Playing the blame game
Six months after six men were seriously injured by TGN1412, the UK media continues to pick over bones of the clinical trial in an attempt to get to the bottom of what went wrong.
Six months after six men were seriously injured by TGN1412, the UK media continues to pick over bones of the clinical trial in an attempt to get to the bottom of what went wrong.
A previous investigation by the MHRA found no fault with the formulation or manufacture of the drug, nor with the trial protocol or the way it was implemented, attributing the adverse reactions in the subjects to an 'unexpected biological effect'.
But the Dispatches programme, screened by the UK's Channel 4 in September, together with The Sunday Times, obtained confidential documents revealing that the drug was infused into the volunteers 15 times faster than into monkeys in an earlier safety study.
The view that this 'reckless error' could lead to potentially life-threatening problems was supported by several industry experts, including Professor Terry Hamblin of Southampton University, a leading authority on monoclonal antibodies, and Dr David Glover, formerly chief medical officer of Cambridge Antibody Technology.
The programme also raised serious concerns that the MHRA did not scrutinise the trial adequately. Not only did it fail to pick up on the different infusion rate, it also did not spot the absence of cytokine data that could also have caused warning bells to sound.
The full scientific explanation for the dramatic effects of TGN1412 has yet to emerge. But while the programme is to be applauded for its dogged persistence in keeping the fate of the injured in the spotlight, I can't help feeling that a more dispassionate approach with less emphasis on finding someone to blame would be more constructive in the long run.
Film of cute macaques in cages - referred to by the reporter as 'these little fellows' - and pictures of the blackened fingers and toes of the most seriously injured trial subject may evoke an emotional response among the British public, but it is unlikely to lead to any real improvement in clinical trial safety. And although the six 'victims' are deserving of utmost sympathy - not to mention substantial financial compensation - a knee-jerk reaction to a one-off event seldom leads to a satisfactory solution in the long term.
The TGN1412 trial was a disaster for the six men and their families, but should not be allowed to become a disaster for the entire pharmaceutical industry and the future development of new medicines. Adopting a culture of blame and accusation could ensure that the whole truth never emerges and the lessons will never be fully learned.