April 15, 1998 Subcommittee on Labor, Health and Human Services, and Education Senate Dirksen Building Room 184 Washington, D.C. 20510 Dear Subcommittee Members, At the Eleventh International Conference on AIDS in Vancouver over a year ago, Donna Shalala announced that the National Institutes of Health would spend $100 million over the next four years on research aimed at developing a safe and effective vaginal microbicide. As women have become the fastest growing group infected with HIV internationally and this disease is serious cause of morbidity and mortality in our community, we are extremely encouraged by your announcement. Although condoms and HIV/AIDS education campaigns have benefited some individuals at risk for AIDS, these methods have not stopped the epidemic. The development of safe and effective microbicides will give women, as well as some gay men, the ability to protect themselves against HIV and other sexually transmitted diseases (STDs) without fear of abuse and condemnation. While we are heartened that money has been allocated for the development of this critical product, we are concerned that at the current pace of research, millions more people will die because the available methods for prevention are inadequate. Pharmaceutical companies have expressed little interest in pursuing micribicide research. Furthermore, to date very few potential microbicide products besides nonoxynol- 9 have even reached Phase I clinical trials. In order to get safe and effective microbicides developed and on the market as soon as possible, more products need to be studied. Ideally, as with the development of HIV/AIDS treatments, multiple products should be examined consecutively in clinical trials. Microbicides need to be available in a variety of formulations, such as gels, foams, and films in order to be effective and acceptable for the greatest number of people. We write to you to ask that you join your fellow legislators Connie Morella, Nancy Pelosi, Nancy Johnson, Sue Kelly, Louise Slaughter, Eddie Johnson, Eleanor Holmes Norton, Lynn Woolsey, Eva Clayton, and Carolyn Maloney in supporting the rapid development of mocrobicides. We also request that you encourage the active collaboration between public and private sector institutions, such as Universities, State and Federal laboratories, Schools of Public Health and pharmaceutical companies, both for the development and formulation of new products and for the implementation of clinical trials and acceptability studies. We also ask that you consider recommending that the Food and Drug Administration be asked to 'fast tract' the development and marketing of these HIV prevention products as they have for AIDS treatments. It is critical that microbicide research is excellerated and that the numerous institutions that have the ability to work on their development are encouraged to pursue this research. We thank you in advance for addressing the need for women-controlled methods of HIV prevention. The development of such methods will provide women and some men an additional tool to protect themselves against infection from HIV and other STDs. Clearly, the rapid development and availability of these products will save countless numbers of lives throughout the world. Sincerely, ___________________________ Shirley Dean, Mayor of Berkeley _____________________________________ Linda Maio, Berkeley City Councilmember _______________________________________ Margaret Breland, Berkeley City Councilmember _______________________________________ Maudelle Shirek, Berkeley City Councilmember _______________________________________ Dona Spring, Berkeley City Councilmember ________________________________________ Diane Wolley, Berkeley City Councilmember _________________________________________ Betty Olds, Berkeley City Councilmember __________________________________________ Kriss Worthington, Berkeley City Councilmember __________________________________________ Polly Armstrong, Berkeley City Councilmember