TABLE 1 Recommendations Made by the IOM Committee on the Relationship Between Oral Contraceptives and Breast Cancer

Maintaining surveillance


  • Twenty to 40 years of epidemiological surveillance of appropriate cohorts to monitor risks and benefits of the long-term use of current and new formulations of the pill when used from an early age. This will assure the relative safety of all oral contraceptive formulations.

  • Establish international, cooperative research in surveillance studies.

  • Consideration of integration by the Food and Drug Administration of premarketing and postmarketing requirements to add greater emphasis on long-term safety.

Developing a broader array of contraceptives


  • Research and development of a broader array of contraceptives, including more effective barrier and nonsteroidal methods.

Assessing knowledge for use in clinical practice


  • The best available knowledge about oral contraceptives and breast cancer does not support any fundamental change in clinical practice with respect to use of oral contraceptives.

  • Reassess this knowledge base at regular intervals and in light of new research results.

  • Repeated NIH consensus conferences (beginning no later than three years hence) to regularly reassess guidelines for clinical practice.

  • Improve dissemination of new and existing information about oral contraceptives and breast cancer among health care providers and women who use oral contraceptives.

  • Provide women seeking contraception with adequate information and counseling relative to the current state of ambiguity with respect to the relationship between oral contraceptives and breast cancer.

Filling gaps in biological and epidemiological knowledge


  • Multidisciplinary research initiatives to resolve the relationship between oral contraceptives and breast cancer.

  • Implement a broad program of basic research in the biology of the breast.

  • Use of classical epidemiologic approaches to analyze the relationship of oral contraceptives and breast cancer, including (i) a large, case-control study involving primarily women below the age of 45, and (ii) a study of postmenopausal women—who experience the bulk of breast cancer incidence.

  • As biological markers become more generally available, they should be incorporated into epidemiological protocols.

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