Secretary Of State For Health Research Articles

The Independent Medicines and Medical Devices Safety Review: Regulatory Reform and Remedies

For years, groups of patients and their families in the United Kingdom raised their concerns about three medical interventions. The first was a possible link between hormone pregnancy tests and fetal malformations and deaths; the second was the physical and neurodevelopmental impacts of in utero valproate exposure; and the third was life-changing adverse events caused by pelvic mesh implants for pelvic organ prolapse repair and stress urinary incontinence management. In response to their tireless campaigning, the Independent Medicines and Medical Devices Safety (IMMDS) Review was commissioned by the Secretary of State for Health and Social Care in 2018. The review, chaired by Baroness Cumberlege, found a catalogue of institutional, systems and structural failures within both the medical establishment and healthcare system more broadly. Drawing on the IMMDS Review findings on pelvic mesh, in this article, I consider the dire consequences when medical devices go wrong. Drawing on firsthand experience as lead researcher for the IMMDS Review, I examine some of the background, outline some key findings and reflect on the strategic changes recommended to medical device regulation and the redress prompted by the pelvic mesh scandal. In so doing, I contextualise and consider the relevant regulatory frameworks, the fundamental systems failures and the other issues identified. Three years on, this article also provides an opportunity to assess the extent to which the IMMDS Review recommendations have been successfully operationalised, as well as to take stock of the improvements that still need to be made.

Discrimination in Abortion Law and the Message the Law is Sending: R (Crowter) v Secretary of State for Health and Social Care

R (Crowter) v Secretary of State for Health and Social Care involved a legal challenge to the law on abortion under the Abortion Act 1967, on the basis that the disability ground ‘expresses’ a negative message about disabled people, based on negative stereotyping, and that this expression is incompatible with Articles 8 and 14 of the European Convention on Human Rights. The case is significant because of the way that rights‐based arguments about abortion were framed; they were not centred on the interests or rights of the pregnant woman or the fetus, but on the rights of disabled people. This framing reflects the well‐known expressivist argument in the disability and bioethics literature. The arguments raised about a potential violation of rights due to ‘the message’ the law is sending could have far‐reaching implications, well beyond the law on abortion.

Rationing of resources in the National Health Service.

The National Health Service was set up to provide healthcare to every citizen, based not on the ability to pay, but on need. However, the Secretary of State for Health's duty under section 1 of the National Health Service Act 2006 to promote a comprehensive health service is to provide services that can be provided within the resources available. As those resources are not unlimited, it is necessary to ration them. The issue of rationing of resources in the NHS came up again in R (Wallpott) v Welsh Health Specialised Services Committee and Aneurin Bevan University Health Board [2021] EWHC 3291 (Admin). This paper reviews that case and comments on it, looking at why there is rationing of NHS resources and at the approach of the courts to the issue. It concludes that, although rationing of NHS resources is controversial, it is lawful and necessary.

A major conditions strategy cannot replace a national cancer plan—patient advocates voice their concerns

The UK Secretary of State for Health and Social Care, Stephen Barclay, has set out plans for an alternative approach to cancer service provision based on a major conditions strategy. 1 Barclay S Major conditions and diseases announcement. Jan 24, 2023. Hansard, Commons. https://hansard.parliament.uk/Commons/2023-01-24/debates/23012433000010/MajorConditionsAndDiseasesDate accessed: February 24, 2023 Google Scholar The six areas for inclusion in the strategy are cancer, cardiovascular disease, respiratory disease, dementia, mental health, and musculoskeletal disorders. All these areas are priorities for a national health strategy but is lumping them all together an effective route to success in treating them? As patients and patient advocates, we do not consider that this approach is wise, either for people with these diseases or for the National Health Service (NHS). A holistic approach to patient care can be helpful and there are many scenarios when “integrated, whole-person care”, as promised by this new strategy, 1 Barclay S Major conditions and diseases announcement. Jan 24, 2023. Hansard, Commons. https://hansard.parliament.uk/Commons/2023-01-24/debates/23012433000010/MajorConditionsAndDiseasesDate accessed: February 24, 2023 Google Scholar is appropriate and beneficial; however, understanding comorbidities is vital to treatment outcomes and experiences and a key part of clinical decision making for individual patients, and is very different to merging diseases in a national strategy that will dilute attention to specific areas.

Human rights and foetal impairment grounds for abortion: Crowter v Secretary of State for Health and Social Care [2022] EWCA Civ 1559

This commentary discusses the Court of Appeal’s decision in Crowter v Secretary of State for Health and Social Care handed down on 25 November 2022. The appellants argued that s.1(1)(d) of the Abortion Act 1967, the foetal impairment ground for abortion, was incompatible with Articles 8 and 14 of the European Convention on Human Rights for perpetuating discriminatory attitudes towards people with disabilities. The appeal was unsuccessful. In rejecting their argument, the Court of Appeal considered European and international human rights standards on discrimination, and distinguished between the direct and social impacts of discrimination. This commentary will engage with these arguments, and situate the decision within the broader context of recent changes to abortion laws in the United Kingdom and worldwide.

Health inequalities and diabetes

AbstractInequalities in health care exist in many countries in the world. In 2008 the then UK Secretary of State for Health commissioned the Marmot review, ‘Fair Society, Healthy Lives’, to propose strategies to address health inequalities in the UK. Most of Marmot's proposals were not acted upon and in 2020, 10 years after the initial recommendations were published, Marmot found that there had been no improvement and some things were worse.In diabetes care inequalities are widespread, impacting on prevention, treatment, access to technology, screening for complications, risk of complications, morbidity and mortality. Ethnicity is a major risk factor, starkly demonstrated by the increased COVID‐19 related mortality in people from minority ethnic groups with diabetes. Disadvantaged groups include, but are not limited to, those with social deprivation, intellectual and physical disabilities and severe mental illness.The decision to shelve the long‐awaited white paper on tackling health inequalities, taken recently by the last Secretary of State for Health amid protests from a coalition of medical organisations, makes it unlikely that the government will take the actions proposed by Marmot. In the absence of a national strategy, responsibility to recognise and address inequalities in diabetes care falls on health care professionals, in teams and as individuals. Copyright © 2023 John Wiley & Sons.

HLA haplotypes and differential regional mortality caused by COVID-19 in Brazil: an ecological study based on a large bone marrow donor bank dataset.

The coronavirus disease 2019 (COVID-19) mortality rates varied among the states of Brazil during the course of the pandemics. The human leukocyte antigen (HLA) is a critical component of the antigen presentation pathway. Individuals with different HLA genotypes may trigger different immune responses against pathogens, which could culminate in different COVID-19 responses. HLA genotypes are variable, especially in the highly admixed Brazilian population. In this ecological study, we aimed to investigate the correlation between HLA haplotypes and the different regional distribution of COVID-19 mortality in Brazil. HLA data was obtained from 4,148,713 individuals registered in The Brazilian Voluntary Bone Marrow Donors Registry. COVID-19 data was retrieved from epidemiological bulletins issued by State Health Secretariats via Brazil's Ministry of Health from February/2020 to July/2022. We found a positive significant correlation between the HLA-A*01~B*08~DRB1*03 haplotype and COVID-19 mortality rates when we analyzed data from 26 states and the Federal District. This result indicates that the HLA-A*01~B*08~DRB1*03 haplotype may represent an additional risk factor for dying due to COVID-19. This haplotype should be further studied in other populations for a better understanding of the variation in COVID-19 outcomes across the world.

As escolas de saúde do SUS: razões de ser e contribuições

Abstract This article seeks to know the perception of state health secretaries, their professors, and their directors on the contributions of state schools of Public Health to the Brazilian National Health System (SUS). Being a qualitative research, the state health secretaries were interviewed, as well as the directors and professors of these schools. The content of the interviews was analyzed in the light of Bardin’s framework. The contributions of the schools to SUS were highlighted, showing the strategic role they play, emphasizing the provision of professionals trained in these schools and who occupy management positions in the SUS; the technical support offered to municipalities; and the recognition of workers for the work developed by these schools. However, one must note that these institutions face difficulties, especially insufficient financial and human resources. Schools are strategic for SUS, being fundamental instruments to maintain the policy of permanent health education and to qualify the health workforce. The difficulties reported indicate the need to prioritize policies of permanent education and professional qualification aimed at health workers.

Os Conselhos de Secretarias Municipais de Saúde e a Política Nacional de Controle do Tabaco: uma aproximação necessária

Abstract Tobacco-related diseases burden the entire public health system, at the three levels of governance: municipal, state and federal. The insertion of the theme of tobacco control in state and municipal Health Secretariats is historic, being present since the initial debates on the health, social, economic and environmental damage that smoking causes to the Brazilian population as a cycle of diseases, poverty and deaths precocious. This article aims to present the importance of articulating the National Tobacco Control Policy with the Councils of Municipal Health Secretariats, given the role that these instances play in the Unified Health System and the contributions that they can add to the Tobacco Control Policy in Brazil, with its constant challenges to advance in the reduction of deaths and illnesses caused by tobacco products.

Evaluation of chest X-ray with automated interpretation algorithms for mass tuberculosis screening in prisons: a cross-sectional study.

The World Health Organization (WHO) recommends systematic tuberculosis (TB) screening in prisons. Evidence is lacking for accurate and scalable screening approaches in this setting. We aimed to assess the accuracy of artificial intelligence-based chest x-ray interpretation algorithms for TB screening in prisons. We performed prospective TB screening in three male prisons in Brazil from October 2017 to December 2019. We administered a standardized questionnaire, performed a chest x-ray in a mobile unit, and collected sputum for confirmatory testing using Xpert MTB/RIF and culture. We evaluated x-ray images using three algorithms (CAD4TB version 6, Lunit version 3.1.0.0 and qXR version 3) and compared their accuracy. We utilized multivariable logistic regression to assess the effect of demographic and clinical characteristics on algorithm accuracy. Finally, we investigated the relationship between abnormality scores and Xpert semi-quantitative results. Among 2075 incarcerated individuals, 259 (12.5%) had confirmed TB. All three algorithms performed similarly overall with area under the receiver operating characteristic curve (AUC) of 0.88-0.91. At 90% sensitivity, only LunitTB and qXR met the WHO Target Product Profile requirements for a triage test, with specificity of 84% and 74%, respectively. All algorithms had variable performance by age, prior TB, smoking, and presence of TB symptoms. LunitTB was the most robust to this heterogeneity but nonetheless failed to meet the TPP for individuals with previous TB. Abnormality scores of all three algorithms were significantly correlated with sputum bacillary load. Automated x-ray interpretation algorithms can be an effective triage tool for TB screening in prisons. However, their specificity is insufficient in individuals with previous TB. This study was supported by the US National Institutes of Health (grant numbers R01 AI130058 and R01 AI149620) and the State Secretary of Health of Mato Grosso do Sul.

COVID-19 Stay at Home Restrictions and the Interpretation of Emergency Powers: A Comparative Analysis

Abstract The COVID-19 pandemic has created immense challenges for governments in their management of the public health response and tested the limits of public law. This article undertakes a comparative analysis of the common law jurisdictions of the United Kingdom, New Zealand, and Australia. It discusses the imposition of ‘stay at home’ restrictions pursuant to public health legislative frameworks, focusing on judicial scrutiny in the context of statutory interpretation. It examines the appellate cases of R (Dolan) v Secretary of State for Health and Social Care [2021] 1 WLR 2326, Borrowdale v Director-General of Health [2022] 2 NZLR 356, and Kassam v Hazzard (2021) 106 NSWLR 520. Using these case studies, this article seeks to reveal key themes and implications for public law. What approaches have the courts adopted to construe public health emergency powers? How have the courts treated ‘rights-based’ principles of statutory interpretation? Have the courts approached interpretation in the usual manner or displayed an unorthodox level of deference to other branches of government? The article concludes on what implications the judicial approaches have for the interpretation of emergency powers in the future.

R (Gardner and Harris) v Secretary of State for Health and Social care and Others [2022] EWHC 967: Scant regard for Covid-19 risk to care homes.

R (Gardner and Harris) v Secretary of State for Health and Social care and Others [2022] EWHC 967: Scant regard for Covid-19 risk to care homes.

“Love Doesn’t Count Chromosomes”: Reflections on Disability, Law and Religious Ethics

In July 2021 Heidi Crowter took the UK Secretary of State for Health and Social Care to court with the aim of challenging the aspects of the Abortion Act that in her view discriminate against people with Down's Syndrome. The case ignited the civic debate on disability, law and public ethics, re-exposing the shaky grounds and inherent contradictions of human rights discourse and legislation and revealing the acute dangers of utilitarian logic that sustains the status quo. In this paper I argue that if we are to safeguard the dignity and rights of those among us who might not satisfy the utilitarian criteria of “worthiness of existence”, the values that underlie human rights legislation need to be firmly situated in the realm of the absolute and the unconditional. This is an area where religious ethics can offer invaluable contribution. The transcendental grounding of faith-based morality endows the notion of human dignity with universality that is not conditional on any “worldly” category of worth (the concept of “ability” being one such category). Also, it provides a radical and counter-cultural redefinition of the notion of what it means to be a “contributor” to the social sphere, a redefinition that does not exclude those among us living with a disability.

The Khan review: the UK Government must act now for a smokefree future

The UK Government set out its smokefree 2030 goal (defined as less than 5% smoking prevalence) for England in 2019. However, it has not introduced policy measures to achieve this target, which on current trends will not be reached for the poorest in society until 2044.1 But Javed Khan's independent 2022 review, The Khan Review: Making Smoking Obsolete,2 gives cause for hope. Commissioned by a previous UK Secretary of State for Health and Social Care, the Khan review sets out a plan to achieve smokefree 2030 and to address the substantial health and economic disparities caused by smoking.

Predicting COVID-19 hospitalizations with attribute selection based on genetic and classification algorithms

The COVID-19 pandemic has been pressuring the whole society and overloading hospital systems. Machine learning models designed to predict hospitalizations, for example, can contribute to better targeting hospital resources. However, as the excess of information, often irrelevant or redundant, can impair predictive models’ performance, we propose a hybrid approach to attribute selection in this work. This method aims to find an optimal attribute subset through a genetic algorithm, which considers the results of a classification model in its evaluation function to improve the hospitalization need prediction of COVID-19 patients. We evaluated this approach in two official databases from the State Health Secretariat of Rio Grande do Sul, covering COVID-19 cases registered up to October 2020 and June 2021, respectively. As a result, we provided an increase of 18% in the classification precision for patients with hospitalization necessities in the first database, while in the second one, considering a temporal evaluation with sliding window, this gain was on average 6%. In a real-time application, this would also mean greater precision in targeting resources and, consequently and mainly, improved service to the infected population.

The duty to provide after-care under section 117 of the Mental Health Act 1983 again.

In December 2021 the Court of Appeal (Civil Division) published its ruling in Worcestershire County Council, R (On the Application Of) v Secretary of State for Health and Social Care [2021] EWCA Civ 1957, a case about a dispute between two local authorities regarding which of them should bear the duty to provide after-care for a patient (service user) following her discharge from her second detention under section 3 of the Mental Health Act 1983. The primary issue in the case was where she was ordinarily resident at the time of her second detention under s 3 of the Mental Health Act 1983. This paper reviews the case, surveys the evolution of the duty to provide after-care and comments on specific aspects of the Court of Appeal's decision.

Inequity in inequity: Disproportional mortality risk in patients with cancer with COVID-19 in Brazil - a call to action

Inequity in inequity: Disproportional mortality risk in patients with cancer with COVID-19 in Brazil - a call to action

Preserving women’s reproductive autonomy while promoting the rights of people with disabilities?: the case of Heidi Crowter and Maire Lea-Wilson in the light of NIPT debates in England, France and Germany

On July 2021, the UK High Court of Justice heard the Case CO/2066/2020 on the application of Heidi Crowter who lives with Down’s syndrome, and Máire Lea-Wilson whose son Aidan...

Vaccine damage schemes in the US and UK reappraised: making them fit for purpose in the light of Covid-19

AbstractVaccines have continued to play a crucial global role in preventing infectious diseases in the twenty-first century. The Covid-19 pandemic has underlined their importance, with vaccines seen as the best way to protect the public from coronavirus. A longstanding problem of governments has been the extent to which they should assume responsibility for the compensation of those injured by vaccines. This paper reappraises the vaccine damage schemes currently available in the US and UK in the light of the Covid-19 pandemic. It argues that any improvements to both US and UK schemes should be included in a revised national vaccine policy which takes into consideration their respective long-term national vaccine strategies to prepare for future pandemics. It supports the adoption of a UK-wide National Vaccine Injury Compensation Programme, similar to the one in the US, to be administered by the Secretary of State for Health and Social Care. To balance the need for rigorous criteria to determine causation with the need for fairness, the programme should adopt the US practice of allowing negotiated settlements between parties in circumstances where review of the evidence has not concluded that the vaccine(s) caused the alleged injury but there are close calls concerning causation.

Risk of hospitalization and mortality due to COVID-19 in people with obesity: An analysis of data from a Brazilian state.

The aim of this article is to assess the odds ratio of hospitalization and mortality due to COVID-19 in people with obesity using data from residents of Espírito Santo, Brazil. An observational, quantitative, cross-sectional study was carried out from the database available on the official channel of the State Health Secretariat of Espírito Santo. Crude odds ratio estimates (ORs) referring to the association between variables were calculated, as well as adjusted odds ratios (adjusted odds ratios-OR adj.) and their respective 95% confidence intervals (CI 95%). The results indicate that men, non-white, no education or with lower education level and age over 40 years old were more likely to be hospitalized and died of COVID-19. People with obesity are at risk of hospitalization and death due to COVID-19 54% and 113% higher than people who do not have obesity. People with obesity had a higher chance of hospitalization when they were over 40 years old, had breathing difficulty, and the comorbidities diabetes (2.18 higher) and kidney disease (4.10 higher). The odds ratio of death for people with obesity over 60 years old was 12.51 higher, and those who were hospitalized was 17.9 higher compared to those who were not hospitalized.