Heart disease is one of the biggest issues in medicine today. It accounts for one in four deaths in the U.S. It’s the number one cause of death for both men and women. This means heart disease is an important focal point for public health policy. It also means it’s a huge profit center for pharmaceutical companies.
Today, statin drugs are the primary agent in the fight to prevent heart disease. They are used to reduce cholesterol, which is thought to contribute to heart disease. Lipitor alone, the most successful pharmaceutical in history, produced $120 billion in sales between 1996 and 2011. Unfortunately, it’s not clear exactly who benefits from these drugs. So when the US Preventive Services Task Force (USPSTF) published their new draft guidelines for statin use, the medical world took notice.
The new draft guidelines change the focus from cholesterol levels to risk profile. This mirrors the 2013 approach recommended by the American College of Cardiology (ACC) and the American Heart Association (AHA). Their recommendations apply to men and women aged 40-75 with no known heart disease. They promote preventive statin therapy if the ten-year risk of a cardiovascular event is 10 percent or more.
With this profile, dosage is based on risk alone. Target cholesterol levels are not used. The question addressed is no longer, “Who should be screened?” It’s, “Who should be medicated?”
The public comment period for these draft guidelines ends today, January 26, 2016. You can be sure the USPSTF inboxes are overflowing with comments. That’s because there are several problems with their recommendations.
The first problem is with the risk calculator they use. It was part of the AHA/ACC guidelines published in 2013. Many in the medical community find it to be an inadequate instrument. This New York Times opinion piece lays out the biggest issues. It underestimates risk for some, and drastically overestimates risk for others. Many involved in its creation had conflicts of interest that should have precluded their participation. The recycling of this calculator makes little sense, and the USPSTF's explanation of its use just shows how little we know.
The second problem is the potential risk of preventive treatment. Treating asymptomatic individuals is a sticky situation. You can create problems where none exist. Statin use can increase risk for muscle pain, memory loss, Type 2 Diabetes, and other issues.
The final problem is the benefit – is it significant enough to recommend preventive treatment for this population? The number needed to treat, or NNT, is 104 to prevent a non-fatal heart attack. This means that 104 individuals would need to be treated with statin therapy to prevent a single heart attack. The NNT is 154 to prevent stroke. There is some debate as to whether preventive treatment with statins prevents death at all in patients who don’t have established heart disease.
At the same time, one out of every 10 ten individuals on statins will develop some degree of muscle damage. One out of every 100 will develop diabetes.
As an aside, the benefits are clearer in individuals who have known heart disease, with a NNT of 83 to prevent death and an NNT of 39 to prevent a non-fatal heart attack.
No doubt we will have to wait a while before the USPSTF final guidelines are released. But in the meantime, if your physician wants to put you on a statin to prevent heart disease, ask about the risks and benefits. If she simply wants to recite the guidelines without engaging with you about your treatment, it’s time to find a new doctor.
Remember, you can always take things into your own hands. Eliminate highly processed foods from your diet and focus on including plenty of colorful fruits and vegetables on your plate. Get out and exercise. If you reduce your own risk for heart disease, you won’t have a doctor - or a drug company – trying to do it for you.
Amy Rogers MD is not a practicing physician and nothing written here should be taken as medical advice from either Amy or AssetBuilder. Medical decisions should be made with care in consultation with your health care provide