Introduction of the Mircrobicide Development Act

Floor Speech

INTRODUCTION OF THE MICROBICIDE DEVELOPMENT ACT

* Ms. SCHAKOWSKY. Madam Speaker, today, on International Women's Day and as we prepare to recognize National Women and Girls HIV/AIDS Awareness Day on March 10th, I am proud to introduce the Microbicide Development Act. This legislation will advance and accelerate efforts to develop an effective microbicide product to protect against HIV infection. While the primary users of microbicides will be women, an effective microbicide would also make significant contributions to the reduction of HIV infections among men and among infants.

* The Microbicide Development Act will bolster and coordinate microbicide research and development programs at the National Institutes of Health (NIH), the U.S. Agency for International Development (USAID), and the Centers for Disease Control and Prevention (CDC). Specifically, this legislation would establish for the first time a clearly-defined branch dedicated to microbicide research and development at the NIH and require the development of a strategic plan to expedite research.

* In the 25 years of the HIV/AIDS pandemic, more than 25 million people have died from HIV/AIDS. Among persons aged 15 to 59, HIV/AIDS is the leading cause of death worldwide. With nearly 40 million people living with HIV/AIDS worldwide and more than 4 million new HIV infections in 2006 alone, HIV/AIDS continues to be a major global health problem, threatening the economic, social, and political stability of many nations.

* Unfortunately, there is today no cure for HIV or AIDS and no magic bullet for prevention. In the global fight against HIV/AIDS, scientists have stressed the need for a comprehensive approach that includes care and treatment for individuals already infected as well as a range of prevention strategies to stop further spread of the disease. Microbicides represent a critical strategy within this comprehensive approach to the HIV/AIDS epidemic, particularly for women. With women accounting for nearly half (48 percent) of all HIV/AIDS cases across the globe and nearly 60 percent of all HIV/AIDS cases (76 percent of HIV/AIDS cases among 15-24 year olds) in sub-Saharan Africa, HIV prevention technologies meeting the special needs of women are increasingly important. In some areas of sub-Saharan Africa and the Caribbean, infection rates among young women are up to six times higher than among young men. The devastating impact of HIV/AIDS on women is certainly not limited to third world nations. HIV/AIDS is also a major problem for women in the United States, as AIDS is the leading cause of death for African American women between the ages of 25 and 34 in the United States.

* Dr. Anthony Fauci, Director of the National Institutes of Allergy and Infectious Disease of the NIH, has emphasized the role of gender inequality in fueling the HIV/AIDS epidemic among women and the need to empower women with strategies over which they have control. In a March statement recognizing National Women and Girls HIV/AIDS Awareness Day, he stated:

``Globally, the vast majority of women with HIV/AIDS became infected through heterosexual intercourse, frequently in settings where saying no to sex or insisting on condom use is not an option because of cultural factors, lack of financial independence, and even the threat of violence. These issues compel us to develop HIV prevention tools that women can use in situations when negotiating with sexual partners is difficult or impossible. One critical avenue of research is the development of safe, effective and acceptable topical microbicides--gels, creams and foams that could be used prior to sexual intercourse to prevent infection with HIV and other sexually transmitted pathogens. The development of these woman-controlled agents is a top HIV/AIDS research priority of the National Institutes of Health (NIH).''

* Current prevention approaches are not practical for everyone, particularly women. The major route of transmission for HIV around the globe is heterosexual sex. Abstinence is often not an option for women. Around the globe, unmarried women are not always in the position to refuse sexual advances and may be the victims of violence. Married women are rarely in the position to be able to refuse sexual advances of their husbands, even if they know that their spouse is infected.

* Many women who are infected with HIV or at risk for infection are monogamous and do not practice high risk behaviors. Frequently, they are married or in committed relationships in which they are placed at risk by the behavior of their male partner, which they have limited power to change.

* Condoms represent the most effective prevention technology currently available. However, male condoms require male cooperation and even female condoms require the consent and cooperation of male partners, placing women's risk for HIV infection under the initiation and control of men. Women, particularly married women and those women in committed relationships, are often powerless to insist on or even request condom use by their male partner. Such requests can be interpreted as evidence of infidelity on the woman's part or accusations of infidelity on the man's part, either of which can result in serious penalties for women, including violence.

* Topical microbicides represent a woman-initiated method of prevention that would not require cooperation from a male partner and may even permit conception. Microbicides are a class of products under development that could be applied topically to prevent the spread of HIV infection. Microbicides may eventually take the form of gels, creams, and films, and be used in cervical caps, pre-loaded diaphragms, or rings. These methods may be invisible to male partners, which would allow women to use these products with or without the knowledge of her partner. While the contraceptive effects of barrier methods such as condoms present an obstacle for women who want to or are expected to bear children, microbicides may be available in both contraceptive and non-contraceptive formulas. With the ability to discreetly protect themselves and the potential to continue to bear children unimpeded, microbicides address the reality of women's prevention needs.

* Mathematical models predict that even a partially effective microbicide could prevent 2.5 million infections over 3 years and that gradual introduction of newer and better microbicides could ultimately save a generation of women. In addition, several prominent scientists anticipate that an effective microbicide will be available within the next 5 to 7 years. Significant advances have been made in the development of microbicides in recent years. By the end of 2006, there were 36 organizations involved in microbicide R&D, with 10 microbicide candidates currently in clinical development and over 30 in preclinical development. We cannot let this momentum slow; we must continue to prioritize microbicide research and development since an effective microbicide is within our reach.

* The Microbicide Development Act affirms our commitment to microbicide research and to the women whose lives will be saved by microbicides in the future. The global community supports microbicide research. Around the world, there is heightened attention to the urgency of meeting the unique prevention needs of women. For the past few years, G8 communiqués and UN declarations have listed microbicides high among key global health priorities requiring focus and support. Numerous governments and donors have provided funding for microbicide development, including Belgium, Canada, Denmark, France, Germany, Ireland, Netherlands, Norway, Sweden, United Kingdom, United States, European Commission, World Bank, the Rockefeller Foundation, and the Bill & Melinda Gates Foundation. Within our own Nation, the Microbicide Development Act has garnered the support of over 120 community groups, including the AIDS Foundation of Chicago, the American Public Health Association, the Global Campaign for Microbicides, the Guttmacher Institute, the National Alliance of State and Territorial AIDS Directors, the National Minority AIDS Council, and the National Women's Health Network.

* On this day, International Women's Day, we need to take a firm stand to validate and affirm the rights of women across the globe. This legislation recognizes the feminization of the HIV/AIDS epidemic and the important role that gender inequity plays in the increasing rates of infection among women. It addresses those gender inequities by recognizing the reality of women's lives and providing women with tools to protect themselves within the context of this reality. Microbicides represent a woman-initiated and woman-controlled method of prevention that will allow women to protect themselves from HIV even in settings where negotiation with male sexual partners is difficult or impossible. This legislation demonstrates that we, as a Nation, value women and it will take the necessary steps to protect their lives and their futures.

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