Four years after it was first announced, the results of a controversial clinical trial have finally been published in the journal JAMA Psychiatry. The study found a testosterone-reducing drug, originally developed as a prostate cancer treatment, lowered sexual interest in children for men with pedophilic disorder.
The unique clinical trial initially made headlines in 2016 when its research team, from the Karolinska Institutet and Gothenburg University in Sweden, turned to crowdfunding after it fell short of its funding goals. The trial set out to offer the first ever randomized, double-blind, placebo-controlled investigation into the efficacy of chemical castration for men with sexual attraction to children.
Chemical castration, an umbrella-term referring to drug treatments designed to lower sex drive and desire, has long been a controversial method for treating convicted pedophiles. In several parts of the world the treatment is forced upon convicted sex offenders, while other places offer the therapy on a voluntary basis for convicted men in prison.
Alongside any ethical considerations, the efficacy of chemical castration as a method to control pedophilic impulses is still yet to be clearly demonstrated. All uses of the method so far have been limited to correctional facilities, and lower rates of recidivism when subjects have been subsequently released are often pointed to as examples of a self-fulfilling prophecy – the men most compelled to undergo the treatment may be the least likely to reoffend.
The only way to eliminate these questions over efficacy would be through a rigorous clinical trial. Of course, there is absolutely no ethical body in the world that would approve giving placebos to men convicted of child sexual abuse and then releasing them into a community as a control group to compare their results against an active drug group. So a team of researchers in Sweden came up with a fascinating way around this ethical dilemma.
In Sweden there is a national telephone help line for individuals with unwanted sexual thoughts called PrevenTell. The goal of the helpline is to prevent sexual abuse or violence before it occurs by offering specialist help to those with problem behaviors. Through the helpline, the researchers recruited 52 men with self-confessed pedophilic disorder. On their initial visit to the hospital for baseline evaluation, the men were administered either a placebo or a drug called degarelix.
Degarelix is a gonadotropin-releasing hormone antagonist first approved for human use as a prostate cancer treatment a little over a decade ago. Because the drug is known to swiftly decrease testosterone levels to almost zero in a matter of days, it was hypothesized as being potentially useful in this context as a way to rapidly reduce acute pedophilic urges.
The primary efficacy outcome in the trial was measured by calculating a composite risk score. The score measured self-rated risk plus four other empirically derived factors: pedophilic disorder, sexual preoccupation, impaired self-regulation, and low empathy. Participants were scored at baseline, two weeks after treatment, and then again 10 weeks later.
The researchers report a statistically significant decrease in the composite risk score of the degarelix group compared to placebo at both the two-week and 10-week follow up. Two of the subjects in the degarelix group suffered from episodes of suicide ideation, noted as the primary adverse affect of the treatment.
“It’s important to be able to offer a relatively fast-acting treatment, and the patients’ own experiences of the drug were overall positive,” says lead on the study, Christoffer Rahm. “This study is an important step towards an evidence-based treatment for pedophilic disorder.”
Questions have been raised, however, over some broad generalizations made in the research. In an interview with The Guardian, Michelle Degli Esposti from the University of Oxford suggests it is unclear whether the treatment would actually reduce real-world occurrences of child sex abuse, as the men in the study are all self-selected and actively reaching out for assistance.
Armon Tamatea, clinical psychologist and president of the Australian & New Zealand Association for the Treatment of Sexual Abuse, also questions whether a sample cohort such as this can be representative in regards to actively reducing acts of child sexual abuse in real-world scenarios.
“The sample was (1) drawn from the community, and the majority (85% for each group) did not have prior contact with a criminal justice agency, (2) were self-referrers who were anxious about their ‘self-identified unwanted sexuality’, so presumably not currently engaged in counseling or treatment of some kind to address these issues, and (3) were clearly distressed by their ‘condition’, hence their motivation to contact the researchers,” Tamatea writes in an email to New Atlas. “Much child abuse occurs within the home and under a code of silence. Men who have come to the attention of the criminal justice system for child sex offences do so because of victim disclosures, or may self-disclose when a court case is immanent in order to access community-based treatment and hopefully avoid a full prison sentence.”
Alongside questions over the real-world veracity of the study, longstanding ethical debates have been rekindled over the medicalization of pedophilic disorders.
“Should we be focusing on medicating individuals who have sexual desire for children and, if so, do we expect these individuals to take drugs that have known side-effects? Or should we instead be focusing on tackling the upstream societal and structural factors that place children at risk of being sexually abused?” asks Degli Esposti, who did not work on this study. “It may not be a question of either/or, and such questions go beyond the findings of this specific study, but it is important to consider the implications of medicalizing profound societal problems such as child sexual abuse.”
Tamatea also points out the utility of medical treatment for these kinds of conditions is limited without broader psychological treatments and interventions. He suggests the cause, course and cessation of sexually harmful behavior cannot be sufficiently explained by biological influences alone.
“Ethically, framing what are really psychological and social problems through a medical lens will miss critical psychological, social, and even environmental factors that contribute to harmful sexual behavior,” writes Tamatea. “Furthermore, relying on biological treatments circumvents important issues like insight and responsibility that are central to assist people to address these kinds of issues – and may perpetuate further harm because the behavior is seen as a medical problem rather than one of poor self-management and seeking opportunities for inappropriate sexual gratification.”
The new study was published in the journal JAMA Psychiatry.
Source: Karolinska Institutet
