Funding for tuberculosis programs on chopping block

The TB Alliance has announced that it will advance the breakthrough formulation, called PaMZ, to Phase III clinical trials after encouraging earlier results. The regimen could provide a shorter, simpler and less toxic means of treating TB – particularly some drug-resistant forms of the disease. Quickly addressing a funding gap for Phase III trials is now essential to preventing any delay of the promising new treatment.

With U.S. government funding for TB on the chopping block, it’s up to Congress to ensure our continued support for this potential life-saving innovation.

The need for new TB drugs is urgent, and growing. In 2012, 8.6 million people became sick with TB worldwide, a half million of whom were estimated to be infected with deadlier strains of multidrug-resistant TB (MDR-TB) – strains which nearly always develop from incomplete or ineffective TB treatment. Some countries face staggering rates of drug resistance, with up to 30 percent of new TB cases resistant to two or more first-line drugs.

Though it’s often portrayed as a disease of the developing world, TB poses a real threat within our own borders. In just the last month, U.S. authorities have identified cases of TB at schools in Kansas, Tennessee and Nevada, and the state of Delaware asked the Centers for Disease Control for help dealing with an outbreak at a prison in Wilmington. And extensively drug-resistant TB – the most dangerous form of the disease – was identified in both Texas and California in the past year.

Chronic underinvestment in TB research and development means we still rely on drugs that are half a century old. Although nearly all forms of TB are curable, even standard TB treatment requires six to nine months to complete. And MDR-TB can require up to two years of intensive drug therapy that is much more expensive and often comes with toxic side effects. Fewer than one in ten MDR-TB patients completes proper treatment – many because they can’t afford it or can’t endure the difficult side effects – increasing the risk of developing more drug-resistant strains.

PaMZ could help address a number of these problems by reducing costs and simplifying treatment. The regimen consists of two new drugs, PA-824 and moxifloxacin, and another drug, pyrazinamide, already in use. Remarkably, combining these drugs could reduce the volume of pills patients have to take to treat some forms of MDR-TB by 97 percent. It also could eliminate the need for injections, while reducing treatment time from two years to just six months and cutting costs by up to 90 percent. The regimen has far fewer side effects than many currently available treatments for MDR-TB, and is compatible with commonly used HIV drugs. Since TB is the leading killer of people with HIV/AIDS, compatible treatments for the two diseases are essential.

The Phase III trial for clinical testing of the three drugs in combination will be a first for TB – an advance over the previous approach, which required initial separate tests for each drug – and could potentially shave years off the testing process. But it is by no means certain when the trial will begin, as it still faces a considerable funding gap.

A range of donors worldwide helped move the process this far, recognizing we all stand to gain from more effective treatments against this pernicious global threat. Getting through the next stage of testing will require the same concerted international response.

Unfortunately, President Barack Obama’s 2015 budget has proposed a deep cut to international TB programs. The budget proposal calls for cutting the U.S. Agency for International Development’s TB budget by $45 million, a 19 percent drop that would gut funding to fight global TB – including potential support for late-stage clinical trials like PaMZ.

This would be a grave mistake, not least of all because USAID has supported PaMZ research and helped get the treatment to this critical stage. Cutting funding now would jeopardize the potential returns on taxpayer investment and stymie progress just as years of effort are about to bear fruit. Such cuts would also undermine our ability to utilize a new treatment regimen and scale up other critical TB tools by reducing the modest but critical support we provide to countries with the biggest burdens of TB.

In recent hearings on the budget, USAID Administrator Rajiv Shah faced concerned members of Congress questioning the wisdom of a deep cut to life-saving TB programs. The recent announcement of a promising new treatment regimen underscores the importance of protecting and actually expanding this funding. Last year, Congress rejected a proposed administration cut to global TB programs, and it will again be up to lawmakers to ensure full funding for USAID’s TB program.

What Congress decides will determine if the United States stays at the forefront of the fight against TB – or if we risk letting this and other life-saving opportunities slip through our fingers.

By Joanne Carter
Dr. Joanne Carter is the executive director of RESULTS Educational Fund, a nonprofit that tries to educate and engage the public on issues of hunger and poverty.

Source: Cleveland.com