Closing the door on research

Mental disorders historically were not a global health priority. Despite their major contribution to the global burden of disease, there is currently no adequate response to this burden.² With the exception of ketamine and current enthusiasm about its rapid antidepressant effects, it has been decades since the last ‘blockbuster’ psychiatric drugs. The world's biggest funder of mental health research, the USA's National Institute of Mental Health (NIMH), has been gradually cutting down on the clinical trials funding. In just 6 years, between 2009 and 2015, the number of clinical trials funded by the NIMH dropped by 45%.^{Reference Reardon3} Major pharmaceutical companies have also been withdrawing from psychiatric medication research and drug discovery. The reasons behind this major disengagement in psychopharmacology apparently lay behind the belief that the probability of success is relatively low, and expenditures are disproportionately high. Most companies that pulled away from psychiatry turned to the field of oncology, immunology and diabetes research, where risks are lower and profits are higher.^{Reference Miller4} Putting it more explicitly, although other groups of patients have a prospect of benefitting from this major shift in research focus, those suffering from mental disorders are left behind, with a large burden of disease and in an already deep treatment and research gap.

Treatment and research gap

The treatment gap for persons suffering from mental disorders exceeds 50% globally. It is estimated that in low- and middle-income countries, up to 85% of individuals with mental disorders receive no treatment.² Even when treatments are available and accessible, they often fail to be effective or evidence-based. Although the lack of research into pharmacological treatments of mental disorders may partially explain the magnitude of this gap, it must, however, be noted that research into psychotherapeutic treatments demonstrated some promising developments. Functional neuroimaging studies of the brain have provided an abundance of tangible evidence demonstrating the effectiveness of psychotherapy. Yet, the number of patients who are either not being offered psychotherapeutic treatment or are not able to access it is increasing.

These large treatment gaps seem to uphold stigma, discrimination and social exclusion experienced by the persons with mental disorders on daily basis. Globally low responsiveness for the needs of persons affected by mental disorders causes their unjust exclusion and further breaches their basic human rights, such as the right to evidence-based treatment and the highest attainable standard of health.

Every person is entitled to the highest attainable standard of health as one of their fundamental human rights. For those suffering from mental disorders, the withdrawal of the biggest funders from mental health research is a barrier on the way to realisation of this right. Over and above the lack of access to mental health support, cutting down funds for psychiatric research represents a ‘glass ceiling’ that keeps those burdened by mental disorders from rising beyond a certain level of well-being. It prevents them from reaching higher levels of attainable standard of health that others suffering from more ‘cost-effective’ conditions enjoy.

A rights-based approach to health creates a legal obligation to ensure appropriate, timely, acceptable and affordable healthcare to all. It also requires that the needs of those who are further behind and least well off must be prioritised to achieve greater equity.

A call for justice and equity

In the research ethics context, the most commonly used principle of justice is that of distributive justice, which requires the equitable distribution of the burdens and the benefits. Any act that denies people benefits to which they have a right, or distributes burdens unfairly, is thus considered failure to treat them justly.^{Reference Beauchamp, Childress, Beauchamp and Childress1} Until recently, ethical analyses looking at the issue of research on vulnerable populations like people with mental health conditions have focused mainly on minimising risks, harms and burdens to the research participants. Nowadays, it seems that risk analysis is predominantly oriented toward safeguarding the research sponsors and minimising their financial burdens by withdrawing from research on conditions they are least likely to profit from. However, principles of ethics still recognise that depriving individuals and groups of the direct and indirect benefits arising from research is in itself unjust. The disengagement from psychiatric research is inherently harmful and discriminatory toward people suffering from mental disorders. Consequentially, these individuals are denied benefits on the basis of their undeserved characteristics.

Justice also refers to the ethical obligation to give to each person according to their need.^{Reference Beauchamp, Childress, Beauchamp and Childress1} Groups of potential research participants should be considered for inclusion if they have a greater need to receive the anticipated benefits. Because people with mental disorders account for a large number of persons with disabilities, there is a great need to prevent and treat these individually and socially disabling and burdensome conditions. Research is necessary to better understand the underlying conditions of those disabilities. Abandoning psychiatric research because of its high risks and low profits is not an ethically neutral practice, as it impedes the efforts to develop new treatments and preventive measures that could meet the needs of persons suffering from mental disorders.

The principle of justice can also be viewed as a requirement for equality of opportunity and fair access to research, both in terms of participation in research and access to the results of research.^{Reference Beauchamp, Childress, Beauchamp and Childress1} This egalitarian view of justice emphasises the ethical obligation to eliminate or reduce social barriers that prevent equality of opportunity. Specifically, justice requires that individuals or groups not be excluded from participation in research for reasons that are unrelated to the scientific question itself. The inclusion and exclusion criteria for participation in research should be scientifically and ethically justified, rather than arbitrarily or conveniently chosen, particularly when there is no ground for morally acceptable discrimination in allocations of benefits of research that other members of society enjoy. The exclusion of individuals suffering from mental disorders from research denies them from the benefits of fair participation in society and results in limited information about the diagnosis, prevention and treatment of conditions and disorders that afflict them.

Global burden of mental disorders and the need for research

Mental health disorders are among top ten leading causes of disability globally. It is estimated that around 300 million persons are affected by depression, 60 million by bipolar affective disorder, 23 million by schizophrenia and another 50 million people by dementia.² This burden does not just gravely affect the overall health of the human population, but also largely afflicts human rights situation and economy all around the globe.² Loss of productivity, sickness absence, unemployment, physical comorbidity, increased hospitalisation or premature death both of persons affected and their carers are just some of the direct and indirect costs of mental disorders burden. The massive burden of poor mental health impels the need to improve the quality of mental healthcare by making it a priority in creating healthcare policies worldwide.