“You need some medicine to help you get back in control. Take this medicine or we may have to give you a shot.”
While this may sound like a line from One Flew Over the Cuckoo’s Nest, it is in fact, the phrase used to secure the agreement of children aged 5-12 to taking liquid Risperidone as part of a clinical study conducted by psychiatrist and pediatrician, Dr Gabrielle Carlson.
In the face of concerns that large numbers of children were being incorrectly diagnosed with pediatric bipolar disorder, the DSM–V introduced Disruptive Mood Dysregulation Disorder (DMDD) as a new mental disorder in children, a disorder characterized by persistent (rather than episodic) irritability and severe and frequent temper tantrums. In the scramble by drug companies to produce evidence that their drug should be prescribed to this new population of mentally ill children, Janssen Pharmaceuticals, the manufacturer of Risperidone, paid Dr Carlson of Stony Brook University Medical School, NY, to test their drug on a group of children hospitalized for ‘rage.’
The study does not investigate whether treatment with Risperidone has any therapeutic benefit to the children, whether it cures or treats DMDD or ‘rage outbursts.’ It is quite open that Risperidone is being trialled for its efficacy as a chemical restraint. As Dr Carlson explains:
The goals of this pilot study were to determine acceptability (whether the child would take the liquid medication when angry), safety and efficacy of liquid risperidone in rage outbursts in general, and in children with severe mood dysregulation and/or possible bipolar disorder in particular, and to compare liquid risperidone to usual treatment (i.e. seclusion and restraint) in terms of time to behavioral control, and need for a 2nd intervention.
In the results of the trial, Dr Carlson reports that all but one child agreed to take the medication. This is hardly surprising given they were threatened with an injection if they refused. Agreement obtained through the use of threats and coercion is identified in the domestic violence literature as a classic tactic of an abuser and in the law as not constituting consent.
Children are scared of injections. They hurt. Of course children will choose to drink a drug rather than be injected with one. Dr Carlson could have achieved the same results if she had told the children that if they didn’t take their drug she would punch them.
As a psychiatrist and pediatrician one would expect that Dr Carlson has worked with children who have been coerced into sexual, criminal or other harmful activity in the face of threats of violence if they resist. Undoubtedly she views this as abhorrent and if asked to give an opinion would consider the child did not consent as their cooperation was obtained under duress. It would appear however that being paid by a pharmaceutical company to support their claim that their drug is suitable for a new indication, Dr Carlson has been blinded to the abuse of power inherent in threatening children with with actions which are painful, and of which they are afraid, in order to test a drug on them.
So who were the children Dr Carlson carried out her experiment on? They were 23 children hospitalized for ‘rage outbursts’ who had 3 or more outbursts during their hospitalization. The demographic data from the study shows they were children more likely to be younger, living away from their parents, to be in special education, to have severe expressive language difficulties and to be victims of domestic violence, than those children who did not display rage. The greatest common factor between these children was not their life experiences or cognitive status however, but the fact that 21 of the 23 were taking atypical antipsychotics on a daily basis prior to, and during, their hospitalization.
And how did Dr Carlson define ‘rage outbursts?’ In her words,
Rages were operationally defined as agitated/angry behaviors requiring seclusion or medication because the child could not be verbally redirected to “time out.”
A rage outburst was defined as sufficient agitation and loss of control such that the child was unable to “time out” (i.e. sit in a chair for 10 minutes on being told to do so) or was a danger to himself or others and a higher level of intervention was needed.
Note the ‘or’ in that sentence. Risperidone was not being used as a chemical restraint only in circumstances where the child was at risk of harming themselves or others but also where the child was unable to sit in a chair for 10 minutes.
This is in direct contravention of every published standard for restraint and seclusion including the Consensus Statement of the American Association for Emergency Psychiatry Project, the regulations developed by the Centers for Medicare and Medicaid Services (CMS), and the guidelines of the Child Welfare League of America amongst others which all require that restraint or seclusion only be imposed to ensure the immediate physical safety of the patient, a staff member, or others.
According to Carlson, children’s rage outbursts are important because they disrupt ward functioning, create management challenges, may indicate greater psychopathology, and are associated with longer hospitalizations. According to both the CMS regulations and guidelines of the Child Welfare League of America which state that restraints should never be used for purposes of discipline, retaliation and convenience, none of these factors justify the use of restraint.
So what did Dr Carlson and Janssen Pharmaceuticals achieve with this study. Very little judging by the conclusions which were that kids who throw tantrums in hospital are kids who are taking antipsychotics, who are frustrated as a result of limited ability to communicate, who threw tantrums before they came to hospital. They are not kids whose tantrums are predicted by their psychiatric diagnosis. She found that giving kids more antipsychotics “appeared to shorten the duration of the last rage episode, though the episodes still continued for almost 30 minutes” but she also noted that it is possible that order effects and other interventions are responsible for the decreased duration of tantrums.
As a result of her study, Dr Carlson decided that “given that outbursts are similar to tantrums in age trends, causal associations, factor structure, and temporal organization, we propose the working hypothesis that they are indeed prolonged and exacerbated versions of ordinary childhood tantrums.”
The Consensus Statement of the American Association for Emergency Psychiatry Project notes that both physical interventions and drugs for the purpose of restraint have short-term and long-term detrimental implications for the patient and the physician-patient relationship.
What did the children learn from being part of this experiment? No one of course asked them, but I guess they learned to fear doctors and other medical staff, to fear hospital and to fear injections. Given their very real risk of developing diabetes and/or cardiac problems from their use of antipsychotics, these fears could significantly affect their willingness to seek and engage in life saving procedures in the future.
I guess they also learned that using threats and coercion against people smaller than you is ok, that adults can’t be trusted, and that they are bad kids. They learned that they need drugs to control themselves. As a mother and a teacher, I’m willing to bet that these messages will negatively impact their self esteem, their ability to form relationships and their prospects for health and happiness in the future.
 Gabrielle A. Carlson, MD, Michael Potegal, PhD, David Margulies, MD, Joann Basile, RN, BA, and Zinoviy Gutkovich, MD Liquid Risperidone in the treatment of rages in psychiatrically hospitalized children with possible bipolar disorder Bipolar Disord. 2010 March; 12(2): 205–212.
 Gabrielle A. Carlson, Michael Potegal, David Margulies, Zinoviy Gutkovich, and Joann Basile, Rages—What Are They and Who Has Them? J Child Adolesc Psychopharmacol. 2009 June; 19(3): 281–288.
 Potegal M, Carlson GA, Margulies D, Basile J, Gutkovich ZA, Wall M. The behavioral organization, temporal characteristics, and diagnostic concomitants of rage outbursts in child psychiatric inpatients. Current Psychiatry Reports. 2009;11(2):127–133.
Daryl K. Knox, MD* and Garland H Holloman, Jr, MD, PhD† Use and Avoidance of Seclusion and Restraint: Consensus Statement of the American Association for Emergency Psychiatry Project BETA Seclusion and Restraint Workgroup West J Emerg Med. 2012 February; 13(1): 35–40.