By now, you may have heard the debate. Earlier this month, the American Heart Association and American College of Cardiology published guidelines on lifestyle, obesity, risk assessment and cholesterol to help patients and physicians determine the best ways to prevent a heart attack or stroke.
In 2008, the National Heart, Lung, and Blood Institute initiated the development of these prevention guidelines. In June 2013, NHLBI invited the American College of Cardiology and the American Heart Association to work with them to assume the joint governance, management and publication of the guidelines.
The new cholesterol guidelines represent a sea change in that they no longer recommend patients shoot for a target cholesterol level. Instead, they recommend options based on an individual's risk of a heart attack or stroke. This new method of prevention and treatment has found its share of critics and has also been the subject of discussion among doctors and patients seeking to understand the new recommendations. The new methods of assessing cardiovascular risk were also groundbreaking, including for the first time not only heart attack, but also stroke, and also allowing the tool to provide guidance specifically for African-Americans.
Many media covered the guidelines for what they are: recommendations that are the end result of a long scientific process that will likely result in millions of people living healthier lives. But controversy drives clicks on Web pages, ratings for television and circulation numbers for newspapers. So breathless reports of flawed guidelines, conflicts of interest and over-prescription of the cholesterol lowering drugs commonly called "statins" soon followed. The stories raised questions in the minds of many Americans about what the guidelines could mean to them. Never mind that many criticisms are dispelled by simply reading the guidelines.
One in three Americans die of a cardiovascular disease, so separating truth from myth about these guidelines could be a life-saving exercise. If you've followed this story, you've probably heard at least one of the myths below. But they've all found their way into media coverage of the risk assessment and cholesterol guidelines. Now let's shine a light to reveal the truth, uncontroversial though it may be.
Myth 1: Lifestyle choices no longer matter since the guidelines recommend medications for nearly everyone.
Truth: Anyone pushing this myth clearly did not read the guidelines. Of course, there is a whole guideline on lifestyle alone. And the cholesterol guidelines clearly state, "It must be emphasized that lifestyle modification (i.e., adhering to a heart-healthy diet, regular exercise habits, avoidance of tobacco products, and maintenance of a healthy weight) remains a critical component of health promotion and ASCVD risk reduction, both prior to and in concert with the use of cholesterol-lowering drug therapies."
In other words, lifestyle choices matter and should be considered before and during any treatment with statins. The American Heart Association has, and always will, encourage Americans to move more, eat well, and avoid smoking. These are the universal and simplest ways to reduce your risk, not only of heart disease and stroke, but of many other diseases as well. Anyone who claims we've strayed from this message simply isn't listening.
Myth 2: The new guidelines will lead to physicians unnecessarily prescribing you a statin.
Truth: These guidelines offer recommendations based on a new risk calculator developed to estimate your future risk for a heart attack or stroke. If your estimated risk falls in the top one-third of adults, the guidelines suggest consideration of statins. Of course, not everyone in the top third of risk should take a statin, because, as the guidelines point out, that number alone doesn't determine a specific treatment. Patients and their physicians or other healthcare providers determine individualized treatment together. The guidelines are simply a tool, based on the best evidence currently available, to help them make those decisions. It's estimated that approximately 30 million people are currently prescribed a statin. Using these guidelines, we estimate that about 32 million people will be encouraged to discuss the risks and benefits of statins with their physician. But at the end, our goal is to have more of the right people -- those who will benefit the most -- and fewer of the wrong people taking these medications.
Myth 3: The guideline development process was influenced by the pharmaceutical industry.
Truth: When the National Heart, Lung, and Blood Institute started the guideline development process, they established a disclosure policy to prevent the pharmaceutical industry from influencing these prevention and treatment guidelines. The writing panel chairs, fellow panelists and expert reviewers, completely and precisely followed the policy -- in some cases, going beyond what the policy requires to further establish the panel's integrity.
Furthermore, panel members were asked to disclose any conflict of interest information to the full panel in advance of any deliberations. Members with conflicts were asked to recuse themselves from voting on any aspect of the guideline where a conflict might exist. These policies were in effect when this effort began in 2008 until the process was transferred to ACC/AHA in 2013. In the interest of transparency, the ACC/AHA requested that panel authors resubmit disclosures as of July 2013. None of the ACC/AHA expert reviewers had relevant relationships with industry.
Importantly, almost all statins, including high potency ones, are now available as generics, and the guidelines call for the use of cholesterol-lowering drugs that have proven that they can prevent heart attacks and strokes, rather than just change a lab value. This is hardly a boon to the pharmaceutical industry, and while that may be a hard pill to swallow for the pharmaceutical industry, it's right for the patient.
Myth 4: Statins have many side effects that cause more harm than good.
Truth: Many studies, and especially the most recent analyses of the available data, show that statins are very safe medications. While side effects can occur, virtually all of them are quickly reversible, and are not life-threatening, unlike the heart attacks and strokes they prevent. The most recent Cochrane analysis shows a decrease in deaths, in all cardiovascular events, in all coronary events, in total stroke events, and in procedures needed to restore blood flow to an organ or to save a limb. An increase in Type 2 diabetes was seen in one of the two trials that analyzed it carefully, but studies have shown that even this risk is outweighed by the benefits of this class of medications. Of course, patients should always discuss the risks of any medications with their health care provider and should report any side effects promptly.
Myth 5: The new risk assessment calculator is flawed and should be ignored.
Truth: The new risk assessment equations, and the calculator based on them, are based on the best available scientific data. They are a significant improvement over previous approaches, which were based on studies that focused primarily on Caucasian men, following their risk factors and their development of heart disease over time. Those familiar approaches were based on the best patient data available at the time. We now know cardiovascular diseases may develop differently in different populations, and we know that the chance of having a stroke is very important to most of us. The new guidelines are based on data that allows African-Americans, for the first time, to assess the risk specific to them. In addition, for all of us, the guidelines include an assessment of our risk for both heart attack and stroke, which was not calculated in the previous risk tools. And for young individuals, especially women, the ability to look at their risk over their lifetime rather than just the next 10 years, gives them greater power to make choices now, while there is still time, that will give them longer and healthier lives.
Science evolves. New data will be considered as it becomes available. So future generations of guidelines will be better than the ones published this month. But to criticize these guidelines based on the limitations of available data misrepresents the scientific process, and is a disservice to patients who will benefit from this information.
To paraphrase Mark Twain, a myth can travel halfway around the world while the truth is putting on its shoes. But we know the truth about how to prevent most heart attacks and strokes. These guidelines show us the way. Embrace a healthy lifestyle, know and understand your risk and work with your healthcare provider to lower that risk and live a healthy life free of cardiovascular diseases and stroke.