A randomised trial raises ethical complications

How do you run an ethical randomised trial to stop paedophilia? This is the question that hovers over research into drugs which are intended to stop unwanted sexual impulses.

Swedish doctors at the Karolinska Institute are investigating the effectiveness of a prostate cancer drug called Firmagon, which blocks the production of testosterone in the testes. It is effectively a form of chemical castration.

Other drugs are already in use, but there is very little hard evidence of how well they work. One of the reasons for this is the legal and ethical issues surrounding paedophilia. Doctors are supposed to report patients if they discover that they have committed a criminal offence like downloading child pornography, so men are understandably reluctant to volunteer for trials. The ethics of giving some patients who are at risk of offending a placebo are also murky. One of the goals of the study is to clarify the ethics of the methodology, in view of the social importance of the topic.

Swedish regulators have approved a trial for Firmagon. Half of the participants will receive a placebo and the other half will receive the drug. They will be tested over three months for three markers of risk: high sexual arousal, self-regulation, and empathy. They hope to recruit 60 volunteers through Preventell, a Swedish website for men who are troubled by unwanted sexual impulses.  

A novel feature of the trial is that the Swedish scientists are raising money through a UK website for crowd-funding science, Walacea. (See promotional video above.) The principal investigator, Dr Christoffer Rahm, says he does not want to rely upon drug company funding. He hopes to raise  £38,000 ($53,000).

The researchers’ broader goal is achieving an understanding of the genetic, neurological, and hormonal markers of paedophilic behaviour. Dr Rahm says: “It’s important we have evidence-based treatment. We need to shift the focus away from what to do when the damage is already done on to preventing the sexual abuse happening in the first place.”

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Michael Cook

Michael Cook edits BioEdge, a bioethics newsletter, and MercatorNet, an on-line magazine whose focus is human dignity. He writes from Sydney, Australia.

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