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Chapter 2  W h y i s bene f i t - t o-h a r m b a lance essential to treatment decisions? The 1962 amendments to the U.S. Federal Food, Drug and Cosmetic Act require that for a new dr ug to be approved for marketing, there needs to be substantial evidence of both safety and efficacy when the drug is prescribed for its inten ded indi cation( s). In other words, a drug has to have benef icial effects that outweigh any potential harm; it has to have what is known as a favorable, or positive, benefit-to-h arm balance. This is also true of other types o f interventions such as medical devices and diagnostic procedures.  What are the goals of treatment? In general, there are three main goals of treating a patient: - to make the patient feel better - to reduce the risk o f future disease complications - to improve survival There are those who include a fourth goal, “economic benefit,” both to the patient and to society , e.g., returning to work, supporting family, paying 5

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