Everyone not living in a cave understands that total cholesterol is linked to heart disease. We understand this almost entirely thanks to the development of the class of drugs called statins, of which Lipitor is king. But is this REALLY true?
Let’s take a moment a review the process by which drug therapies are developed, researched and marketed. We identify a condition such as heart disease. Then we study a large group of people and look at their rates of heart disease and try to find lab values that correlate with disease risk. In thas case, researchers found that those with low rates of heart disease had low total cholesterol levels. This is called an observational study and we use it to determine associations.
Then we find a drug that can modify the risk factor that we found. The drug than lowers the level of the risk factor (in this case, cholesterol) and the drug gets approved to lower risk of death for the disease. Did you notice that we skipped a step? These drugs were NOT approved based on their ability to lower the risk of the disease, but rather the RISK FACTOR for the disease.
So what if we were wrong in the observational study in the first place?
What if this $20 billion + a year drug class is based on weak data?
This particular study looks at how close the observational studies were to what is seen in the studies done later when statins were used in clinical trials. The conclusions of the authors are pretty powerful….
“If our findings are generalizable, clinical and public health recommendations regarding the ‘dangers’ of cholesterol should be revised. This is especially true for women, for whom moderately elevated cholesterol (by current standards) may prove to be not only harmless but even beneficial.”
Still want to refill your prescription for your statins, which, by the way, increase your risk of diabetes…?