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In March 2006, the world press reported the case of the 6 British volunteers who after and the injection of a monoclonal antibody found themselves in serious conditions in intensive care. (Wadman. Nature 2006). The tragic consequences of this accident have led to an increased level of concern among the population. One year after, what lessons have been learned ? Are volunteers for medical research really at risk?
A study conducted by a reputable company, in respect of the ethical regulations in place(Emanuel et al. Am.J.Bioeth. 2007). An exceptional accident, unacceptable at the same time. The scientific community has had to learn some lessons. New recommendations have strengthened risk analysis procedures and the planning of dosages (Kenter et al. Lancet 2006). A minimum interval between the administration of the new molecule to different volunteers has sought to avoid any situation where the same secondary effect could be repeated on six people at the same time (Hemelaar. Lancet 2007). These precautions are even more essential, as it relates to new therapeutic approaches issued by recent research in biotechnologies.
But this accident should not mask the considerable benefits of medical research on human volunteers. Without it, no therapeutic, diagnostic or preventive progress would be possible. Thousands of tests on volunteers take place everyday in the entire world, in very good security conditions. We still wait for the day when computer models will allow a simulation of the human body. Unfortunately, this is still a long way away!
On the other hand, there are not only drug studies recruiting volunteers. The testing spectrum is very wide and includes psychological, genetic and imaging tests cosmetic products’ testing, nutritional products and medical equipment itself.
Medical research on volunteers is a cause of rare accidents, that’s true... Domestic accidents cause 20,000 deaths in France every year… which must also be considered…
Références
- Emanuel and Miller. Money and distorted ethical judgments about research: ethical assessment of the TeGenero TGN1412 trial. Am.J.Bioeth. 2007, 7:76-81.
- Hemelaar. Minimising risk in first-in-man trials. Lancet 2007, 369:1496-1497.
- Kenter and Cohen. Establishing risk of human experimentation with drugs: lessons from TGN1412. Lancet 2006, 368:1387-1391.
- Wadman. London's disastrous drug trial has serious side effects for research. Nature 2006, 440:388-389.
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