Vytorin Mess Attracts Attention of New York Attorney GeneralJan 28, 2008 | Parker Waichman LLP
The Vytorin mess seems to be getting worse for Merck and Schering-Plough. Already facing a firestorm over its handling of the so-called ENHANCE study that found Vytorin worked no better than cheaper generic statins, the companies now face a subpoena from the New York State Attorney General’s office. Andrew Cuomo wants to know if Merck and Schering-Plough purposely withheld the results of ENHANCE in an effort to protect sales of Vytorin. The attorney general has also questioned the timing of stock sales made by company executives prior to the release of ENHANCE.
Vytorin, which was developed and marketed jointly by Merck and Schering-Plough, was approved for use by the Food and Drug Administration in 2004. Since it came on the market, Vytorin sales have reached $5 billion per year. Vytorin is a combination of cholesterol-lowering Zetia and the statin Zocor. Statins like Zocor reduce the amount of cholesterol produced by the liver, while Zetia lessens the amount of cholesterol in food that is absorbed in the intestines. High cholesterol levels put a person at risk of developing clogged arteries – a major risk factor for heart attacks and strokes. Doctors and Vytorin users were led to believe that the drug would effectively reduce both sources of cholesterol, thereby lessening the amount of plaque build up in the arteries, as well as the risk of having heart attacks and strokes.
But the ENHANCE study finding that Vytorin was in fact not effective in reducing arterial plaque was completed in April 2006. ENHANCE, focused on a group of 720 patients with a rare condition predisposing them to high cholesterol. The patients were given either Vytorin or a high dose of simvastatin, the generic form of Zocor. The ENHANCE study found that Vytorin worked no better to reduce clogged arteries than a high dose of a less-expensive, generically available statin alone. In fact, some of the Vytorin patients in ENHANCE actually developed more arterial plaque than those taking Zocor alone, putting them at an even greater risk of heart attacks and strokes. In spite of the findings, Merck and Schering-Plough delayed releasing ENHANCE for nearly 2 years – something critics of the company have likened to fraud.
According to an email released by the New York Attorney General’s office on Saturday, the state’s Vytorin investigation focuses on the marketing of the drug. "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. "Dru g companies are on notice that concealing critical information about life-saving prescription drugs, profiting at the expense of patients' health, and wasting taxpayer dollars, is simply unacceptable."
The attorney general also sought information to determine whether insider sales of stock were appropriate and whether statements to investors were accurate. According to Bloomberg.com, Carrie Smith Cox, a Schering-Plough executive vice president, sold 900,000 shares for $28 million on April 20, according to a Securities and Exchange Commission filing. No reference to her was made in yesterday's statement.
On its website, Schering-Plough reiterated that executives followed rigorous processes to ensure they complied with federal securities laws in trading company stock. Among these are that executive officers must pre-clear every transaction in company shares with one of the company's securities lawyers. The companies maintain that top executives were only made aware of the ENHANCE findings days before they were made public.