Two men who took part in a clinical trial for an experimental drug to treat chronic inflammatory conditions and leukaemia are currently critically ill in Northwick Park hospital, UK. The neck of one of the men has swollen to three times its normal size. A girlfriend of one of the drug trial volunteers said her boyfriend looked like ?Elephant Man’ (BBC). Apparently, his head became wider than his waist.
Eight healthy men volunteered to take part in this drug trial. Two of them were given a placebo (dummy drug) while the other six were given the experimental drug – TGN 1412. All six men who were given TGN 1412 are now ill, two of whom are in a critical condition. The other four became seriously ill, but are now said to be making a recovery.
This is unheard of in clinical trials. The APBI (Association of the British Pharmaceutical Industry) said nothing comparable has ever happened.
The clinical trial was in its first phase – this means the experimental drug is tested on healthy human volunteers.
The MHRA (Medicines and Healthcare products Regulatory Agency) has inspectors on site trying to find out exactly what happened. For the moment, everyone is baffled.
The MHRA has suspended the trial and told other European agencies about the incident.
This bizarre complication could be caused by one of several factors. Perhaps something went wrong in the manufacturing of the drug, it could have been contaminated, the patients could have been contaminated by something in the hospital (doubtful as the placebo patients were OK), there could have been an error in the dosage – or it could be something completely unrelated to anything we have knowledge of.
Parexel International Corp. (USA) was running the trial for TeGenero AG (Germany).
The volunteers were paid ?2000 ($3500) each for taking part in the trial.
In a BBC interview, the girlfriend of one of the men who is now critically ill said doctors told her that her boyfriend needs a miracle to pull through.
Written by: Christian Nordqvist
Editor: Medical News Today