TVScope: This World - Drug Trials: The Dark Side, BBC 2, 9 pm, Thursday, April 27th
Outsourcing services to Asia has become the norm in the world of commercial business. But now it seems that the concept of outsourcing has spread to people being used, often without their knowledge, to do things the western world does not want to do itself.
This episode of This World, the BBC investigation programme, looked at an entire industry that has grown out of the recruitment of patients and the management of drug trials on behalf of multinational drug companies.
It has been estimated that by 2010, approximately two million people in India will be taking part in clinical trials. With most of the world's largest pharmaceutical companies having a presence in India, there are serious concerns being raised about how these companies recruit "volunteers" and how the issue of informed consent is handled.
Dr Kumar, a US-based doctor who recruits patients and manages drug trials in India, says India is a good place to do these type of experiments because its people are "treatment naive".
Kumar estimates that India has a lot to offer the pharmaceutical world as it can recruit "one-third more patients, in one-third less time, at one-third less cost".
Since experiments were carried out on the inmates of concentration camps during the second World War, international rules govern how medical research is conducted. Known as the Nuremberg Code, medical trials can take place only on individuals who have given their informed consent. This means that they must understand what is being done to them, why it is being done and what side effects may occur as a result of the trial.
Disturbingly, viewers saw no evidence that patients recruited onto drug trials in India are afforded these basic ethical standards. All consent forms were written in English, unintelligible to the impoverished and often illiterate patients, who routinely signed with a thumb print. As a result, many patients didn't even know they were part of a drug experiment.
A drug trial being conducted on behalf of Johnson & Johnson was carried out in a psychiatric unit at a hospital in Gujurat. Patients suffering from severe bi-polar manic depression were enrolled to test a new anti-psychotic drug.
One gentleman was told his current drugs were discontinued and that he would have to take a new one. In order to test the efficacy of the drug, the patient Mr Parmar had to undergo a three-week "wash out" period when he received no medication at all. Following the 12-week trial of the experimental drug, it was withdrawn from him. He had no idea he was part of a trial.
"I am poor and I live in a small hut and I don't understand many things . . . We just sign because I believe the doctors take the signature to help us. That's why I sign it."
Johnson & Johnson spokesman Dr Vivek Kusumaker said: "We have looked at this trial and we've got consent for patients or from a relative in every case."
If this is the pharmaceutical industry's understanding of the Nuremburg code, then we have a serious problem on our hands.
Even if the drug was found to have been suitable in controlling Mr Parmar's condition, it would have been inaccessible to him as it cost 1,500 per cent more than his original medication.
Withdrawing treatment from patients is unethical; using them as human guinea pigs is unacceptable; and exploiting people who are disadvantaged is abhorrent.
Paying doctors in India to carry out human experiments which offer patients there nothing in return is little short of immoral.
The drugs industry may feel that the highest code of ethics are being maintained, but the evidence from This World tells a different story.
Marion Kerr is an occupational therapist.