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.

Who Cares What the Doctor Feels: The Responsibility of Health Politics for Burnout in the Pandemic.

Modern health has become a defining facet of contemporary life managed by health policy. The COVID-19 pandemic has significantly affected mental health, resulting in stress and anxiety in doctors' professional and private life. Since the beginning of the pandemic, doctors have been facing chronic stress, which was reported to the hospital managers and health-care agencies, but nothing was done in the practice to protect them. Although doctors are trained to stay emotionally restrained, a large number of patients in intensive care, along with the personal concerns for their families, has led to burnout. This article highlights the need for health politics to take responsibility for dealing with burnout in health-care workers with a new approach that should help doctors recognize, understand, and manage work-related stress with additional support in the pandemic.

Antipsychotic augmentation for major depressive disorder: A review of clinical practice guidelines.

Clinical Practice Guidelines (CPGs) are seen as the gold standard of evidence-based care. Because of their influence, these guidelines can have profound legal and economic effects. Despite their proliferation and influence, the trustworthiness and quality of guidelines have been seriously questioned and they have been implicated as drivers of overtreatment. In the U.S, augmentation with second generation antipsychotics (SGAs) is becoming an increasingly common strategy for treating major depressive disorder (MDD) when initial antidepressant treatment does not result in remission of symptoms. However, there is debate about the evidence for augmentation and whether this strategy is a form of overtreatment. We conducted a systematic search to identify treatment guidelines for MDD. Fourteen international guidelines met inclusion criteria and we reviewed them to determine: 1) if augmentation with SGAs was recommended for patients who did not respond to antidepressant medication; 2) what evidence was cited for the recommendation for or against augmentation; 3) the extent to which the guidelines addressed risk/benefit concerns when making their recommendations. There was significant variation among the CPGs regarding the recommendation to augment with antipsychotic medication for Major Depressive Disorder. Seven guidelines explicitly recommended augmentation with antipsychotics; 1 guideline reviewed the evidence but neither recommended for nor against; 1 guideline did not make a clear recommendation; 2 guidelines explicitly recommended against augmentation; and 3 guidelines did not address augmentation with antipsychotics as a potential treatment strategy. There was wide variation in terms of attention to risk/benefit issues and to the conditions under which augmentation should be considered. The results are discussed in terms of the implications for risk management and informed consent practices.

Is Helplessness Still Helpful in Diagnosing Posttraumatic Stress Disorder?

Criteria A2, experience of helplessness, fear, or horror at the time of the traumatic event, was removed from the posttraumatic stress disorder diagnosis in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. We argue that there is empirical support for retention of A2, a criterion that has clinical value and may improve diagnostic accuracy. Specifically, we demonstrate that A2 has high negative predictive power, aids in the prediction of symptom severity, and can be indispensible to detecting the disorder in children. We examine how augmenting A2 with other peritramautic emotions could improve clinical and diagnostic utility. In our opinion, rather than being eliminated, A2 needs to be reconstructed and included as one criterion of PTSD.

Recognizing misleading pharmaceutical marketing online.

In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences.

Conflicts of interest and the quality of recommendations in clinical guidelines.

BACKGROUND: There is increasing concern that conflicts of interest affect the development process of clinical practice guidelines. We evaluated The American Psychiatric Association's Practice Guideline for the Treatment of Patients with Major Depressive Disorder to determine the existence of financial and intellectual conflicts of interest and examine their possible effects. We selected this guideline because of its influence on clinical practice and because this guideline recommends pharmacotherapy for all levels of depression, despite controversies over the evidence base. METHODS AND FINDINGS: We determined the number and type of financial conflicts of interest for members of the guideline development group as well as for the independent panel charged with mitigating any effect of these conflicts. We also quantified the potential for intellectual conflicts of interest. We examined the quality of references used to support recommendations, as well as the degree of congruence between the research results and the recommendations. Fewer than half (44.4%) of the studies supporting the recommendations met criteria for high quality. Over one-third (34.2%) of the cited research did not study outpatients with major depressive disorder, and 17.2% did not measure clinically relevant results. One-fifth (19.7%) of the references were not congruent with the recommendations. Financial ties to industry were disclosed by all members (100%) of the guideline development committee with members reporting a mean 20.5 relationships (range 9-33). The majority of the committee participated on pharmaceutical companies' speakers' bureaus. Members of the independent panel that reviewed the guidelines for bias had undeclared financial relationships. As a marker of intellectual conflict of interest, 9.1% of all cited research and 13% of references supporting the recommendations were co-authored by the six guideline developers. CONCLUSIONS: The prevalence of conflicts of interest among panel members was high. The quality of the evidence cited raises questions about the validity of the recommendations. Attention to the quality of cited studies and to the risk of bias resulting from conflicts of interest should be a priority for guideline development groups.

Vulnerabilities to misinformation in online pharmaceutical marketing.

Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users' vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain.

Dynamic informed consent processes vital for treatment with antidepressants.

Advances in technology and transparency have greatly accelerated the ability of clinicians to remain current with regards to being informed and informing patients about the risk/benefit ratio when considering antidepressant medication. In spite of this, the current climate of pharmaceutical industry influence on medical practice does much to hinder informed consent processes. Recent findings of previously unknown and potentially dangerous adverse effects of the second- and third-generation classes of antidepressants underscore the importance of enhancing the practice of informed consent. After considering the concept of informed consent as it has evolved over time, the authors summarize some of the newer side effects associated with second- and third-generation antidepressants and then move on to describe impediments in the way of achieving adequate informed consent at the clinical encounter. Among these impediments, the authors discuss the impact of industry influence, cognitive bias in decision-making, and time constraints. These obstacles and the notion that modern antidepressants are not as safe as once thought offer an opportunity to revisit the process of informed consent. A dynamic concept of informed consent is proposed with the acknowledgement that a mere listing of side effects or pro forma approach to informed consent is inadequate, and that a mindful and ongoing dialog with patients in which clinicians are responsive to patients' evolving needs as new information becomes available will more likely result in patient empowerment and a strengthening of the therapeutic alliance, thereby allowing patient and doctor to shoulder the burden of uncertainty together and leading to more optimal treatment outcomes.

Why did so many German doctors join the Nazi Party early?

During the Weimar Republic in the mid-twentieth century, more than half of all German physicians became early joiners of the Nazi Party, surpassing the party enrollments of all other professions. From early on, the German Medical Society played the most instrumental role in the Nazi medical program, beginning with the marginalization of Jewish physicians, proceeding to coerced "experimentation," "euthanization," and sterilization, and culminating in genocide via the medicalization of mass murder of Jews and others caricatured and demonized by Nazi ideology. Given the medical oath to "do no harm," many postwar ethical analyses have strained to make sense of these seemingly paradoxical atrocities. Why did physicians act in such a manner? Yet few have tried to explain the self-selected Nazi enrollment of such an overwhelming proportion of the German Medical Society in the first place. This article lends insight into this paradox by exploring some major vulnerabilities, motives, and rationalizations that may have predisposed German physicians to Nazi membership-professional vulnerabilities among physicians in general (valuing conformity and obedience to authority, valuing the prevention of contamination and fighting against mortality, and possessing a basic interest in biomedical knowledge and research), economic factors and motives (related to physician economic insecurity and incentives for economic advancement), and Nazi ideological and historical rationalizations (beliefs about Social Darwinism, eugenics, and the social organism as sacred). Of particular significance for future research and education is the manner in which the persecution of Jewish physician colleagues was rationalized in the name of medical ethics itself. Giving proper consideration to the forces that fueled "Nazi Medicine" is of great importance, as it can highlight the conditions and motivations that make physicians susceptible to misapplications of medicine, and guide us toward prevention of future abuse.

Emerging perspectives on adolescents and young adults with high-functioning autism spectrum disorders, violence, and criminal law.

As the prevalence of autism spectrum disorders (ASDs) has increased, attention has shifted toward consideration of ASDs in adolescence and adulthood, as well as public health repercussions for this population. Since the social and emotional deficits within ASDs may be salient during incidents of unintended criminal or violent behavior, one area of focus is involvement of adolescents and young adults with ASD in the criminal justice system. Without a thorough understanding of how and why individuals with ASDs may exhibit criminal behavior, judicial and legislative state systems have begun to develop policies lacking a substantial evidence base. In this article, we attempt to synthesize the literature on one type of ASD (high functioning) and criminal behavior. Three specific deficits characteristic of individuals with ASDs (theory of mind, emotion regulation, and moral reasoning) are examined as potential confluent forces leading to criminal behavior among individuals with ASDs. Legal and policy recommendations are presented.

Response: Clinical wisdom and evidence-based medicine are complementary.

A long-debated question in the philosophy of health, and contingent disciplines, is the extent to which wise clinical practice ("clinical wisdom") is, or could be, compatible with empirically validated medicine ("evidence-based medicine"--EBM). Here we respond to Baum-Baicker and Sisti, who not only suggest that these two types of knowledge are divided due to their differing sources, but also that EBM can sometimes even hurt wise clinical practice. We argue that the distinction between EBM and clinical wisdom is poorly defined, unsupported by the methodology employed, and ultimately incorrect; crucial differences exist, we argue, not in the source of a particular piece of clinical knowledge, but in its dependability. In light of this subtle but fundamental revision, we explain how clinical wisdom and EBM are--by necessity--complementary, rather than in conflict. We elaborate on how recognizing this relationship can have far-reaching implications for the domains of clinical practice, medical education, and health policy.