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More on Vytorin and Cancer.

Posted Sep 22 2008 10:59am

Lou points me to this article, which inspires me to beat up on statins a little more.

Earlier this year, the ENHANCE study pointed to a greater chance of cardiovascular death in folks taking a statin than controls. In fact, the greater the statin’s effect (the lower the patients’ LDL went), the greater the level of atherosclerosis! The statin in question? Vytorin, from Merck/Schering-Plough.

Well, in July, another study came out - the SEAS study. What the SEAS study showed was that patients on Vytorin had a greater, statistically significant chance of developing cancer vs. patients who were not taking Vytorin. In other words, take Vytorin, and you’re more likely to die of cancer.

This isn’t much of an intellectual leap - the science clearly shows that the lower your LDL cholesterol is, the greater your chance of dying. All-cause mortality increases, and patients tend not to die of (just) heart disease, but of liver disorders, mental disease, and cancers.

The makers of Vytorin, of course, claimed was that there was no discernible reason that the drug should cause an increase in cancer deaths and released a report by epidemiologist Sir Richard Peto that showed the cancer deaths to be statistical error.

“But, at the same time, they presented an analysis by Oxford University’s Sir Richard Peto, who argued there is “no credible evidence” of a link between the active ingredient in Vytorin and Zetia and cancer.

“I don’t think there is any evidence of hazard here,” concluded Sir Richard Peto, a cancer epidemiologist who is helping lead one of the drug company-sponsored studies.”

But are they merely error? Or is Sir Peto in err?

Well, Thomas Fleming, statistician at the University of Washington, doesn’t think the data should be blown off so quickly. Check out his awesome editorial in the New England Journal of Medicine, published yesterday. I’ll translate Dr. Fleming’s phD-speak into English:

Vytorin has a side-effect that probably promotes cancer (it blocks absorption of phytonutrients that are known cancer-fighters), so it’s probably worth looking into. Don’t just take this guy’s massaging of the data at face value; let’s test it. Besides, the data wasn’t even what the researchers were looking for - they just happened to notice their patients dying of cancer - so the data really isn’t that useful anyway. We need more and specifically-designed trials before we say, “Don’t worry, Mr. Jones. This pill is perfectly safe.”

It sounds almost comical. But contrast that with a quote from cardiologist Dr. Christer Hoglund:

“We don’t know that this drug is bad, but we don’t know that it’s any good either.”

Then why take it? And yet, cardiologists still prescribe Vytorin for heart patients. It goes to show, just because a drug has an incredibly delightful advertising campaign doesn’t mean it does anything good for you.

Let the buyer beware.

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