The British Government's drugs safety authority was warned in advance about a drug trial which was to leave six men, including a New Zealander, in intensive care.
The warning of a risk of a catastrophic reaction came from TeGenero, the German manufacturer of TGN1412, in its application to the Medicines and Healthcare Products Regulatory Authority.
TeGenero told the MHRA that there had been previous incidence in which similar drugs had provoked serious adverse reaction in human volunteers.
Yet the MHRA allowed the trial to go ahead and six men who received the drug suffered a massive immune response known as a "cytokine storm".
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# posted by madthumbs @ 9:14 PM
