 April 26, 2006
| Topic: |
The TeGenero Monoclonal Antibody Study and
the Science and Ethics of Generalizing Animal Test Results to Humans |
| Presenter: |
Gayle Simon,
San Diego State University |
| Location: |
SDSU Foundation: Sky Park |
| Discussion: |
Last month, six healthy volunteer male subjects involved in a phase I study to test a new anti-inflammatory drug became critically ill during their participation. The drug caused hyper-stimulation of the immune system resulting in severe swelling, convulsions and organ failure. As of April 5, 2006, five of the six subjects have been released from the hospital and one is "making steady progress." The drug was developed by the German company "TeGenero."
A TeGenero spokesperson defended the trial results: "The drug was tested extensively in laboratories and has been tested on rabbits and monkeys. We saw no drug-related adverse events and there were no drug-related deaths." It was later publicized that the drug caused lymph gland swelling in monkeys which was known to the ethics board that reviewed the study. Since the subjects became ill, expert scientists have argued that this type of drug stimulates a protein that is found exclusively in humans which raises questions about the validity of the animal results. It was recently revealed that the study was conducted according to protocol and that the drug given to participants was in no way contaminated which further raises doubt about the validity of the animal results.
This discussion will mainly focus on the scientific process by which animal models are chosen to represent human responses to investigational drugs and chemicals. Additionally, we will discuss how accurate animal models are in predicting human responses to investigational drugs and chemicals. The possibilities for using alternatives to animal models such as in vitro models will be raised. Examples from other studies will be explored in which inadequate review of animal literature was allegedly related to the deaths of research subjects. This study also raises other ethical red flags which may lead to other potential topics for discussion such as involving healthy volunteers in risky studies and the value of the incentive used to attract participants. |
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