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Despite note that AIDS vaccine had failed, India changed rules and continued trials

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    The first-ever AIDS vaccine trial in India, flagged off by Union Health Minister Anbumani Ramadoss and Union Science and Technology Minister Kapil Sibal two years ago, ended in failure when it was announced in Pune last month that although it was “well tolerated,” it did not “elicit the acceptable immune response.”

    The announcement overlooked one glaring fact: the trial, conducted on 30 healthy volunteers at Pune’s National AIDS Research Institute (NARI), continued for a whole year although it was known within the first fortnight that the same vaccine had failed in tests in Germany and Belgium — with exactly the same conclusions.

    And yet the Government amended its policy to accommodate the trial. But more of that later.

    The trial, a tripartite venture of the Indian Council of Medical Research (ICMR), the International AIDS Vaccine Initiative (IAVI), and the National AIDS Control Organization (NACO), began on February 7, 2005 at NARI. India was one of the three countries chosen for this “multi-country trial.”

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    When contacted by The Sunday Express, NARI director Ramesh Paranjape said: “The Pune trial ended safely and the health of volunteers has not been compromised at all.” Asked why the trial continued for one year when it was known that the vaccine had failed, he said: “Scientists learnt a lot in how to conduct and manage trials for an AIDS vaccine.” Officially, informed consent and necessary ethical clearances were accorded to the trial.

    The IAVI spokesman declined to comment.

    “There was no justification for the trial,” said Pushp M Bhargava, founder-director of the Centre for Cellular and Molecular Biology, Hyderabad, and a member of IAVI’s board. “It was unethical and totally uncalled for. The volunteers can’t be treated like guinea pigs, they should have been told that he vaccine being tested on them had failed. We were not shown the data from Germany and Belgium — till date that has not been shared with us.”

    ... contd.

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