Monday, October 16, 2006

UK Drug Trial Gone Horribly Wrong

While the drug trial on TGN1412 that caused catastrophic systemic failure in six subjects earlier this year has been painted in broad strokes in the UK media, most American news sources have brushed it aside as unimportant. For those of you still catching up, TGN1412 is an anti-cancer drug produced by the now bankrupt TeGenero Immuno Therapeutics and went through phase I testing by the US company Parexel in a trial that took place in the UK.

Animal testing on TGN1412 suggested that the drug would react differently in humans that it did in chimpanzees, and as a result essential information was absent in the report when researched decided to move ahead with a human trial.

Of the six volunteers, Ryan Wilson affected the worst and had to have several fingers and tows amputated, and his future prognosis is still uncertain. He received £2000 for participating in the study.

Most information on the government investigation into TGN1412 is still unavailable to the public. One thing that the trial does demonstrate, however, is the need for better information management in clinical trials. Pharmaceutical companies keep most of their data under wraps until seeking approval from the government so as not to tip off the competition on what they are working on, and to keep negative results under wraps; this information management scheme can have lethal effects when the results of previous investigations are unavailable to current researchers.

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