Reforming disease definitions : a new primary care led, people-centred approach

Drug Companies Shouldn’t Help Decide Who Is Sick, 2019

Abstract

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.

Conclusion

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.

  1. 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.
  2. 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.
  3. 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.
  4. Fourth, given the novel nature of this proposal, there is not yet a mature evidence-base to support it.
  5. 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.
  6. 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.

Dealing with strategies used by industry to influence scientific evidence

Commercial interests, transparency, and independence: a call for submissions

Help the move towards independence from commercial interests

A decade ago the US Institute of Medicine (IOM) issued a landmark report on conflicts of interest in research, medical education, and practice.1 Highlighting benefits of collaborations between physicians, researchers, and companies to develop new products that can improve health, the report also raised substantial concerns that extensive financial ties could unduly influence professional judgments. It concluded these financial conflicts of interest could jeopardise the integrity of science, the objectivity of education, the quality of care, and public trust in medicine. The report recommended more research on conflicts of interest, improvements in transparency, and greater independence from industry.

Today we announce plans for a stream of BMJ content to revisit these concerns and ask you to join us. A key aim is to identify and respond to commercial influences on health and healthcare, to understand under what circumstances involvement with industry is truly necessary. Where it is not necessary, we want to forge a new independence from those who make and sell products, to strengthen trust in how evidence is produced and disseminated, and to drive more rational and safer use of drugs, devices, diagnoses, and data in the public interest.

Key Points

  • Problematic relationships
  • The BMJ’s response so far
  • Call for submissions

Read

Is early detection always the best medicine ?

The Recommended Dose, with Alexandra Barratt

Hosted by acclaimed journalist and health researcher Dr Ray Moynihan, The Recommended Dose tackles the big questions in health and explores the insights, evidence and ideas of extraordinary researchers, thinkers, writers and health professionals from around the globe. The series is produced by Cochrane Australia and co-published with the BMJ.

Press Play > to listen to the recording.

Dr Ray Moynihan’s guest has led something of a double life, using both medicine and the media to explore and promote the critical role of evidence in healthcare. Now based at the University of Sydney, Alexandra Barratt‘s journey from clinician to journalist to global advocate for evidence based medicine and shared decision-making is a fascinating one.

Here Alexandra talks with Ray about her varied career and the reasons she’s ended up challenging conventional wisdom. She also talks about her research into the pros and cons of breast cancer screening and questions the widely-accepted idea that early detection is always the best medicine.

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JAMA 2017 Guidance for Modifying the Definition of Diseases

Loose disease definitions cause millions misdiagnoses and excess testing/treatment. Checklist stops disease mongering

A landmark paper addressing overdiagnosis, published yesterday in the journal JAMA Internal Medicine, outlines the first serious attempt to set some global rules for those experts who move diagnostic goalposts that label more people as sick.

Abstract

Importance
No guidelines exist currently for guideline panels and others considering changes to disease definitions. Panels frequently widen disease definitions, increasing the proportion of the population labeled as unwell and potentially causing harm to patients. We set out to develop a checklist of issues, with guidance, for panels to consider prior to modifying a disease definition.

Observations

“Medical science is making so much great progress soon none of us will be well”
Allen Frances

We assembled a multidisciplinary, multicontinent working group of 13 members, including members from the Guidelines International Network, Grading of Recommendations Assessment, Development and Evaluation working group, and the World Health Organisation. We used a 5-step process to develop the checklist:

  1. a literature review of issues,
  2. a draft outline document,
  3. a Delphi process of feedback on the list of issues,
  4. a 1-day face-to-face meeting,
  5. and further refinement of the checklist.

The literature review identified 12 potential issues. From these, the group developed an 8-item checklist that consisted of definition changes, number of people affected, trigger, prognostic ability, disease definition precision and accuracy, potential benefits, potential harms, and the balance between potential harms and benefits. The checklist is accompanied by an explanation of each item and the types of evidence to assess each one. We used a panel’s recent consideration of a proposed change in the definition of gestational diabetes mellitus (GDM) to illustrate use of the checklist.

Conclusions and Relevance
We propose that the checklist be piloted and validated by groups developing new guidelines. We anticipate that the use of the checklist will be a first step to guidance and better documentation of definition changes prior to introducing modified disease definitions.

Sources and Media Releases
  • Changes in Disease Definition and Prevalence of a ConditionWiser Healthcare, 04:59 – 16 mai 2017.

    How does a new disease definition impact the prevalence of a condition ?
  • Checklist of Items to Consider When Modifying a Disease DefinitionWiser Healthcare, 03:31 – 16 mai 2017.

    Preventing #overdiagnosis: a checklist to guide modification of #disease definitions
  • Guidance for Modifying the Definition of Diseases, A Checklist, JAMA Internal Medicine Special Communication, doi:10.1001/jamainternmed.2017.1302, May 15, 2017.
  • How to rein in the widening disease definitions that label more healthy people as sick, the conversation, May 15, 2017.

Too Much Medicine, a Campaign by The BMJ

The threat to human health posed by overdiagnosis and the waste of resources on unnecessary care

The BMJ logo
BMJ Launched ‘its Too Much Medicine‘ Campaign in 2013 To Tackle The Harms Of Overdiagnosis And Overtreatment.

In 2002 the BMJ published a theme issue called “Too Much Medicine?” with articles on the medicalisation of birth, sex, and death, among other aspects of ordinary life. Its opening editorial wondered whether doctors could become pioneers of de-medicalisation, handing back power to patients, resisting disease mongering, and demanding fairer global distribution of effective treatments.

A decade later, as data on overuse and overdiagnosis mount the BMJ announces its Too Much Medicine campaign aiming to highlight the threat to human health posed by overdiagnosis and the waste of resources on unnecessary care.

There is growing evidence that many people are overdiagnosed and overtreated for a wide range of conditions, such as prostate and thyroid cancers, asthma, and chronic kidney disease.

Through the campaign, the journal plans to work with others to increase awareness of the benefits and harms of treatments and technologies and develop ways to wind back medical excess, safely and fairly. This editorial by Fiona Godlee, editor in chief of The BMJ and overdiagnosis researcher Ray Moynihan, senior research fellow at Bond University, Australia, explains more about the campaign:

Dr Godlee said: “Like the evidence based medicine and quality and safety movements of previous decades, combatting excess is a contemporary manifestation of a much older desire to avoid doing harm when we try to help or heal.

Making such efforts even more necessary are the growing concerns about escalating healthcare spending and the threats to health from climate change. Winding back unnecessary tests and treatments, unhelpful labels and diagnoses won’t only benefit those who directly avoid harm, it can also help us create a more sustainable future.”

The BMJ was a partner in the international scientific conference, Preventing Overdiagnosis, held in September 2013 in Hanover, New Hampshire. The conference brought together the research and researchers, advanced the science of the problem and its solutions, and developed ways to better communicate about this modern epidemic.

Sources and More Information:

  • Too much medicine, BMJ, 2013.
  • BMJ Launches ‘Too Much Medicine’ Campaign To Tackle The Harms Of Overdiagnosis And Overtreatment, MNT, releases/256903, 26 February 2013.
  • Winding back the harms of too much medicine, BMJ, 346:f1271, 26 February 2013.

Selling Sickness, Lots of Money made from Healthy People who believe they are Sick

How the World’s Biggest Pharmaceutical Companies are turning Us All into Patients

image of Selling Sickness book
A lot of money can be made from healthy people who believe they are sick… by @AKECassels

A lot of money can be made from healthy people who believe they are sick. Pharmaceutical companies sponsor diseases and promote them to prescribers and consumers. Thirty years ago, Henry Gadsden, the head of Merck, one of the world’s largest drug companies, told Fortune magazine that he wanted Merck to be more like chewing gum maker Wrigley’s. It had long been his dream to make drugs for healthy people so that Merck could “sell to everyone.” Gadsden’s dream now drives the marketing machinery of the most profitable industry on earth. Drug companies are systematically working to widen the very boundaries that define illness, and the markets for medication grow ever larger. Mild problems are redefined as serious illness and common complaints are labeled as medical conditions requiring drug treatments. Runny noses are now allergic rhinitis, PMS has become a psychiatric disorder, and hyperactive children have ADD. When it comes to conditions like high cholesterol or low bone density, being “at risk” is sold as a disease. Selling Sickness reveals how widening the boundaries of illness and lowering the threshold for treatments is creating millions of new patients and billions in new profits, in turn threatening to bankrupt health-care systems all over the world. As more and more of ordinary life becomes medicalized, the industry moves ever closer to Gadsden’s dream: “selling to everyone.”

Summary

Ray Moynihan, Iona Heath, and David Henry give examples of disease mongering and suggest how to prevent the growth of this practice. Selling sicknes book is organized as a series of case studies, each focused on a particular drug. Each chapter explores a different aspect of drug marketing, with evidence drawn from published editorials, news reports, academic journals, and, most interestingly, original interviews with physician-spokespersons and pharmaceutical sales experts.

More Information

  • amazon book reviews.
  • Newsweek Interview with Ray Moynihan.
  • Selling sickness: the pharmaceutical industry and disease mongering, BMJ, PMC1122833, Apr 13, 2002.
  • Drug companies profit hugely from creating “diseases,” then the “cures”, CCPA, publications/monitor, September 1, 2005.
  • The Fight against Disease Mongering: Generating Knowledge for Action, PLoS Med., PMC1434508, Apr 2006; 3(4): e191.
  • Our posts tagged Alan Cassels and DrugMoney.
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