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High Profile Drugs Turn Out to be Duds

Apr 7, 2008 | Parker Waichman LLP

Millions of Vytorin users recently learned that Vytorin and its component drug, Zetia, failed to work as initially expected.  Final results of a clinical trial showed the drugs reduced LDL cholesterol, but failed to slow the buildup of artery-clogging plaque, thus suggesting they will do little or nothing to prevent heart attacks.  “It hasn’t hurt my body, but apparently it hasn’t done any good either,” said C.W. MacLeod, a 57-year-old Texas businessman, who has spent about $100 a month in co-payments for a brand-name drug that doesn’t work.

“If lowering your cholesterol doesn’t reduce your risk, then what’s the point?” another Vytorin user wrote on an message board about the issue. “Maybe I’m dense, but I just don’t understand.”  When MacLeod’s cholesterol shot up, he was thrilled to find a drug to bring it down, taking Vytorin for two years and believing his doctor’s assurance that as his "bad" cholesterol dropped, so would his risk of heart attack.

But, recently, some of the nation’s best-selling and most heavily promoted drugs have come under fire.  The popular diabetes drug, Avandia, may raise the risk of heart attack; antidepressants may work no better than placebo; and top cancer drug, Avastin, may slow breast cancer, but does not impact overall survival.  It’s a confusing situation for consumers who assume that widely used drugs are both safe and effective, said Fran Visco, president of the National Breast Cancer Coalition and a 20-year survivor of the disease.  “You want drugs that save lives, that have a significant impact on the quality of life,” said Visco, whose agency helps patients make treatment decisions.  “The drugs do not show these things.”

According to Dr. Harlan M. Krumholz, a professor of medicine at Yale University, the problems began in late 2006, when an increase in patient deaths halted development of torcetrapib, a promising cholesterol drug that boosted “good” HDL cholesterol.  This was followed by Avandia, which raised questions about the benefits of lowering blood sugar, and later by Vytorin and Zetia, which challenged the benefits of lowering LDL cholesterol, Krumholz said.  “It was a time to pause and say ‘Whoa,’’’ he said. “It has caused us to take a step back and say ‘How much do we really know?’”

Critics wonder if drugs are being released to market too soon and if—instead of relying on ultimate outcomes such as a reduction in heart attacks or strokes—many studies measure a drug’s effectiveness by using interim markers, such as lowered blood pressure.  The Food and Drug Administration allows  such markers because the cost is prohibitive when waiting for the results of large-scale outcome trials and the waits could possibly delay life-saving advances for millions, said Dr. Robert Temple, director of the agency’s office of medical policy.  But the practice has been called into question, said Dr. Nortin M. Hadler, a professor of medicine at the University of North Carolina.  “In our zeal to do modern medicine ... we’ve managed to lose our way,” he said. “We’ve forgotten to ask: ‘Does this matter to the patient?’”

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