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GlaxoSmithKline, the UK pharmaceutical group, and the Walter Reed Institute, the US army's medical research body, are facing criticism for clinical trials in Nepal to test an experimental vaccine for Hepatitis E.
Jason Andrews, a researcher at Yale School of Medicine based in Nepal, said they violated international ethical guidelines by using vulnerable subjects, failing to publish rapidly the results and not having a clear plan on how to bring the vaccine to market.
The allegations, raised with the Financial Times and detailed in the latest issue of Perspectives in Biology and Medicine, a US academic journal, will reopen the debate over the international system governing clinical trials. It also highlights the difficulties facing researchers attempting to develop drugs and vaccines for the developing world, where the commercial incentives are limited.
GSK and Walter Reed began co-operating in 1998 on the development of a vaccine for Hepatitis E, an infection under study since the 1980s and estimated to affect 1.0 per cent of India's adult population. About 1.0 per cent of those with the disease die as a result.
After considering holding trials in Thailand and then among villagers in Nepal, local controversy over the motives and benefits of the research pushed the scientists to shift testing to Nepalese soldiers, beginning in 2001. The findings showed 96 per cent efficacy after three doses, with no significant side-effects.
Even before launching the trials, GSK said it had decided the vaccine did not have a commercial application for travellers, while Walter Reed decided it was unsuitable for its soldiers.
However, the partners went ahead with the trials, which Mr Andrews said violated the ethical principle that a commitment should already have been made to develop the vaccine for local use if it were a success.
He accused the trial researchers of undue delay in seeking support for development of the vaccine by only publicly presenting their findings almost two years after the results were finalised In January 2004.
He said the use of soldiers as volunteers was questionable under ethical research guidelines because they could easily be coerced into taking part.
However, Bruce Innis, who co-ordinated GSK's efforts and used to work at Walter Reed, said: "It's easy to take pot shots. The real world is very complex. The flip side is that if we didn't do [something], that could also be unethical."
He pledged that GSK would strive to find a sponsor to help develop the vaccine, potentially working in India or China. "It's not our philosophy to leave something good like this on the shelf," he said.
But he said Hepatitis E was not judged to be a major killer disease in the developing world, which had meant so far it had not identified a partner.
He said "a lot of procedural safeguards" had been put in place in preparing for the trials, and that 5,500 of 12,000 soldiers approached agreed to participate. "People were free to say no."
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Under syndication arrangement with FE
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