11. Chemistry in the Pharmaceutical Industry

This chapter discusses the role of chemistry within the pharmaceutical industry [1–3]. Although the focus is upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first-world nations such as Japan and those in Europe. The primary objective of the pharmaceutical industry is the discovery, development, and marketing of safe and efficacious drugs for the treatment of human disease. However, drug companies do not exist as altruistic, charitable organizations. As with other shareholder-owned corporations within a capitalistic society, drug companies must earn profits in order to remain viable. Profits from the enterprise finance the essential research and development that leads to new drugs designed to address unmet medical needs. Thus, there exists a tension between the dual goals of enhancing the quality and duration of human life and that of increasing stockholder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships these place upon the elderly and others of limited income. Consequently, some consumer advocate groups support governmental imposition of price controls on ethical pharmaceuticals in the United States, such as those that exist in a number of other countries. However the out-of-pocket dollars spent by patients on prescription drugs must be weighed against the more costly and inherently risky alternatives of surgery and hospitalization, which can often be obviated by drug therapy. Consideration must also be given to the enormous expense associated with the development of new drugs. It typically takes 10 or more years from the inception of a drug in the laboratory to registrational approval and marketing at an overall cost which is now estimated to be in excess of $800 million and increasing, a figure that includes the opportunity costs of failed development campaigns. Only 1 out of 10,000–20,000 compounds prepared as potential drug candidates ever reach clinical testing in humans and the attrition rate of those that do is >80%, a success rate that has been stubbornly difficult to change despite advances in improving candidate quality and significant increases in investment in research and development. The expense of developing a promising drug grows steadily further through the pipeline it progresses; clinical trials can be several orders of magnitude more costly than the preclinical development of a compound. While the sales of drugs that complete clinical trials and reach the shelves of pharmacies can eventually recoup their developmental expenses many times over if successful, many fail to do so and the cost of the drugs that fail is never recovered.