Ethics of giving antipsychotic medication to at-risk young people

To the Editor

In his response to critics of early intervention for psychosis, Patrick McGorry (2012) makes some negative statements about those who have questioned the ethics of using antipsychotic medication with young people at risk of psychosis. He charges that these critics ‘have recently sought to censor such research through coordinated pressure exerted through mainstream and social media, through frivolous freedom of information requests which consume the time and energy of researchers in universities, and through concerted public pressure exerted on the decisions of independent NHMRC-approved ethics committees, as well as in the pages of this journal’. He accuses them of ‘anti-scientific behavior’ and of seeking to ‘threaten further legitimate and ethical research in a field which clearly remains in equipoise and is in need for more data.’

I think this is an unfair characterization of the critics’ position. The objection is specifically to the use of antipsychotic medication as a preventive intervention with young people who are not psychotic, and relates to the risk profile of these medications. To my knowledge, there has not been any objection to research on lower-risk interventions, such as psychological therapy or fish oil, for preventive purposes.

According to the National Statement on Ethical Conduct in Human Research (National Health and Medical Research Council, 2007), researchers should adhere to the ethical principle of beneficence. According to this principle, ‘the likely benefit of the research must justify any risks of harm or discomfort to participants’. The National Statement makes researchers responsible for the welfare of participants and for clarifying for participants the potential benefits and risks of the research. Unfortunately, there are major risks in using antipsychotic medication, which researchers must take into account and inform participants about. Firstly, these medications can be associated with weight gain, metabolic syndrome and diabetes (Foley and Morley, 2011). Secondly, there is recent evidence that they may be associated with brain atrophy (Dorph-Petersen et al., 2005; Ho et al., 2011). Thirdly, these medications may induce psychiatric symptoms in people who are not psychotic (Artaloytia et al., 2006; Veselinović et al., 2011). These risks may very well be justified for a person with a psychotic disorder, given the potential therapeutic benefits for positive psychotic symptoms. However, it is questionable that the benefits outweigh the risks for participants in a research trial where the overwhelming majority will not become psychotic.

To any researcher who believes that these risks are justified for non-psychotic participants, I have a simple challenge: take the treatment yourself at the same dose and duration as your participants to show your confidence that the risks are not serious. If you feel any reluctance to do this, how can you ask participants to expose themselves to this treatment?

In conclusion, carrying out research to prevent psychosis must remain an important goal. Low-risk treatments such as psychological therapies and fish oil pass the principle of beneficence. However, research on antipsychotic medication for this group of young people does not.