Doctors Without Borders/Médecins Sans Frontières (MSF) is calling on world leaders to #StepUpForTB and to take measures to address tuberculosis as a global health emergency that kills millions of people each year.

 

Tuberculosis (TB) is one of the most deadly infectious diseases in the world. In 2015, 10.4 million people became ill with TB and 1.8 million people died from the disease, mainly in developing countries. Today, TB is the leading killer infectious disease, followed by malaria and HIV/AIDS.

TB is often thought of as a disease of the past, but a recent resurgence and alarming rise in cases of drug-resistant (DR-TB) and multidrug-resistant TB (MDR-TB) make it very much an issue of the present day and age. Drug resistance – when TB does not respond to the customary first-line drugs – can result from inappropriate or incorrect use of antimicrobial drugs, premature treatment interruption and, increasingly, from person-to-person transmission.

Tuberculosis is the world’s leading infectious killer. TB kills one person every 18 seconds, yet the disease can be prevented, treated and cured.

For the first time ever, world leaders will come together later this year at a special United Nations High-Level Meeting (UNHLM) to discuss TB and the steps needed to tackle this global health emergency.

We need countries like Canada to be leaders in making sure that the outcome of the UNHLM is robust and sets measurable targets to close the testing, treatment, and prevention gaps that exist around the world (including in Canada itself).

Canada at the UN High-Level Meeting on TB

Right now, Canada is participating in negotiations leading up to the UN's High Level Meeting on Tuberculosis (UNHLM) which takes place in September 2018. MSF is counting on Canada to #StepUpForTB by:

1. Taking the lead and using Canada's status as a global health leader to close the gap in access to TB diagnosis and treatment, including ensuring that there is sufficient and sustainable financing to end the epidemic.

2. Actively pushing for a global commitment to finance TB research and development (R&D), including a short-course oral cure for TB (and its drug-resistant forms), better TB diagnostics that are affordable, specific, and sensitive, and novel vaccines to prevent infection or disease by 2030.

3. Pushing for countries to commit to national and global targets for testing, treatment and prevention of TB that are time-bound, ambitious and measurable.

4. Pushing to ensure that the UNHLM results in an accountability and review mechanism that defines clear, country-specific deliverables. The HLM should reconvene in 2023 and regularly thereafter to assess country progress toward the agreed upon outcomes.

What’s missing in the draft outcome document being negotiated for the UN's High Level Meeting on Tuberculosis?

1. National Testing & Treatment Coverage Targets

Countries need to commit to national-level targets in the draft declaration, not just global cumulative goals. National targets for testing, treatment, and prevention coverage are essential for scaling-up the response.

2. Access To Medicines/Technologies

The declaration needs to include strong language around access to medicines that re-affirms the rights of countries to use TRIPS flexibilities and other safeguards to protect public health.

These rights were laid out in the WTO Declaration on the TRIPS agreement and public health in 2001, and have been further clarified and re-affirmed in the outcomes documents following the UN High-Level Meeting (HLM) on HIV in 2011 and the UN HLM on NCDs in 2011, the Sustainable Developments Goals (SDG3), and 3 weeks ago at the World Health Assembly.

Why it matters: These rights are not just a legacy from the last two decades of people fighting for their lives as part of a larger access to medicines movement, but also a lifeline for people tomorrow who will need of affordable medical technologies. Champions of affordable access — be it government or civil society need to ensure that we don’t slide backwards. (Canada should be one of them!)

3. Innovation And Access

The best chance we have of ensuring access to new medical tools is to build in equitable access principles and practices into how research and development is financed and conducted. Governments need to recognize that TB R&D is a shared responsibility and they need to ensure that the products of government-funded research are affordable and accessible, including by delinking the cost of R&D from the final price.

There is a precedent: such language was part of the political declaration of the 2016 UN HLM on anti-microbial resistance. While similar strong language appeared in the first draft of the TB outcomes document, some governments are now actively trying to remove it.

4. Funding Targets

Governments need to include financial targets for TB programs and to support TB R&D to develop the new tools and technologies to prevent, diagnose and treat TB.

5. Follow-Up And Accountability

What happens after TB gets its day at the UN? Either we slide back into mediocrity, lack of transparency and accountability, or we hold governments to account for the commitments they made. This will depend largely on whether there will be regular reporting on progress, or the lack there of, an accountability body such as a Global TB Leaders Taskforce, and a follow-up HLM in meeting in 2023. Member states are resistant to some of these suggestions from the TB community.

Canada has plenty of reasons to #StepUpforTB

Every year, there are approximately 1,600 cases of tuberculosis in Canada alone. Supporting new treatment regimes for TB would benefit patients in Canada and millions of others around the world, including in MSF’s programs. Getting there requires a new approach for developing new TB treatments, and it is clear that the current model of research and development is not meeting the public health needs for TB — only two new compounds for for drug-resistant TB have been registered in the last 50 years and only seven are currently in clinical development.

That’s why in October 2017, MSF told the Standing Committee on Health how Canada can Step Up and support the development of new TB regimens that are short and affordable for patients who need them through a new mechanism we’re supporting called The Life Prize. MSF is also using new six-month treatment combinations of TB medicines in our TB-PRACTECAL clinical trial to find a new treatment regimen for drug-resistant TB that is better than what is currently available. We launched TB-PRACTECAL because we treat more than 20,000 people with TB each year and we felt compelled to search for new improved treatments ourselves, and because too few pharmaceutical companies and other organizations were doing enough about it.

We can’t do this alone – we need governments like Canada to #StepUpforTB and help support a pipeline of new drugs to find new, better treatments for TB that are shorter, more effective, and more affordable.

One-third of the world’s population is currently infected with the TB bacillus – but, with a latent form of the disease, have no symptoms and cannot transmit it. In some people, the latent TB infection progresses to acute TB, often due to a weak immune system. Of the 10.4 million new cases of TB in 2015, 5.9 million (56%) were men, 3.5 million (34%) were women and 1.0 million (10%) were children.Every year, about nine million people develop active TB and 1.5 million die from it.

Tuberculosis Facts

Transmission: TB is caused by bacteria (Mycobacterium tuberculosis) that are spread through the air when infected people cough or sneeze. While anyone can be infected with TB, people with weakened immune systems are at particular risk of developing active TB. People living with HIV are more likely to develop active TB and accounted for 1.2 million (11%) of all new TB cases in 2015.

Signs and symptoms: Most people exposed to TB never develop symptoms, since the bacteria can live in an inactive form in the body. The disease most often affects the lungs. Symptoms include a persistent cough, fever, weight loss, chest pain and breathlessness in the lead-up to death.

Diagnosis: In countries where TB is most prevalent, diagnosis depends largely on the microscopic examination of sputum, or lung fluid, for the TB bacilli. The test is only accurate half of the time, even less so for patients who also have HIV.

Treatment: A course of treatment for uncomplicated TB takes six months. Treatment for multidrug-resistant TB (MDR-TB) is especially arduous, taking up to two years and causing many side effects. When patients show resistance to MDR-TB drugs, they are considered to have extensively drug-resistant TB (XDR-TB) and have even fewer treatment options.

Activities 

Doctors Without Borders has been fighting TB for over 30 years. We provide treatment for the disease in many different contexts, from chronic conflict situations, such as Sudan, to vulnerable patients in stable settings such as Uzbekistan, southern Africa and the Russian Federation.

Doctors Without Borders has TB treatment projects in 24 countries around the world, and in 2015 supported more than 20,000 TB patients on treatment, including 2,000 patients with DR-TB. Two new drugs – bedaquiline and delamanid – have recently become available to some patients who have no other treatment options left. MSF and other treatment providers are showing that stronger TB regimens containing one of the new TB drugs along with ‘repurposed’ drugs (not specifically developed for TB but that have shown efficacy in treating it) can significantly improve the health of people with MDR-TB.

As of October 2016, Doctors Without Borders has initiated more than 1,000 patients on bedaquiline and/or delamanid in 12 countries. Programmatic data has shown promising early results on the effectiveness of these regimens, while patients report that the toxic side effects of treatment are reduced. It is also hoped that using the two new drugs in combination will be particularly effective in treating patients with the most severe forms of drug-resistant TB. In Doctors Without Borders projects in Armenia, Belarus, India, Mozambique, South Africa, and Swaziland, medical teams are already piloting the combination of the two new drugs as part of the regimen for patients with very limited treatment options.

Doctors Without Borders is involved in two TB clinical trials – TB PRACTECAL and as part of the endTB partnership – to find new, shorter, more effective combination treatments for multi-drug resistant TB that include the new drugs. Patients’ needs are at the heart of both trials, which aim to find treatments that contain no injectable drugs and have manageable side effects. Both trials are expected to enrol the first patients by the end of 2016.

Globally, there is still an unacceptable gap between those who would benefit from these new drugs and those who are able to access them. As of October 2016, only 5,738 patients have been able to access bedaquiline globally through programmatic use (i.e. outside clinical trials) or compassionate use, the majority of them in South Africa. There is an urgent need to increase people’s access to these more effective treatments by making them affordable and available.

Access to appropriate diagnostic tools for detecting TB must also be prioritised, including developing affordable rapid tests that deliver results on the spot. The most widely-used test for diagnosing active TB in developing countries relies on examining a patient’s phlegm under a microscope, known as microscopy. This method, developed nearly 140 years ago, detects less than half of all active TB cases and largely fails to detect the disease in children, people co-infected with HIV and those with drug-resistant forms of TB. Other diagnostic methods exist, but most require laboratories, a steady power supply and, like microscopy, skilled staff to deliver results – all of which are mainly unavailable in remote and rural settings. Diagnostic tests that can determine if patients are resistant to standard TB treatments are also needed.