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Bad News on the Cholesterol Front?


A couple of reports hold bad news for some of us with high cholesterol. According to the New York Times, Zetia a cholesterol lowering drug that acts on cholesterol from food may not be effective. Zetia is probably best known as one of two cholesterol lowering medicines in Vytorin. The other cholesterol medicine in Vytorin , the statin Zocor is believed to be both relative safe and effective.What is interesting is that Merck and Shering-Plough, the companies that make these drugs repeatedly missed deadlines in reporting these these clinical trial results, meanwhile heavily marketing Vytorin. This trial, a small scale clinical trial involving 720 patients, was designed to see if the combination of Zocor and Zetia would have an enhanced cholesterol lowering effect and reduce the build up of plaques in arterial walls that lead to heart attacks.Zetia did lower cholesterol but unexpectedly increased plaque formation, raising concerns about its safety. Merck and Shering-Plough are conducting longer term clinical studies to examine of Zetia on the rate of heart attacks. The hope of the drug companies of course is that Zetia will be shown to lower the risk of heart attacks. But the the small scale clinical results related must have drug company executives sweating.Also, Merck and Shering-Plough are being investigated by the House Energy and Commerce Committee as to reasoning for the company's suspicious delay in reporting the clinical results.The finding that Zetia lowered cholesterol but seemed to increase the rate of plaque formation has led a few scientists to wonder if the link between cholesterol levels, specifically Low Density Lipoprotein or LDL, and heart disease is as simple as we currently believe. This concern is discussed in a second Times article here. This link is so well accepted that the FDA typically approves LDL lowering drugs if they are safe and lower LDL levels in the absence of completed long term clinical trials, on the drug's effectiveness at actually reducing heart attacks.Meanwhile large scale clinical trials on the experimental cholesterol lowering drug, torcetrapib, produced by Pfizer, were halted when scientists found that while the drug raised high density lipoproteins (HDL) and lowered LDL levels, contrary to expectations the drug increased the rate of heart attacks. This was bad news for Pfizer which desperately needs a new drug to replace Lipitor which is due to loose patent protection in 2010. Possibly, Pfizer went right away to long term clinical trials to save time. If so it probably was a wise decision in retrospect.Clearly lowering LDL levels and overall cholesterol level is a good thing, but there is a lot we don't understand about the details connecting cholesterol levels to build up of plaques and heart disease. Personally, I am on a statin (a generic of Zocor) and see no reason to stop taking it-it does lower LDL levels, unlike the pizza I just ate.These results do call into question again the way in which drugs are tested. The current system creates a clear conflict of interest between the ethical responsibilities of clinicians and scientists involved in drug testing and the high economic stakes for the drug companies. So how should we test drugs, and what should the role of drug companies be in drug testing? Can government's ability to oversee drug testing be enhanced? If so who will pay?


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