Why Public Health Agencies Cannot Depend on Good Laboratory Practices as a Criterion for Selecting Data: The Case of Bisphenol A

作者：John Peterson Myers, Frederick S. vom Saal, Benson T. Akingbemi, Koji Arizono, Scott M. Belcher, Theo Colborn, Ibrahim Chahoud, D. Andrew Crain, Francesca Farabollini, Louis J. Guillette, Terry Hassold, Shuk‐Mei Ho, Patricia A. Hunt, Taisen Iguchi, Susan Jobling, Jun Kanno, Hans Laufer, Michele Marcus, John A. McLachlan, Ángel Nadal, Jörg Oehlmann, Nicolás Olea, Paola Palanza, Stefano Parmigiani, Beverly S. Rubin, Gilbert Schöenfelder, Carlos Sonnenschein, Ana M. Soto, Chris E. Talsness, Julia A. Taylor, Laura N. Vandenberg, John G. Vandenbergh, Sarah Vogel, Cheryl S. Watson, Wade V. Welshons, R. Thomas Zoeller · 发表于：Environmental Health Perspectives · 年份：2008 · DOI：10.1289/ehp.0800173 · 被引用次数：305 · 研究领域：Effects and risks of endocrine disrupting chemicals、Health, Environment, Cognitive Aging、Animal testing and alternatives

BACKGROUND: In their safety evaluations of bisphenol A (BPA), the U.S. Food and Drug Administration (FDA) and a counterpart in Europe, the European Food Safety Authority (EFSA), have given special prominence to two industry-funded studies that adhered to standards defined by Good Laboratory Practices (GLP). These same agencies have given much less weight in risk assessments to a large number of independently replicated non-GLP studies conducted with government funding by the leading experts in various fields of science from around the world. OBJECTIVES: We reviewed differences between industry-funded GLP studies of BPA conducted by commercial laboratories for regulatory purposes and non-GLP studies conducted in academic and government laboratories to identify hazards and molecular mechanisms mediating adverse effects. We examined the methods and results in the GLP studies that were pivotal in the draft decision of the U.S. FDA declaring BPA safe in relation to findings from studies that were competitive for U.S. National Institutes of Health (NIH) funding, peer-reviewed for publication in leading journals, subject to independent replication, but rejected by the U.S. FDA for regulatory purposes. DISCUSSION: Although the U.S. FDA and EFSA have deemed two industry-funded GLP studies of BPA to be superior to hundreds of studies funded by the U.S. NIH and NIH counterparts in other countries, the GLP studies on which the agencies based their decisions have serious conceptual and me...