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Please use this identifier to cite or link to this item: http://hdl.handle.net/10481/24821

Title: Why Public Health Agencies cannot depend on good laboratory practices as a criterion for selecting data: the case of bisphenol A
Authors: Myers, John Peterson
Saal, Frederick S. vom
Akingbemi, Benson T.
Arizono, Koji
Belcher, Scott
Colborn, Theo
Chahoud, Ibrahim
Crain, D. Andrew
Farabollini, Francesca
Guillette, Louis J.
Hassold, Terry
Ho, Shuk-Mei
Hunt, Patricia A.
Iguchi, Taisen
Jobling, Susan
Kanno, Jun
Laufer, Hans
Marcus, Michele
McLachlan, John A.
Nadal, Ángel
Oehlmann, Jörg
Olea, Nicolás
Palanza, Paola
Parmigiani, Stefano
Rubin, Beverly S.
Schoenfelder, Gilbert
Sonnenschein, Carlos
Soto, Ana M.
Talsness, Chris E.
Taylor, Julia A.
Vandenberg, Laura N.
Vandenbergh, John G.
Vogel, Sarah
Watson, Cheryl S.
Welshons, Wade V.
Zoeller, Thomas R.
Issue Date: 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.
Publisher: National Institute of Environmental Health Sciences
Description: This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original DOI.
Keywords: Bisphenol A
Endocrine disruptors
Food and Drug Administration (FDA)
Good laboratory practices (GLP)
Low-dose
Nonmonotonic
Positive control
URI: http://hdl.handle.net/10481/24821
ISSN: 0091-6765
Rights : Creative Commons Attribution-NonCommercial-NoDerivs 3.0 License
Citation: Myers, J.P. et al. Why Public Health Agencies cannot depend on good laboratory practices as a criterion for selecting data: the case of bisphenol A. Environmental Health Perspectives, 117(3): 309-315 (2009). [http://hdl.handle.net/10481/24821]
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