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Vanilla with a twist
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Would you ever take part in a drug trial for money?
drug tral
Drug trial ignored guideline on safety
By Nigel Hawkes, Health Editor
DRUG trials that left six healthy volunteers fighting for their lives did not conform to best medical practice, The Times has been told.
Senior doctors expressed concern that all six were given the same dose of the experimental drug TGN1412 at the same time. According to the standard medical text, trials of this sort should avoid giving all the doses simultaneously. The Textbook of Pharmaceutical Medicine specifically gives warning that such practices can be “very difficult to manage” and “put subjects at unnecessary risk”.
Last night the Medical and Healthcare Products Regulatory Agency was urgently investigating what went wrong in the the trials, as families kept up a vigil at the patients bedsides. It is trying to determine whether it was a fault in production, contamination or more likely an intrinsic problem with the drug itself.
“They haven’t got a cure,” said Myfanwy Marshall, whose boyfriend fell ill 90 minutes after taking the drug. “This is a drug they have never tested on humans before so they don’t know what they are dealing with. It’s completely messed up their vital organs.”
There was confusion last night about whether the drug had been tested successfully on animals before the tests on human volunteers.
“They [the drugs company] said there was an oversensitivity in monkeys,” Ms Marshall said. She went on to say that in the tests a “dog and some animals had died . . . so they reduced the amount to humans”.
Thomas Hanke, chief scientific officer of TeGenero, last night refused at a press conference to say whether animals had died during earlier tests. “There has been no issue on the safety of the drug on animals. This is not relevant,” he said. He said the drug had been tested on mammals but not dogs or rats.
He said that the company had apologised to relatives of the six ill volunteers. “We are devastated at these shocking developments which we were not anticipating. The investigation must proceed as quickly as possible (into) the testing of a new medicine which showed no signs of any safety problems in previous testing.”
drug tral
Drug trial ignored guideline on safety
By Nigel Hawkes, Health Editor
DRUG trials that left six healthy volunteers fighting for their lives did not conform to best medical practice, The Times has been told.
Senior doctors expressed concern that all six were given the same dose of the experimental drug TGN1412 at the same time. According to the standard medical text, trials of this sort should avoid giving all the doses simultaneously. The Textbook of Pharmaceutical Medicine specifically gives warning that such practices can be “very difficult to manage” and “put subjects at unnecessary risk”.
Last night the Medical and Healthcare Products Regulatory Agency was urgently investigating what went wrong in the the trials, as families kept up a vigil at the patients bedsides. It is trying to determine whether it was a fault in production, contamination or more likely an intrinsic problem with the drug itself.
“They haven’t got a cure,” said Myfanwy Marshall, whose boyfriend fell ill 90 minutes after taking the drug. “This is a drug they have never tested on humans before so they don’t know what they are dealing with. It’s completely messed up their vital organs.”
There was confusion last night about whether the drug had been tested successfully on animals before the tests on human volunteers.
“They [the drugs company] said there was an oversensitivity in monkeys,” Ms Marshall said. She went on to say that in the tests a “dog and some animals had died . . . so they reduced the amount to humans”.
Thomas Hanke, chief scientific officer of TeGenero, last night refused at a press conference to say whether animals had died during earlier tests. “There has been no issue on the safety of the drug on animals. This is not relevant,” he said. He said the drug had been tested on mammals but not dogs or rats.
He said that the company had apologised to relatives of the six ill volunteers. “We are devastated at these shocking developments which we were not anticipating. The investigation must proceed as quickly as possible (into) the testing of a new medicine which showed no signs of any safety problems in previous testing.”
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