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Every night like five million other people world wide, I take Vytorin- at least until tonight.  My cholesterol is high and my family history is one of cardiovascular problems.  I control my blood pressure with generic medications (a low dose diuretic and beta blocker, both generic), work on losing weight and blog to reduce some stress.  

Tonight the article published an article indicating that Vytorin has been shown to not reduce plaque formation in arteries, and may even marginally increase the plaque formation.  I am contacting my physician about this and maybe you should too.

Vytorin is a mixture of an earlier drug, Zocor and a newer drug, Zetia.  Studies show Vytorin reduces cholesterol better than Zocor alone.  Vytorin is a blockbuster drug and its manufacturers, Scherring-Plough and Merck conducted a two year study, ending in 1996, in order to confirm the effectiveness of the drug combination on arterial plaque- a bad actor in cardiovascular disease.  Reducing cholesterol is good, right?  So a drug that reduces cholesterol better should reduce cardiovascular disease better, right?  Well maybe it is more important to prevent cardiovascular incidents than to just reduce cholesterol.

In a press release, Merck and Schering said that not only did Zetia fail to slow the accumulation of fatty plaque in the arteries, it actually seemed to contribute to plaque formation — although by such a small amount that the finding could have been a result of chance.

Dr. Steven E. Nissen, the chairman of cardiology at the Cleveland Clinic, said the results were "shocking."

"This is as bad a result for the drug as anybody could have feared," said Dr. Nissen, a widely published researcher and senior consulting editor to the Journal of the American College of Cardiology. Millions of patients may be taking a drug that does not benefit them, raising their risk of heart attacks and exposing them to potential side effects, he said. Patients should not be given prescriptions for Zetia unless all other cholesterol drugs have failed, he said.

Over-reacting?  Maybe, but this is something I am now skeptical.  It has been two years almost since the author of the study concluded the clinical trials, and they have supposedly not sent the data on to the company until two weeks ago.  I began hearing rumors that there might be a problem with this drug a few months ago, but hadn't call the doctor to change prescriptions-waiting for the data.  The older drug has a better track record, and now that the data is in, I want to change to something with a track record of success.  

The House Energy and Commerce Committee, which is investigating the delay, said in a statement Monday that the negative results added to suspicions that the companies had deliberately sat on their findings from the study, which was known as Enhance.

"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," Representative Bart Stupak, Democrat of Michigan, said in the statement. Mr. Stupak is chairman of the committee’s Subcommittee on Oversight and Investigations.

Dr. Harlan M. Krumholz, a cardiologist at Yale, said drug companies had a responsibility to release all their trial findings, positive or negative, as quickly as possible — even if the results might hurt sales.

"People may have been on this drug without the ability to know that there was additional data that may have thrown into question its effectiveness," Dr. Krumholz said. "That’s extremely unfortunate, and that’s an understatement."

I do statistics and frankly, they must have been reanalyzing and looking at this data for months.  The study will be presented at a conference in March, but I am not going to wait.  I also suspect my somewhat inflated prescription price will go down with the older drug.

We need more data based decision-making for our drugs.  We should consider the possibility that the drug did lower cholesterol, and all prior drugs that lowered cholesterol lowered risk as reasonable.  But once they had data that indicated it wasn't better than a generic drug with a pretty good record, they owed it to us consumers to give us that information.

I already eat a low-fat diet, have been on Weightwatchers, try to exercise more,  but my genetics don't favor my success with this alone.  I'll be back at the doctors for a second look at my prescriptions.  Right now I have no vote of confidence in the pharmaceutical industry.  

Originally posted to murrayewv on Tue Jan 15, 2008 at 12:40 AM PST.

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