Pharma firms use Indian women as 'fodder' for trials

Wednesday, 11 February 2004, 20:30 IST
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NEW DELHI: Indian activists are campaigning against rising incidence of "unethical and exploitative" clinical trials by pharma companies, alleging they are using "poor Indians as guinea pigs", reports OneWorld. Prompted by the trial of 790 women in West Bengal, the All India Democratic Women's Association (AIDWA) has written to Health Minister Sushma Swaraj expressing their concern. "We are planning to meet the drug controller to press our demand for stricter regulations on such trials," said AIDWA general secretary Brinda Karat. "No one seems to know what the rules and regulations are. But we can't have a free-for-all," she said. The letter follows recent reports that the antibiotic Erythromycin was placed in the wombs of 790 women to test the drug as a contraceptive. The study found the antibiotic had a failure rate of up to 35 percent after a year. The trials, conducted between August 1999 and October 2002, became public after a paper was published last month in the international journal Contraception. "It is no coincidence that though all the big pharma companies are based in the US or Europe, their major tests are conducted on poor people in Third World countries," says the letter to the minister. "They believe that in countries like India they can exploit the vulnerability caused by unemployment and poverty to induce people to participate in clinical trials through material incentives," it says. The West Bengal trial was conducted by a doctor who stirred a furore when he tested the anti-malarial drug Quinacrine as a contraceptive for women in India in the late 1990s. In 1998, the Indian drug control body banned its use for female sterilisation after a sustained campaign by women activists, who said more than 30,000 women in India had been sterilised with Quinacrine over five years without permission from the health authorities. As in the case of Quinacrine, the Erythromycin trial sought to check the drug's efficacy as a contraceptive by blocking a woman's fallopian tubes. The tablets were placed in the fundus, or the upper part of the uterine cavity. Reports from West Bengal said the women were divided into two groups. Each member of the first group was given a 500 mg tablet, while women in the second group received 10 50 mg tablets. A year later, 35 percent of the women in the first group and 28 percent in the second group had become pregnant. The doctors did not take permission from the Indian authorities for the trials despite the fact that doctors in the US have conducted only animal studies in this field so far -- on rats. "This points to an extreme laxity in regulations on trials in India," said Amit Sengupta of the Delhi Science Forum, a New Delhi-based organisation researching drugs and health policy. "It seems that anybody and everybody can conduct a trial in India," he said. In contrast, there are stringent norms for conducting human trials in developed countries. AIDWA states that according to pharmaceutical industry estimates, the clinical studies market in India could multiply from the present $70 million to $300-500 million or even as much as a billion dollars within a decade. "Poverty forces cruel strategies for survival on the poor, including offering themselves as fodder for trials for drugs which when finally produced will be of little use to them or their children because the prices will be far beyond their reach," says AIDWA. "In any case, no government with even a minimum moral concern for the health rights of poor Indians can allow them to become guinea pigs for multinational companies," it states. Sengupta pointed out that such trials were being conducted in India because it had a technical manpower that is cheaper than in Western nations, a research base as well as existing health infrastructure. For its part, the government is reported to have prepared a draft law, which will make any violation of guidelines for biomedical research on human beings a severely punishable criminal act. "The draft is ready and is likely to be introduced in parliament this year," Indian health secretary J.V.R. Prasada Rao said. But AIDWA, which is still awaiting a reply from the health minister, remains sceptical about how seriously the government will pursue the issue.
Source: IANS
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