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Unformatted text preview: Ashley B. Hilliard 258-10-0169 October 4, 2010- January 21, 2011 BA 541 Lesson#3, Assignment 4 Read Case #6, "Samuel Waksal and ImClone," on pages 129-131 of Business Ethics: A Stakeholder and Issues Management Approach (5 th Edition). Consider and respond to the following questions in an essay of 300-350 words: 1. What might motivate an individual or a company to shortcut drug testing that is crucial for FDA approval? 2. Why did Samuel Waksal react as he did pursuant to learning that the FDA would not approve Erbitux? 3. Why were Samuel Waksals actions unethical? Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions. These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place. Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies...
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