Title: Safety of oral contraception.

POPLINE Document Number: 702189

Author(s):

Mastroianni L Jr

Source citation:

Fertility and Sterility, March 1970;21(3):281.

Abstract:

The recent U.S. Senate hearings on oral contraception have engendered statements of opinion from both The American College of Obstetricians and Gynecologists and the Board of Directors of the American Fertility Society. Both have endorsed the Second Report on Oral Contraceptives of the Advisory Committee on Obstetrics and Gynecology to the U.S. Food and Drug Administration (FDA), which gives tacit approval for the continued prescription of oral contraceptives. Confusion regarding oral contraceptive usage stems from the difficulty involved in assessing and interpreting numerous variables. Such evaluation is necessarily influenced by the moral, ethical, social, political, economic, and medical attitudes of the assessor, as well as the user. Inasmuch as we do not have a legal definition of "safety," our actions are modulated by the collective opinions of responsible agencies - in this case the FDA. Presently there is no consensus on what comprises adequate toxicity evaluation of pharmacologic agents in general. The unqualified assumption that observations in the laboratory animal are uniformly applicable to the human is not justified. Furthermore, in interpretation of human data, hereditary and social factors must be considered. It is generally acknowledged that associated serious side effects of contraceptive pill usage occur infrequently. Causal relationships are difficult to establish, but the possibility of such relationships cannot be dismissed summarily. Since these agents are so utterly effective as contraceptives, any potential hazard must be weighed against the medical and social risks of an undesired pregnancy, as well as the risk of daily activity. The public has a right to accurate, unbiased information. Overreaction to some preliminary findings does not serve the best interests of either the public or science. Careful, responsible reporting and interpretation of data within the context of a given study are to be encouraged. There must be continued efforts to establish reasonable guidelines for the use of all pharmacologic agents, including the "pill". Physicians are accepting increasing responsibility for society's needs. Contraception is no exception. It is clear that every effort must be made to make periodic physical examinations, with cytologic studies, available to all. A careful review should always be undertaken to uncover potential contraindications to any contraceptive practice. Such comprehensive care necessarily includes helping the couple in their selection of the contraceptive modality most appropriate to their individual circumstances. Within such limitation, the oral contraceptives are a reliable therapeutic method and may yet prove to be the most valuable contribution to the welfare of society in the past decade. (FULL TEXT)

Keywords:

Oral Contraceptives
Standards
Contraceptive Methods
Contraception
Family Planning
Research Methodology