Chemistry in the Pharmaceutical Industry
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about the high prices of prescription drugs This chapter will discuss the role of chemistry and the hardships this places upon the elderly within the pharmaceutical industry. Although and others of limited income. Consequently, the focus will be upon the industry within the some consumer advocate groups support United States, much of the discussion is governmental imposition of price controls, equally relevant to pharmaceutical companies such as those that exist in a number of other based in other first world nations such as countries, on ethical pharmaceuticals in the Japan and those in Europe. The major objec- United States. However the out-of-pocket dollars spent tive of the pharmaceutical industry is the discovery, development, and marketing of by patients on prescription drugs must be efficacious and safe drugs for the treatment of weighed against the more costly and unpleashuman disease. Of course drug companies do ant alternatives of surgery and hospitalizanot exist as altruistic, charitable organizations tion, which are often obviated by drug but like other share-holder owned corpora- therapy. Consideration must also be given to tions within our capitalistic society must the enormous expense associated with the achieve profits in order to remain viable and development of new drugs. It can take 10 competitive. Thus, there exists a conundrum years or more from the laboratory inception between the dual goals of enhancing the qual- of a drug to its registrational approval and ity and duration of human life and that of marketing at an overall cost which is now increasing stock-holder equity. Much has $600-800 million dollars and increasing. been written and spoken in the lay media Only 1 out of 10 to 20,000 compounds prepared as drug candidates ever reach clinical testing in man and the attrition rate of those that do is >80 percent. The expense of devel*Bristol-Myers Squibb Company, Wallingford, CT. **Achillion Pharmaceuticals, New Haven, CT. oping a promising drug grows steadily the INTRODUCTION
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Riegel Handbook ofIndustrial Chemistry, 1Oth Edition
Edited by Kent. Kluwer Academic/Plenum Publishers, New York 2003
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RIEGEL'S HANDBOOK OF INDUSTRIAL CHEMISTRY
further through the pipeline it progresses; clinical trials can be several orders of magnitude more costly than the preclinical evaluation of a compound. While the sales of successful drugs that run the gauntlet and reach the shelves of pharmacies can eventually recoup their developmental expenses many times over, the cost of the drugs that fail is never recovered. To a large extent, the difficulties associated with bringing a drug to market have arisen from the increasingly stringent but appropriate criteria that have been imposed by the Food and Drug Administration (FDA) in the United States and analogous regulatory agencies in other countries. It is unlikely that an occurrence like that of the thalidomide disaster, which resulted in horrible birth defects several decades ago, would happen again today. Furthermore the era of easy approval o
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