Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: the case of bisphenol A.
Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: the case of bisphenol A.
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DOI：
10.1289/ehp.0800173
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发表时间：
2009-03
影响因子：
10.4
通讯作者：
Zoeller RT
中科院分区：
文献类型：
--
作者：
Myers JP;vom Saal FS;Akingbemi BT;Arizono K;Belcher S;Colborn T;Chahoud I;Crain DA;Farabollini F;Guillette LJ Jr;Hassold T;Ho SM;Hunt PA;Iguchi T;Jobling S;Kanno J;Laufer H;Marcus M;McLachlan JA;Nadal A;Oehlmann J;Olea N;Palanza P;Parmigiani S;Rubin BS;Schoenfelder G;Sonnenschein C;Soto AM;Talsness CE;Taylor JA;Vandenberg LN;Vandenbergh JG;Vogel S;Watson CS;Welshons WV;Zoeller RT
在美国食品药品监督管理局（FDA）和欧洲的对应机构欧洲食品安全局（EFSA）对双酚A（BPA）的安全评估中，它们特别突出了两项由行业资助且遵循良好实验室规范（GLP）所定义标准的研究。同样是这些机构，在风险评估中却对大量由世界各地不同科学领域的顶尖专家使用政府资金进行的、且经过独立重复的非GLP研究重视程度低得多。
我们回顾了商业实验室为监管目的而进行的由行业资助的双酚A的GLP研究与学术和政府实验室为确定危害以及介导不良影响的分子机制而进行的非GLP研究之间的差异。我们研究了GLP研究中的方法和结果，这些研究在美国FDA判定双酚A安全的草案决定中起关键作用，同时我们也对比了那些为争取美国国立卫生研究院（NIH）资金而进行竞争的研究结果，这些研究经过同行评审得以在主要期刊上发表，可进行独立重复，但却因监管目的被美国FDA拒绝。
尽管美国FDA和EFSA认为两项由行业资助的双酚A的GLP研究优于数百项由美国NIH以及其他国家的NIH对应机构资助的研究，但这些机构据以做出决定的GLP研究存在严重的概念和方法上的缺陷。此外，美国FDA和EFSA错误地假定GLP能产生有效且可靠的科学发现（即“好的科学”）。它们青睐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合适且最灵敏的先进检测方法，而这两者都不是由行业资助的GLP研究的预期要求。
公共卫生决策应基于使用适当方案、适当对照以及最灵敏检测方法的研究，而不是基于GLP。相关的由NIH资助的使用先进技术的研究应在化学品安全评估中发挥重要作用。
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.
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影响因子：
3.7
作者：
Alonso-Magdalena, Paloma;Ropero, Ana B.;Carrera, M. Pilar;Cederroth, Christopher R.;Baquie, Mathurin;Gauthier, Benoit R.;Nef, Serge;Stefani, Enrico;Nadal, Angel
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发表时间：
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影响因子：
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影响因子：
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通讯作者：
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影响因子：
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作者：
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影响因子：
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