{"title":"The Paroxetine 352 Bipolar Study Revisited: Deconstruction of Corporate and Academic Misconduct","authors":"J. Amsterdam, L. McHenry","doi":"10.35122/jospi.2019.958452","DOIUrl":"https://doi.org/10.35122/jospi.2019.958452","url":null,"abstract":"Medical ghostwriting is the practice in which pharmaceutical companies engage an outside writer to draft a manuscript submitted for publication in the names of “honorary authors,” typically academic key opinion leaders. Using newly-posted documents from paroxetine litigation, we show how the use of ghostwriters and key opinion leaders contributed tothe publication of a medical journal article containing manipulated outcome data to favor the proprietary medication.The article was ghostwritten and managed by SmithKline Beecham, now GlaxoSmithKline (GSK) and Scientific Therapeutics Information, Inc. without acknowledging their contribution in the published article. The named authors with financial ties to GSK had little or no direct involvement in the paroxetine 352 bipolar trial results and most had not reviewed any of the manuscript drafts. The manuscript was originally rejected by peer review; however, its ultimate acceptance to the American Journal of Psychiatrywas facilitated by the journal editor who also had financial ties to GSK. Thus, GSK was able to take an under-powered and non-informative trial with negative results and present it as a positive marketing vehicle for off-label promotion of paroxetine for bipolar depression. In addition to the commercial spin of paroxetine efficacy, important protocol-designated safety data were unreported that may have shown paroxetine to produce potentially harmful adverse events.","PeriodicalId":318895,"journal":{"name":"Journal of Scientific Practice and Integrity","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126649221","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Behind the Scenes at JOEH: Questionable Actions Lead to the Publication of an Industry-funded Benzene Exposure Article and Refusal to Publish Letter to the Editor","authors":"Melvyn Kopstein","doi":"10.35122/jospi.2019.1.875441","DOIUrl":"https://doi.org/10.35122/jospi.2019.1.875441","url":null,"abstract":"This Commentary discusses the decision-making and conduct of the Journal of Occupational and Environmental Hygiene (JOEH) and its Editor in Chief (EIC) regarding two versions of a scientifically flawed benzene exposure article published in JOEH.1,2 The author of this commentary submitted a letter to the editor concerning an “Accepted” manuscript (AM)1 published on the JOEH website. JOEH did not publish the letter, but permitted the authors to make at least nine substantive revisions to the AM that were all responsive to Letter 1. The AM was removed from the JOEH website and replaced by a Short Report (SR)2 having the same title. Questions of publishing ethics arise as a result of the refusal by JOEH to publish any of my additional Letters to the Editor, submitted between May and December of 2018. JOEH failed to address author conflicts of interest and major analytical testing anomalies that led to scientifically untenable results. Further, JOEH did not require the authors to disclose that 1) all tabulated results were drawn from an unpublished 2017 report prepared by the authors for the study sponsor (CRC Industries), and 2) one of the authors based her testimony on behalf of CRC on the unpublished report in at least two trials. JOEH’s refusal to publish the Letters to the Editor regarding undisclosed conflicts of interests, flawed scientific results, misleading conclusions, and other issues brings up numerous ethical questions.","PeriodicalId":318895,"journal":{"name":"Journal of Scientific Practice and Integrity","volume":"38 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121891109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Cognitive Disorders Among Incoming College Football Athletes: Legal and Medical Implications of Undisclosed Inclusion in Concussion Research","authors":"Ted Tatos, D. Comrie","doi":"10.35122/JOSPI.2019.873611","DOIUrl":"https://doi.org/10.35122/JOSPI.2019.873611","url":null,"abstract":"Concussion research in the United States commonly relies on collegiate athletes as study subjects. Such research recognizes learning disabilities and attention deficit disorders (LD/ADHD) as co-morbidities that should be addressed in concussion research and management. This forensic study has three objectives: 1) to investigate the prevalence of such diagnoses and examine neuropsychological test results among incoming college football players at a major US university 2) to examine how LD/ADHD diagnoses were addressed in concussion research that included such athletes, and 3) to address the implication of these results for ongoing concussion litigation. This study observed LD/ADHD rates among football athletes exceeding 50% in multiple cohort-years, a degree of magnitude greater than the rate among general college student populations. Neuropsychological testing revealed scores among some incoming freshman college football players consistent with those of severe traumatic brain injury (TBI) patients. Evidence of cognitive impairment among incoming college football players raises concern over the potential effects of cumulative exposure to head trauma and the increased risk associated with continued participation in collision sports. We discuss the implications of our findings for concussion litigation and research ethics.","PeriodicalId":318895,"journal":{"name":"Journal of Scientific Practice and Integrity","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117329475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Massive Faculty Donations and Institutional Conflicts of Interest","authors":"B. Kahr, M. Hollingsworth","doi":"10.35122/JOSPI.2019.740579","DOIUrl":"https://doi.org/10.35122/JOSPI.2019.740579","url":null,"abstract":"Most research universities have concrete policies for navigating the conflicts of interest of faculty members. Policies that might constrain university administrators acting on behalf of their schools, so-called institutional conflicts of interest, are absent or poorly developed at most places that could benefit from them. Researchers have argued for the illustration of institutional conflicts as a foundation for policy development. Here, we show the failure of research accountability when a faculty member made massive gifts to a leading American public research university, the University of Washington in Seattle, thereby creating allegiances that undermined commitments to academic values. Correspondence, some from thousands of pages acquired through the Washington State Public Records Act, show faculty colleagues, department chairs, deans, a provost, presidents, and the Board of Regents soliciting and accepting the donor's money but not sufficiently guarding the integrity of science when that was required. These records offer a rare look inside a university scientific misconduct investigation, a process typically shrouded in secrecy under the guise of confidentiality. They amount to a forensic analysis of what can go wrong with science at the nexus of a secret history of misconduct, spectacularly ambitious science, and large donations. The inabilities of federal and state authorities to reckon with institutional conflicts of interest are highlighted. The collective inaction can be understood within Lessig’s framework of institutional corruption. The failings described herein are metaphorical holes in the safety net intended to protect the integrity of American science, a shared practice that is under increasing strain. All public records are available from the authors upon request. Those cited here are included in an appendix posted by the journal.","PeriodicalId":318895,"journal":{"name":"Journal of Scientific Practice and Integrity","volume":"40 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122228700","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Academic Publishing and Scientific Integrity: Case Studies of Editorial Interference at Taylor & Franci","authors":"B. Kahr, L. McHenry, M. Hollingsworth","doi":"10.35122/JOSPI.2019.848394","DOIUrl":"https://doi.org/10.35122/JOSPI.2019.848394","url":null,"abstract":"Editorial independence is a bedrock principle of academic publishing. The growing domination of academic publishing by large, for-profit corporations threatens this independence. There is alarming evidence that large companies too often serve their own business interests and those of powerful clients rather than serving the scientific community and the general public. This evidence includes the publication of infelicitous commercial science and concealing scientific misconduct. We present two case studies in which the UK-based publisher Taylor & Francis interfered in the editorial process by blocking publication of legitimate criticism that had been reviewed and approved for publication by its specialized editors. The integrity of science depends in part on the transparency and intellectual honesty of all stakeholders. The widely-acknowledged inadequacies of English libel law are reviewed as context for some of Taylor & Francis’s fearful decisions.","PeriodicalId":318895,"journal":{"name":"Journal of Scientific Practice and Integrity","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129755565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kathleen Ruff, Eliezer João de Souza, F. Giannasi, Evelyn Glensk, M. Hindry, Linda H. Reinstein, A. Prieto, Gopala Krishna, L. Kazan-Allen, Eric Jonckheere, Robert Vojakovic, P. Iselin
{"title":"Asbestos and insurance interests continue to use discredited scientific argument to sell asbestos and to deny justice to asbestos victims","authors":"Kathleen Ruff, Eliezer João de Souza, F. Giannasi, Evelyn Glensk, M. Hindry, Linda H. Reinstein, A. Prieto, Gopala Krishna, L. Kazan-Allen, Eric Jonckheere, Robert Vojakovic, P. Iselin","doi":"10.35122/JOSPI.2019.719640","DOIUrl":"https://doi.org/10.35122/JOSPI.2019.719640","url":null,"abstract":"Chrysotile asbestos represents ninety-five percent of all asbestos sold over the past century. For more than two decades the global asbestos trade has consisted entirely of\u0000chrysotile asbestos. For this reason, it has been imperative for the asbestos industry, in order to ensure its survival, to claim that chrysotile asbestos can be used safely and that only other amphibole forms of asbestos are harmful. The scientific evidence is overwhelming that chrysotile asbestos causes deadly diseases, such as asbestosis, mesothelioma, lung, and other cancers, and that use of chrysotile asbestos should stop. The asbestos industry has, therefore, spent millions of dollars paying scientists to carry out a misinformation campaign to deny the scientific evidence and claim that, while amphibole asbestos causes harm to health, chrysotile asbestos does not.","PeriodicalId":318895,"journal":{"name":"Journal of Scientific Practice and Integrity","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134497636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"An Introduction to the Journal of Scientific Practice and Integrity","authors":"Tess Bird, D. Egilman","doi":"10.35122/jospi.2019.873868","DOIUrl":"https://doi.org/10.35122/jospi.2019.873868","url":null,"abstract":"Corruption in science is a significant problem in the United States and internationally, especially in fields that impact perceived economic growth. While many reputable journals have published on scientific integrity, we recognize a need to provide ongoing critical attention to the diverse means used to manipulate science and science policy. This journal is an independent, peer-reviewed, open-access publication, as well as a call for greater integrity in scientific practice.","PeriodicalId":318895,"journal":{"name":"Journal of Scientific Practice and Integrity","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129559977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}