Wednesday, November 15, 2006

An opportunity to end health care slumber

Read the published version at India Together

The HIV epidemic has brought into focus multiple public health issues facing rural India today. In this respect, it presents us with an opportunity to deal with issues that have been neglected and even been actively ignored for too long. Supriya Kumar writes that dealing with the HIV epidemic could lead to a fortuitous tackling of chronic problems in India's public health set-up.

It wasn't until she heard the village gossip about HIV having been the cause of her husband's death, that Leela decided to get tested for the dreaded virus. Her worst fears having been realised, Leela had no choice but to focus all her energies on staying healthy for as long as possible so that she could care for her daughter. When Pratima Patil of SAATHII (Solidarity & Action Against The HIV Infection in India) visited them, Leela's nine-year old daughter, who aspires to be a singer, sang a breathtakingly beautiful song about prayer - she spends long hours praying for her mother's health. "There are many women like Leela - they end up finding out only after the husband is dead that they were at risk of contracting the virus, and it's often too late to protect themselves. These women are then shunned by their families and left to fend for themselves", says Patil.

I spoke to Patil, the associate director of SAATHII in the US, after she returned from a fact-finding research trip to rural India. She visited patients and orphanages for HIV-infected children in rural Maharashtra, bringing back heart-wrenching stories of the stigma that infected people (and even people who are not infected but have lost a family-member) have to face. SAATHII is an organization based in the US and in three cities in India, working to raise awareness about issues related to HIV/AIDS, with the aim of expanding access to prevention and treatment services.

Parts of rural India are in the throes of an HIV epidemic. Upto 5% of all people in some areas carry the virus. Women who test positive in antenatal clinics most often claim to have never had casual sex. However, like Leela, they are dependent on their husbands to also be faithful in their relationships in order to steer clear of HIV. Men in rural India, however, often migrate to cities after a harvest, looking to earn some extra money. The three M's, Migrant men with money, it turns out, have played a large role in the spread of the virus from high-risk populations into the general rural population.

The number of people migrating from villages in search of work has increased since the agricultural sector was faced with a crisis. Fluctuations in the price of agricultural commodities like cotton and rubber have left many farmers deep in debt, forcing them to migrate in search of jobs in cities. This situation, however, of being away from home and family, presents its own harsh set of stresses. Many migrants, having contracted HIV from sex-workers (prevalence of the virus among whom is greater than 20% in some cities), bring it back to their villages. “With husbands leaving the villages, and in some cases, committing suicide because they were unable to escape from the trauma of debt, selling sex also becomes a matter of survival for their wives”, says Dr. L. Ramakrishnan, SAATHII’s Director of Programs and Research in India. Voluntary testing centers are few and far between in rural India. People who suspect that they may be infected are reluctant to make repeated journeys to the testing center in the district headquarters for fear of being suspected of carrying the virus. So migrants returning from cities rarely get tested.

"The country is in the process of setting up testing facilities at the Taluk level, but this will still not bring testing to the doors of the rural population", says Dr. Sai Subhasree Raghavan, founder and director of SAATHII. "One way to really bring testing to the villages is to integrate it with the rural health mission, which does reach villages via their village level workers", she says. The National Rural Health mission (NRHM) is an ambitious project set up by the UPA government that could in fact bring voluntary testing and basic health care to villages. But this will happen only if innumerable vertical programs can be integrated and if primary health centers (PHCs) are allowed access to funds for the specific tests and drugs needed in the villages they serve. By contrast, in the present scenario, people that Patil met had to travel 4 hours on a bus to the district headquarters to get tested; this cost them their day's wages and forced them to forgo earnings, and by extension, food for the day – an obvious deterrent in itself to voluntary counseling and testing.

HIV is mostly sexually transmitted in India, with the exception of the north-eastern states, where injecting drug users are the majority of HIV-infected people, the virus being transmitted via used needles. Large areas of southern India, notably Tamil Nadu, Andhra Pradesh and Karnataka, as well as parts of rural Maharashtra, have been labeled "high prevalence" areas. Prevalence is measured in terms of percentage of people who test positive for the virus. Overall in the country, prevalence is put at about 0.8% in the general population and less than 5% in the groups most at risk, which makes ours a low-prevalence country. In parts of India though, general prevalence is as high as 5%, making those parts, very high prevalence. Of course, when we're talking about a country with a population of 1.1 billion people, a small increase in percent infected people translates to a very large increase in the sheer number of people carrying the virus.

The virus has taken the largest toll on the most productive people in society. Grandparents - grandmothers, most often - take on the burden of caring for their grandchildren. Patil tells the story of Paribai, a grandmother of two, who, at a frail 60 years of age, works 10 hours a day in the fields to earn Rs.30. That's just enough to bring home enough flour, lentils, sugar and salt to feed the four of them that day. Somedays, the grandparents go without food to allow the grandchildren to eat. "And this is by no means an uncommon story", says Patil. She visited an HIV-infected boy suffering from Tuberculosis (TB) in hospital; he weighed 17.5kgs at 12 years of age. His grandmother, his sole caretaker, was at his bed-side; she cleans houses everyday to make money for medical expenses, resorting to borrowing money for school fees.

TB is one of the major killers in India. It is treatable with a regimen of drugs. Patil visited a little boy who is HIV positive, and has TB, in addition to other treatable conditions such as skin rashes. "He is most-probably a candidate for Anti-RetroViral Drugs (ARVs)", says Patil. His grandparents (also his caretakers), can't afford the trip to the hospital in the district headquarters in order to access either ARVs or drugs to fight his TB and skin infection. The latter should be available in the PHC near their village, but availability of even drugs to treat TB is sporadic here and the PHC discriminates against HIV-infected people. This leaves the boy grappling with conditions that are immensely treatable if only our health care system functioned as it is supposed to. We have a stated need for one PHC for every 30,000 people, yet the number of people served by a PHC is more than double that today. Existing PHCs are poorly equipped and poorly staffed. Coupled with this has been a rising negative perception among rural Indians about government-run publicly funded health centers. People cite lack of availability of drugs and long distances from their villages to the PHCs for not using them. "The first point of contact with a health care center is inevitably a private center", says Patil. Such private care centers are not regulated by the government, and may not provide drugs at the most affordable prices. HIV-hit families find themselves spiralling into debt; parents of infected people spend their life-savings trying in vain to save their children, only to be left with the burden of taking care of their grandchildren in penury.

While anti-retroviral therapy is being made available to the public free of cost, on a limited scale, there is no government fund that grandparents of children orphaned by HIV, or even the children themselves, can tap into to. The government is in the process of consultations to provide some aid to such people, says Patil. We will have to wait and see what comes out of these consultations. We can hope, in the meanwhile, that the government takes a well-rounded approach to dealing with the problem: an approach that addresses the need for testing centers accessible to villages and for reliable availability in PHCs of not just ARVs but also even more basic drugs to treat opportunistic infections. Most importantly, the government needs to step up education of people at the grassroots so that women at risk know about the disease, how it is spread, how to protect themselves, where to get tested, and where to access ARVs.

There has been some argument about whether India is, in fact, faced with an HIV crisis at all. Arguments over the numbers of infected people, though, are beside the point. With government hospitals in district headquarters being the only publicly funded testing centers in densely populated states like UP, it is quite likely that we are underestimating the number of infected people. That aside, though, the fact that we can get Anti-retroviral treatment (ART) to only 50,000 of the 500,000 (and only 1,500 children out of 15,000) who need them, even as we boast of exporting these drugs to African countries, speaks quite poorly of our own basic health system. In the past few years, policies to tackle the HIV/AIDS epidemic have all targeted urban centers, leading to the availability of Voluntary Testing and Counseling Centers and ART in a large number of government hospitals in big cities. It is only now that the government is turning to rural areas as the disease spreads into our villages. The government aims to have set up close to 100 treatment centers by the end of this year.

"We need to come up with dramatic, innovative approaches to get ART at affordable prices to our own citizens", says Raghavan. She visited Malawi last year where drugs are given by community-based organizations in the communities. "Such a decentralised approach is the only way we will be able to expand services", she continues. India's health budget is a dismal 0.9% of the total budget. As a result, the current level of funding to provide ART to 135,000 patients over the next five years is coming from the Global Fund. "We need to identify sources of funding within the country to cover funding for the rest of the 350,000 patients who need ART. Unfortunately, there has been no large-scale initiative from the pharmaceutical industry to come together to scale-up these services to the patients. And accountability lies with all of us - with the government, with civil society, with the pharmaceutical industry, with the activist and with the private sector. We have not been able to come together to make this happen - and it should be very possible to make it happen", says an impassioned Raghavan. Government policy is still reacting to the spread of the virus into rural India. This would be a good time to reverse that trend and pro-actively take a bottom-up approach allowing primary health centers and sub-centers a degree of autonomy, so that they can spend an allocated budget on drugs and treatments most required in the particular villages they serve. This would also allow the private sector and pharmaceutical industries to step in and fill the most glaring gaps in supply of not just ARVs, but also drugs to treat TB and rashes.

There are signs that the government is on the right track: On August 8th this year, representatives from 620 districts were invited to Delhi to discuss a grassroots approach to tackling the issues surrounding HIV/AIDS. Such approaches need to be backed up by renewed spending by both the state and union governments to revamp our public health system. Dealing with the HIV epidemic could lead to a fortuitous tackling of chronic problems in India's public health set-up. HIV-infected people may then be able to access not just ARVs but also basic drugs to treat TB and skin rashes without the delay and uncertainty present in PHCs today. Even patients without HIV who need access to health care would be well-served by an improvement in access to a reliable supply of drugs at well-run and well-maintained PHCs. The HIV epidemic has brought into focus multiple public health issues facing rural India today. In this respect, it presents us with an opportunity to deal with issues that have been neglected and even been actively ignored for too long.

Names of HIV-affected people have been changed to protect identities

Tuesday, August 01, 2006

Genetically Modified Food: A Case for Stricter Regulation

This is a paper I wrote last year.

Food security around the world, especially in developing countries is an extremely important issue. Genetic Engineering has been proposed as a technology that will increase food production and decrease starvation. Here, I will analyze the science of and policies formulated to regulate genetically engineered organisms. I will weigh the European view against the US view regarding production and consumption of genetically engineered (GE) crops and propose that developing countries should formulate policies with their own unique situations in mind. This is critical for the long-term food security of the world.

Genetic engineering of food crops results in two broadly classifiable types of genetically modified organisms (GMOs): Process-based GMOs are those that result from engineering the process that goes into the generation of the organism. For example, herbicide-tolerant soybean, in which the plant is engineered to be resistant to an herbicide, results in no externally identifiable change to the end product itself. Product-based GMOs are those where the end product is substantially different from traditional varieties of the product, either in terms of nutritional value or in terms of shelf life or aesthetic appeal [1]. For example, “Golden Rice” is rice engineered to produce high levels of beta-Carotene, which is the precursor to Vitamin-A.

The first GE crop to be cultivated commercially was planted in 1996 in the US. Since then, many countries have adopted GE crops. 25% of the world’s cultivated land is now under GE crop cultivation. That is about 200 million acres, of which 63% is in the US and 21% is in Argentina. Of the three most cultivated crops in the US, 85% of all soybean, 76% of cotton and 45% of the corn cultivation in the US is now genetically engineered [2]. This represents a major change in cultivation that affects large numbers of consumers as well as the environment. It also makes trade in GE food produce an important issue, especially for countries that produce large quantities of it.

Consumers are affected by changing patterns of cultivation as the produce they buy contains higher amounts GE food or seeds. If GE foods were labeled as such, it would represent new choices for the consumer. If, however, as in the US, there is no requirement to label GE foods, the consumer then has no choice but to consume the new kind of food or to rely on producers of non-GE foods labeling their products. There are many reasons why consumers may want GE food labeled. Being a relatively new technology, we are forced to rely on laboratory tests rather than data about direct effects on humans, as there has not been adequate time for such data to accumulate. All laboratory tests of nutrient content in process-based GE foods suggest that they are entirely benign with respect to human health, but without adequate data on direct effects on humans, there will always be a large percentage of the population that would simply rather have nothing to do with the new technology. As regards effects on the environment, cultivation of GE crops on farms, even process-based crops, could have adverse effects on the diversity of plants and animals in the vicinity. The possible effects have been documented and range from effects on non-target species to escape of the transgene from the GE plant to neighboring wild species. These risks are much greater when the country importing GE seeds has high levels of natural biodiversity, either in terms of wild species of the crop in question or animal and plant species in general. This makes countries importing GE seeds apprehensive of the effect accidental or intentional planting of these seeds in traditionally non-GE farms could have on their own production and exports. On the positive side, however, GE crops like Bt-cotton do have the potential to reduce pesticide use on farms, thus affecting the environment positively. The bottom line is that perceptions about GE crops around the world with respect to their effects on health, the environment and the economy are polarized, and this inevitably has an effect on the largest producer of GE foods, the US, in terms of export markets. Policies that deal with the production, labeling and trade of GE crops and food products differ between the European Union (EU) and the US, with the rest of the world left as yet largely, grappling with the issue.

The effect adopting GE crops could have on exports of countries is evident by looking at the exports of the US, the largest producer of GE foods in the past few years. As of 1999, 18% of all US corn production was marked for export, with Japan representing 37% of the world market for exported US corn. There have been restrictions imposed recently on GE corn in major Asian markets including Japan and Korea, requiring labeling of GE-containing shipments. This has resulted in apprehension among US exporters about the effect it will have on already falling US corn exports. Revenue from exports to Europe for exported US corn fell from $300 million in the mid-1990s to only $10 million in recent years because GE-varieties of US corn have not been approved by the EU. While Europe represents only 5% of the world market for US corn, this is still significant considering the sheer magnitude of the fall in revenue. As for Soybean, 29% of the production is exported, with the EU being the major importer of US soy. With only one variety of GE soy having been planted in the US, and its approval by the EU, soy exports from the US have not suffered as much as corn exports [3]. It is obviously in the best interest of US exporters to push for market access for their GE produce. However, some countries are formulating regulations that look at each product on a case-by-case basis, making a decision as to grant market access based on the specific risks associated with it. Furthermore, countries are taking into consideration EU import policies while making decisions on whether to adopt GE seeds on their own farms. Adopting the technology brings with it the risk of losing the European market for their food exports.

GE Policies and the issues that inform them

Policies to regulate import and production of GE crops are decided by countries concerned. However, trade between countries is regulated by the world trade organization (WTO). The Codex Alimentarius commission, created by the World Health Organization (WHO) is responsible for food safety standards that traders and countries adhere to. As far as Biosafety and environmental concerns go, the Convention on Biodiversity set up by the United Nations drafted the Cartagena Protocol on Biosafety, which came into effect after 50 countries ratified it. This happened in September 2003. Presently, 110 countries are signatories to the protocol, the US not being one of them. The Cartagena Protocol gives importing countries the power to ask for risk assessments and scientific tests if they have any doubt about the environmental risk associated with a “living modified organism” being imported [4]. The protocol thus adopts a “precautionary principle”, much like the European Union, whose regulatory policies are defined by it. The precautionary principle requires that it be proved that GE food or crops are risk free before they are deregulated. Of course, this requires defining the possible risks associated with GE foods or crops (see below for possible risks). In the absence of a scientifically defined risk associated with a particular food/crop, restricting import of the product may be viewed as going against the WTO’s trade rules.

US policy with respect to GE crops is quite different. The US is the largest producer of GE products. Market forces drive the country’s policy with respect to internal consumption of GE food products or crop cultivation. The US consumer has not demanded labeling of products that contain GE foods; the Biotech industrial lobby is of course large and powerful enough in the US to be able to ward off any such demands, should they surface. The US Department of Agriculture (USDA) oversees issues that deal with the environmental safety of GE crops, while the Food and Drug Administration (FDA) deals with issues about food safety. Crops and products are viewed as harmless unless there is a proven risk associated with them. There is, of course, a risk associated with an approach such as this. Once commercialization of a GE crop has been allowed and a crop planted on many thousands of acres of land, it may be too late to deal with a risk, should one emerge. Likewise, with respect to food safety, the “don’t ask, don’t see” approach will only identify the largest problems while any subtle risks associated with a GE food product will go unnoticed, especially if GE foods are not labeled as such [5].

This brings us to the issue of labeling GE food products. Europe has adopted the most stringent rules yet requiring that all products in which genetically modified substances make up 1% or greater of the total be appropriately labeled. This of course presents a problem for most large-scale exporters in the US as their packaging and handling practices make it economically unviable and practically impossible to keep non-GE produce completely free from GE produce. Many other countries are adopting rules requiring labeling of products that contain GE food. Consumers in Europe seem to be much more apprehensive of GE foods than consumers in the United States though some surveys do suggest that a growing percentage of US consumers may also want to have GE produce-containing foods labeled as such [6]. Survey after survey has shown that the European consumer believes that the risks associated with GE foods outweigh the benefits. The widespread European apprehension has been analyzed to be due to the high importance Europeans give to dining practices and their food in general [7]. Whatever the reasons, European people remain vehemently opposed to consuming GE food products. This leads to an interesting quandary for developing nations. They are faced with the option of either adopting GE seeds in the hope of increasing production and decreasing pesticide use, or rejecting GE crops for fear of losing the European market. The recent food aid crisis, which saw African nations faced with a famine turn away food aid from the US because it contained GE corn seeds, highlights this quandary.

Scientific studies of the risks of GE crops

In order to understand if the apprehension regarding GE crops is justified, we need to look at what the risks associated may be. The most popular GE crops have been Herbicide tolerant (HT) varieties of corn and soybean as well as Bt-Cotton. The HT varieties are, as the name suggests, tolerant to a particular herbicide that the farmer can then buy from the same Biotech Company he/she buys the seeds from. Application of this herbicide indiscriminately still allows targeting weeds for death while allowing the HT crop to survive. Possible risks associated with the HT technology are
* Resistance development in weeds
* Leeching of herbicide into ground water
* Any possible effects on plant and animal populations that make up the ecosystem of the HT crop plants.

Bt-crops have been engineered to produce a bacterial toxin that makes the plants resistant to lepidopteran pests. The risks associated with Bt-crops are
* Resistance development in target insects
* Undesirable effects on non-target insects and other organisms
* Introgression of the transgene into wild plant varieties growing near GE plants

The US Department of Agriculture (USDA) oversees most regulation of GE crops in the US. The USDA however, does not have a firm set of regulations and tests that must be performed on a crop that is proposed for commercial planting. The onus for setting up consultations with the USDA regarding any possible environmental risks associated with a GE crop rests with the company producing the seed. This makes the legal framework extremely weak. There is documented evidence suggesting there may be unforeseen effects of genetically engineered crops.
1. A recent study [8] in the journal, Nature, showed that a nematode-resistance gene from transgenic potato grown in the central Andes was transferred to wild potato plants growing near transgenic varieties. There is a possibility that stable introgression of transgenes could confer altered fitness on wild plants. Especially in areas of high biodiversity (the Central Andes is the center for biodiversity for potato), escape of transgenes presents a major risk of the technology.
2. A Nature study in 2000 [9] showed that Bt-corn pollen could kill Monarch larvae in laboratory tests. (Monarch butterflies are also lepidopterans, like the bollworm which is the target of Bt toxin) This was extremely worrisome as Bt-corn had already been commercialized and planted in huge areas of the US Midwest, through where Monarchs are known to migrate. However, miraculously, further studies showed that in the field, the variety of Bt-corn that proved most harmful to Monarchs had not sold well and hence had not been planted extensively.
3. Finally, a recent study [10] showed that there was considerable escape of the HT transgene from a creeping bentgrass variety that Monsanto is trying to commercialize. Creeping bentgrass is used in golf courses etc. as a perennial grass variety, and is known to be wind-pollinated, which makes it likely, right at the outset, for escape of the transgene to occur.

These are but three studies and by no means the only ones, that show that environmental risks associated with transgenic crops are very real and, as illustrated by the Monarch case, regulations to assess and deal with these risks are not in place even in the largest producer of GE crops, the US. There is also the possibility that more effects will be uncovered as time goes on; this is a young technology, which has had only 8 years since the first commercial cultivation of a GE crop. Furthermore, any effects on humans right now is probably going undocumented due to the lack of a labeling requirement in the US, the largest consumer of GE produce. The (as yet) unpredictable nature of the technology and the rush to commercialization by the Biotech companies should urge us to demand that the US government strengthen the regulatory framework within which the companies and traders operate.
Europe has adopted the precautionary approach, which mandates that until you prove that there are no detrimental effects of the proposed technology, it be treated as a risk. Thus, if there is any doubt regarding the risks associated with a technology, they follow the precautionary approach. Developing nations should waste no time in formulating policy to regulate entry of GE crops and foods. Many tropical countries have very high levels of Biodiversity. Any leakage of transgenes into wild relatives in biologically diverse environments, especially in the centers of biodiversity for the crop in question could wreak havoc. Why however, would developing nations be more concerned about effects on the environment than about ensuring food security for their people? We should hope that they adopt a long-term outlook; GE food crops may be able to feed the hungry now, but if transgenes introgress into wild varieties, long term biodiversity of the crop and hence, long term food security will be in peril. There are analyses that show that poor people are hungry in developing nations not for lack of available food, but for lack of buying power to acquire that food. Even if we accept the premise that increasing production is important in developing nations, sufficient safeguards to regulate use of GE crops and decrease risks associated with them are simply not in place in most cases. Safeguarding biodiversity, and thus, ensuring long-term world food security should be the foremost priority for all regulatory bodies and policy formulators, especially in the biodiverse tropical countries.

End Notes:
Fitness The fitness of an individual is measured by its contribution to the next generation.
Introgression Crossing of two plant populations to introduce new genes into a wild population
Lepidopterans The genus comprising butterflies and moths is called Lepidoptera.
[1] Phillips, P and Isaac, G. (1998). GMO labeling: Threat or opportunity? AgBioForum, 1(1), 25-30. Available on the World Wide Web:
[2] Fact Sheet of The Pew Initiative on Food and Biotechnology. Available on the World Wide Web:
[3] International Trade Concerns over Biotechnology Challenge U.S. Agriculture Exports, Report of the US General Accounting Office to the US Senate (2001). Available on the World Wide Web:
[4] Cartagena Protocol on Biosafety. Available on the World Wide Web:
[5] Mellon, M. and Rissler, J. (2004) Environmental Effects of Genetically Modified Food Crops. Available on the World Wide Web:
[6] Genetically Engineered Organisms Policy Issues Education Project. Labeling of foods derived from GE crops. Available on the World Wide Web:
[7] Richardson, JB. (2000). EU agricultural policies and implications for agrobiotechnology. AgBioForum, 3(2&3), 77-83. Available on the World Wide Web:
[8] Celis, C., Scurrah, M. Cowgill, S., Chumbiauca, S., Green, J., Franco, J., Main, G., Kiezebrink, D., Visser, RGF. and Atkinson, HJ. (2004) Environmental biosafety and transgenic potato in a centre of diversity for this crop. Nature 432, 222 – 225
[9] Losey, JE., Rayor, LS. and Carter, ME. 1999. Transgenic pollen harms monarch larvae. Nature 399: 214.
[10] Watrud LS, Lee EH, Fairbrother A, Burdick C, Reichman JR, Bollman M, Storm M, King G, Van de Water PK. Evidence for landscape-level, pollen-mediated gene flow from genetically modified creeping bentgrass with CP4 EPSPS as a marker. Proc Natl Acad Sci U S A. (2004) 101(40):14533-8.