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Title: Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of Bisphenol A
Authors: Myers, JP
Vom Saal, FS
Akingbemi, BT
Arizono, K
Belcher, S
Colborn, T
Chahoud, I
Crain, DA
Farabollini, F
Guillette, LJJ
Hassold, T
Ho, S
Hunt, PA
Iguchi, T
Jobling, S
Kanno, J
Laufer, H
Marcus, M
McLachlan, JA
Nadal, A
Oehlmann, J
Olea, N
Palanza, P
Parmigiani, S
Rubin, BS
Schoenfelder, G
Sonnenschein, C
Soto, AM
Talsness, CE
Taylor, JA
Vandenberg, LN
Vandenbergh, JG
Vogel, S
Watson, CS
Welshons, WV
Zoeller, RT
Keywords: Bisphenol A;Endocrine disruptors;FDA;Food and drug administration;GLP;Good laboratory practices;Low-dose;Monmonotonic;Positive control
Issue Date: 2009
Publisher: National Institute of Environmental Health Sciences
Citation: Environmental Health Perspectives 117(3):309–315, Mar 2009
Abstract: 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 methodologic flaws. In addition, the U.S. FDA and EFSA have mistakenly assumed that GLP yields valid and reliable scientific findings (i.e., “good science”). Their rationale for favoring GLP studies over hundreds of publically funded studies ignores the central factor in determining the reliability and validity of scientific findings, namely, independent replication, and use of the most appropriate and sensitive state-of-the-art assays, neither of which is an expectation of industry-funded GLP research. Conclusions Public health decisions should be based on studies using appropriate protocols with appropriate controls and the most sensitive assays, not GLP. Relevant NIH-funded research using state-of-the-art techniques should play a prominent role in safety evaluations of chemicals.
Description: EHP is a publication of the U.S. government. Publication of EHP lies in the public domain and is therefore without copyright. Research articles from EHP may be used freely; however, articles from the News section of EHP may contain photographs or figures copyrighted by other commercial organizations and individuals that may not be used without obtaining prior approval from both the EHP editors and the holder of the copyright. Use of any materials published in EHP should be acknowledged (for example, "Reproduced with permission from Environmental Health Perspectives") and a reference provided for the article from which the material was reproduced.
ISSN: 0091-6765
Appears in Collections:Institute for the Environment

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