Merck Delayed Release of Clinical Study Revealing Failure of Vytorin Cholesterol Drug

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(NaturalNews) The long-awaited release of the results from a clinical trial of Merck and Schering-Plough's cholesterol drug Vytorin has renewed allegations that the companies deliberately delayed in making the study data public.

"It is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data," said U.S. Rep. Bart Stupak of Michigan, who is involved in a Congressional inquiry into the study.

The drug trial, called ENHANCE, compared the effects of cholesterol drug Vytorin with the effects of Zocor alone.

Vytorin is a mix of a mix of Merck and Schering's cholesterol drug Zetia (ezetimibe) and the now-generic Zocor (simvastatin), originally marketed exclusively by Merck. Because Zetia works differently than the older of cholesterol drugs known as statins, which include Zocor, Lipitor and Crestor, the two kinds of drugs are often prescribed in tandem to create a greater increase in cholesterol levels.

Zetia interferes with the intestine's ability to absorb cholesterol, while statins increase the rate at which LDL ("bad") cholesterol is removed from the blood.

In ENHANCE, researchers tested both Vytorin and Zocor alone on 720 patients with a genetic disease known as heterozygous familial hypercholesterolemia, which causes dangerously high cholesterol levels and an elevated risk of heart attacks, stroke and death. In addition to measuring blood cholesterol levels, researchers used ultrasound images of arteries in the participants' thighs and necks to compare how well the drugs reduced plaque formation.

Initiated in 2002, ENHANCE was completed two years later, and the companies had analyzed all of the data by April 2006. Yet Merck and Schering did not publish or otherwise release the results, leading to speculation that Vytorin had failed the test. In spite of expectations by cardiologists, the companies failed to present the results at conferences in November 2006, March 2007 and November 2007.

As questions continued to mount as to the reason for the delay, the companies announced that they were having problems analyzing the data. Contrary to standard procedure, no committee had been set up ahead of time for dealing with problems that might arise in the ENHANCE study. So Merck and Schering-Plough announced on November 16 that they had put together an expert panel to help them decide how to analyze the ENHANCE data. On November 19, they announced a decision to only analyze neck arteries, and not both neck and thigh as had originally been planned.

The announcement drew fierce and instant criticism.

"You just don't change a primary endpoint in a major important trial partway through," said drug safety expert Bruce Psaty, from the University of Washington.

Further criticism arose from the fact that the lead ENHANCE researcher, John J. P. Kastelein of the University of Amsterdam, was not present when Merck and Schering decided to change the study's goals.

The drug companies backtracked on December 11, saying they would stick with the original procedure. But the antics attracted the attention of the House Committee on Energy and Commerce, which announced on the same day that it would be launching an investigation into "the delay in releasing the results of the study, the timing of ENHANCE trial registration and the apparent manipulation of trial data."

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Related Articles: • Merck Committed Scientific Fraud in Delays, Distortions of Vytorin Drug Trial (opinion) • Expert Panel Recommends Doctors Abandon Vytorin Cholesterol Drug • Vytorin Drug Shows No Benefit Over Older, Cheaper Cholesterol Drugs	Take Action: Support NaturalNews.com Email this article to a friend Share this article on: NewsVine | digg | del.icio.us Permalink to this article: http://www.NaturalNews.com/023889_Vytorin_Merck_patients.html Reprinting this article: Non-commercial use OK, cite NaturalNews.com with clickable link. Embed article link: (copy HTML code below): <a href = "http://www.NaturalNews.com/023889_Vytorin_Merck_patients.html">Merck Delayed Release of Clinical Study Revealing Failure of Vytorin Cholesterol Drug</a>