U.S. AIDS Policy Threatens Lives


U.S. AIDS Policy Threatens Lives

By David Rabin, M.D.

On Monday, March 29th, Ambassador Randall Tobias, the Bush administration's "AIDS Czar," convened a conference in Gaborone, Botswana to develop international policies on the use of generic drugs. He questioned international quality standards established by the World Health Organization (WHO) in favor of only permitting the use of medicines that have been approved by regulatory authorities like the Food and Drug Administration (FDA). The FDA has not approved generic drugs that fight AIDS due to patent barriers.

Such a move would be devastating for the world's 42 million people currently infected with HIV, the large majority of whom reside in Africa and other parts of the developing world. To facilitate access to high quality, affordable generic AIDS drugs, WHO has certified selected generic fixed-dose combination (FDC) antiretrovirals as meeting the strongest standards of drug quality, safety and efficacy. Tobias suggests that these drugs could endanger patient lives.

The contentions about safety and efficacy are questionable, while the increased benefits of treating more people with less costly generic antiretroviral drugs are dramatically clear. Of the estimated six million people living with AIDS in developing countries, three million of them face imminent death and only 300,000 people are receiving treatment.

In November, I had the privilege of participating in a conference on "Faith-Based Initiatives and the President's Emergency Plan for AIDS Relief (PEPFAR)." The conference was convened by Georgetown University on behalf of Ambassador Tobias who oversees PEPFAR to document and explore the work of faith-based organizations on global AIDS. Faith-based organizations provide 30 to 50 percent of all HIV/AIDS services in the developing world.

I represented American Jewish World Service, which coordinated the participation of three community workers from grassroots groups it funds in Uganda and Zimbabwe who do not receive any government money for their AIDS programs. They shared their challenges and successes and encouraged the Bush administration to support community efforts such as theirs that are reaching the bulk of the population who do not have access to government sponsored health care and facilities.

I was impressed with the openness by Ambassador Tobias and other government representatives to listen, and by their sincere desire to do the right thing. But Tobias' proposed drug policies threaten to undermine the efforts of community-based groups and derail PEPFAR's goals by increasing the burden on the poor and the sick.

PEPFAR did get off to a good start. Four PEPFAR awards totaling $350 million have been made to U.S.-based organizations for programs in selected Sub-Saharan African and Caribbean nations that are suffering severe AIDS epidemics. However, broader and more widely applicable strategies, essential for the containment of this preventable disease, are not sufficiently emphasized.

For example, PEPFAR does not sufficiently emphasize education about condom use although there are an estimated 30 million HIV infected people in Sub Saharan Africa, most young and sexually active. While the proportion of funds that should be allocated to treatment versus prevention is debatable, it is essential that local - urban and rural - communities be permitted to use whatever prevention money is available on the most effective strategies for prevention, which includes sex education and condom distribution, just as it is vital that availability of safe and affordable treatment medicines remain of the highest priority.

The cost of drugs for treatment in Sub-Saharan nations, where drugs have to be imported by currency-poor countries, can amount to as much as half of all treatment expenditures. In addition to cost, lack of patient compliance with therapy can compromise the benefits of treatment programs. Compliance and cost concerns have been addressed by the development of the WHO approved FDCs. One pill, taken twice a day, is more likely to ensure compliance than multiple pills taken six times a day, as demanded by the currently approved FDA brand drugs. Furthermore, generic FDCs can cost as little as $140 per person per year while a similar combination of brand name drugs costs a minimum of four times more.

The only ones to benefit from restricting generic drugs are the pharmaceutical companies who own the patents. The United States must work to strengthen the WHO program to ensure drug safety and efficacy for generics rather then further restrict access to these vital medicines. Strengthening the WHO program will also ensure the most productive use of the U.S. moneys for the low cost generics critically needed for AIDS treatment. Only when effective AIDS treatment is made widely available, can the ambitious goals of PEPFAR be met. And only when prevention and care resources are available to grassroots groups to use for programs that they know work, can we ever hope to deter the AIDS pandemic.

David Rabin, M.D., is an internist and professor of family and community health at Georgetown University's Medical School. He is a board member of American Jewish World Service, for which he served as a volunteer in the clinics of Senegal and presented a program on AIDS in the Developing World at a conference on "Faith-Based Initiatives and the President's Emergency Plan for AIDS Relief (PEPFAR)" convened by Georgetown University on behalf of Ambassador Tobias and PEPFAR.