RT Generic
T1 Why Public Health Agencies Cannot Depend on Good Laboratory Practices as a Criterion for Selecting Data: The Case of Bisphenol A
A1 Myers, John Peterson
A1 vom Saal, Frederick S
A1 Akingbemi, Benson T
A1 Arizono, Koji
A1 Belcher, Scott
A1 Colborn, Theo
A1 Chahoud, Ibrahim
A1 Crain, D Andrew
A1 Farabollini, Francesca
A1 Guillette, Louis J Jr
A1 Hassold, Terry
A1 Ho, Shuk-mei
A1 Hunt, Patricia A
A1 Iguchi, Taisen
A1 Jobling, Susan
A1 Kanno, Jun
A1 Laufer, Hans
A1 Marcus, Michele
A1 McLachlan, John A
A1 Nadal, Angel
A1 Oehlmann, Jorg
A1 Olea, Nicolas
A1 Palanza, Paola
A1 Parmigiani, Stefano
A1 Rubin, Beverly S
A1 Schoenfelder, Gilbert
A1 Sonnenschein, Carlos
A1 Soto, Ana M
A1 Talsness, Chris E
A1 Taylor, Julia A
A1 Vandenberg, Laura N
A1 Vandenbergh, John G
A1 Vogel, Sarah
A1 Watson, Cheryl S
A1 Welshons, Wade V
A1 Zoeller, R Thomas
K1 Técnicas de Laboratorio Clínico
K1 Ecotoxicología
K1 Disruptores Endocrinos
K1 Fenoles
K1 Práctica de Salud Pública
K1 Medición de Riesgo
AB 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.
PB National Institute of Enviromental Health Sciences (NIEHS)
SN 0091-6765
YR 2009
FD 2009-03
LK http://hdl.handle.net/10668/486
UL http://hdl.handle.net/10668/486
LA en
NO Myers JP, vom Saal FS, Akingbemi BT, Arizono K, Belcher S, Colborn T, et al. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: the case of bisphenol A. Environ Health Perspect. 2009 ;117(3):309–15.
NO Reproduced with permission from Environmental Health Perspectives. Acceso temporal a través de PMC.Comment in Good laboratory practices and safety assessments: another view.
DS RISalud
RD Feb 15, 2025