From: Reuters
Published April 1, 2008 08:43 AM

Cholesterol scientist balked at delay: lawmaker

By Susan Heavey

WASHINGTON (Reuters) - The lead researcher for a study of Schering-Plough Corp and Merck & Co's controversial cholesterol drug Vytorin had expressed strong concern over the companies' decision to delay the findings, according to e-mails released on Monday.

In a note to Schering executive John Strony last July, John Kastelein said he was troubled that the drugmakers delayed publication of the results, which found that their jointly sold drug Vytorin failed to reverse heart disease any better than cheaper statin drugs.

"This starts smelling like extending the publication for no other political reasons and I cannot live with that," wrote Kastelein, a professor of medicine at the Academic Medical Center in Amsterdam who oversaw the Vytorin study known as Enhance.

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The e-mails, released by the Senate Finance Committee's ranking member Sen. Charles Grassley, come after scientists on Sunday urged patients to try older cholesterol drugs, and turn to pricier Vytorin as a last resort.

The companies first released some of the findings in January on Vytorin -- a drug that combines the statin Zocor, known generically as simvastatin, with Zetia, or ezetimibe. The full study was released on Sunday at the American College of Cardiology annual meeting.

Vytorin and Zetia have annual sales of about $5 billion, helped in large measure by a clever TV advertising campaign and aggressive marketing to doctors.

In the e-mails, Kastelein said he had been cleared by the companies to present the findings at the American Heart Association meeting last November.

"You will be seen as a company that tries to hide something and I will be perceived as being in bed with you!" he wrote.

Grassley, an Iowa Republican, made the e-mails public in a letter sent to Schering Chief Executive Officer Fred Hassan and Merck Chief Executive Officer Richard Clark asking for documents.

Schering-Plough spokeswoman Rosemarie Yancosek said the drugmaker had received the letter and was cooperating with the request. She added that the e-mails from Kastelein involved issues the companies consider "long resolved."

A spokesman for Merck did not immediately return a call seeking comment.

It was not immediately clear if Democrats, who hold majority control in Congress, would take any action over the delayed results. Some analysts have said the drugmakers could face legislative scrutiny and possibly fines.

Grassley said he was particularly concerned because the government pays for cholesterol drugs for patients under its Medicare and Medicaid insurance programs.

(Additional reporting by Julie Steenhuysen in Chicago; Editing by Braden Reddall)

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