When her husband took chronically ill after communal riots drove them to Juhapura, a ghetto on the outskirts of Ahmedabad, poverty made life seem unmanageable. Free will then became a matter of Rs 8,000 for 40-year-old Zainab Bi. For a sum like that she was willing to swallow an unknown pill once in three months. It wasn’t much they were asking for really, so she gladly gave her thumb impression on the dotted line.

For companies researching new drugs the thumb impression was proof that Bi submitted herself to the experiment of her own free will. It was far more expensive to have such proof in countries where the multinational drug companies that sponsored the research had their headquarters. They were far more cumbersome, involved lengthy documentation and rigorous insurance plans. Clinical research organizations (cros) made the task far easier for these companies by carrying out their research in the ghettoes of India’s big cities. Drug trial was far less daunting; and inexpensive. People were more than willing to offer their bodies for bio-chemical experimentation. The official guidelines warned against monetary inducement.

It took Bi, and so many like her in Juhapura, only moments to make up their mind when a woman agent from a newly opened cros, Lambda Therapeutic Research Ltd, approached them for participation. She explained they would be required to take newly developed drugs for diseases like malaria, chikungunya, hiv/aids even. The agent spoke of possible risks, side effects and what not. Not all of it made sense to Bi. What did sink in was that she was going to be paid Rs 8000 for some new medicine that could cure hiv/aids. She had heard of this disease in radio messages.

In the beginning, Juhapura’s women were not sure how they would get their family’s permission to spend a night, or may be two, at the clinical research lab on the national highway not far from their slum area. When they learnt they were going to be paid between Rs 4,000 and Rs 10,000 the deal was too sweet to resist. The family could not afford to object either.

The transition from the city centre, where they earlier lived, to Juhapura made economic refugees of most people living here. Before the riots many of the 5 lakh inhabitants of Ahmedabad’s largest Muslim ghetto lived in thriving bustling areas like Naroda Patiya, Gulbarg Society, Vatwa. But Juhapura was a world apart, where the community was both the consumer and the vendor. The tailors, vegetable and meat sellers, small time hair-dressers and watch repairers that practised their trade sold services and products to one another. The vibrant market of the city centre was absent here.

Naturally therefore, if a tailor was making Rs 200 a day in Naroda Patiya, he could barely manage Rs 50 a day in Juhapura, said Noorjahan, community leader attached to a group ambitiously called Bharatiya Muslim Mahila Andolan, Indian Muslim women’s movement. Once Bi’s husband fell chronically ill, it was hand to mouth for the couple and their four children. Under the circumstances, nitpicking over side  effects and other safety issues was a luxury. Rs 8000 was what mattered most.

Did they not worry at all? Jannat Bibi said she had heard they were tested for drugs for diabetes, asthma, cancer and even neurological disorders. Noorjahan said some women did complain of stomach problems and rashes on the body. Bi, who has been doing this for three years, said there was no reason for worry. “It is perfectly safe. I haven’t had a single problem in all these years.”

“…All eyes are on the women after a paper printed their photos. But what can they do? Going for these trials is their main source of income” NOORJAHAN, Community leader

Exposé leads to gossip

The problem Bi and her co-travellers in clinical trials faced was of a very different nature and not anticipated by any of the 300-odd women who made an occasional windfall by offering to participate in drug trials. In June this year an Ahmedabad Gujrati daily published an article on clinical drug trial and reported how multinationals made guinea pigs of the city’s poor; the article carried photographs of the Juhapura women with their names. In the uproar that followed, the women became the subject of gossip and criticism for venturing in the night to experiment with unknown drugs. Embarrassed by the fingers pointed at them, 55-year-old Amiya Bano’s son and daughter-in-law made her leave the house.

“These women are angry with me for bringing the newspaper reporter here. They are troubled because all eyes are on them now. But what can they do? Going for these trials is the main source of income for their families,”

said Noorjahan.

The trial

The drug trials were indeed a bit like Kafka’s trial for these women. They were not very clear, like the protagonist in the novel, what they were being tried for. Nor were they sure who was behind the trial. “They make us stay overnight, take our blood samples and then we have to take the pill next morning. We are not supposed to seek remedies anywhere else but the company if some ailment crops up,” said Bi.

So far nothing dramatic has taken place, said Noorjahan. But who can tell what manifestations will show up may be years later? And links between cause and any devastating side-effect will be lost in the hurly burly of India’s ghettoes, where clinical trials are gaining popularity as a livelihood option.

India offered just the perfect setting and plenty of business sense for conducting clinical trials. The subjects and patients who could be recruited at low cost made India a favourite destination for global pharma companies like Pfizer, GlaxoSmithkline, BristolMyers, and others. Add a technically competent workforce and a friendly drug control system and the clinical trial business was set to touch us $1 billion by 2010, up from us $200 million in 2007, estimated India’s Associated Chambers of Commerce and  Industry.

The drug regime would become even friendlier when regulations proposed by the Drugs Controller General of India were formalized; this was likely to be soon. The proposed regulations recommended phase i trials that tested safety and tolerability of a dosage of drugs developed outside India be allowed if the manufacturing company collaborated with an Indian one. At present India allowed phase i trials only for drugs formulated in India and drugs to treat hiv or cancer.

However, phase ii and iii trials for drugs formulated abroad were allowed in the country as they had already been tested safe. Phase ii trials checked the efficacy and side effects of a drug while phase iii trials confirmed its benefits and side effects on a wider sample. “Phase i and ii are the most dangerous stages of clinical trials in human beings.

Opening the doors to these trials will only increase exploitation of the poor. Why should we allow phase i trials of medicines which may not even be used in India and even if they are, it will only be the richer sections that will benefit,” said a public health activist.  “If these trials were for diseases that affected the masses, like tuberculosis and kala azaar (leishmaniasis), then we could support them as the result was going back to them and not feed corporate interest,” said Mira Shiva, chairperson of the ngo Health Action International, Asia Pacific.

An official of the cro, Lambda, was upbeat about the proposed regulations “This will only benefit the community. Even if the mncs do not share their intellectual property now, they will eventually have to come to India to market the drugs.”

The pharma giants collaborated with an Indian research agency for clinical trials that did the job for them at dirt-cheap rates, said a senior sales manager of a leading Ahmedabad based pharma company. In 2005, the government also passed the Patents (Amendment) Act, which assured protection of patents held by foreign companies, thus encouraging them to conduct trials in India. If and when something did go wrong, there was no punitive mechanism. “It is a long chain where work has been sourced down from the company to a clinical research organization to a hospital and finally to doctors. If a problem occurs, all of them will pass the blame to the other. There have been cases of suppression of mistakes in the past,” said Shiva.

Remunerations for clinical trials were also an issue. Volunteers were not supposed to be lured with payments.

“Participants may be paid for the inconvenience and time spent… However, payments should not be so large…as to make prospective participants consent readily to enroll in research against their better judgment, ”

said Indian Council for Medical Research guidelines on clinical trials. Clearly, the guidelines had no bearing on the brisk business of clinical trials in distant Juhapura.

The guidelines also stated a government-registered institutional ethics committee, comprising doctors, activists, lawyers and pharmacologists, would ensure there were no monetary inducements. With a gush in the number of clinical trials, several private ethics committees sprang up overnight. The cros needed an approval from an ethics committee before they could initiate a drug trial. It was simple. These  committees approved of trials for a fee. cros were only too happy to pay.

High inorganic arsenic exposure to diabetes has been established earlier by studies in Bangladesh, Taiwan and Mexico. But the effect of low and moderate levels of arsenic was unknown. A study in the US has found that inorganic arsenic, even at low levels, may cause diabetes. Found in mineral deposits in rocks and soil, arsenic leaches into groundwater, which when supplied for drinking, can be harmful, say researchers of Johns Hopkins Bloomberg School of Public Health, USA.

The researchers studied data from the US National Health and Nutrition Examination Survey of 2003-04 for 788 adults. They found that individuals with diabetes had higher levels of inorganic arsenic compared to those without diabetes. Apart from contaminated drinking water, flour and rice can also contain small quantities of inorganic arsenic, if grown or cooked in areas with arsenic contaminated soil or water.

The study says that 8 per cent of the public water supply system in the US may exceed arsenic levels of 10 micrograms per litre, the US Environmental Protection Agency’s standard for arsenic concentration in drinking water.

“Estimated daily dietary intake of inorganic arsenic in the US ranges from 8.4-14 micrograms per day for various age groups,”

said the study published in the August 20 issue of the Journal of the American Medical Association.

This study predicts a grim future for India where arsenic poisoning is spreading to new areas. India is also called the diabetes capital of the world. However, one problem with the study is that the direct linkage between arsenic exposure and diabetes has not been explored.

“This is a cross-sectional study. Two observations have been made on the basis of data available. Only the association can be claimed, not the causality. The two things may happen together, but it’s not necessary that one causes the other. Further studies need to be carried out,”

said Nikhil Tandon, professor in the Department of Endocrinology and Metabolism, AIIMS, Delhi.

Shashank R Joshi, endocrinologist at Lilawati Hospital and Research Centre, Mumbai, says,

“Arsenic related diabetes would form a very small percentage of the total diabetes in the country which is high, due to susceptible genes, bad diet and lack of exercise.”

1. The Other Side Law:
   If my side of the road has a traffic jam, then I can start driving on
   the wrong side of the road, and all incoming cars will be rerouted via
   Meerut.
2. The Queue Nahin Rule:
   If there is a queue of many people, no one will notice me sneaking
   into the front as long as I am looking the other way.
3. The Mind Over Matter Law:
   If a red light is not working, four cars from different directions can
   easily pass through one another.
4. The Auto Axiom:
   If I indicate which way I am going to turn my auto rickshaw, it is an
   information security leak.
5. The In Spit Of Thing:
   The more I lean out of my car or bus, and the harder I spit, the
   stronger the roads become.
6. The Cinema Hall Fact:
   If I get a call on my mobile phone, the film automatically goes into pause mode.
7. The Brotherhood Law:
   If I want to win an argument, I need only to repeatedly suggest that
   the other person has illicit relations with his sister or mother.. .
8. The Baraat Right:
   When I’m on the road to marriage, all the roads in the city belong to me.
9. The Heart Of Things:
   If I open enough buttons on my shirt, the pretty girl at the bus stop
   can see through my hairy chest into the depths of my soul.
10. The Name Game:
    It is very important for the driver behind me to memorise the
    nicknames of my children.
11. Parking Up The Wrong Tree:
    When I double-park my car, the road automatically widens so that the
    traffic is not affected.
12. The Chill Bill Move:
    When I park and block someone else’s car I am giving him a chance to
    pause, relax, chill and take a few moments off from his rushed day.
13. The Brrrrp Break:
    The louder I burp in a public place; the more it helps other people
    digest their food.
14. The Bus Karo Law:
    If I don’t stop my bus at the correct place near the bus stop, the
    city will explode and blow into 6 million pieces.
15. The VIP Rule:
    There are only 7 important persons in this city-Me, I, Myself, Main,
    Mainu, Aami and Moi !

PS: Although these rules have been made for Delhi – BUT – they are
applicable to MOCOI.
Scroll for this acronym.

(Most other cities of India)

People from all the states and provinces and from all professions in India are there in Delhi.
So it makes Delhi a very competitive state and provide good opportunities for those who survive as it is well connected by air and road to all parts of India and World.
You can get everything and everyone in New Delhi, India.

1. Take a bus and leave your car home. Don’t ever drive an SUV (sports utility vehicle). Say no to diesel cars.
2. Junk bottled water. Demand clean water for all.
   Insist water-free and as a right which is entitled to everyone but be ready to pay more if you use more.
3. Use less water, to discharge sewage.Think of the poluted river,every time you flush.
   Insist your colony recycles its waste-water, even reuses it after treatment.
4. Demand justice for both tiger and poor tribal people who coexist in the habitat
5. To make your beautiful home green, harvest rain, use water saving toilets, segregate garbage and compost kitchen waste.
   Use CFL bulbs and solar hot water heaters.
6. Impose economic sanctions against US for rogue climate behaviour .
7. Do not use any product which uses plastic to pack food or other stuff. This will put pressure on manufacturers to make recyclable packaging.
8. Levy a global “greenwash service” tax on Corporates. Make them fully liable for products that damage the environment today or tomorrow.
9. Do not first adopt wasteful and environmentally bad habits and then become GREEN. Think of the last parson. Do not first buy processed food and then ask for organic and home made food. Do not firs eat junk food and then go on a diet. Enjoy biodiversity in food and lifestyle. Boo MCDonalds.
10. Use less of everything that you use in your daily life.Not greed of some, but need of all is the only way ahead.

This post is dedicated to world environment day 2008
Download the copy of this article in pdf here.

The Dalmiya group-operated Gujarat Heavy Chemicals Limited (ghcl) unit in Junagadh district’s Sutrapada taluka faces more serious allegations: it has refused to comply with a high court order for more than a year, after violating salt lease conditions for about 20 years.

This is the cover story on salt in Down to Earth magazine that I talked about.
Here is the link to it.

http://www.downtoearth.org.in/

Its about how Conservation has become a ruse to evict Agarias, but so far as allegations of widespread pollution and environment destruction against big companies is concerned, authorities have chosen not to be strict. Local communities face a dual threat: they are dispossessed in the name of conservation and then large companies destroy farms forcing them to migrate.

At Kingsway Camp an experiment is under way. Delhi’s Department of Social Welfare (DSW) has installed a biometric machine at its classification centre there. It records the picture, fingerprint and the height of the person brought there by the department’s raiding squads, besides his/her address, begging history and health record. The system is part of a grand plan to rid the city of beggars by the 2010 Commonwealth Games. “We have increased the pace of raids. In 2005, we caught 1,000, while the number went up by 475 in 2006. In 2007, we apprehended 2,533; target is 5,000,’ says a DSW official.

“This way we will be able to maintain a file on each beggar and monitor his/her rehabilitation in the long run,’ says Ranjan Mukherji, secretary to the Lieutenant Governor of Delhi. But will it work? dsw, the Delhi police and the Lieutenant Governor affirmed their faith in it when they cleared the scheme last month, but social activists see it as criminalization of poverty.

“By recording their fingerprints, cornea and photographs, they are treating beggars like criminals. Are they trying to prove that poverty is a crime?’ asks Indu Prakash Singh, national theme leader (shelters and housing), ActionAid India. Javed says he wants to work, so that he can send money home. “I haven’t been able to do that. But that isn’t as bad as staying inside a jail like this,’ he says. Sewa Kuteer has hundreds of other inmates, young and old, picked up from temples and gurdwaras across the city. There is 60-year-old Devi Prasad who came from Kanpur in search of his son Deepak. “I am not a beggar. It does not matter even if they take my photograph. The sad part is I will not be able to come here often to see my son, who is my only family,’ he says.

A source in DSW said they caught beggars only from temples and gurdwaras and avoided traffic junctions. “Chances are we will have to run after a beggar. That can lead to accidents,’ he said. The department also avoids drug addicts. “They have suicidal tendencies. Once a beggar swallowed a blade. If they do not get anything else, they eat up soaps. If something goes wrong, the National Human Rights Commission will get after us,’ he said. This means hardened beggars remain out of the reach of the biometric system and only those who come to the capital to work can be monitored. “No work or bad working conditions leave many with no option but to beg. And then the authorities arrest them,’ says Singh. “Even vending is an offence.’

As per the Bombay Prevention of Begging Act, 1959, the definition of beggars includes anybody who receives alms at public places, even by way of selling small articles, or has no visible means of subsistence. A 2000 study by the Centre for Media Studies on beggars says the rehabilitation measures required under the act have not been taken. One would hardly find any beggar after his release from a beggars’ home taking up an income-generating activity by undergoing vocational training provided by dsw, says the study. Delhi has 11 beggars’ homes.

Even DSW officials are not sure whether the biometric system will help control begging. “What will happen with this machine? Beggars will keep coming here and we will keep recording their data,’ says the dsw official. At Kingsway Camp, though, the test run on the biometric software is on. Outside, a raiding squad has spotted another unsuspecting boy accepting a few coins from a kind stranger.

The study noted that transferring, a protein that transports iron from the blood to the brain, may not be doing its job well. That may lead to exposure of other cells to iron, and their subsequent degeneration and the diseases. The protein binds iron on to its surface. It then curls around the iron and seals it. This prevents the iron from getting exposed to other cells till it reaches its destination organ—the brain.

In the experiment, transferring was placed on an open surface and observed over a period of time.

“We simulated conditions for ageing so that the existing molecules interacted with each other. We found the molecules self-assembled into fibres and iron that was earlier wrapped inside the protein started settling in bands along the length of the fibre,’

says Sandeep Verma of the Department of Chemistry, IIT, Kanpur. “Iron when exposed to molecular oxygen, leads to degeneration of cells,’ says Verma. The study was published in Angewandte Chemie (Vol 9999, No 2008). Although the researchers say exposure of brain cells to iron leads to the diseases, they say there is no clear reason for the exposure.

“Dehydration may be responsible for it. There are restricted membranes where water does not go easily or has been removed from the vicinity of the protein, resulting in the protein malfunction,’ says Verma.

However, their experiment is not foolproof because the biological environment is more complicated. Experiments need to be conducted in that medium. “Definitive proof will come only from clinicians who can slice out a part of the brain and test for iron deposition,’ he added.

“When the organ trade act came into effect in 1994, the focus was on banning trade in human organs and setting up of a system for cadaver donations. After the Amit Kumar expose, the media has been concentrating on illegal organ trade. But what about a control mechanism?’

asks Rana of the Indian Society of Nephrologists.

“Cadaver organ does not require a special infrastructure. But rather than encouraging such transplants, the government is promoting transplants from live donors,’ Trivedi of ztcc rues. She carried out Maharashtra’s first successful cadaver kidney transplant on March 27, 1997. She has conducted 36 such transplants since. But there aren’t many like her in the country.

A bad contrast

Rashmi Jadhav, a government employee in Mumbai, is a living testament to the advantages of cadaver transplants. She got a new lease of life after a kidney donation from a brain dead person in 2004. “We do not have the words to thank the parents of our beneficiary,’ says Jadhav, a resident of a slum-settlement in Mumbai.

Developed countries have a lot more people like Jadhav. For cadaver donations provide a large majority of the organs required for transplant. “For example, 95 per cent of kidneys used for transplant in Spain come from cadavers,’ says Katti. In the uk, one in seven organ transplants is from non-beating heart donors, individuals whose deaths result from heart and respiratory failure. In India, contrastingly, most cadaver transplants are from brain dead people. Organ retrievals are very difficult when deaths happen outside a hospital, medics say.

There are many who believe retrieval from the brain dead would go a long way in dealing with the organ shortage problem.

“Every year, about 4,000 people end up brain dead in the country. That means 8,000 potential kidneys and corneas and 4,000 heart, lungs, pancreas and livers that can be used for transplants,’

says Suniel Shroff, managing trustee of the Mohan Foundation, a Chennai-based charitable organization that promotes transplants from cadavers.

Many doctors are pinning hopes on dghs‘ National Organ Transplant Programme. It is slated to be in operation in the next three to four months. dghs sources say the programme will emphasize cadaver donations, and make live donations simpler. “We have proposed that the donor be given medical insurance for three years and the first premium be paid by the organ recipient,’ says Jauhari one of the programme’s architects.

Other doctors say that a cadaver donation programme must have the provision for a national network that allows hospitals to exchange organs so that they can be used for the best matched recipient. Creating such a registry is not much of a problem, says Sanjay Agarwal, senior consultant at the nephrology department of the All India Institute of Medical Sciences. The institute has an organ retrieval system which does precisely that. But then it is not a national network.

Many doctors are, however, sceptical of registries. For one, doctors cannot legally remove organs without the family’s consent. “Anyhow, a very small percentage of people who register as donors will die a brain death,’ says Sumana Sundaram, project coordinator at the Mohan Foundation. “The challenge is in getting brain dead road accident victims to the hospital quickly,” she says.

Draft in limbo
Katti says India needs a national organ retrieval programme to boost cadaver transplant; it should require the setting up of retrieval centres across the country. Suggestions such as Katti’s were considered by a committee set up by the Union Ministry of Health and Family Welfare (mohfw) in 2004. Its mandate was to review the organ transplant act. The committee recommended that:

• it be incumbent on hospital staff to request families of brain dead people for organ donations;
• increase in icu facilities in hospitals to keep the brain dead; and
• organ retrievals from non-beating heart donors.

A draft amendment to the organ transplant act put up on the mohfw‘s website does not give much space to these recommendations. Is the ministry dragging its feet? No, assures an official at the ministry. “A cadaver donation programme is in the making and it will take another month or so,” he says.

Trivedi remains optimistic. “If we promote a cadaver transplant programme sincerely, 75 per cent of the organ demand can be met. Only after this option is exhausted should we consider live donor transplants,” she says.

With contributions from Vibha Varshney, Sumana Narayanan and Ravleen Kaur

In another development, the Central Empowered Committee, which advises the supreme court on forest-related cases, recommended that mines, steel plant and captive port— POSCO‘s proposed projects—should be considered as one and reviewed in entirety for its ecological significance and rehabilitation plans rather than as three different projects. POSCO filed an affidavit in the apex court on January 4, contesting the recommendations and asking for separate clearances for its three “separate’ projects. The case will come up for hearing in the third week of January.

While POSCO officials haven’t agreed to the people’s demands of sharing the company’s profits yet, the Orissa government is planning to set up a high-level committee to discuss them. The villagers also want Rs 25 lakh per acre for their agricultural land and Rs 40 lakh per acre for their homestead land. Other demands include job guarantee, Rs 1,000-monthly allowance to people above 60 and Rs 3,000 per month for families who do not have members eligible for jobs, including the landless who were employed as daily wagers in the betel farms.

The demands were finalized in a meeting organized by Damodar Rout, a local MLA.

“The 52-member committee I formed has made the demand. The state government will take a final decision after the demarcation survey is done. However, it appears unlikely that the company will share its profits with people,’ Rout said.

When officials went for the survey, the villagers did not allow them to do it. They said their demands must be fulfilled first. The survey has been put off for an indefinite period.

Under duress Activists from Orissa Bachao Andolan (oba), a protesting organization, say the demands have been made by “so-called POSCO supporters’ only, mostly in the Nuagaon panchayat.

“The talk of 5 per cent share in profits is a rumour. Some people had earlier demanded Rs 14 lakh per acre for their agricultural land and a two-room house with all amenities. But POSCO officers rejected the demands saying they were exorbitant. The officers told them to come up with a charter of demands, which they have now,’ says Nikunj Bhutia of oba.

People of three panchayats—Dhinkia, Nuagaon and Gandhakujanga—have been protesting against land acquisition for the steel plant and a captive port for POSCO since July 2005. Activists also say people gave in to POSCO because of the threats and punishments they were being subjected to after the villages were cordoned in November last year (see ‘POSCO war’, Down To Earth, December 31, 2007). SP Mishra, public relations officer of the Orissa governor, says the imbroglio will be resolved soon. “A lot of time has been lost and constructions have to begin by April. So, the government may give in to the demands,’ he said.

The present proposal comes after Aiyar’s visit to Pakistan where the delegation interacted with Pakistan’s local government officials on the three-tier model followed there (see box: Governance models).

Experts say the proposal will help urban areas in better implementation of the 74th Amendment that aimed at decentralisation in urban local bodies, which are under the purview of the Union ministry of urban development at present.Decentralisation of rural local bodies under the 73rd Amendment has been effectively implemented. Thus, the proposal, if implemented, will give better participatory rights to migrant population, they say.

According to Aiyar,

“Rajiv Gandhi wanted an employment programme for urban areas along the lines of Jawahar Rozgar Yojna, which is why district planning committees were laid down as part of the 74th Amendment.”

Of late, the planning commission has been insistent on states forming district planning committees which, under the 74th Amendment, are supposed to consolidate plans prepared by panchayats and municipalities in each district before allocating funds. But many states still do not have such committees. Kerala is the only state to follow the model.

In response to Aiyar’s letter, which he gave to the prime minister’s office (pmo) in the last week of July, the pmo has asked the Union ministries of urban development and urban employment and poverty alleviation to comment. The ministries, however, don’t seem too keen. “Urban and rural bodies have different functions. An urban structure is tax-based while a rural one is grant-based. If both are merged, it will be against the interests of the rural people,” says an official of the ministry of housing and urban employment and poverty alleviation.