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  • Title: Depo-Provera--ethical issues in its testing and distribution.
    Author: Potts M, Paxman JM.
    Journal: J Med Ethics; 1984 Mar; 10(1):9-20. PubMed ID: 6231379.
    Abstract:
    Ethical issues relating to the use of the injectable contraceptive in developed and developing countries alike involve public policy decisions concerning both criteria for testing a new drug and individual choices about using a specific form of contraception approved for national distribution. Drug testing consists of an important but still evolving set of procedures. Depo-Provera is not qualitatively different from any other drug and some unpredictable risks are inevitable, even after extensive animal experiments and clinical trials. In assessing the risks and benefits of Depo-Provera use, epidemiological data from large-scale human use is now beginning to become more important than data from animal experiments and clinical trials. The consumer's best interest is central to any ethically responsible system of drug distribution. Systems of informed choice are needed, even in societies where illiteracy remains common and medical services are weak. In the case of a contraceptive, the risks of non-use leading to unintended pregnancy, which can result in high mortality, are relevant as well as the side-effects of the method. An attempt, therefore, is made here to categorise those issues which are universal and those which are country-specific. Depo-Provera, an injectable steroid with both therapeutic and contraceptive applications, has not been approved for contraceptive use in the United States or the United Kingdom, although it is marketed for this purpose in many other countries. The authors analyze the public policy question of whether clinical trials and contraceptive use of the drug should be allowed in terms of risk-benefit assessment and the individual's right to make reproductive choices. They conclude that it is reasonable to test and distribute Depo-Provera in either developed or developing countries, provided that the potential user is given sufficient information to make an informed choice. Ethical issues relating to the use of the injectable contraceptive in developed and developing countries alike involve public policy decisions concerning both criteria for testing a new drug and individual choices about using a specific form of contraception approved for national distribution. Drug testing consists of an important but still evolving set of procedures. Depo-Provera is not qualitatively different from any other drug and some unpredictable risks are inevitable, even after extensive animal experiments and clinical trials. In assessing the risks and benefits of Depo-Provera use, epidemiological data from large scale human use is now beginning to become more important than data from animal experiments and clinical trials. The consumer's best interest is central to any ethically responsible system of drug distribution. Systems of informed choice are needed, even in societies where illiteracy remains common and medical services are weak. In the case of a contraceptive, risks of nonuse leading to unintended pregnancy, which can result in high mortality, are relevant as well as are the side effects of the method. An attempt, therefore, is made here to categorize those issues which are universal and those which are country specific.
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