Some of India’s poorest people may have been used as guinea pigs by drug companies to test new drugs without their prior consent, a BBC Newsnight investigation has revealed.
The Newsnight investigation heard from families in India who spoke of being given ‘special’ treatment and expensive ‘foreign drugs’ paid for by a ‘special government fund for poor people’.
The report has resulted in growing pressure on drug companies to fully investigate these claims.
One family member of a potential victim, Nitu Sodey, said she took her mother-in-law, Chandrakala Bai, to Maharaja Yeshwantrao Hospital in Indore in May 2009, after Bai was suffering chest pains.
Instead of using their BLPs (Below the Poverty Line) voucher to pay for their treatment, as they were accustomed, Bai was taken to a private room, normally reserved for upper class patients, and given Tonapofylline which was being tested by Biogen Idec.
Sodey told Newsnight that she can’t read and doesn’t remember signing a consent form, nor did she know her mother-in-law was being enrolled in a drug trial.
In India it is illegal to trial a drug on a patient without their prior consent.
After suffering heart abnormalities day after being prescribed the drug, Bai was taken off it but then went on to suffer fatal cardiac arrest a month later. She was only 45 years old at the time.
The trial was registered in the UK by Biogen Idec, but was later halted due, say the company, to the number of seizures recorded.
One doctor whose name was mentioned repeatedly to Newsnight reporter Sue Lloyd Roberts in relation to suspected non-consensual drug trials is Dr Anil Bharani, who has since been charged by the government for receiving illegal payments and foreign trips from drug companies.
The alarm was first raised by Dr Arnand Rai who became suspicious after he saw poor patients being ushered into the best consulting rooms. After raising questions he was sacked from the hospital.
In 2005 the Indian government relaxed its drug trial laws. Since then nearly 2,000 trials have taken place, with the number of deaths increasing from 288 in 2008 to 668 in 2010, and then falling to 438 in 2011.
According to the Newsnight investigation, there are many stories like Sodey’s but because post-mortems are rarely carried out it is difficult to prove a cause of death.
Barrister Satnam Singh Bains, who is looking into several cases, told Newnight that there are real concerns; "About, at the very least, collusion between experts and the drug manufacturers or, at worse, there is a suggestion that there is a fraud taking place – that these reports are being signed off without any independent, clinical scrutiny of their findings in the way that conclusions are expressed."
Image: Drug companies are under pressure to investigate Newsnight’s claims. Photo: Courtesy of Petre Birlea.