Tropical Health Matters

BBC’s Focus on Africa has identified Africa as the dumping ground for counterfeit goods. Some are cheap knock-offs of branded luxury goods that consumers know are not the real deal. Electronics are another area where the customer should beware. Others camouflage as the original product with packaging that is indistinguishable from the authentic item.

Toothpaste is a good example where the fake, which retailers call ‘Chinese’ contains a poison known as diethylene glycol which is used in anti-freeze.  The retailers sell both products for about the same price, but the incentive for pushing the fakes is profit.

On the genuine product he has made a 13% mark-up, on the counterfeit an impressive 50%. Fair play to him, some might say – after all it is only toothpaste.

But one cannot say ‘it is only medicine’ when drugs are fake. BBC notes that, “According to the World Health Organization (WHO), 30% of medicines sold in developing countries are fakes, and a major problem is that high numbers of government-owned drugs are being illegally obtained and then sold on for profit in the private sector.” BBC worries that …

… with the rising number of direct trade routes between Africa and China, together with porous border controls, outdated legislation and weak enforcement mechanisms, the continent has become fair game for counterfeiters – and the recession has made it worse.

Furthermore, “A UN report published in July 2009 reveals that revenues gained from 45 million counterfeit anti-malarial medicines were worth $438m – more than the annual gross domestic product of Guinea-Bissau.”

SafeMedicines.org keeps an update of fake medicine reports. For example in Ghana, “A citizen brought suspect antimalarial medication to a sentinel site set up by the U.S. Agency for International Development (USAID)’s Drug Quality Information Program (DQI).” This was reported July 22, 2009, and involved a fake of Novartis Pharmaceuticals’ malaria product Coartem.

Researchers at Georgia Tech University shared information on the magnitude of the problem. “The percentage of over-the-counter counterfeit artesunate tablets containing no artesunate apparently increased from 38 to 53 percent in southeast Asia between 1999 and 2004.”

Fake drugs kill directly with dangerous ingredients or indirectly when inadequate or no active ingredients are present. They also may drive legitimate manufacturers out of business.  The threat is real and widespread in its impact.

The new funding program, Affordable Medicines Facility malaria (AMFm) aims to enable countries to place quality low-cost antimalarials into the private sector at prices that will supposedly compete favorably with inappropriate and fake medicines. Careful monitoring will be needed to see if this really happens.

Considering the profit margins mentioned above, the fake drugs may still out-compete the subsidized ones.  In short, nothing can replace a vigorous drug regulatory system and donors need to strengthen technical assistance to countries to regulatory capabilities actually work.

The 2009 World Malaria Report was launched with ‘cautious optimism.’  The WMR “found that the increase in international funding commitments (US$ 1.7 billion in 2009 compared to US$ 730 million in 2006) had allowed a dramatic scale up of malaria control interventions in several countries, along with measurable reductions in malaria burden.”

These figures represent a jump from only $0.3 billion in 2003. The improvements still fall short of the estimated $5 billion needed annually to reach Millennium Development Goals by 2015.

The WMR says that, “In countries that have achieved high coverage of their populations with bed nets and treatment programmes, recorded cases and deaths due to malaria have fallen by 50%.” The five countries referred to do not fit the overall picture of endemic counties where only 24% of children under 5 years of age had slept under an insecticide treated bednet and only 15% of such children had received artemisinin-based combination therapy to treat malaria.

With efforts to find more funds it “scale up for impact” by the end of 2010 in all endemic countries, a new large scale evaluation of child survival interventions appearing in the Lancet, awakens us to the need to be ‘cautious’ but maybe not ‘optimistic. The study evaluates UNICEF’s Accelerated Child Survival and Development ACSD program in Benin, Ghana and Mali that took place between the years 2001-05. ACSD package was supposed to include –

• Routine immunisation and periodic measles catch-up and mop-up
• Vitamin A supplementation to children twice yearly
• Distribution and promotion of insecticide-treated nets for children and pregnant women, and re-dipping of bednets every 6 months
• Intermittent preventive treatment of malaria with sulfadoxine-pyrimethamine for pregnant women
• Tetanus immunisation during pregnancy to prevent maternal and neonatal tetanus
• Supplementation with iron and folic acid during pregnancy and with vitamin A post partum
• Promotion of exclusive breastfeeding up to 6 months, timely complementary feeding
• Improved and integrated management (at the health facility, community, and family levels) of children with pneumonia† malaria, and diarrhoea
• Promotion of household consumption of iodised salt

Unfortunately mortality reduction in the ACSD districts did not achieve the 25% target, and in Benin and Mali there was greater reduction in the non-ACSD districts (Ghana did not have comparison data).  There was variability in introducing the package of interventions. Contextual factors such as worsening economic conditions at the community level and broad national level policy and programming technical assistance by donors may have affected outcomes.

A Lancet editorial concluded that, “The results of this evaluation do not match with the extravagant claims UNICEF made about the programme in 2005, but show potential for advantages if sufficient resources are directed to interventions addressing the major causes of death.”

The research team also observed that, “The analysis showed that child survival was not accelerated in Benin and Mali focus districts because coverage for effective treatment interventions for malaria and pneumonia were not accelerated, causes of neonatal deaths and undernutrition were not addressed, and stock shortages of insecticide-treated nets restricted the potential effect of this intervention.”

Instead of going away from their analysis discouraged, the researchers actually did take an optimistic view that such evaluations provide valuable lessons for improving service delivery.  Likewise a comment in The Lancet stressed that such large scale evaluation can, “create generalisable knowledge that can accelerate child survival by bridging the know-do gap.”

So what are the lessons of the ACSD evaluation for scaling up malaria control to reach the MDGs? Decreasing funding for fear of failure is certainly not an option.  Instead the evaluation study tells us to pay attention to how the funds are spent, to address structural and contextual barriers to effective implementation and coverage, and to ensure that there is enough funding for proper monitoring and evaluation to give us continual feedback for improvement.

On an almost daily basis new research studies about malaria are published. What happens to these studies? In particular how does such research affect policies and programs? Wellcome Trust has reported that, “Research funded by the Wellcome Trust has helped shaped international and national health policy for two of the world’s most important public health challenges: malaria and dengue fever.”

Wellcome points out that, “Research by Dr Noor from the Kenya Medical Research Institute-University of Oxford-Wellcome Trust Collaborative Programme has fed directly into the Kenyan government’s 10-year plan for the monitoring and evaluation of malaria,” which was launched in November 2009. This research contributed to a refined mapping of malaria in the country which will enable better targeted interventions.

The study by Noor et al. led to a “Model based geo-statistical methods (that) can be used to interpolate malaria risks in Kenya with precision … our model shows that the majority of Kenyans live in areas of very low P. falciparum risk. As malaria interventions go to scale effectively tracking epidemiological changes of risk demands a rigorous effort to document infection prevalence in time and space to remodel risks and redefine intervention priorities over the next 10-15 years.”

There is a history of WHO and the Tropical Disease Research Program conducting and using research to update malaria guidelines and policies. The 2004 document, “Scaling up home-based management of malaria: From research to implementation” explains that …

Large-scale research studies and pilot studies have shown that scaling up home-based management of malaria is both feasible and effective – and is already being implemented on a limited scale in some African countries. Research experience and demonstration projects have provided guidance on how home-based management of malaria can be scaled up to reach the majority of populations.

In developing malaria treatment guidelines in 2006 WHO explained that, “Wherever possible, systematic reviews of randomized trials that directly compare two or more treatment alternatives in large populations were identified and used as the basis for recommendations.”

The dissemination and adoption of research at the country level may be slow. The value of Artemisinin-based Combination Therapy (ACT) was proven by the time Roll Back Malaria was launched over ten years ago, but it took five or more years before some countries adopted this medicine as first-line treatment. Even after a new treatment policy was promulgated, the actual practice of ACT use by practitioners in the field lagged another 2-4 years.

Researchers themselves often need to learn how to become advocates for their own findings. The Future Health Systems Consortium has stressed the need for the research community to learn about “influencing health policy at various levels, either as a direct or indirect outcome of the proposed (research).”  FHS stresses the “need for systematic analysis of strategies to promote integration of research into policy processes.”

Research will definitely be a crucial component for progress along the pathway to malaria elimination. Vaccine research continues, new drugs must be discovered, and better net distribution mechanisms should be tested. We must always facilitate communication between researchers and policy makers to ensure progress along that pathway.

Researchers from the Indian Institute of Health Management Research launched a report on the health situation of communities in the Sundarbans of West Bengal State yesterday. The According to the IIHRM team, led by Dr Barun Kanjilal, Sundarbans are a unique bioshpere of islands of mangrove forests in the river delta just south of Kolkata in West Bengal State, India.

The study conducted as part of the Future Health Systems Consortium examined the health and health care situation of the over 4 million people living on 54 of the 102 islands in the Sundarbans. Some of the key findings on health status include –

• General morbidity rate is higher that the state average
• There is a mixed burden of communicable (e.g. diarrhoea) and non-communicable diseases (e.g. coronary health disease) and injury (e.g. snake bite)
• Mental health problems are higher than expected
• Half of the children <5 years of age are malnourished
• Women have a higher burden of disease than men

These health issues must be viewed in light of the findings on health systems –

• Most care is delivered by informal providers known as rural medical practitioners (RMPs)
• Utilization of maternal health care is low
• Child immunization rates are lower than the state average
• There are serious shortages of public health facilities and trained human resources

These conditions were worsened by the effects of Cyclone Aila.

The team recommends developing what they are calling Basic Health Guard Units (BHGU) at the village level, which includes improving the skills of RMPs who were frequently found to prescribe inappropriate and even harmful medicines. In particular the BHGU should provide appropriate and timely treatment for common communicable diseases such as diarrheal diseases, respiratory infections, kala-azar and malaria.

India generally and West Bengal specifically are not highly endemic for malaria, which is usually seasonal.  Malaria deaths may be decreasing but continue to occur. Outbreaks result “from weaknesses in malaria control measures and a combination of factors, including vector breeding, low implementation of personal protection and weak case detection.”

Even in low endemic areas vigilance is needed to prevent, detect and treat malaria if elimination is going to happen.  If these proposed BHGUs bring better malaria diagnosis and treatment to the grassroots – or in this case the mangrove roots – West Bengal will be closer to eliminating malaria.

TropIKA.net is one of the latest to comment on the World Malaria Report and data from specific countries that show a drop in malaria cases that are ‘believed’ to be a results of stepped up intervention. Zambia, which is reporting a 50% drop in cases, is contrasted with Sierra Leone where there is a reported increase coupled with malaria control program implementation challenges.

In another part of the world, often known as a seed bed for malaria drug resistance, an increase is also reported. In Cambodia …

Figures for malaria cases in 2009 are still being tallied, said Ministry of Health and World Health Organization officials, but are already higher than in 2008, when there were 58,887 cases and 209 deaths. In 2009, 60,157 recorded malaria cases led to 213 deaths from January through September.

In either situation – more malaria or less – the real question is how do we know?  Diagnostics, monitoring, documentation and evaluation systems are not strong yet in most countries.  Until these are improved we may not recognize malaria elimination when we achieve it – or worse, falsely claim victory.

While safe larviciding measures exit today, an old mosquito larvae control measure often suggested by your district health inspector was pouring petroleum products like used engine oil on breeding sites.  Over the years the Shell Petroleum Development Corporation of Nigeria appears to have taken this old suggestion too far.

The Guardian reports that now, “A judge in the Netherlands has opened the door to a potential avalanche of legal cases against Shell over environmental degradation said to be caused by its oil operations in the Niger Delta.”

Common Dreams expanded on the story explaining that, “The Nigerian farmers say they lost their income after crude oil from a Shell pipeline poured over their fields. Fishermen also lost money when the leak contaminated their fishponds.”

Shell is also famous in Nigeria for Shelltox, a aerosol insecticide.  Apparently Shell and other oil producers have also taken chemical release too far. “Shell has also been under heavy fire from environmentalists over allegations of unnecessary flaring of gas from oil wells, something that is regarded as a prime source of global warming.”

Pollution results not only in the slow destruction of livelihoods, but when people challenge the polluters, they too are destroyed. According to the Guardian, “Shell, one of the world’s biggest oil firms, is accused of complicity with the then Nigerian government in the execution of Ken Saro-Wiwa, a well-known environmental activist and author, and several other campaigners against the oil industry.”

Shell on its part blames the spills on sabotage. For example in 2005 the BBC reported that, “Oil giant Shell has been forced to delay shipments of Nigerian crude after an apparent dynamite attack on one of its main pipelines in the country.” While environmental campaigners acknowledge the damage, we should note that the oil spillage and gas flaring have been going on long before the populace became disgruntled enough to take action against the pipelines.

The oil situation in the Niger Delta may not cause malaria directly, and the oil spills certainly aren’t controlling it. The loss of livelihood and the violence in the region leads to displacement, which in itself makes people more vulnerable to malaria. Elimination of malaria cannot succeed in an unstable social and political environment.

Guinea worm is close to being eradicated.  This disabling water-born helminthic disease attacked millions of people annually from West Africa through to South Asia about 20 years ago. International eradication activities took shape in the late 1980s, and today only Mali, Ethiopia, Sudan and Ghana had only 1948 cases among themselves during the first 7 months of 2009.

Twenty years elapsed from Nigeria’s first national guinea worm case search survey, which documented that 653,492 people had suffered from the disease during the 1987-88 until the last victim was identified in November 2008. According to the Carter Center …

… her worm has made her a minor celebrity. The fact that Otubo can be specifically identified as the final victim of the disease in her country shows the relentless tracking required to eliminate Guinea worm disease. Thousands of volunteers have worked in Nigeria since 1988, documenting every case of the disease and providing the tools and education necessary to defeat it.

Nigeria still needs to maintain surveillance for at least another year, or two years total after the last reported case, before it can be certified by WHO as having eliminated guinea worm.

Guinea worm was initially thought to be relatively easy to eradicate. The vector stays put in ponds until people come to collect drinking water. It is seasonal, and there are no other reservoirs of the disease besides humans. Thus, 1995 had been initially set as the date by which guinea worm was to have been eliminated from all endemic countries – i.e. eradicated. But in 2007, WHO said –

… meeting eradication targets by 2009 is overly optimistic. To achieve this goal, it is necessary to deploy adequate human and financial resources. Guinea-worm disease is now solely a problem of the African continent: providing safe water to poor populations may immediately solve this problem. However, this is not anticipated to occur in the near future.

If guinea worm eradication has been so elusive, what of malaria? The financial resources are only now reaching levels that might have some impact if interventions can be scaled up AND sustained.

As Carlos Campbell observed in mid-2009, malaria “Programs in Equatorial Guinea, Ethiopia, Rwanda, Zambia, and Zanzibar have shown that when coverage of these interventions exceeds 50 to 60% of the population, the prevalence of infection withmalaria parasites and mortality among children from such infection falls by 20 to 25% within 12 to 36 months.”

If we can achieve 80% coverage in 2010 and reach 50% mortality reduction by 2015, we will be well on the road to elimination.  Detours may arise from drug and insecticide resistance, threats to funding and basic fatigue from communities, program staff, politicians and donors.  In the meantime advocacy, monitoring, surveillance, evaluation and biomedical and operations research need to continue to anticipate and prevent these detours.