Oral Contraceptives and Breast Cancer (1991) / Chapter Skim
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5. Policy Issues and Recommendations
5. Policy Issues and Recommendations
Pages 61-67
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From page 61... ...
In view of the high costs, in human and financial terms, associated with a continuously rising incidence of breast cancer and the potential importance of any possible relationship with oral contraceptives, the committee offers recommendations that address four policy areas: maintaining surveillance; · developing a broader array of contraceptives; · assessing knowledge for application in clinical practice; and · filling gaps in biological and epidemiological knowledge. Taken together, the committee's recommendations call for a new, more explicit level of planning, investment, and commitment directed toward the study of breast cancer in general and its relationship to steroid hormones in particular, oral contraceptives.
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From page 62... ...
Plans are already being formulated to establish sound Medicare data bases and cohorts to permit studies of the effectiveness of medical interventions (Heithoff and Lohr, 1990~. Consideration should be given to ways in which linkages with the new Medicare data bases could be used to explore the influence of earlier oral contraceptive use on breast cancer incidence among older, postmenopausal women.
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From page 63... ...
Yet, the information from premarketing testing alone cannot answer questions about rare adverse or beneficial effects, such as those central to any consideration of oral contraceptives and reproductive cancers. The Phase III clinical trials of new drugs required by FDA for new drug application approval cost between $10 and $30 million per trial and are paid for by the developers, or manufacturers.
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From page 64... ...
It will take many years of careful study to acquire as much information about a completely new method of contraception as is now available about oral contraceptives. ASSESSING KNOWLEDGE FOR APPLICATION IN CLINICAL PRACTICE Health care providers and patients are compelled to make clinical decisions about the use of oral contraceptives based on the best knowledge available to them.
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From page 65... ...
These channels include continuing medical education courses, the technical bulletins and other activities of the American College of Obstetricians and Gynecologists and other professional organizations, the activities of state and local health departments, services delivered by the health units of colleges and high schools, and the "one-on-one" contacts so common to the health profession. The committee emphasizes the obligation of health care providers to offer adequate, accurate information to women seeking contraception and to counsel them regarding the current state of ambiguity with respect to the relationship between oral contraceptives and breast cancer.
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From page 66... ...
One such study is currently being conducted by the National Cancer Institute; it involves primarily women below the age of 45. A study of postmenopausal women who experience the bulk of breast canceris needed to elucidate the effects of both oral contraceptive use alone, and oral contraceptive use followed by hormone replacement therapy.
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From page 67... ...
The cost of such action must be weighed against the sobering costs of inaction: increased suffering and loss of life, the cost of treating breast cancer, and the cost of mammography screening programs, which lead to earlier detection but not to primary prevention. With oral contraceptives now being used by an estimated 10.7 million American women (Mosher and Pratt, 1990)
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