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Global TB targets – DOTS & DOTS-Plus, plans to stop TB

The problem of global TB and the failure to reach targets for TB control, results in the deaths each year of nearly one and a half million people. Deaths from a disease that for many years has been treatable and curable.1“Global Tuberculosis Control 2011”, WHO, Geneva, 2011, 9 www.who.int/tb/publications/global_report/ It is not clear though whether this continuing high level of deaths is due to a failure of global TB control strategies, the impact of the joint TB and HIV epidemics, the increasing problem of drug resistant TB, a lack of TB funding or more likely a combination of all four.

“We have known how to cure TB for more than 50 years. What we have lacked is the will and the resources to quickly diagnose people with TB and get them the TB  treatment they need.”

Nelson Mandela July 15, 2004 2Remarks by Nelson Mandela: “Confronting the Joint HIV/TB Epidemics”, XV International AIDS Conference, Bangkok, 2004 http://quod.lib.umich.edu/c/cohenaids/

The Suffering of a Million People

Each year, for those people with pulmonary TB the following can often be true:

“When TB wakes up and gets into the lungs, it eats them from the inside out, slowly diminishing their capacity, causing the chest to fill up with blood and the liquidy remains of the lungs. A wet, hacking cough is evocative of TB. The lungs now in liquid form are sloshing around in the chest. Cough that up, even in microscopic, impossible to see droplets, near other people, and they have a very good chance of getting TB too.”

“Eventually, liquid replaces the lungs, the suffering patients cannot get enough oxygen, and respiratory failure occurs, they can no longer breathe and they drown. It’s painful, it’s drawn out. It’s an awful way to die. But before any of this happens the disease weakens you, diminishes your capacity for work, and puts your family and friends, and anyone else you come into contact with, at risk. Individual death is only part of the problem.”

Christian W. McMillen, Discovering Tuberculosis

A Global TB Emergency

In 1993 the World Health Organisation (WHO) declared TB to be a global emergency saying that:

“Tuberculosis today is humanity’s greatest killer, and it is out of control in many parts of the world. The disease, preventable and treatable, has been grossly neglected and no country is immune to it.”

Arati Kochi, Manager WHO Tuberculosis Program 3“WHO Calls Tuberculosis a Global Emergency”, Los Angeles Times, 1993 //articles.latimes.com/1993

DOTS

Subsequently WHO in the mid 1990s further developed their “DOTS”, or Directly Observed Treatment Short course strategy. This was to become the internationally recommended approach to TB control until 2006. The strategy was built on model programmes developed in African countries from the late 1980s and subsequently expanded worldwide.

DOTS - A woman takes her TB drugs under supervision in a pharmacy

DOTS – A woman takes her TB drugs under supervision in a pharmacy

DOTS has five components, which were initially as follows.4“What is DOTS? WHO Tuberculosis Factsheet”, WHO, 2006 What is dots?

  • Sustained political and financial commitment.
  • Diagnosis by quality ensured sputum smear microscopy.
  • Standardized short course anti TB treatment (SCC) given under direct and supportive observation (DOT).
  • A regular uninterrupted supply of high quality anti TB drugs.
  • Standardized recording and reporting.

Setting new global TB targets in 2000

By the year 2000 some global TB targets set in 1991 had not been met. So further international meetings were held, at which the same goals were once again set, but this time to be achieved by 2005.5“Amsterdam Declaration to Stop TB”, Amsterdam, The Netherlands, 24th March 2000 www.stoptb.org/assets/documents/events/meetings/amsterdam_conference/decla.pdf

The Amsterdam Declaration to Stop TB

At a meeting in Amsterdam in March 2000, the 20 “high burden” TB countries again confirmed their commitment to meeting, amongst other goals, the detection of 70% of active TB cases, this time to be achieved by 2005.6“Amsterdam Declaration to Stop TB”, Amsterdam, The Netherlands, 24th March 2000 www.stoptb.org/assets/documents/events/meetings/amsterdam_conference/decla.pdf

Global TB Initiatives

In the eighteen months after the Amsterdam Declaration a number of global TB initiatives were to be started. These included:7“First Stop TB Partners’ Forum”, Washington, 22 October 2001, 6  www.stoptb.org/events/meetings/partners_forum/2001/

  • The Stop TB Partnership
  • The Global Drug Facility
  • The Green Light Committee
  • The Global Alliance for Tuberculosis Drug Development
  • The Global Plan to Stop TB 2001–2005

The Stop TB Partnership

The Stop TB partnership was set up in 2001 following the Amsterdam Conference in 2000. Initially the partnership comprised just six organisations and one of its first initiatives was the Global Drug Facility.

The Global Drug Facility

The Global Drug Facility was established in 2001 to expand access to and the availability of high quality TB drugs, in order that DOTS programs could be expanded. It was established in response to the difficulties that countries had in the 1990s in finding and funding high quality supplies of TB drugs. It was believed that patients were developing resistance as a result of poor quality drugs.8“What is the GDF?”, www.stoptb.org/gdf/

The Green Light Committee and DOTS-Plus

In 2000 the WHO and some international partners, were beginning to develop an initiative called DOTS-Plus. It was considered that the development of the DOTS strategy had been very successful in expanding effective TB treatment. However in some areas its success was being threatened by the emergence of multi drug resistant TB. DOT-Plus was to be developed as a comprehensive initiative that was to build upon the five elements of DOTS, but would take into account specific issues, such as the use of second line anti TB drugs, that needed to be used in areas where there were significant levels of MDR TB.

One of the difficulties with the implementation of some of the DOTS-Plus pilot projects, was the need for quality second line anti TB drugs, which were normally very expensive. WHO and their partners made an arrangement with the pharmaceutical industry for preferential prices for second line drugs used for the pilot projects. However, it was considered important that these beneficial prices were only used in projects that were organised according to certain standards. So the Green Light Committee was established to review project applications, and to decide whether they were sufficiently in accordance with the guidelines that had been established for the pilot projects.9“DOTS-Plus & the Green Light Committee”, www.who.int/tb/publications/2000/en/index.html

The Global Alliance for Tuberculosis Drug Development

The Global Alliance for Tuberculosis Drug Development (now called the TB Alliance) was launched in October 2000, at a time when there were no TB drugs in clinical development. Since then the resulting organisation has, amongst other things, launched the first clinical trial to test multiple new drugs, and co–founded the Critical Path to TB Drug Regimens (CPTR) initiative.10“TB Alliance History and Impact”, http://www.tballiance.org/about/history.php

The Global Plan to Stop TB 2001–2005

By the time the first Stop TB Partners’ Forum took place in October 2001 the partnership had grown from six to over 120 organisations. At the Forum the launch took place of the Global Plan to Stop TB 2001–2005. Its aim was to provide a “roadmap” towards a TB free world, and it was considered that the 2005 TB control targets were realistic.11“First Stop TB Partners’ Forum”, Washington, 22 October 2001, 6 www.stoptb.org/events/meetings/partners_forum/2001/

The Global Plan to Stop TB 2001–2005 made a number of commitments including that:12“First Stop TB Partners’ Forum”, Washington, 22 October 2001, 6  www.stoptb.org/events/meetings/partners_forum/2001/

  • Within the next 50 months — by the end of 2005:
  • A global DOTS case detection rate of at least 70% would have been achieved, while maintaining a treatment success rate of at least 85%
  • Effective responses to TB-HIV and MDR-TB would have been developed and scaled up
  • A Global Plan to Stop TB for the period 2006–2010 would have been developed

The Global Plan to Stop TB 2006–2015

Once again the targets set in a Global Plan to Stop TB had not been reached. This time it was the targets in the Global Plan to Stop TB 2001–2005, and these targets had been considered realistic back when they were set in 2001.

People were to be treated under DOTS-Plus

People were to be treated under DOTS-Plus

In the new global plan for 2006–2015, the targets were no longer set in terms of the percentage of people reached in case detection rates, or a treatment success rate of at least 85%. Instead there were a range of targets covering specific areas such as the development of improved diagnostics and drugs, and the target set in the Millenium Development Goals.

The Global Plan to Stop TB 2006–2015 has as its main targets:13“The Global Plan to Stop TB 2006-2015”, WHO, Geneva, 2011, 9 www.stoptb.org/global/plan/

  • To meet the MDG target to have halted and begun to reverse the incidence of TB by 2015
  • To meet the Stop TB partnerships own targets, to by 2015, halve prevalence and death rates from the 1990 baseline
  • Over the ten years of the plan, 50 million people will be treated under DOTS Plus, 800,000 people will be treated for MDR TB, and three million people with TB and HIV co–infection will start antiretroviral therapy.
  • By 2010 simple tests for use at peripheral levels of the health system, will enable rapid, sensitive detection of active TB at the first point of care, and by 2015 there will be tests to identify those at greatest risk of progressing to active disease.
  • The first new TB drug for 40 years will be introduced in 2010, and by 2015 the target will have nearly been reached of a new regime that will achieve cure in 1–2 months, and that also will be effective against MDR TB
  • By 2015 there will be the first of a series of new, safe, effective TB vaccines.
  • There were also aims of involving communities and TB control featuring on the political agendas of countries.

The Global Plan to Stop TB 2011–2015

In 2009 the Stop TB Partnership produced a report on the progress that had been made in global TB control between 2006 and 2008.14“The Global Plan to Stop TB 2006-2015: Progress Report 2006-2008”, WHO, 2009 www.stoptb.org/resources/publications/plans_strategies Many different areas were highlighted and in some, significant progress had been made, whereas in others, such as screening HIV positive people for TB, it was noted that much less progress had occurred. It was particularly noted that the provision of funding for TB was an area of particular difficulty with a funding gap still existing of over US$1 billion per year.

The Global Plan was subsequently updated in 2010, to become the “Global Plan to Stop TB 2011–2015”.15“The Global Plan to Stop TB 2011-2015”, WHO, Geneva, 2010 www.stoptb.org/global/plan/

After 2015 — TB is still a Global Emergency

In 1993 the WHO declared TB to be a global emergency, stating that the disease would claim more than 30 million lives in the next ten years unless sufficient action was taken. Since then some action has been taken, but TB still claims one and a half million lives a year, and more than 30 million people have died since the global emergency was declared. What was said by WHO in 1993 is still probably true today.

“Tuberculosis today … is out of control in many parts of the world. The disease, preventable and treatable, has been grossly neglected and no country is immune to it.”

Arati Kochi, Manager WHO Tuberculosis Program 16“WHO Calls Tuberculosis a Global Emergency”, Los Angeles Times, 1993 //articles.latimes.com/1993

References

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1. “Global Tuberculosis Control 2011”, WHO, Geneva, 2011, 9 www.who.int/tb/publications/global_report/
2. Remarks by Nelson Mandela: “Confronting the Joint HIV/TB Epidemics”, XV International AIDS Conference, Bangkok, 2004 http://quod.lib.umich.edu/c/cohenaids/
3. “WHO Calls Tuberculosis a Global Emergency”, Los Angeles Times, 1993 //articles.latimes.com/1993
4. “What is DOTS? WHO Tuberculosis Factsheet”, WHO, 2006 What is dots?
5. “Amsterdam Declaration to Stop TB”, Amsterdam, The Netherlands, 24th March 2000 www.stoptb.org/assets/documents/events/meetings/amsterdam_conference/decla.pdf
6. “Amsterdam Declaration to Stop TB”, Amsterdam, The Netherlands, 24th March 2000 www.stoptb.org/assets/documents/events/meetings/amsterdam_conference/decla.pdf
7. “First Stop TB Partners’ Forum”, Washington, 22 October 2001, 6  www.stoptb.org/events/meetings/partners_forum/2001/
8. “What is the GDF?”, www.stoptb.org/gdf/
9. “DOTS-Plus & the Green Light Committee”, www.who.int/tb/publications/2000/en/index.html
10. “TB Alliance History and Impact”, http://www.tballiance.org/about/history.php
11. “First Stop TB Partners’ Forum”, Washington, 22 October 2001, 6 www.stoptb.org/events/meetings/partners_forum/2001/
12. “First Stop TB Partners’ Forum”, Washington, 22 October 2001, 6  www.stoptb.org/events/meetings/partners_forum/2001/
13. “The Global Plan to Stop TB 2006-2015”, WHO, Geneva, 2011, 9 www.stoptb.org/global/plan/
14. “The Global Plan to Stop TB 2006-2015: Progress Report 2006-2008”, WHO, 2009 www.stoptb.org/resources/publications/plans_strategies
15. “The Global Plan to Stop TB 2011-2015”, WHO, Geneva, 2010 www.stoptb.org/global/plan/
16. “WHO Calls Tuberculosis a Global Emergency”, Los Angeles Times, 1993 //articles.latimes.com/1993