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October 1995

The Crime of Saving LivesThe FDA, John Najarian, and Minnesota ALG

Author Affiliations

Dr Leonard G. Wilson is Professor and Head, Department of History of Medicine, University of Minnesota, Minneapolis.

Arch Surg. 1995;130(10):1035-1039. doi:10.1001/archsurg.1995.01430100013002

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The indictment of John Najarian, MD, and Richard Condie at Minneapolis, Minn, on April 10, 1995, was a defining episode in the prolonged agony that has ensued since August 1992, when the federal Food and Drug Administration (FDA) placed Minnesota Anti—Lymphocyte Globulin (MALG) on clinical hold, bringing to an end its use as an immunosuppressive agent for patients undergoing transplantation. The principal charge in the indictment is that from about 1968 until 1992—the whole period of the development and use of MALG—Dr Najarian and Mr Condie conspired to defraud the United States by impeding the FDA in its oversight of biological drugs and that they did so for the purpose of financial gain. If the charges can be considered seriously, they mean that Dr Najarian's purpose in the development and manufacture of MALG was to make money, presumably for himself, and that the possible benefit of MALG to the

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