Hopeful signs for sick drug triallists
Hopeful signs for sick drug triallists
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Monday, 20, Mar 2006 01:42
Doctors treating six men who were involved in a clinical trial that went seriously wrong have been able to remove artificial organ support from four of them.
And there are also hopeful signs for the two sickest men, who remain in a critical condition at Northwick Park hospital in north-west London but are showing what doctors describe as "very early signs of improvement".
However, both men continue to need specialist care, and remain under the "close supervision" of the critical care team, a hospital statement released this afternoon said.
The men also continue to be sedated "for their own comfort" and remain on organ support.
All six fell ill last week after being involved in trials for the TGN 1412 drug, developed by German firm TeGenero to treat rheumatoid arthritis and leukaemia and trialled in a private unit of the hospital by American drug testing company Parexel.
Amid fears that the two most seriously ill men could remain in comas for up to a year, it has emerged today that previous tests of the drug on monkeys led to what TeGenero described as a temporary swelling of the animals' glands.
But the firm insists that the monkeys' response to the drug was different to that of the men last Monday and that the triallists were made aware of this fact.
Dr Benedikte Hatz, the chief executive officer of TeGenero, earlier said such a severe reaction to the drug trials was "completely unexpected" and does not reflect the results obtained from initial laboratory studies.
"The clinical trial performed by Parexel adhered to standard clinical research guidelines," he said.
The Medicines and Healthcare Products Regulatory Agency (MHRA) and the Metropolitan police are investigating the circumstances surrounding the trial.