"We were surprised," Nitu Sodey recalls about taking her mother-in-law Chandrakala Bai to Maharaja Yeshwantrao Hospital in Indore in May 2009. "We are low-caste people and normally when we go to the hospital we are given a five-rupee voucher, but the doctor said he would give us a foreign drug costing 125,000 rupees (£1,400)." The pair had gone to the hospital, located in the biggest city in Madhya Pradesh, an impoverished province in central India, because Mrs Bai was experiencing chest pains.
Their status as Dalits - the bottom of the Hindu caste system, once known as untouchables - meant that they were both accustomed to going to the back of the queue when they arrived and waiting many hours before seeing a doctor. But this time it was different and they were seen immediately. "The doctor took the five-rupee voucher given to BLPs [Below the Poverty Line] like us and said the rest would be paid for by a special government fund for poor people," Mrs Sodey explains. "This was really expensive treatment for the likes of us."
What Mrs Sodey says she did not know was that her mother-in-law was being enrolled in a drugs trial for the drug Tonapofylline, which was being tested by Biogen Idec. Neither could read and Mrs Sodey says she does not remember signing a consent form.
Mrs Bai suffered heart abnormalities after being given the trial drug. She was taken off it and discharged after a few days. Less than a month later, she suffered a cardiac arrest and died at the age of 45. The trial, which was registered in the UK by Biogen Idec, was later halted due, say the company, to the number of seizures recorded. The company also says Mrs Bai's death was not reported to them. Her case is not an isolated incident.
In a different trial with a different company, Narayan Survaiya says neither he nor his late mother Tizuja Bai were asked if she wanted to participate, or even told that she was taking part in one, when she sought treatment for problems with her legs. And, like Mrs Sodey, he claims the family were told that a charity was footing the bill for the care. A few weeks after taking the drug, Mr Survaiya says his mother's health deteriorated and she was left unable to walk. "I told the doctor, but he said don't stop the doses. It is a temporary paralysis and the drug will make it better." His mother died a few weeks later.
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BBC News - Have India?s poor become human guinea pigs?
