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Research on Bhopal gas victims waits, not drug trials on them by Abantika Ghosh

The Indian Council of Medical Research (ICMR) has posted an advertisement inviting, by December 31, research proposals on long-term effects of methyl isocyanate (MIC) gas on Bhopal’s residents.

However, while it is yet to conduct this research 27 years after the Bhopal gas tragedy caused by MIC that left hundreds dead, data shows that the “gas patients” have been routinely used for clinical trials for new drugs at the Bhopal Memorial Hospital and Research Centre (BMHRC), the 350-bed superspeciality hospital set up on the orders of the Supreme Court to provide free services to them.

A report by the Union Health Ministry’s Central Drugs Standard Control Organisation (CDSCO), that inspected the trials, said “gas patients” comprised a bulk of those tested.

“The MIC-exposed people are not fit for clinical trials because they have known and unknown disorders not even documented in medical science,” said Dr C M Gulhati, editor of the journal, Monthly Index of Medical Specialities, questioning the validity of these tests. “Nobody knows what kind of pathological reactions or physiological changes are happening in the body. This is apart from the ethical dilemma of whether patients dependent on just one hospital for free treatment should be subjected to trials at all.”

A “gas patient,” as per medical records, is someone who has received compensation because of his/her presence in one of the 36 designated gas-affected wards of the city on the night of December 3-4, 1984, and deemed to have been affected by the gas leak three years after the incident. It neither implies nor rules out a medical condition because of MIC. Last year, the Rajya Sabha was told that eight clinical trials were conducted at the BMHRC between 2004 and 2008 for which the hospital received Rs 77.43 lakh.

In the Tigecycline trial sponsored by US-based Wyeth Pharmaceuticals, of the 34 patients with abdominal infection who participated in the study, 32 were “gas patients”. There were five deaths. These deaths, the CDSCO inspection found, were because of natural course of the disease: post-operative haemorrhage, ventricular fibrillation, pulmonary embolism. The hospital was paid Rs 29.99 lakh. Tigecycline is an advanced antibiotic used in diseases with resistance to certain antibiotics. It got US FDA approval in 2005. When the trial started in 2006, it had not yet got clearance for being sold in India. The trial, which ended in 2008, was to fulfil the necessary criteria of a study in India before it is approved.

In the Fondaparinux trial sponsored by Organon, the results were published in the Journal of American Medical Association as part of a trial involving 12,092 patients from 447 hospitals in 41 countries — of the 57 patients who participated in the trial in Bhopal, 42 were “gas patients”. There were six deaths — five of them “gas patients”. The hospital received Rs 5.73 lakh for the trial carried out between 2004 and 2006. These deaths too, according to the inspection report, were a result of the natural course of the disease, that is cardiac death, cardiogenic shock and reinfarction.

Both these drugs have since been approved for sale in India.

Doctors at the Bhopal hospital defended the high ratio of gas patients in those tested, pointing out that there are more than 5 lakh “gas patients” in a city of 23 lakh. “Around 85 per cent of our patients are gas patients. The cohort represents that ratio,” said a BMHRC doctor. All participants had been screened for any illnesses. “The past MIC exposure was not relevant,” he said.

Asked about the delay in research into MIC’s effects on the gas patients, Bela Shah, ICMR’s senior deputy director general (non-communicable diseases), said the council withdrew in 1994 and handed over the research to the state government’s Centre for Rehabilitation Studies.

Dr Arvind Pandey, director of clinical trial registry in the ICMR, said: “Examining the scientific authenticity of trial data or its protocol is the onus of the ethics committee that approved the trial.”