Drug Companies Shouldn’t Help Decide Who Is Sick, 2019
Expanding disease definitions are causing more and more previously healthy people to be labelled as diseased, contributing to the problem of overdiagnosis and related overtreatment. Often the specialist guideline panels which expand definitions have close ties to industry and do not investigate the harms of defining more people as sick. Responding to growing calls to address these problems, an international group of leading researchers and clinicians is proposing a new way to set diagnostic thresholds and mark the boundaries of condition definitions, to try to tackle a key driver of overdiagnosis and overtreatment. The group proposes new evidence-informed principles, with new process and new people constituting new multi-disciplinary panels, free from financial conflicts of interest. Image wikimedia.
Developing a framework for this long-term reform and facilitating a global collaboration to enact it will involve proactive and reactive efforts that we hope will drive a cultural shift and a practical change in how diseases are defined. Research teams will continue to quantify estimates of overdiagnosis arising from current disease definitions, informing priorities for action. Actions include the constitution of new panels, with new processes and new people, to review and revise existing definitions. Concurrently, primary care organisations will become more reactive to expansions in definitions seen as increasing the risk of overdiagnosis, such as the controversial 2017 hypertension widening, explicitly rejected by the American Academy of Family Physicians, and other groups, and the rejection of the expanded definition of gestational diabetes by the Royal Australian College of General Practitioners. An international meeting to review progress on our proposal and develop more detailed strategies for change will take place at the December 2019 Preventing Overdiagnosis conference in Sydney
There are important limitations, uncertainties and caveats to note as we propose this ambitious reform of disease definitions, which will provoke opposition from those whose markets are directly threatened.
First, we write as a group working across a multitude of influential national and international organisations, but we do not in this instance represent them.
Second, our backgrounds and thinking are largely medical, and there is clearly opportunity for this initiative to be informed by evidence, experience and theories outside medicine, including, for example, from philosophy.
Third, addressing the problem of expanding disease definitions is but one of many potential solutions to overdiagnosis, and much important work is underway already to try and wind back the harms of too much medicine, safely and fairly, such as calls to action within our associations, creation of new medical curricula, scientific discussion at national and international meetings and new information materials for the public.
Fourth, given the novel nature of this proposal, there is not yet a mature evidence-base to support it.
Fifth, there is clear synergy between this proposal and the calls for reform of clinical practice guidelines, which has not been explored in this analysis.
And finally, we acknowledge moves to expand definitions, to detect and treat people earlier, are often driven by the best of intentions, and we see great merit in identifying those who will benefit from a medical label and subsequent care.
However, notwithstanding the good intentions driving a bad system, the human person can no longer be treated as an ever-expanding marketplace of diseases, benefiting professional and commercial interests while bringing great harm to those unnecessarily diagnosed.
The UK government and NHS have accepted the recommendation from the Independent Medicines and Medical Devices Safety Review, 17 July 2018
Following their acceptance of the recommendation from the Independent Medicines and Medical Devices Safety Review, the government and NHS have paused the use of vaginally inserted surgical mesh for stress urinary incontinence until a set of conditions to ensure that patients receive safe and high-quality care are met. This pause has been extended to include vaginally inserted surgical mesh for pelvic organ prolapse and will be implemented through a high vigilance programme of restricted practice.
These procedures have not been banned and during this pause, they will continue to be used when there is no viable alternative and after close and comprehensive consultation between patient and clinician.
There has not been any new evidence which would prompt regulatory action and the position of MHRA remains the same on these medical devices. We continue to work with other regulators in the EU and wider, as well as colleagues across the health sector, to monitor and examine evidence as it becomes available.
New drugs : where did we go wrong and what can we do better ?
More than half of new drugs in Germany lack proof of added benefit over existing treatments. International drug development processes and policies are responsible and must be reformed, the BMJ reports.
“Medicines regulators around the world are pursuing a strategy aimed at accelerating the development and approval of drugs. These approaches are based on the assumption that faster access to new drugs benefits patients. The rhetoric of novelty and innovation creates an assumption that new products are better than existing ones.
But although gaps in the therapeutic armamentarium undoubtedly exist, research covering drug approvals since the 1970s suggests only a limited number of new drugs provide real advances over existing drugs. Most studies put the proportion of true innovation at under 15%, with no clear improvement over time.”
Institute of Medicine (US) Committee on Quality of Health Care in America, 2000
Patient safety has made great progress since the publication of To err is human 20 years ago but there is much more to do.
Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That’s more than die from motor vehicle accidents, breast cancer, or AIDS – three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems.
To Err Is Human (free full text) breaks the silence that has surrounded medical errors and their consequence–but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agenda–with state and local implications–for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients’ expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errors–which begs the question, “How can we learn from our mistakes?” Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care.
To Err Is Human (free full text) asserts that the problem is not bad people in health care–it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocates–as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine.
Safer culture, safer systems, safer patients – July 2019
Patient safety has made great progress since the publication of To err is human 20 years ago but there is much more to do. The NHS does not yet know enough about how the interplay of normal human behaviour and systems determines patient safety. The mistaken belief persists that patient safety is about individual effort. People too often fear blame and close ranks, losing sight of the need to improve. More can be done to share safety insight and empower people–patients and staff –with the skills, confidence and mechanisms to improve safety. Getting this right could save almost 1,000 extra lives and £100 million in care costs each year from 2023/24. The potential exists to reduce claims provision by around £750 million per year by 2025.
Addressing these challenges will enable the NHS to achieve its safety vision; to continuously improve patient safety.To do this the NHS will build on two foundations: a patient safety culture and a patient safety system. Three strategic aims will support the development of both:
improving understanding of safety by drawing intelligence from multiple sources of patient safety information (Insight)
equipping patients, staff and partners with the skills and opportunities to improve patient safety throughout the whole system (Involvement)
designing and supporting programmes that deliver effective and sustainable change in the most important areas (Improvement).
The actions we –the NHS– will take under each of these aims are set out below.
adopt and promote key safety measurement principles and use culture metrics to better understand how safe care is
use new digital technologies to support learning from what does and does not go well, by replacing the National Reporting and Learning System with a new safety learning system
introduce the Patient Safety Incident Response Framework to improve the response to and investigation of incidents
implement a new medical examiner system to scrutinise deaths
improve the response to new and emerging risks, supported by the new National Patient Safety Alerts Committee
share insight from litigation to prevent harm.
The NHS will:
establish principles and expectations for the involvement of patients, families, carers and other lay people in providing safer care
create the first system-wide and consistent patient safety syllabus, training and education framework for the NHS
establish patient safety specialists to lead safety improvement across the system
ensure people are equipped to learn from what goes well as well as to respond appropriately to things going wrong
ensure the whole healthcare system is involved in the safety agenda.
The NHS will:
deliver the National Patient Safety Improvement Programme, building on the existing focus on preventing avoidable deterioration and adopting and spreading safety interventions
deliver the Maternity and Neonatal Safety Improvement Programme to support reduction in stillbirth, neonatal and maternal death and neonatal asphyxial brain injury by 50% by 2025
develop the Medicines Safety Improvement Programme to increase the safety of those areas of medication use currently considered highest risk
deliver a Mental Health Safety Improvement Programme to tackle priority areas,including restrictive practice and sexual safety
work with partners across the NHS to support safety improvement in priority areas such as the safety of older people, the safety of those with learning disabilities and the continuing threat of antimicrobial resistance•work to ensure research and innovation support safety improvement.
Download/Read the full publication – The_NHS_Patient_Safety_Strategy_.pdf – on improvement.nhs.uk.
UK Parliament, House of Lords Hansard, 28 February 2019
“For the families involved, it is life-changing and extremely distressing. For those women who took Primodos and sodium valproate, there is an intense feeling of guilt. They took the medication and they blame themselves. However hard one tries to persuade them that it was not their fault, the guilt remains.”
“That tells me something is seriously wrong; the system is not working as it should. People who have been harmed should not have to fight to be heard or to access the care they need.”
FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
April 16, 2019 – The U.S. Food and Drug Administration today ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately. The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to repair POP.
The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since the agency reclassified them in class III (high risk) in 2016. As part of the 2016 reclassification, manufacturers were required to submit and obtain approval of premarket approval (PMA) applications, the agency’s most stringent device review pathway, in order to continue marketing their devices in the U.S. The companies will have 10 days to submit their plan to withdraw these products from the market.
New UK recommendations emphasise shared decision making
As the tree of overdiagnosis has grown, efforts have been made to trim the branches. Initiatives such as Preventing Overdiagnosis, Too Much Medicine, Slow Medicine aim to increase our understanding of how it manifests itself. Efforts such as Choosing Wisely are underway to affect policy and change patient expectations and to change well-entrenched medical practices.
Overdiagnosis and overtreatment are common, harmful to patients, and expensive. Doctors and patients tend to overestimate the benefit and underestimate harm of interventions. Choosing Wisely is a medically led campaign focusing on engaging doctors and patients in decisions about potentially unnecessary medical tests, treatments, and procedures. It started in the US in 2012 and has now been taken up in 22 countries worldwide, including the UK.
This statement grandly assumes that patients have no wisdom. Whilst it might well apply to many patients, there are equally many who are very well aware and informed of the best course of action to be taken.
“Ironically, even though it causes harm, the effects of overdiagnosis look like benefits. People with disease that is overdiagnosed do well because, by definition, their disease was non-progressive. They are “cured” when cure was not necessary in the first place. This creates a cycle that reinforces efforts leading to more overdiagnosis. “
Healthcare is in a tailspin as the rush to offer technology and services turns otherwise healthy people into concerned patients by identifying disease that is not destined to cause them harm.
Why overdiagnosis is hard to spot and to explain to individuals
Overdiagnosis, sometimes known as “pseudodisease,” turns people into patients unnecessarily. It identifies deviations, abnormalities, risk factors, and pathologies that were never destined to cause harm (such as symptoms, disability, or death). Overdiagnosis causes anxiety and other negative consequences of labelling; it leads to wasted resources and side effects as a result of unnecessary treatment. Here we consider overdiagnosis in asymptomatic people. Overdiagnosis also occurs (and causes harm) in symptomatic individuals when expanded disease definitions overmedicalise unpleasant ordinary life experiences, but we do not consider it here due to distinct conceptual differences between the two in terms of driving causes and ability to identify overdiagnosis in individuals.
Overtesting and overtreatment can be identified in a given patient. There is a consensus based on solid evidence that a patient with low back pain but without specific neurological signs or deficits who undergoes magnetic resonance imaging of the spine…