URGENT NEED FOR WOMEN-CONTROLLED PREVENTION METHOD GALVANIZES 55 EXPERTS FROM 15 COUNTRIES IN CONSENSUS PLAN FOR TESTING OF MICROBICIDES

Media Contacts:
-- Hilary Maddux, Director of Communications
International Women's Health Coalition, (212) 979-8500
-- Sandra Waldman, Director, Office of Public Information
Population Council, (212) 339-0525

(New York City - December 24) In a report issued today as a result of an innovative collaboration of women's health advocates, scientists, ethicists, and industry representatives, a new consensus was offered on design and implementation of large-scale trials to evaluate efficacy of microbicides, substances that would reduce the transmission of sexually transmitted infections (STIs). The expert report, entitled Practical and Ethical Dilemmas in the Clinical Testing of Microbicides, highlights the rapid spread of HIV and other STIs worldwide, especially among women, and stresses the urgent need for the development and testing of microbicides as a new HIV/STI prevention alternative. Microbicides would provide a method of protection for individuals and couples unable or unwilling to use condoms and would be within a woman's control.

Defining microbicides

Microbicides are chemical substances that when applied in the vagina or the rectum would substantially reduce transmission of STIs. They could be produced in many forms, including gels, creams, suppositories, films or as a sponge or vaginal ring. Currently, there are no products on the market, but there are some 40 microbicidal products in development, 15 of which are now being tested in humans.

The Report

The report on microbicide development was produced jointly by the Center for Health and Gender Equity (CHANGE), the International Women's Health Coalition (IWHC), and the Population Council. The report summarizes extensive deliberations and key decisions made at a historic 1997 symposium that brought together 55 advocates, scientists, policy makers, and industry representatives from 15 countries across Africa, Asia, Latin America, Europe, and the United States. Despite the complexity of the topic and the diversity of the group, a remarkable consensus was reached that sets forth a series of recommendations for how to address such ethical issues as informed consent and standard of care and still achieve scientifically rigorous results. If implemented, this plan would speed the development of microbicides and help get new products into the hands of women and men as soon as possible.

"With HIV and STI infections soaring worldwide, especially among women, we have no time to lose in resolving the ethical and practical dilemmas at the heart of microbicide research," stated Lori Heise of CHANGE and co-author of the report along with Elizabeth McGrory of the Population Council and Susan Wood of IWHC.

Heise continued, saying "This report reflects how women's health advocates, scientists, ethicists, and industry representatives embraced diversity and made real progress on the compelling issues that lie at the confluence of reproductive technology development, women's vulnerability to STIs, and the democratization of science. Recent controversies over clinical trials of AZT to prevent woman-to-child transmission in Thailand and Africa and discussions about HIV vaccine testing only highlight the fundamental concerns over trial design, standard of care, community involvement, and informed consent. Our consensus is an important step forward."

Among the main points of consensus reached by participants at the symposium are:

• There is tremendous need for greater public-sector investment in microbicide research; such investment should include resources directed specifically toward developing several products at the same time;
• Trials should be multisite, in both industrial and developing countries, in order to share the burdens and benefits of research and to increase the generalizability of results;
• The informed consent process must be formulated and implemented at the individual level (community consent is not sufficient), and women's participation in trials should not be contingent on the consent of their male partners;
• All clinical trials should include an active effort to promote consistent condom use by all trial participants; other issues related to standard of care will best be determined through a local, consultative process. Researchers should consider partnering with local NGOs to provide the trial's condom and counseling interventions;
• Researchers should pursue different formulations, as women are likely to have a variety of needs and preferences with respect to product characteristics, and should aim for an over-the-counter product that could be made widely available through multiple channels without a prescription;
• Issues of access must be addressed now so that any future microbicidal products are available to and affordable for women who need them most.

The symposium and the consensus of its participants have already had an impact on microbicide research. New trials planned on Nonoxynal-9 products will enroll women from diverse populations, instead of only commercial sex workers, as in the past, and will take place in multiple sites in industrialized and developing countries. The symposium also inspired new collaborations and consultative meetings on microbicides in Thailand and South Africa convened by the Population Council and local colleagues to build consensus concerning future microbicide trials being planned in those countries.

A Global Campaign

Release of this report is part of a Global Campaign for Microbicides and Woman-Controlled HIV/STI Prevention Alternatives designed to raise awareness, educate the public, and increase public investment in the research and development of microbicides. The campaign is an umbrella for activities of various organizations in developed and developing countries working in education and advocacy. Initiatives include the following:

• Global circulation of a petition calling for investment in HIV/STI prevention options for women;
• Information exchange among funders, policy makers, and researchers in the microbicides field;
• Outreach to industry; and
• Legislative and policy activities.

The new spirit of collaboration and partnership reflected in this report bodes well for meeting challenges to find new means by which women can gain greater control of their health and lives.

The Center for Health and Gender Equity (CHANGE) works to ensure that the health and population policies of international institutions supported by the U.S. government actively promote women's reproductive and sexual health. Lori Heise is Co-Director of CHANGE.

The International Womens Health Coalition (IWHC) provides technical, financial, managerial, and moral support to women's organizations, advocacy groups, health and rights activists, and service providers in Africa, Asia, and Latin America. Susan Wood is Program Director at the International Women's Health Coalition.

The Population Council is a nonprofit, nongovernmental, international institution that works to improve reproductive health and to achieve an equitable balance between people and resources. The Council has an active program of microbicide development and its lead compound will begin clinical testing early in 1999. Elizabeth McGrory is Staff Program Associate in the Reproductive Health Program at the Population Council.