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Human Drug Trial Catastrophe Proves Once Again Animal Tests Cannot Be
Posted 16 March 2006
With news of the critical harm caused to six men who took part in the trial of a test medicine vaunted as a new treatment for rheumatoid arthritis, multiple sclerosis, leukaemia and cancer, calls have gone up for novel pharmaceutical products to be tested on animals. The key point is that all such pharmaceutical products go through exhaustive animal tests and are passed sufficiently safe on the basis of those tests, before progressing to the kind of trials in which these men took part.
The experimental drug, known as TGN1412, was produced using cancer cells and immune cells from mice. Prior to being given to the human guinea pigs, it was extensively tested on animals. Within hours of being injected with TGN1412, the human participants started displaying signs of severe organ failure and extensive inflammation caused by a breakdown of the immune system.
The phase 1 clinical (human) trial had been approved by the Medicines and Healthcare products Regulatory Agency after the animal tests failed to show any negative effects and, in fact, indicated that the new drug had the potential to boost the immune system, reduce infection and improve the control of certain cancers. Scientific journals had also reported on TGN1412 favourably.
Says Animal Aid's Scientific Consultant, Andre Menache:
'It is time the scientific community acknowledged that animal tests do not work. These men have been exposed to a double risk. They have had cancerous and immune cells from mice introduced into their blood stream, and it was left to animals to answer the question as to whether or not the drugs were safe to take. Clearly such a system, as we are being tragically reminded, is not supportable on public health grounds, irrespective of the morality of animal testing.'
Notes to Editors
- Before progressing to phase 1 clinical trials on human volunteers, new medicines are tested on two species of animal, typically a rodent or a dog followed by a primate.
- Adverse drug reactions to correctly-prescribed prescription drugs are the fourth biggest killer in Britain after heart disease, cancer and stroke.
- Based on its laboratory studies, the manufacturers of TGN1421, German pharmaceutical company TeGenero AG, is reported to have raised $14 million from investors to test the new drug, and to have paid each volunteer taking part in the trial $3500.
- Professor Desmond Laurence of University of London was recently quoted in the media as warning patients who volunteer for clinical trials that they do not have any legal protection in the eventuality that things go wrong.