Developing multipurpose reproductive health technologies: an integrated strategy.

WOMEN WORLDWIDE CONFRONT TWO FREQUENTLY CONCURRENT REPRODUCTIVE HEALTH CHALLENGES: the need for contraception and for protection from sexually transmitted infections, importantly HIV/AIDS. While conception and infection share the same anatomical site and mode of transmission, there are no reproductive health technologies to date that simultaneously address that reality. Relevant available technologies are either contraceptive or anti-infective, are limited in number, and require different modes of administration and management. These "single-indication" technologies do not therefore fully respond to what is a substantial reproductive health need intimately linked to pivotal events in many women's lives. This paper reviews an integrated attempt to develop multipurpose prevention technologies-"MPTs"-products explicitly designed to simultaneously address the need for both contraception and protection from sexually transmitted infections. It describes an innovative and iterative MPT product development strategy with the following components: identifying different needs for such technologies and global variations in reproductive health priorities, defining "Target Product Profiles" as the framework for a research and development "roadmap," collating an integrated MPT pipeline and characterizing significant pipeline gaps, exploring anticipated regulatory requirements, prioritizing candidates for problem-solving and resource investments, and implementing an ancillary advocacy agenda to support this breadth of effort.

A new model for collaboration: the alliance for microbicide development.

Vaginal microbicides for preventing sexually-transmitted infection and/or conception are a novel, much needed technology, yet not seen by industry as having attractive market potential. Nor is the public sector acting with the urgency, priority, and investment that would compensate for lack of private financing, shape the necessary basic and applied research agendas, and spur the dedicated development crucial to advancing this field. The Alliance for Microbicide Development was constituted through a Rockefeller Foundation grant to advocate for and educate about microbicide development, track and communicate product development and regulatory status, contribute to enhanced efficiency in preclinical and clinical processes and, later, help establish a base for matching funds to support combination and comparative studies. After 1 year of existence, the Alliance has proved its value as an innovative collaborative model, having generated and catalyzed a large volume of activity towards its objectives in all priority areas identified by its members.

Research, introduction, and use: advancing from Norplant.

As the first real contraceptive innovation in over 20 years, and as a long-acting method requiring clinical intervention for insertion and removal, Norplant raised an especially wide range of issues. It also encountered a number of difficulties. In April 1997, an Institute of Medicine (IOM) workshop on implant contraceptives reviewed newly available data on Norplant's efficacy, safety, and use; considered lessons learned from the method's development, introduction, and market experience; and explored approaches based on those lessons that could improve the environment for contraceptive research and development and make market entry for new contraceptive technologies less troubled. In addition to presenting the IOM workshop findings, the present article calls attention to the rich scientific prospects available for development of the next generation of contraceptives, and notes signs of an evolving new paradigm, essential if those prospects are to be realized to any significant extent.

PIP: An April 1997 workshop, convened by the US Institute of Medicine, reviewed data on Norplant's efficacy, safety, and use; considered lessons learned from the method's development, introduction, and market experience; and explored approaches based on these lessons that could improve the environment for contraceptive research and development and facilitate market entry for new contraceptive technologies. A review of clinical experience with Norplant suggested the importance of delivery in a medically controlled environment, provider training in insertion and removal techniques, intensive client counseling, and free choice. Negative mass media coverage and litigation have had an adverse impact on Norplant use patterns. Nine areas were identified for consideration or action: clinical research on hormonal effects, market research and regularized interactions with industry, a preintroductory phase permitting various assessments in advance of full-scale product introduction, mechanisms to ensure informed decision making, postmarketing surveillance, provider credentialing, core guidelines for long-acting contraceptives, cost analyses, and product liability legislation. Dialogue at the workshop provided evidence of a paradigm shift toward a woman-centered contraceptive research agenda.

The life span approach to female morbidity and mortality: an application to female health in sub-Saharan Africa.

PIP: Women play a central and increasingly complex role in most societies of the world. That role, however, has been poorly reflected in the fields of medicine and public health. Scientific attention and preventive health efforts have almost focused exclusively upon women's health as it affects their reproductive functions and offspring. Women have been treated as mothers or wives, rather than as individual female human beings with more comprehensive needs. This narrow perspective has adverse consequences for women's health and the social and economic well-being of the communities and societies in which they live. A study was undertaken to elaborate and test a more inclusive way of thinking about illness and to provide a unified documentary base for use in developing a systematic agenda for research and health policy formulation around female health in sub-Saharan Africa. The authors chose a life span model taking health and illness as cumulative products of synergy among different diseases and conditions, and between those diseases and conditions and the circumstances of real life. The Board on International Health of the Institute of Medicine study demonstrates the general utility of the life span model to the study of male and female health worldwide.^ieng