Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A

John Peterson Myers, Frederick S. vom Saal, Benson T. Akingbemi, Koji Arizono, Scott 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, Angel NadalJörg Oehlmann, Nicolás Olea, Paola Palanza, Stefano Parmigiani, Beverly S. Rubin, Gilbert Schoenfelder, 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

Research output: Contribution to journalArticle

206 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)309-315
Number of pages7
JournalEnvironmental health perspectives
Volume117
Issue number3
DOIs
StatePublished - 2009

Keywords

  • Bisphenol A
  • Endocrine disruptors
  • FDA
  • Food and Drug Administration
  • GLP
  • Good laboratory practices
  • Low-dose
  • Nonmonotonic
  • Positive control

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Health, Toxicology and Mutagenesis

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    Myers, J. P., vom Saal, F. S., Akingbemi, B. T., Arizono, K., Belcher, S., Colborn, T., Chahoud, I., Crain, D. A., Farabollini, F., Guillette, L. J., Hassold, T., Ho, S. M., Hunt, P. A., Iguchi, T., Jobling, S., Kanno, J., Laufer, H., Marcus, M., McLachlan, J. A., ... Zoeller, R. T. (2009). 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. https://doi.org/10.1289/ehp.0800173