HUMAN GUINEA PIGS
Volunteers for drug testing queue for cash as pharmaceutical companies rush to India
BANGALORE
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 checkered 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 says, disclosing that for the latest test he will be paid US$111. "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 US$111 he would be paid for testing the drug on himself for 48 hours was more than his monthly income.
Mahesh and Kumar are among more than a dozen volunteers 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 US$1.5 billion dollars by 2010, at which time the country will need 50,000 professionals and about 300,000 "subjects" or patients.
Abuse warnings
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 detalied 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 washout 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 that have gone off patent and are manufactured in the country are permitted, and on healthy volunteers. All preclinical trials other than on rodents are banned.
But as soon as preclinical 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.
Industry officials say it costs upwards of US$1 billion 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 percent due to cheap and skilled scientific manpower and availability of abundant volunteers.
An Indian scientist works for an average US$444 a month while his US counterpart is paid 10 times that.
"India is certainly becoming a mainstream destination," says Ferzaan Engineer, chief executive officer of Quintiles Research India Private Limited, the Indian subsidiary of US-based Quintiles Transnational. "A strong patents law, changes in clinical-trial regulations, and a large pool of cheap English-speaking scientific manpower has fueled the growth," he says.
Data concerns
Sudhir Pai, managing director of Lotus Labs Private Limited, says India's diverse disease population offers foreign drug firms a huge testing ground. "The main reason for them coming to India may be the cost factor. But when it comes to disease population, such as diabetes, cancer, HIV/AIDS, and cardiac patients, there is no competition for India," Pai says. "But quality of services (accuracy of data) is an area of concern as we are dealing with human beings," he adds, noting a shortage of doctors to conduct the trials.
Kumud Sampath, head of US Pharmacopeia India, an independent, science-based public-health organization, says there are many question marks over the accuracy and reporting of clinical trial data.
"I am concerned about the unbiased recording of data by these firms. Do we have a mindset or culture about the integrity of data? We need globally acceptable good clinical practices," Sampath says. "Efficiency, prompt execution, reliability, quality of product, and precision in reporting are all critical factors. We need to get our act together. Do we have good doctors who have time to do good clinical trials? Do we have technology support on the medical, hospital, and statistical side? I personally doubt it. We are new in this game. It is a challenging area for India."
Ashwini Mathur, senior general manager of Biomedical Data Sciences India, GSK Pharmaceuticals, defends the industry.
"The problems that are being highlighted here are global problems and not specific to India alone," he says. "The quality of data is as good as anywhere in the world. Are volunteers in foreign nations who undergo testing not [also] guinea pigs?"
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