Safety and Efficacy of Fertility-Regulating Methods: A Decade of Research(*)

Article excerpt

Voir page 719 le resume en francais. En la pagina 719 figura un resumen en espanol.

Introduction

In 1984 an international conference on population in Mexico urged governments and funding agencies to allocate increased resources for research in human reproduction and fertility regulation. One of the needs highlighted was for "epidemiological research on the short- and long-term adverse and beneficial medical effects of fertility regulating agents" (1). This led to action by the Special Programme of Research, Development, and Research Training in Human Reproduction, established by WHO and now cosponsored by the United Nations Development Programme, the United Nations Population Fund, the World Bank, and WHO. The Special Programme formed a new Task Force on the Safety and Efficacy of Fertility Regulating Methods. Research on such matters had previously been conducted by task forces concerned with specific methods (2), but it was decided to increase epidemiological and biostatistical input to evaluate the issues of safety and effectiveness that arise after a method has been approved for marketing (3).

Statements about gaps in knowledge and research strategies in population studies are often published, but there is seldom critical review of the outputs of programmes -- including their successes and failures. In the decade since its research programme was launched, the new task force (renamed twice) has been responsible for the publication of over 200 scientific papers. The purpose of this review is not to document all this research, but to describe the process that ,,vas followed and the most important findings. An attempt is also made to assess the impact of the research on family planning policies and practice. It is sometimes alleged that mission-oriented research is doomed to failure, and that significant advances in knowledge nearly always result from investigator-initiated research. To what extent has this venture fulfilled its aims?

Selection of priorities

A steering committee for the new task force met for the first time in February 1985. It included 13 scientists from developing and developed countries, together with representatives of other agencies which support and conduct research in human reproduction. After reviewing published information and research in progress, the committee listed more than 100 questions about the safety or effectiveness of currently used fertility-regulating methods.

Priority was given to research relevant to developing countries, because most previous research had been conducted in Western Europe or the USA. Other criteria for selection included the feasibility and expected cost of suitable projects, and the likelihood that these might be undertaken by other agencies. Members of the committee presented their views on which topics deserved immediate attention. Following further discussion and debate about possible projects, the committee identified nine priority areas for research, as shown in Table 1.

Table 1. Research priorities identified in 1985

1. Contraceptive use during lactation -- effects on infant
health

2. Pelvic inflammatory disease and contraception

3. Cardiovascular disease and hormonal contraception

4. Cancer and hormonal contraception

5. Interactions between contraceptive use and disease

6. Morbidity due to female sterilization

7. Morbidity due to induced abortion

8. Safety of Norplant

9. Safety and efficacy of IUDs

Implementation of research strategy

Several different approaches were used for attacking research priorities. To answer questions about hormonal contraceptives and risk of cancer, particularly in developing countries, the task force assumed responsibility for an ongoing multicentre case-control study: the WHO Collaborative Study of Neoplasia and Steroid Contraceptives (4). In other instances, pilot projects were conducted before the launching of new multicentre studies, such as the WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception (5). …