This Article  • References  • Full text PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citing articles on Web of Science (6)  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Social Bookmarking   What's this?

Jere E. Goyan, PhD

JAMA. 1988;260(20):3052-3053.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

The 1962 amendments to the Food, Drug, and Cosmetic Act require that scientific proof of drug efficacy be established prior to marketing. During the years since, the Food and Drug Administration (FDA) has established an elaborate regulatory scheme for implementation that usually includes studies involving random allocation of patients to treatments (including placebo controls) and blinding of both patient and physician as to the treatment received.

Studies of this type are costly in terms of both time and money, but when properly performed they successfully balance out factors, other than the treatments themselves, that may affect outcomes. Such studies have been able to guarantee the United States the most reliable supply of safe and effective drugs in the world.

However, from the beginning, many have perceived a conflict between the needs of science to establish the validity of a new treatment and the needs of patients for early access to . . . [Full Text PDF of this Article]

Author Affiliations
University of California, San Francisco

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?