Getting the EPA back on track

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Science  06 Dec 2019:
Vol. 366, Issue 6470, pp. 1173
DOI: 10.1126/science.aba3769

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  • Criticism of Miranda Editorial and Joint Statement in December 6, 2019 Science Magazine
    • James E. Enstrom, Epidemiologist and Physicist, UCLA and Scientific Integrity Institute

    The Miranda Editorial (1) and the Joint Statement (2) in the December 6 Science misrepresent the proposed EPA rule “Strengthening Transparency in Regulatory Science” (3). Its true purpose is to increase scientific rigor and transparency in the research findings used to justify EPA regulations. This rule is needed because certain EPA-related findings are etiologically implausible and the authors of these findings refuse to address criticism and/or to conduct requested reanalysis. I demonstrated the importance of this rule when I independently reanalyzed the ACS CPS II data underlying the seminal 1995 Pope analysis of these data. Pope 1995 (6) provided the primary justification for establishing the 1997 PM2.5 NAAQS. My reanalysis found NO robust relationship between PM2.5 and total mortality (4,5) and it directly challenges the positive relationships in Pope 1995, HEI 2000 (7), and HEI 2009 (8). My reanalysis did not violate subject confidentiality and is a model for data sharing.

    Unfortunately, Science does not publish null research findings that challenge the scientific validity of EPA air pollution regulations. In July 2016 I submitted my ACS CPS II reanalysis manuscript for peer review, but it was quickly rejected by both Science and Science Advances after initial screening and NO in-depth review. My manuscript was published on March 28, 2017 in Dose-Response (4), which includes the rejection history. Subsequently, it has been entirely ignored by Science,...

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    Competing Interests: None declared.
  • RE: Getting the EPA onto the science track
    • S. Stanley Young, Statistician, CGStat
    • Other Contributors:
      • Warren Kindzierski, Epidemiologist, University of Alberta

    There are two sides to every coin. Miranda(1) takes one side: poor air quality is a killer, among other health effects, and any request for data access is a simple ruse to overturn established fact(2). Humans including scientists can get it wrong and stay wrong for a long time(3). In addition to two sides, there is the edge of the coin – we just don’t know the answer. Two recent reports based on massive data sets find no association of air components with heart attacks or mortality(4,5). Contemporary with the Harvard Six Cities, a large and well-conducted study, also funded by the Environmental Protection Agency found no effect of air quality on mortality(6). Two reports in 1988(7,8) noted that for 56 health questions the literature was roughly equally divided for and against the claims and that selective reporting was a possible cause of the replication problem; we now call that p-hacking. If false positive studies are reported and negative studies are suppressed, there can be a canonization of false claims(9). Reviews(10,11) of The Lancet and JAMA meta-analysis studies note that base papers in these studies provided contradictory evidence; many of the base papers had very small p-values whereas many others appeared to be completely random, a mixture. Both claims cannot be right. At best the results reported in these meta-analysis studies were ambiguous. An agency can support external research and base its decisions on this research and so long as it does not take possess...

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    Competing Interests: None declared.

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