TUBERCULOSIS: Global Alliance for TB Drug Development document

FALLING SHORT
Falling short: ensuring access to simple, safe and effective first-line medicines for tuberculosis.

Produced by: Global Alliance for TB Drug Development (2010)
This report presents evidence to document the challenges hindering effective first-line TB treatment worldwide. Many TB patients around the world are at risk because:
they are not receiving the medicines they need, whether because of poor quality, interruptions in the drug supply known as stock-outs
they receive loose, single-drug pills that complicate treatment.
Key recommendations to address these issues include:
preventing stock -outs: national TB programmes and procurement officials should increase supervision and monitoring to catch early signs of stock-outs and respond quickly and aggressively
ensuring quality assured medicines: at the same time, regulators need to work with manufacturers, the WHO and others to ensure that patients are getting quality-assured Fixed-Dose Combinations (FDCs), even in the private sector
increasing the uptake of FDCs: international donors also have a role to play by ensuring timely delivery of funds, supporting Public-Private Mix (PPM) programmes to improve private sector treatment, and providing targeted resources and assistance to regulators and manufacturers for implementation and enforcement of quality standards.

The document argues that there is a need to refocus on the most basic level of TB care to protect the gains of recent years and speed momentum in the fight against TB. A renewed commitment from everyone engaged in the fight against TB is required to ensure all TB patients are getting the treatment they need when they need it.
Every tuberculosis (TB) patient in the world has the right to an uninterrupted supply of simple, safe and effective medicines for TB. But for too many TB patients globally, this is not happening. These patients
are not getting the treatment they need when they need it.
When manufactured, administered and used correctly, first-line TB medicines are one of the most costeffective health interventions in the world. In the 50 years or so since they were developed, these drugs
have been used to successfully treat millions of TB patients. Yet many TB patients around the world are at risk because they are not receiving the medicines they need, whether because of poor quality, interruptions
in the drug supply known as stock-outs, or because they receive loose, single-drug pills that complicate
treatment. Without consistent access to the right medicines at the right time, TB patients can default on their treatment and continue infecting those around them. Worse, they risk the development of drug-resistant TB strains or even death.
http://www.tballiance.org/downloads/publications/Falling_Short.pdf

TUBERCULOSIS: Cost of resistance to treatment

Multi-drug resistant strains of tuberculosis (TB) could become dominant forms of the disease in the next few decades, adding heavy financial and medical burdens to already struggling health systems, doctors said on Wednesday.
In a series of studies into TB, scientists said “superbug” strains of the disease were already gaining ground in some countries and called for greater investment into research and development of new drugs and possible vaccines.
Multidrug-resistant tuberculosis, known as MDR-TB, has much lower cure rates, higher death rates, and costs far more to treat than normal TB, they warned.
An estimated 440,000 MDR-TB infections occurred around the world in 2008, accounting for 3.6 percent of known cases.
Neel Gandhi of New York’s Yeshiva University and Paul Nunn of the World Health Organization in Geneva, who conducted one of the studies, found that India and China had around 50 percent of the global MDR-TB burden, followed by Russia with 9 percent.
“Unless countries invest substantially in management of MDR TB, the possibility remains that MDR strains could become the dominant form,” they wrote.
“The future possibility of strains that are totally resistant to all anti-tuberculosis drugs is not inconceivable.”
TB — which causes around 1.8 million deaths worldwide every year, or nearly 5,000 people a day — is often associated with poverty and is one of the leading causes of death among people in economically productive age-groups in developing nations.
Of a 11 million active cases of TB recording in 2008, 95 percent of cases were in low- and middle-income countries.
It is caused by the Mycobacterium tuberculosis bacteria and can be cured with antibiotics, but they must be taken daily for months to be effective and public health funding cuts in some countries may mean fewer drugs are available.
Because people do not always take the drugs properly, MDR-TB strains are starting to take hold and the WHO says there is an urgent need for countries to set up laboratories to fight it.
Gandhi and Nunn said MDR-TB treatment is less effective, requiring 24 months of treatment rather than the usual 6 months, and far more expensive — costing an average of $3,500 in drugs per patient versus around $20 per patient for normal cases.
“Even though there are fewer cases of drug-resistant TB, the cost and complexity of their management place a significantly greater burden on the health system,” they said.
In other studies in the series, which was published by The Lancet on Wednesday, scientists said the combined impact of new drugs, vaccines, and diagnostic tests could cut worldwide incidence of TB by 94 percent by 2050, but the investment needed to bring this about it falling way too short.
Only around a quarter of the funding needed is being put into TB drug research and development, they said, and called for new ways of encouraging pharmaceutical firms into the field.
“Development of new drugs for TB is lengthy, expensive, and risky, and the expected revenues are too small to justify commercial investment,” wrote Zhenkun Ma of the Global Alliance for TB Drug Development. “New financing and market incentive mechanisms are needed.”
According to the studies, there are 11 potential TB vaccines being tested in human trials and up to 10 experimental medicines in the TB drug “pipeline.” Since many drugs fail in late-stage trials, this handful of possibilities is unlikely to be enough.
“To eliminate TB as a public health concern by 2050, all responsible parties need to work together to strengthen the global anti-tuberculosis drug pipeline,” the scientists said.
http://www.ethiopianreview.com/news/116379