Research on Bhopal gas victims waits, not drug trials on them

National

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.

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