Tropical Health Matters

by Edward Mwangi, Kenya NGO Alliance Against Malaria (KeNAAM)

The community voice in Nairobi filled the street on Wednesday at the 5th Multilateral Initiative on Malaria Pan-Africa Conference when they held a procession to call on US president Barrack Obama to take leadership for Global Fund AIDS TB and Malaria (GFATM) to increase to USD 2 billion US contribution to the Global Fund. Started in 2002, Global fund has recorded positive results in over 140 countries globally.

The community, chanting “we need the other half” was conveying the message that half of those benefiting from the GFATM commodities are living on hope that commodities will be availed to them. Chanting the popular Obama slogan, “Yes we can,” the demonstrators made their way along Nairobi streets.

The aim of the procession was also to mobilize signature on postcards to the US President Barrack Obama to be sent before the Thanksgiving holiday with the following wording:

Dear President Obama,

We’ve made great progress that has made in the fight against HIV/AIDS, TB and Malaria that nearly 50% of the people who need treatment are now receiving it, “still the other half is not” I know you don’t do things halfheartedly.  So please lead the world in achieving universal access to treatment by fully funding the Global Fund AID, TB and malaria.

The procession in Nairobi was co-organized by national network organizations for the three diseases; Kenya AIDS consortium, NEPHAK and Kenya NGO Alliance Against Malaria through the Action Advocacy to control TB internationally consortium.

PS – leadership from the US would have a stronger face if a Director for the US Agency for International Development were appointed. Al Jazeera reports on the leadership gap this problem has created for the US in the development world, and we believe it also affects the credibility of US malaria efforts – Bill

Additional media coverage of the procession can be found at the Wall Street Journal and CNN (a 7+ minute video where Nairobi appears about 3 minutes into the clip).

If you want to walk fast, walk alone
If you want to walk far, walk together  (Maasai Proverb)

Walking together in partnership was the theme of the launching, held last night, of Kenya’s second national malaria strategy covering the years 2009-2017.  Officials from the Ministry of Public Health and Sanitation acknowledged throughout the ceremony the value of  partnership with the donor, research and civil society communities.

The document had been one year in the making and is accompanied by the Kenya Malaria Monitoring and Evaluation Plan for the same years. Dr Elizabeth Juma, who heads the Division of Malarial Control explained that the two documents are based on an extensive Malaria Program Performance Review, so that it is not a theoretical exercise.

In his keynote address Dr. James Gesami, the Assistant Minister for Public Health and Sanitation, reported that Kenya has made substantial progress in reducing child mortality and hospital admissions for malaria by to date distributing 90 million nets, prescribing 41 million doses of ACTs and protecting 8 million people in targeted areas with IRS.

A new feature of the strategic plan is to make future targeting of these interventions more epidemiologically appropriate based on a new map of malaria prevalence across the country. Dr Gesami said we have fallen short in the past of adequate documentation. Therefore, M&E is intended an a strong companion to the Strategy so that intervention can be monitored and impact measured.

Partnership at all levels was seen as the way to achieve the goals of the new strategy – involvement is needed of the public health sector, the private health sector, civil society, research institutions, donors, the communities and other public and private sector agencies such as agriculture and education. An example of the latter is the malaria free schools initiative enshrined in the Strategy. In short, “Malaria control is not the preserve of the Health Ministries, but is the responsibility of all of us.”

Speakers acknowledged that there are areas where past performance could be better, such as providing Intermittent Preventive Treatment to pregnant woman. There was hope though that the Strategy will guarantee a uniformity of purpose among all partners to achieve targets and result in a malaria free Kenya by 2017.

Wen Kilama of the African Malaria Network Trust brought a challenging idea to the malaria researchers gathered at MIM’s 5th Pan-African Malaria Conference on Tuesday. He explained that while we have a strong tradition of biomedical ethics that protect the individual from harm in research trials, we do not have a clear code of ethical processes, not the mechanism to oversee and regulate these for public or population health research.

His thoughts are also expounded in a current article in a supplement to Acta Tropica and ask us to consider difficult questions such as weighing individual protection and public benefit of an intervention beijng tested.  Examples of these have included immunization regimens, water fluoridation and iodization of salt. In malaria research we also must consider individual freedoms and choices balanced against the community protective effects of indoor residual spraying or wide coverage long lasting insecticide treated net (LLIN) campaigns.

Dr Kilama raised an interesting ethics about the distribution of two different types of LLINs.  One is a polyester multifiber net with insecticide coated yarn has received only Phase 2 approval from WHOPES, which approves insecticides for human safety. The other is a polyethylene monofilament net with insecticide incorporated into the yard. This has received Phase 3 WHOPES approval.  Ironically three times as many of the former were made available to the public than the later in recent years. Is this ethical?

Dr Kilama also raised an equity issue – how can we justify testing health interventions like LLINs on rural poor people who bear the greatest malaria burden when at the start of most programs, it is better off urban people who can afford the nets?

Corporate social responsibility also plays a role after research and testing for regulatory approval have been done. The manufacturers of the monofilament polyethylene nets have made provision for royalty free transfer and have already set up operations in one African country and are ready to move into others.  Their first African factory employs 6,000 people locally and has a positive economic impact on at least 30,000 in the community.

Ethical considerations in a population/public based research like vector control is complex. Community awareness and consent processes come at the start, but then effort must be made to enlist the informed participation of households and individuals.  Ghana’s Navrongo community research facility was mentioned as an example of an institution that has a codified community ethics process.

Dr Kilama called on the public health research community, and especially community malaria researchers, to develop consensus ethical procedures for community studies.

A new malaria control tool is closer to joining the arsenal of malaria interventions according to vaccine researchers and their sponsors at a press briefing today during the MIM 5th Pan-African Malaria Conference in Nairobi.

A joint venture between PATH’s Malaria Vaccine Initiative and GlaxoSmithKline Biologicals, with support from The Bill and Melinda Gates Foundation, WHO and African Governments and the participation of African malaria researchers at 11 sites in seven countries has recently completed a successful Phase 2 Clinical Trial of the RTS,S vaccine.

Mozambique, one of the Phase 2 trial sites reported that, “vaccine efficacy against new infections was 65 percent over a three-month follow-up period after the infants received all three doses of the vaccine. The results also showed that the vaccine reduced episodes of clinical malaria by 35 percent over a six-month follow-up period starting after the first dose.” At the Ghanaian study site it was confirmed that “Three dose schedules were more immunogenic than 2 dose schedules.”

Joe Cohen of GSK Biologicals explained at the press conference that vaccine efficacy in children 5-17 months was 53% after 8 months. The trials also showed that the new vaccine can be integrated into the EPI vaccine process.  Continuing research will determine if it will also be effective in younger children.
Phase 3 trials have started and have already enrolled 5,000 of the expected 16,000 volunteer participants. Reporters were anxious to know when the vaccines might actually be available for general use. The panelists outlined steps that included filing results of Phase 3 and previous trials with regulatory agencies around 2012. If approved, vaccines could be available around 2015. In the meantime partners are gearing up to find funding to support adequate production.

Christian Loureq of the PATH Malaria Vaccine Initiative said that partners ranging from researchers, producers and funders were all thinking ahead.  No one wants the vaccine to sit on the shelf after proving its efficacy.  A decision making framekwork is helping planners identify the data and resources needed to start rolling our vaccines on the day they are approved.

As noted, the partners recognize that an effective vaccine will be only one of the needed interventions to sustain malaria control, especially since the efficacy, though good, is not perfect. Thus, they are already thinking about research for the next generation of vaccines for 2020 or 2025

A key component to planning roll-out is research for understanding the community perspective, recognizing that the mothers who brought their children to the trials are also central partners in this initiative. The EPI program itself is full of lessons about acceptance and dropping out. The 3-dose vaccine regimen will certainly pose many implementation challenges, but hopefully the malaria community will be ready to tackle these.

The potential demise of presumptive treatment for malaria was the topic of a ‘Controversies’ session at the 5th MIM Pan-African Malaria Conference on Monday.  One view was expressed by Ambrose Talisuna from Uganda Ministry of Health that as we move into the phases of sustained control toward elimination, there will be a greater need for parasitological diagnosis of malaria and more rational provision of ACTs.  Since the process of policy formulation to full implementation may take 2-4 years, Ambrose Talisuna thought it would not hurt to get started on efforts to update malaria treatment guidelines to emphasize a parasitological diagnostic component as a requirement for prescribing ACTs

Another perspective expressed by Mike English from Kenya Medical Research Institute was that it may be very difficult to change case management norms away from presumptive treatment until we can increase the confidence of clinicians in parasitological diagnostic methods by guaranteeing quality. Also there is concern that at least half of children in endemic areas live in high burden countries where presumptive treatment is still be a rational choice.

An interesting viewpoint came from Franco Pagnoni from TDR who said all treatment is presumptive. Even with parasitological diagnosis there are presumptions based on perceived quality of the diagnostic procedures and their interpretation.

There was a general sense that some Rapid Diagnostic Tests are clearly effective under research conditions, but have not been thoroughly tested in real life clinical conditions.  Another RDT challenge includes the general procurement and supply management difficulties facing all malaria commodities. There are cost issues too – will AMFm or a similar effort guarantee affordable malaria tests?  Another challenge of malaria treatment is the private sector, especially the informal component, and the community/home – how far will RDTs be distributed, and how can quality be maintained under such conditions?

As with all our efforts to move toward elimination we must recognize that different countries and different regions within countries are at different epidemiological stages.  We need development of flexible and appropriate case management and diagnostic guidelines. These must be disseminated in a way that builds diagnostic capacity at all levels – from the research lab to the community – with back-up to ensure 1) RDT and microscopy quality and 2) training that builds clinicians’ and treatment providers’ confidence in the tests and their own ability to use the tests correctly.

In a relatively short period, 2003 – 2007, all malaria endemic countries in Africa adopted artemisinin-based combination therapy (ACT) drugs as their nationally approved first line treatment.  Unfortunately the uptake of ACTs in actually treating children remains extremely low. The Press Center at the Multilateral Initiative for Malaria 5th Pan-African Malaria Conference hosted a press conference to highlight efforts to promote and keep track of ACT use.

Suprotik Basu, Advisor to the UN Special Envoy for Malaria, moderated the panel and explained that the United Nations is promoting universal coverage of correct and prompt malaria treatment by the end of 2010 with a goal of ending malaria deaths by 2015. This is a huge challenge starting from a baseline in 2006 of only 3% of children who received any malaria treatment getting ACTs.

While there are efforts underway to ensure that more ACTs will be available at prices people can afford, including the new ‘experimental’ program Affordable Medicines Facility – malaria (AMFm), it is also important to have a mechanism in place to track what is happening with ACTs.

Des Chavasse, PSI’s Vice President for Malaria Control and Child Survival, is also heading up the ACT Watch project, funded by the Bill and Melinda Gates Foundation. ACT Watch is monitoring malaria medicine outlets – public and private – in 7 countries in Africa and Southeast Asia and conducting community surveys to achieve this goal of ACT tracking.

At its start, ACT Watch has documented that more than half of parents access malaria medicines for their children in private outlets, and where ACTs are available in these shops, a rare occurrence, they can cost 10 to 20 times more than the (ineffective) common treatments available. Many parents are not aware of ACTs as the new approved malaria medicine, but those who do are four times more likely to get ACTs at a private outlet.

While efforts are underway to promote and track ACTs, ACT Watch is also tracking the distribution of other antimalarials.  Peter Olumese who focuses on malaria case management at WHO’s Global Malaria Program, explained that due to cost and communication challenges, monotherapy artesunate drugs are often sold in the private sector. This will exacerbate the development of resistance of malaria parasites to artemisinin-based drugs. The availability of effective and cheap ACTs through programs like AMFm will hopefully drive the ineffective or dangerous antimalarials from the market.

Oliver Sabot from the Clinton Foundation shared that although US$ 180 million was now available annually to buy ACTs, but in the best situation only about 25% of children who receive malaria treatment get ACTs.  There needs to be a dramatic scale-up if even 80% coverage is to be achieved by the end of 2010. AMFm may make a dent if ACTs can actually reach the consumer at only 5% of current retail costs.

The most exciting aspect of the press briefing was a report by Ambrose Talisuna who represents Medicines for Malaria Venture in Uganda. Uganda has been experimenting with with subsidized ACTs in the private sector. Child doses are only 10 US cents and 40 cents for adults in contrast to $US 6-10 generally.  ACT market share has increased from below 1% to 50-60%, and consumers seem to like ACTs. At the same time share of ‘obsolete’ malaria medicines in the market has dropped by 50%.

AMFm will not be a magic bullet to achieve universal coverage since the first few pilot countries will not receive funding until 2010 at the earliest. AMFm will also operate for only 2 years until an evaluation will guide further work. In the meantime more efforts like those in Uganda are needed – nothing stops countries using their existing GFATM grants to subsidize ACT costs in the private sector as Nigeria is doing.

The first Plenary session of the Multilateral Initiative for Malaria’s 5th Pan African Malaria Conference in Nairobi started with Awa Coll-Seck, the Executive Director of Roll Back Malaria, emphasizing the role of malaria research in the Global Malaria Action Plan (GMAP).  She explained that the GMAP drew on malaria programming experiences over recent years to outline six main needs and directions for malaria research that will guide us from current control efforts into the future. These needs include –

• continuous research at each stage along the pathway, as well as continuous training of malaria researchers and all levels of malaria programming staff
• knowledge to help focus interventions locally and the burden of disease is changing and varies within and among countries
• how to achieve sustainability that reduces cases, reduces deaths and leads to eradication
• continuous advocacy for research and programming funds to see us through 2040 and beyond and based on evidence generated by program research and evaluation
• greater attention to social and cultural aspects of malaria control including community ownership and community systems strengthening
• maintaining a strong malaria partnership of diverse members including the research community

The importance of operations research (OR) in this process was stressed by Dr Robert Newman, the Director of WHO’s Global Malaria Program. Tying in with Dr Coll-Seck’s call for generating local research, Dr Newman noted the importance of enhancing the local decision making about program choices by using locally generated data.

A major concern expressed during the session was not just the need for more research funds designated specifically for malaria OR.  Very few countries use the availability of up to 10% of funds in their Global Fund Grants to conduct program relevant OR.

In contrast, Dr Newman reported that programs involved with Neglected Tropical Diseases use between 9-20% of their funds on OR.  He saw OR as a was to protect the investment of funds in disease control.

Today’s plenary session emphasized that research in malaria is not just an academic exercise. It generates new tools and helps us overcome program implementation bottlenecks.

Jambo

The Permanent Secretary of the Ministry of Public Health and Sanitation (MPHS), Mark Bor livened up the opening ceremony of the 5th MIM Pan African Malaria Conference in Kenya by encouraging the participants to greet each other in Kiswahili. He then introduced the Honorable Minister of MPHS, Beth Mugo.

The Minister stress key points in a malaria research agenda for the future and the importance of adequate investment in scaling up current and new malaria interventions so that eradication can one day be achieved.  She stressed research needs for …

• better diagnostic tools
• effective and affordable medicines
• vaccine development AND deployment
• community level vector control
• health systems strengthening including human resource capacity development

The Minister reminded the participants of the substantial increases in malaria funding over the past 10 years and the results that are becoming visible such as a 40% reduction in child mortality from malaria in Kenya.  Without sustaining this funding for research and intervention, she noted, we could see a backlash that made the resurgence of malaria after the failed eradication efforts of the 1950s and ‘60s look tame by comparison. Interventions must not only be sustained, but also improved, hence the need for continued research.

A regional approach is needed, the Minister stressed, since ‘mosquitoes don’t know boundaries.’ The Minister called on the malaria community to guarantee equal access of all countries to malaria resources as one country that lacks funds needed for control could help reintroduce malaria to its neighbors.  A regional approach to both funding and research is needed.

Karibu

see MIM Press Center here