April 15, 1998

The Honorable Donna Shalala
Secretary
Department of Health and Human Services
200 Independence Ave, SW
Washington, D.C. 20201

Dear Secretary Shalala,

	At the Eleventh International Conference on AIDS in Vancouver over a 
year ago, you
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 
the research, millions more people will die because they lack a viable 
method for prevention.  Large pharmaceutical companies have expressed 
little interest in pursuing micribicide research. Furthermore, 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 
evaluated. Ideally, as with the development of HIV/AIDS treatments, 
multiple products should be examined consecutively in clinical trials.  
As you know,  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 are writing to ask that you encourage the active collaboration 
between public and private sector institutions, including Universities, 
State and Federal laboratories, Schools of Public Health, and small 
biotech companies, both for the development and formulation of new 
products and for the implementation of clinical trials and acceptability 
studies. It is critical that microbicide research is accelerated and that 
the numerous institutions that have the ability to work on their 
development are encouraged to pursue this research.  While research 
protocols that go through the standard Request For Proposal (RFP) routes 
are appropriate for many types of research, research that goes through 
this process can often  take months and sometimes years to get 
administratively approved.  Clearly for the development of products for 
HIV prevention, these delays can cost the lives of millions. We ask that 
you consider an expedited process for this research, perhaps through 
contracting specific research institutions or biotech companies or 
through creating incentives to private pharmaceutical companies to 
develop and market microbicides. The Food and Drug Administration should 
be asked to 'fast track' AIDS prevention methods, such as microbicides, 
in the way it has treatments and to look at ways to encourage 
pharmaceutical companies to develop microbicides.  We also believe that 
international cooperation will be essential to secure success in this 
field.

	We thank you again 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