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dc.contributor.authorMyers, John Peterson
dc.contributor.authorSaal, Frederick S. vom
dc.contributor.authorAkingbemi, Benson T.
dc.contributor.authorArizono, Koji
dc.contributor.authorBelcher, Scott
dc.contributor.authorColborn, Theo
dc.contributor.authorChahoud, Ibrahim
dc.contributor.authorCrain, D. Andrew
dc.contributor.authorFarabollini, Francesca
dc.contributor.authorGuillette, Louis J.
dc.contributor.authorHassold, Terry
dc.contributor.authorHo, Shuk-Mei
dc.contributor.authorHunt, Patricia A.
dc.contributor.authorIguchi, Taisen
dc.contributor.authorJobling, Susan
dc.contributor.authorKanno, Jun
dc.contributor.authorLaufer, Hans
dc.contributor.authorMarcus, Michele
dc.contributor.authorMcLachlan, John A.
dc.contributor.authorNadal, Ángel
dc.contributor.authorOehlmann, Jörg
dc.contributor.authorOlea, Nicolás
dc.contributor.authorPalanza, Paola
dc.contributor.authorParmigiani, Stefano
dc.contributor.authorRubin, Beverly S.
dc.contributor.authorSchoenfelder, Gilbert
dc.contributor.authorSonnenschein, Carlos
dc.contributor.authorSoto, Ana M.
dc.contributor.authorTalsness, Chris E.
dc.contributor.authorTaylor, Julia A.
dc.contributor.authorVandenberg, Laura N.
dc.contributor.authorVandenbergh, John G.
dc.contributor.authorVogel, Sarah
dc.contributor.authorWatson, Cheryl S.
dc.contributor.authorWelshons, Wade V.
dc.contributor.authorZoeller, Thomas R.
dc.date.accessioned2013-04-26T10:39:21Z
dc.date.available2013-04-26T10:39:21Z
dc.date.issued2009-03
dc.identifier.citationMyers, 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]es_ES
dc.identifier.issn0091-6765
dc.identifier.otherdoi: 10.1289/ehp.0800173
dc.identifier.otherPMCID: PMC2661896
dc.identifier.urihttp://hdl.handle.net/10481/24821
dc.descriptionThis 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.en_US
dc.description.abstractBACKGROUND 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.es_ES
dc.language.isoenges_ES
dc.publisherNational Institute of Environmental Health Scienceses_ES
dc.rightsCreative Commons Attribution-NonCommercial-NoDerivs 3.0 Licensees_ES
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/es_ES
dc.subjectBisphenol Aes_ES
dc.subjectEndocrine disruptorses_ES
dc.subjectFood and Drug Administration (FDA)es_ES
dc.subjectGood laboratory practices (GLP)es_ES
dc.subjectLow-dosees_ES
dc.subjectNonmonotonices_ES
dc.subjectPositive controles_ES
dc.titleWhy Public Health Agencies cannot depend on good laboratory practices as a criterion for selecting data: the case of bisphenol Aes_ES
dc.typeinfo:eu-repo/semantics/articlees_ES
dc.rights.accessRightsinfo:eu-repo/semantics/openAccesses_ES
dc.relation.publisherversionhttp://dx.doi.org/10.1289/ehp.0800173es_ES


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