Myers John Peterson, vom Saal Frederick S, 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 Angel, 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 R Thomas
Environmental Health Sciences, Charlottesville, Virginia 22902, USA.
Environ Health Perspect. 2009 Mar;117(3):309-15. doi: 10.1289/ehp.0800173. Epub 2008 Oct 22.
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.
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.
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.
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.
美国食品药品监督管理局（FDA）和欧洲同行欧洲食品安全局（EFSA）在对双酚A（BPA）进行安全性评估时，特别重视两项由行业资助且符合良好实验室规范（GLP）标准的研究。而对于全球各科学领域顶尖专家利用政府资金开展的大量独立重复的非GLP研究，这两个机构在风险评估中给予的权重则要小得多。
我们回顾了商业实验室为监管目的开展的行业资助的BPA的GLP研究与学术及政府实验室开展的非GLP研究之间的差异，以确定介导不良反应的危害和分子机制。我们研究了GLP研究中的方法和结果，这些研究在美国食品药品监督管理局宣布BPA安全的决策草案中起关键作用，而这些研究结果与那些为获得美国国立卫生研究院（NIH）资助而竞争、经同行评审可在顶级期刊发表、经过独立重复但因监管目的被美国食品药品监督管理局拒绝的研究结果形成对比。
尽管美国食品药品监督管理局和欧洲食品安全局认为两项行业资助的BPA的GLP研究优于美国国立卫生研究院及其他国家国立卫生研究院同行资助的数百项研究，但这两个机构所依据的GLP研究存在严重的概念和方法缺陷。此外，美国食品药品监督管理局和欧洲食品安全局错误地认为GLP能产生有效且可靠的科学发现（即“好的科学”）。他们青睐GLP研究而非数百项公共资助研究的理由忽视了决定科学发现可靠性和有效性的核心因素，即独立重复以及使用最恰当、最灵敏的先进检测方法，而这两者都不是行业资助的GLP研究的要求。
公共卫生决策应基于采用适当方案、具备适当对照和最灵敏检测方法的研究，而非基于GLP。利用先进技术开展的相关美国国立卫生研究院资助的研究应在化学品安全性评估中发挥重要作用。
