Merck & Co and Schering-Plough Corp will cooperate in the probe of Vytorin by New York Attorney General Andrew Cuomo, who wants to know if the pharmaceutical companies hid research on the cholesterol-lowering drug.
Cuomo's investigation focuses on the marketing of the drug and sales of the companies' shares before the negative results were made public, the attorney general's office said on Saturday in an e-mailed statement.
A study released on Jan. 14 showed that Vytorin, a combination of the drugs Zocor and Zetia that had US$5 billion in sales last year may be no more effective at reducing plaque buildup inside the arteries than Zocor alone.
New York's Medicaid program for those with low incomes has paid about US$21 million for Vytorin in the past two years rather than buying a cheaper generic version that might be at least comparable to the name brand, Cuomo said.
"We are aware of the subpeonas and will cooperate with the New York attorney general," Schering-Plough spokeswoman Rosemarie Yancosek said. "We stand behind our products as we have done nothing wrong."
"Merck received the subpoenas and will cooperate fully," spokesman Chris Garland said. "Merck stands behind the safety and efficacy profiles of Zetia and Vytorin. We acted with integrity and good faith with respect to the trial."
The attorney general also sought information to determine whether insider sales of stock were appropriate and whether statements to investors were accurate.
He declined, however, to pinpoint any specific trading in the shares of Merck, based in Whitehouse Station, New York, or Schering-Plough, based in Kenilworth, New Jersey.
Carrie Smith Cox, a Schering-Plough executive vice president, sold 900,000 shares for US$28 million on April 20, according to a Securities and Exchange Commission filing. No reference to her was made in Saturday's statement. The company said on Jan. 22 that Cox followed procedures in making the sale.
"We will investigate and, when appropriate, hold accountable drug companies for engaging in irresponsible and deceptive conduct and any deceitful marketing of prescription drugs," Cuomo said in the statement.
The company-sponsored study from October 2002 to April 2006 measured the thickness of the carotid arteries of 720 patients with a predisposition to high cholesterol who took the largest dose of Vytorin over two years. A blocked carotid cuts blood supplies to the brain and can cause a stroke.
Lawmakers are probing whether Schering and Merck acted improperly in their marketing for Vytorin, which cost an average of US$3 a pill compared with US$0.03 for Zocor.