FDA Requires Diabetes and Memory Loss Warning Labels for Statin Medications

Pharmaceuticals are a double-edged sword. With help can come harm, as the FDA recognized yesterday in its announcement requiring an addition to the labels of all statin medications of new warnings about increased risk of diabetes and memory loss , which are used to lower cholesterol levels.

Whenever considering use of a medication, there are two key questions. Are the benefits likely to outweigh the risks for a particular individual? And, is there a different method that is safer, more effective or less costly?

The prevention and treatment of heart disease is the main rationale for statins, which are the best selling drugs in history. Is there an alternative approach that is safer, or more effective, or less costly? It happens that there is a method that meets all of these goals — Dean Ornish’s program for reversing heart disease.

Ornish’s methods have been extensively researched over decades, with the results published in journals including The Lancet and the Journal of the American Medical Association, consists of a very low-fat vegetarian diet, exercise (walkign and yoga), and stress management methods including meditation and emotional support groups. In his 1990 landmark article in The Lancet, Ornish and colleagues demonstrated something previusly believed to be impossible — a decrease in plaqueing of the coronary arteries, as measured by quantitative coronary angiography and other scanning methods.

The Ornish program has been covered by insurance policies for many years and was recently approved for coverage by Medicare.

If I am less than enthusiastic about the highly-touted statins, it is because heart disease, with rare exceptions, is both treatable and preventable via the Ornish approach. (I provide a list of references on page 2 of this post.)

Most people are never told by their physicians that heart disease can be prevented through these natural methods, even though the scientific literature shows this to be beyond dispute. Why? First and foremost, I think it’s that contemporary medical practice, so skilled in diagnosis, still has a major blind spot when it comes to non-pharmacologic methods. In other words, the drug option is almost always the first option. And sadly, too often patients are not even told that there is an effective non-drug option.

Part of the problem is that there exists no equivalent of the multi-billion dollar drug company infrastructure to push the lifestyle-based, diet/exercise/stress reduction approach. That is one of the great tragedies of our time.

References after the jump for those wanting to explore the science more deeply …