Depo-Provera--ethical issues in its testing and distribution.

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.

Involving Minority and Underrepresented Women in Clinical Trials: The National Centers of Excellence in Women's Health

“…Not only does this challenge the principle of informed consent, but women in communities of color often view the advances in contraceptive technology as efforts to commit genocide among their communities. [13][14][15] Policies emanating out of the crack cocaine epidemic of the 1980s and 1990s led to disproportionate testing of pregnant black women for drugs, without their knowledge, even though white women are just as likely to abuse drugs and alcohol during pregnancy. 16 In one study of nonpregnant, primarily black patients using a public hospital, involuntary drug testing was built into the research design.…”

Medicines For Women

“…On the other hand, the mass roll-out of the injectible contraceptive Depo-Provera in developing countries brings its own ethical and professional concerns, noted as early as 1984 (Potts and Paxman 1984). Are women given adequate risk information about the drug, including the FDA black box warnings about menstrual and bone-density problems?…”

Factors affecting acceptability of long-acting contraceptive injections in a rural Egyptian Community

“…Depomedroxyprogesterone acetate (DMPA or Depo-Provera) has been suggested as the contraceptive of choice for post-partum women. It is registered for use in Egypt and many other countries, such as the United Kingdom, but is not approved as a contraceptive in the USA (Benagiano & Fraser, 1981;Potts & Paxman, 1984). It has the advantage of providing several months of protection against pregnancy.…”