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The Empirical Basis for the Discovery of New Therapies

It is commonly held that a major change in the search for new therapies took place some time in the early decades of this century. Therapies used before that time, whether efficacious or not, are considered to have been derived on empirical grounds, while many therapies introduced in the past half-century are seen as the product of scientific reasoning. It is said that we have now entered the age of "rational drug design" [1, 2]. Indeed, "empirical" has become something of a dirty word in pharmacology [3]. Such a broad dichotomy as empirical versus scientific or rational does have some validity for understanding how therapies are introduced, but the usefulness of this distinction is limited. Empirical is defined as "relying or based solely on experiment and observation rather than theory" [4]. In this article, I will argue that the discovery of new therapies has always been and will continue to be an empirical science. The vast majority of efficacious ancient and modern drugs were discovered and initially used without any understanding of how they work. To the extent that we deny or ignore that reality in our future attempts to discover new therapies, we risk fostering a system wherein potentially efficacious treatments may be overlooked while inefficacious therapies are accepted [5]. I shall propose five patterns by which we understand how new therapies are discovered. These patterns apply to both ancient and modern times. Each of the five ways has resulted in important advances in therapeutics, and each is still a valuable path for the discovery of new therapies. Two major goals in the search for new therapies are to avoid