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Expanded Access and Insights from the Pioneering Work of Dr. Thomas E. Starzl

Snyder, Christopher (2023) Expanded Access and Insights from the Pioneering Work of Dr. Thomas E. Starzl. (Unpublished)

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Expanded Access is a program designed to connect patients with experimental therapeutics when no other FDA-approved options are available for their given disease. In the 1980s, Dr. Thomas E Starzl, the father of modern organ transplantation, pursued the development and approval of multiple experimental immunosuppression compounds to prevent acute organ rejection in transplant patients. We will examine a historical case study of Dr. Starzl’s work with OKT-3 (muromonab) which will provide context for a discussion regarding the degree of autonomy we should grant physicians to make ethical decisions in critical Expanded Access cases, as well as the amount of oversight necessary to protect these vulnerable patients. Although this case is historical, we may gain insight into the modern problem of Expanded Access which parallels Dr. Starzl’s compassionate use requests for experimental therapies nearly three decades ago.


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Item Type: Article
Status: Unpublished
CreatorsEmailPitt UsernameORCID
Snyder, Christophercms339@pitt.educms3390009-0005-6093-941X
ContributionContributors NameEmailPitt UsernameORCID
CollaboratorBrodt, Zacharyzlb2@pitt.eduUNSPECIFIEDUNSPECIFIED
CollaboratorRampelt, Jasonrampelt@pitt.eduUNSPECIFIEDUNSPECIFIED
CollaboratorZautra, Nicholasngz4@pitt.eduUNSPECIFIEDUNSPECIFIED
Date: 26 May 2023
Refereed: No
Article Type: Research Article
Additional Information: Research made possible by the Archival Scholars Research Award (ASRA) 2023
Date Deposited: 31 May 2023 14:01
Last Modified: 31 May 2023 14:01


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