WE MAY never know why six healthy young men were left fighting for their lives by a drug trial in London this year. The official report on the catastrophic safety trial of the drug TGN1412, published on 25 May, certainly brings us no closer to discovering exactly what went wrong.
The novel drug, TGN1412, caused multiple organ failure in the six men who were injected with it at Northwick Park Hospital in March. One of the men is still recovering in hospital, where he is said to be making steady progress.
The final report by the UK鈥檚 Medicines and Healthcare Products Regulatory Agency (MHRA) severely criticised Parexel, the firm that carried out the trial, for failing to complete proper patient medical records and not providing 24-hour medical cover. Parexel insists it followed all the correct procedures during the trial.
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The report concludes that the serious adverse reactions experienced by the volunteers were the result of an 鈥渦npredicted biological action of the drug in humans鈥�, echoing an interim report by the MHRA in April. Though it has been suggested that the drug may have caused a super-immune reaction in its recipients, exactly why this should have happened is still unknown.
For a fuller explanation, we may have to wait for the report of an expert consultation group that was set up in April to examine the incident and suggest ways to ensure that nothing like it happens again. The group鈥檚 interim report is expected in a month or two.
