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No Drug Resistance
Some 35 women and a few men in Piduguralla village of Guntur district have become unwitting guinea pigs to what looks like clinical trials for breast cancer drugs. The women, all lime kiln workers, were recruited by brokers and taken to Axis Clinical Labs in Miyapur area of Hyderabad sometime between February-April where they were kept for four days. They were given medicines, their urine and blood samples taken at regular intervals and then sent home.
The victims earned around Rs 10,000 each and were promised up to Rs 30,000 more if they “passed the test”. It was only when one of the women, wracked by severe joint pains, dizziness, nausea and chest pains complained to a local leader that the truth was out. She bore on her a slip showing that she had been tested for a drug by Axis Lab on behalf of GVK Bio, a leading pharmaceutical firm. The rest of the women soon followed with a litany of similar complaints. A check on their profiles showed that all the women were poor, some were widows, some single mothers with ailing kids, others were deep in microfinance debts and some needed the Rs 10,000 to finish building their houses.
Surprisingly, the state government’s reaction has been to play down events. Health secretary P.V. Ramesh even claimed that “the condition of the women is not too serious. Clinical trials on humans are not uncommon. How do you think we are now taking drugs like paracetamol and amoxycillin? But we are ordering an inquiry because of the keen media interest.” Ramesh refused to name the pharma company or the kind of drugs used (said to be for treating breast cancer). Axis Lab officials have said that it was a generic drug and not a breakthrough one and the studies were “bio-equivalent in nature”. This means what was tested was a new drug with the same composition as an existing one, but with some additives.
Andhra seems to be a favoured lab for pharma majors for there have been instances of botched clinical trials earlier too. In ’09, teenage girls in the tribal welfare hostels in Khammam district were given HPV vaccines (to prevent cervical cancer) like Gardasil (from MAD Pharmaceuticals) and Cervarix (GSK Pharmaceuticals). Seattle-based NGO PATH wanted to inject 14,000 girls with the vaccine as part of its Phase III trials (the last stage of a clinical trial where a large section of people are tested). It was only after the death of five girls that the trials stopped. “The consent forms were all signed by hostel wardens and the remaining had thumb prints. This shows that the experiment was conducted on vulnerable people who had no knowledge of what they were getting into,” says Babu Gogineni, founder of the Humanist Center for Bioethics in New York.
“MNCs are attracted to India because of the huge human patient pool. Also, ethics committees are not robust here, neither are the compensation/insurance policies huge as in the West. So companies find it easy to cut corners here and get clinical trials done quickly,” says Dr P. Raghu Ram, director and consultant oncoplastic breast surgeon at the KIMS-Ushalakshmi Centre for Breast Diseases.
The doctor points to the fact that Hyderabad has more corporate hospitals that Mumbai or Delhi. “Almost every corporate hospital has some form of research going on,” he says. Unofficial estimates say that clinical trials in India cost 60 per cent less than in Europe or the US.