Thursday, March 23, 2006

A radical proposal: body donors for drug testing

As you probably know, at the beginning of this week there was a clinical trial that ended badly.

An antibody called TGN1412, from a Biotech called TeGenero was tested on six healthy men. All of them fell very ill. At this moment, it is not clear if the violent reaction that the biological induced in the volunteers was due to a contaminated batch or to the drug itself. The drug, an anti CD28, was thought to be useful to treat leukaemias and rheumatoid arthritis. Although some experts say that such a violent reaction is not something totally unexpected, others believe that this effect couldn't be anticipated.

This kind of situation shows us one of the biggest problems of drug research and development. By definition, new drugs may have unforeseen effects. They may not have any therapeutic value, regardless of the hypothesis that fostered the work on them. Moreover, they can even be dangerous because of pleiotropy at the target (i.e., the target is involved in other functions that are needed for maintain health), or they can be harmful because they have off target effects (toxic metabolites, lack of enough selectivity, and many other possibilities). The absolute truth is that there is no reliable way to predict with 100% of certainty what will do a new molecule to humans. There are many ways to reduce the risk: in vivo (animal) tests, in vitro (e.g., cellular), and in silico (e.g., structural alerts). But, in the end, the real "smoke test" will be the first administration in humans. That's why I would like to make a radical (and humble) proposal:

Les't enroll body donors to make the First In Man drug development step

What do I mean? As there are donors for organ transplant, there could be body donors. A body donor would be a person that, in case of brain death, would allow to assay innovative drugs in their artificially sustained body. The person would be no longer there. His brain would be dead, but the rest of his body would be kept alive for a while to make possible studies that would be too risky to perform in living humans. I regard this solution as technically possible and ethically acceptable.


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