New medicine drugs : No evidence of added benefit for most

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.”

continue reading on The BMJ, 10 July 2019.

To Err is Human : Building a Safer Health System

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.

Excerpt

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.

July 2019 : read The NHS Patient Safety Strategy, safer culture, safer systems, safer patients.

The NHS Patient Safety Strategy

Safer culture, safer systems, safer patients – July 2019

Summary

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.

Insight

The NHS will:

  • 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.

Involvement

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.

Improvement

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.

Primodos, Sodium Valproate, Surgical Mesh : Baroness Cumberlege Talks

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.”

More information

FDA bans sales of transvaginal mesh

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.

continue reading the FDA press announcement.
Read the meshCNN press release. Image credit leakylily.

In the UK

 

Harms in Healthcare: Primodos, Vaginal Mesh Implants and Sodium Valproate

How concerned should we be about treatment side-effects, innovation and regulatory failures?

Prof Carl Heneghan discusses the evidence about three NHS treatments undergoing government review:

  • Primodos,
  • vaginal mesh implants
  • and the anti-epilepsy sodium valproate.

Oxford University Department for Continuing Education,
Open Event Dec 2018.

Prof Carl Heneghan is Director of the Centre for Evidence-Based Medicine. Information about the postgraduate courses and qualifications in EBHC can be found here.

More information

Helping patients choose wisely

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.

Abstract

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.

Read the full text on The BMJ, 2018.

“Helping patients choose wisely”

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.

bm Patient Karyse Day’s response, 2018.

Focusing on overdiagnosis as a driver of too much medicine

“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.

Abstract

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.

Real but elusive trigger of too much medicine

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…

… continue reading on The BMJ, 17 August 2018.

Image credit newlifefoundation.

Overtreatment : When Medicine Does More Harm Than Good

Why do millions of people a year get tests and procedures that they don’t really need ?

Researchers estimate that 21% of medical care is unnecessary.

Kaiser Health News senior correspondent Liz Szabo moderated a discussion a panel of experts to explore overtreatment.

KHN panelists were:

  • Dr. Louise Davies, An associate professor of otolaryngology – head and neck surgery in The Dartmouth Institute for Health Policy & Clinical Practice
  • Dr. Saurabh Jha, an associate professor of radiology at the University of Pennsylvania
  • Dr. Barry Kramer, director of the division of cancer prevention at the National Cancer Institute
  • Dr. Jacqueline Kruser, a pulmonologist and critical care physician at Northwestern University Feinberg School of Medicine
  • Dr. Ranit Mishori, professor of family medicine at the Georgetown University School of Medicine.
  • Reference.
  • Video source : KHN was live.

Will Brexit harm the NHS ?

Patients lack answers to too many questions about their healthcare after Brexit

Predictions of a smaller UK economy, at least in the short term, and fewer EU healthcare staff present challenges for the NHS after 29 March 2019, argues Anand Menon.

But Graham Gudgin is unconvinced by what he believes are biased estimates promoted by a government pushing for a soft Brexit.

Read Could Brexit harm the NHS? on The BMJ, 26 September 2018.