The era of personalized medicine based on validated biomarkers is at hand. As the increasing numbers and types of cancer drugs are developed, oncologists become more and more likely to misuse them in their practice. Developing a good and clinically practical drug selection system is no less important than the discovery of new drugs or how to put them into the body.

The needed change in the 'war on cancer' will not be on the types of drugs being developed, but on the understanding of the drugs we have. The system is overloaded with drugs and underloaded with the wisdom and expertise for using them.

The single most neglected area of cancer research has been the development of methods and technologies to be matchmakers between individual cancer with individual cancer treatment. The single most neglected area of cancer treatment has been the unwillingness to utilize the matchmaker technologies which have already been developed and which are already available.

Two years ago, three federal agencies, NCI, FDA, and CMS, announced their program to try to identify biological indicators, or biomarkers, which may indicate whether a cancer patient is likely to benefit from a given anti-cancer therapy, or even whether they will suffer from certain side effects. Biomarkers were already a part of drug development, but health officials wanted to routinely incorporate those measurements into clinical trials.

We have the biomarkers for who will respond so we don't give these powerful and expensive medicines to those who won't. Just look at the Iressa/Tarceva story. A total failure of huge clinical trials because the proper patients were not selected. We should be able to detect cancer pathways with biomarkers and choose patients for a trial based on who responds very quickly to a drug. The ordinary trial system will not suffice if we are to encourage new drugs for restricted numbers of patients.

The methods of cancer medicine during the last thirty some years are coming to haunt the "one-size-fits-all" establishment. Technologies, developed over the last twenty years by private researchers, hold the key to solving some of the problems confronting a healthcare system that is seeking ways to best allocate available resources while accomplishing the critical task of matching individual patients with the treatments most likely to benefit them.