Date published: 2006/03/17
The BBC says:
Animal tests on the kind of drug given to the six men ill in a London hospital may not be the best way of evaluating the effects in people, an expert warns.
The drug they took stimulates a protein only found in humans.
Dr David Glover, an expert in drug testing, said this meant animal tests of medicines of this sort might give falsely reassuring results.
He said it might be better to look at innovative ways of testing small amounts of such drugs on people.
The drug, TGN 1412, which the six men took belongs to a class called monoclonal antibodies.
It is hoped they could combat a wide range diseases, including cancer.
They are created in the lab by fusing or merging a cell that produces antibodies - the foot soldiers of the immune system - with a cancer cell.
People's lives have been saved, and the quality of people's lives has improved dramatically over the last 25 years, thanks to monoclonal antibodies such as Herceptin, hailed as a significant breast cancer drug.
Most monoclonal antibodies prevent something happening in the body - they are "antagonists".
For example, Herceptin works by blocking the action of the Her2 protein, which can fuel the growth of breast cancers.
But TGN 1412 is an "agonist" - which boosts a particular action.
It boosts the activity of human immune system protein called CD28 which is present on the surface of white blood cells.
There have been concerns it might have been inappropriate to test such drugs on healthy volunteers, whose immune systems are already working effectively, as a further boost might push their systems into over-drive.
At this stage, there is no hard evidence to suggest this is what happened in the study that left six men seriously ill.
The problem might equally be due to a fault with the manufacturing process, or simply a unique reaction to the drug in humans that could not have been predicted.
...
Professor Chris Higgins, director of the Medical Research Council's clinical sciences centre, said that currently, all drugs were tested on at least two species of animals before they can be tested on humans."Animals are the best models we have for humans, but we all know they aren't absolutely perfect.
"Very occasionally animals do not pick up potential problems.
"But, of course, there are thousands of potential drugs that were tested on animals, and never got to humans because their potential toxicity effects were recognised."
A sensible article, for once. Nobody ever claimed that animal tests were perfect, the real question is whether they are good enough given how many animals are tortured and killed in the process. And as noted in the article, it is too early to tell what was the real problem with the TGN 1412 test.
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