New Numbers On Tuberculosis Burden Must Galvanize India To Act

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Dr. Madhukar Pai

Last week, WHO released its 2016 Global TB Report. The news, unfortunately, is not good. The report shows that the TB burden is actually higher than previously estimated, mainly because of new data from India. In 2015, there were an estimated 10.4 million new TB cases worldwide. Six countries accounted for 60 per cent of the total burden, with India accounting for 27 per cent of the global cases, followed by Indonesia, China, Nigeria, Pakistan and South Africa.

An estimated 1.8 million people died from TB in 2015, of whom 0.4 million were co-infected with HIV. Gaps in testing for TB and reporting new cases remain major challenges, as they have in the past. Of the 10.4 million new cases, WHO estimated that only 6.1 million were detected and officially notified in 2015, leaving a huge gap of 4.3 million cases that are “missing” — either not diagnosed, or managed in large unregulated private sectors and not notified to TB programs.

Global TB elimination is an impossible goal without significant progress in this emerging superpower.

India continues to bear the brunt of the TB epidemic, with 2.8 of the 10.4 million new TB cases that occurred in 2015. TB is also a major killer of Indian people. The latest Global Burden of Disease estimates from Institute of Health Metrics and Evaluation, published earlier this month, show TB to be the sixth leading cause of deaths in India. In 2005, TB was the sixth leading cause of deaths in India, and ten years later, in 2015, it holds its place as a leading killer of people in India.

These new estimates from WHO and GBD are disappointing and underscores the need for greater investments in global TB control. In particular, India really needs to wake up to the enormity of the epidemic in the country, and put some serious money behind its under-funded TB program. Global TB elimination is an impossible goal without significant progress in this emerging superpower.

It is worth comparing China’s TB situation with that of India. China had 0.9 million TB cases in 2015, while India had over 2.8 million. The number of drug-resistant TB cases in China was 57,000, while India was estimated to have over 79,000. TB is no longer a major killer of people in China, and does not make the top 10 most important causes of death.

It is remarkable that China more than halved its TB prevalence over the last 20 years. Marked improvement in quality of TB treatment, driven by a major shift in treatment from hospitals to the China CDC public health centres (that implemented the DOTS strategy) was likely responsible for this effect, which has been demonstrated by repeated national TB prevalence surveys.

So, why does India struggle with a much higher TB burden? There are many reasons. For one, India has many social determinants that fuel the TB epidemic — poverty, malnutrition, smoking, and indoor air pollution. Secondly, India has under-funded TB control for a very long time. And much of the focus was only on the public TB program. It is only recently that the national TB program has seriously started to address the problem of TB in India’s large, dominant, private sector.

With new research, our understanding of the true burden of TB in India is improving. We are now aware that private sector manages over half of all TB in India, new research suggests that enormous quantities of TB drugs are sold in the Indian private market.

For a long time, India ignored TB patients managed in the private sector, and national prevalence and drug-resistance surveys were not periodically done (unlike China and other high TB burden countries). Furthermore, the Indian national TB program was (and still is) heavily reliant on insensitive diagnostic tools such as sputum microscopy. India is “fighting the TB war with 19th century cannons.” All of this meant that India has been under-diagnosing and under-reporting the burden of TB for a long time.

With new research, our understanding of the true burden of TB in India is improving. We are now aware that private sector manages over half of all TB in India, new research suggests that enormous quantities of TB drugs are sold in the Indian private market.

In addition, although India made TB notification mandatory in 2012, it has taken a few years for private sector notifications to accumulate. Now, thanks to several public-private partnership programs, significant increases are being noticed in case notifications from private sector.

Overall, the path forward for India is very clear — acknowledge the reality of a massive TB epidemic, collect better data on true burden of TB, deaths, and drug-resistance, and allocate greater funding to tackle this huge problem. This will not happen without high-level political commitment.

Last week, on the same day of the WHO TB report release, The Lancet published a comment by the Indian Health Minister Mr Jagat Prakash Nadda and Dr Poonam Khetrapal Singh, head of India’s WHO Regional Office for South East Asia.

Overall, the path forward for India is very clear — acknowledge the reality of a massive TB epidemic, collect better data on true burden of TB, deaths, and drug-resistance, and allocate greater funding to tackle this huge problem.

In their Comment, they acknowledged that TB is a bigger problem than imagined in India and other Asian countries, and suggested that TB should be made a top priority on national agendas. They also argue that political commitment should be translated into a comprehensive national TB control plan, and such a plan must be fully funded and implemented promptly by an empowered body that reports to the highest levels of government.

These statements by the Indian Health Minister is very impressive and progressive, as is the commitment from Dr Soumya Swaminathan, India’s Secretary of the Department of Health Research about India’s plans conduct prevalence surveys, develop innovative new tools for TB, address social determinants such as malnutrition, and create an India TB Research Consortium.

Hopefully, these leaders will deliver on the vision that they have articulated, and make TB a national priority in India. In fact, India has already started the process for creating the National Strategic Plan for TB Control in India (2017-2023). This plan must be ambitious, and fully funded by the Indian government. Otherwise, future TB reports will continue to bring bad news.

Madhukar Pai is the Director of McGill Global Health Programs, and the Associate Director of McGill International Tuberculosis Centre. (@paimadhu)

This article was originally published in The Huffington Post. See the original article here.

Why The World Needs An Essential Diagnostics List

Lee Schroeder, Timothy Amukele and Madhukar Pai

This article was originally posted on Forbes website. See the original post here.

Without diagnostics, medicine is blind. And yet, diagnostics receive much less attention than vaccines and drugs. Imagine a sick infant with bacterial sepsis in sub-Saharan Africa. Without diagnostics, they will likely get incorrectly treated for malaria. Every year, 1 million patients with TB in India are either not diagnosed or not reported. Pregnant women with anemia, syphilis and diabetes are often missed in low-income countries where laboratory capacity is severely lacking. And where there is testing, it is often of low quality.


Hepatitis and HIV diagnostic tool. Photo by Dr. Nitika Pai.

recent NEJM article proposes a simple way to improve access to critical diagnostics: make a list. In 1977, the World Health Organization started (and has since maintained) a Model List of Essential Medicines (EML). The EML, a global health success, has improved access to medicines. Sadly, there is no equivalent Model List of Essential Diagnostics (EDL). Such a list would be impactful for these reasons:

1.  Improve patient care and clinical outcomes

Patients will get consistent access to quality essential diagnostics that will be affordable and always available. When a diagnostic is added to an EDL, governments, funders and manufacturers will work to ensure availability and access.

2. Help detect emerging infectious threats

The Ebola and Zika epidemics have underscored the need for surveillance. While many countries have reference laboratories, laboratory capacity at lower health system tiers is often weak. By increasing laboratory capacity at all tiers, an EDL could help countries better prepare for epidemics and implement international health regulations.

3. Increase affordability

Bulk and advanced purchasing, volume discounts and pooling mechanisms are widely used for vaccines and drugs. Without such mechanisms, quality diagnostics can be unaffordable. Xpert MTB/RIF is a good TB test, but affordability is limited. An EDL could promote group purchasing by international organizations (e.g., Global Fund). With larger, predictable volumes, manufacturers can lower prices. Countries can use EDL to impose price controls and waive import duties to ensure affordability.

4. Reduce antimicrobial resistance (AMR)

Indiscriminate antimicrobial use drives AMR. Without adequate diagnosis,antimicrobials get widely abused. In half of malaria-endemic African countries over 80% of malaria treatments are applied without diagnostic testing, leading to legitimate concern for the emergence of drug resistance.

5. Improve regulation and quality of diagnostics

Unlike developed countries, regulatory agencies that approve the accuracy of diagnostic devices either do not exist or are weak in resource-poor settings. An EDL could focus such agencies on priority tests and help to harmonize regulation at the regional level. An EDL could aid in the identification of sub-standard diagnostics, as is already occurring formalaria rapid tests.

6. Facilitate laboratory accreditation and training

Even if a diagnostic test is of high quality, its impact can be crippled by improper use. In Kampala, Uganda, 95% of all laboratories failed to get the lowest score on the WHO laboratory quality checklist. Country-level laboratory accreditation groups could use the EDL to establish targeted and appropriate quality assurance programs. An EDL could also help shape in-country training of laboratorians.

7. Improve supply chain and laboratory infrastructure

As is too often the case in low-income settings, poor infrastructure and inconsistent supply chains render laboratory devices unusable. An EDL could encourage ministries of health to strengthen necessary infrastructures and develop targeted supply chains for the essential tests.

8. Facilitate change in healthcare provider behavior

Healthcare professionals trained in countries where laboratory testing is either unavailable or of low quality are likely to treat based on clinical suspicion. The impact of the Xpert MTB/RIF TB test has been blunted because of such issues. Likewise, in several settings, providers continue to give anti-malarial therapies, despite negative rapid test results. An EDL could improve providers’ confidence in test results and strengthen thediagnostic-treatment cascade.

9. Inform new technology development

Several teams are now developing point-of-care diagnostics for global health. An EDL could help develop target product profiles that can inform new product development. In fact, such initiatives already exist for several key diagnostics.

10. Facilitate epidemiological surveys, program evaluation and disease elimination

Policy makers need data on disease burden. An EDL could support national surveys and help track changes in disease burden and efficacy of interventions (e.g., diagnostics to support polio elimination).

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TB diagnostic tools. Photo by Dr. Madhukar Pai.

In summary, essential medicines require essential diagnostics. The NEJM article has proposed an EDL to set the ball rolling. While many agencies could establish an EDL, WHO is the obvious choice, since they maintain the EML, make health policies, run prequalification programs and oversee international health regulations. So, we call upon WHO to take the lead in creating a List of Essential Diagnostics. We also call on key stakeholders (e.g., FINDPATHTDRCHAIASLMGHTCStop TB PartnershipRoll Back MalariaUNAIDS), civil society (e.g., MSFTAGACTION) and donors (e.g., Global FundBill & Melinda Gates FoundationUNITAIDUSAID) to support WHO to make this happen.


Dr. Lee Schroeder is assistant professor at the University of Michigan,  where he is director of Point-of-Care Testing and associate director of Chemical Pathology. Dr. Timothy Amukele is an assistant professor at the Johns Hopkins University School of Medicine, where he is the director of the Bayview Medical Center Clinical Laboratories. Dr. Madhukar Pai is a Canada Research Chair in Epidemiology & Global Health at McGill University, Montreal, Canada. He serves as the director of McGill Global Health Programs and associate director of the McGill International TB Centre.


This article was originally posted on Forbes website. See the original post here.

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