The Telegraph
Since 1st March, 1999
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Ethics row on cancer vaccine

New Delhi, Sept. 19: The move to manufacture a vaccine for cervical cancer has revived the debate on the ethics of clinical human trials.

At a two-day workshop organised by the World Health Organisation and the Indian Council for Medical Research, policy makers and doctors agreed in principle to have a vaccine to treat cervical cancer, which accounts for 30 per cent of cancer among women.

“But the discussion has just begun. There are lots of issues to be sorted out — among them, ethical issues as well,” said N.K. Ganguly, director of the research council.

Although health activists like Meera Siva of the Voluntary Health Association agree that cervical cancer is a serious problem, they question the overall ethics of clinical human trials.

In the West, there are four types of vaccines that have reached phase II of the clinical trial involving humans. Incidence of cervical cancer has, however, gone down in the West. In India, barring isolated pockets like Chennai, the illness shows an upward graph.

“In India, the conditions are very different from the West. There the vaccine is administered after an examination. But in India we will not be able to examine unmarried girls,” said Ganguly. He maintained that the two-day workshop, which ended today, was only a “brainstorming session” to probe the opinions of policy makers and doctors.

Those present at the workshop maintained that clinical human trials will be carried out only after receiving the “informed consent” of volunteers. “The first vaccine may or may not work,” said Ganguly. According to health activists, past experience of clinical human trials has shown that volunteers “disappear” after the trial and research institutes do not keep track of their movements.

As a rule, most of the volunteers are picked up from poor backgrounds — from the resettlement colonies. Many of them are unlettered and not properly informed of the side-effects of the tests.

Recently, a case in the regional cancer institute of Thiruvananthapuram drew the nation’s attention to the issue of ethics of clinical human trial. The allegation levelled against the cancer institute was that it was conducting experiments with ‘M4N’, a drug banned in the USA.

Two inquiry committees were instituted to look into the complaints and the institute was categorically asked not to conduct clinical human trials without the “informed consent” of the people being experimented upon.

Although Siva did not dismiss the need for a vaccine, the health activist pointed to vested interests pharmaceutical companies have in pushing through these products. “What we want to ask is who will pay for this research' asked Siva.

Many of these questions were also raised at the time the government had announced its decision to launch an anti-AIDS vaccine.

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