Trial of risperidone in India – concerns

Although it is encouraging to see the Journal take an active role in redressing ‘editorial racism’ as discussed in a previous editorial (Tyrer, 2005), there is a need to ensure that promotion of positive discrimination does not exacerbate the problem.

We feel that a recently published randomised double-blind placebo-controlled trial of risperidone performed in India illustrates the dangers inherent in such a policy (Khanna et al, 2005). The report had a number of serious shortcomings, which included omission of crucial details of the process of randomisation, interrater reliability and the measures taken to ensure masking. However, the most worrying aspect of the trial was the use of a placebo in the control group and the apparent absence of any ethical approval to proceed with this study. What was the justification for denying severely unwell and vulnerable patients access to appropriate treatment? Why was there no discussion about the ethical dilemmas associated with this study?

We support the Journal policy of combating editorial racism by promoting positive discrimination in the instructions to referees. However, the Journal must not relinquish its responsibilities as the official journal of the Royal College of Psychiatrists by failing to act as final arbiter for the quality (including the ethics) of the Journal's content.