Epstein Argues That Medical Innovation Occurs in Spite of, Not Because of, Government Regulators
One of the most pressing questions of modern biomedical research asks what the relationship between government regulation and scientific innovation is. Nothing is more common today than the plea that extensive government regulation, at every stage of the development process, is needed to protect innocent and uninformed patients and their families from exploitation by pharmaceutical companies, hospitals, and physicians. The underlying assumption is that good-faith government regulators can fill the void between ordinary people and the self-interested institutions that dominate our private lives. Indeed, filling this void is the purpose of the Food and Drug Administration (FDA), which supervises pharmaceutical companies.
It was not always thus. Recently, I had occasion to visit the New York City Historical Society , which is featuring an excellent exhibit on the 1921 discovery of insulin by scientists Frederick Banting and Charles Best at the University of Toronto. That exhibit displayed a superb book by Thea Cooper and Arthur Ainsberg called "Breakthrough: Elizabeth Hughes, the Discovery of Insulin, and the Making of a Medical Miracle." The title is not hyperbole. In fact, it behooves us to ask: could the same miracle be achieved today under the weight of our heavy system of regulation?