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Bad News Cholesterol Drug Data Withheld

Posted by Jane Akre
Tuesday, January 15, 2008 12:36 AM EST
Category: Major Medical, Protecting Your Family
Tags: Medical Malpractice, FDA and Prescription Drugs, Defective Drugs, Cholesterol Drugs


Cholesterol drugs may not be effective in lowering the risk of heart attacks and stroke


InjuryBoard Vytorin information

Zocor Information

Zetia Information

Cholesterol lowering drugs are big business, about $20 billion a year and Vytorin promised to be the breakthrough therapy that would address cholesterol from two sources “food and family” (the ads where your Uncle Pete dresses like a pizza). 

So the results of a two year study on Zetia (ezetimibe) which is given to about a million Americans and a companion drug Zocor (simvastatin), which together are marketed as Vytorin, was much anticipated.

Instead the results are bad news for drug makers Merck and Schering-Plough.

Completed in April 2006, the study shows that patients taking Vytorin had almost double the pace of artery clogging plaques formation when compared to taking Zocor alone.  Most patients are prescribed the two together in Vytorin.

Patients and their doctors now will have to consider whether to discontinue the drug the combined drug therapy as is in Vytorin, or opt for Zocor (simvastin) alone.

Zetia (ezetimibe) alone was found to lower levels by 15 to 20 percent of “bad cholesterol” or LDL.  Whether it also contributes to a risk of heart attack or stroke is unclear.

Cholesterol is the soft substance sometimes found in a harder waxy form lining the heart arteries increasing the risk of coronary heart disease and heart attacks. Found among the fats in the bloodstream, cholesterol helps cell membranes form and is used in the functioning of hormones.

Dr. Howard Weintraub, clinical director of the Center for the Prevention of Cardio-Vascular Disease at New York University Medical Center, New York City tells U.S. News and World Report that threat of cholesterol on the body is a real one.

"But, the real take-home message here is that getting LDL down is important, and that's not something that should be lost as a consequence of this study" he said.

Why did it take more than two years to complete the report?  In the meantime billions were made in the sales of Vytorin?

Maker Merck and Schering-Plough made available data that was completed in April 2006 but not released until Monday.  Public Citizen says that “Unfortunately, we are not surprised.” The drug makers tell the New York Times that the data was complex and needed analysis.

Public Citizen is reporting that the FDA failed to warn the public about the risks of Zetia and Vytorin and the potential for liver damage found in the FDA documents. The latest lax warnings join drugs such as Vioxx, Avandia and Zyprexa that the agency knew or should have known had serious side effects.

Reportedly some of the participants in the  study were dropped after they had raised liver enzymes, Schering-Plough confirms to the New York Times. If you want to see that full report you’ll have to wait until March.

Public Citizen, the consumer watchdog group had warned people to wait seven years to begin taking Vytorin on their Web site 2004 Worstpills.org.  

Back then, Public Citizen reports that FDA reviewers in the pharmacology department warned against approval of Vytorin because of serious toxicity in lab rats and it didn’t matter how small an amount was tested.  

Public Citizen says the drug industry was very generous in giving $400 million to the drug division of the FDA, the very division that gives approval of data submitted by the drug companies.

Zetia and Vytorin sales totaled about $3.7 billion in the first three quarters of 2007 and make up 70 percent of earnings for Schering-Plough reports the New York Times.

New drugs may be on the horizon as scientists announced Monday that they’ve discovered seven genes that affect HDL cholesterol, LDL cholesterol and triglycerides.

The discovery by University of Michigan researchers who analyzed the DNA from more than 8,000 people, may make it easier to develop drugs to “target” the genes and lower the risk of heart disease.  #



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