DOI: 10.1097/01.yco.0000133823.09887.ed

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Issn Print: 0951-7367

Publication Date: 2004/07/01


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The SSRI debate and the evidence base in child and adolescent psychiatry

Jonathan Green

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In April 2003 [1], the UK Committee on the Safety of Medicines set up an expert working group to consider the safety of selective serotonin reuptake inhibitors (SSRIs) and in December 2003 declared that the expert group ‘… has now studied all available evidence and found that the risks of treating depressive illness in under 18s with certain SSRIs outweigh the benefits of treatment’ (Department of Health 2003). Also quoted was the chair of the UK's Medicines and Healthcare Regulatory Agency (MHRA), who said that ‘The majority of SSRIs … - the most commonly prescribed type of anti-depressants - are not suitable to be used by under 18s’. The regulatory language of the MHRA advice was intended as a ‘strong signal’, while falling short of an outright ban; however it has been treated as an effective ban by many practitioners and trusts around the country, and widely interpreted as such in the media. Related action by the US Food and Drugs Administration (FDA) based on the same evidence took a less assertive line, issuing ‘supplementary warnings’ only. These announcements have initiated a period of heated, often partisan debate and media attention, intensified by strongly held positions in relation to drug companies, and some confusion in clinicians about their right course of action. The MHRA has published abstracts of the evidence base on which their decision was based and the FDA has minuted further documentation of ongoing review work [2]. Further academic reviews of published and unpublished studies [3,4] have put intensive focus on the evidence base, raising key issues about the internal and external validity of the trials undertaken, the nature of data from unpublished trials and the reporting of adverse events.
At the time of writing (April 2004), the issues are far from settled, although the more work that is undertaken, the more questionable seems the evidence base on which inferences about safety and effectiveness of SSRIs in young people have been made. Whatever the final outcome, the furore has raised welcome and long overdue questions about the conduct of drug trials and the evidence base for child and adolescent psychiatry psychopharmacology as a whole. Highlighting and addressing these issues could be a real value to future practice in the field.
The medicine of childhood (including child psychiatry and paediatrics) has long suffered an anomalous position in relation to prescribing. The general absence of licensing for most medications in under 18s has led child and adolescent specialists to extrapolate from adult data in treating their patients. In child psychiatry there has been characteristically a period of 3 or 4 years while medications introduced into adult practice trickle down into child and adolescent practice - often in an idiosyncratic and patchy fashion and dependent on local and national peer consensus. Given the considerable increase in general Child and Adolescent Mental Health Services (CAMHS) prescribing over the last decade and an increasingly litigious environment, it is not surprising that this working arrangement (unsatisfactory as it always was) has come under scrutiny.
The fundamental problem is the lack of good quality and purposefully designed psychopharmacological research in childhood and adolescence. Detailed evidence to the FDA specialist advisory committee [5] confirms that the FDA actually issued invitations to drug companies to undertake the studies in childhood and adolescence, which form the basis of the current debate, as a condition of conferring continuing licensing exclusivity with this age group. This may have been their motivation, but major questions have since been raised about the internal and external validity of the resulting studies.
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