LEVEL B2 · RESEARCH WING · CROSS-REFERENCE TERMINAL
BUILDING AMBIENCE — OFF Study 329: Paroxetine Clinical Trial Data Suppression and Publication Bias REGISTER → PARALLEL-PATTERN Tuskegee Syphilis Study: Government Medical Experimentation and 1972 Exposure [file] — Both cases involve institutional suppression of adverse health data, failure of oversight mechanisms, and harm to vulnerable research subjects (adolescents in Study 329, African Americans in Tuskegee). → PARALLEL-PATTERN Project MKUltra: CIA Behavioral Modification Research Program (1950s–1970s) [file] — Both represent instances of institutional research programs in which informed consent, data transparency, and independent verification were inadequate, with consequent harm to subjects. ← PARALLEL-PATTERN USPHS Internal Memos on Tuskegee Study Ethics (1945–1972): Documented Discussion and Justifications [file] — Both cases involve institutional knowledge of research problems (ethical in Tuskegee, scientific integrity in Study 329) and questions about whether internal communications documented concerns. ← PARALLEL-PATTERN Tuskegee Syphilis Study: Pre-Exposure Physician and Public Health Official Objections [file] — Both cases involve institutional suppression or obscuration of ethical concerns about research—one through absence of oversight mechanisms, the other through data manipulation and selective reporting. ← SUPPORTS Study 329 Adverse Event Data Exclusion and FDA Disclosure [file] — This dossier details the general issue of data suppression and publication bias in Study 329, providing context for specific adverse event data exclusion. ← SHARES-EVENT GSK Contractual Restrictions on Paroxetine Research Publication [file] — This dossier directly investigates claims related to the handling and publication of data from Study 329, which is the subject of the target document. ← SUPPORTS Paroxetine Prescriptions for Adolescents (2001-2015) After Study 329 Publication [file] — This dossier directly expands on the impact and aftermath of Study 329's publication and subsequent reanalysis, linking prescription numbers to data suppression and publication bias. ← SHARES-EVENT Study 329 Ghostwriting: Prior Disclosure in Review Boards or Journals [file] — Both dossiers concern the same clinical trial, Study 329, and its problematic publication. ← SHARES-EVENT Study 329: Regulatory and Journal Policy Changes on Trial Registration and Data Sharing [file] — This dossier focuses on the policy responses to the same clinical trial, Study 329, which is the subject of the linked document. ← PARALLEL-PATTERN Tuskegee Syphilis Study: Documented Participant Mortality and Causes (1932–1972) [file] — Both cases involve significant ethical breaches in medical research and the withholding of crucial information or treatment from subjects. ← SHARES-EVENT Paroxetine Prescription Rates for Adolescents (2001-2015) [file] — Both dossiers discuss 'Study 329' and its implications regarding paroxetine use in adolescents. ← SHARES-EVENT Study 329 RIAT Reanalysis: Previously Unreported Adverse Events [file] — This dossier focuses on the specific adverse events identified by the RIAT reanalysis, building upon the broader context of data suppression and publication bias in Study 329. ← SHARES-EVENT SmithKline Beecham Study 329 Adverse Event Data Submission to FDA [file] — This dossier directly investigates the submission of data from Study 329, which is the subject of the 'data suppression' dossier. ← SHARES-EVENT FDA Internal Review of Study 329 Adverse Events Pre-RIAT [file] — Both dossiers concern the same clinical trial, Study 329, and issues related to its data and publication. ← SUPPORTS Study 329: Contents of Appendix H and GSK's Data Provision to RIAT [file] — This dossier details the reanalysis that revealed previously unlisted adverse events, supporting the broader narrative of data suppression in the original Study 329. ← SHARES-EVENT Study 329: FDA and International Regulatory Investigations into Adverse Event Reporting [file] — This dossier directly addresses regulatory responses to the data suppression and publication bias alleged in Study 329. ← SHARES-EVENT GSK Paroxetine Trials: Publication Rights and Ghostwriting Agreements [file] — This dossier directly investigates claims and evidence related to GSK's Study 329, which is the focus of the existing document. ← SHARES-EVENT Eliot Spitzer vs. GlaxoSmithKline Lawsuit: Research Contracts and Publication Restrictions (2004) [file] — The Eliot Spitzer lawsuit against GSK is directly related to the alleged data suppression surrounding pharmaceutical clinical trials, including those for paroxetine (Paxil), which is the subject of the Study 329 dossier. ← PARALLEL-PATTERN GSK Whistleblower Claims: Suppression of Unfavorable Research Findings [file] — The broader narrative around GSK whistleblowers and misconduct aligns with the theme of pharmaceutical companies potentially suppressing unfavorable data, as seen in the Study 329 case involving paroxetine. ← SHARES-EVENT Martin Keller's Role and Statements in Study 329 Paroxetine Trial [file] — This dossier focuses on Martin Keller's specific role within the broader context of Study 329's data suppression and publication bias. ← SHARES-EVENT Pharmaceutical Company Contractual Suppression of Negative Trial Results [file] — The Study 329 case exemplifies broader concerns about pharmaceutical company influence and publication bias in clinical trials, which could be facilitated by contractual clauses. ← SHARES-EVENT Paroxetine Off-Label Adolescent Use Data Prior to 2015 Reanalysis [file] — This dossier's inquiry into pre-2015 paroxetine sales is directly related to the context of Study 329 and its reanalysis. ← SHARES-EVENT Medical Guidance on Paroxetine for Adolescents and Study 329 Reference (2001-2015) [file] — This dossier directly investigates the context and consequences of Study 329, which is the subject of the linked document. ← SHARES-EVENT GlaxoSmithKline Financial Impact from Adolescent Paroxetine Prescriptions (2001-2015) [file] — This dossier directly discusses the financial consequences stemming from the suppressed data and misleading publication of Study 329. ← SHARES-EVENT ICMJE Data Sharing Recommendations and Study 329 Controversies [file] — Both dossiers concern the controversies and impact of Study 329. ← SUPPORTS Study 329's Impact on Adolescent Antidepressant Prescriptions [file] — This dossier directly investigates the claims and impact stemming from Study 329, which is about clinical trial data suppression and publication bias. ← SHARES-EVENT GlaxoSmithKline Study 329: Ghostwriting and Non-Disclosure Claims [file] — This dossier directly relates to Study 329 and allegations of data misrepresentation and publication bias. ← SHARES-EVENT Study 329: IRB Approval Process and Conflicts of Interest Review [file] — This dossier focuses on the IRB review of the same clinical trial, Study 329, which faced controversies regarding data suppression. ← SHARES-EVENT Journal of the American Academy of Child and Adolescent Psychiatry Pre-2015 Ghostwriting Policies [file] — This dossier directly investigates editorial context for the original publication of Study 329. ← SHARES-EVENT Study 329: Allegations of Ghostwriting in Paroxetine Clinical Trial [file] — This dossier directly addresses the context and impact of Study 329, which is the subject of data suppression and publication bias. ← SHARES-EVENT Study 329's Influence on FDA/EMA Data Sharing Policies [file] — This dossier investigates the regulatory impact of the clinical trial detailed in the 'Study 329: Paroxetine Clinical Trial Data Suppression and Publication Bias' dossier. ← SHARES-EVENT Major Medical Journals' Citation of Study 329 in Policy Changes [file] — This dossier directly investigates the impact of Study 329's controversy on journal policies, which is an outgrowth of the data suppression and publication bias issues detailed in the existing dossier. ← SHARES-EVENT Clinical Trial Data Transparency Policy Changes and Study 329 Re-analysis [file] — This dossier directly discusses the re-analysis of Study 329, which is the subject of the linked document. ← SHARES-EVENT Pharmaceutical Industry Transparency Guidelines Post-Study 329 Scrutiny [file] — The lead question directly concerns the pharmaceutical industry's response to scrutiny arising from GlaxoSmithKline's Study 329. ← PARALLEL-PATTERN USPHS Guidelines on Treatment for Study Participants and Penicillin (1940s) [file] — Both dossiers involve ethical concerns related to medical studies, specifically regarding the treatment or non-treatment of participants and the integrity of the research process. ← PARALLEL-PATTERN Peter Buxtun's Complaints and USPHS Response to Tuskegee Study [file] — Both cases involve the suppression of ethical concerns or negative information related to human subject research. ← PARALLEL-PATTERN Internal Inquiries Regarding Ethical Complaints in Research Studies [file] — Study 329 involved issues of data suppression and publication bias, which often follow or accompany ethical complaints about research conduct and could be a focus of internal inquiries. ← PARALLEL-PATTERN Tuskegee Syphilis Study: Internal Ethical Concerns and Whistleblowers (Post-1947) [file] — Both cases involve allegations of unethical conduct in medical research and a lack of transparency or suppression of information concerning harm or ethical issues. ← PARALLEL-PATTERN Tuskegee Syphilis Study: Internal Ethical Objections (1932-1972) [file] — Both cases involve documented unethical research practices and the withholding or manipulation of information that harmed research subjects. ← PARALLEL-PATTERN Tuskegee Study: Ethical Objections from Non-Official Personnel [file] — Both the Tuskegee Study and Study 329 highlight severe ethical breaches in medical research, including lack of informed consent and manipulation of information.