ABSTRACT
In a field not without controversy, lymphocyte immunization therapy (LIT) has arguably generated the most intense debate. LIT is an immunologic treatment for miscarriage involving the immunization of the prospective mother with paternal mononuclear cells. In January of 2002, the U.S. Food and Drug Administration (FDA) posted a letter limiting LIT to the terms of an investigational new drug application, an “IND.” Two reasons were given for the restriction: first, the FDA claimed LIT involved unsafe administration of a human blood product. Second, a randomized controlled trial published in the Lancet concluded that LIT does not work.1 Citing these two concerns, the FDA restricted use of the therapy in the United States.2 Despite the U.S. restriction, many practitioners continue to utilize the therapy elsewhere in the world, claiming (a) LIT is effective; (b) LIT can be administered within legal blood transfusion guidelines; and (c) the study reported in the Lancet, the “Ober study,” was fatally compromised by poor design and execution. We will show that the study results were rendered uninterpretable by a number of methodological problems. Supporters claim that, when used in accordance with procedures advocated by Beer on appropriately selected patients,3 LIT is both safe and effective. We will argue for the need for larger prospective trials to overcome flaws of the study if we are to fairly judge LIT’s efficacy.
