Research Related Tumour Biopsies in Early-Phase Trials with Simultaneous Molecular Characterisation - a Single Unit Experience.

Early-phase cancer clinical trials are becoming increasingly accessible for patients with advanced cancer who have exhausted standard treatment options and later phase trial options. Many of these trials mandate research tissue biopsies. Research biopsies have been perceived as ethically fraught due to the perception of potential coercion of vulnerable human subjects. We performed an audit of two years of practice to assess the safety of ultrasound (US)-guided research biopsies, and to look at the yield of a simultaneous tumour next-generation sequencing (NGS) and immunohistochemistry (IHC) molecular characterisation programme. We show that in our institution, US-guided research biopsies were safe, produced adequate tumour content and in a selected subset who underwent in-house NGS sequencing, showed a high rate of actionable mutations with 30% having a Tier 1 variant. Nevertheless, these research biopsies may only provide direct benefit for a minority of patients and we conclude with a reflection on the importance of obtaining truly informed consent.

Pela vida das pessoas com doenças crônicas e patologias

O encontro virtual do Comitê do CNS de acompanhamento da Covid-19 será transmitido ao vivo na quarta-feira (22/7), às 17h, pelo Facebook e Youtube. A falta de medidas efetivas de proteção à saúde e planos de apoio às pessoas com doenças crônicas e outras patologias, durante a pandemia da Covid-19, serão temas da próxima live do Conselho Nacional de Saúde (CNS) na quarta-feira (22/7), às 17h, com transmissão pelo Facebook e Youtube. Desde o início da pandemia o CNS tem manifestado preocupação com a ausência de medidas protetivas para esta população. A infecção por Covid-19 em pessoas com doenças crônicas e patologias pode representar em torno de 25% a 50%, sendo que estes pacientes apresentam maiores taxas de mortalidade devido à dificuldade de recuperação dos sintomas graves. Para debater o assunto, participarão da live do CNS o diretor do Departamento de Doenças de Condições Crônicas e Infecções Sexualmente Transmissíveis (DCCI/SVS) do Ministério da Saúde, Gerson Pereira, a secretária de Articulação Política da Articulação Nacional de Luta contra a Aids (Anaids), Carla Almeida e a coordenadora da BioRede Brasil (Biored), Priscila Torres. O programa será mediado pelo conselheiro nacional de saúde Artur Custódio, que representa o Movimento de Reintegração das Pessoas Atingidas pela Hanseníase (Morhan) no CNS. O programa também terá representações dos segmentos de gestores, usuários e trabalhadores do SUS, com as participações de Maíra Botelho, diretora do Departamento de Atenção Especializada e Temática, da Secretaria de Atenção Especializada à Saúde do Ministério da Saúde, Eduardo Fróes, conselheiro nacional de saúde pela Associação Brasileira de Linfoma e Leucemia (Abrale) e Laís Souza, representante da Associação Brasileira de Ensino em Fisioterapia (Abenfisio) no CNS, respectivamente. Em abril, o Conselho solicitou ao Ministério da Saúde a apresentação de um plano de apoio para estas pessoas, com o objetivo de reduzir o risco de desenvolvimento de comorbidades e óbitos. O que se tem observado a cada dia são as dificuldades de acesso ao tratamento, baixo diagnóstico, falta de medicamentos e fechamento de atendimento ambulatorial de diferentes especialidades. Entre as medidas efetivas de proteção à saúde das pessoas com doenças crônicas e patologias, recomendadas ao Ministério da Saúde, estão: testagem prioritária, alternativas ao acesso de medicamentos com a estratégia de fornecimento ampliado (para dois ou três meses), enquanto durar o período de isolamento social e construção de protocolos específicos de atendimento a esta população. Essas estratégias devem ser voltadas às pessoas com HIV/Aids, câncer, celíacos, hanseníase, lúpus, doença falciforme, esclerose múltipla, doenças reumáticas, alzheimer, síndrome de down, Transtorno do Espectro Autista (TEA), diabetes, cardiopatas, transplantados, doenças raras, entre outras. Este é o 9º encontro virtual organizado pelo Comitê do CNS de acompanhamento da Covid-19 com transmissão ao vivo.

Medication monitoring and drug testing ethics project.

In 2012, Duke University initiated a research project, funded by an unrestricted research grant from Millennium Laboratories, a drug testing company. The project focused on assessing the frequency and nature of questionable, unethical, and illegal business practices in the clinical drug testing industry and assessing the potential for establishing a business code of ethics. Laboratory leaders, clinicians, industry attorneys, ethicists, and consultants participated in the survey, were interviewed, and attended two face-to-face meetings to discuss a way forward. The study demonstrated broad acknowledgment of variations in the legal and regulatory environment, resulting in inconsistent enforcement of industry practices. Study participants expressed agreement that overtly illegal practices sometimes exist, particularly when laboratory representatives and clinicians discuss reimbursement, extent of testing, and potential business incentives with medical practitioners. Most respondents reported directly observing probable violations involving marketing materials, contracts, or, in the case of some individuals, directly soliciting people with offers of clinical supplies and other "freebies." While many study respondents were skeptical that voluntary standards alone would eliminate questionable business practices, most viewed ethics codes and credentialing as an important first step that could potentially mitigate uneven enforcement, while improving quality of care and facilitating preferred payment options for credentialed parties. Many were willing to participate in future discussions and industry-wide initiatives to improve the environment.

Financiación de medicamentos: Los aspectos jurídicos / Financing of drugs: legal aspects

El derecho a la protección de la salud impulsa al poder ejecutivo a establecer una política sanitaria conducente, dentro de los principios de equidad, calidad y participación ciudadana, a la promoción del uso racional del medicamento y a adoptar medidas dirigidas a que la prestación farmacéutica, por el Sistema Nacional de Salud, se realice a precios razonables y con un gasto publico ajustado, dentro de la necesidad de optimizar los recursos disponibles. En la actualidad el Estado de Bienestar alcanzado en nuestro país se hace cada día más gravoso, de aquí que para garantizar la sostenibilidad del Sistema Nacional de Salud el Estado español haya promovido una reforma sanitaria a través de normas, entre otras, el Real Decreto Ley 16/ 2012 del cual analizamos el impacto y consecuencias más destacables en el sector farmacéutico

The right to health protection encourages the Executive to establish a leading health policy according to the principles of equity, quality and citizen participation, to promote a responsible use of drugs and to adopt measures in order to make the provision of pharmaceutical care affordable and with reasonable public health expenditure by the Spanish National Health System as part of the need of optimizing the available resources. Nowadays, the welfare state achieved in our V country is progressively more expensive. Hence, in order to guarantee the sustainability of the Spanish National Health System, the Spanish government has promoted a health reform through standards, among others the Royal Decree-]Law16/ 2012, of April 20, 2012. From this Royal Decree-] Law we analyze the impact and the most noteworthy consequences in the pharmaceutical sector

Public awareness and views on unlicensed use of medicines in children.

AIMS: To explore awareness and views of the general public on unlicensed use of medicines in children and on the participation of children in clinical trials. METHODS: Members of the public completed a questionnaire survey administered by face-to-face interview in public areas in N. Ireland. The main outcome measures were the views on unlicensed use of medicines in children and on clinical trials in children. RESULTS: One thousand participants (59.2% female) took part; 610 were parents. Most participants (86%) had no previous knowledge about unlicensed use of medicines in children. Being a parent did not influence this nor did being a parent of a child who suffered from a health problem (P > 0.05). Most participants (92%) felt that parents should be told about unlicensed use of medicines, with the doctor most frequently selected as the person who should inform parents. At the outset, only 1.8% of participants felt that the use of medicines in children was unsafe. However, having been informed about unlicensed use of medicines, this proportion increased dramatically (62.4%; P < 0.001). Views on whether participants would enter a child of their own into a clinical trial varied according to the health status of the child (P < 0.05) i.e. a child in good health (3.9%) vs a child with a life-threatening condition (41.9%). CONCLUSIONS: There is limited public knowledge of unlicensed use of medicines in children and a general reluctance to involve children in clinical trials unless the child to be involved has a life-threatening condition.

Use of electronic monitoring in clinical nursing research.

In the past decade, the introduction of electronic monitoring systems for monitoring medication adherence has contributed to the dialog about what works and what does not work in monitoring adherence. The purpose of this article is to describe the use of the Medication Event Monitoring System (MEMS) in a study of patients receiving isoniazid for latent tuberculosis infection. Three case examples from the study illustrate the data that are obtained from the electronic device compared to self-reports and point to the disparities that may occur in electronic monitoring. The strengths and limitations of using the MEMS and ethical issues in utilizing this technology are discussed. Nurses need to be aware of these challenges when using electronic measuring devices to monitor medication adherence in clinical nursing practice and research.

Antipsychotic depot medication and attitudes of community psychiatric nurses.

Utilization of long-acting antipsychotic injections (depots) shows wide regional variation. In many countries, community psychiatric nurses (CPNs) administer depots but their concerns and attitudes regarding these drugs are seldom considered. We aimed to investigate attitudes and knowledge towards depots in a cross-sectional survey of CPNs in London, and compare them with those of psychiatrists obtained in a previous study. Three subscales of a depot attitude/knowledge questionnaire were used with additional items which referred to aspects of the CPN role. Participants were 70 CPNs who attended an academic meeting. Most CPNs reported that they were involved in treatment decisions (78%) although some CPNs seldom asked their patients about side effects (19%) and felt that they did not have sufficient time for consultations (23%) or training (23%). Several CPNs believed that depots are old fashioned (34%) and stigmatizing (44%). Compared to psychiatrists, CPNs believed more that depots compromised patient autonomy (28%, P = 0.003) and were coercive (42%, P < 0.001). Familiarity with depots and their knowledge of side effects were positively associated with favourable attitudes. CPNs have several strongly endorsed attitudes towards depot medication. Interprofessional group differences also exist which may undermine the treatment process. Training/refresher courses about depots should highlight systematic treatment decision-making and side effect monitoring which, in turn, may improve professionals' attitudes, knowledge and clinical monitoring of depots.