Final drug trial victim out of the woods
PrintAs placebo man balks at follow-ups
Posted in Biology, 5th April 2006 16:03 GMT
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All of the volunteers given an experimental immune drug in a London trial have now made it off the critical list at Northwick Park hospital.
The last of six men given biotech firm TeGenero's TGN1412 compound is now fully conscious and looks set to make a full recovery.
Intensive care clinical director Dr Ganesh Suntharalingam said: "We are delighted that the six patients have come through safely from the most critical stage of their condition."
He praised intensive care staff for how they dealt with the victims' very serious condition when they were transferred there from a private testing unit more than three weeks ago.
TeGenero said today its preliminary investigations showed it had followed all correct procedures in the animal testing phase of the drug. It also says the problem was unforseeable based on preclinical results (see here for why many think the problems might have been foreseeable though).
Watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) agreed, saying it hasn't been able find a problem with how the trial was carried out.
It also couldn't find evidence of contamination of the drug. Some had speculated bacterial toxins might be responsible for the multiple organ failure.
MRHA added that its findings are not yet conclusive, but that the suspected flaws in the action of the drug itself were the most likely cause. The Secretary of State for Health is assembling a panel of experts to investigate why the animal trials didn't pick up the near-deadly complications.
Meanwhile, Raste Khan, 23, one of the men given a harmless placebo, appeared in The Sun today, saying he was still traumatised by what he saw during the trials. "I still feel haunted by it and I know my family have been extremely upset. I am too frightened even to get sleeping pills from the doctor."
He claims test contractor Parexel is demanding he honour the terms of his contract by attending follow-ups in order to pocket his £2,000 volunteer fee.
Testing contractor Parexel was unavailable for comment. ®
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