Vytorin Cancer Link Opens Can of Worms

In an unprecedented change of posture the New England Journal of Medicine has reversed itself on the issue of whether Vytorin causes cancer. In the initial release of data back in July NEJM stood by Merck and Schering-Plough, who hired an Oxford consultant to rule that a 50% statistically significant increased risk of cancer was by chance. I pointed out in an earlier posting that such statistical manipulation, based primarily on the opinion of the Oxford reviewer, was ridiculous. NEJM has had a sudden change of heart and now agrees with me.

On September 2, 2008 NEJM published the full study in question, along with the Oxford report, and its own editorial now stating “Whether the increased mortality risk is due solely to the play of chance is uncertain. Ezetimibe [the Zetia portion of Vytorin] interferes with the gastrointestinal absorption not only of cholesterol, but also of other molecular entities [fat soluble antioxidants and isoprenoids] that could conceivably affect the growth of cancer cells….Physicians and patients are unfortunately left for now with uncertainty about the efficacy and safety of the drug.” This rare reversal of opinion has sent a shock wave through Big Pharma's world, like having your stamp of approval withdrawn at the last minute.

Vytorin is the controversial cholesterol lowering drug that is the center of a major advertising fraud that netted Merck and Schering-Plough over 10 billion dollars in sales in the past two years. Merck and Schering-Plough are facing congressional investigation, various state attorney general investigations, and plaintiff class action lawsuits. All the negative publicity has caused sales to fall off, yet the questionable drug is still a top seller for Merck and Schering-Plough in 2008.

Underneath the advertising fraud is a far more damaging prospect from the Big Pharma point of view, that the theory of lowering LDL cholesterol with drugs to prevent heart disease is itself a major fraud that has been perpetrated on the American public for the past decade. Indeed, while Vytorin is the most effective drug combination of all time in terms of lowering LDL, doing so does not produce cardiovascular health or reduce cardiovascular mortality.

The current study that uncovered cancer risk, called the SEAS trial, was supposed to prove that patients whose heart valves were partially blocked would benefit from Vytorin and not need valve replacement therapy or have heart failure. In this regard, the SEAS trial showed that Vytorin is worthless, despite lowering LDL cholesterol. This finding is consistent with another unrelated study (GISSI-HF trial) just published in the Lancet that showed fish oil was more helpful, while the statin drug Crestor could not. The researchers in this study concluded that “patients with heart failure should not be treated with statins.”

Adding more alarm to the statin industry's safety is another article published in the NEJM just last week. It reported on a detailed analysis of the human genome in those with statin-induced muscle damage. Scientists uncovered an alteration in a gene that causes statin drugs to be more readily absorbed by the liver, thereby making the drugs very toxic. 15% of our population has the risk-related gene variant. At this time no screening is done to see who is at potential risk, meaning that 1 in 6 patients taking statins are likely to be damaged to a greater or lesser degree based on this one variable alone. Whatever happened to “first do no harm.”

Adding fuel to the low cholesterol and cancer link was another study recently published in the Canadian Medical Association Journal that found a 33% increased risk of cancer and mortality in type II diabetic patients when their LDL cholesterol reached 107 and a 50% increase when their LDL reached 87. This is particularly alarming because type II diabetic patients (like Tim Russert) are aggressively treated with statins to lower their cholesterol to the very numbers that are now associated with increased cancer risk and death from any cause.

Pathetically, various forces in the Big Pharma world are recommending that children as low as 7 months of age have their LDL cholesterol levels maintained at 50 for their entire lives (which obviously will require statin drugs since such levels are highly abnormal). Big Pharma is always looking to expand their market share – focusing now on our children – a truly sad state of affairs.

Statin drugs do not produce cardiovascular health. The lower your cholesterol goes the more likely you are to develop cancer and/or die from any cause. This is massive public health fraud on a grand scale.