Call to Check "Unethical" Drug Trials in India
Prompted by the trial of 790 women in the eastern Indian state of West Bengal, last week the All India Democratic Women's Association (AIDWA) sent a letter expressing their concern, to the Indian Health minister, Sushma Swaraj.
"We are also planning to meet the drug controller to press our demand for stricter regulations on such trials," says 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 protests.
The letter follows recent reports that an 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 per cent after a year.
The trial became public after a paper was published in January in the international journal "Contraception." The trials were conducted between August 1999 and October 2002.
"It is no coincidence that though all the big pharma companies are based in the United States 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 up a furor when he tested the anti-malarial drug, Quinacrine as a contraceptive for women in India in the late 90s.
In 1998, after a sustained campaign by women activists who said more than 30,000 women in India had been sterilized with Quinacrine over five years without permission from the health authorities, the Indian drug control body banned its use for female sterilization.
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 say 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 ten 50 mg tablets. A year later, 35 percent of 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 the only animal study in this field so far -- on rats.
"This points to an extreme laxity in regulations on trials in India," says Amit Sengupta of the Delhi Science Forum, a New Delhi-based organization researching drugs and health policy. "It seems that anybody and everybody can conduct a trial in India," he says.
In contrast, there are stringent norms for conducting human trials in developed countries.
Significantly, the AIDWA letter states that according to pharmaceutical industry estimates, the clinical studies market in India could multiply from the present US $70 million to US $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 says.
Sengupta points out that such trials are being conducted in India because it has a technical manpower that is cheaper than that in western nations, a research base and an existing health infrastructure.
"At the same time, patient or consumer awareness is very low and informed consent does not exist," he says. "People are more gullible and doctors are seen as infallible," he says.
The activists believe the Indian government should implement strict guidelines for human testing.
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 told a newspaper recently.
AIDWA, which is still awaiting a reply from the health minister, remains skeptical about how seriously the government will pursue the issue.
Karat says she fears the issue of unethical human trials will get buried because of impending elections in the country. "But we are certainly going to take it up with the new government," she stresses.
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