In January 2005 it was reported that a patient benefitting from an experimental cancer drug was taken off it because it was not working for other patients in a phase I clinical trial, and it was considered too risky financially to move on to phase II trials. You might have thought then that the idea of custom-tailoring drugs to suit individual patients (the central component of personalized medicine) was a non-starter on financial grounds alone.
But a year later the one-size-fits-all “blockbuster” drug paradigm behind such thinking began to be turned on its head, and a drug that works for a more or less small subset of patients is now at least somewhat more likely to be pursued than to be summarily abandoned. Such was the case with BiDil, approved by the US Food and Drug Administration in June 2005 specifically for African-Americans with heart disease.
BiDil was only one of several portents of the imminent arrival of personalized medicine. Others included the injection of big venture capital into pharmacogenomics — the development of drugs to fit an individual’s genomic quirks — and the rapid growth of the Personalized Medicine Coalition, launched in 2004. At the end of 2006, the PMC’s 100 or so members included not only major venture capitalists, major biotech companies, and major traditional drug makers, but also IBM and General Electric. IBM saw big business opportunities in personalized medicine as more researchers turned to supercomputers to mine mountains of data for cures for disease.
IBM was right. 2006 marked the beginning of a true revolution in medicine. The following sections show that despite barriers, which are not likely to go away anytime soon, there was an explosion of personalized medicine research and resulting diagnostic tests and preventive or curative