Verdict: Heart drug's a bust
I remember when I was a kid poking around the woods — I got a kick out of turning over a rock and watching the bugs scurry, blinded by the sunlight. That image came to me as I pored over the latest study on the cholesterol pill Vytorin. Think of the drug manufacturers as scattering bugs.
A major European study has shed new light on the use of Vytorin in patients with heart valve disease, specifically aortic stenosis, finding that the drug didn't stop progression of the disease or alleviate the need for valve surgery. The drug performed no better than placebo at lowering the risk of major cardiovascular events in these patients.
Could this news be any worse for Big Pharma? Funny you should ask. The study also raised new questions about Vytorin's safety. Preliminary analysis of the data showed about 50 percent more new cancer cases and cancer deaths in patients who received Vytorin, compared with those who took a placebo.
Some researchers hustled to bring in data from two larger, ongoing Vytorin studies. In a hastily called press conference, they claimed there was no elevated risk of cancer. But just the possibility of such a link should give pause to patients considering this drug. Indeed, even mainstream experts have roundly criticized using data from incomplete experiments to refute results from completed trials, such as this one.
Researchers were hoping that Vytorin would offer a nonsurgical way to treat aortic stenosis by reducing cholesterol and plaque buildup. Aortic stenosis is a sometimes deadly condition, which can cause syncope (regular passing out), chronic chest pain and heart failure, that is becoming increasingly common in older folks and affects more than 5 million Americans to some degree.
Red flags were already fluttering for Vytorin, which is a one-pill combination of Merck's statin drug Zocor and Schering-Plough's Zetia. Statins block the formation of LDL "bad" cholesterol in the liver, while Zetia blocks its absorption in the intestines. A study earlier this year found that LDL reduction does not always translate into measurable medical benefits.
With this latest study calling into question the safety and effectiveness of Vytorin, I wonder how many strikes will it take before it's finally out? I don't know, but I volunteer to play umpire.
