What would an alternative process be?
When you do things wrong with drugs you can do real harm, and we don't want to walk down that road either. The challenge is to make full use of the most powerful scientific tools, which now make possible this amazingly promising and powerful form of molecular medicine. You want to integrate this into every level of your analysis. We want comprehensive molecular data during the diagnostic stages. We want to encourage drug companies to develop targeted drugs, and we want to have an FDA approval process which assumes that molecular tracking is possible and in the trials themselves takes full advantage of this and develops these precision prescription protocols.
What are the obstacles to change?
The FDA has some very good people. I quote some of them in my book. [But] the protocols these institutions are using, they're now 50 years old. I think agencies develop some inertia. They get very good at doing something they've done for a long time and, when revolutionary change occurs, it's difficult to adapt.