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Vytorin Debacle Sheds Light on FDA Drug Approval Policies | cialis online

Vytorin Debacle Sheds Light on FDA Drug Approval Policies

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The Vytorin controversy has caused criticism of a Food & Drug Administration (FDA) policy that allows drug companies to employ so-called “proxy markers” during clinical trials of new medications. Clinical trials for Vytorin, and the controversial drug Avandia both employed proxy markers. Because of the scandals surrounding Vytorin and Avandi,a some FDA critics are calling for the elimination of proxy markers, or changes in the ways drug companies may use them. Others counter that proxy markers are important because they help lower the costs of new drugs and bring life-saving drugs to the market faster.

Aa proxy measure is a surrogate for a drug’s broader and more important effect on the body. For example, the FDA approved Vytorin based on clinical trials that measured cholesterol reduction. It was believed that cholesterol reduction was an adequate proxy marker for reducing clogged arteries and heart attacks.

But as Vytorin has shown, proxy markers are not always an accurate measure of a more important outcome. Vytorin’s ability to lower cholesterol did not translate into less artery clogging plaque. In the case of another drug, Avandia, clinical trials that measured only blood sugar reduction did not make it apparent that the diabetes drug carried significant cardiac side effects that outweighed its benefits.

Some experts interviewed for a recent The Wall Street Journal article did not favor ending the use of proxy markers, but do want to see the FDA require follow up studies that measure the truly desired endpoint, and tight timelines for starting, completing and releasing data from such studies. “The FDA needs to have more teeth,” John Buse, a professor at the University of North Carolina, and a frequent critic of Avandia told the Wall Street Journal. “They need to demand hard endpoint studies at the time of approval and they need to have some system for monitoring progress.”

Other sources interviewed for the Journal article agreed, and went even further, saying that drug makers should face marketing restrictions until a medications’ desired endpoint has been proven. One suggested that direct-to-consumer advertising shouldn’t be permitted until those results are in. That expert also felt prescribing information, or labels, for such medicines should clearly reflect the uncertainty of the long-term benefit until the data are in.

Such monitoring might have been useful in the case of Vytorin. To measure whether or not Vytorin really did reduce artery clogging plaque in the carotid artery, Merck and Schering-Plough designed the ENHANCE study. Vytorin is a combination of cholesterol lowering Zetia and the statin Zocor. The point of the ENHANCE study was to determine how well Vytorin prevented clogged arteries by reducing the formation of plaque. ENHANCE focused on a group of 720 patients with a rare condition predisposing them to high cholesterol. The patients were given either Vytorin or a high dose of simvastatin, the generic form of Zocor. Vytorin did not provide any significant benefit versus the statin drug Zocor in slowing down clogging of the arteries. Overall, the study failed to meet its primary goal, which was to show whether Vytorin was more effective than Zocor alone in preventing progression of atherosclerosis in the carotid artery, which is in the neck.

ENHANCE was finished in April 2006, but was delayed twice before Merck and Schering-Plough finally released its results in a press release on January 14. Merck and Schering-Plough also tried to change the ENHANCE studies endpoint after it was finished, but a public outcry caused them to scrap those plans. Some think that it a desire to protect Vytorins $5 billion in annual sales that caused to the companies to attempt to manipulate ENHANCE and delay release of its findings.

A stricter FDA policy on proxy markers, as well as requirements on the handling of post-market studies like ENHANCE could have avoided the entire Vytorin drama.

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