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Young human guinea pigs Children of 13 being used in drugs trials by major firms
Gethin Chamberlain in Delhi VULNERABLE children as young as 13 are being used as human guinea pigs by firms testing drugs for use in the UK, a People investigation reveals. Poor families in India put kids up for drug trials carried out for major international companies in return for free medicines. When marketed in the West these drugs earn billions. But 1,725 people including children have died in the past four years after taking part in tests in India – and their families have received pittances in compensation or none at all. Our probe discovered companies paid out the equivalent of just £39 damages for each life lost – as against £300,000 in only one comparable British case. The total paid adds up to £68,343 but that covers only 22 cases at an average of £3,657 each. The death rate has risen year after year while an unknown number of people have been left disabled – and now some drug trials have been abandoned. Health campaigners say the soaring death rate and failure to pay adequate compensation show drug firms are deliberately targeting poor and badly-educated Indians. These figures do NOT include the controversial deaths of seven children after they had taken part in a trial of cervical cancer vaccines by MSD Pharmaceuticals – part of the Merck Group – and GlaxoSmithKline. Pretty Sodi Sayamma and Sarita, both 13, were given the jab two years ago. Sarita’s parents Nageshwara and Venkatamama said she started having fits after being given the vaccination and they found her dead on the floor of their hut in January last year. Doctors said she had committed suicide by taking poison, though none was found in her body. Sayamma died the previous August in similar circumstances, only seven weeks after the jab. Her mother Marmamma said her death was also blamed on suicide. Neither girl’s family has received any compensation and both companies are adamant there is no link between the tests and the deaths. Although India’s health ministry concluded guidelines had not been followed during the tests, its official report cleared the drug companies and attributed all seven children’s deaths to suicide, snake bites or malaria. Campaigners claim many of the girls selected for trials came from tribal communities who were unlikely to have been able to give informed consent. The rapidly expanding clinical trials market in India is forecast to be worth around £380 million by next year. But a study into the use of India as a testing ground for international drugs, carried out by the Mumbai-based Centre for Studies in Ethics and Rights, accused drug companies of acting unethically. In the UK, drug trial volunteers can expect to be paid as much as £3,000 for taking part. In India most people have to pay for their own medicines so the chance to get any free is enough to persuade large numbers to take part in trials. They may also be offered up to £300 – a small fortune in a country where the poverty line was recently set by its own government at 42p a day. A report by the Mumbai centre concluded: “These trials exploit the fact most Indians do not have access to good quality and affordable care and therefore may accept offers that might provide better quality and free treatment. “They were conducted on people who were vulnerable because they could not afford good quality treatment or the most effective drugs. The patients were also vulnerable because many were seriously ill.” Figures from Indian health ministry the Directorate General of Health Services show that in 2007, when registration of drug trials was still voluntary, there were just 11 in the country. In 2008 – when registration became compulsory – the figure rose to 137, then 548 in 2009 and 806 last year. The figures also show deaths rose sharply from 132 in 2007, to 288 in 2008, then 637 in 2009 and 668 in 2010 – a total of 1,725. Ministry documents record that 10 drug companies and one research firm paid compensation totalling £68,343 over just 22 deaths, all of which happened in 2010. The payouts include £1,932 by MSD while Wyeth, Quintiles, Lilly, Bayer, Amgen, Bristol Myers, Sanofi, PPD and Pfizer have also made payments. No payments have been made by GlaxoSmithKline. Individual payouts in India pale into insignificance com- pared to the £300,000 awarded in January to the family of 27-year-old Gary Foster, of Essex, who died in a London hospital during a Government- funded cancer drug trial. They are also dwarfed by the £108,000 paid out in August to each of four Nigerian families affected by an anti-meningitis drug trial which left 11 children dead and dozens disabled. Now some Indian trials have been abandoned. Drugs giant Pfizer – which paid out £6,731 in compensation for three cases involving deaths – last year scrapped tests of the drug sitaxsentan which it had hoped could be used to treat pulmonary artery hypertension. Details of the deaths and com- pensation were secured by right- to-information campaigner Ramesh Verma after a five- month battle with the DGHS which had initially refused to disclose the data. Sandhya Srinivasan of the Indian Journal of Medical Ethics said drugs companies liked India because it was cheap and easier to find recruits than in the West. And he feared the death toll could be even higher than officially stated. He said: “We have no idea what kind of in-vestigation and response system is in place. We can’t be assured that all deaths in trials are reported, that all deaths are followed up. “Companies know they can get away with absurd figures. This is apparently the first time that any compensation has been given at all.” Nor are there any rules on how much compensation should be given. The DGHS states only that if volunteers die their families are entitled to “material compensation” and says drug companies should not target people who are “economically or socially disadvantaged”. Irene Schipper of SOMO, a Dutch campaign group which researches multinational corpo- rations, said drug companies were attracted to India because they could save up to 60 per cent on the cost of trials in some other countries and the standards demanded by ethics committees were lower. London-based GlaxoSmithKline, the world’s third-largest pharmaceutical company, said: “Our sponsored clinical trials are conducted to the same ethical standards irrespective of where they take place “Our vaccine Cervarix, had already been approved for use in over 100 countries, including India. These approvals were based on the results of more than 50 rigorous clinical trials involving approximately 90,000 women worldwide, including in Europe and the United States. “In the case of the Gujarat study, unfortunately two girls who participated died but these deaths were not related to the vaccine they were given. One died from a snake-bite and the other from malaria. “No other deaths were reported and the report on the study concluded there was no major violation of any ethical norm.” A spokesman for Pfizer added: “Patient safety is a top priority at Pfizer. “All clinical studies in every country follow accepted ethical, scientific and medical standards that protect the rights of participants.. “Clinical trials for four cases in India involved patients in pro- gressive diseases such as cancer and pulmonary arterial hypertension. The compensation amount for these cases was determined in consultation with the Investigators and the Ethics Committees in India.”
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Copyright ©2011 Gethin Chamberlain. All rights reserved. |
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