Shobha Shukla, CNS (Citizen News Service)
The immortal words of Edison, "If there is a way to do it better, find it!" flash in mind when we see low rates of TB decline - which are currently a fraction of what is required to end TB by 2030. Will new TB diagnostics, drugs and vaccines propel us towards the #endTB targets? The WHO End TB Strategy, aims to end the global TB epidemic by 2035.
To reach its interim targets, the annual decline in global TB incidence rates must accelerate from the current 2% per year in 2015 to 10% per year by 2025. Also, the proportion of people with TB who die from the disease needs to decline from 15% in 2015 to 6.5% by 2025.
All this would require not only efficient use of existing tools, but also availability of new technologies from the research pipeline.
Deliberations at the WHO Global TB Symposium and the ongoing 48th Union World Conference on Lung Health in Guadalajara, made a strong case for increased political and financial commitment for TB research in the field of improved and point of care diagnostics, safer, easier and shorter treatment regimens, and effective pre- and post-exposure vaccines for TB.
Strong case for TB diagnostics
Dr Celine Garfin, National TB Programme Manager, Philippines, lamented that even though smear microscopy is not very sensitive and cannot detect drug resistance, it is still used as a primary diagnostic tool. Then again, X-ray as a screening tool is not specific and not available at point of care (POC) and a reader is needed to interpret results. While GeneXpert is a vastly improved diagnostic tool, but it requires stable electricity, is expensive and the used cartridges produce significant amounts of waste material. Garfin’s wish list for a good TB diagnostic tool implies that the specimen needed should be easy to collect (perhaps urine or just the breath of presumptive TB patient); a one step diagnosis that can be performed by a non medical person and is not dependent on electricity and is usable in small islands’ settings (like in the Philippines). Well, Amen to this, as of now.
Dr Claudia Denkinger, Head of TB at the Foundation for Innovative New Diagnostics (FIND) informed that currently there are limited bio markers for POC platforms. Moreover, while funding for TB is decreasing over all, diagnostic development is particularly underfunded and private sector support is decreasing. Also, funding to support low margin but high volume products is a difficult market to penetrate.
Better TB vaccines are an urgent need
The only TB vaccine that we have today is the almost 100 years old BCG vaccine which offers very limited protection from the disease. Listing some of the current challenges in TB control in his country - TB incidence was high at 834/100,000 and 20-30% cases of TB were being missed out, number of multi drug resistant TB (MDR-TB) cases was increasing, and 20% of them were lost to follow up - Dr Norbert Ndjeka, MDR-TB Director from South Africa, reiterated the need of a TB vaccine that could go a long way in decreasing TB incidence and reducing TB transmission. It would also cut down the high treatment costs and result in huge economic benefits.
Dr Jacqui Shea, Chief Operating Officer, Aeras, said that there was severe under investment in R&D of TB vaccine, more so because of a general lack of awareness that new TB vaccines are essential to stop the epidemic.
Novel TB drugs and regimens could be game-changing!
Dr Carl Mendel, Senior Vice President, TB Alliance (Global Alliance for TB Drug Development) rightly pointed out that the current TB treatment is too lengthy, too toxic and not effective enough in programmatic settings. The best case scenario would be a universal drug regimen - same or similar treatments for drug sensitive TB (DS-TB) as well as MDR-TB. This will do away with the need of separate healthcare systems, manufacturers, drug supplies and distribution channels for DS-TB and MDR-TB. We might be on the verge of it, but not there as yet, he added.
Key link: Research literacy and community participation
Research literacy is key to a successful community engagement strategy. Without community, research for new tools for ending TB is not possible.
True engagement with community stakeholders in the process of TB drugs and vaccine research and development requires a high level of understanding about TB disease, the need for new tools, and the process of clinically testing experimental products. There is need of a patient centred diagnostics network.
According to Maurine Murenga, Community Representative at Stakeholders' Association of TB Alliance, “Without informed and empowered community involvement we cannot have effective clinical studies. Stakeholders engagement, including communities, should be an integral part of new protocols being put in place. But instead of being tokenistic, it should be a respectful and sustained partnership.”
The way forward
While we wait impatiently for new diagnostics and treatments to see the light of the day, let us at least ensure simplification and harmonization of regulations to accelerate and drive the uptake of existing proven tools—like the TB-LAMP (loop-mediated isothermal amplification) test, line probe assays (LPAs) for the detection of resistance to the first and second line anti-TB drugs; the shortened MDR-TB treatment regimen, fixed dose combinations for paediatric TB, etc.
The slow uptake of the two relatively new TB drugs, Bedaquiline and Delamanid, is proof that getting a drug approved is not enough. The development plan must address a usage that will have a meaningful impact on the persons who need them most. Systems need to be in place to ensure that transitions are done in the most efficient way possible with minimum interruption for patients, and there is coordination at all stages of pharmaceutical and supply chain management. Prioritizing global health emergencies, like TB, for clinical studies and regulatory reviews; and streamlining regulatory systems for clinical study approvals, and marketing authorization approvals is also very important.
Shobha Shukla, CNS (Citizen News Service)
12 October 2017
(Shobha Shukla is the Managing Editor of CNS (Citizen News Service) and has written consistently on health and gender justice for several years. With support from the Global Alliance for TB Drug Development (TB Alliance) this article is part of in-depth thematic coverage of the 48th Union World Conference on Lung Health, provided by Shobha Shukla and her CNS Correspondents Team. Follow her on Twitter @Shobha1Shukla or visit www.citizen-news.org)
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To reach its interim targets, the annual decline in global TB incidence rates must accelerate from the current 2% per year in 2015 to 10% per year by 2025. Also, the proportion of people with TB who die from the disease needs to decline from 15% in 2015 to 6.5% by 2025.
All this would require not only efficient use of existing tools, but also availability of new technologies from the research pipeline.
Deliberations at the WHO Global TB Symposium and the ongoing 48th Union World Conference on Lung Health in Guadalajara, made a strong case for increased political and financial commitment for TB research in the field of improved and point of care diagnostics, safer, easier and shorter treatment regimens, and effective pre- and post-exposure vaccines for TB.
Strong case for TB diagnostics
Dr Celine Garfin, National TB Programme Manager, Philippines, lamented that even though smear microscopy is not very sensitive and cannot detect drug resistance, it is still used as a primary diagnostic tool. Then again, X-ray as a screening tool is not specific and not available at point of care (POC) and a reader is needed to interpret results. While GeneXpert is a vastly improved diagnostic tool, but it requires stable electricity, is expensive and the used cartridges produce significant amounts of waste material. Garfin’s wish list for a good TB diagnostic tool implies that the specimen needed should be easy to collect (perhaps urine or just the breath of presumptive TB patient); a one step diagnosis that can be performed by a non medical person and is not dependent on electricity and is usable in small islands’ settings (like in the Philippines). Well, Amen to this, as of now.
Dr Claudia Denkinger, Head of TB at the Foundation for Innovative New Diagnostics (FIND) informed that currently there are limited bio markers for POC platforms. Moreover, while funding for TB is decreasing over all, diagnostic development is particularly underfunded and private sector support is decreasing. Also, funding to support low margin but high volume products is a difficult market to penetrate.
Better TB vaccines are an urgent need
The only TB vaccine that we have today is the almost 100 years old BCG vaccine which offers very limited protection from the disease. Listing some of the current challenges in TB control in his country - TB incidence was high at 834/100,000 and 20-30% cases of TB were being missed out, number of multi drug resistant TB (MDR-TB) cases was increasing, and 20% of them were lost to follow up - Dr Norbert Ndjeka, MDR-TB Director from South Africa, reiterated the need of a TB vaccine that could go a long way in decreasing TB incidence and reducing TB transmission. It would also cut down the high treatment costs and result in huge economic benefits.
Dr Jacqui Shea, Chief Operating Officer, Aeras, said that there was severe under investment in R&D of TB vaccine, more so because of a general lack of awareness that new TB vaccines are essential to stop the epidemic.
Novel TB drugs and regimens could be game-changing!
Dr Carl Mendel, Senior Vice President, TB Alliance (Global Alliance for TB Drug Development) rightly pointed out that the current TB treatment is too lengthy, too toxic and not effective enough in programmatic settings. The best case scenario would be a universal drug regimen - same or similar treatments for drug sensitive TB (DS-TB) as well as MDR-TB. This will do away with the need of separate healthcare systems, manufacturers, drug supplies and distribution channels for DS-TB and MDR-TB. We might be on the verge of it, but not there as yet, he added.
Key link: Research literacy and community participation
Research literacy is key to a successful community engagement strategy. Without community, research for new tools for ending TB is not possible.
True engagement with community stakeholders in the process of TB drugs and vaccine research and development requires a high level of understanding about TB disease, the need for new tools, and the process of clinically testing experimental products. There is need of a patient centred diagnostics network.
According to Maurine Murenga, Community Representative at Stakeholders' Association of TB Alliance, “Without informed and empowered community involvement we cannot have effective clinical studies. Stakeholders engagement, including communities, should be an integral part of new protocols being put in place. But instead of being tokenistic, it should be a respectful and sustained partnership.”
The way forward
While we wait impatiently for new diagnostics and treatments to see the light of the day, let us at least ensure simplification and harmonization of regulations to accelerate and drive the uptake of existing proven tools—like the TB-LAMP (loop-mediated isothermal amplification) test, line probe assays (LPAs) for the detection of resistance to the first and second line anti-TB drugs; the shortened MDR-TB treatment regimen, fixed dose combinations for paediatric TB, etc.
The slow uptake of the two relatively new TB drugs, Bedaquiline and Delamanid, is proof that getting a drug approved is not enough. The development plan must address a usage that will have a meaningful impact on the persons who need them most. Systems need to be in place to ensure that transitions are done in the most efficient way possible with minimum interruption for patients, and there is coordination at all stages of pharmaceutical and supply chain management. Prioritizing global health emergencies, like TB, for clinical studies and regulatory reviews; and streamlining regulatory systems for clinical study approvals, and marketing authorization approvals is also very important.
Shobha Shukla, CNS (Citizen News Service)
12 October 2017
(Shobha Shukla is the Managing Editor of CNS (Citizen News Service) and has written consistently on health and gender justice for several years. With support from the Global Alliance for TB Drug Development (TB Alliance) this article is part of in-depth thematic coverage of the 48th Union World Conference on Lung Health, provided by Shobha Shukla and her CNS Correspondents Team. Follow her on Twitter @Shobha1Shukla or visit www.citizen-news.org)
Published in:
- CNS (Citizen News Service)
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