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EBM opinion and debate
Ongoing inadequacy of quadrivalent HPV vaccine safety studies
  1. Deirdre T Little1,2,
  2. Harvey R Ward3,4
  1. 1General Practice, North Bellingen Medical Services, Bellingen, New South Wales, Australia
  2. 2General Practice, Bellingen River District Hospital, Bellingen, New South Wales, Australia
  3. 3Rural Clinical School, University of New South Wales, Coffs Harbour, New South Wales, Australia
  4. 4Department of Obstetrics and Gynaecology, Coffs Harbour Health Campus, Coffs Harbour, New South Wales, Australia
  1. Correspondence to Dr Deirdre T Little, General Practice, Bellingen River District Hospital, Bellingen, NSW 2454, Australia; dlittle{at}

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The quality of quadrivalent human papillomavirus vaccine (QHPV) safety studies has been a source of conflict within the Cochrane Collaboration. The establishment of its safety for the young girl target age group has been a source of unease in other sectors including those with an interest in ovarian safety. Academic rigour and integrity in medical journal publications is guarded by editorial and peer-reviewed processes. The observation, however, that medical journals are at risk of becoming arms of the pharmaceutical industry1 highlights an increased scientific need for alert and active critique of industry-funded trials. Where biased publications are identified around one product there is perhaps a greater cause for concern.

A problem identified by the Cochrane conflict is that internal validity and generalisability of published drug trials need more probing than afforded by current systematic analyses. Cochrane2 confirms the limitations of using vaccine components as controls, since these components may be important to safety analysis. The importance of correctly identifying all placebo components is also just this. The Cochrane QHPV review and its critique,3 however, did not identify the misrepresentation of safety trials’ control constituents in published Future I and Future II trials. Both trials represent their controls as ‘aluminum hydroxyphosphate sulfate’. However Future I,4 Future II5 and Villa et al’s6 published trials passing both Cochrane’s inclusion standards …

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  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Therapeutic Goods Administration correspondence available on request.

  • Correction notice This article has been updated since its first publication to correct the appearance of the author names and initials.

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