March 1999, Vol. 5, No. 1

Ethics
Symposium Explores Dilemmas in Testing Microbicides

By the year 2000, women will constitute roughly half of the 40 million people in the world infected with HIV, the virus that causes AIDS. Condoms can prevent the transmission of HIV and other sexually transmitted infections (STIs). The partners of many women, however, refuse to use condoms, and some women fear they will face abandonment or abuse if they suggest it. Women who want to get pregnant while protecting themselves from STIs currently have no option. For these reasons, an urgent need exists for products that women can use to protect themselves from STIs, with or without their partners’ knowledge, and with or without contraception.

Microbicides, chemical compounds that would reduce the transmission of STIs when applied in either the vagina or rectum, offer a promising option. While no microbicides are currently on the market, dozens are in various stages of development by a number of organizations, including the Population Council. Clinical trials dealing with HIV and AIDS have been plagued by such thorny ethical and practical dilemmas as what standard of care should be provided to participants and how people in developing and industrialized countries can share the burdens as well as the benefits of research. In an effort to address such challenges in microbicide trials, the Population Council and Women’s Health Advocates on Microbicides gathered scientists, ethicists, health advocates, policymakers, and experts in the field of microbicide development at a symposium in April 1997.

“The meeting was unique in that it brought together a diverse group and there was real dialogue without polarization,” said Lori Heise of the Center for Health and Gender Equity. “People were really grappling with the complexity of it all.”

The participants reached a remarkable consensus on the issues before them. Council Staff Program Associate Elizabeth McGrory—along with Heise and Susan Wood of the International Women’s Health Coalition—summarized the findings in a new report, Practical and Ethical Dilemmas in the Clinical Testing of Microbicides. The release of the report is part of the Global Campaign for Microbicides and Woman-Controlled HIV/STI Prevention Alternatives, designed to raise awareness, educate the public, and increase investment in the research and development of microbicides. The publication sets forth a series of guidelines for testing microbicides.

“This symposium and two further meetings we held in Thailand and South Africa were crucial for understanding issues that are bound to arise in the communities where the trials will take place,” notes McGrory.

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

• To increase the generalizability of the results, trial participants should include diverse populations, not just sex workers.
• All trials should include an active effort to promote consistent condom use by trial participants; other issues related to standards of care will best be determined through a local, consultative process. Researchers should consider partnerships with local nongovernmental organizations to provide the trial’s condom and counseling intervention.
• Women are likely to have a variety of needs and preferences with respect to product characteristics, so multiple formulations should be pursued; investigators should aim for an over-the-counter product that can be made widely available through multiple channels.
• Trials should be multisite in both developed and developing countries, in order to share the burdens and benefits of research and to increase the generalizability of results.
• Investigators should not substitute community or household consent to undertake trials for explicit consent by the individual women participating in the trial. Once the safety of microbicides has been established, investigators should not seek the consent of the male partners of women in the trials; doing so may put such women at risk.
• Issues of access must be addressed now, so that future microbicidal products are available to and affordable by the women who need them most.

The symposium and the recommendations that arose from it quickly influenced the way that investigators structure microbicide research. An upcoming trial in South Africa of the Council’s lead microbicide candidate, PC-515, will involve women who are not sex workers. Trials planned by other organizations of the effectiveness of the spermicide nonoxynol-9 as a microbicide will also enroll women from diverse populations and will take place at several locations in both developed and developing countries. The Council has joined with local colleagues in Thailand and South Africa in a consultative process regarding future microbicide trials in those countries.

“These recommendations will help us test microbicides as ethically as possible, as quickly as possible, getting the products into the hands of women who desperately need them,” emphasizes McGrory.

Source
Heise, Lori L., C. Elizabeth McGrory, and Susan Y. Wood. 1998. Practical and Ethical Dilemmas in the Clinical Testing of Microbicides: A Report on a Symposium. New York: International Women’s Health Coalition.

Outside funding
The William and Flora Hewlett Foundation, The John D. and Catherine T. MacArthur Foundation, The Andrew W. Mellon Foundation, The Rockefeller Foundation, United Nations Population Fund

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