Dear Colleagues!  Today is Pharma Veterans Blog Post #179. Pharma Veterans shares the wealth of knowledge and wisdom of Veterans for the benefit of entire Pharma Community. It aims to recognize and celebrate the Pharma Industry Professionals. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. If you wish to share your stories, ideas and thoughts, please email to for publishing your contributions here.

Continued from Previous……

Controversy about Statins

Most information, and excerpts, for this part have been taken from the published article ‘Cholesterol confusion and statin controversy’ DuBroff R, de Lorgeril M. Cholesterol confusion and statin controversy. World J Cardiol 2015; 7(7): 404-4091

From the time the statins were introduced more than twenty years ago, the case for use of statins has been consistently built up through various clinical trials. The first major study, the 4S study demonstrated that the use of a cholesterol-lowering statin reduced mortality by 30%. Several more studies have been published later elucidating the efficacy and safety of statins. The USFDA has issued warnings about increased risk of diabetes and decreased cognition. More importantly, studies on the relationship between cholesterol and ischemic heart disease have not been able to show conclusively that the two have cause and effect relationship and that lowering cholesterol will reduce mortality due to heart disease or even all-cause mortality.

statin 2

Statins are among the top revenue generating products all over the world. Pharmaceutical industry therefore has a direct, intense interest to keep statins in news. More clinical studies are sponsored, published and presented at clinical forums; patient awareness campaigns focusing on cholesterol and heart disease are run; screening camps are arranged for prospective high cholesterol people who could become candidate for statin prescription.

We look at the associated facts more closely.

Relationship/ Association of Cholesterol with Cardiovascular Disease

The cholesterol theory aims to establish a link between cholesterol intake and blood levels with development of cardiovascular disease. Cholesterol is considered a risk factor for atherosclerosis and lowering cholesterol in the blood may be seen as the best way to prevent heart disease. However, risk factors do not affect everyone the same way and ideally, it should be distinguished as to who will or will not develop a disease. From the original Framingham Heart Study Data shows that the cholesterol levels of those who developed coronary heart disease and those who did not, were similar except when the total cholesterol level exceeded 380mg/dL or was less than 150mg/dL. Moreover, while cholesterol may be associated with coronary heart disease (CHD) but that does not prove that it actually causes it. Another important fact is that the studies designed to raise HDL (High Density Lipoprotein) or lower triglycerides have failed to reduce CHD mortality. Whether cholesterol control should become automatically become a treatment target, is under debate.

The rare incidence of CHD in isolated, rural societies such as Tukisenta, New Guinea has been attributed to low cholesterol levels. However, it is equally plausible that the diets and lifestyles of these individuals may protect from CHD. While we may never be certain about this, there is ample evidence that lowering cholesterol does not consistently lower CHD mortality. It is also recommended that the intake of dietary saturated fatty acids should be restricted in order to lower cholesterol levels in blood. However, an exhaustive review and meta-analysis of 72 dietary studies concluded that reduced consumption of saturated fat does not reduce cardiovascular mortality. Many drugs such as niacin, fibrates and bile-acid sequestrants can lower cholesterol levels, but the recent AHA/ACC guidelines on cholesterol concluded that these do not lower CHD mortality rates. Similarly, the results of cholesterol-lowering statins trials demonstrate that the statins do not consistently lower mortality rates.

Why then there has been so much hype about statins?

Early statin trials reported significant mortality benefits, yet serious concerns have been raised in some studies regarding biased results, premature trial terminations, under-reporting of adverse events, high numbers of patients lost to follow up, and oversight by pharmaceutical company sponsor. Heightened awareness within the scientific community regarding problems in clinical trial conduct and analysis – exemplified by the unreported risk of heart attacks in patients taking the pain-killers Vioxx (rofecoxib – later withdrawn) and Celebrex (celecoxib – still selling), led to new regulatory rules for clinical trials in 2005. It is curious to note that statin trials conducted after 2005 have failed to demonstrate consistent mortality benefit.


  1. 4330/wjc.v7.i7.404



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