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.”

“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