Sunday, January 27, 2008

Merck and Schering Plough, scapegoats

By now the whole world has heard the story of the Vytorin trial, Enhance, which showed that the drug, a combination of Zocor and Zetia, was a failure. What this trial did--or should have done--is lay to rest the spurious cholesterol hypothesis for once and for all. But here's where I think the drug companies are getting an inappropriate amount of undeserved flack.

What's going on is that a cherished hypothesis is heading for the trash heap, and people are looking around for someone to blame.

So now we have NY Attorney General Andrew Cuomo investigating whether the two pharma companies that were collaborating on the drug, Merck and Schering-Plough deliberately buried the results of the Enhance trial.

Who knows whether or not they did this. But as damning as it sounds, the whole drama around the results is just a distraction. The real news here is that the trial failed, as did the Torcetrapib trial before it, which had the same results. And as long as we're assigning blame, why don't we consider some of the other, more obvious culprits? Maybe Mr. Cuomo should look in his own backyard.

For starters, there's the FDA. This government agency was so enamored of the idea that LDL is bad, it decided to approve any drug that lowered it, without requiring that the drugmaker show that the pill had any effect on heart disease. Then there's NHBLI, which has doggedly pushed the cholesterol theory. And what about university and government backed medical researchers? Shouldn't one of them have taken note of the mounting evidence against the hypothesis and done something about it?

And why, I might ask, is no blame placed at the feet of doctors--the men and women who routinely prescribe such treatments at Zetia and Vytorin and Tocetrapib without considering their worth. As any citizen knows, it's impossible to get through an appointment with one of these folks--no matter his or her specialty--without a lecture about the dangers of high cholesterol and saturated fat.

With all this in mind, I think we should cut these companies a little slack. Clearly, they were sincere in their belief that the drug would work. Otherwise, why would they conduct the trial? So instead of shooting the messenger, I suggest everyone stop and look at the message. Because when it comes down to it, we're all going to be looking to these evil, terrible drug companies for the next panacea.

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