Sumisión química en casos de presuntos delitos contra la libertad sexual 2016-2018, Lima, Perú / Chemical submission in cases of alleged crimes against sexual freedom 2016-2018, Lima, Peru

Introducción: La sumisión química es el uso de sustancias químicas con el fin de manipular la voluntad en las personas produciendo una incapacidad o inconsciencia que facilita la acción criminal, por lo que han tomado un gran protagonismo en los últimos años, debido al uso frecuente en los casos de presuntos delitos contra la libertad sexual.Materiales y métodosSe ha realizado un estudio observacional descriptivo-retrospectivo de casos de presuntos delitos contra la libertad sexual ejercidos mediante sustancias químicas, con el fin de determinar el perfil de las víctimas según las muestras analizadas y las sustancias detectadas en los años 2016, 2017 y 2018, que han sido registrados en la Dirección de Criminalística (DIRCRI) de la Policía Nacional del Perú (PNP).ResultadosDe los 1841 casos de delito contra la libertad sexual, 445 (24,17±2%) cumplieron los criterios de inclusión. El perfil de la víctima es de una mujer limeña joven con una edad media de 22,56±1,14 años. La procedencia de casos fue San Juan de Lurigancho (10,56±2,9%). Las muestras remitidas han sido orina (62,47±4,5%), y en conjunto con el sarro ungueal (37,53±4,5%). El análisis toxicológico de los casos probables han sido sustancias identificadas como psicofármacos (57,53±4,6%, fundamentalmente benzodiacepinas), etanol (26,29±4,1%), y drogas ilícitas (11,24±2,9%, fundamentalmente marihuana y cocaína), solas o en combinación.ConclusionesEl estudio demostró que el 24,17±2% fueron casos probables de mujeres limeñas, agredidas sexualmente bajo efectos de sustancias químicas, predominando el distrito de San Juan de Lurigancho con el 10,56±2,9%, cuya mayoría de muestras analizadas fueron a partir de la orina con el 62,47±4,5%; el grupo de sustancias en el que más prevalencia se obtuvo fueron los psicofármacos con 57,53±4,6%, siendo las benzodiacepinas los únicos subgrupos que fueron registrados. (AU)

Introduction: Chemical submission is the use of chemical substances to manipulate the will of a person, producing incapacity or unconsciousness that facilitates criminal action. It has gained in prominence in recent years, due to its frequent use in cases of alleged crimes against sexual freedom.Materials and methodsAn observational descriptive-retrospective study of cases of alleged crimes against sexual freedom committed using chemical substances was carried out, to determine the profile of the victims according to the samples analysed and the substances detected in 2016, 2017 and 2018,registered with the Criminalistics Directorate (DIRCRI) of the Peruvian National Police (PNP).ResultsOf the 1841 cases of crime against sexual freedom, 445 (24.17%±2%) met the inclusion criteria. The victim's profile is that of a young (Lima) woman (mean age: 22.56±1.14 years). The cases were from San Juan de Lurigancho (10.56%±2.9%). The samples submitted were urine (62.47%±4.5%), and urine and nail plaque (37.53%±4.5%). The toxicological analysis of probable cases showed substances identified as psychotropic drugs (57.53%±4.6%, mainly benzodiazepines), ethanol (26.29%±4.1%), and illicit drugs (11.24%±2.9%, mainly marijuana and cocaine), alone or in combination.ConclusionsThe study showed that 24.17%±2% were probable cases of Lima women who had been sexually assaulted under the influence of chemical substances, predominantly in the district of San Juan de Lurigancho at 10.56%±2.9%, most of the samples analysed were urine with 62.47%±4.5%; the most prevalent group of substances were psychotropic drugs at 57.53%±4.6%, with benzodiazepines being the only subgroups that were recorded. (AU)

The Dobson-Rawlins pact and the National Institute for Health and Care Excellence: impact of political independence on scientific and legal accountability.

This analysis considers whether the independence of the National Institute for Health and Care Excellence (NICE), while safeguarding guidelines from commercial lobbying, may render NICE legally and scientifically unaccountable. The analysis examines the role of judicial reviews and stakeholder consultations in place of peer review in light of current debates concerning the depression guideline.

Restricción química en ancianos institucionalizados, el proyecto chrome / No disponible

En los últimos años se ha ido cuestionando con cada vez mayor asiduidad la práctica psiquiátrica habitual en los pacientes ancianos con o sin demencia, institucionalizados o no institucionalizados. El motivo de ese cuestionamiento es el empleo frecuente de medidas de restricción física y de psicofármacos en estos pacientes, práctica que con frecuencia constituye lo que se denomina sujeción física o química. Este artículo se focaliza en la medida de sujeción más desconocida, que es la sujeción química, debido al empleo inadecuado de psicofármacos. Se repasarán causas, dinámicas y soluciones propuestas con respecto al empleo de sujeciones, así como los usos de psicofármacos que pueden ser considerados sujeción química. Además, se resumirán aspectos importantes del proyecto CHROME, pionero en España en sistematizar el abordaje de las sujeciones químicas

The usual psychogeriatric clinical practice regarding elderly patients with or without dementia living at home or in an institution has been questioned in recent years. The reason is the frequent use of physical and chemical restraints in this population. This article focusses on chemical restraints, the most unknown measure of them, when an inappropriate use of psychoactive drugs occurs. We review reasons, dynamics and solutions for restraints `s use and when the use of a drug can be considered a chemical restraint. In addition, we summarize the most important aspects of the CHROME criteria, the first initiative in Spain to systematize the chemical restraints use

[The new German drug market law AMNOG from a child and adolescent psychiatry perspective]. / Das Arzneimittelmarktneuordnungsgesetz aus kinder- und jugendpsychiatrischer Perspektive.

BACKGROUND: The European Union (EU) regulation 1901/2006 plus the implementation of pediatric investigational plans by the European Medicines Agency (EMA) have contributed to more clinical studies in pediatric psychopharmacology. A new drug market law (AMNOG) has been in force in Germany since 2011 that requires an additional process of assessment of benefits of newly authorized medications by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G­BA), which also holds for medications licensed for pediatric populations. OBJECTIVES: Summary of early assessments of benefits for newly registered compounds in the treatment of psychiatric disorders and critical discussion from the perspective of child and adolescent psychiatry. MATERIAL AND METHODS: Application and critical review of documents and written statements by various institutions and stakeholders related to assessment procedures and respective decisions by the G­BA for these medications. RESULTS AND CONCLUSION: Clearly differing requirements for study designs and outcome parameters characterize the conditions for market authorization and for the assessment of benefits. Further adjustments to the regulations in implementing the AMNOG appear to be essential, integrating agencies involved so far, complimented by expertise from regulatory agencies and medical scientific societies.

[Significance of the German Act on the Reform of the Market for Medicinal Products for psychopharmacotherapy]. / Bedeutung des Arzneimittelmarktneuordnungsgesetzes für die Psychopharmakotherapie.

The German Act on the Reform of the Market for Medicinal Products (AMNOG) will lead to rapid disappearance of many new psychotropic drugs from the market in Germany over the next few years or their not being introduced in the first place. This article lists the reasons and discusses possible solutions. In the long term, the AMNOG could not only lead to an improvement of psychopharmacology but also contribute to the development of psychiatry as a whole, especially if its standards become an international reference.

Unmet needs in paediatric psychopharmacology: Present scenario and future perspectives.

Paediatric psychopharmacology holds great promise in two equally important areas of enormous biomedical and social impact, namely the treatment of behavioural abnormalities in children and adolescents, and the prevention of psychiatric disorders with adolescent- or adult-onset. Yet, in striking contrast, pharmacological treatment options presently available in child and adolescent psychiatry are dramatically limited. The most important currently unmet needs in paediatric psychopharmacology are: the frequent off-label prescription of medications to children and adolescents based exclusively on data from randomized controlled studies involving adult patients; the frequent lack of age-specific dose, long-term efficacy and tolerability/safety data; the lack of effective medications for many paediatric psychiatric disorders, most critically autism spectrum disorder; the scarcity and limitations of randomized placebo-controlled trials in paediatric psychopharmacology; the unexplored potential for the prevention of psychiatric disorders with adolescent- and adult-onset; the current lack of biomarkers to predict treatment response and severe adverse effects; the need for better preclinical data to foster the successful development of novel drug therapies; and the effective dissemination of evidence-based treatments to the general public, to better inform patients and families of the benefits and risks of pharmacological interventions during development. Priorities and strategies are proposed to overcome some of these limitations, including the European Child and Adolescent Clinical Psychopharmacology Network, as an overarching Pan-European infrastructure aimed at reliably carrying out much needed psychopharmacological trials in children and adolescents, in order to fill the identified gaps and improve overall outcomes.

The placebo arm in clinical studies for treatment of psychiatric disorders: a regulatory dilemma.

BACKGROUND: The use of placebo in clinical trials, and, related to this, ethical and feasibility aspects, are often debated. However, regulatory authorities must ensure that only new drugs with a positive benefit/risk would be granted a marketing authorization. It is therefore not surprising that they often put forward the need for placebo control in clinical trials in an area where many trials fail, and assay sensitivity is not self-evident. To illustrate the complexity that regulatory authorities encounter when faced with the registration dossier of products in the main psychiatric therapeutic areas, Major Depressive Disorder (MDD) and schizophrenia, the trial outcome for products receiving an opinion in the EU during the past 15 years were reviewed. DATA SOURCE: European Public Assessment Reports and registration files. RESULTS: A total of 45 studies qualified for analysis. For the indication MDD 38% of the studies (10/26) were recorded as failed, and another 15% (4/26) as negative. For schizophrenia, these figures were 16% (3/19) and 11% (2/19). Further exploration of the trials in MDD revealed an inconsistent pattern in terms of magnitude of placebo- and drug-mediated response (i.e. similar studies with consistent placebo response provided different treatment outcomes). CONCLUSION: From a regulatory perspective the dilemma of a priori exclusion of the placebo arm in clinical trials in the domains of depression or schizophrenia cannot be solved at this time as long as factors influencing trial variability are not better identified or understood. This counts in particular for MDD where the added drug effect is not consistent across trials with almost identical inclusion criteria. Unfortunately, this trend has not changed over the past 15 years. However, all efforts should be taken to optimize the clinical development of drugs in the psychiatric domain, and improve the intrinsic quality of the clinical trials in order to allow for a different viewpoint.

The EU paediatric regulation: effects on paediatric psychopharmacology in Europe.

Child and adolescent psychiatry is a relatively young field and the recognition, classification, and treatment of disorders in children and adolescents lag behind those in adults. In recent years there is an increasing awareness of the differences between children and adults in psychopathology and pharmacology. Related to this new paediatric regulations have been introduced. This article reviews the regulatory and legislative measures that were adopted in the EU in 2007 and the subsequent impact of these measures on the field of paediatric psychopharmacology. The consequences of the paediatric regulation in the EU are reflected in several domains: regulatory, research aimed at drug development and clinical practices. In the regulatory domain, the consequences include: new paediatric indications, inclusion of special (class) warnings, specification of dose regimens, and information on safety specific to children and adolescents, and development of new medicinal formulations. The paediatric regulation leads to timely development of paediatric friendly formulations and better quality of the clinical evidence. In clinical practices, an increased awareness of the uniqueness of paediatric pharmacology is emerging among medical professionals, and subsequent improvement of medical care (i.e. correct doses, appropriate formulation, monitoring for expected adverse events). In addition, clinical guidelines will have to be revised more frequently in order to integrate the recently acquired knowledge. The new regulations stimulate transparency and discussions between academia, pharmaceutical industry, and regulators. The purpose is to optimize clinical research and obtain evidence for paediatric psychopharmacology, thereby providing adequate support for treatment.

Safeguarding children's rights in psychopharmacological research: ethical and legal issues.

OBJECTIVE: Research on psychopharmacological treatment in children and adolescents is the subject of ongoing ethical discussion, as minors with mental disorders constitute a vulnerable patient group. Considering the important legislative changes in pediatric research over the past decade in both the US and Western Europe, there is a need to review recent developments in this area. METHOD: Based on a systematic literature review, a hermeneutical analysis focusing the main issues of ethics in child and adolescent psychopharmacology is provided. Legal and regulatory aspects of psychopharmacological research in children are compared between the US and Europe. Relevant issues were informed assent and consent to research participation, minimal risk and burden of research, ethics of pharmacogenetics, research on "me-too" medications, and justice in global research. Additionally, the concern about undue influence of financial interests in research is also addressed. CONCLUSION: Incentives for the conduct of clinical trials with children comparable to those contained in US legislation are now provided in the EU. Research to develop "me-too" preparations may have no significant benefit for children, but can cause research burden and detract from clinically more important projects by utilizing limited investigator time and patient resources. Thus far, pharmacogenetic studies may bring more individualized treatment approaches into child psychiatry but they remain at present a promise for the future. Finally, the issues of avoiding undue influence from funders and conflicts of interest remain a prominent concern which can be solved by declaring conflicts and publishing all results of studies extensively.

Neuroscience, power and culture: an introduction.

In line with their vast expansion over the last few decades, the brain sciences -- including neurobiology, psychopharmacology, biological psychiatry, and brain imaging -- are becoming increasingly prominent in a variety of cultural formations, from self-help guides and the arts to advertising and public health programmes. This article, which introduces the special issue of "History of the Human Science" on "Neuroscience, Power and Culture," considers the ways that social and historical research can, through empirical investigations grounded in the observation of what is actually happening and has already happened in the sciences of mind and brain, complement speculative discussions of the possible social implications of neuroscience that now appear regularly in the media and in philosophical bioethics. It suggests that the neurosciences are best understood in terms of their lineage within the "psy"-disciplines, and that, accordingly, our analyses of them will be strengthened by drawing on existing literatures on the history and politics of psychology -- particularly those that analyze formations of knowledge, power and subjectivity associated with the discipline and its practical applications. Additionally, it argues against taking today's neuroscientific facts and brain-targetting technologies as starting points for analysis, and for greater recognition of the ways that these are shaped by historical, cultural and political-economic forces.

Psychopharmacology for children: from off label use to registration.

Pharmacological treatment of children and adolescents is largely based on evidence from adults' studies. There is, however, growing awareness that this evidence cannot simply be extrapolated to children. The Dutch Medicines Evaluation Board (MEB) in collaboration with the Child and Adolescent section of the Dutch Association of Psychiatry and the National Expertise Centre Child and Adolescent Psychiatry have organised a workshop to discuss the kind of evidence that would be necessary and the methods involved. There was consensus about the need to demonstrate efficacy in targeted disorders as well as symptoms within specific disorders and about the need for separate evidence for children and for adolescents. In addition, too little is known about safety, especially long-term safety, as consequences of treatment. Main issues are effects on growth, cognitive, motor, emotional, and sexual development, metabolic symptoms, cardiotoxicity, and dependence. Specific methodological issues were discussed, such as the role of different informants and the high rate of comorbidity.

The impact of European regulatory policies on psychotropic drug prescribing patterns.

Thanks to their alleged better tolerability atypical or second-generation antipsychotic drugs (SGA) have gained a considerable fraction of the market at the expense of the classical antipsychotics. The massive advertising of SGA focussed the doubtful reduction of extra-pyramidal side effects (EPS) overlooking the information about the cardiovascular risk induced by SGA. This also led to extensive off-label use as the control of behavioural symptoms associated with dementia in elderly patients. Although the European Medicine Agency (EMEA) eventually warned physicians and patients of the risk associated with SGA use in this area, the regulatory system has some responsibility in this situation. No added therapeutic value is required for new drugs to be approved for the market. They are only evaluated for their own quality, efficacy and safety with no comparison with available alternative treatments. This implies that new drugs may, in fact, be potentially less effective or less safe than other drugs currently in use.