Ethical challenges in developing drugs for psychiatric disorders

Abstract

As the classification of mental disorders advances towards a disease model as promoted by the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC), there is hope that a more thorough neurobiological understanding of mental illness may allow clinicians and researchers to determine treatment efficacy with less diagnostic variability. This paradigm shift has presented a variety of ethical issues to be considered in the development of psychiatric drugs. These challenges are not limited to informed consent practices, industry funding, and placebo use. The consideration for alternative research models and quality of research design also present ethical challenges in the development of psychiatric drugs. The imperatives to create valid and sound research that justify the human time, cost, risk and use of limited resources must also be considered. Clinical innovation, and consideration for special populations are also important aspects to take into account. Based on the breadth of these ethical concerns, it is particularly important that scientific questions regarding the development of psychiatric drugs be answered collaboratively by a variety of stakeholders. As the field expands, new ethical considerations will be raised with increased focus on genetic markers, personalized medicine, patient-centered outcomes research, and tension over funding. We suggest that innovation in trial design is necessary to better reflect practices in clinical settings and that there must be an emphasized focus on expanding the transparency of consent processes, regard for suicidality, and care in working with special populations to support the goal of developing sound psychiatric drug therapies.

Trends in off-label use of antipsychotic medications among Texas Medicaid children and adolescents from 2013 to 2016

“…Because of ethical considerations regarding the inclusion of children in clinical trials, many drugs are not tested in children and thus are not approved by the FDA in this population. 37 Effectiveness and safety have not been well established for off-label use in this vulnerable population. In this study, approximately two-thirds of off-label use was supported by evidence in practice guidelines.…”

Ethical Implications of Mental Health Stigma: Primary Health Care Providers’ Perspectives

“…The Preceded information ascertained that stigma associated with mental illness have many ethical implications in the context of Responsible Conduct of research (RCR). These ethical implications can be seen in the form of issues related to consent form (Fisher & Oransky, 2008;Vaz & Srinivasan, 2014), fair treatment and good respect for individual rights concerning treatment choices (Carrier, Banayan, Boley, & Karnik, 2017;Corcoran, 2016), use of various forms of treatments, participation in the clinical studies at the national level and issue of possible use of data for national or governmental purpose (Alahmad, Al-Jumah, & Dierickx, 2012;Ayalon, Karkabi, Bleichman, Fleischmann, & Goldfracht, 2015;Campbell et al, 2015;Sharma et al, 2013;Vaz & Srinivasan, 2014). Indeed, scientific researchers and those who are conducting research studies about mental health in the primary health care settings (Dubois et al, 2011); must consider the applications of ethical standards as suggested by RCR with cautions.…”

“…Researchers should follow rules concerning use of consent forms and how it might vary according to the target population being studied, the setting or cultural context where the study taking place (Alahmad et al, 2012;Carrier et al, 2017;Chowdhury, 2016;Corcoran, 2016;Mittal, Dean, Mittal, & Saks, 2015;Pires Marques, 2017;Sharma et al, 2013;Shen et al, 2017;Vaz & Srinivasan, 2014). Literature noted different components for consent forms, however they all point to the one important piece of "providing enough and detailed information in order to get the consent".…”

Evaluation of screening for drug use using postmortem prolactin levels in serum and cerebrospinal fluid

“…Psychotropic drugs (e.g., sedative-hypnotic, anxiolytic, antidepressant) are often prescribed in the treatment of patients with mental disorders. 1 Psychotropic drugs can improve symptoms, but various side effects have also been reported. 2,3 Drugs that antagonize dopamine (DA) D2 receptors (i.e., DA antagonists) are often prescribed for schizophrenic patients, 4 but the use of these DA antagonists increases prolactin (PRL) levels and can lead to hyperprolactinemia.…”

“…sedative-hypnotic, anxiolytic, antidepressant) are often prescribed in the treatment of patients with mental disorders. 1 Psychotropic drugs can improve symptoms, but various side effects have also been reported. 2,3 Drugs that antagonize dopamine (DA) D2 receptors (i.e.…”