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Lancet. 1994 Sep 10; 344(8924):698-700.Benagiano of the World Health Organization's (WHO) Special Program of Research, Development, and Research Training in Human Reproduction (HRP) stresses that the high standards of safety demanded in the testing and use of contraceptives should apply whether the subjects recruited to the studies are from developed or developing countries. The author of this commentary, however, with particular regard to transcervical quinacrine pellet research for nonsurgical female sterilization, criticizes the ethical and professional stand of Benagiano and HRP. He instead argues that the only sensible global standard for contraceptive research is a risk-benefit one which will vary according to the circumstances of the country involved in the research. Benagiano's September 3 letter is criticized as omitting an historical perspective and failing to discuss the differences of opinion concerning the appropriateness of proceeding with current and expanded clinical trials concurrently with additional toxicology testing. The author argues that in applying a developed country standard for contraceptive research to a developing country, HRP is making a value judgement based upon neither science nor logic. To support his argument, the author points to a difference between HRP guidelines and those of the WHO Special Program for Research and Training in Tropical Disease (TDR). TDR, unlike HRP, favors a risk-benefit guideline which takes account of the circumstances in which research is conducted. Although both programs follow accepted procedures for phase I, II, and III clinical studies, TDR is more likely to encourage these to proceed concurrently when the benefits seem to outweigh the risks of the trial. Feminist concerns discussed in Geneva, the self-imposed regulations of donor agencies such as the US Agency for International Development, the use of quinacrine as an anti-malarial drug, and North-South differences in contraception research are discussed.
ANNALS OF MEDICINE. 1993 Feb; 25(1):57-60.A key element of international support for family planning programs in developing countries is research in the development, evaluation, and introduction of family planning methods and services. These countries have the capacity to do high quality contraceptive research (from early preclinical research to phase III clinical trials). 3 international organizations are leaders in collaborating with researchers in developing countries to develop and support a network of clinical research centers in family planning. USAID assists 2 of these organizations because of its interest in family planning research: The Population Council and Family Health International. The Population Council's chief goal is the development and introduction of new contraceptive modalities. The Council developed Norplant, the sole new contraceptive approved by the US Food and Drug Administration in recent years. The International Committee for Contraceptive Research (ICCR) implements most of the Council's development program. ICCR consists of a group of research clinics and laboratories in Chile, the Dominican Republic, Finland, France, India, and the US. It is responsible for the development of 3 Copper-T IUDs and a levonorgestrel-releasing IUD. Family Health International conducts evaluation of family planning programs, epidemiological research in reproductive health, and clinical trials. WHO's Special Programme of Research, Development and Research Training in Human Reproduction is the other major player in family planning research in developing countries, specifically, assessment of contraceptive safety and efficacy, development of new contraceptives, and infertility. WHO and the Rockefeller Foundation have established a South to South collaboration in research to promote cooperation between developing countries. National and international agencies need to further develop and maintain these various international efforts.
POPULI. 1993 Feb; 20(2):12-3.The Delhi Declaration and Vision 2000 is IPPF's strategic plan for directing efforts through the end of the 20th century. This brave and angry plan points out the need for IPPF to interact more closely with women's groups and nongovernmental organizations to address the needs of marginalized people. Women's status is lower than that of men in most societies. During the 1980s, family planning (FP) programs in some developing countries (e.g., Bangladesh, Brazil, India, and Mexico) directly or structurally pressured women to become sterilized or take part in clinical trials of injectable contraceptives and subdermal implants. IPPF calls for more funds from donor governments for research and development because pharmaceutical companies do the research, but lawsuits, adverse publicity, and consumer campaigns have resulted in reduced pharmaceutical company supported research. Adverse publicity has also been waged against international FP and population control groups, mainly because they do not include women in decision-making roles in all aspects of contraception research. The Declaration calls for a wider women's role in making decisions affecting FP, sexual health, and reproductive rights. Developed and developing countries should share power and freedom. Contraception has brought about positive changes in women's lives, e.g., better health for mother and child. About 51% of couples in developing countries use FP methods, but 300 - 500 million married women who want to use contraceptive still do not have access to it. Since religion, tradition, and peer pressure influence family size, public education is needed. The media needs to become more objective when they report on FP successes rather than on 1 problematic sterilization. AIDS, more unsafe abortions, and unwanted pregnancies make this brave and angry plan even more relevant to addressing today's needs.