Further lessons from the TGN1412 tragedy

As eight young men assembled at a London hospital on 13 March this year, they had no idea that within an hour their lives would be changed irrevocably and they would have contributed to a fundamental rethinking of the development and testing of new drugs. The first trial of TeGenero's TGN1412 (a T cell agonist) in humans took place at Parexel's clinical pharmacology research unit at Northwick Park Hospital, London. The events that followed fuelled speculation not only into the conduct of the trial and the nature of the drug, but also into aspects of research as diverse as comparative molecular biology, bioethics, and health economics.1

The Medicines and Healthcare Products Regulatory Agency initiated an investigation, but the BMJ and other journals called for a more far reaching inquiry independent of the regulatory agency that had approved the trial. On 5 April the agency released its interim report,2 and the government announced that an independent Expert Scientific Group, chaired by Professor Gordon Duff, would be appointed “to learn from the Parexel clinical trials incident.” On 25 July this group released their interim report and recommendations.3

Inevitably, the report has pleased some people and disappointed others.4 5 Although it …