Vytorin controversy confuses patients, doctors

By Julie Steenhuysen - Analysis

CHICAGO (Reuters) - Shortly after news reports saying the popular cholesterol drug Vytorin had missed the mark in a long-awaited study, calls and e-mails started pouring in to doctors in the United States.

"We've had over 400 phone calls from patients after seeing the news coverage," said Dr. Vincent Bufalino, president of Midwest Heart Specialists in Naperville, Illinois.

"People are worried they are taking drugs that are hurting them," said Bufalino, who directs 50 cardiologists in the suburban Chicago practice.

The patients were reacting to news on Monday from drugmakers Merck & Co Inc (MRK.N) and Schering-Plough Corp SGP.N that Vytorin, a pill that fights cholesterol in two ways, did not stop the accumulation of fatty deposits in arteries any better than one of its components -- an older, far cheaper cholesterol fighter known as a statin.

Millions of people take statins to lower cholesterol in the hope of preventing a heart attack or stroke. When they cannot get cholesterol levels low enough, doctors often reach for a drug like Vytorin, which combines the companies' Zetia cholesterol-lowering drug with Merck's older statin Zocor, which is now generic.

The trial involved 720 patients with very high levels of cholesterol from an inherited form of heart disease.

It used imaging to see whether Vytorin or Zocor could slow the build-up of fatty deposits in the carotid arteries that supply blood to the brain. The hope was that Vytorin might work better.

While Vytorin did reduce cholesterol levels, it did not slow the disease any better than Zocor alone.

Because it took the companies nearly two years to release the study results, Michigan Democratic Reps. John Dingell, chairman of the Committee on Energy and Commerce, and Bart Stupak, chairman of the Subcommittee on Oversight and Investigations, said they suspect the drugmakers suppressed the data to protect their profits.

They said they are investigating the way Merck and Schering-Plough handled the study and have asked the U.S. Food and Drug Administration for records related to television commercials promoting the drug.

The trial has garnered intense investor interest because Vytorin and Zetia have annual sales of about $5 billion, and are important to future earnings growth of the companies.

The American Heart Association and the American College of Cardiology issued statements this week urging patients not to panic and to call their doctors if they have concerns.

"Unfortunately, the coverage created a concern that they are at risk," Bufalino said in a telephone interview.

STAY ON THE DRUG

For Bufalino and colleagues, the advice is: Stay on the drug. "None of us are reacting by stopping the drug," he said.