Guinea pigs' drug ordeal remains a mystery as no errors found
Lyndsay Moss
Scotsman, UK
__________
The future of clinical trials appeared to be in jeopardy last night after a medicine watchdog said a drug that left six men seriously ill had an "unpredicted" response in humans.
The Medicines and Healthcare Products Regulatory Agency (MHRA) found there were no errors in the manufacture, formulation, dilution or administration of the TGN1412 drug tested on volunteers last month. It concluded that the most likely cause of the adverse reaction seen was an "unpredicted biological action of the drug in humans".
Six men suffered multiple organ failure after being given TGN1412, which is designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis. Two further men were given placebos. The MHRA said it appeared the samples of TGN1412 used had not been contaminated or "contained anything other than the correct ingredients".
It found no errors in the way the trial, conducted by research company Parexel, was carried out, or any errors in the dosage - which was 500 times weaker than that given to monkeys. The findings raise questions over the use of animals in testing and the implications for human trials. An expert group has now been formed to examine the issue and will report to the Health Secretary, Patricia Hewitt, in the next three months.
Apr 06, 2006
Lyndsay Moss
Scotsman, UK
__________
The future of clinical trials appeared to be in jeopardy last night after a medicine watchdog said a drug that left six men seriously ill had an "unpredicted" response in humans.
The Medicines and Healthcare Products Regulatory Agency (MHRA) found there were no errors in the manufacture, formulation, dilution or administration of the TGN1412 drug tested on volunteers last month. It concluded that the most likely cause of the adverse reaction seen was an "unpredicted biological action of the drug in humans".
Six men suffered multiple organ failure after being given TGN1412, which is designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis. Two further men were given placebos. The MHRA said it appeared the samples of TGN1412 used had not been contaminated or "contained anything other than the correct ingredients".
It found no errors in the way the trial, conducted by research company Parexel, was carried out, or any errors in the dosage - which was 500 times weaker than that given to monkeys. The findings raise questions over the use of animals in testing and the implications for human trials. An expert group has now been formed to examine the issue and will report to the Health Secretary, Patricia Hewitt, in the next three months.
Apr 06, 2006
