by Anthony Chicotel, CANHR Staff Attorney
A new study in the October 18, 2012 issue of the venerable New England Journal of Medicine assesses the efficacy of drugging dementia patients with Risperdal versus abruptly discontinuing the drug and substituting a
placebo. Dementia patients were divided into three categories:
1) those receiving Risperdal for 32 weeks;
2) those receiving Risperdal for 16 weeks followed by a placebo for 16 weeks; and
3) those receiving a placebo for 32 weeks.
The study showed a remarkable increase in the risk of “adverse events” for patients who received Risperdal throughout the study period. The patients who received Risperdal for 32 weeks were about twice as likely to suffer a “serious” adverse event (such as death or a heart attack) and more than twice as likely to suffer less serious adverse events (such as nausea or falling) than patients who remained Risperdal-free.
Despite confirming the high risk of harm and death when giving Risperdal to people with dementia, the authors primarily focused on the second group of patients – those who were started on Risperdal and abruptly stopped. The authors found that the “relapse” rate for those patients, measured by agitation-aggression and psychosis, is higher for patients who are taken off of Risperdal than for those who are not. The authors indicate this risk of relapse should factor against having Risperdal withdrawn from patients with dementia. This troubling conclusion raises a number of the study’s flaws.
The biggest flaw in the study is that it measures a patient’s “condition” by incidents of agitation such as aggression and psychosis. This measure excludes other important components of a patient’s condition, such as cognitive awareness, ability to communicate needs, and overall quality of life. In other words, the study is designed so Risperdal’s worst side effect – extreme sedation that reduces the patient’s ability to communicate needs – is considered a positive. Risperdal, and other antipsychotics are well known and increasingly notorious for rendering many patients with dementia into a near-vegetative state. When a patient is sedated and subdued, he or she will of course appear to be less agitated or psychotic.
The best dementia care providers in the country have long known that “agitation and aggression” is usually a patient’s way of expressing distress or discomfort. Agitation typically has an identifiable trigger, such as untreated pain or confusion. The fundamental problem with Risperdal and other antipsychotics is they do not address the root cause of a person’s agitation; rather they mask it by inhibiting the only remaining means of patient communication, behavior.
The study’s finding that patients who were drugged with Risperdal display increased signs of agitation, aggression, and psychosis when the drug is abruptly taken away is no surprise. Risperdal inhibits dopamine transmission in the brain, causing the brain to work harder to produce additional dopamine. When the drug is suddenly stopped, the brain may be left with excess dopamine, which can itself induce temporary psychosis.
Beyond the neurophysiologic impact of abrupt Risperdal cessation, taking a person with dementia off of a sedating drug, without doing anything more, can be expected to potentially lead to incidents of agitation and aggression. If agitation and aggression are properly understood as communication of distress or discomfort and the cause of those feelings is never addressed, the agitation and aggression are probably going to re-occur. Drugging a dementia patient for 16 weeks does not remedy the problems that led to the agitation in the first place.
As one can imagine, we have our own conclusions drawn from the study and others like it:
- Risperdal nearly doubles the risk of death or serious harm for patients with dementia;
- Risperdal is a chemical restraint, preventing patients with dementia from expressing distress or discomfort through communicative behavior;
- Treating people with dementia with an antipsychotic drug for “agitation,” without addressing the underlying cause of their behavior, is irresponsible and dangerous. For patients who have already been started on a drug, a responsible course of gradual dose reduction coupled with an emphasis on comfort-focused care is likely going to prove much better for the patient than continued chemical restraint.
 According to a medical journal disclosure form, many of the study’s authors have financial ties to pharmaceutical companies and at least two have financial ties to Johnson and Johnson, the manufacturer of Risperdal. In addition, Johnson and Johnson provided free Risperdal pills for the study.
 Despite Risperdal’s sedative properties, the authors nonetheless found it is “not highly effective in achieving and maintaining a reduction in symptoms of psychosis and agitation.
 While abrupt removal from Risperdal, without providing any additional care interventions, might be expected to lead to increased agitation, the renown DART-AD trial, in which patients with Alzheimer’s Disease were withdrawn from antipsychotic drugs (including Risperdal), were found to have no detrimental effect on functional and cognitive status. In fact, some patients improved. (Ballard, Clive, (2008) A Randomised, Blinded, Placebo-Controlled Trial in Dementia Patients Continuing or Stopping Neuroleptics (The DART-AD Trial)