problem is that the drug approval process is built around assessing individual drugs on their own and looking for levels of activity that are greater than existing ‘‘standards.’’ If the level of activity is simply equivalent, even if the mechanism of action is different, then it is likely that the new agent will not be approved. The whole process is based on the discredited notion that there are magic bullets for cancer and that combination therapy is something that can be done after a single agent is approved. Unfortunately, if the new agents are not dramatically effective on their own, they will not be approved and we will continue on the fruitless search for a magic bullet. A process that was developed for sleeping pills has to be harmonized with what will likely be required for effective cancer therapies (22).

CONCLUSIONS

The management of most kinds of epithelial cancers has in a sense ‘‘hit the wall.’’ It seems reasonable to expect, however, that common sense will prevail in the drug development and approval process. Scientific and technological advances have given us immensely powerful tools for expanding our understanding of cancer and for producing therapeutic agents of greatly enhanced specificity and effectiveness. Also, if it can be convincingly demonstrated that many of the major clinical malignancies have an infectious basis then truly efficacious prevention strategies can be initiated.

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