bad cholesterol, which is a major risk factor for heart attacks.

The trial was completed in April 2006, but the companies didn't disclose the disappointing results until Jan. 14 of this year. During that time, combined annual sales of Vytorin and Zetia grew to more than $5 billion.

In November, a firestorm erupted after the companies announced they were changing the trial's primary measure of effectiveness to "expedite" analysis of data -- a move generally considered a violation of scientific protocol. That triggered complaints from cardiologists and a congressional inquiry. The companies have since said they went back to the original primary endpoint.