A diligent search for new cytotoxic and cytostatic agents is being conducted from the depths of the seas to the treetops of the rain forests. Thousands of substances need to be tested until one or the other pans out, first in models that, more often than not, have little resemblance to the human disease. Sometimes the results are so promising that the substance is put to trial. A carefully orchestrated process is started, moving from Phase 1 to 3 in time-consuming, laborious and costly steps. Ethics require that a novel drug be evaluated under rigorously defined conditions: to replace currently accepted treatments without violating a patient?s right to optimal therapy is not easy. Informed consent is a legalistic obfuscation; it is next to impossible to realistically impart the consequences of untried medicine to a layperson ? and untried it remains?.until tried in statistically valid numbers of patients.
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