Documents obtained under FOI for adverse drug trial reactions

A "reckless" mistake caused the adverse drug trial reactions at Northwick Park, according to a Channel 4 investigation.

Documents obtained by the programme Dispatches revealed drug TGN1412 was administered 15 times more quickly than it had been in animal safety studies.

Six men were left seriously ill after receiving the drug.

But data obtained under the Freedom of Information Act by Dispatches revealed that the MHRA (Medicines and Healthcare products Regulatory Agency) could have calculated the speed at which the drug should have been given. Professor Terry Hamblin of Southampton University, a monoclonal antibody expert who has worked on TGN1412, told the Sunday Times: "When you give an antibody, the quicker you put it in, the more likely you are to get an infusion reaction. To quickly infuse it over three to six minutes in six individuals I think is... reckless."

But Dr David Glover said: "I think it is too simplistic to simply blame it on the speed of administration. It was probably one of many factors that played out to influence the outcome of the disaster. The speed of administration probably compounded the error, but on its own it is probably not the sole error."

Drug 'administered too quickly' (BBC website, 25 September 2006)