The Chloresterol Mystery

Anyone who knows me has heard my rant about the lack of evidence that Cholesterol at moderate levels has any relationship with heart disease. Now it seems that some vindication may be in the wind. The New York Times’s Alex Berenson reported that two widely read studies of cholesterol lowering drugs were not able to establish that the drugs provided any medical benefits to patients. Of particular note was the questioning, mentioned at the end of the article, of the assumption that cholesterol levels are related to heart disease in the first place. In a quote from the article we can see that it is a questionable foundation on which this assumption rests.

“Because the link between excessive LDL cholesterol and cardiovascular disease has been so widely accepted, the Food and Drug Administration generally has not required drug companies to prove that cholesterol medicines actually reduce heart attacks before approval. They have not had to conduct so-called outcome or events trials beforehand, which are expensive studies that involve thousands of patients and track whether episodes like heart attacks are reduced.”

In other words, the link between moderately high cholesterol and the incidence of cardio-vascular episodes like heart attacks is not as certain as the public has been lead to believe. Moreoever, there is little evidence that dieting, even extreme low fat dieting, can lower cholesterol by more than a few percentage points, so the medical community has turned to their usual remedy, medicines.

But the medicines are far from benign. And worse, the long-term studies assessing the effects to taking these drugs over many years have not been done for the simple reason that the drugs are relatively new. So no one really knows what the cost of taking, say Lipitor, for ten years. Is anyone doing these studies?

Yes these trials are expensive, but they are critical to setting health policy. Billions has been spent on the assumption that increasing cholesterol levels leads to increased risk of cardio-vascular disease. Is there any scientific basis for this assumption? Who should do the studies needed to answer the question.

Under recent administrations research in this area has been left to the private sector and, for the most part, the research has not been done. Expense is the issue, but in the light of the fact that pharmaceutical industries are among the most profitable industries in the country, what is their obligation to do research for public benefit, not only resrearch into their own products. But their interest is obviously in developing the allegedly cholesterol lowering drugs. They have been accused of not working very hard on an HIV vaccine because the profit is in treating the disease, not eradicating it. The pharmaceutical industry does not want to hear that lowering cholesterol shows little benefit and may, in fact, increase harm. We know only to well how some companies have hidden negative research results in the past. Someone without a profit motive must do the research and that would be the government.

My original questioning began when I read an article in The Atlantic Monthly entitled (if memory serves) “The Chloresterol Myth: A Journalistic Failure.” It was written by Thomas J. Moore and was a part of his subsequent book, Heart Failure: A Critical Inquiry into American Medicine and the Revolution in Heart Care published in 1990. My attempt to find the original article on the Atlantic Monthly archive service was unsuccessful, but I was able to get the text of the article and have created a link to it.

My point of including this subject here (other than a satisfying ‘I told you so’) is that another example comes forth where the medical research supporting clinical protocols is simply often not there. Physicians like to think of themselves as scientists and they study a lot of science (to good effect). But when it comes to doing research they are not very well educated, I’m disappointed to say. Their use of even rudimentary research design expertise and their frequent mis-use of statistical techniques has been shown again and again.

What is particularly disappointing in this season of nearly obssessive conern for the healthcare (non) system, is that when one considers the hundreds of millions spent on drugs, diets, etc. to lower cholesterol we are left wondering if it was spent for naught. Who could tell? Sure cardio-vascular disease has gone down, but epidemiologically that probably has more to do with the decrease in smoking than the advent of a diet of lawn clippings.