[Congressional Record (Bound Edition), Volume 146 (2000), Part 2]
[House]
[Pages 2651-2652]
[From the U.S. Government Publishing Office, www.gpo.gov]



                  MICROBICIDES DEVELOPMENT ACT OF 2000

  The SPEAKER pro tempore (Mr. Hayes). Under a previous order of the 
House, the gentlewoman from Maryland (Mrs. Morella) is recognized for 5 
minutes.
  Mrs. MORELLA. Mr. Speaker, today I am joined by the gentlewoman from 
California (Ms. Pelosi) in introducing the Microbicides Development Act 
of 2000, legislation to promote the development of a new technology for 
preventing sexually transmitted diseases, including HIV.
  Across this country and around the world, AIDS is rapidly becoming a 
women's epidemic. In the United States, women constitute the fastest 
growing group of those newly infected with HIV. Worldwide almost half 
of the 14,000 adults infected daily with HIV in 1998 were women, of 
whom nine out of 10 live in developing countries. In Africa, teenage 
girls have infection rates five to six times that of teenage boys, both 
because they are more biologically vulnerable to infection and because 
older men often take advantage of young women's social and economic 
powerlessness.
  Equally alarming, the United States has the highest incidence of 
sexually transmitted diseases, STDs, in the industrialized world. 15.4 
million Americans acquired a new STD in 1999 alone. Sexually 
transmitted diseases, including HIV/AIDS, represent a women's health 
emergency. Biologically and socially, women are more vulnerable to STDs 
than men. Many STDs, again I say that is sexually transmitted diseases, 
are transmitted more easily from a man to a woman and are more likely 
to remain undetected in women, resulting in delayed diagnosis and 
treatment and more severe complications. Not only are women at greater 
risk of acquiring STDs than men; but in most cases the consequences of 
contracting STDs, including infertility, ectopic pregnancy, cancer, and 
infant mortality, are more serious and permanent for women.
  Yet 20 years into the AIDS crisis, and at a time when the incidence 
of STDs is reaching epidemic proportions, the only public health advice 
to women about preventing HIV and other STDs is to be monogamous or to 
use condoms. Experience has shown, however, that for many women, 
neither message is realistic or effective. A woman cannot protect 
herself by being faithful if her sexual partner is not, nor can every 
woman always insist on condom use. In Africa, for example, where women 
account for 55 percent of the continent's HIV infections, women 
typically have little say over condom use and too often the 
consequences in terms of lost trust, abandonment, or abuse are 
perceived as more threatening than the risk of contracting a disease. 
Women clearly need an alternative.
  This legislation has the potential to save billions in health care 
costs. The total cost to the U.S. economy of STDs, excluding HIV 
infection, was approximately $10 billion in 1999 alone. When the cost 
of sexually transmitted HIV infection is included, that total rises to 
$17 billion.
  Federal funding is key. Currently, less than 1 percent of the budget 
for HIV/AIDS-related research at the National Institutes of Health is 
being spent on microbicide research, and best estimates show that less 
than half this amount is dedicated directly to product development. 
Clearly, this is not nearly enough to keep pace with the growing STD 
and HIV epidemics. For 2001, our legislation will ensure that Federal 
investment in this critical research be doubled from the current level 
of less than $25 million.
  There is an urgent need for HIV and STD prevention methods within 
women's personal control. Since the early 1990s, topical microbicides 
have attracted scientific attention as a possible new technology for 
preventing STDs, including HIV.
  Not only do microbicides make good sense from a public health 
perspective but recent studies demonstrate that women want and need 
prevention alternatives. A recent survey by the Alan Guttmacher 
Institute estimated that 21 million American women are interested in a 
microbicidal product. Microbicide acceptability studies in 13 countries 
worldwide, six in Africa, two in Latin America, three in Asia plus 
France and Poland, have documented high interest and willingness to use 
microbicides.
  Five of the top 10 most frequently reported infectious diseases, that 
is 87 percent of all cases, are sexually transmitted. Over one in three 
adults age 15 to 65 are now living with an incurable viral STD. Dr. 
Anthony Fauci, director of the National Institute of AIDS and 
Infectious Diseases, has stated that he considers microbicide research 
a priority in the fight against AIDS and STDs.
  Dr. Peter Piot, Executive Director of UNAIDS, the United Nations 
agency that coordinates a global response to the HIV epidemic, has 
said,

       There is an urgent need for more methods to prevent HIV 
     infection, especially those that put women in control. The 
     search for an effective and safe vaginal microbicide has been 
     progressing too slowly--we need more researchers from the 
     public and private sectors acting with appropriate urgency to 
     develop a microbicide.

  A number of obstacles currently impede the development and 
introduction of microbicides. For major pharmaceutical companies, there 
is skepticism about whether such products would be profitable after the 
costs of research and marketing are met because such products would 
have to be inexpensive. Concern has also been raised over liability, 
since microbicides would promise to offer some protection against life-
threatening illness, even though levels of product efficacy would be 
stipulated in labeling.
  Absent leadership by major pharmaceutical companies, small 
biopharmaceutical firms, academic and nonprofit institutes have taken 
the lead on microbicide research and development. However, many small 
companies and nonprofit entities lack the resources to take a potential 
product through the rigorous clinical trials required to evaluate 
products for FDA approval.
  Researchers estimate that it costs up to $50 million to complete 
research on an existing compound (and at least twice that to start from

[[Page 2652]]

scratch with a new compound)--far more than many of these small 
companies and nonprofit entities have the capacity to invest.
  Public funds are necessary to fill in the gaps in the research and 
development process and to create incentives for greater investment by 
private industry. Without federal leadership and funding, a microbicide 
is not likely to be available anytime soon.
  Despite scientific promise and public health need, investment in 
microbicide research has been woefully inadequate. Through the work of 
the National Institutes of Health, non-profit research institutions, 
and small private companies, a number of microbicide products are 
poised for successful development. Some 24 products are currently in or 
ready for clinical (human) trials and 36 promising compounds exist that 
could be investigated further. But this ``pipeline'' will only be 
unblocked if the federal government helps support the necessary safety 
and efficacy testing necessary to move the best candidates to the 
marketplace.
  Public health officials and members of Congress need to take notice. 
Given the growing number of promising microbicides in development, we 
have everything we need to bring a microbicide to market within five 
years--except the money. That's why Representative Nancy Pelosi and I 
are introducing legislation today that increases the federal investment 
in this potentially life-saving technology. Specifically, our bill, the 
``STD Microbicide Development Act of 2000,'' does the following:
  Instructs the Director of the National Institutes of Health to 
establish a program to support research to develop microbicides, 
including expanding and intensifying basic research on the initial 
mechanisms of STD infection, identifying appropriate models for 
evaluating safety and efficacy of microbicidal products, enhancing 
clinical trials, and expanding behavioral research on use, 
acceptability and compliance with microbicides.
  Instructs the NIH Director, in consultation with all relevant NIH 
institutes and federal agencies, to develop a 5-year implementation 
plan regarding the microbicides research program.
  Authorizes $50 million in FY 2001, $75 million in FY 2002, and $100 
million in FY 2003 for federal microbicide research and development.
  Mr. Speaker, thanks to the leadership of Leslie Wolfe and the Center 
for Women Policy Studies who first brought the need for microbicides 
research to my attention, I introduced Women and HIV/AIDS research and 
prevention legislation back in 1990. Congress has confirmed the 
importance of microbicides research by including report language I 
submitted during the appropriations process calling for greater NIH 
attention to this research. Now that the reality of a microbicide is 
much closer, more resources and greater coordination of federal 
research is urgently needed. With vigorous attention and sustained 
investment, a microbicide could be available within five years.
  Microbicides represent another potential weapon in the arsenal 
against HIV/AIDS and Stds. Microbicides would be an important 
complement to potential HIV vaccines since they are likely to be 
available sooner, will be easier and cheaper to distribute, and will be 
effective against a range of sexually transmitted infections. They are 
particularly important for women, whose risk of infection is high and 
whose direct control over existing prevention options is low.
  Microbicides will give women all over the world one more way of 
protecting themselves against the ravage of HIV/AIDS and other Stds. I 
urge all of my colleagues to support the important legislation we are 
introducing today, and give women and their families a fighting chance 
against the HIV and STD epidemics. Women in this country and around the 
world, as well as their partners and children, desperately need and 
deserve more options to stop the spread of deadly infections.

                          ____________________