Policy Cures Submission to. Senate Foreign Affairs, Defence and Trade References Committee. Inquiry into

Transcription

1 Policy Cures Submission to Senate Foreign Affairs, Defence and Trade References Committee Inquiry into The delivery and effectiveness of Australia s bilateral aid program in Papua New Guinea 4 May 2015 Policy Cures Limited is a Health Promotion Charity incorporated in Australia. Australian Company Number: Head Office: Suite 206, 68 York Street, Sydney, NSW 2000 Australia Tel: +61(2) Fax +61(2)

2 Policy Cures is an independent group providing research, information, decisionmaking tools and strategic analysis for those involved in the creation of new pharmaceuticals for neglected diseases such as malaria, TB, HIV, pneumonia, sleeping sickness and helminth infections. Our focus is on providing governments, funders and civil society organisations with the information they need to make optimal research and development (R&D) policy and funding decisions for diseases of the developing world. This Inquiry will likely have received evidence from a range of submissions confirming that despite economic growth of 5.8 percent per year on average over the last 10 years, Papua New Guinea (PNG) continues to face substantial development challenges. PNG is lagging against all development indicators 1, 40 percent of the population live in poverty 2, and they will not meet any Millennium Development Goals (MDGs) or associated targets. 3 In the area of health, in particular, you may have heard many times that diseases such as leprosy remain endemic, while tuberculosis (TB) and malaria are leading causes of morbidity and mortality. PNG has the highest rate of TB infection in the Pacific. 4 Each TB patient infects up to others per year 5 and drug-resistant TB is a growing crisis on our doorstep. Many submissions make the case for much needed investments in improving primary care and health infrastructure. However few, if any, other submissions will have mentioned three crucial facts: 1. That in 2014, the World Health Organisation acknowledged that none of the new TB incidence and death reduction targets over the next 20 years can be met, in PNG or elsewhere, with the current tools used to fight TB That new and better TB tools are being developed which can solve this problem 3. That Australia provides very substantial funding to TB programmes, care and infrastructure (tens of millions per year in PNG alone) - as it should; but very little to develop the new tools that the WHO and patients are crying out for ($3m per year each for new TB drugs and diagnostics). 1 Pacific Islands Forum Secretariat, August Pacific Regional MDGs Tracking Report. 2 Department of Foreign Affairs and Trade, Overview of Australia s aid program to Papua New Guinea, United Nations Statistics Division, July Millennium Development Indicators: Country and Regional Progress Snapshots. URL: 4 World Health Organization. Papua New Guinea. Tuburculosis /profile Available from: /Reports?op=Replet&name=/WHO_HQ_Reports/G2/PROD/EXT TBCountryProfile&ISO2=pg&outtype=pdf 5 World Health Organization. Tuberculosis: Fact sheet N [cited /2014 Aug 4]. Available from: 6 World Health Organization. Global strategy and targets for tuberculosis prevention, care and control after th World Health Assembly 2014; Available from:

3 The current TB tools The main TB diagnostic test used today was developed in 1882, only detects 45-60% of active cases, and can not detect resistant strains of the disease. The current BCG vaccine, was developed in 1921 but is largely ineffective in preventing adult TB. 7 Patients are treated with drugs developed in the 1940s-1970s. Due to their weak effectiveness, they only work if given in multiple daily doses for months or sometimes years. They can have serious side effects, and the lengthy regimen places a high burden on patients, their families and health systems. 8 These inadequate tools are failing in the face of TB today. This is fuelling the emergence and spread of drug resistant strains of disease, which are far more difficult and costly to diagnose and treat. The new TB tools Given this, it is crucial to know that a range of new and innovative tools are on the way with the potential to deliver large step changes in the delivery of health care, and curing or eradicating serious, debilitating diseases like TB and malaria in the developing world. Their development is being supported by most major countries (US, UK, EC and other) as well as by the Bill & Melinda Gates Foundation and industry philanthropy. The global health R&D community is working very hard to convert an exciting pipeline of new products for the serious health challenges of the developing world. Ensuring accelerated development, approval, availability and adoption of such products can save lives, money and free resources for allocation to other development priorities. Australia s aid programs need to prepare for this future and provide the funding and policy leadership required to ensure it is realised. Increasing investment on rolling out current ineffective tools while not also increasing investment into new and better solutions does not make economic sense for Australia s aid programme. 7 Colditz GA, Brewer TF, Berkey CS, Watson ME, Burdick E, Fineberg H, et al. Efficacy of BCG Vaccine in the Prevention of Tuberculosis. JAMA Mar 2;271(9): Médecins Sans Frontières. Running out of breath? TB care in the.21st century. Switzerland; 2005 p. 23. Available from: _msfaccess.org/sites/default/files/msf_assets/tb/docs/ttb_report RunningOutOfBreath_21stCentury_ENG_2005.pdf

4 A picture of TB today vs the vision of TB tomorrow The following patient scenarios demonstrate the challenges in TB management today and a divergent future vision of tuberculosis (TB) treatment in 2025 that will be safer, simpler and more effective. Sisia lives in a community in the North Fly region of Western Province, PNG with her husband Raho, daughters Gidae (18 months) and Magdelin (five years) and their extended families. Sisa runs a market stall and Raho gets casual work driving trucks transporting goods and supplies for the Ok Tedi mine. But this means he often stays away from home as the nearest town, Kiunga, is a three hour journey away. Most people in Western Province must travel 4-8 hours to their closest health service centre, often by outboard motor boat and canoe along the rivers as there are almost no major roads. Travel is often dangerous due to the presence of large saltwater crocodiles in the rivers and deadly snakes in the jungle. One of Sisia s co-workers has had a cough and fever for several months.

5 Time Line TB treatment in PNG today 1 month After a month of coughing, chest pains and fever, Sisia s husband takes her to the hospital in Kiunga, three hours away. The community healthworker asks Sisia to cough up a sputum sample so that she can test it for TB by adding a coloured dye to the sputum and examining it under a microscope the same test used for the past 100 years. She asks Sisia to return for the results in two days. 7 months When they return, the healthworker tells Sisia she has TB. The clinic cannot test for drug resistance so Sisia is commenced on the six-month treatment for standard TB. A treatment supporter visits Sisia each day to observe her swallow her medication and mark her treatment card but Sisia is not improving. Raho takes Sisia back to the hospital in Kiunga and the healthworker suspects Sisia has multidrug-resistant TB (MDR-TB). The TB Ward at Kiunga is full so Sisia is referred to the larger hospital in Daru, the provincial capital, located far to the south, on the island of Daru where they can test for MDR-TB). The journey down the rivers takes days and is very expensive because of the high cost of fuel in PNG. In Daru the doctor takes more sputum samples and is able to confirm that Sisia has MDR-TB. However, they cannot test to see drugs her TB is resistant or sensitive to. Samples must be sent to Australia, a process that can take months. Sisia is admitted to the MDR-TB isolation ward and is started on MDR-TB treatment with painful daily injections and many tablets. She will need to be isolated for two months. However, while she is there Sisia see s numerous patients with MDR-TB mixing together and leaving their isolation wards, resulting in the risk of drug-resistant TB spreading through the community. While extended family help with care for young Gidae and Magdelin, Raho still has to give up many days of work, with significant loss of income for the family.

6 Family at PNG's Daru hospital, Papua New Guinea Photo: Philippe Schneider / World Vision 1 year When she is able to return home, Sisia must continue daily injections for another four months and taking TB drugs up to 18 tablets a day - for another 22 months. The pills cause Sisia to be very sick with nausea, vomiting and dizziness but, more worryingly, Gidae is sick and losing a lot of weight is it TB? When they take Gidae to the hospital, she is unable to cough up sputum for the test so the doctor puts a tube down her nose into her stomach to collect a sample. Gidae also has MDR-TB and she is started on treatment. There are no child formulations for many of the tablets, so the doctor tells Sisia to cut up the adult medications based on Gidae s weight she does so, but is worried she is giving too much, or not enough. The doctor also warns them that the daily injections can cause permanent hearing damage in a child her age. 2 years After another year of MDR-TB treatment for both Sisia and Gidae totalling thousands of pills and a number of admissions to the TB ward in Kiunga, the burden on the family is becoming too great. Sisia still suffers from gruelling side effects of the toxic treatment, she is often sick in bed and cannot walk, so cannot care for their two young daughters. They worry about how much time Raho is taking off work the family is already struggling now that he is the sole source of income. Because of this Sisia no longer wants to continue taking her treatments.

7 Discontinuing treatment increases the risk of her TB reactivating as extensively drug-resistant TB (XDR-TB). Gidae is also still very sick. In many parts of Western Province the default rate can be up to 40 percent and about 10 percent of those treated for TB die. 6-year-old TB sufferer Christina, bathed in PNG's Daru hospital which lies less than 10 kilometres from Australia's border. Photo: Jason South Time Line TB treatment in 2025 with the new tools being developed 3 hours Sisia feels perfectly well but a local TB Officer visits and tells her she needs to have a TB test because her co-worker on the market stall has been diagnosed with TB. At the hospital she is screened for TB using a simple, reliable diagnostic test by a basically-trained health worker. After her test is positive a second simple test for drug resistance is done. Within another hour it is confirmed that Sisia has MDR-TB and the drugs her infection is likely to respond to identified. 4 hours Sisia is started on treatment immediately. She only needs to take 1-2 pills a day for eight weeks, which will cure her TB. Unlike the MDR-TB treatments used in the past,sisia s treatment requires no injections. It also rapidly stops her from being infectious, so there is no need for her to be admitted to hospital to stay in a TB isolation ward. She is able to take her TB treatment at home, which means she can look

8 after young Gidae and Magdelin and there is less strain placed on Raho, who does not have to take time off work to care for his family. Her treatment now costs between $50-$90(US) instead of $5000(US).9 2 months The risk of Gidae or Magdelin contracting MDR-TB from Sisia is now low, as both have already received vaccinations that, unlike the previous BCG vaccine, provide reliable protection against TB. CURE With the availability of safe, effective, and affordable products, Sisia and her family are able to recover quickly. Both they and the PNG health system avoid the catastrophic health outcomes and costs associated with TB. The TB product pipeline in 2014 In 2014, the WHO made a decisive statement that R&D is the key to controlling and eventually eliminating TB: without discovery, development and uptake of new drugs, diagnostics and vaccines the world will never be free of the threat of TB. Dozens of new TB leads are in the pipeline. While many of these are early stage projects with a higher chance of failure, others are late-stage products already close to registration. New TB diagnostics are needed, including tests for latent TB (where the patient s infection has not yet become active), low-cost accurate screening tests, and point-of- 9 World Health Organization. The Global Plan to Stop TB :Transforming the Fight Towards Elimination of Tuberculosis. Geneva, Switzerland; Report No.: WHO/HTM/STB/ Available from: assets/documents/global/plan/tb_globalplantostoptb pdf

9 care tests that can be used by health workers to diagnose TB and drug resistance on the spot. Of the approximately 40 tests in development, five new TB diagnostics are already in clinical trials in humans. New TB drugs are urgently needed to meet the Post-2015 TB Strategy goals and to allow scale-up of TB treatment globally, including for AIDS and MDR-TB patients, and children. Of the 66 drug candidates in the TB pipeline, 11 are already in clinical trials and four new regimens are in final-stage clinical trials (all from the TB Alliance, a non-profit product development partnership (PDP). The front-runner drug, PaMZ, was recently reported in Lancet 10 as clearing TB twice as fast as the existing TB treatment; and could be available in PNG as early as Multiple new drugs are needed because TB must be treated with combined multidrug regimens, rather than one medicine alone. Once registered, these will be the first new TB drug regimens developed for and suited to developing countries in over 50 years. New TB vaccines have been highlighted by the WHO as the single biggest potential contributor to overcoming TB. New vaccines that are needed include more effective and long-lasting childhood vaccines and an adolescent/adult booster vaccine. Of the 28 products in the pipeline, 19 TB vaccine candidates are in clinical trials.11 Government investment in R&D Replacing old and failing tools with better ones and making interventions specifically designed for developing world challenges is an clear priority if we want to improve health, enabling economic growth and prosperity for world s poorest people. The problem is that there is no commercial driver for pharmaceutical companies to create new tools for developing world diseases such as TB and malaria, which almost entirely affect populations with little purchasing power. In this not-for-profit space the public sector plays a vital role. Government funding working in conjunction with philanthropy and industry investment is key to discovering and developing new life-saving products for those who desperately need them. Investing in neglected disease R&D makes good economic and health sense for governments. For example the invention of Vaccine Vial Monitors a device that 10 Diacon AH, Dawson R, von Groote-Bidlingmaier F, Symons G, Venter A, Donald PR, van Niekerk C, Everitt D, Winter H, Becker P, Mendel CM, Spigelman MK. 14-day bactericidal activity of PA-824, bedaquiline, pyrazinamide, and moxifloxacin combinations: a randomised trial. Lancet Sep 15;380(9846): Two therapeutic TB vaccines are also in development with the aim of boosting response to TB treatment

10 shows whether a vaccine is still safe and effective after exposure to tropical temperatures have saved governments $135m over the last decade by preventing the discard of undamaged vaccines.12 Similarly, the new PaMZ regimen will be only 10% of the cost of today s old and ineffective treatments for drug-resistant TB, offering major savings to health systems and patients. However, creation of these new products requires not only basic scientific research (something Australian researchers are very good at) but also investment into product development the vital practical step that turns scientific discoveries into drugs, diagnostics and vaccines that save patients lives. Without this step, basic research investment is wasted. The overwhelming majority of product development for the developing world today is done by Product Development Partnerships (PDPs). About PDPs While academic and public research groups conduct the majority of early-stage work (basic research, discovery, and laboratory testing), Product Development Partnerships (PDPs) are the lead organisations in converting these discoveries into new products for the developing world. PDPs are responsible for more than 70% of the new developing world drugs and vaccines created since PDPs are non-profit organisations that collaborate with industry, public and philanthropic partners to identify, develop and commercialise promising R&D leads for non-profit use in the developing world. They help to accelerate the research, development and approval of new and repurposed neglected disease products by pooling resources and filling gaps that exist between the academic and commercial sectors. They are based overseas (US, Geneva, UK) but draw on global leads, including many from Australia. PDPs leverage funding from different stakeholders, maximising the impact of investment, offering great value for money for Australian aid dollars. Australia has to contribute only a fraction of the cost of developing each new product (along with other donors) but reaps the entire benefit when each new product comes to fruition. 12 Program for Appropriate Technology in Health. Technology Solutions for Global Health: Vaccine Vial Monitors [cited 2014 Aug 6]. Available from:

11 Improving the efficiency of aid spending and current budget allocations In 2012, Australia s aid agency disbursed its first funding to Product Development Partnerships (PDPs), In 2014, the government further improved Australia s investment profile with a commitment of $30m per year for the next three years to global health and medical research: $10m per annum to PDPs - The TB Alliance (TB drugs), The Foundation for Innovative New Diagnostics (TB and malaria diagnostics) and the Medicines for Malaria Venture (malaria drugs). $20m per annum for operational (field) research. In March 2015, Policy Cures were informed by DFAT that $15m of this funding had been allocated to DFAT posts for disbursement to local research identified by country managers. (The remaining $5m went to the innovationxchange.) The proportion of the global health and medical research budget allocated to discretionary spending by country managers is inconsistent with the new aid paradigm emphasis on more effective and innovative approaches. The recent report from the Office of Aid Effectiveness ( February 2015) questioned the efficiency of DFAT s devolved research investment and the extent that this research reflects strategic regional aid priorities. This large sum of funding spent through devolved research is significantly more than that invested in targeted development of new TB and malaria products. This devolved funding suffers from not being aligned with the Government s strategic goals; and, unlike in investment into PDPs, it does not leverage investment from other international and regional private and public sector donors. Recommendations Policy Cures makes the following recommendations: 1. That the Australian Government actively looks to the future, identifying new tools such as diagnostics, treatments and vaccines in different stages of development that could be integreated into Australia s aid programmes, and planning for this. 2. That the Australian Government reiterate its commitment to DFAT s global health and medical research funding (currently $30m per year), and expand this funding.

12 3. That the Australian Government increase the proportion of funding going to strategic research (including the development of new tools) vis a vis devolved operational research funding by posts, ensuring that ground-breaking research can be translated into life-saving medicines, vaccines and diagnostics being delivered to those who need them. 4. That the Australian Government specifically consider increasing funding for development of: - New TB drug regimens, including a regimen that is potent against even multi-, extensively- and (the recently emerged) totally-drug-resistant TB. Given that there are 24,800 TB patients in PNG today, the savings from these far shorter, far more potent treatments would be dramatic - New TB diagnostics that will allow on the spot testing for drugsensitivity to guide treatment - New TB vaccines that have been highlighted by the WHO as the single biggest potential contributor to overcoming TB. 5. That DFAT releases information on all the in-country research initiatives that have received funding from the $15m allocated for so that the global health research community can identify opportunities to collaborate and contribute.