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Systematic violations of patients’ rights and safety: Forced medication of a cohort of 30 patients
The current paradigm in psychiatry is that psychosis should be treated with neuroleptics as first-line therapy. Neuroleptics should not be used at all. Randomised trials have shown that they kill many patients and do not have clinically relevant effects but cause permanent brain damage in most patients treated long-term and prevent them from coming back to a more normal life. If an acutely disturbed patient feels that a drug is needed, benzodiazepines work faster than neuroleptics, are much less toxic, and are also what virtually all patients prefer if asked. Psychiatry seems to be the only area in society where the law is systematically being violated all over the world. We need to respect the patients’ rights and the law, which will also lead to better outcomes.KeywordsPsychosisPsychiatryPsychiatric drugs
Background
Psychiatric patients’ human rights are often violated when forced treatment orders are issued.
Methods
We assessed the records for 30 consecutive petitions for mental health commitment in which an involuntary medication order was requested, from Anchorage, Alaska.
Results
In 29 cases, the commitment petition was granted. The forced medication order was granted in 27 of the 30 cases. In 26 cases, in violation of previous Supreme Court rulings, the patients’ desires, fears, wishes and experiences were ignored even when the patients were afraid that the neuroleptics might kill them or when they had experienced serious harms such as tardive dyskinesia. The ethical and legal imperative of offering a less intrusive treatment was also ignored. Benzodiazepines were not offered. Psychotherapy was not offered or mentioned in 15 cases. The providers claimed, contrary to the evidence, that psychotherapy does not work.
Dicussion
The legal procedures can best be characterized as a sham, in which the patients are defenseless. The power imbalance and abuse were extreme, and several of the psychiatrists who argued for forced treatment obtained court orders for administering drugs and dosages that were dangerous. We suggest forced medication be abandoned.
Peter C Gøtzsche and Anders Sørensen in their article titled "Systematic violations of patients' rights and safety: Forced medication of a cohort of 30 patients" alleged violation of patient rights by psychiatrists with the use of force, thereby causing immense harm. In this commentary I try to understand their motivation, expose their bias, make an evidence based counterpoint, explore real life consequences of their views and make a case for nuanced discussion on complexities in mental health.
This triple-blind (participants, clinicians, and researchers) randomized controlled noninferiority trial examined whether intensive psychosocial intervention (cognitive-behavioral case management, CBCM) for first-episode psychosis (FEP) in 15–25 year-olds managed in a specialized early intervention for psychosis service was noninferior to usual treatment of antipsychotic medication plus CBCM delivered during the first 6 months of treatment. To maximize safety, participants were required to have low levels of suicidality and aggression, a duration of untreated psychosis (DUP) of less than 6 months, and be living in stable accommodation with social support. The primary outcome was level of functioning as assessed by the Social and Occupational Functioning Scale (SOFAS) at 6 months. Ninety young people were randomized by computer, 46 to placebo, and 44 antipsychotic medication and 33% of those who commenced trial medication completed the entire 6-month trial period. On the SOFAS, both groups improved, and group differences were small and clinically trivial, indicating that treatment with placebo medication was no less effective than conventional antipsychotic treatment (mean difference = −0.2, 2-sided 95% confidence interval = −7.5 to 7.0, t = 0.060, P = .95). Within the context of a specialized early intervention service, and with a short DUP, the immediate introduction of antipsychotic medication may not be required for all cases of FEP in order to see functional improvement. However, this finding can only be generalized to a very small proportion of FEP cases at this stage, and a larger trial is required to clarify whether antipsychotic-free treatment can be recommended for specific subgroups of those with FEP.
Trial Registration: ACTRN12607000608460 (www.anzctr.org.au).
Objective:
To study the benefits and harms of antipsychotics in drug-naïve patients with psychosis.
Methods:
This study is a systematic review and meta-analysis of placebo-controlled trials.
Main outcome measures:
Mortality, activities of daily living, quality of life, core psychiatric events, and relapse and recovery rates.
Data sources:
PubMed, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), two trial registers and references in potentially eligible articles.
Data extraction:
Two researchers extracted data independently. The outcomes were planned to be meta-analysed using Review Manager based on a fixed effect model.
Results:
Our searches resulted in 493 unique records of which 447 were clearly not eligible. We read the full text of the 46 potentially eligible articles and found one eligible trial in drug-naïve patients, which was unreliable. It was a Chinese trial comparing olanzapine with placebo in 261 patients with first-episode schizophrenia. After 12 weeks, there was an extremely large difference favouring placebo, but the authors reported the opposite, that olanzapine was effective.
Conclusions:
The use of antipsychotics cannot be justified based on the evidence we currently have. Withdrawal effects in the placebo groups make existing placebo-controlled trials unreliable.
Joanna Moncrieff looks at the lack of long-term evidence for antipsychotic medication and considers what is needed to ensure we have the knowledge to maximize benefits and minimize harms.
Catatonia is a severe motor syndrome with an estimated prevalence among psychiatric inpatients of about 10%. At times, it is life-threatening especially in its malignant form when complicated by fever and autonomic disturbances. Catatonia can accompany many different psychiatric illnesses and somatic diseases. In order to recognize the catatonic syndrome, apart from thorough and repeated observation, a clinical examination is needed. A screening instrument, such as the Bush-Francis Catatonia Rating Scale, can guide the clinician through the neuropsychiatric examination. Although severe and life-threatening, catatonia has a good prognosis. Research on the treatment of catatonia is scarce, but there is overwhelming clinical evidence of the efficacy of benzodiazepines, such as lorazepam, and electroconvulsive therapy.
To understand what given scores of the Brief Psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS) mean from a clinical point of view is important for the translation of research results into practice. We therefore (a) compared the absolute change of the BPRS/PANSS with the Clinical Global Impressions Ratings (CGI) -improvement score and the change of the CGI severity score, (b) analyzed whether the severity of illness at baseline had an impact on the latter association, and (c) attempted to replicate previous BPRS findings using a completely different data set based upon the PANSS-derived BPRS. The method used was equipercentile linking of BPRS and CGI ratings from 14 drug trials in acutely ill patients with schizophrenia (n=5970). An absolute reduction of the BPRS/PANSS by approximately 10/15 points corresponded to a CGI change of 'minimally improved' and to a change of the CGI severity score by one severity step. However, the latter associations depended on the severity of symptoms at baseline. Less severely ill patients required less BPRS/PANSS total score reduction to achieve the same CGI-improvement score than more severely ill patients. This effect of initial severity was attenuated using percentage rather than absolute BPRS/PANSS reduction scores. The linking analysis between the absolute BPRS/PANSS reduction and the CGI may have an implication for the interpretation of efficacy differences found in clinical trials, and for sample size estimations. Clinicians seem to base CGI ratings on relative change rather than on absolute change of symptoms.
Objective:
We investigated if the law and the patients' rights are being respected in Denmark when patients appeal forced medication orders.
Method:
We assessed 30 consecutive cases described on the webpage of the Psychiatric Appeals Board.
Results:
No clear and convincing evidence was presented in any case that the proposed treatment was in the patient's best interests. Furthermore, according to Danish law, forced medication should be with drugs with the fewest possible adverse effects, but this condition was violated in 29 of the 30 cases (97%).In seven cases (23%), where the board disagreed with an earlier decision made by the Psychiatric Patients' Complaints Board and resolved that the conditions for forced treatment with an antipsychotic had not been met, the issues were formal and minor, and the Appeals Board argued, also in these cases, that force was justified because the patient was insane and that the prospect of cure or a significant and decisive improvement in the condition would otherwise be significantly impaired. This view lacks support in reliable science.The board seems mainly to have a cosmetic function, rubber stamping what the psychiatrists want. It focused on uncontroversial issues it could easily check and not on what is important for patients.
Conclusions:
Patients' rights and the law were not being respected. We suggest forced medication be abandoned, in accordance with the United Nations Convention on the Rights of Persons with Disabilities.
Importance
Cognitive interventions increasingly complement psychopharmacological treatment to enhance symptomatic and functional outcome in schizophrenia. Metacognitive training (MCT) is targeted at cognitive biases involved in the pathogenesis of delusions.Objective
To examine the long-term efficacy of group MCT for schizophrenia in order to explore whether previously established effects were sustained.Design, Setting, and Participants
A 2-center, randomized, controlled, assessor-blind, parallel group trial was conducted. A total of 150 inpatients or outpatients with DSM-IV diagnoses of schizophrenia spectrum disorders were enrolled. All patients were prescribed antipsychotic medication. The second follow-up assessment took place 3 years later after the intervention phase was terminated.Interventions
Group MCT targeting cognitive biases vs neuropsychological training (COGPACK). Patients received a maximum of 16 sessions.Main Outcomes and Measures
The primary outcome measure was a delusion score derived from the Positive and Negative Syndrome Scale (PANSS). The PANSS positive syndrome and total scores, the Psychotic Symptom Rating Scales, the jumping to conclusions bias, self-esteem, and quality of life served as secondary outcome measures.Results
The intention-to-treat analyses demonstrated that patients in the MCT group had significantly greater reductions in the core PANSS delusion score, after 3 years compared with the control group (η2partial = .037; P = .05). Among the secondary outcomes, the intention-to-treat analyses also demonstrated that patients in the MCT group had significantly greater reductions in the PANSS positive syndrome score (η2partial = .055; P = .02) and the Psychotic Symptom Rating Scales delusion score (η2partial = .109; P = .001). Significant group differences at the 3-year follow-up were also found on measures of self-esteem and quality of life, which did not distinguish groups at earlier assessment points. Attention was improved in the neuropsychological training group relative to the MCT group. The completion rate was 61.3% after 3 years.Conclusions and Relevance
Metacognitive training demonstrated sustained effects in the reduction of delusions, which were over and above the effects of antipsychotic medication. Moreover, there were some unanticipated (“sleeper”) effects as both self-esteem and quality of life were improved after 3 years. Effects on self-esteem and well-being were found even in the absence of an improvement on the jumping to conclusions bias.Trial Registration
isrctn.org Identifier: ISRCTN95205723
Background:
Clinical equipoise regarding preventative treatments for psychosis has encouraged the development and evaluation of psychosocial treatments, such as cognitive behavioural therapy (CBT).
Method:
A systematic review and meta-analysis was conducted, examining the evidence for the effectiveness of CBT-informed treatment for preventing psychosis in people who are not taking antipsychotic medication, when compared to usual or non-specific control treatment. Included studies had to meet basic quality criteria, such as concealed and random allocation to treatment groups.
Results:
Our search produced 1940 titles, out of which we found seven completed trials (six published). The relative risk (RR) of developing psychosis was reduced by more than 50% for those receiving CBT at every time point [RR at 6 months 0.47, 95% confidence interval (CI) 0.27-0.82, p = 0.008 (fixed-effects only: six randomized controlled trials (RCTs), n = 800); RR at 12 months 0.45, 95% CI 0.28-0.73, p = 0.001 (six RCTs, n = 800); RR at 18-24 months 0.41, 95% CI 0.23-0.72, p = 0.002 (four RCTs, n = 452)]. Heterogeneity was low in every analysis and the results were largely robust to the risk of an unpublished 12-month study having unfavourable results. CBT was also associated with reduced subthreshold symptoms at 12 months, but not at 6 or 18-24 months. No effects on functioning, symptom-related distress or quality of life were observed. CBT was not associated with increased rates of clinical depression or social anxiety (two studies).
Conclusions:
CBT-informed treatment is associated with a reduced risk of transition to psychosis at 6, 12 and 18-24 months, and reduced symptoms at 12 months. Methodological limitations and recommendations for trial reporting are discussed.
There has been concern about a high rate of placebo response and a decline in treatment effect over time in schizophrenia trials as well as the implications of increasing conduct of such trials outside North America. This report explores differences in efficacy data over an 18-year period from randomized placebo-controlled trials submitted in support of new drug applications (NDAs) for the treatment of schizophrenia and differences in results between trials conducted in North America and elsewhere.
Clinical trial data that were submitted to the US Food and Drug Administration (FDA) as part of NDAs for the indication of schizophrenia between 1991 and 2009.
Efficacy data were compiled from 32 clinical trials with 11,567 evaluable patients with schizophrenia. Data from completed, randomized, multicenter, double-blind, placebo-controlled, 4- to 8-week clinical trials in adult patients diagnosed with schizophrenia according to DSM-III or DSM-IV criteria were included.
Baseline demographic and disease characteristics, including mean Positive and Negative Syndrome Scale (PANSS) total scores, were summarized and compared between North American and multiregional trials. Mean change from baseline to endpoint in PANSS total scores was utilized as the primary outcome of interest. We explored differences in treatment effect and success rate of these trials based on when and where the studies were conducted, sample size, trial duration, and baseline patient characteristics.
Twenty-one of the 32 trials were conducted solely in North America, and 11 were carried out in multiple regions. Of those 11 multiregional trials, 2 were conducted exclusively in foreign countries. Although the observed responses (change from baseline) in placebo and drug-treated groups in multiregional trials tended to be larger than in North American trials, the treatment effects (drug-placebo difference) were -9 and -8 PANSS units for North American and multiregional trials, respectively. When time of trial conduct was taken into account, an increasing placebo response and a diminishing treatment effect over time were observed in North American trials from -10.8 PANSS units for the first period (1991-1998) to -6.0 PANSS units for the later period (1999-2008). The overall trial success rate over the almost 2 decades was 78%, declining slightly in trials conducted after 1999, the time period during which multiregional trials were first conducted (74% for 1999-2008 vs 85% for 1991-1998), despite increasing sample sizes in the later period. The mean baseline PANSS total score was in the range of 87-100 for most of these trials. Trials in patients with higher mean baseline PANSS total scores tended to show larger treatment effects than those in patients with lower scores. The mean body weight and body mass index (BMI) were higher in patients in North American trials and North America-predominant multiregional trials compared to those in foreign-predominant multiregional trials (mean body weights of 85 kg and 81 kg vs 72 kg, and BMIs of 29 and 27 vs 25, respectively). Treatment effects decreased as body weights increased, especially in North American trials. In foreign-predominant multiregional trials, there were higher proportions of women than in North American trials and North America-predominant multiregional trials (40% vs 22% and 27%, respectively) and a relatively larger proportion of Asians (21% vs 1% and 8%, respectively).
A high and increasing placebo response and a declining treatment effect are of great concern in schizophrenia trials conducted in North America. In this era of global clinical trials, close attention is needed to the design and conduct of these trials.
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