SciCombinator

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Journal: Indian journal of medical ethics

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There have been a number of spontaneous reports of sudden unexpected death soon after the administration of Infanrix hexa (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenza type B vaccine). The manufacturer, GlaxoSmithKline (GSK), submits confidential periodic safety update reports (PSURs) on Infanrix hexa to the European Medicines Agency (EMA). The latest is the PSUR 19. Each PSUR contains an analysis of observed/expected sudden deaths, which shows that the number of observed deaths soon after immunisation is lower than that expected by chance. This commentary focuses on that aspect of the PSUR which has a bearing on policy decisions. We analysed the data provided in the PSURs. It is apparent that the deaths acknowledged in the PSUR 16 were deleted from the PSUR 19. The number of observed deaths soon after vaccination among children older than one year was significantly higher than that expected by chance once the deleted deaths were restored and included in the analysis. The manufacturer must explain the figures that have been submitted to the regulatory authorities. The procedures undertaken by the EMA to evaluate the manufacturer’s claims in the PSUR need to be reviewed. The Drugs Controller General of India nearly automatically accepts drugs and vaccines approved by the EMA. There is a need to reappraise the reliance on due diligence by the EMA.

Concepts: Vaccine, Vaccination, Tetanus, Pertussis

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The majority of persons with mental distress (PWMD) in India do not have access to care, and even those who seek care are pushed to attend private providers, given the weak and largely absent public mental health services framework. The aim of this study was to examine the experiences in help-seeking and with unethical health service provision among persons with mental distress in the Saharanpur and Bijnor districts of Uttar Pradesh. In-depth interviews were conducted with twenty persons with mental distress and their caregivers. Thematic analysis yielded four key findings about help-seeking: first, that it was syncretic and persistent; second, that expenditure for private care was high and often catastrophic; third, that investigations and care provided were pharmacological and predominantly irrational and excessive; and lastly, that help-seeking was abandoned. This study demonstrates that PWMD are particularly vulnerable to exploitation by private providers with illnesses that are stigmatising, poorly understood, chronic, relapsing, and disabling and that often require complex management. Responding to mental distress requires multiple empowering and interacting policy and programme initiatives that must include regulation of private and public providers, resources, and actions to strengthen public and primary mental healthcare and promotion of mental health competence in communities.

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The patient-physician relationship in India is in a state of rapid decline with fresh incidents of violence highlighting the scale of the problem. The medical fraternity needs to reflect on certain issues plaguing its conduct with patients and colleagues and embark on steps to address them. In this article, I highlight some major points which could help us arrest the deteriorating trust and heightened violence in hospitals.

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There has been an increase in the incidence of attacks on doctors in recent times. It is important that some measures are taken to ensure the safety of doctors at the workplace, because only when they feel safe will they be able to treat their patients without any hesitation or fear. We call upon all concerned authorities to ensure a safe hospital environment for better healthcare, and we also suggest remedial steps to that end.

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On March 6, 2019, a workshop was held as part of a larger public consultation exercise to evaluate the perceptions of participants from diverse backgrounds of studies involving Controlled Human Infection Models (CHIMs) (1,2) in India, through three specific case scenarios. This workshop was organised by the Health and Humanities Division of the St. John’s Research Institute, Bangalore with funding from the Translational Health Science and Technology Institute (TSHTI), Faridabad (www.thsti.res.in), an autonomous institute of the Department of Biotechnology, Government of India This was an on-going effort of the Division to bring public discourse centre stage in the discussion on the use, ethics and regulations related to CHIM studies, and the introduction of such studies in India. Participants included epidemiologists, community/public health experts, microbiologists, infectious disease specialists, basic and translational scientists, ethicists, journalists and lawyers.

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I was greatly saddened to hear the news of a young resident, Dr Payal Tadvi, committing suicide at the BYL Nair Hospital and Topiwala Medical College in Mumbai. However, it is heartening to see that some fellow students, her family and the Tadvi Bhil community have made this issue public and are rallying for justice for her. Meanwhile, the three seniors that she has named have been arrested, and a faculty member suspended.

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Understanding perspectives on whistleblowing is important in tackling a resistance to speaking out. This study aimed to elicit the views of medical students and doctors in Edendale Hospital, South Africa using a mixed-methods questionnaire study incorporating free text and tick-box answers. Thematic analysis and descriptive statistics were used to interpret the results. Fifty-eight doctors and medical students responded (87% response rate); the majority were surgeons at Edendale hospital. Seventeen percent did not understand the concept of whistleblowing, while 42% felt unable to report an adverse event. Motivation for reporting adverse events was overwhelmingly in the interests of patient safety (91%), but reluctance was mainly due to the potential consequences on workplace relationships (24%). The most common innovation suggested was a reporting structure (54%). These observations indicate workplace relationships are an important barrier to whistleblowing. Further research should expand on these concerns and explore staff knowledge about whistleblowing.

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The Cabinet chaired by the Prime Minister has accepted six amendments to the National Medical Commission Bill suggested by the Department-related Parliamentary Standing Committee (1). These amendments are: the proposed National Licentiate Examination has been replaced by a countrywide final MBBS examination called the National Exit Test (NEXT); the bridge course to train practitioners from AYUSH (Ayurveda, Unani, Siddha and Homeopathy) in modern medicine has been removed, and it has been left to individual states to take a decision about this; the percentage of seats in private medical training institutions under fee regulation has been increased from 40% to 50%; the number of nominees from the states and Union territories who are members of the Commission has been increased from three to six; the penalties for non-compliance with educational norms for colleges has been modified; and the punishment for practising modern medicine without qualification has been made imprisonment up to one year and a fine of Rs 5 lakh.

Concepts: Medicine, Ayurveda, Avicenna, Sociology, Alternative medicine, Prime minister, Cabinet, Westminster system

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In 2013, an independent group of researchers developed the CARE guidelines, a checklist to standardise reporting of case reports. This study assesses adherence to CARE guidelines among PubMed-indexed Indian medical journals in 2015 and the extent of endorsement of these guidelines by the journals. Case reports published in 2015 in journals indexed by PubMed, belonging to the medical stream, currently active, and that had an impact factor were included for analysis. Case series and journals that were published from India but for another country were excluded. Total adherence score and classification of adherence as “excellent”, “very good”, “good”, and “poor” as also adherence to individual components of the checklist were the outcome measures. A total of 162 journals were identified by the search strategy, of which 36 satisfied the selection criteria. In these 36 journals, 1178 case reports were published. We tested the association between the type of journal and impact factor with adherence by using the chi-squared test and generated crude odds ratios. All analyses were done at 5% significance. Based on the total percent score, no case report had excellent adherence, and 19% had good, 70.7% average, and 10% poor adherence, respectively. Among the sub-items, the best adherence was seen in the clinical findings [97.9%], followed by keywords [88.5%], and introduction [71.5%]. The items with extremely poor adherence were patient perspective [0%], informed consent [2.8%], and timeline [4.6%]. Journals with an impact factor of more than 1 had better adherence, relative to those with an impact factor lower than 1. Only one journal’s website mentioned the CARE guidelines. Greater awareness needs to be created among authors, peer reviewers, and editors about using these guidelines. As informed consent is a metric of autonomy, all stakeholders must ensure its reporting.

Concepts: Medical terms, Informed consent, Report, Academic publishing, Autonomy, Case series, Case report, The New England Journal of Medicine

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India’s approach to disseminating information about the first three cases of the Zika virus was criticised nationally and internationally after the issue came to light in May 2017 through a World Health Organization news release. We analyse the incident from a risk communication perspective. This commentary recaps the events and synthesises key arguments put forth by the news media and public health stakeholders. We use Peter Sandman’s risk = hazard + outrage framework - also adopted by India’s risk communication planners - to analyse India’s risk communication response and contextualise it against the mandate of the National Risk Communication Plan and Integrated Disease Surveillance Programme. We conclude with recommendations for India’s risk communication policymakers, including the need to develop capacity for risk communication research and scholarship in the country.

Concepts: Public health, Epidemiology, Risk, Management, World Health Organization, Public relations, Nonviolent Communication, Media studies