Merck settles lawsuit over delayed study results
TRENTON, N.J.—Merck & Co. has settled a lawsuit over claims the drugmaker delayed releasing disappointing results of a study management had hoped would instead boost sales of a key drug.
The settlement ends a four-year-long case shareholders had filed after the company for 21 months delayed releasing results on a study of Vytorin likely to hurt future sales of the blockbuster pill for treating high cholesterol.
The settlement's key provision is aimed at ensuring patients and investors get important study data promptly. That's important because pharmaceutical companies in the past have failed to publish some studies indicating their drugs aren't very effective or have significant side effects.
The study that triggered the lawsuit, known by the acronym ENHANCE, showed that pricey Vytorin, which brought in billions of dollars each year, was no better at reducing plaque buildup in neck arteries than Zocor. Zocor is one of the two components in Vytorin, and inexpensive generic Zocor had been on the market since 2006.
The settlement was approved Tuesday at a hearing in federal court in Newark, N.J.
It requires Merck's research division to report each year to the research committee of Merck's board of directors on any delay over a year in publicly disclosing results of patient studies, the reasons for the delay and any corrective action taken after the delay. The committee could then investigate or raise the issue with the full board.
The requirement remains in force for at least three years and covers all drugs already on the market, but not experimental ones in development.
"It's a very appropriate resolution of the case," said Merck spokesman Ron Rogers.
Merck, based in Whitehouse Station, N.J., denied any wrongdoing in the court documents.
U.S. District Judge Dennis M. Cavanaugh, who approved the settlement, also ordered Merck to pay $5.1 million to cover fees and expenses of the plaintiff, a retirement plan called the Plymouth County Contributory Retirement System. The plan's attorney did not return calls seeking comment Wednesday.
Cholesterol drugs are taken by millions of Americans to reduce risk of heart attack and stroke, particularly if they have heart disease or diabetes.
Vytorin combines two types of cholesterol drugs. Zocor is part of the hugely popular drug class called statins, which include heavily advertised Lipitor and Crestor. Those drugs reduce the amount of cholesterol naturally produced in the liver. The other Vytorin component, Zetia, reduces the amount of cholesterol absorbed from food.
The lawsuit was originally filed in February 2008 by a couple, Mary E. and James D. Cain. They were shareholders of Schering-Plough Corp., another drugmaker that became part of Merck in November 2009. The couple sued Fred Hassan, who was Schering-Plough's CEO at the time, and other corporate officers on behalf of other shareholders and the company. After Cain died and his wife became ill, the pension plan took over as plaintiff a year ago.
When the case was filed, Merck and Schering-Plough had a joint venture that developed and sold cholesterol drugs, including Vytorin and Zetia.
Company executives had expected positive results of the ENHANCE study. When they kept delaying disclosing the results at a medical conference or in a medical journal, a congressional panel started investigating. Under pressure, Merck released partial results in January 2008. The lawsuit was filed the next month.
Merck officials at the time blamed the delay on difficulties in analyzing the complex results, including high-tech imaging of patients' neck arteries.
Critics, however, said the companies deliberately held up the release to protect sales of Vytorin, which Merck and Schering-Plough sold jointly, as well as Schering-Plough's Zetia. The two drugs racked up $5.2 billion in sales in 2007, but that began declining sharply after the results were released.
Merck has since started a large patient study called IMPROVE-IT to show whether Vytorin reduces heart attacks and strokes in heart patients. That study is expected to be completed next year.
Linda A. Johnson can be followed at http://twitter.com/LindaJ--onPharma