Human guinea pigs queue for cash in India

BANGALORE, India (AFP)

Lured by the money being offered by the dozens of global pharmaceutical firms doing clinical trials in India, human guinea pig M. Mahesh, is testing his sixth drug - this time helping in the search for a cure for asthma.

Dressed in chequered green hospital dress and wearing a badge bearing his photograph and a number, Mashesh, a welder, has no inkling at all about the drugs he has allowed doctors to introduce into his body over the past two years.

For now he has no regrets.

"So far no drug has had an adverse impact on my health. I will continue to do this for the money I get," 27-year-old Mahesh tells AFP, disclosing that for the lastest test he will be paid 5,000-rupees (111 dollars) by the research firm. "It is the sixth time that I am testing a drug on myself," he adds. "They (officials of the firm) briefed me in local language about the side-effects of the drug." His 19-year-old friend, Bala Kumar, an electrician, said the 111 dollars he would be paid for testing the drug on himself for 48 hours was more than his monthly takings.

Mahesh and Kumar are among more than a dozen volunteers staying at a "Subjects Housing" room at the Bangalore facility of Lotus Labs Private Limited, a fully-owned subsidiary of Iceland-based Actavis which is engaged in clinical and drug research.

Thousands of volunteers like them are driving India's nascent clinical research industry which has attracted global pharmaceutical firms such as Aventis, Eli Lilly, GlaxoSmithKline, Novo Nordisk, Novartis, Pfizer and Sandoz.

According to a report by consultants McKinsey and Co., the Indian clinical research industry can earn revenues of 1.5 billion dollars by 2010, at which time the country will need 50,000 professionals and about 300,000 "subjects" or patients.

Critics say India's huge illiterate population is in danger of being misused by unethical firms to test suspect drugs. But industry officials say each trial follows a strict code of ethics. "The volunteers undergo health tests such as blood, urine, chest X-rays and heart check-up. If they fail we do not enroll them for the test," says Sandhya Ravi, chief of clinical services of Lotus Labs.

"A detailed presentation on the side-effects of the drug are made to these volunteers. Their consent is also taken," she says.

"Blood samples are collected about 21 times during the testing which varies from 36 hours to 72 hours. A drug wash-out period of 90 days is strictly adhered to. So these volunteers cannot enroll for testing for the next three months," she said.

"Strict protocols for safety are followed and the trial is monitored by an ethics committee comprising doctors, lawyers and even housewives," Ravi says.

Under Indian laws, only testing of new and generic drugs which have gone off patent and are manufactured in the country are permitted, and on healthy volunteers. All pre-clinical trials other than on rodents are banned.

But as soon as pre-clinical trials on animals are over in a foreign country and the new drug has been tested on healthy volunteers in that nation, the drug can be used in India for so-called second and third phase trials.

Clinical research organisations recruit volunteers through newspaper advertisements or word-of-mouth. Industry officials say it costs upwards of one billion dollars to make a new drug, with clinical trials accounting for almost two-thirds of the cost. In India the trials can cut costs by more than 55 per cent due to cheap and skilled scientific manpower and availability of abundant volunteers.