JCL roundtable: Risk evaluation and mitigation strategy.

Many factors enter into the decision by the Food and Drug Administration (FDA) to approve a new drug for use by physicians and other health care providers in treating diseases. Initially, the FDA authority was restricted to issues of safety and only later did the documentation of efficacy become part of the review process required for approval. However, all drugs have the potential for causing harm at some dose level to all and at lower doses in certain patients with vulnerability to the particular pharmacology of the agent.

Atherosclerosis and teen eating study.

Background: Low-density lipoprotein, high-density lipoprotein, serum triglyceride concentrations, blood pressure, obesity, and blood glucose are all known to contribute to risk for development of atherosclerosis. Research demonstrates that dietary modifications, which reduce saturated fat intake, impact the likelihood of development of atherosclerosis.

Objective: The Atherosclerosis and Teen Eating Study was designed to determine whether a short-term health educational program, complemented by availability of alternative low-fat school lunches, could result in favorable changes to healthier eating patterns.