Hey, so what if the results were in two years ago and the company didn't release them until right now, coincidentally right after (the Democratic) Congress got involved. I mean, sure, the drug doesn't really seem to work (and am I reading this correctly that it may actually make things worse?), but hey, it's only two years of people building up plaque in their arteries, and after all, who's ever died from a heart attack? How do these drugs even get approved? Why are we finding out now that it doesn't work, years after it was approved?
A clinical trial of a widely used cholesterol drug has raised questions both about the medicine’s effectiveness and about the behavior of the pharmaceutical companies that conducted the study, cardiologists said Monday.
Merck and Schering-Plough, which make the drug, Zetia, and a pill that contains it, Vytorin, said Monday morning that Zetia had failed to benefit patients in a two-year trial that ended in April 2006.
Merck and Schering repeatedly missed their own deadlines for reporting the results, leading cardiologists around the world to wonder what the study would show. At the same time, millions of patients have continued taking Zetia and Vytorin.
Much more after the jump...
The drug companies blamed the complexity of the data for the delay. Now, barely a month after news articles noted the delay and Congress pressured the companies to disclose the study’s findings, the results are out....
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....
“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....
Statins like Zocor and Lipitor have been shown to lower cholesterol by 35 to 60 percent in most patients and have also been proved to reduce heart attacks. Zetia, which works by a different mechanism, reduces cholesterol 15 to 20 percent, but it has never been proved to reduce heart attacks.
The Enhance trial was meant to prove that Vytorin’s combination of Zetia and Zocor would reduce the growth of fatty plaque in the arteries more than Zocor alone. Instead, the plaque actually grew almost twice as fast in patients taking the combination.
Reducing plaque growth is crucial, because plaque formation — known as atherosclerosis — can lead to the blockages and blood clots that cause heart attacks and strokes...
