Two Years Later the Truth Comes Out

1/18/2008
The million or so Americans who've been prescribed Zetia to lower their cholesterol have been duped by the pharmaceutical companies.

Merck and Schering-Plough funded an "independent study" and dragged the trial on for two years, testing 720 patients."This wraps it up," said Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic. "That's all there is. There just isn't any evidence that adding ezetimibe to simvastatin produces any advantage."

Another group questioned why patients should be prescribed more expensive cholesterol-lowering drugs, such as Vytorin, versus cheaper, generic statins such as Zocor."We already know that millions of people who take these brand drugs probably don't need to; they could be taking a less expensive generic instead.

This study lends support to that cost-saving strategy for the health system and for consumers," said Steven Findlay, managing editor of Consumer Reports Best Buy Drugs, a public information and education project of Consumers Union, publisher of Consumer Reports."If there is no apparent clinical benefit, why take a drug that cost three or four times more?" Findlay said in a statement. "Most people do not need that magnitude of cholesterol reduction anyway."

Sales of Zetia and Vytorin totaled $3.7 billion in the nine months ending Sept. 30, up 33 percent from a year ago. Analysts estimate that about 70 percent of Schering-Plough's earnings depend on the drugs, the Times noted.

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Merck and Schering-Plough concealed data in clinical trials

Congressmen John Dingell (D-MI) and Bart Stupak (D-MI) say that Merck and Schering-Plough concealed or manipulated clinical trial data for Vytorin. Trial results showed that Vytorin was no more effective than the cheap, generic versions.“Today’s announcement that the ENHANCE study failed to find any positive benefit from the addition of Zetia to a common, inexpensive, generic therapy raises concerns that attempts were made to mask the minimal value of this new drug. Additionally, Merck and Schering-Plough’s delay in releasing study results, as well as their attempt to manipulate the data is, quite frankly, suspicious,” said Dingell.

The House Energy and Commerce Committee wants more information about the so-called independent panel formed to review the Vytorin trial data, the study’s Data Safety Monitoring Board, stock sales by Schering-Plough execs and the amount of money spent on Vytorin by the Centers for Medicare and Medicaid Services.

Release of the Vytorin data was delayed almost two years and the primary endpoint was briefly changed without the consent of the lead investigator. “In light of today’s results, which were released nearly two years after the ENHANCE trial ended, it is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data,” said Stupak. “It’s currently unclear whether these companies knew that adding a new expensive drug accomplished nothing more than an established, cheaper, generic. But it is clear that our investigation is far from over."

The investigation is also focusing on the heavy advertising for Vytorin.