May 2008 PEPFAR Editorial Packet

In phase two of the president’s AIDS initiative, Congress must address the threat of drug-resistant TB

Critical global health bill stalled in Senate

May 2008 — During his recent trip to Africa, President Bush noted the progress made against AIDS, thanks in no small part to the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). The emergence of drug-resistant tuberculosis, however, threatens to undermine that progress. People living with HIV/AIDS are much more susceptible to TB, and without effective diagnosis and treatment of drug-resistant strains, TB becomes a rapid death sentence. With TB already the biggest killer among people with HIV/AIDS, these drug-resistant cases — far more difficult and costly to treat — must be detected and cured, so the deadly cycle of transmission can be stopped before death rates skyrocket.

A new TB drug-resistance surveillance report, “Anti-tuberculosis drug resistance in the world,” recently released by the World Health Organization, provides compelling evidence for the need for a greatly scaled-up U.S. response to the global TB epidemic — including worrisome information about what we don’t know about the epidemic in Africa. The most comprehensive global survey ever done — with data from over 80 countries — finds multidrug-resistant TB (MDR-TB) at the highest rates ever recorded, at nearly half a million new cases of MDR-TB a year, making it clear that more resources must be made available, especially in high-risk areas, to quell the upsurge in deadly drug-resistance. The report finds that extensively drug-resistant TB (XDR-TB), which has demonstrated death rates approaching 100 percent in some settings, has been identified in 45 countries; however, there are major gaps in our knowledge of how dire the situation actually is — particularly in sub-Saharan Africa, where countries lack the lab capacity to even detect drug-resistant TB.

Fortunately, the House has taken initial steps to mount a response commensurate with the scale and seriousness of the TB pandemic as it moves forward legislation to reauthorize the president’s AIDS initiative. On April 2, the House of Representatives took the bold step of passing a reauthorization of PEPFAR that calls for $50 billion over the next five years[1], adding important investments such as training new health professionals and at least a doubling of funding for the Global Fund to Fight AIDS, TB and Malaria. In addition, the legislation — titled the Tom Lantos and Henry J. Hyde United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008 — comprehensively addresses TB (based on a well-developed Global Plan to Stop TB — see below), authorizing $4 billion over the next five years in critical resources for TB treatment and prevention worldwide, as well as key provisions for scaling up life-saving TB-HIV efforts.

The bill must now be passed by the full Senate. However, passage of the bill is currently being stalled in the Senate by a few senators who have voiced concerns about the size of the bill. Members of the global health community — as well as voices from across the political spectrum — have acknowledged that the scale-up is necessary to transform PEPFAR from an emergency response program, into one that produces sustainable, long-term results. This is accomplished by funding not only treatment programs, but prevention efforts and programs to address TB-HIV co-infection, AIDS orphans, maternal health, nutrition and other broader aspects of keeping those living with HIV/AIDS healthy and thriving.

In a May 14 op-ed, Washington Post columnist Michael Gerson wrote of the stalled bill, “It is the nature of the Senate that the smallest of minorities can impede the work of the majority. But it takes a conscious choice — an act of tremendous will and pride — for members to employ these powers against an AIDS bill with overwhelming bipartisan support.”

The deadly connection between TB and HIV

When PEPFAR was first authorized, little attention was given to TB and its impact on people living with HIV/AIDS, and XDR-TB had not even been officially identified. While U.S. global AIDS funding made major gains, TB funding has languished — and this neglect has left both efforts terribly vulnerable. The House of Representatives has taken a bold step in increasing funding for PEPFAR and for global TB programs. As the bill moves forward, the critical TB policy and funding provisions must remain intact. Armed with the knowledge we now have — and the latest data on the growing crisis of drug-resistant TB — Congress must connect the dots to see that the fight against AIDS will not ultimately succeed without an equally aggressive effort against TB. The emergence of XDR-TB is a consequence of our collective failure to adequately address the TB epidemic. For decades, TB programs and health systems have been shortchanged, leaving them ill-equipped to control a disease that kills about 1.7 million people a year — 4,700 people per day — despite a low-cost cure. XDR-TB occurs nowhere in nature. It’s a human-made problem arising from inadequate or incomplete TB treatment provided in the context of under-funded TB control and weak health systems.

The new WHO report identifies 45 countries with confirmed cases of XDR-TB (with several more identified since the report was finalized) — including the U.S., Canada, Mexico and the entire roster of G8 member states. Although XDR-TB represents a relatively small percentage of overall TB cases, its high mortality rate and difficult treatment make it a global threat to public health. Knowledge about the full extent of XDR-TB is incomplete, because of major gaps in lab capacity to test for drug-resistance — let alone to track the epidemic and respond.

Some facts about XDR-TB:

• XDR-TB is resistant to not only the most effective first-line drugs, but also to critical second-line drugs. An outbreak of XDR-TB in KwaZulu Natal (KZN), South Africa, in 2006 killed 52 of 53 patients. A result of improper treatment and management of regular TB, XDR-TB is entirely human-made.
• In the first group of 53 XDR-TB patients reported in KZN, 70 percent died within one month of being diagnosed with TB (untreated or ineffectively treated TB is rapidly fatal in people living with HIV/AIDS). Current methods of testing for drug-resistance can take between 6 to 16 weeks, so many HIV-positive patients with drug-resistant TB die before the disease can even be accurately diagnosed.
• According to the U.S. Department of Homeland Security (DHS), in some sampled populations, XDR-TB has had fatality rates approaching 100 percent. DHS has identified XDR-TB as an “emerging threat to the homeland.”

The Global Plan to Stop TB

Launched in 2006, this comprehensive 10-year business plan to fight TB, if fully implemented, will save an estimated 14 million lives and put humanity on track to wipe out one of our oldest and deadliest killers by:

• Expanding access to high-quality TB testing and treatment for all
• Treating 50 million people for TB
• Developing more effective tools to diagnose and treat TB and creating a new vaccine

In June 2007, the WHO released the MDR/XDR Global Response Plan to complement the existing Global Plan, with strategies and resources necessary to address the MDR/XDR-TB emergency, including lab strengthening, infection control, more aggressive treatment, and prevention efforts. If fully implemented, the plan will increase by ten-fold the number of MDR- and XDR-TB patients being treated and cured under WHO guidelines.

The challenge for PEPFAR

As the Senate prepares to reauthorize PEPFAR, they must also prioritize a comprehensive and robust approach to TB. Failure to address TB will undermine the gains made in reducing AIDS deaths and could push us to an almost pre-antibiotic era in the TB battle. As Archbishop Desmond Tutu — himself a TB survivor — has written, “XDR-TB sounds a clamorous warning: without the political will to control TB, we will not only fail to defeat HIV but may enable the rise of an incurable, airborne disease.”

Improving access to TB diagnosis and treatment will not only directly address the biggest killer of people with AIDS, but can also help ensure the success of AIDS efforts. TB programs are one of the most important entry points for access to HIV testing, counseling, and comprehensive services and are therefore critical to reaching global HIV/AIDS treatment, prevention, and care targets.

The Senate’s reauthorization of PEPFAR would go a long way to close the gap in the fight against TB. In doing so, it will protect the billions invested in AIDS efforts as well. Bold action by the Senate can help bring these diseases under control, but there is no time to lose.

[1] President Bush has asked for $30 billion for the reauthorization of PEPFAR over the next five years – but this funding level equates to a near flatlining of the current funding levels, and would slow the rate of progress.