[Congressional Record Volume 153, Number 44 (Wednesday, March 14, 2007)]
[Extensions of Remarks]
[Pages E545-E546]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




            INTRODUCTION OF THE MICROBICIDE DEVELOPMENT ACT

                                 ______
                                 

                       HON. JANICE D. SCHAKOWSKY

                              of illinois

                    in the house of representatives

                       Wednesday, March 14, 2007

  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

[[Page E546]]

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 
communiques 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.

                          ____________________