The recent changes in the Indian government’s drug policy for the treatment of the deadly falciparum malaria are illogical and harmful. Sandhya Srinivasan analyses the short-sighted response to this public health crisis
I: The burden of malaria
Community health activists have come out strongly against recent changes in the Indian government’s drug policy for treatment of the deadly falciparum malaria, which is responsible for almost all deaths due to malaria in India.
In February 2009, a two-day consultation on Revisiting Issues in Falciparum Malaria was organised by the Chhattisgarh-based community health organisation Jan Swasthya Sahyog. The meeting was held in the JSS health centre at Ganiyari village, near the town of Bilaspur. It was attended by community health activists, technical experts, government programme officers, and representatives of international organisations and non-governmental organisations working in the malaria-high-burden states in central, eastern and north India –Assam, Orissa, Chhattisgarh, Jharkhand and Madhya Pradesh – as well as Maharashtra, Gujarat and West Bengal where there are pockets of high prevalence.
Many of the government’s changes are illogical and harmful, the activists argued. Like all other health programmes in India, the malaria control programme is increasingly depending on technical, “targeted interventions” in isolation from the conditions in which the disease exists and the health system that must treat it. But this approach just doesn’t work.
Some of the changes in the national vector-borne disease control programme’s new National Drug Policy on Malaria (2008) are particularly worrisome. Artemesinin, an expensive drug of last resort, will be given as first-line treatment for all proven falciparum malaria cases in certain states – even when chloroquine might be the best choice. All studies on the malaria parasite’s sensitivity to various drugs such as chloroquine and sulphadoxine-pyrimethamine will be stopped. Expensive rapid diagnostic tests are promoted in place of microscopy. Pregnant women will no longer receive preventive drugs, taking away whatever little protection they used to receive from this important cause of maternal mortality. Finally, the changed treatment protocols, as well as new guidelines for treating complications in severe malaria, are to be implemented by a health system that doesn’t have the necessary infrastructure, personnel or other facilities.
These are not mere technical quibbles. According to the organisers of the consultation and many of the participants, these and other changes in the policy will have devastating consequences on the health and lives of the poor. Public health specialists argue that they will further worsen an already difficult situation. Millions of people suffer malaria each year, and hundreds of thousands die from this mosquito-borne disease.
“Our single biggest public health problem”
At its height in the 1940s, official reports estimated that some 75 million Indians contracted malaria every year, and 1 million died. An aggressive malaria control programme with a focus on spraying insecticide was launched and by 1965, the estimated number of annual cases had dropped to 100,000. An overconfident government renamed it an “eradication” programme. Then the numbers started rising once more, because of a combination of factors: environmentally destructive development projects were started, the mosquito developed resistance to insecticides (the government’s focus) and the parasite showed resistance to anti-malarial drugs. By 1976, there were at least 6.5 million cases annually. The National Malaria Eradication Programme is now renamed the National Anti-malaria Programme.
Today, according to official figures, 2 million people get malaria every year in India, and about 1,000 people die of it. But quote those numbers to people like Johnny Oommen and you’ll be met with a grim laugh.
“One-third of all deaths in our hospital in Rayaada district are from malaria,” said Oommen at the consultation. A medical doctor with a degree in community health, he has lived and worked in Bissamcuttack, Orissa, for decades. “Malaria is our single biggest public health problem.” According to government estimates, about 50% of all malaria deaths occur in Orissa – which has just 4% of the country’s population.
The government’s figures are restricted to laboratory reports from its health facilities. But most people go to private doctors for treatment and few people suspected to have malaria actually get tested – treatment is usually presumptive. “We’re working without complete information,” said Oommen. “We’re looking at the fish in the net, not the fish in the pond.” Efforts are not being made to improve reporting of malaria cases and deaths.
The World Health Organisation estimates 15 million cases in India annually, with 20,000 deaths every year. According to another estimate, based on the consumption of the anti-malarial drug chloroquine, there are anywhere from 30 million to 40 million cases of malaria a year.
“I’m seeing a pandemic of malaria in the northeast,” said Sunil Kaul of the NGO The ANT in Chirang, Assam. Kaul estimates that at least 4,000 people die every year of malaria in Assam, at least 1,000 people in just one district, Karbi-Anglong. “In the administrative capital of this district, you will find entire medical wards with only malaria patients.”
“In terms of numbers, malaria is the number one disease,” says Ravi D’Souza of the JSS. “It destroys the red blood cells and causes anaemia.” Malnutrition caused by malaria can only be reversed by treating the disease – it’s not enough to give good food.
Before moving to Chhattisgarh, D’Souza worked in rural Orissa. He remembered one incident vividly: “We had an American medical student with us who visited a village in Kalahandi district and came back shocked that 80% of the people had a palpable spleen – the effect of untreated malaria. But that’s the reality.”
Good nutrition has a lot to do with whether a person survives the disease and public health experts have found a spike in death rates from malaria during times of famine. In tribal areas malaria is an important cause of infant and maternal deaths.
The two most common types of malaria are plasmodium falciparum and plasmodium vivax. Almost all deaths due to malaria are from the more serious falciparum which has gone from 20% of all malaria cases in the country in 1965 to 50% in 2007 and is responsible for deadly outbreaks in Rajasthan, Assam, Nagaland, Andhra Pradesh and elsewhere.
“Falciparum malaria is one of the few infections which can kill a person in the span of a day,” said Anurag Bhargava of JSS who spoke at the consultation on the guidelines for treating complicated malaria. “In its severe form it requires the most intensive care, a blood bank, dialysis facilities and a ventilator – all virtually inaccessible for rural Indians.”
A governance issue
“Map the worst-affected states and you also map the poorest states,” said Johnny Oommen. Ironically, these states are rich in natural resources even as the people are desperately poor. “Malaria deaths occur where political power ends.”
“Malaria is a governance issue,” declared Anurag Bhargava at the consultation. “The worst-affected areas – and most of the deaths -- are where the health services don’t work.”
Jharkhand, Chhattisgarh, Madhya Pradesh, Orissa and Assam are high-burden states for falciparum malaria. “Falciparum malaria was once restricted to forested regions but it is now becoming an urban phenomenon,” noted Dhruv Mankad of the NGO Vachan in Nashik, Maharashtra. The high-burden areas in Maharashtra were earlier limited to tribal districts such as Gadchiroli. “Today, chloroquine resistant falciparum malaria is also reported from Navi Mumbai, satellite town of the state’s capital. Urban malaria is a direct consequence of haphazard construction and poor drainage. The people affected are largely the poor, like the construction workers living in makeshift housing, surrounded by debris and stagnant water. As unorganised workers with pitiable access to any services, they don’t get treatment.”
There is also a clear link between environmental disruption and vector-borne diseases like malaria. Bhargava pointed out that malaria was once rare in the Narmada valley; today it is common. In the 1990s, waterlogging caused by the Indira Gandhi canal was responsible for an epidemic of falciparum malaria in Rajasthan killing hundreds of people. In the early-2000s, the Sama Resource Group for Women documented the epidemic of falciparum malaria around the Tenughat dam across the Damodar river in Gomia, Jharkhand. The victims were daily wage labourers who survived by selling coal from abandoned coalmines, working in brick kilns and stone quarries, or as agricultural labourers. They could not even afford to buy food from the public distribution system.
No magic bullet
But there is no magic bullet for malaria control, said Prabir Chatterjee, a community health activist based in West Bengal. The anopheles mosquito, the environment and human behaviour all work together. Some mosquitoes breed in stagnant water which can be drained or sprayed with oil to kill the larvae. But others breed in slow-moving water at the margins of rivers and streams in forest fringe areas, for which environmental spraying will not work. Some mosquitoes bite at night, and when people sleep outdoors insecticide-treated bed nets are necessary. Others bite only in the evenings and can be kept at bay with insect repellents. Control needs a combination of all such preventive measures. It also needs accessible treatment facilities with the available personnel and drugs.
The healthcare system
We’re all bored of hearing about how India’s expenditure on public health is one of the lowest in the world – less than 1% of its gross domestic product. We may also feel we’ve heard enough about the structural adjustment programme (implemented since 1991 as a condition of the International Monetary Fund loan) effectively dismantled existing public services.
But these facts will colour any discussion on healthcare – how can the poor get medical treatment if the government washes its hands of healthcare? Casual surveys of government health centres show how appalling the situation is: buildings are in disrepair, equipment not working, the staff absent, and the pharmacy shelves bare. In Gomia, Jharkhand, Sama found that the government hospital didn’t even have a microscope, let alone a person trained to use it.
“But who is there to say anything?” asked Kaul of The ANT. “My own district of Chirang has only 80% of the staff it is supposed to have -- and that’s a huge improvement from a couple of years ago when barely one in four posts was filled. This increase in staff strength is because of the National Rural Health Mission. But the situation has not improved much. There’s a severe shortage of MBBS doctors who don’t come here because of the pay. These posts have been filled by ayurvedic doctors who may not be very familiar with the malaria drug doses – and they’re not getting the training they need. The interior areas still don’t have lab technicians. Malaria work is being done by the NRHM’s accredited social health activist (ASHA). The ASHA is supposed to be an activist – a representative of the people who demands services on their behalf. She has been turned into a service provider. ASHAs have been given rapid detection kits but many don’t know how to handle them. The NRHM has not been accepted by the state health system. There is no accountability of health staff.
“Regular slide collection was last done in 1992-93. Since then, slides are taken in fits and starts – really, it’s mostly on paper these days. Then, half the time, there are no medicines. For example, my district has been identified as one of those in which artemesinin combination treatment is to be given for all proven cases of falciparum malaria. ACT has been available with the private sector for five years. But we haven’t received it. These drugs are supposed to come from the centre.
“Some years ago I got a letter from a gram panchayatin district Baksa that they had lost 80 people to malaria. Not one government person came there in the entire season. I forwarded the letter to the national malaria control programme but didn’t hear back from them. Nobody could be bothered. When 80% of households in Assam don’t have electricity, health personnel never go there, forget about doctors. In the forests it’s much worse.”
The people’s movement against malaria
Oommen runs a successful malaria control effort in Rayagada district in Orissa. The Mitra programme was kicked off with a long education campaign and today people in the 50 villages where the Mitra programme is run have bought their own insecticide-treated bed nets.
“We looked at the options – DDT, chloroquine, treated nets, etc,” he said. “Then we came out with a strategy for a people’s movement that enables people to choose the right option for themselves. People need to protect themselves. No government, no World Bank can protect you.”
II. People need healthcare, not rapid diagnostic tests
The malaria parasite is becoming resistant to chloroquine.
There is a standard treatment protocol for suspected malaria, said Ravi D’Souza of the Jan Swasthya Sahyog. Do a blood smear for the malarial parasite, and treat positive cases with chloroquine. If the fever doesn’t come down in 72 hours, this might be a case of resistance to chloroquine, for which there is a combination drug, sulphadoxine pyrimethamine. If this too doesn’t work, then there is quinine and if not that, the drug of last resort is artemisinin. Artemesinin is to be used directly in very few situations.”
Noting evidence of growing chloroquine resistance, the Malaria Drug Policy 2008 has advocated a change in first-line treatment in Orissa, Chhattisgarh, MP, Jharkhand and Andhra Pradesh and all states of the northeast. In these states, where studies have shown a chloroquine resistance of more than 10%, all proven falciparum malaria cases will be treated with a drug combination that includes artemesinin.
Artemesinin is very expensive, more than 20-30 times more expensive than chloroquine. More important, once resistance develops to this drug, there’s nothing in the research pipeline to replace it. Will this large-scale use of artemesinin dramatically strengthen the malaria control effort or will it take away the last drug for malaria?
“Artemesinin is the last drug we have for malaria; there are no new drugs on the horizon,” said Yogesh Jain of JSS. If it is used unnecessarily the parasite will soon become resistant – and then we don’t have anything.
“Every pundit would agree that malaria is not like TB,” said Jain. “It follows a local and regional epidemiology. Resistance to drugs and insecticides varies from district to district. Each area should be checking out its own drug sensitivity. Yet the new guidelines apply across each state.” Indeed, the consultation discussed two studies of chloroquine resistance from different parts of Chhattisgarh. Though both studies were from the same state, they found very different levels of drug resistance.
Jain and others at the consultation argued that drug prescriptions cannot be made for entire states or regions. “Chloroquine should be used where it works, and for this we need to monitor resistance patterns locally. It’s reasonably simple to monitor chloroquine resistance with a microscope, a lab person, and a system to get slides on time so people get treated on time.” He also pointed out that the 44 studies used to justify the decision on ACT are not public; the little information available on them indicates that they are insufficient grounds for such a decision.
But the new Malaria Drug Policy advocates a halt to any further monitoring of resistance, though resistance has been reported to sulphadoxine-pyrimethamine (SP), the drug used in the government’s ACT combination. (Incidentally, the artemesinin-SP combination was chosen because it is cheaper than other ACTs.)
Yet the government has not been able to tackle the widespread misuse of anti-malarial drugs in the private sector where the majority of people go for treatment. Artemesinin is available in the private sector as a single drug – though it is to be given only in combination.
As Sunil Kaul of The Ant in Assam pointed out, “Everyone is making money, prescribing ACT, hooking patients up with saline drips... With the government system in such shambles, people go to private doctors who prescribe artemesinin as a single drug costing Rs 600 even for a simple fever. The entire course of treatment for uncomplicated malaria with chloroquine costs just Rs 6. But people take half the course of artemesinin because they can’t afford the full treatment.”
Doing away with the microscope
The gold standard for diagnosis of malaria is a blood smear viewed through a microscope. In a functioning health system, blood smears for malaria can be taken from the village to a health centre, tested and the results sent back to the village in time for treatment to be started. But when half the health centres don't have microscopes and the others don't have technicians, “it takes 15 days to get a blood smear from a village to a centre where a microscope is available, and get the test report back”, according to Jain. “By that time the report results are irrelevant.”
“Instead of improving the system, they are starting testing strips for the health worker to read and prescribe right away,” said Kaul. “But these cost Rs 40 to 100 per test compared to Rs 10 per microscope slide inclusive of all other costs. And they’re there because the government system doesn’t work as it should.”
This is not unique to the malaria control programme. The microscope is being replaced throughout the public health system with disease-specific rapid diagnostic tests (RDTs) that can be read on the spot by a health worker.
“But a microscope test costs less than Rs 10 and is 100% accurate: All you need is a microscope and a person trained to use it,” said microbiologist Biswaroop Chatterjee of JSS who presented the results of a survey of leading brands of RDTs in the market. He found that the most commonly used one picked up just 59% of all cases. He also pointed out that RDTs need to be stored at certain temperatures and have short shelf lives.
“On the other hand, a microscope is a multipurpose instrument with an important role in diagnosis, and resistance monitoring. It’s a one-time cost of Rs 25,000 plus the monthly Rs 12,000 for a microbiologist. And unlike an RDT, it can detect all sorts of infections, blood problems, some cancers, besides malaria.”
As a participant at the consultation pointed out, “We can’t throw away microscopes because the system doesn’t work; the ability to provide microscopy is a test of a public health system.” RDTs may be necessary where it is very difficult to obtain timely microscopy results but they cannot strengthen and solve the problems of the public health system.
The government advocates the use of RDTs because it says it’s not possible to get the results of blood smears to the village before two weeks. JSS has proved the government wrong. Its health workers prepare blood smears on slides which are then carried in a box by school children to roadside shops, from where buses carry them to the community health centre. And the results go back to villages in the same way. Results get to the village within 24 hours.
If an NGO like JSS can do it, why can’t the government?
No drugs for pregnant women
Malaria is an important cause of death during pregnancy. Till recently pregnant women were given chloroquine prophylaxis. The National Drug Policy on Malaria 2008 does away with this practice on the argument that chloroquine resistance renders the drug useless. Further, it states, pregnant women with falciparum malaria may not receive ACT because its safety in pregnancy has not been established. But ACT has been approved by the WHO for malaria treatment during the second and third trimesters of pregnancy. Instead, pregnant women must rely only on insecticide-treated bed nets for protection – even if the mosquito bites during the day when bed nets are of no use. Or they must wait until they get falciparum malaria and then go to the nearest subcentre for quinine tablets. “But less than 10% of all subcentres have quinine,” said AV Ramani of JSS who spoke at the consultation on the drug policy for pregnant women. “Barely 5% of primary health centres and no subcentres had insecticide to treat the nets that are supposed to be provided.” Finally, if it’s okay to give chloroquine as presumptive (without testing) treatment in low-burden states when microscopy is not available, shouldn’t this be available to pregnant women as a preventive measure in high-burden areas?
Johnny Oommen asked a rhetorical question: “If I am a pregnant woman in an endemic state, you’re going to tell me, ‘Sorry, the rules have changed, we can’t give you chloroquine. Use a bed net and if you get ill find your way to the subcentre.’ Whose perspective on malaria is this?”
And bed nets are not a sufficient solution. For one, they can work in areas where the mosquito bites only at night. They’re of no use when the mosquito bites through the day, or even only in the evening. Second, the policy advocates the use of long-lasting insecticide-treated bed nets which must be imported. “We have 22,000 pregnant women and 2,000 nets,” said Anurag Bhargava. “Why are bed nets imported?”
“Insecticide-treated bed nets can be made locally and cheaply,” noted AV Ramani. “They need to be soaked in insecticide every few months. Indeed, the villages in Johnny Oommen’s Mitra programme raised the money for their own bed nets.”
The straw that broke the camel’s back
The new strategy involves the Accredited Social Health Activist (ASHA), the backbone of the National Rural Health Mission. The ASHA is now the community-level point person for malaria detection, treatment and referral to higher facilities for treatment of complications. But the ASHA doesn’t have the training, especially not as a volunteer, and especially when she cannot rely on the public health services.
And this brings us back to the very idea of running a programme through a non-functional public health system.
“Falciparum malaria is a medical emergency,” said Bhargava at the consultation. “But people must travel for days for treatment – and even then they are not assured of prompt care.” Essential therapy can be given at more basic levels of care, but even this requires proper diagnosis, round-the-clock medical supervision and access to safe blood. And it must be possible to refer people with complications to facilities with the right services – for this, the facilities must exist.
But many requirements for the treatment of severe malaria are not available in the high-burden states. Reiterating the need to look at comprehensive care, Bhargava noted that services like safe blood, diagnostic facilities on an emergency basis and critical care are needed for many problems including malaria. These are missing even at the medical college level in Chhattisgarh.
What is behind such decisions in the National Malaria Drug Policy? Is someone making money on the expensive drugs, tests and imported bed nets? Or is it just misguided thinking? Or is it a bit of both? Some senior officials smirked at the idea that the health system could do its job with microscopes rather than expensive test kits. Others may have felt that such tests were the easy – or only – option when the system didn’t work. Others were embarrassed about the illogical decision to withdraw all preventive drugs for pregnant women.
One thing was clear at the Ganiyari meeting. Experts from within the government as well as outside had serious reservations about the changes in the Drug Policy on Malaria. And these were not just a group of idealists holding forth on primary healthcare. They included community health workers as well as government functionaries. They spoke from decades of experience working in the interiors and remote corners of the country. And their message was: that programmes cannot work independently of the people for whom they are meant. The community must be involved in malaria control and they must have the knowledge, the skills and the equipment necessary to protect themselves. It is their perspective and their needs that should determine life-and-death decisions.
InfoChange News & Features, May 2009