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The Pharmaceutical Industry’s Responsibility for Protecting Human ...

Source: www.columbia.edu
Topic: Pharmaceutical Industry

Sort Desciption: vate litigation plays in pressuring the pharmaceutical industry to ...... ture of the pharmaceutical industry means that the actions of one ...

Content Inside: File: Kelleher15 Created on: 10/19/2004 2:24 PM Last Printed: 10/19/2004 2:36 PM The Pharmaceutical Industry’s Responsibility for Protecting Human Subjects of Clinical Trials in Developing Nations F INNUALA K ELLEHER * Pharmaceutical companies increasingly perform clinical trials in develop- ing nations. Governments of host nations see the trials as a way to provide otherwise unaffordable medical care, while trial sponsors are drawn to those countries by lower costs, the prevalence of diseases rare in developed nations, and large numbers of impoverished patients. Local governments, however, fail to police trials, and the FDA does not monitor trials in for- eign countries, resulting in the routine violation of international standards for the protection of human subjects. This Note proposes independent ac- creditation of those institutions involved in clinical trials — the institu- tional review boards which oversee trial protocol; the organizations, such as pharmaceutical companies, which sponsor the trials; and the research organizations that conduct the trials. Accreditation, similar to that used in the footwear and apparel industries, would increase the transparency of pharmaceutical trials and would enable the United States government and consumers to hold trial sponsors accountable for their actions. I. I NTRODUCTION In August 2001, thirty Nigerian families sued Pfizer, the world’s largest pharmaceutical company, in the United States under the Alien Tort Claims Act, alleging that Pfizer had violated the law of nations in the course of clinical trials conducted during * Articles Editor, C OLUM . J.L. & S OC . P ROBS ., 2004–2005. The Author would like to thank her family and friends for their support over the last year. File: Kelleher15 Created on: 10/19/2004 2:24 PM Last Printed: 10/19/2004 2:36 PM 68 Columbia Journal of Law and Social Problems [38:67 a meningitis epidemic in Kano, Nigeria. 1 The plaintiffs claimed that Pfizer and it ...

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