The Lipid Research Clinics Coronary Primary Prevention Trial, LRC-CPPT
This massive seven and a half-year study, begun in 1973, using 3800 randomized men with “primary hypercholesterolemia” taking 4 to 5 packets per day of foul-tasting, constipating cholestyramine resin (total packets 3,500,000) did not save one life but did reduce coronary events by 1.5%. But even this marginal result was enough to engender the cholesterol myth which was later to be exploited by the makers of statins, the best selling and most profitable drugs in history. We remember cocktail parties of the mid 1980′s, before the statins were licensed, where the main topic of coversation was how many packets of cholestyramine one should take per day to prevent a heart attack and prolong life.
LRC-CPPT was run by the National Institutes of Health under pressure from the public to something about the epidemic of heart attacks and strokes. Although the NIH realized that the disease was mostly diet related and stated in the LRC paper that “The most appropriate clinical trial of the efficacy of cholesterol lowering would be a dietary study, because of the links between diets high in saturated fat and cholesterol typical of most industrialized populations, high plasma total and LDL-C levels, and a high incidence of CHD.” But “…the 1971 National Heart and Lung Institute Task Force on Arteriosclerosis recommended against conducting a large-scale, national diet-heart trial in the general population because of concern regarding the blinding of such a study, the large sample size, and the prohibitive cost, then estimated to range from $500 million to $1 billion.” The NIH didn’t seem concerned that it was impossible to do a blinded trial with cholestyramine because just about everyone on it gets constipation and/or bloating. Spending that money at that time would have been a bargain. In constant dollars the same amount of money is spent today in less than week on drugs and procedures for atherosclerosis, all of which would be unnecessary if the population had adopted a non-atherogenic diet in 1984 and the pandemic or obesity and Type 2 diabetes would have been averted. One suspects that NIH was under some pressure from the White House of Richard Nixon, a Republican under great stress from the Vietnam war and then the Watergate scandal, not to alienate the cattleman, dairy farmers and food processors and so backed off of any “radical” dietary experiment. One would also like to know who sat on Task Force on Atherosclerosis that advised drug treatment for a lifestyle disease and if they had any connection to the drug industry.
Note also that the LRC-CPPT recruited only men with primary hypercholesterolemia, a rare disorder of lipid metabolism that affects at most one in five hundred of the population and a very small fraction of the total number of people dying of heart attacks. The results, insignificant as they were, were then extrapolated to the entire population without primary hypercholesterolemia.
So it was left to small independent groups to do the right thing. Obviously, a blinded diet trial is impossible but randomization can be done. Even small diet trials such as those of Ornish, STARS and Lyon show dramatic reductions in coronary events in a shorter time than the LRC-CPPT as well as proven regression of plaque in the cases of Ornish and STARS and with no change in blood lipids in the case of Lyon. The NIH missed the boat at the start because of its fixation on blood lipids and political timidity and cost the US and the world untold billions of dollars, millions of deaths and much misery. As it turned out, deaths from atherosclerosis had already begun a steady decline beginning in the late 1960′s, probably due to a general improvement in nutrition and a reduction in smoking, a decline that had nothing to do with drugs or procedures for atherosclerosis because they had yet to be invented.
Note again, as in the WOSCOPS trial, how a small absolute reduction in events gets translated into a much larger relative reduction through the magic of taking a ratio of a ratio.
The importance of this absurd trial cannot be overemphasized. To quote Dr. Daniel Steinberg:
“The positive result of the CPPT trial prompted the NIH to convene a panel of experts to advise whether the evidence was now strong enough to justify policy recommendations regarding control of cholesterol. The panel, which I [Daniel Steinberg] chaired, reached unanimous agreement on an interim set of guidelines and recommended that the NIH initiate a national program to educate patients and practitioners on the importance of controlling blood cholesterol levels. About 600 interested health professionals attended a 2-day set of formal presentations and were invited to comment and to add new data they considered relevant. The following year the NIH launched the National Cholesterol Education Program, which has been highly successful.” As we said above, the results in a highly selected group with primary hypercholesterolemia was extrapolated to the entire population with no justification. The cholesterol myth was entrenched by this meeting.
The NCEP has only been “highly successful” in selling hundreds of billions of dollars worth of statins. There is no evidence that the life expectancy of the general population (primary prevention) has been increased by the NCEP but there is strong circumstantial evidence that the NCEP has also been very successful in encouraging the pandemic of obesity and Type 2 diabetes which will eventually kill many more people than could ever have been saved by lowering blood cholesterol with drugs.