The past decade has seen significant progress in scaling up effective treatment and case management programs for tuberculosis (TB) control, and the global incidence rate is now declining. Yet a new report released today by a consortium of leading international TB organizations highlights a major issue that is stalling progress: many TB patients worldwide are still not getting simple, quality-assured first-line medicines—raising the threat of drug resistance and heightening the risk of an untreatable epidemic.
Entitled Falling Short: Ensuring Access to Simple, Safe and Effective First-Line Medicines for Tuberculosis, the report demonstrates that TB patients around the world are too often given poor quality medicines or complicated, non-user friendly treatment formulations that consist of up to 16 pills at a time. Additionally, they may be unable to take their medicines as prescribed because of drug stock-outs. Without the appropriate medicine at the right time, patients risk stopping treatment, spreading the disease to others, developing drug resistance or even death.
“This report is a wake-up call for the TB community,” said Dr. Nils Billo, Executive Director of the International Union Against Tuberculosis and Lung Disease. “All TB patients should have the right to consistent supplies of simple, quality-assured medicines when they need them. The world desperately needs to refocus on the most basic level of TB care or we risk returning to the time before antibiotics.”
Quality-assured fixed-dose combination drugs (FDCs) are considered the international "gold standard" for TB treatment and are extremely effective when prescribed and administered correctly. At US$26 for a full six-month regimen, they are also affordable—even in developing countries where the TB burden is greatest. Yet TB continues to kill approximately 1.8 million people each year and drug resistance is growing. In 2008, there were roughly half a million cases of multidrug resistant TB globally. The drugs for treating drug resistant TB can cost between US$2,000 and US$9,000 per patient and must be taken for up to two years.
The report describes a number of reasons that patients are not currently getting the first-line drugs they need, whether from private sector health providers or public sector ones. In the private sector they may be given single-drug treatments consisting of as many as 16 loose pills at a time as opposed to FDCs, which consist of only three or four. Numerous loose pills make treatment more burdensome for patients and may increase the risk that they will take incomplete treatments and not be completely cured.
Quality assurance is also a serious problem in many places. In the private sector the quality of TB medicines is largely unknown. In the public sector some countries spend large portions of their procurement budgets on TB medicines that are not required to meet standards of quality assurance equivalent to those recommended by the World Health Organization. Even when countries do provide quality-assured FDCs, they may experience stock-outs that leave patients without access to any medicine at all. All of these challenges place patients at risk of ineffective treatment, drug resistance or death.
“We took a broad look at what sort of medicines TB patients are taking around the world and found major cause for concern,” said Elizabeth Gardiner, Vice President of Market Access at the TB Alliance and a contributor to the report. “Quality assurance, treatment formulations and stock-outs are all major issues, but issues that can often be resolved with relatively simple solutions. It will take renewed commitment and political will, but we cannot continue to gamble with the lives of TB patients.”
There are signs of progress, however. A handful of emerging economies with high TB burdens—including China and Brazil—are already leading the drive to improve basic TB treatment. Their national TB programs have made new commitments and pioneered new approaches to ensure that every patient has access to quality-assured FDCs. The Global Drug Facility, an initiative of the Stop TB Partnership, is also taking steps forward by launching a Rapid Response Facility, which will address some of the key drivers of stock-outs.
“It is great to see so many partners come together on this critical issue that has been neglected for too long,” said Mark Harrington, Executive Director of the Treatment Action Group (TAG), another contributor to the report. “Fixing this problem will require everyone doing their part—TB program managers, international donors, national regulatory authorities, and private sector providers.”
The report was produced by the Bill & Melinda Gates Foundation, the Clinton Health Access Initiative, the Global Drug Facility, Treatment Action Group, the International Union Against Tuberculosis and Lung Disease, the Global Alliance for TB Drug Development, and Management Sciences for Health.
It was presented at the 41st Union World Conference on Tuberculosis and Lung Health at a symposium on “Fixed-Dose Combinations: Past Introduction and Future Innovation.” The symposium was co-chaired by Michael Kimerling of the Bill & Melinda Gates Foundation and Margareth Dalcolmo of Brazil’s Ministry of Health.
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Ian Temple
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