NCL Health Issues
Cholesterol is a waxy substance made by the liver and supplied in our diet through animal products such as meats, poultry, fish and dairy. Cholesterol is needed (in the body) to insulate nerves, make cell membranes and produce certain hormones. However, too much cholesterol can be unhealthy. How do you know if you are at risk?
Why should you care?
Elevated cholesterol levels can significantly increase the risk of coronary events, such as heart attack and stroke.
What is cholesterol?
Cholesterol is a waxy substance made by the liver and also supplied in the diet through animal products such as meats, poultry, fish and dairy products. Cholesterol is needed (in the body) to insulate nerves, make cell membranes and produce certain hormones. However, the body makes enough cholesterol, so any dietary cholesterol isn't needed.
Why should you care?
Elevated cholesterol levels can significantly increase the risk of coronary events, such as heart attack and stroke. Excess cholesterol in the bloodstream can form plaque (a thick, hard deposit) in artery walls. The cholesterol or plaque build-up causes arteries to become thicker, harder and less flexible, slowing down and sometimes blocking blood flow to the heart. When blood flow is restricted, angina (chest pain) can result. When blood flow to the heart is severely impaired and a clot stops blood flow completely, a heart attack results.
Are you at risk?
An estimated 104.7 million American adults have high cholesterol (total blood cholesterol values of 200 mg/dL and higher) and about 37 million of these are consideredhigh risk, having levels of 240 or above.
A family history of high blood cholesterol increases the risk of heart disease. Other factors can contribute to a person’s risk of heart disease; these are called risk factors. Some risk factors such as age, family heredity, and gender (male), cannot be controlled. But others — such as smoking tobacco, high blood pressure, physical inactivity, and being overweight — can be controlled. Changes to these controllable risk factors are called “lifestyle modifications.”
For some, lifestyle modifications are enough to lower cholesterol to safer levels. For others with a hereditary pre-disposition, or who have a hard time making lifestyle adjustments, medical therapy is necessary.
Millions of people trying to control their cholesterol have turned to a class of drugs called statins, which have been used in the United States for more than 18 years to lower LDL (“bad”) cholesterol levels. They have been shown to reduce risk for heart attack and stroke by up to a third, and generally have few immediate short-term side effects.
An OTC statin?
Two companies are working to bring statin therapies — in doses identical to lower strengths currently available by prescription — over-the-counter (OTC). These low-dose options would be recommended only for individuals with borderline-high cholesterol. These companies believe that an OTC statin will both increase public awareness about high cholesterol and encourage people with moderately-elevated cholesterol levels (who don’t often seek treatment) to do something about it.
Recognizing that an OTC statin would have a large impact on consumers, in July 2004, NCL convened a small roundtable of consumer and patient advocates to discuss the issue, explore whether there is existing research on the subject, and discuss the possibility of further research by NCL. Following that meeting, NCL began working with Harris Interactive, an international survey research and polling firm, to conduct a study to explore consumers’ attitudes toward the possibility of an OTC statinoption. NCL commissioned Harris Interactive to conduct a survey with an unrestricted educational grant from Johnson & Johnson Merck. NCL will continue its collaboration with other interested groups to provide relevant information to consumers about statin therapy options. For the results of the study and more information about this issue, visit www.nclnet.org.
A number of stakeholders are awaiting FDA evaluation of the OTC statin options. We anticipate that the FDA will consider the following issues with great scrutiny:
- Would patients be interested in using an OTC statin if one were to be made available in the US?
- Would patients have enough information about the OTC product, written in clear language on the package, to determine whether it would be appropriate for them?
- Would patients have enough information about the OTC product, written in clear language on the package, to determine how to use it safely?
- Would patients be likely/willing to undergo the regular cholesterol testing required to determine whether, and to what extent, the medication is working?
- Would patients still talk with their doctors before and during treatment with an OTC statin?