The Bhopal Disaster and Medical Research


Vol – XLVII No. 49, December 08, 2012 |  EPW-C Sathyamala and N D Jayaprakash

The Supreme Court, in its fi nal order of October 1991, upheld the compensation settlement with Union Carbide which made the Government of India liable for any shortfall in compensation or any new claims from the Bhopal gas victims. Following this order the Indian Council of Medical Research disbanded its medical esearch on the long-term medical effects of the disaster. A recent Supreme Court order directs the ICMR to resume that research, but the question that looms is why the ICMR abdicated its ethical mandate and allowed its subordination to a political diktat. Why did the ICMR as aninstitution allow itself to become an apologist of the Indian state?

C Sathyamala (csathyamala@gmail.com) is an epidemiologist and a member of the Advisory Committee on Bhopal set up by the Supreme Court of India on 17 August 2004. N D Jayaprakash (jaypdsf@gmail.com) is convenor, Bhopal Gas Peedit Sangharsh Sahyog Samiti, a Delhi-based coalition of over 30 all-India organisations founded in 1989 to support the gas victims.

The Supreme Court, in its final order of October 1991, upheld the compensation settlement with Union Carbide which made the Government of India liable for any shortfall in compensation or any new claims from the Bhopal gas victims. Following this order the Indian Council of Medical Research disbanded its medical research on the long-term medical effects of the disaster. A recent Supreme Court order directs the ICMR to resume that research, but the question that looms is why the ICMR abdicated its ethical mandate and allowed its subordination to a political diktat. Why did the ICMR as an institution allow itself to become an apologist of the Indian state?

C Sathyamala (csathyamala@gmail.com) is an epidemiologist and a member of the Advisory Committee on Bhopal set up by the Supreme Court of India on 17 August 2004. N D Jayaprakash (jaypdsf@gmail.com) is convenor, Bhopal Gas Peedit Sangharsh Sahyog Samiti, a Delhi-based coalition of over 30 all-India organisations founded in 1989 to support the gas victims.

The 9th of August 2012 witnessed the culmination of a protracted litigation in the Supreme Court of India (SCI) by the survivor groups and their support organisations in the Bhopal gas leak disaster case for appropriate medical relief and rehabilitation. The ­order passed on the writ petition No 50 of 1998 (Bhopal Gas Peedith Mahila Udyog Sanghatan (BGPMUS) & Ors1 vs Union of India & Ors2), directed the Government of India (GoI), the Government of Madhya Pradesh and the Indian Council of Medical Research (ICMR), to ensure the continuation of medical research, prepare standardised protocols for diagnosis and treatment of the exposed, as well as provide patient-retained health booklets for recording their medical history and treatment.3 Though the order can be considered radical given the context, as rightly pointed out in the EPW editorial (2012), it is indeed disturbing that it requires a Supreme Court order to direct ICMR to continue research on what is patently their role as a medical scientific body. Why did the ICMR abdicate its ethical mandate and allow its subordination to a political dictate is the story that needs to be told.

The industrial disaster in Bhopal on the night of 2/3 December 1984 exposed more than two-thirds of the nearly 9,00,000 population to a mixture of toxic gases4 that escaped from the pesticide factory owned by Union Carbide India Limited (UCIL), a subsidiary of ­Union Carbide Corporation (UCC), a US multinational company currently owned by another US multinational, Dow Chemicals. As was to be expected, the UCC ­denied any wrongdoing on their side but would not part with the toxicological ­information on methyl isocyanate (MIC), the chemical which had been stored in liquid form in the factory premises and whose runaway exothermic reaction was responsible for the ­disaster. In the absence of this critical toxicological ­information, the scientific bodies had to generate their own data for understanding the nature of the chemical injury and develop possible antidote and therapies.

Suppression of the Health Impact

In the period immediately following the disaster, both the central and state governments appeared to be serious about mapping its health impact. The first systematic survey on the exposed population was carried out by the Tata Institute of Social Sciences (TISS), which had been approached by the Commissioner of Relief and Rehabilitation for the gas victims (Singh 2010). Funded by Sir ­Dorabji Tata Trust (since the Madhya Pradesh (MP) government had refused to finance it), the house-to-house survey was conducted from 1 January 1985 to the second week of February 1985, by “… [a] total of 478 students, 41 faculty members and 13 staff members cover[ing] 25,259 households” (Singh 2010).

Alongside, the ICMR began the process of providing the gas-exposed families with a unique identifying number as a first step towards developing a sampling frame for long-term epidemiological studies. Based on post-mortem studies on the dead which indicated a “cyanide-like” poisoning,5 ICMR conducted a ­double-blind clinical study to assess the efficacy of Sodium Thiosulphate (NaTS), as an antidote to the poisoning and ­concluded,

…the rationale for the use of sodium thiosulphate as an antidote has been established to ameliorate the lingering sickness of gas affected victims of Bhopal (ICMR 1985).

Yet, the ICMR did not follow through with this recommendation both because of opposition from the powerful medical lobby in Bhopal which was heavily influenced by Union Carbide and because of the Indian government’s wavering stand. The MP government on its part decided to suppress the data collected by TISS which had been handed over to it in good faith.

In early 1985, the Indian Parliament passed the Bhopal Gas Leak Disaster (Processing of Claims) Act (deemed to have come into effect from 20 February 1985), purported to prevent the exploitation of the victims by the ambulance-chasing American lawyers. However, with this Act, the Indian state assumed the role of parens patriae vis-à-vis the victims thereby appropriating their rights under its umbrella of care. The Bhopal Act gave the Indian government,

exclusive right to, represent, and act in place of (whether within or outside India) every person who has made, or is entitled to make, a claim for all purposes connected with such claims in the same manner and to the same effect as such person(GoI 1994, emphasis added).

Under this Act the victims had no rights to represent themselves and, though it was challenged in the SCI as early as 1986,6 it was upheld as being constitutionally valid.7 The logical consequence of this legal appropriation of a citizen’s right to litigate meant that the state had the right to medical appropriation as well (Jaising and Sathyamala 1992). Hence, it became the government’s ­exclusive right to determine whether they would study the health effects of the toxic gases, which aspects they would research on, whether they would share the findings with the claimants and whether they would submit the research findings in their litigation against UCC.

With the passing of the Act the changing stance of the Indian government could be discerned, and the victim groups were forced to approach the courts for medical relief. The petition filed on behalf of the victims in August 1985 brought to the notice of the SCI the refusal of the medical community in Bhopal to administer NaTS as well as the lack of adequate healthcare facilities for the gas exposed.8

The Supreme Court then set up a committee of seven experts with three representatives from the ICMR, two from GoI and two representatives of the gas victims. The committee was to examine the detoxification of the gas victims by NaTS therapy; suggest appropriate design for an epidemiological ­survey for the purpose of documentation, and for determining compensation payable to the victims; and to recommend guidelines for the provision of medical relief, and monitoring of the ­exposed population. The SCI, convinced of the need for long-term medical monitoring, stated in their order of 4 Nov­ember 1985:

It is desirable that some independent machinery must be set up which would…carry out a proper epidemiological survey and also a house-to-house survey of the gas affected victims both of which will also be necessary for the purpose of determining the compensation payable to the gas affected victims and their families. It would be necessary for the purpose of ensuring proper medical ­facilities to the gas affected victims.

Inadequate Epidemiological Study

However, the members of the committee, representing divergent interests, could not come to a consensus. In 1987-88, the two representatives of the gas victims in the committee9 submitted a separate minority report entitled “Final Report on Medical Relief and Rehabilitation of Bhopal Gas Victims”. This pointed out the inadequacies in the studies initiated by the ICMR, specifically the long-term epidemiological study, and outlined a set of well-considered recommendations on how they could be improved upon. Though this was submitted to the Court on 30 August 1988, it was not ­taken cognisance of.10

Seemingly in response to this petition, the GoI on its own set up the “Scientific Commission for Continuing Studies on Effects of Bhopal Gas Leakage on Life Systems” headed by C R Krishna Murti (former director, Indian Institute of Toxico­logy Research). The commission’s report submitted to the GoI in July 1987 (publicly accessible only a decade later) was also not submitted to the courts. The 1,000+page report, entitled “The Bhopal Gas Disaster: Effects on Life Systems” commented on the ICMR studies that

..[t]he progress of the epidemiological programme mounted in Bhopal has been tardy and suffers from many inadequacies in the design and in the infrastructure for implementation (Krishna Murti 1987: 11-12).

The report highlighted certain important areas for research:

What is the prognosis of the continuing suffering of the thousands of gas exposees [sic] including a large number of children?
How many of the gas exposees [sic] are likely to be condemned to life-long disability?
Will there be an imprint of the disaster on the progeny of the gas-victims? (Krishna Murti 1987: 3).

It recommended that

… the Ministry of Health with the assistance of ICMR and other agencies creates the requisite mechanism for high level coordination and monitoring of the long-term health studies of the Bhopal Gas Victims (Krishna Murti 1987: 26).

State Complicity

On 14/15 February 1989, empowered by the Bhopal Act, when the GoI settled all claims of the present and the future arising out of the disaster, it was clear that it was not based on any scientific understanding of the nature of injuries or the numbers of injured as none of the data collected by the several scientific bodies was placed before the Court. Due to countrywide protests that followed the unjust arbitrary settlement, the SCI, forced to come out with some justification, in their 4 May 1989 clarificatory order, used arbitrary numbers to provide a mathematical rationale for the amount of money settled for. It was during the hearing of the review petitions challenging the settlement that the victim groups became aware for the first time of the real numbers involved. The numbers provided by the MP government showed that, as of 31 January 1989, i e, 15 days prior to the settlement of the approximately 6,00,000 claimants, only 29,320 persons had been categorised for injury, and of these less than 100 persons had been found to be permanently disabled (partial or full).11

It was left to the victim groups to demonstrate that the process of Personal ­Injury Evaluation (PIE), adopted by the Directorate of Claims for categorisation of injuries, was designed to underestimate the nature of injuries and that by

…inadequately examining the claimants (clinically and through investigations) and by evaluating the injuries and categorizing them with the use of faulty tools biased against the gas victims, the Directorate of Claims, Bhopal, ha[d] ‘defined’ away the injuries of more than 90% of the victims as ‘no injury’ or ‘temporary injury’ (Sathyamala et al 1989).12

With the settlement of 13/14 February 1989, and the SCI’s clarificatory order of 4 May 1989, the complicity of the Indian state became apparent and it was from this period onwards that the victim groups realised that they could no longer depend on the GoI and would need to enter into litigation on their own to ­represent their interests from their point of view.

Through an order from the SCI, the victims were allowed access to their PIE assessment and the newly elected government (the National Front government) made available the ICMR studies on the gas exposed which had till then been held under the Official Secrets Act. The ICMR studies showed the effects of exposure to be multi-systemic, irreversible and progressive; the exposure had affected the immune system, previously asymptomatic persons were becoming symptomatic and there was a grave possibility of carcinogenic and mutagenic changes in the exposed population.

Unfortunately, the victim groups were not able to put up an effective challenge against the civil settlement particularly against the faulty medical categorisation based on the faulty personal injury evaluation process. The National Front government too failed to raise this issue before the Court. However, it was when the counsel for UCC argued on the basis of the numbers provided by the MP government13 and showed, mathematically, using the same rationale provided in the SCI’s clarificatory order of 4 May 1989, that UCC had in fact paid up more than what was warranted,14 that the central importance played by the injury assessment in compensation became clear.

Why Stop Research?

After 3 October 1991, when the final ­order on the review petitions, upholding the civil part (compensation) of the settlement, was pronounced by the SCI, the GoI decided to disband its medical studies. This was in contravention to the court ruling that,

…for at least a period of eight years from now the population of Bhopal exposed to the hazards of MIC toxicity should have provision for medical surveillance by periodic medical check-up for gas related afflictions.15

There was a compelling reason for the GoI’s decision to disband the medical studies. The settlement had quashed all future litigations against UCC and in the event of shortfall in the compensation payable to the victims and in case of newer claims (new manifestation of injuries both in the directly exposed and in their progeny, i e, new generation of claimants), it was the GoI that was liable. It was now not in the interest of the GoI to document the long-term medical effects of the disaster as they were now legally liable to compensate the new claims, if any, and therefore in the same year all ICMR studies were brought to an end. This was also the reason why the victims, even after repeated demands and many legal directions, were never provided with health booklets to record their medical history; for doing so would turn such booklets into a legal document on the basis of which they could claim compensation for long-term effects.

Since the GoI showed no signs of ­re-initiating medical research, the victim groups and their supporters approached the SCI in 1998 for legal remedy. Though the SCI gave several orders16 directing the ICMR to restart the medical research and the health directorate of MP to issue health booklets to record patient history of the gas exposed, they have been largely ignored.

As though to justify the unjustifiable, in a recent report, ICMR is stated to have withdrawn from conducting medical ­research because,

[i]n 1994, after review/recommendations of the projects by the Project Advisory Committee (PAC) and Scientific Advisory Committee (SAC), it was observed that the projects had achieved the objectives and were thus completed… (ICMR 2012).

With this statement, the ICMR has cut at its root of scientific integrity, because all evidence points to the contrary. In fact, ICMR’s recent publication based on data from 1985-94, the period after which the studies were discontinued, confirms that in Bhopal,

…cancer of all sites in both males and females showed a significant increasing trend in incidence rates over the years in Area 1 … while in Area 2 no linear trend was observed (ICMR undated: 174).17

While there have been and there continue to be individual scientists within the ICMR who have done work that has been in keeping with their scientific-­ethical mandate, ICMR as an institution has allowed itself to become an apo­logist of the Indian state. The Bhopal ­expe­rience does not infuse confidence among people who live near potential disaster sites about the seriousness and commitment on the part of the government, both central and state, to protect its citizens. With such a track record, the people who are currently protesting the nuclear power plant in Koodankulam are right to distrust the state which has demonstrated that its interests lie elsewhere

 

#India-Ganga is now a deadly source of cancer,#study


Anirban Ghosh | Oct 17, 2012, 12.52AM IST

 
KOLKATA: The holy Ganga is a poison river today. It’s so full of killer pollutants that those living along its banks in Uttar PradeshBiharand Bengal are more prone to cancer than anywhere else in the country, says a recent study.

Conducted by the National Cancer Registry Programme (NCRP) under the Indian Council of Medical Research, the national study throws up shocking findings. The river is thick with heavy metals and lethal chemicals that causecancer, it says.

“We know that the incidence of cancer was highest in the country in areas drained by the Ganga. We also know why. Now, we are going deeper into the problem. Hopefully, we’ll be able to present a report to the Union health ministry in a month or two,” NCRP head A Nandkumar said.

The worst-hit stretches are east Uttar Pradesh, the flood plains of Bengal and Bihar. Cancer of the gallbladder, kidneys, food pipe, prostate, liver, kidneys, urinary bladder and skin are common in these parts. These cases are far more common and frequently found here than elsewhere in the country, the study says.

Even more frightening is the finding that gallbladder cancer cases along the river course are the second highest in the world and prostate cancer highest in the country. The survey throws up more scary findings: Of every 10,000 people surveyed, 450 men and 1,000 women were gallbladder cancer patients. Varanasi in Uttar Pradesh, Bihar’s Vaishali and rural Patna and the extensive tract between Murshidabad and South 24-Parganas in West Bengal are the hot zones. In these parts, of every 1 lakh people surveyed, 20-25 were cancer patients. This is a national high. Relentless discharge of pollutants into the riverbed is responsible.

“This is the consequence of years of abuse. Over years, industries along the river have been releasing harmful effluents into the river. The process of disposing of waste has been arbitrary and unscientific. The river and those living along its banks are paying a price for this indiscretion,” Chittaranjan National Cancer Institute director Jaideep Biswas said. The Kolkata-based cancer institute is an associate of the National Cancer Registry Programme.

Biswas, a senior oncologist, said Ganga water is now laced with toxic industrial discharge such as arsenic, choride, fluoride and other heavy metals. Dipankar Chakarabarty, director, Jadavpur University School of Environmental Studies, concurs. “We’ve been extremely careless. Indiscriminate release of industrial effluents is to blame for this.”

“The arsenic that’s gets into the river doesn’t flow down. Iron and oxygen present in the water form ferroso ferric oxide, which in turn bonds with arsenic. This noxious mix settles on the riverbed. Lead and cadmium are equally heavy and naturally sink in the river. This killer then leeches back into the groundwater, making it poisonous,” Chakrabarty explains.

Surface water, Chakrabarty explains, is treated before use. But that’s clearly not the case with groundwater and it’s mostly consumed raw, often straight from source. The impact is devastating. “The consequences of using or drinking this poison can manifest earliest in two years and latest in 20. But by then, it’s way too late.” Those who’ve been bathing in this poison river are equally at danger, says Biswas. The need of the hour is to strictly implement laws regulating discharge of industrial waste into the river.

 

When battered people took on the pesticide industry #Endolsulphan


Author(s): Sunita Narain, Down to Earth
Date: Aug 15, 2012

English: Sunita Narain director, Centre for Sc...

English: Sunita Narain director, Centre for Science and Environment (Photo credit: Wikipedia)

Today, I want to tell you a true story of extraordinary courage. The past week, I was in Kasaragod, a district in Kerala, splendid in beauty and with abundant natural resources, but destroyed by the toxic chemical, endosulfan. The pesticide was aerially sprayed over cashew plantations, for some 20 years, in complete disregard of the fact that there is no demarcation between plantations and human habitation in this area. It is also a high rainfall region and so, the sprayed pesticide leached into the ground and flowed downstream. The poison contaminated water, food and ultimately harmed human beings.

This story is known. But the personal battles that make up the story of this poisoned land and its diseased people are not known. More importantly, it is not asked where this story ends?

Leelakumari Amma is the original heroine of this plot. In early 1990s, she came to Kasaragod, ironically, as an agriculture scientist, whose job was to push farmers to use pesticides. Her brother died mysteriously while she was building her house. But she did not connect the dots and moved in, only to realise that the pesticide spray was poisoning her land and water. Fish she put in her well died. She could not open the windows of her house for days when the helicopter sprayed poison. It seemed a thick cloud was hanging over her house. She could not breathe and worried about her children. Then she noticed that many people living close to her seemed diseased— children were born with deformities and severe neurological problems afflicted people.

Leelakumari Amma petitioned for help. But received threats from the Plantation Corporation of Kerala (PCK)—the public sector company, which owned the cashew lands. In 1998, she filed a case in the local court. The threats became more venomous. But she did not give up. In 2000, the court ordered an interim ban on spraying. Some months later, the vehicle she was travelling in was hit by a truck. Leelakumari Amma lost a leg. She told me that this was an accident. Maybe, but then maybe not.

About this time, Mohana Kumar, a doctor practicing in a neighbouring village, wrote to the medical fraternity about the incidences of abnormality and deformities, but got nowhere. Shree Padre, a freelance journalist of the area, also decided to write explaining the plight of people. His email reached Anil Agarwal, director of the Centre for Science and Environment (CSE), who decided in mid-2000, to send a team to investigate and collect water, soil and blood samples. The results showed high levels of endosulfan—proving what was only suspected till then. The question, still, was what this meant for human health?

The pesticide industry hit back. It first hired a laboratory to ‘clean up’ the results. When this failed, it decided to hurt the storytellers. Mohana Kumar was served legal notices—so many he cannot even count. But hope was not dead. In 2001, the National Human Rights Commission intervened and asked the Indian Council of Medical Research for a detailed report. Scientists from the Ahmedabad-based National Institute of Occupational Health (NIOH) analysed blood samples for pesticides and concluded there was significantly higher incidence of abnormalities and diseases in populations exposed to endosulfan as compared to the control population. Endosulfan’s effect on humans was established.

This study was even more inconvenient to industry. The investigators were attacked and vilified. A case was filed against the key scientist, Aruna Dewan, the day she retired from government service. The Centre set up committee after committee, headed by ‘eminent’ scientists to debunk the CSE and NIOH reports. This was fought back, at considerable personal cost. Thanal, a Kerala-based NGO, plays a critical role in research and campaign against pesticide industry smear and smut. This battle has not been easy. Over the past 10 years, industry has made it a habit to attack all research and threaten all scientists.

As a result, it has taken over 15 years for the truth to be known. Currently, the Kerala government’s ban on endosulfan prevails. Last year, the Supreme Court banned manufacture and use of the pesticide in the country. The state has accepted the need to provide compensation to ‘endosulfan victims’. A part of the compensation money will be paid by the PCK. Liability has been established.

Much more remains to be done—from rehabilitating the living to providing specialised health care to the very ill. Also cleansing traces of endosulfan in Kasaragod’s soil, and taking the district towards organic farming. The stigma of pesticide contamination has to be wiped clean.

This will happen. I am sure. In the Buds school—seven special schools for endosulfan victims opened by the district administration—I saw signs of hope. Some 27 children from Padre and Perle village are enrolled there. I saw their teacher hold their hands, teach them how to smile, as they counted and drew flowers. Their laughter filled the room. The physiotherapist told me he was working hard to make sure these special needs children could walk. A few steps today, maybe more tomorrow.

Pesticides And ToxinsEditor’s PageAnil AgarwalCashew NutCompensationCourt,CSEEndosulfanGenetic DisordersHealth EffectsKasaragod (D)keralaLand pollutionPadre VillagePesticide IndustryPesticide ResiduesPesticide UsePesticides And ToxinsSunita NarainWater Pollution

A quarter of India’s mentally ill homeless


 

Jul 31, 2012

 

New Delhi: In the dimly-lit lobby of a shelter for the mentally-ill homeless, she sits reading the tattered printout of an e-mail from her US-based brother. The 55-year-old scans every word – her brother has sternly refused to accept her following her recovery from mental illness.

It’s a body blow but she refuses to give up. After a long and hard battle against mental illness at Sudinalaya, a shelter for such homeless women in north Delhi, the doughty woman has drawn on her inner resilience to carry on living. She misses her family, fights the rejection, but is trying to come to terms with the fact that the shelter home is perhaps her refuge – for the foreseeable future.

Agencies

“My family has refused to accept me even after recovery. I have nowhere to go, so now I have to accept this shelter home as my home,” the former schoolteacher, who is not being identified for fear of further taint, said.

“These women here are my family. I cook here and talk to friends,” the economics graduate from Nagpur, who was found on the streets last August and was treated at the the Delhi government’s Institute of Human Behaviour and Allied Sciences (IHBAS), said in a determined voice.

Tragically, she’s not the only one.

According to the Indian Council of Medical Research (ICMR), there are over 70 million people with some form of mental illness in the country and about a quarter of them are homeless. Experts say familial apathy and an attitudinal shift in society are pushing millions of recovered mentally-ill people into homelessness.

“A shelter home cannot replace the emotional support provided by a family,” said Sudinalaya director Sreerupa Mitra.

“I will file a petition in the high court asking whether and how much penalty can be imposed on families who abandon people in our society, put them in utmost misery and render them homeless,” Mitra told IANS.

According to Nimesh Desai, director of IHBAS, a major concern is rehabilitating those who have recovered.

“Generally, the outlook towards people with mental illness has improved. But homelessness of millions of mentally-ill is a major concern because of the changing face of society,” Desai said.

“There have been cases where the family members corner property worth crores and throw the individual into a mental asylum,” he added.

“It is frustrating to see such active deprivation of economic and social rights even in well-to-do families. Are the families falling short of physical space in their apartments or do they lack emotional space?” Desai wondered.

Interestingly, families declining to accept a loved one with a history of mental illness have been more evident in “urban and economically well-off families”, said experts.

While “legal persuasion” could be applied on families to support a patient, more often than not, patients are left with no option but to struggle in custodial asylum or languish on streets – both of which are worse after recovery.

Back at Sudinalaya, lunch is over and the utensils have been washed and put away. The now recovered woman, hoping to get back to a teaching job, heads for the carom board for a game she excelled at when in college.

“If no one comes for me, I will stay here and teach the other women this game,” she says.

IANS

 

Brahmin sperm in high demand among childless couples # WTFnews


Mansi Choksi & Sharmila Ganesan Ram, TNN | May 13, 2012

MUMBAI: Dr Aniruddh Malpani, an infertility expert in Mumbai, often invokes playwright George Bernard Shaw‘s conversation with French actress Sarah Bernhardt when inundated with elitist requests from couples seeking sperm donors. “Just think Monsieur… a child with my looks and your brains!” Bernhardt is said to have told Shaw. To which he had famously quipped, “But Madam, what if he is born with my looks and your brains?”

In India, it’s well known that couples shopping for sperm demand both looks and brains. What isn’t so well known, despite being fairly commonplace, is a more outrageous request: caste-based sperm. Three years ago, Dr Saurav Kumar, a Patna gynaecologist, created a furore when he told a newspaper that childless couples insisted on knowing the caste of sperm donors. But while one may be tempted to assume that caste biases are entrenched only in states likeBihar, the city’s infertility experts insist otherwise.

Dilip Patil, founding president of Trivector, an infertility solutions firm, says there is a definite preference for Brahim donors in Mumbai.Even among Muslims, couples want to know whether the donor is Sunni or Shiite,” he says. “However, going by Indian Council of Medical Research guidelines, we reveal only the religion of the donor, not the caste.”

Patil, who dismisses requests about caste as “byproducts of the Indian mindset”, happily obliged varying queries about educational and professional backgrounds, extra-curricular preferences and linguistic skills until a woman perched on stilettos tick-tocked into his clinic with a bizarre request a few months ago. “A Page 3 personality walked in with a strange chart in her hand. There was a list of Bollwyood actors such as John Abraham and Emraan Hashmi and each of them was graded as A+, A, B+ and so on. She asked my staff if there were donors in these graded categories and insisted that she was ready to pay anything. We told her that we could not accept such demands; this was not a clinic for designer babies,” says Patil, who was on the medical research team for the recent film on sperm donation called Vicky Donor.

Perhaps the designer baby syndrome is inspired in elite sperm shoppers by what happens abroad, where, says Dr Malpani, couples have the option of going through a whole “shopping catalogue” with details of various sperm donors. In India, however, the donor remains anonymous. All that couples are told is that it is “a young, healthy and fertile physical match”. Yet, they persist. “They want to match the primary characteristics such as height, skin and colour with their husband. Mostly, they want someone who is taller and a shade fairer than their husband,” says Malpani, who points out that this may be a “very consumeristic” approach.

While most couples are concerned about medical history of the donor (Patil’s clinic produces the medical history of three generations of the donor’s family), skin colour is another priority. “Certain communities prefer a fair-skinned donor,” says Dr Pai, adding that couples want them to find the closest skin, hair and eye colour match. During his fellowship in a semen bank in Australia around ten years ago, he had observed that they would bear the race of the donor in mind as the physical characteristics could differ depending on this. Similarly, in India, where the physical features of people from the North-East may differ from other regions, “we have to isolate donors based on these considerations”, he says.

While in a majority of cases, it is the gynaecologists who contact sperm banks and request for semen samples based on the client’s height, skin and hair colour preferences, some high-flying couples, especially NRIs, visit the sperm bank personally in their desperation. Infertility specialist Dr Arun Patil, partner at Medilabs, a leading sperm bank, says that around ten per cent of his clients, who come from a higher socio-economic strata, are curious about the donor’s background. Among these are people who ask for “the name of the college the donor went to” and tend to favour prestigious institutions such as IIT and IIM. Then there are also those who leave their photograph at the sperm bank so that the doctor can find the closest match.

In 2008, when Dilip Patil tried to popularise the concept of sperm donation in India through an awareness booth at IIT’s annual Mood Indigo festival, it was, he says, “an anti-climax”. “The students were so shy that they changed their lanes while passing by the stall,” he says. Patil, whose real-life anecdotes about convincing people to donate sperm made it to Vicky Donor, says that he used references about sperm donation in ancient mythology, props and money (Rs 500 per sample) to convert donors.

The success of the film, says Patil, has vindicated Mumbai’s community of sperm donors. One indication is in the increasing number of walk-in donations. “We had a 43-year-old father who was keen to donate his sperm. We told him he was too old to be a donor,” says Patil, “so he sent his son the next day.”

Drug trials : Madhya Pradesh chief secretary fails to report to NHRC


 Feb1, 2012, Asish Gaur TOI

INDORE : The National Human Rights Commission (NHRC)’s order to the Madhya Pradesh chief secretary to report to it the details of the controversial human drug trials in Indore, has run into a procedural wall.

Taking suo motu cognisance of a TOI report on drug trials conducted on 233 patients of the government-run mental hospital attached to the Mahatma Gandhi Medical College in Indore, the NHRC had asked the chief secretary to furnish the details by last Tuesday. But the latter has not obliged, maintaining that the laws allow the concerned doctors to keep all details of the trials confidential.

Forty two of these patients were given Dapoxetine, a drug to cure premature ejaculation. However, an earlier report of the Drug Controller General of India (DCGI) had said they were not mentally ill, but were seeking psychiatric help for premature ejaculation.

Among other points. the NHRC had also specifically asked the MP chief secretary to report if the doctors had followed Indian Council of Medical Research (ICMR) guidelines, while conducting the trials on the basis of approval obtained from independent ethics committees attached to private hospitals _ bypassing the medical college’s own institutional ethics committee.

The chief secretary, Avni Vaishya, told TOI that he was not in a position to submit the report.”The doctors have kept the trial documents under wraps. The details are confidential according to the laws for the conduct of clinical trials. Only central regulatory bodies such as the DCGI or MCI can investigate the matter,” he said.

The NHRC, however, has decided to press the issue. NHRC spokesperson Jaimini Kumar Srivastava said the commission will write to the chief secretary again. “We have not received any communication from the chief secretary as of now. The time allowed to submit report has lapsed. We are going to write again asking to submit the report at the earliest.”

2-FEB-2012

NEW DELHI : Union health minister Ghulam Nabi Azad on Wednesday asked an explanation from the Madhya Pradesh government on the malpractices surrounding the recent clinical trials conducted in Indore.

“Irregularities were found in the clinical trials conducted there and the state government needs to explain what action has been taken against the doctors involved,” he said.

The drug controller general of India (DCGI) had recently issued a stern show cause notice to five doctors of Indore’s Mahatma Gandhi Medical College for not following good clinical trials (GCT) norms, while conducting clinical trials on 241 patients visiting the College’s psychiatry ward.

Notices had also been sent to three companies – Cadilla, Mcure and Intas – to explain the deficiencies at the earliest.

The DCGI has threatened blacklisting of the doctors from all other trials they are involved in if they fail to reply at the earliest. Two hundred and forty one patients in Indore were subjected to clinical trials to check the efficacy of various drugs, including 42 for Dapoxetine, a drug used to cure premature ejaculation.

An independent team of investigators sent by the DCGI submitted its report to the health ministry recently.

The report has cleared the investigators of carrying out the trial on “mentally ill” patients. The investigating team however took serious cognizance to the fact that investigators did not posses with them the original informed consent forms.

The forms were taken away by the sponsors of the trial, “which is a serious offence”.

A ministry official said, “Most of the patients were suffering from erectile dysfunctions and were being treated by psychiatrists from that medical college. That is why they were visiting the psychiatric ward and not because they were suffering from any mental illness.”

“However, show cause notices have been served on the doctors for the serious administrative lapses and deviation from GCT guidelines while carrying out the trial,” the official added.

Indore psychiatrists admit to conducting drug trials on mentally ill patients



INDORE : Days after several government doctors of Indore were penalised for illegally conducting drug trials on mentally ill patients, some doctors admitted on camera to the ongoing unethical practices in the profession.

Headlines Today conducted a sting operation to exposes how doctors have been actively violating drug trial laws, converting patients into guinea pigs and then abandoning them to die.

The Madhya Pradesh government washed off its hands by imposing a meagre fine of Rs.5,000 each on five doctors for conducting trials on mentally ill patients between 2008 and 2010. It has now passed on the buck to the Centre to take further action.

Headlines Today recorded on hidden cameras how doctors, motivated by blind ambition and greed for money, conducted trials on patients and found out how patients were duped into volunteering for trials and later abandoned to suffer.

Hemant Jain, one of the leading psychiatrists in Indore, shares the credit for inventing the bivalent polio vaccine. However, according to an Economic Offences Wing (EOW) report submitted to the chief secretary of the state, 18 deaths were recorded during the trials conducted by Dr Jain.

Headlines Today asked Dr Jain on hidden cameras what was the scope of making a profit per case by conducting drug trials.

Headlines Today: Doctor, this whole thing about money… Can you give me a rough break up?
Dr Hemant Jain: I will tell you. It is about 18-20 per cent margin.

Amongst several others, Dr Jain conducted a trial on Ajay Naik’s newborn son, Yatharth in 2010 for a polio vaccine. Ajay was informed by Dr Jain’s assistants that the government has started a scheme under which it was vaccinating the newborn babies for free.

“We were not told about the trial at all. Had I known, do you think I would have gone,” asked Naik.

Naik’s son was just two-day-old when Dr Jain tried for a vaccine meant for one-month-olds. The newborn developed white spots all over his body. When Dr Jain was contacted, he refused to acknowledge the side effects. Naik still did not know that it was a drug trial until he started getting his son treated by a skin specialist.

Naik said that when his case was taken up by the media, Dr Jain threatened him and even tried to bribe him.

“After there was uproar in the media, Hemant Jain called me to his clinic and said that writing to the National Human Rights Commission will not help my case. He offered me a help of Rs.40,000 and a job and asked me to keep shut,” Naik said.

He, however, rejected the offer and since then has been paying for it. Now no doctor agrees to vaccinate his one-and-a-half-year-old son for basic ailments. “They ask me to get a written permission from Dr Jain first,” Naik said.

Trials for career progression
While money has been a driving force behind these trials, there was another major factor. Pali Rastogi, one of the psychiatrists who conducted clinical trials on 20 patients, revealed on spy camera that apart from the money that was paid to him per patient for the trial, why the trials were so important for the doctors.

Headlines Today: Apart from the money aspect, how else do the trials benefit you?
Dr Pali Rastogi: Our promotions depend on the number of international researches we have conducted. That is why they are very important.

Death of trial victim
In the frenzy to conduct such trials, patients are often duped into volunteering for the trial. Krishna Kumar Gehlot, 80, died within a week of Headlines Today’s interaction with him. Known as an extremely skilled tailor at one point of time, he was confined to his bed for the last seven years before finally succumbing to death.

In 2007, Dr Apoorva Puranik and his team of assistants told Gehlot that he should volunteer for an asthma trial and it would treat him fully because it was as American medicine.

Gehlot, enticed by the foreign remedy for his lung infection, volunteered. For months on end, he was supposed to use several TFT pumps and record the data. When the trial ended, he could hardly walk on his feet.

“When I told the doctors, they said they cannot do anything. I should go die in my bed and not bother them,” Gehlot, who struggled to survive and with no money to pay for the medical expenses died, had said before his death.

Violation of guidelines
According to the Indian Council of Medical Research (ICMR) rules, all patients should have a copy of the insurance under which they are covered for the trial. Moreover, they should be fully informed about the side effects of the trial.

Niranjan Lal Pathak, 70, suffered a massive heart attack in 2008. He was taken to the MYM Hospital for treatment.

“We were told that his case has been selected for a special government project for free treatment. So we agreed,” said Niranjan’s nephew Alok Pathak.

Headlines Today found that the one-page consent form suggested that it was for a “study” and not for a trial. Headlines Today has a copy of the original 16-page form in English that should be signed by the patients instead. The original form has details about the side effects, risks and the insurance terms. In none of the cases above, the patients were made to sign the original form. Pathak was actually made a part of a trial for cardiac problems. As a side effect, Pathak was later diagnosed with dementia.

“They have turned a hail hearty man into a dependant. Sometimes, he loses the way to his own house, refuses to recognise his family members,” Alok alleged.

Dr Apporva Puranik refused to help him or acknowledge the side effect.

Headlines Today also got exclusive copy of the insurance papers that say that “mentally ill patients are only insured for a physical injury during the trial”. As a result, volunteers are not eligible for any compensation if they suffer from any mental illness as a side effect. When Headlines Today tried to contact the doctors, they refused to comment.

’81 deaths in 3 years’
The EOW report also mentions 81 deaths between 2008 and 2010 due to drug trials in Indore. No post-mortem examinations were conducted on the dead. As a result, doctors are getting away by calling them natural deaths, like Dr Hemant Jain did when Headlines Today questioned him on spy camera.

Headlines Today: Tell us something about the deaths during your trial.
Dr Hemant Jain: There were no deaths.

Headlines Today: But the Vidhan Sabha papers show that there were 18 deaths.
Dr Hemant Jain: They were natural deaths.

Another loophole that is exploited across the country is the Schedule Y of the Drugs and Cosmetics Act. It can be used to form an independent ethics committee with a minimum of seven members who can approve a drug trial in any part of the country. Once the trial is approved the doctors conduct them by duping the patients and make money. An ethics committee is also supposed to monitor the progress of the trial, which never happens. Dr Hemant Jain himself admitted on the spy camera that they were ineffective.

Headlines Today: How much can an ethics committee monitor a trial?
Dr Hemant Jain: They cannot do much. It is difficult for them.

Retired judge Justice P Mulye, a member of the institutional ethics committee, said, “We are open to suggestions. We understand there are loopholes and we are contemplating action.”

Despite many people dying between due to drug trials hardly any action has been taken so far and patients continue to be used as guinea pigs in the name of advancement of medical science.

By- Neha Dixt