Lunch Discussion with Bartley J. Madden

and the

Competitive Enterprise Institute

About the Book

Deaths from an approved drug make headlines and often lead to congressional inquiries, so avoiding such negative publicity is an overriding goal of the Food and Drug Administration.  The resulting tunnel focus on safety means delayed access to innovative drugs, which in turn causes millions of people to suffer and many to die needlessly.  It is clear that the appropriate system goal should be better drugs, sooner, at lower cost.  But the goal of faster access at lower cost is downplayed by the FDA while it demands ever more testing.

In Free to Choose Medicine, Bartley J. Madden proposes to break this bottleneck in the drug development system by empowering patients to choose experimental medicines that have successfully passed early safety and efficacy trials.  Their decisions would be informed by an innovative Tradeoff Evaluation Database, but the choice of whether the potential benefits of a not-yet-approved drug outweigh its risks would be placed in the hands of patients and their doctors.

In this bold and provocative book, Madden explains how this Free to Choose Medicine approach would provide a drugs-to-patients system that can adapt to a future with an accelerated pace of medical innovation, coupled to the widespread advancement of personalized medicine.

Copies of Free to Choose Medicine will be available at the luncheon.

About the Author

Bartley J. Madden is an economist and engineer whose current research applies a systems analysis and economic problem solving mindset to public policy issues, including FDA reform, the interdependence between knowledge building and wealth creation, and corporate governance.  He has written about his dual tracking proposal in scientific and other scholarly journals, including Cancer Biotherapy & Radiopharmaceuticals, Medical Hypotheses, and Regulation.