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.

The Bleeding Edge, Trailer

A searing exposé of the medical device industry from Academy Award-nominated filmmakers Kirby Dick and Amy Ziering

Technological advances have been responsible for many groundbreaking developments in modern medicine. Countless individuals have seen their quality of life improve through research and development, from the advent of pacemakers to bionic limbs. But there is a dark side to the relentless pace of all this innovation.

    • Video published on 12 Jul 2018 by Netflix. About the documentary.

Failures in reproductive health policy: overcoming the consequences and causes of inaction

Inaction and its consequences in Reproductive Health

Achieving safer pregnancies and thriving babies is within reach here and now. The key is finally taking robust action on these public health measures. The next generation deserves no less.

The focus of this Journal of Public Health article, published 18 August 2018, is on public health actions that should have been implemented in Scotland (and the rest of the UK) years ago, but were not.

Overview

  • Profiles in procrastination
    1. Case 1: Not fortifying flour with vitamin B9
    2. Case 2: Minimizing the existence and importance of foetal alcohol harm
    3. Case 3: Failing to control access to, and gain informed consent about, valproate prescribing for women of reproductive age
  • The price of passivity
  • The causes of inaction
  • Replacing inaction with accomplishment
  • Replacing inaction with accomplishment

Abstract

It is assumed that long-established research findings and internationally accepted evidence should, and will, be translated into policy and practice. Knowledge about what prevents harm and promotes health has, in fact, guided and resulted in numerous beneficial public health actions. However, such is not always the case.

The authors examine three notable, and unwelcome, exceptions in the UK—all in the field of reproductive health and all focused on the period prior to pregnancy. The three examples of counterproductive inaction discussed are:

  1. fortifying flour with Vitamin B9 (folic acid);
  2. preventing foetal alcohol spectrum disorders;
  3. and reducing risks and better regulating a highly teratogenic medication (valproate).

The adverse consequences, as well as the causes, of inaction are analysed for each example. Reasons for optimism, and recommendations for overcoming inaction, are also offered, in particular, greater priority should be accorded to preconception health, education and care.

Too Much Medicine Helsinki Symposium 2018

Paulo Foundation International Medical Symposium, Helsinki, 15 – 17 Aug 2018

Abstracts

  • Overestimation of depression prevalence in meta-analyses via the inclusion of primary studies that assessed depression using screening tools or rating scales rather than validated diagnostic interviews
  • Clinician, patient and general public beliefs about diagnostic imaging for low back pain: A qualitative evidence synthesis
  • Overdiagnosis of low back pain
  • Defining Overdiagnosis of Mental Health Disorders: Secondary Analysis of an Overdiagnosis Scoping Review
  • Evaluating the content of Choosing Wisely recommendations and prevalence of interdisciplinary finger pointing
  • Inadequate Prescription of medicines for Parkinson’s disease in the Autonomous Community of the Basque Country. An observational study
  • Is it always necessary to treat nocturia? Natural history of nocturia among men and women during the 5-year period
  • The monocriterial source of over-testing and over-treatment: the case of bone scanning
  • Increasing prescription of opioid analgesics and neuropathic pain medicines for spinal pain in Australia
  • No benefit of additional care for ‘high-risk’ patients with acute low back pain: The PREVENT randomized, placebo-controlled trial
  • Overdiagnosis, overtreatment and low-value care in physiotherapy: a scoping review
  • Targeted information based on reimbursed drug registry
  • Journal Registration Policies and Prospective Registration in Randomized Trials of Non-Regulated Interventions: A Meta-Research Review
  • Pharmacotherapy and behavioural problems in Autism Spectrum Disorders
  • Simultaneous under and over care of eye health care in Finland
  • Decision Support and Knowledge Translation Tools to Highlight the Benefits and Downstream Harms of Screening: Resources from the Canadian Task Force for Preventive Healthcare
  • A Free Access Literature Awareness Portal That Surveilles High Quality Research and Guidelines to Inform Benefits and Downstream Harms of Screening and Prevention Strategies in Healthcare
  • From “Non‐encounters” to autonomic agency. Conceptions of patients with low back pain about their encounters in Finnish health care system
  • Does the use of CAM reflect a patients´ response to “too much medicine”?
  • Preferred Reporting Items for Overview of Systematic Reviews for abstracts (PRIO-abstracts)

Reference.