Ethics

The production of monoclonal antibodies requires the deliberate induction of cancer in mice.The mice are used to produce antibodies and tumour cells. There are guideline for the use of mice in these procedures to minimise any suffering but some animal welfare groups oppose using mice in this way.The use of monoclonal antibodies for direct monoclonal antibody therapy is not without significant risk.Some deaths occur in the use of monoclonal antibodies to treat multiple sclerosis and other auto-immune diseases.The patient must be fully aware of the risks of the treatment before giving informed consent.The benefit to the patient should outweigh the risks of the treatment.In March 2006 clinical trials of a new monoclonal antibody TGN1412 resulted in six healthy volunteers suffering multiple organ failure.Drug trials of monoclonal antibodies may also involve significant risk and have to be carefully monitored and regulated.