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Conflicts of Interest and Trust in the Journal of Pediatric and Adolescent Gynecology

      I state at the outset: there is no scandal brewing at the Journal of Pediatric and Adolescent Gynecology (JPAG). Yet my editorial is prompted by an article in the Sunday New York Times (Times), titled, “‘Broken’ system lets doctors omit industry ties in journals.”
      • Ornstein C.
      • Thomas K.
      “Broken” system lets doctors omit industry ties in journals.
      This piece raises concerns about the influence of pharmaceutical, medical device, and biotech companies on medical research. In the article on the front page of the Times, a number of prominent physicians are called out for having failed to disclose financial relationships when their studies were published in medical journals as prominent as the New England Journal of Medicine. The Times article cites an Institute of Medicine publication from 2009 that was a consensus report that examined conflicts of interest (COI) in medicine, and recommended steps to address those conflicts without negatively affecting productive collaborations.
      Institute of Medicine
      Conflict of interest in medical research, education, and practice.
      The confidence of the public in scientific and medical reports is potentially undermined by reports of physicians' failures to disclose, such as the article in the Times. Systemic guidelines for disclosure include the use of the International Committee of Medical Journal Editors Conflict of Interest form (available online at http://www.icmje.org/conflicts-of-interest). This form and other COI forms generally address financial relationships “in the biomedical arena that could be perceived to influence or that give the appearance of potentially influencing” the journal submission. Transparency and authors' disclosures allow readers to draw their own conclusions about the potential influence of financial conflicts.
      My own institution requires annual reporting of COI as “Outside Professional Activities,” a policy that was clarified and strengthened by the former Dean of the Stanford University School of Medicine, Dr Phil Pizzo, who is prominent in the national conversation about conflicts of interest. As Dean of the Stanford medical school, his policies were characterized as “no pens or pizza,” because the policy limited all gifts from the pharmaceutical industry, no matter the size.
      • Miller J.D.
      Conflict-of-interest spurs new rules, not consensus.
      Dr Pizzo has argued that the leadership of academic medical centers have an important role to play in drawing boundaries between collaborations with industry in research and education, in contrast to marketing.
      • Pizzo P.A.
      • Lawley T.J.
      • Rubenstein A.H.
      Role of leaders in fostering meaningful collaborations between academic medical centers and industry while also managing individual and institutional conflicts of interest.
      The 2010 federal law, titled the Physician Payments Sunshine Act requires pharmaceutical and device makers to publicly report their payments to physicians (see https://openpaymentsdata.cms.gov).
      As the Editor-in-Chief of JPAG, part of my job is to be responsible to readers and to the truth of science. This entails attending to authors' disclosures of their potential financial relationships or conflicts of interest. Although many journals use the International Committee of Medical Journal Editors conflict of interest form for reporting, this is by no means universal, and the manner in which an author is required to testify about COI or even what constitutes COI varies. For example, indirect payments to an institution rather than personal compensation might carry a different implication, and these relationships are not always disclosed or required to be disclosed. The Times described the guidelines used by medical journals and professional societies about what types of relationships must be reported as “fragmented and weakly enforced.”
      • Ornstein C.
      • Thomas K.
      “Broken” system lets doctors omit industry ties in journals.
      The New England Journal of Medicine in partnership with the Association of American Medical Colleges is reportedly testing a new system that would act as a central repository for reporting financial relationships, a development which, if adopted by more journals, would begin to correct some of the systemic flaws that have led to the public's justifiable outrage.
      • Ornstein C.
      • Thomas K.
      “Broken” system lets doctors omit industry ties in journals.
      It is understandable that there is concern that physicians who have earned large sums from corporate affiliations might have been inappropriately influenced in their reporting of scientific findings without a disclosure of such relationships.
      For further information about JPAG's policies on disclosure and conflict of interest, see the Author Information page on the JPAG Web site (https://www.jpagonline.org/content/authorinfo). This page also describes nonfinancial competing interests (sometimes called “private interests”), which can be personal relationships, political, religious, or personal convictions, academic writing or consulting, or serving as an expert witness, that might lead to bias or a conflict of interest. JPAG's publisher, Elsevier, further describes conflicts of interest on the Web site (https://service.elsevier.com/app/answers/detail/a_id/286/supporthub/publishing). Authors submitting to JPAG must state that they do not have conflicts of interest or disclose any conflicts. While I am reasonably confident that JPAG is not publishing manuscripts by authors without appropriate disclosure of potential or seeming financial conflicts, I will be addressing JPAG's policies with the Editorial Executive Committee, and we will discuss whether the policies go far enough and are as clear as they need to be, because this is a very important issue in keeping the trust of JPAG readers, and honoring our commitments to science and to our patients. Please e-mail me with any comments or thoughts on this important issue.
      I can't end my editorial without calling attention to the remarkable breadth and depth of the articles published in this issue of JPAG. This issues contains 3 worthwhile reviews: on complementary and alternative health approaches in pediatric and adolescent gynecology; obstetrical outcomes for individuals born with complex anorectal or cloacal anomalies; and reproductive health considerations for sexual and/or gender minority adolescents.
      • Biro F.
      • Bloemer N.L.
      “Complementary medicine”: complementary and alternative health approaches in pediatric and adolescent gynecology.
      • Vilanova-Sánchez A.
      • McCracken K.
      • Halleran D.R.
      • et al.
      Obstetrical outcomes in adult patients born with complex anorectal malformations and cloacal anomalies: a literature review.
      • Leonardi M.
      • Frecker H.
      • Scheim A.I.
      • et al.
      Reproductive health considerations in sexual and/or gender minority adolescents.
      As usual, the issue covers a wide variety of pediatric and adolescent gynecology topics, from issues for babies with Differences of Sex Development (DSD) to sexually transmitted infections in teens, contraception, adolescent pregnancies, and adnexal masses. It also includes an important and needed study with careful measurements of adolescents' external genitalia; I am not alone in seeing so many adolescents who are dissatisfied with their labia, thinking that there is some idealized “norm” that their own genitalia do not fit.
      • Brodie K.
      • Alaniz V.
      • Buyers E.
      • et al.
      A study of adolescent female genitalia: what is normal?.
      We need more data such as these to reinforce our reassurances that there really is a wide range of normal for adolescent young women's labia.

      References

        • Ornstein C.
        • Thomas K.
        “Broken” system lets doctors omit industry ties in journals.
        The New York Times. 2018; A (1, 17)
        • Institute of Medicine
        Conflict of interest in medical research, education, and practice.
        Institute of Medicine, Washington, DC2009
        • Miller J.D.
        Conflict-of-interest spurs new rules, not consensus.
        J Natl Cancer Inst. 2006; 98: 1678
        • Pizzo P.A.
        • Lawley T.J.
        • Rubenstein A.H.
        Role of leaders in fostering meaningful collaborations between academic medical centers and industry while also managing individual and institutional conflicts of interest.
        JAMA. 2017; 317: 1729
        • Biro F.
        • Bloemer N.L.
        “Complementary medicine”: complementary and alternative health approaches in pediatric and adolescent gynecology.
        J Pediatr Adolesc Gynecol. 2019; 32: 3-6
        • Vilanova-Sánchez A.
        • McCracken K.
        • Halleran D.R.
        • et al.
        Obstetrical outcomes in adult patients born with complex anorectal malformations and cloacal anomalies: a literature review.
        J Pediatr Adolesc Gynecol. 2019; 32: 7-14
        • Leonardi M.
        • Frecker H.
        • Scheim A.I.
        • et al.
        Reproductive health considerations in sexual and/or gender minority adolescents.
        J Pediatr Adolesc Gynecol. 2019; 32: 15-20
        • Brodie K.
        • Alaniz V.
        • Buyers E.
        • et al.
        A study of adolescent female genitalia: what is normal?.
        J Pediatr Adolesc Gynecol. 2019; 32: 27-31