- The Washington Times - Wednesday, February 13, 2008

TRENTON, N.J. (AP) — A congressional committee broadened its probe of the delay by drug makers Merck & Co. and Schering-Plough Corp. in releasing study data about their cholesterol drug Vytorin, saying Internet postings indicate that they knew the results long before releasing them.

The controversial study found that Vytorin wasn’t as effective as advertised, and the fallout has hammered the stocks of both companies, cut sales of Vytorin, triggered numerous potential class-action lawsuits and raised questions about the drug makers’ honesty.

In the latest development, the House Committee on Energy and Commerce demanded a host of documents from the chief executives of both drug makers, as well as the Food and Drug Administration and the operator of and Webmaster for a Web site called Cafepharma.com

On the site, anonymous postings by pharmaceutical sales representatives indicate that some of them knew about the study’s results as early as March 2007.

“These Web site entries are obviously troubling and raise further questions as to whether anyone within Merck or Schering-Plough knew the results of the ENHANCE trial prior to the official release of data,” committee letters to the officials state.

The Vytorin study, called ENHANCE, was meant to show Vytorin”s effectiveness at reducing plaque buildup in arteries. It was completed in April 2006, but the companies didn’t release partial results until Jan. 14, 2008, five weeks after the committee began investigating the delay.

Vytorin combines Schering-Plough’s cholesterol fighter Zetia with Merck’s older cholesterol drug Zocor, a former blockbuster available since June 2006 as a generic for about one-third Vytorin’s cost.

The study found Vytorin was no more effective than the generic at limiting plaque buildup in neck arteries but did lower cholesterol a bit more.

The companies have said that the complexity of the study, which the companies paid for, and difficulty reading ultrasound images of participants” arteries delayed the results.

The two New Jersey companies have a joint venture that markets Vytorin and Zetia, which together brought in $5.1 billion in sales in 2007, up one-third from $3.8 billion in 2006.

“We will cooperate with the committee,” Merck spokesman Chris Garland said yesterday. “We stand by the safety and efficacy profiles of both Zetia and Vytorin.”

He said that Merck acted in good faith and that company officials first learned the study results starting in late December.

The House committee”s letters state it is “investigating the withholding of clinical trial data” and cite entries from the Cafepharma Web site.

A March 13, 2007, posting included in the letters states: “have a buddy at (Schering-Plough Research Institute). He says that the study is a bust. Adding Zetia to already maxed-out statin is useless,” a reference to the maximum dose of Zocor used in the study.

A June 3, 2007, posting says of the study: “Heard it crashed and burned!”

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