Undisclosed financial conflicts of interest in DSM-5-TR: cross sectional analysis.

OBJECTIVE: To assess the extent and types of financial ties to industry of panel and task force members of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, fifth edition, text revision (DSM-5-TR), published in 2022. DESIGN: Cross sectional analysis. SETTING: Open Payments database, USA. PARTICIPANTS: 92 physicians based in the US who served as members of either a panel (n=86) or task force (n=6) on the DSM-5-TR with information recorded in the Centers for Medicare and Medicaid Services Open Payments database during 2016-19. This period was chosen to include the year that development of the DSM-5-TR began and the three years preceding, a time consistent with previous research on conflicts of interest and consistent with the American Psychiatric Association's disclosure requirements for the fifth revision (DSM-5) of the manual. MAIN OUTCOME MEASURES: Type and amount of compensation the panel and task force members of DSM-5-TR received during 2016-19. RESULTS: After duplicate names had been removed, 168 individuals were identified who served as either panel or task force members of the DSM-5-TR. 92 met the inclusion criteria of being a physician who was based in the US and therefore could be included in Open Payments. Of these 92 individuals, 55 (60%) received payments from industry. Collectively, these panel members received a total of $14.2m (£11.2m; €13m). One third (33.3%) of the task force members had payments reported in Open Payments. CONCLUSIONS: Conflicts of interest among panel members of DSM-5-TR were prevalent. Because of the enormous influence of diagnostic and treatment guidelines, the standards for participation on a guideline development panel should be high. A rebuttable presumption should exist for the Diagnostic and Statistical Manual of Mental Disorders to prohibit conflicts of interest among its panel and task force members. When no independent individuals with the requisite expertise are available, individuals with associations to industry could consult to the panels, but they should not have decision making authority on revisions or the inclusion of new disorders.

Becoming a Phronimos: Evidence-Based Medicine, Clinical Decision Making, and the Role of Practical Wisdom in Primary Care.

There has been much discussion about the overmedicalization of human experience and the problems incurred by overzealous action-oriented medical care. In this paper we describe the Aristotelean virtue of phronesis, or practical wisdom, and discuss how it can be developed by interested clinicians. We argue that becoming a phronimos requires conscious attention to one's practice by using feedback to continually improve. But there must also be judicious adherence to clinical practice guidelines and advocacy for people-as-patients at individual, community, and national levels.

Why psychiatry needs an honest dose of gentle medicine.

The pharmaceutical industry's influence on psychiatric research and practice has been profound and has resulted in exaggerated claims of the effectiveness of psychotropic medications and an under-reporting of harms. After the regulatory approval of fluoxetine, the pharmaceutical industry began promoting (and continues to promote) a chemical imbalance theory of emotional distress. In the last decade, there has been an increased awareness about the limits of this theory and the risks of psychotropic medications. Nonetheless, the medicalization of distress, the sedimented belief in "magic bullets," and the push to "scale up" mental health treatment have contributed to the meteoric rise in the prescription of psychiatric drugs and of polypharmacy. A major premise of this paper is that the conceptual framework of medical nihilism can help researchers and clinicians understand and address the harms incurred by inflated claims of the efficacy of psychotropic medications. We propose that psychiatry, and the mental health field more generally, adopt a model of 'gentle medicine' with regard to both the diagnosis of and treatment for mental health conditions and focus greater attention on the upstream causes of distress.

Industry influence on mental health research: depression as a case example.

Emotional distress has been rising since before the COVID-19 pandemic and the public is told that depression is a major public health problem. For example, in 2017 depressive disorders were ranked as the third leading cause of "years lost to disability" and the World Health Organization now ranks depression as the single largest contributor to global disability. Although critical appraisals of the epidemiological data raise questions about the accuracy of population-based depression estimates, the dominance of the medical model and the marketing of psychotropics as "magic bullets," have contributed to a dramatic rise in the prescription of psychiatric drugs. Unfortunately, the pharmaceutical industry's influence on psychiatric research and practice has resulted in over-estimates of the effectiveness of psychotropic medications and an under-reporting of harms. This is because the principles that govern commercial entities are incongruent with the principles that guide public health research and interventions. In order to conduct mental health research and develop interventions that are in the public's best interest, we need non-reductionist epistemological and empirical approaches that incorporate a biopsychosocial perspective. Taking depression as a case example, we argue that the socio-political factors associated with emotional distress must be identified and addressed. We describe the harms of industry influence on mental health research and show how the emphasis on "scaling up" the diagnosis and treatment of depression is an insufficient response from a public health perspective. Solutions for reform are offered.

Industry effects on evidence: a case study of long-acting injectable antipsychotics.

A vigorously debated issue in the psychiatric literature is whether long-acting injectable antipsychotics (LAIs) show clinical benefit over antipsychotics taken orally. In addressing this question, it is critical that systematic reviews incorporate risk of bias assessments of trial data in a robust way and are free of undue industry influence. In this paper, we present a case analysis in which we identify some of the design problems in a recent systematic review on LAIs vs oral formulations. This case illustrates how evidence syntheses that are shaped by commercial interests may undermine patient-centered models of recovery and care. We offer recommendations that address both the bioethical and research design issues that arise in the systematic review process when researchers have financial conflicts of interest.

Conflicts of Interest in Psychopharmacology Textbooks.

While most medical journals require disclosures of industry payments to authors and editors, there is no requirement for textbooks. In this study we evaluated nine well-known psychopharmacology textbooks to identify payments to their writers and editors. Two-thirds of the textbooks had at least one editor or author who received personal payments from one or more pharmaceutical companies, for a total of 11,021,409 USD paid to 11 of 21 editors/authors over a seven-year period. Much of this money was paid to a single author but 24% of the writers received over 75,000 USD each over this time period. There are several psychopharmacology textbooks authored by writers without apparent financial conflicts of interest. Just as with medical journals, medical textbooks should be transparent about payments made to their authors and editors.

Ten years later: a review of the US 2009 institute of medicine report on conflicts of interest and solutions for further reform.

Conflicts of interest (COIs) in healthcare are increasingly discussed in the literature, yet these relationships continue to influence healthcare. Research has consistently shown that financial COIs shape prescribing practices, medical education and guideline recommendations. In 2009, the Institute of Medicine (IOM, now the National Academy of Medicine) published Conflicts of Interest in Medical Research, Practice, and Education-one of the most comprehensive reviews of empirical research on COIs in medicine. Ten years after publication of theIOM's report, we review the current state of COIs within medicine. We also provide specific recommendations for enhancing scientific integrity in medical research, practice, education and editorial practices.

Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent.

The US Food and Drug Administration (FDA) has approved two drugs for 'hypoactive sexual desire disorder' in women, flibanserin (Addyi) in 2015 and bremelanotide (Vyleesi) in 2019. In this paper we examine the outcome measures and clinical trial data upon which regulatory approval was based. In clinical trials, flibanserin led to an average of only one additional enjoyable sexual experience every two months, bremelanotide to none. Trials for both drugs feature shifts in primary outcomes and a contested indication. A politicised industry-sponsored advocacy campaign and conflicted patient and expert testimony likely influenced flibanserin's approval at its third attempt. Bremelanotide, with even weaker efficacy, capitalised on the regulatory precedent set by the approval of flibanserin. Reconsideration of regulatory decisions to approve these drugs is in order, as well as a broader examination of how future regulatory decisions can better address conflicts of interest and clinically meaningful benefit.

The Cultural Politics of Mental Illness: Toward a Rights-Based Approach to Global Mental Health.

The movement for global mental health (MGMH) has raised awareness about the paucity of mental health services, particularly in low- and middle-income countries. In response, policies and programs have been developed by the World Health Organization and by the Lancet Commission on global mental health, among other organizations. These policy initiatives and programs, while recognizing the importance of being responsive to local needs and culture, are based on Western biomedical conceptualizations of emotional distress. In the paper, we discuss how a rights-based approach can promote the voice and participation of people with lived experience into the MGMH. We argue that a human rights framework can be enhanced by incorporating the conceptual approaches of critical inquiry and community mental health. We also discuss how rights-based approaches and service-user activism can productively reconfigure Western psychiatric conceptualizations of distress and provide both a moral and empirical justification for a paradigm shift within the MGMH.

Mental Health as a Basic Human Right and the Interference of Commercialized Science.

Although there is consensus that a rights-based approach to mental health is needed, there is disagreement about how best to conceptualize and execute it. The dominance of the medical model and industry's influence on psychiatry has led to an over-emphasis on intra-individual solutions, namely increasing individuals' access to biomedical treatments, with a resultant under-appreciation for the social and psychosocial determinants of health and the need for population-based health promotion. This paper argues that a robust rights-based approach to mental health is needed in order to overcome the effects of commercial interests on the mental health field. We show how commercialized science-the use of science primarily to meet industry needs-deflects attention away from the sociopolitical determinants of health, and we offer solutions for reform.