The Hindu : Front Page : Lives that depend on studies in labs

Online edition of India's National Newspaper
Wednesday, Nov 16, 2005

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Lives that depend on studies in labs

Divya Ramamurthi

IMPORTANT TESTS: A volunteer taking part in a clinical trial at Manipal Hospital in Bangalore. — Photo: K. Gopinathan

BANGALORE: Zakia Pathak (77), a retired English teacher, has been in-and-out of hospital for the past three years as a volunteer for a clinical trial for a new cancer drug. For the moment, she says she has no regrets.

"So far, I seem to be getting better on the drugs. The lesions that developed after my operation in the year 2000 are becoming smaller," she says.

Another compelling reason for her to be a part of the trial, she says, is the constant check-ups that are free. "My medical check-ups and medicines over the past few years would have cost more than Rs. 2 lakhs. I would never have been able to afford it on my own," she says. Ms. Pathak says that since she got onto the trial, being conducted at the Kidwai Memorial Institute of Oncology, she did not have to wait in the hospital to meet her doctor. "It is such a relief for an elderly person like me."

For 28-year-old Sandhya Rao, who enrolled in a clinical trial a few months ago, the motivating factor was her doctor's recommendation. "My doctor told me about the trial and suggested that I sign up for it. As I was not getting better with my old medicines, I decided to sign up," says Ms. Sandhya, who is on a trial for a medicine for kidney problems. She says she is comforted by the fact that the drug has already been approved for use in the U.S. and the U.K.

While free medicine, medical attention and the promise of better health are luring several ailing persons to clinical trials, the offer of money is luring more healthy persons to volunteer for bio-equivalence studies, where clinical research organisations (CRO) evaluate the standard of the generic drug against the patented drug.

Subash Chandra, car driver, says he has tried out two CROs in the past two years. "Some of the CROs pay Rs. 4,000 a day. That is more than what I earn in a month," he says. Though he does not know what drugs he is being tested for, he has no regrets. With such a large human pool available for clinical trials and cheaper cost of trials here, the Indian clinical research industry is booming. From five CROs a decade ago, the country now has 50 of them.

According to a report by consultants McKinsey and Co., the Indian clinical research industry can earn revenues of $ 1.5 billion by 2010, by which time the country will need 50,000 professionals and around 3,00,000 "subjects." CROs say the cost of conducting a drug trial in India is one-third of that in the U.S. or the U.K.

However, critics and some pharmaceutical companies are still expressing concern over the way trials are conducted here. Some companies fear that Indian CROs may not possess the necessary skills or sufficient number of doctors to conduct trials.

Alan Boyce, Vice President of Europe Kendell International, says that India CROs need to employ highly experienced investigators as well as a good management team. "The trials should also be conducted in special clinical research wards under controlled conditions," he says. The concept of informed consent is another area of concern.

"How many people understand all that they are reading. Even well-read people do not understand the reports that doctors present to them," says Sandhya Rao, an activist.

But CROs defend themselves saying they follow strict ethical practices. Sudhir Pai, Managing Director of Lotus Labs, a CRO that has more than 11,000 volunteers on its list, says that informed consent is available to the person in five south Indian languages.

Question of ethics

H. Sudarshan Ballal, a nephrologist at Manipal Hospital, who is in charge of a trial, says that all clinical trials are routed through the ethics committee before they are conducted.

Mr. Pai says: the treatment of volunteers at the trial and the veracity of the trial depends on the CROs.

"Ultimately it all boils down to personal ethics. If someone wants to subvert the system they always can. We can only hope that they are not too many people who are trying to do it."

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