Drug trials outsourced to India

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Drug trials outsourced to India

Recruiting patients for drug trials in India is big business

India's outsourced call centres are well known, but not its

outsourced patients.

By 2010, some estimate there will be two million patients in India

on clinical trials.

An entire industry has sprung up, specialising in recruiting

patients and managing experiments.

And a BBC investigation into the conduct of these trials has found

that some patients are unaware they are being experimented on at

all.

Most of the world's largest pharmaceutical companies have a presence

in India, but there is concern about how the country achieves its

exceptional recruitment rates and questions about fully-informed

consent.

Medical language

Six years ago, an experimental drug from the US called M4N was

injected into cancer patients in India without being properly tested

on animals first.

Later it was discovered that several patients had not known they

were part of a clinical trial.

Most of the patients sign on the dotted line without understanding

the nature and the consequences of what is being administered to

them. Dr Shashank Joshi

One of the doctors who later blew the whistle, Dr V Narayan

Bhattathiri, told the BBC: " I can only say that what they did is

something unbelievable or incomprehensible.

" I couldn't find any example of such a thing being done, maybe in

the last 50 years or so. Maybe something similar could have happened

in say concentration camps. "

Giving informed consent to be part of an experiment is the golden

rule of all clinical trials which goes all the way back to the

Nuremberg Code.

But one doctor at the prestigious Lilavati hospital in Mumbai, Dr

Shashank Joshi, says the idea of all patients giving informed

consent in India is " a myth according to me... because I do not

think it's truly informed in the language the patient understands.

" Most of the patients sign on the dotted line without understanding

the nature and the consequences of what is being administered to

them. "

Lack of understanding

Reporter Kenyon tracked down a drug trial being conducted for a

major drug company in a psychiatric unit at a hospital in Gujurat.

It was to test an anti-psychotic drug developed by the world's

second largest drug pharmaceutical company and .

" I didn't know that experiments were being carried out on me "

Parshottam Parmar

There is already controversy over what is happening, with some

doctors levelling the accusation that patients are being taken off

their existing medication as part of the trial, with the potential

they could suffer unnecessarily .

Dr Vikram Patel from the British Journal of Psychiatry says: " The

most obvious problem is that they won't get better or they will

continue to suffer this extremely severe psychiatric illness, much

longer than they need to. "

But the ethical concerns go deeper when Kenyon finds a patient who

took part in the trial.

" I was just told that the drugs were American. They used to give me

the tablets and I used to eat them, " says Parshottam Parmar.

" We just sign because I believe the doctor takes the signature to

help us. That's why I sign it. "

He says he had no idea that he was part of a clinical trial.

" I didn't know that experiments were being carried out on me. I was

told that the old drugs were discontinued and were no longer

available in the pharmacies.

" I don't know a lot about all these things. I am poor and I live in

a small hut and I don't understand many things. The doctors are

intelligent. They write the drugs for me so I have to take them

accordingly. "

and 's spokesman Dr Vivek Kusumaker told us: " We have

looked at this particular trial and we've got consent from the

patient or from a relative in every case.

" If there is any instance brought to our attention that something

was not OK we will take that seriously. We have said that we shut

down sites if we don't think we are carrying out research to the

highest code of ethics in which we believe. "

Drug Trials: The Dark Side will be broadcast on Thursday, 27 April,

2006 at 2100 BST on BBC Two.

http://news.bbc.co.uk/1/hi/world/south_asia/4932188.stm