Tuberculosis – a curable disease which claims 2 million lives a year

A devastating disease

More people die from tuberculosis (TB) than from any other infectious disease in the world. This devastating disease is considered a global emergency. It spreads easily, is being fuelled by the HIV/ AIDS epidemic and drug resistant strains of TB are on the increase and spreading with greater mobility of populations.

The World Health Organization (WHO) estimates that between 2002 and 2020, approximately 1000 million people will be newly infected, over 150 million people will get sick, and 36 million will die of TB - if control is not further strengthened.TB also impedes socio-economic development of countries as it affects people in their most productive age.

TB is caused by the bacillus mycobacterium tuberculosis and is spread through the air like a common cold. If left untreated, one person with active TB will infect on average between 10 and 15 people every year. One-third of the world’s population is infected with the TB bacillus. Malnutrition, poor sanitation and overcrowding contribute to the spread of the disease.

In addition, HIV co-infection greatly increases the risk of the disease progressing from latent to active TB by weakening the immune system. Multidrug resistant TB (MDR TB) has been increasing over the past 20 years as many patients do not complete a full course of treatment and the TB bacilli becomes resistant to the most powerful anti-TB drugs. People infected by such patients will have the same drug-resistant strain which is far more difficult and extremely expensive to control.

Learn more about TB on the WHO website

Learn more about TB on the Stop TB partnership website

 

DOTS cures TB

TB can be cured with DOTS (Daily Observed Treatment Short Course), the WHO recommended strategy for the control of TB. DOTS cures patients, prevents the development of drug resistance and reduces the transmission of TB.

It combines five elements crucial for the successful control of the disease: political commitment, microscopy services, drug supplies, surveillance and monitoring systems and use of highly efficacious regimes with direct observation of treatment.

DOTS was introduced on a global scale in 1991 but according to WHO estimates only 27% of people with infectious TB are treated in DOTS programs. Unless there is a rapid acceleration of DOTS expansion, the global targets of detecting 70% of people with infectious TB and curing 85% of those detected by 2005 will not be met until 2013.

Learn more about DOTS

 

The Novartis DOTS donation

In December 2003, Novartis signed a Memorandum of Understanding with WHO committing itself to donate the WHO gold-standard for the treatment of half a million patients over a five-year period.

This was in response to United Nations Secretary General, Kofi Annan’s call for support for the fight against HIV/AIDS, TB and malaria. Rifampicin, a key drug in TB treatment, was co-developed in the labs of Novartis. Sandoz is one of the leading suppliers of TB treatment and also developed the fixed drug combinations in line with WHO guidelines.

The Novartis donation comprises the rifampicin-based fixed-dose combinations which will be provided in blister packs within patient kits. Fixed-dose combinations offer significant advantages over loose drugs. They reduce the risk of resistance by preventing monotherapy and stock outs of any individual drug, simplify logistics and minimize the risk of prescribing errors. They are very patient friendly as they dramatically reduce the number of tablets patients need to take (from 12-16 tablets a day to 3-4) and thus improve patients’ compliance.

Rifampicin is clinically more effective than Ethambutol, the standard drug used in the continuation phase of treatment, shortens the duration of treatment from eight to six months and is particularly recommended for areas with widespread HIV co-infection.

The Novartis donation will be provided through the Global Drug Facility (GDF) of the Stop TB Partnership, which is hosted by WHO. This will ensure that countries get the necessary technical support at the country level to ensure the correct use of the drugs.

Novartis will also provide the necessary funds for logistics and independent quality control, to be carried out in addition to the quality control of the Novartis group.

Any country which receives support for TB control from the Global Fund to Fight AIDS, Tuberculosis and Malaria is eligible for the Novartis donated drugs. Country selection will start in April.

Applications will be reviewed by the GDF Technical Review Committee on technical grounds. Another key criteria is that the Novartis donation should cover a significant part of the drug requirements of the country.

WHO press release announcing the donation

 

Building on the experience made with the leprosy drug donation

The Novartis Foundation for Sustainable Development will manage the TB DOTS donation and support field activities to build on the experience made with improving access to leprosy treatment.

The ready availability of the fixed dose combinations in blister packs is crucial for the cure of patients, however additional measures need to be taken to ensure the early detection and cure of patients.

TB, like leprosy, is a highly stigmatized disease and the fear of TB is increasing with the high HIV AIDS co-infection rates. Dispelling the fear of TB, using social marketing methods, is crucial to encourage people to seek early treatment and complete a full course of treatment.

Compliance with treatment is a major challenge in TB as patients have to go everyday to a health facility to take their treatment for the first two months of treatment. This places a significant burden on them due to the costs involved and the inevitable loss of earnings for the day.

It is also a barrier to treatment for the poorest people and women who tend to discontinue treatment as soon as they feel better, thus increasing the risk of developing drug resistant TB. A further difficulty is the poor physical condition of patients as TB is a debilitating disease.

The Novartis Foundation will work closely with local health ministries to develop innovative ways to help address some of these major challenges.

Read an interview with Klaus Leisinger, head of the Novartis Foundation for Sustainable Development, about DOTS donation

Learn more about the Novartis Foundation for Sustainable Development

 

Developing new drugs

Novartis is also investing significantly in research and development for TB, multidrug resistant TB and dengue. At the recently established Novartis Institute for Tropical Diseases (NITD), headed by Alex Matter, former head of Novartis Oncology, Novartis is investigating new drugs for tropical diseases using state-of-the art tools.

The products of the NITD research will be made available to countries where the disease is endemic without any profit.

The Tuberculosis Research Unit works amongst other projects, on the finding of novel targets, that are responsible for the dormancy state of Mycobacterium tuberculosis in the host. This status enables the pathogen to survive for a long time and resist commonly available treatments.

The NITD facilities are currently being equipped with state of the art BSL-3 facilities for studying the pathogen and the whole institute is designed to become a training center for drug discovery science in this field.

The NITD closely collaborates with the Global TB Alliance to find new cures for TB, and leverages infectious disease knowledge from all other Novartis research institutes.

NITD Fact Sheet