According to a report in BusinessWeek,half of all heart attacks and newly-diagnosed cases of cardiovascular disease occur in people with normal or even low levels of LDL (the “bad” cholesterol).
Recent studies suggest that statins – drugs that are used to lower cholesterol – seem to benefit some people whose cholesterol levels are already low, but who exhibit signs of inflammation within their blood vessels. (1)
These findings imply that some other mechanism besides cholesterol – one that might be addressed through lifestyle changes or some other non-statin means – plays a significant role in the generation of coronary artery disease.
The National Cholesterol Education Program, the Framingham Heart Study, and Faulty Cholesterol Guidelines
For doctors who have tried to follow the recommendations of influential bodies like the National Cholesterol Education Program (NCEP) and whose practice protocols are based on data from the Framingham Heart Study (arguably the longest, most comprehensive, and most respected analysis of heart disease in the world) the news of cholesterol’s demotion must be sobering.
It is understandable that the Framingham Study is the yardstick for measuring a given individual’s risk for developing cardiovascular disease; after all, this longitudinal trial has been generating valuable information since 1948.
Unfortunately, despite the statistical power of the Framingham Study, it remains, in fact, a conglomeration of numbers – susceptible to mathematical manipulation and open to disparate interpretation.
For example, Framingham’s outcomes form the basis for the “treat-to-target” rationale used by most physicians to prevent heart disease in their patients. This concept, which is practically the standard of care in the United States, mandates the reduction of LDL cholesterol levels (almost always through the aggressive use of statin drugs) to below 70 mg/dL for people who are at high risk for coronary artery disease, and to less than 130 mg/dL for people who are not at high risk.
Such a reduction in LDL cholesterol usually parallels a reduction in total cholesterol, often to less than 160 mg/dL. Oddly enough, many medical experts, including John Abramson, MD, a Robert Woods Johnson Fellow, medical statistician, faculty member at Harvard Medical School, and author of Overdosed America, the Broken Promise of American Medicine, believe that lowering total cholesterol to such levels actually increases the risk of death from causes other than heart disease for both men and women after they reach the age of 50. (2)
Allan Spreen, MD, a panelist for the Health Sciences Institute, contends that Framingham data show that when total cholesterol levels fall below 160 mg/dL, the incidence of heart disease once again increases, indicating that the benefits from cholesterol reduction bottom out around that point.
Furthermore (and somewhat chillingly), the recommendations of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults – whose guidelines are incorporated into the NCEP – were promulgated by a group of individuals whose decisions may have been influenced by their relationships with statin-manufacturing pharmaceutical firms: Five of the 14 panel members who wrote the guidelines – including the panel chair – disclosed financial ties to these companies. (2)
Thus, it is possible that cholesterol guidelines disseminated to American physicians and their patients have been more intent on promoting greater statin use than on presenting a balanced interpretation of the science that surrounds heart disease.
Finally, to further reinforce the notion that doctors must rethink the cholesterol issue, a new study from Annals of Internal Medicine supports what some experts now believe is the best approach to preventing coronary artery disease.
In this trial, Dr. Rodney Hayward and his associates demonstrated that a “tailored” approach, where fixed doses of statin medications are administered based on an estimate of a patient’s net benefit, is far superior to simply increasing a patient’s statin doses to achieve a targeted cholesterol level. In fact, the research team could find no circumstances under which “treat-to-target” therapy was preferable to a tailored approach. (3)
Alas, it seems that addressing the modifiable risk factors for heart disease (smoking, obesity, sedentary lifestyles, poor diet, etc.) may once more become vogue; the days of simply pouring statins into a patient to reach an arbitrary and hitherto magical cholesterol level may be numbered.