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Unformatted text preview: drug testing in the United States. The roots of an expanding drug-testing regime are traceable to the post – World War II pharmaceutical boom in the United States, when a fee-for-service industry evolved in response to a demand for more safety testing in animals. Another point of origin for the expansion of humansubjects recruitment efforts dates back to the early 1970s, when the use of prisoner subjects in the United States was exposed and severely limited. According to one prominent executive, widely regarded as a founder of the CRO industry, pharmaceutical companies in the United States began internationalizing their human-subjects recruitment efforts as a response to regulatory limitations on prison research. (He directed the internationalization effort for one company in the mid-1970s.)7 The scale of U.S. prison research was impressive: An estimated 90 percent of drugs licensed prior to the 1970s were first tested on prison populations (Harkness 1996). When the ban on use of prisoners set in (for particular phases of testing), pharmaceutical companies lost almost an entire base of human volunteers and shifted a good deal of their research elsewhere, namely, to Europe (and countries with regulatory-friendly environments), but also to other areas with large subject pools whose access could be guaranteed because of centralized health systems and the closed nature of referral systems. By the early to mid-1980s, pharmaceutical companies were routinely outsourcing laboratory and clinical services, including preclinical bioassays, in which the activity of a chemical is assessed (mainly in animal models), and the monitoring of inv...
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This note was uploaded on 10/10/2010 for the course ENG 000121 taught by Professor Mcgrand during the Spring '10 term at Cornell.
- Spring '10