UK TGN1412 report blames "unexpected biological effect"

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued its final report into the TGN1412 clinical trial accident at London's Northwick Park Hospital (Marketletters passim). The document itemizes a number of Good Clinical Practice discrepancies, some of which were seized upon by the BBC (the UK's public broadcaster) to imply that the MHRA has "heavily criticized the firm."

A spokesperson for the MHRA told the Marketletter that, "it was not uncommon to find three or four discrepencies of this kind in a Good Clinical Practice trial." One of the discrepencies involved the correct checking procedure that the two patients who were allowed to leave the testing unit on the day of the accident, were the ones who had been given the placebos. The MHRA report specifically did not attribute any of these as being responsible for the accident, in which six previously-healthy men suffered multiple organ failure moments after being given TGN1412, a monoclinal antibody. The report's conclusion remains that the event was caused by an "unexpected biological effect."

Lawyers representing the affected triallists criticized the report, claiming that it was a "whitewash" and complained of a "lack of transparency" by the MHRA.