Weekend reads: Why rhetoric and self-censorship is bad for science; an author threatens to sue his critics; why whistleblowing is critical

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The week at Retraction Watch featured the departure of a professor in Glasgow amidst three retraction; the mysterious removal of a 26-year-old paper, and a four-page correction for a six-page paper. Here’s what was happening elsewhere:

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3 thoughts on “Weekend reads: Why rhetoric and self-censorship is bad for science; an author threatens to sue his critics; why whistleblowing is critical”

  1. I read with interest Melinda Moyer’s Editorial, The Censorship of Vaccine Science, which appeared in the NYT on Sunday, 5 August.

    While I certainly agree with the key points that she makes, I find it curious that she did not address the requirements to publish scientific data. These requirements make it far less likely that clinical study results are suppressed, particularly those generated from studies sponsored or underwritten by large, multinational vaccine companies wishing to commercialize their vaccine products.

    There are statutory requirements mandating posting of clinical trial results (submission to National Library of Medicine’s ClinicalTrials.gov) within 12 months of the study completion. These requirements have been in effect since September 27, 2007, have been codified at section 402(j) of the Public Health Service (PHS) Act, and include conforming amendments to the Federal Food, Drug, and Cosmetic FD&C Act (FD&C Act). The regulation became effective on January 18, 2017, and responsible parties have been required to be in compliance starting April 18, 2017.

    In addition, global study results disclosure requirements have been established, including Policy 0070, issued by the European Medicines Agency (EMA), which mandate Clinical Study Report (CSR) disclosure. EMA proactively publishes clinical study reports and clinical overviews for studies submitted as part of commercial marketing applications.

    Certainly, there are opportunities to “cherry-pick” data, and there are restrictions to access full data sets – usually requests to do so are vetted by independent adjudication committees. One suggestion would be to include a section in any publication of study results (in a peer-reviewed medical/scientific journal) that would require a critical set of caveats, explaining, as per the author’s Paul Offit example, that the study was small and conflicted with earlier research. One would also hope that effective and critical peer review would raise concerns along these lines.

    Yes – in this era of data denial and politicization of science, the consequences to public health should not be underestimated. Sound study design, resulting empirical data, and objective analyses are essential to the better understanding of causality. Educating the public with respect to consequences of foregoing vaccination should be high on the HHS list; however, this requires trust in the source and a willingness to listen.

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