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Statins, Chronic Disease -- and the Definition of Insanity

Posted by John McDonough  March 11, 2012 06:00 PM

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Two recent developments -- an advisory from the U.S. Food and Drug Administration (FDA) and one new study -- caught my attention over the past week. This involves cardiovascular disease (CVD), statin drugs, type II diabetes, patient education and empowerment, and more. Neither seemed to get much attention, and to my knowledge, no one connected the dots between them. So let me give a try.

First, on Feb. 28, the FDA announced the development of new warning labels for cholesterol-lowering statin drugs, warning of the risk of type II diabetes and memory loss from taking the drugs. FDA pegged the risk as "small," but read a bit from this New York Times analysis by Eric J. Topol and judge for yourself:

"Let's just round this off and say that one in every 200 patients treated with any of the three most potent statins [Lipitor, Crestor, Zocor] will get the side effect of diabetes. That's quite a conservative number because diabetes was not even being carefully looked for in most of the trials. And we have data for only 5 years of treatment; it might be worse with longer statin therapy.

"More than 20 million Americans take statins. That would equate to 100,000 new statin-induced diabetics. Not a good thing for the public health and certainly not good for the individual affected with a new serious chronic illness.

"If there were a major suppression of heart attacks or strokes or deaths, that might be justified. But in patients who have never had heart disease and are taking statins to lower their risk (so-called primary prevention), the reduction of heart attacks and other major events is only 2 per 100. And we don't know who the 2 per 100 patients are who benefit or the one per 200 who will get diabetes! Moreover, the margin of benefit to risk is quite narrow."

100,000 new statin-induced diabetics. Hmmm. I have had more than a few statin-taking friends tell me the drug has no side effects. Yet, more and more reports are challenging that assumption.

Second, a new study in the Journal of General Internal Medicine found that only 10% of patients receiving stents were "presented with options to seriously consider." Most patients reported talking with their doctors about the reasons for the stents (77%), though only 19% recalled talking about reasons not to do so, and only 16% were asked about treatment preferences.

Treatment preferences? Like what?

Like serious diet, exercise, and other lifestyle changes.

I find it disturbing how little support and direction patients get to help them make lifestyle changes as an alternative to surgery and drugs. It is disturbing that so much of the medical establishment's message is about "managing and controlling" CVD and diabetes for the millions who suffer from these chronic diseases when both conditions are often reversible. The only options provided to most patients involve surgery, drugs, and maintenance.

Who buys the idea that there are alternatives? Lots and growing numbers of folks. Here are two.

Regarding CVD, Dr. Caldwell Esselstyn of the Cleveland Clinic has been working for about 30 years with patients who could easily have gone under the knife, and who chose instead his recommended plant-based, whole-grain diet as an alternative. His book, Preventing and Reversing Heart Disease, describes how his patients go beyond managing chronic disease to reversing it. No surgery, no drugs -- and no revenues/profits for hospitals, docs, or drug companies.

Think of it as the choice between the different paths taken by former Vice President Dick Cheney and former President Bill Clinton. Cheney, who had his first heart attack in 1978 at the age of 37 continues to live with the disease, because none of the conventional treatments provide cure, only maintenance. Now consider the alternative -- former President Bill Clinton who has embraced a vegan diet and got his weight down to what it was when he was in high school -- let's watch and see if he ever experiences another cardiovascular event again. If he stays with this diet and suffers another heart episode, I'll gladly eat these words. I don't think so.

Second, regarding type II diabetes, consider the work of Dr. Neal Barnard, President of the Physicians Committee for Responsible Medicine, a national organization of physicians who embrace the plant-based, whole-grain approach to health. Barnard's book is called Preventing and Reversing Diabetes, and describes his and others' work with diabetic patients who kicked their disease completely. So much of society's message on type II diabetes is that it's a life sentence and irreversible. It's often not true.

So here's where I get radical. Over many years, we have developed U.S. food and medical systems with enormous financial stakes in the occurrence and maintenance of chronic diseases which are preventable and reversible. We spend vast sums of money subsidizing a U.S. food system that guarantees an endless flow of new individuals with food-induced chronic disease. (Esselstyn, smartly, calls heart disease a "food-borne illness.") And then we spend vast sums of money paying for medical services to care for people with these preventable and reversible conditions.

And we spend next to nothing to prevent or reverse these conditions -- unless, of course, the preventative is a profitable procedure, drug, or device.

"Insanity is doing the same thing over and over but expecting different results."

Here's an innovation challenge I would like to see: let's have a national competition to see who can reverse CVD and/or type II diabetes in 1,000 patients and keep them that way for at least five years. Count up the costs and count up the savings.

Let's begin to kick our drug and surgery habits, and start acting to reverse chronic disease. Let's change the conversation from managing chronic disease to reversing it.

Now there's a way to fix U.S. health care.

This blog is not written or edited by Boston.com or the Boston Globe.
The author is solely responsible for the content.

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About the author

John E. McDonough is a professor of practice at the Harvard School of Public Health. He is the author of the book “Inside National Health Reform”, published in 2011 by More »

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