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 Nadal & 16 others Jörg 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

    195 Citations (Scopus)

    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

    Fingerprint

    Public Health
    United States Food and Drug Administration
    National Institutes of Health (U.S.)
    Food Safety
    Industry
    bisphenol A
    Chemical Safety
    Research
    Reproducibility of Results
    Publications
    Safety
    Weights and Measures

    Keywords

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

    ASJC Scopus subject areas

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

    Cite this

    Myers, J. P., vom Saal, F. S., Akingbemi, B. T., Arizono, K., Belcher, S., Colborn, T., ... 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

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

    In: Environmental Health Perspectives, Vol. 117, No. 3, 2009, p. 309-315.

    Research output: Contribution to journalArticle

    Myers, JP, vom Saal, FS, Akingbemi, BT, Arizono, K, Belcher, S, Colborn, T, Chahoud, I, Crain, DA, Farabollini, F, Guillette, LJ, 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 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, vol. 117, no. 3, pp. 309-315. https://doi.org/10.1289/ehp.0800173
    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. / Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data : The case of bisphenol A. In: Environmental Health Perspectives. 2009 ; Vol. 117, No. 3. pp. 309-315.
    @article{60ad66a4ff244665b5c5ad5dbf7ed676,
    title = "Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A",
    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.",
    keywords = "Bisphenol A, Endocrine disruptors, FDA, Food and Drug Administration, GLP, Good laboratory practices, Low-dose, Nonmonotonic, Positive control",
    author = "Myers, {John Peterson} and {vom Saal}, {Frederick S.} and Akingbemi, {Benson T.} and Koji Arizono and Scott Belcher and Theo Colborn and Ibrahim Chahoud and Crain, {D. Andrew} and Francesca Farabollini and Guillette, {Louis J.} and Terry Hassold and Ho, {Shuk Mei} and Hunt, {Patricia A.} and Taisen Iguchi and Susan Jobling and Jun Kanno and Hans Laufer and Michele Marcus and McLachlan, {John A.} and Angel Nadal and J{\"o}rg Oehlmann and Nicol{\'a}s Olea and Paola Palanza and Stefano Parmigiani and Rubin, {Beverly S.} and Gilbert Schoenfelder and Carlos Sonnenschein and Soto, {Ana M.} and Talsness, {Chris E.} and Taylor, {Julia A.} and Vandenberg, {Laura N.} and Vandenbergh, {John G.} and Sarah Vogel and Watson, {Cheryl S.} and Welshons, {Wade V.} and Zoeller, {R. Thomas}",
    year = "2009",
    doi = "10.1289/ehp.0800173",
    language = "English (US)",
    volume = "117",
    pages = "309--315",
    journal = "Environmental Health Perspectives",
    issn = "0091-6765",
    publisher = "Public Health Services, US Dept of Health and Human Services",
    number = "3",

    }

    TY - JOUR

    T1 - Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data

    T2 - The case of bisphenol A

    AU - Myers, John Peterson

    AU - vom Saal, Frederick S.

    AU - Akingbemi, Benson T.

    AU - Arizono, Koji

    AU - Belcher, Scott

    AU - Colborn, Theo

    AU - Chahoud, Ibrahim

    AU - Crain, D. Andrew

    AU - Farabollini, Francesca

    AU - Guillette, Louis J.

    AU - Hassold, Terry

    AU - Ho, Shuk Mei

    AU - Hunt, Patricia A.

    AU - Iguchi, Taisen

    AU - Jobling, Susan

    AU - Kanno, Jun

    AU - Laufer, Hans

    AU - Marcus, Michele

    AU - McLachlan, John A.

    AU - Nadal, Angel

    AU - Oehlmann, Jörg

    AU - Olea, Nicolás

    AU - Palanza, Paola

    AU - Parmigiani, Stefano

    AU - Rubin, Beverly S.

    AU - Schoenfelder, Gilbert

    AU - Sonnenschein, Carlos

    AU - Soto, Ana M.

    AU - Talsness, Chris E.

    AU - Taylor, Julia A.

    AU - Vandenberg, Laura N.

    AU - Vandenbergh, John G.

    AU - Vogel, Sarah

    AU - Watson, Cheryl S.

    AU - Welshons, Wade V.

    AU - Zoeller, R. Thomas

    PY - 2009

    Y1 - 2009

    N2 - 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.

    AB - 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.

    KW - Bisphenol A

    KW - Endocrine disruptors

    KW - FDA

    KW - Food and Drug Administration

    KW - GLP

    KW - Good laboratory practices

    KW - Low-dose

    KW - Nonmonotonic

    KW - Positive control

    UR - http://www.scopus.com/inward/record.url?scp=64049090987&partnerID=8YFLogxK

    UR - http://www.scopus.com/inward/citedby.url?scp=64049090987&partnerID=8YFLogxK

    U2 - 10.1289/ehp.0800173

    DO - 10.1289/ehp.0800173

    M3 - Article

    VL - 117

    SP - 309

    EP - 315

    JO - Environmental Health Perspectives

    JF - Environmental Health Perspectives

    SN - 0091-6765

    IS - 3

    ER -