Dispensing of psychotropic medications to Australian children and adolescents before and during the COVID-19 pandemic, 2013-2021: a retrospective cohort study.

Objective: To determine longitudinal patterns of dispensing of antidepressant, anxiolytic, antipsychotic, psychostimulant, and hypnotic/sedative medications to children and adolescents in Australia during 2013-2021.

Design: Retrospective cohort study; analysis of 10% random sample of Pharmaceutical Benefits Scheme (PBS) dispensing data.

Participants, Setting: People aged 18 years or younger dispensed PBS-subsidised psychotropic medications in Australia, 2013-2021.

Industry-corrupted psychiatric trials.

The goal of this paper is to expose the research misconduct of pharmaceutical industry sponsored clinical trials via three short case studies of corrupted psychiatric trials that were conducted in the United States. We discuss the common elements that enable the misrepresentation of clinical trial results including ghostwriting for medical journals, the role of key opinion leaders as co-conspirators with the pharmaceutical industry and the complicity of top medical journals in failing to uphold standards of science and peer review. We conclude that the corruption of industry-sponsored clinical trials is one of the major obstacles facing evidence-based medicine.

The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance.

Objective: Deconstruction of a ghostwritten report of a randomized, double-blind, placebo-controlled efficacy and safety trial of citalopram in depressed children and adolescents conducted in the United States.

Methods: Approximately 750 documents from the Celexa and Lexapro Marketing and Sales Practices Litigation: Master Docket 09-MD-2067-(NMG) were deconstructed.

Results: The published article contained efficacy and safety data inconsistent with the protocol criteria.

Aripiprazole in the maintenance treatment of bipolar disorder: a critical review of the evidence and its dissemination into the scientific literature.

Background: Aripiprazole, a second-generation antipsychotic medication, has been increasingly used in the maintenance treatment of bipolar disorder and received approval from the U.S. Food and Drug Administration for this indication in 2005.

Conflicted medical journals and the failure of trust.

Journals are failing in their obligation to ensure that research is fairly represented to their readers, and must act decisively to retract fraudulent publications. Recent case reports have exposed how marketing objectives usurped scientific testing and compromised the credibility of academic medicine. But scant attention has been given to the role that journals play in this process, especially when evidence of research fraud fails to elicit corrective measures.

Industry-sponsored ghostwriting in clinical trial reporting: a case study.

In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential.

Educating health professionals about drug and device promotion: advocates' recommendations.

Mansfield and colleagues outline the recommendations from four advocacy groups for improving the education of health professionals on promotion of drugs and devices.

The ethics of pharmaceutical industry relationships with medical students.

Little research has been done on the extent of the relationship between the pharmaceutical industry and medical students, and the effect on students of receiving gifts. Potential harms to patients are documented elsewhere; we focus on potential harms to students. Students who receive gifts may believe that they are receiving something for nothing, contributing to a sense of entitlement that is not in the best interests of their moral development as doctors.

Efficacy and safety of antidepressants for children and adolescents.

How safe and effective are antidepressants in children and adolescents? The authors of this review have found disturbing shortcomings in the methods and reporting of trials of newer antidepressants in this patient group

Childhood tetanus in Australia: ethical issues for a should-be-forgotten preventable disease.

Refusal of a parent to have a child vaccinated against tetanus raised ethical issues for the treating clinicians. The clinicians felt their duty to the child was compromised, but recognised that our society leaves the authority for such decisions with the parents. As there was no reason, other than different beliefs about vaccination, to doubt the parent's care for the child, the clinicians limited their response to providing strong recommendations in favour of vaccination.

"Munchausen by proxy syndrome": not only pathological parenting but also problematic doctoring?

Certain social expectations of medicine combine with characteristics of subspecialised technological paediatrics to facilitate the form of child abuse labelled "Munchausen by proxy syndrome". Examining this form of child abuse highlights possible shortcomings of medical practice. The primary medical tasks of diagnosing and curing illness and of preventing suffering are sometimes overridden by other motivations of which doctors may not be fully aware.