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Society's Choices: Social and Ethical Decision Making in Biomedicine
crease over 1992. This investment amounts to 16.7 percent of the industry's expected sales in 1993, four times the average of R&D investment for all U.S. industries that conduct research (Beary, 1993). Since 1988, the member companies of the Pharmaceutical Manufacturers Association (PMA) have supported more R&D than the NIH, with industry spending totaling $9.2 billion in 1991 (PMA, 1991). Although it is difficult to accurately estimate the costs of developing any single drug, DiMasi et al. (1991) estimated that the average cost of developing a single drug was $231 million. A more recent report by the OTA (1993) estimates that the average cost to a company for moving a single new medicine from laboratory to practice is presently $359 million.
The high cost of drug development is partly a result of the rigorous testing process that a new drug undergoes. It takes an average of 12 years for a new drug to reach the market, and for every 5,000 compounds that are evaluated, only 5 enter clinical trials in humans and only 1 is approved (Wierenga and Eaton, 1993). In spite of the huge investments of time and money required to produce a single drug, the pharmaceutical industry has been highly productive, commercially successful, and highly profitable to its investors. Kaitin et al. (1993) studied 196 new chemical entities that had been approved by the FDA between 1981 and 1990, and found that 181 drugs (92.4 percent) were developed by the pharmaceutical industry, 7 by academia, 2 by the government, and 2 by individuals.
As the biotechnology and pharmaceutical industries play an increasing role in the economic competitiveness of our society, industry needs new resources from various sectors of society. From the regulatory agencies, it needs clear guidance on what is expected in terms of safety and efficacy regarding the testing process, as well as an efficient approval process. The success of industry also depends on basic biomedical research in academic and government laboratories, a vital academic research enterprise that generates new scientific insights. Industry also looks to the academic research community for new skills and techniques, specific assays and reagents, personnel to conduct clinical trials, consultants and collaborators, individuals to provide expertise to regulatory agencies, and highly skilled scientists and technicians to work in industry. To facilitate cooperation between academia and industry, value questions related to ownership of intellectual property rights and conflicts of interest must be resolved.
A 1990 National Academy of Sciences (NAS) report on industrial perspectives on innovation and interactions with universities concluded that, in the early stages of large scientific breakthroughs, industry needs interaction with university scientists, who are at the forefront of scientific knowledge. As a breakthrough matures, however, incremental improvements (product- and process-oriented technical changes that are related to competitiveness) occur most often within industry only. Thus, primary roles