We realize that AIDS is a special case which may require special measures. Thus, while we do not believe that compromising intellectual property rights is the solution to the greater problem, contrary to our general approach, we raise no objection to compulsory licensing or parallel importing of pharmaceuticals on the part of South Africa, as long as it is done in a way that complies with TRIPS. Of course, we are also committed to working with South Africa to ensure the safety and efficacy of pharmaceutical imports. This is the policy of the Administration. Mr. MICA. We now recognize Dr. John Killen, who is the Director of the Division of AIDS for the National Institutes of Health's National Institute of Allergy and Infectious Diseases. Dr. KILLEN. Thank you, Mr. Chairman. I am pleased to have the opportunity to discuss with you recent developments related to the human immunodeficiency epidemic. As we have heard already today, HIV is a looming tragedy, a global catastrophe to public health and a threat to political stability. Overcoming it will require a sustained commitment by public and private sector partners working together in research and prevention. Our remarks today will focus on progress in and challenges to biomedical research relevant to the control of the epidemic. AIDS diagnoses and deaths have dropped significantly in the United States in the past 2 years. The same is true in other developed countries. Several factors are responsible, as we have heard, especially through the increased use of potent, albeit expensive combinations of anti-HIV drugs. Unfortunately, many HIV-infected individuals have not responded adequately to the medications, cannot tolerate their side effects, or develop viral resistance to the current drugs, even in this country where we have virtually everything going for us. In this context, the development of new and better therapies remains a priority. Research is focusing on new strategies, including drugs that prevent the virus from entering a cell, and approaches to boosting an infected person's immune response. A number of new agents are in various stages of preclinical and clinical testing. We have also heard at length today how use of antiretroviral drugs is simply not currently feasible in developing countries, where per capita health care spending may be only a few dollars per year. Therefore, the identification of effective, low-cost tools for preventing infection and disease caused by HIV is absolutely crucial to slowing the epidemic. I will highlight two examples of relevant NIH-supported research in this important endeavor. In early 1994, an NIH-funded clinical trial showed that passage of HIV from an infected mother to her infant could be reduced by as much as two-thirds when an intensive regimen of AZT is given to a mother and her newborn baby. Unfortunately, costs and formidable logistical barriers prohibit the widespread application of this proven regimen in most of the developing world. To surmount these obstructions, a globally coordinated effort was launched to identify simpler, less costly alternatives. Several recently reported studies have shown that shorter regimens of AZT can also be beneficial, reducing transmission by as much as 50 percent, but the same logistical and cost factors have precluded widespread implementation of these drug regimens. Last week, scientists from Uganda, Johns Hopkins University, and the NIAID reported exciting results of an NIH-supported study carried out in Uganda which demonstrated that just two doses of the antiretroviral drug nevirapine, when administered to the mother at the onset of labor and one to the baby shortly after birth, reduced the instance of maternal-to-infant transmission of AIDS-reduced by nearly 50 percent when compared to a similar brief course of AZT. This study could have profound implications for the epidemic of HIV in children worldwide because nevirapine is extremely inexpensive and easy to administer. In fact, the regimen costs approximately $4, and is 70 times cheaper than the previously studied regimens of the shorter course of AZT. The development of a safe and effective vaccine for HIV remains the Holy Grail of AIDS prevention research. To hasten HIV vaccine discovery, many public and private agencies, including the NIH, have dramatically increased the resources devoted to HIV vaccine research. At the NIH we've created new programs to foster innovative research on HIV vaccines and to expedite their development in clinical testing. In addition, the Dale and Betty Bumpers Vaccine Research Center has been established on the NIH campus in Bethesda. Since 1998, we have enrolled more than 3,000 healthy volunteers into 52 clinical trials involving 27 possible HIV vaccines. The results with the combination vaccine approach have been especially encouraging. The vaccine appears safe and has invoked several types of immune responses that may have an important role to play in protection from HIV-associated disease. Additional phase 2 trials will open later this year in Brazil, Haiti, Trinidad, and Tobago. A very important milestone in AIDS vaccine research was the initiation this spring of the first AIDS vaccine study in Africa. This NIH-supported clinical trial, which is being conducted in Uganda, is designed to help determine whether it will be possible to design universal vaccines that work against more than one strain of HIV. Training and infrastructure are essential underpinnings of a robust biomedical enterprise, and part of NIH's commitment to international AIDS research involves the Fogarty International Center's initiative to build HIV training and research capacity in developing countries. This vitally important effort has expanded research capabilities in a number of countries and facilitated many NIH international AIDS research initiatives. Two years ago, President Clinton set a national goal of developing a useful HIV vaccine within 10 years. We are well positioned in our attempt to meet this goal with an extraordinarily strong program of basic and applied research that is now under way. As we work to contain the global HIV/AIDS epidemic, it is essential that public and private sector partners strengthen their commitment to working together to speed HIV vaccine development, refine prevention efforts, and develop new treatments for those infected with the virus. Thank you for the opportunity to address the subcommittee. [The prepared statement of Dr. Killen follows:] STATEMENT OF JOHN Y. KILLEN, M.D. DIRECTOR DIVISION OF ACQUIRED IMMUNODEFICIENCY SYNDROME NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NATIONAL INSTITUTES OF HEALTH BEFORE THE COMMITTEE ON GOVERNMENT REFORM UNITED STATES HOUSE OF REPRESENTATIVES JULY 22, 1999 Mr. Chairman and Members of the Committee, I am pleased to appear before you today to discuss the human immunodeficiency virus (HIV) epidemic, recent developments in HIV research, and the many challenges that remain in the fight against HIV and the acquired immunodeficiency syndrome (AIDS). The Scope of the Epidemic AIDS was recognized eighteen years ago this summer, and continues to exact an enormous toll throughout the world, in both human and economic terms. In the United States, the rate of new HIV infections—approximately 40,000 per year-remains unacceptably high, despite an encouraging downturn in new AIDS cases and AIDS-related deaths. In the developing world, the HIV/AIDS epidemic continues to accelerate, notably in subSaharan Africa, southeast Asia and on the Indian sub-continent. There are also signs of expanding epidemics in Russia and other New Independent States of the former Soviet Union. As of the end of 1998, more than 33 million people worldwide were living with HIV/AIDS, according to estimates by the Joint United Nations Programme on HIV/AIDS (UNAIDS). An estimated 5.8 million new HIV infections occurred worldwide during 1998-approximately 16,000 new infections each day. More than 95 percent of these new infections occurred in developing countries. Alarmingly, in 27 developing countries, HIV prevalence more than doubled between 1995 and 1997. In 1998, HIV/AIDS was the fourth leading cause of mortality worldwide, resulting in an estimated 2.3 million deaths. Beyond the human tragedy of HIV/AIDS, the economic costs of the epidemic are staggering, posing a significant impediment to the growth and stability of many countries where the epidemic is decimating a limited pool of skilled workers and managers as well as young people at the peak of their productive years. According to UNAIDS, life expectancy in the |