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The Rise of Cholesterol as a Risk Factor

I don’t plan to use this blog to debate cholesterol risks or statin benefits. I do, however, want to talk about how the marketing of cholesterol as a risk factor paved the way for the triumphant rise of statins. Today, America holds the worldview that high (LDL) cholesterol is bad regardless of age, sex, race, and/or personal or family medical history. How did this worldview come about?

These days, it is taken for granted that you are less likely to die from cardiovascular disease if you take pills to lower your cholesterol levels. This medical wisdom is so pervasive that total US statin sales were $16.9 billion in 2012–2013. Lipitor, the gold standard of cholesterol-lowering statins, continues to generate roughly $2 billion per year in sales for Pfizer, even though its patent expired 8 years ago.

Copernicus feared excommunication for saying that the sun, not the earth, was the center of the universe. Galileo published a book saying the same thing, but recanted to spare himself from being burned at the stake (although he did spend the last 8 years of his life under house arrest!). Fortunately, medical scientists who question the status quo no longer face such harsh punishment. However, we tend to hear not from the heretics, but from the medical experts who have a worldview similar to that of the pharmaceutical industry. 

The Rise of Cholesterol
Lovastatin, the first statin, was approved by the FDA in 1987. “Me too” statins flourished over the next decade. Pharmaceutical companies now had to develop new markets for these new agents. The problem, however, was that doctors did not consider high cholesterol a major health issue.

A 1983 National Heart, Lung, and Blood Institute (NHLBI) survey of 1,610 physicians reported that 91% of doctors believed quitting cigarette smoking would reduce heart disease risks, and 86% said that treating high blood pressure could help lower rates of heart disease. Only 40% of physicians, however, said that lowering high cholesterol lowered risks of heart disease. Just 3 years later, the updated NHLBI survey revealed that a considerably higher number of physicians — 64% — now believed that reducing cholesterol levels would reduce heart disease. 

The Marketing of a Risk Factor
Publication of the LRC-CPPT study in 1984 [link to ] and the formation of the NHLBI’s Adult Treatment Panel (ATP) contributed to the new emphasis on high cholesterol, but so did the powerful pharmaceutical industry’s reeducation efforts over the following decade. 

Drug companies aggressively publicized findings from studies like the Framingham Heart Study and MR FIT (Multiple Risk Factor Intervention Trial) that supported the benefits of lowering cholesterol. I myself wrote one of the first cholesterol speaker slide programs that key opinion leaders (KOLs) used to educate their peers. Its purpose: Persuade physicians that cholesterol was a primary risk factor for heart disease.

Disease Education in America
Highly acclaimed researchers may question the status quo; however, they face limited means for distributing their points of view. They may publish papers or Op Ed pieces, but their impact is limited because they lack the means to speak to a wider audience.

In contrast, industry funds KOLs to communicate selective evidence through educational, publishing, and marketing channels. Pharmaceutical companies retain an army of public relations specialists, medical communication firms, and continuing medical education agencies who are paid handsomely to book KOLs at conferences, get their articles published in medical journals, and arrange for them to be interviewed by the news media. Medical information that is not generated by industry, or that is likely to shake up the status quo, is unlikely to be publicized. How many primary care clinicians and consumers, for example, know the reasons that European statin guidelines are much less aggressive than US guidelines?

Consider a study on cholesterol reduction and life expectancy published in Annals of Internal Medicine in 1987. The authors concluded that a lifelong program of cholesterol reduction in low-risk persons aged 20 to 60 years would increase life expectancy 3 days to 3 months. The authors calculated gains ranging from 18 days to 12 months for high-risk patients. The debate over who really benefits from statin therapy continues to this day, with a lot of dollars riding on these decisions. 

European vs US Guidelines
The 2013 ACC/AHA guidelines increase the number of people who would receive statins to 8.2 million additional adults. The guidelines would expand treatment among patients who were previously thought to be at moderate risk, and would increase the intensity of treatment for many patients at high risk. 

Many organizations publish guidelines or statements on the use of statins for primary prevention of cardiovascular disease: the American College of Cardiology/American Heart Association (ACC/AHA); the UK’s National Institute for Health and Care Excellence (NICE), the Canadian Cardiovascular Society (CCS); US Preventive Services Task Force (USPSTF) and the European Society of Cardiology/European Atherosclerosis Society (ESC/EAS). These guidelines differ dramatically in their assessments of the number of patients who need primary preventive care. But from the perspective of drug companies whose profits are driven by price and volume, the more the merrier.

The 2016 USPSTF guidelines recommend low-to-moderate dose statins to a much narrower population — those 40 to 75 years of age with 1 or more CVD risk factors (i.e., dyslipidaemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 10% or higher. The USPSTF concluded that there was insufficient evidence available to determine whether initiating statin use in adults 76 years and older not already taking a statin could reduce the incidence of CVD events and mortality.

Someday in the future, medical experts without biases will inform our choices regarding pharmaceutical care. However, this will require a radical change in the ways that healthcare information is developed and disseminated. American healthcare is driven largely by the dictates of industry. As long as this is the case, let us be grateful for researchers and public health specialists who, like Galileo, are not afraid to speak out, whatever the consequences, whatever the cost.