Healthy new rules for defining who is sick

New reform aims to prevent overdiagnosis and stop defining healthy people as diseased – with strict new independence from pharmaceutical companies

An international group of leading doctors and researchers has today launched a reform proposal to change the rules for defining disease and setting thresholds for medical diagnoses. 

Published in BMJ Evidence-Based Medicine the proposal calls for a new process to be led by family doctors or GPs, with strong engagement from consumer or citizen groups, and entirely free of ties to drug companies or other vested interests.

Lead author, Dr Ray Moynihan, an Assistant Professor at Bond University's Centre for Research in Evidence-Based Practice (CREBP), in Australia, said the proposal is a response to the problem of expanding disease definitions which are “causing too many people to be diagnosed and treated unnecessarily, producing harm and waste, and posing a major threat to human health and the sustainability of health systems.”

Co-author, Dr Anna Stavdal, president-elect of the World Organisation of Family Doctors, said: “The aspiration is to see diagnoses offered to those who will benefit from them, rather than those for whom they may cause more harm than good.”

Examples of the problem of inappropriately expanded definitions of disease mentioned in the proposal include:

• The controversial definition of Chronic Kidney Disease, which labels many older people who will never experience related symptoms, and was launched at a meeting sponsored by a drug company
• A vastly expanded definition of Gestational Diabetes, which may now label up to one in five pregnant women, despite a lack of good evidence that the newly labelled women or their babies will gain meaningful benefits that outweigh potential harms
• A proposal to expand the definition of High Blood Pressure, which would label one in every two adults in the US, but has been rejected by a family doctor organisation and others over concerns it may cause more harm than good to many people
• The creation of “pre-diseases” such as pre-osteoporosis, or pre-diabetes, which classify healthy people who are essentially “at risk of being at risk”.

As the BMJ Evidence Based Medicine Analysis article points out, in general disease definitions are currently set by panels which are led by disease-specialists – including those with ties to drug companies – and these panels often tend to expand definitions and label more healthy people as sick.

The new proposal recommends replacing existing panels with much more multi-disciplinary panels, with representatives from consumer/citizen organisations, led by generalists, with all members free of financial ties to pharmaceutical or other interested companies.

Summarising the need for reform, the authors of today’s Analysis in BMJ Evidence-Based Medicine conclude: “The human person can no longer be treated as an ever-expanding marketplace of diseases, benefitting professional and commercial interests, while bringing great harm to those unnecessarily diagnosed.”

The 13 authors of the reform proposal come from Europe, Latin America and Australia, and include doctors working at a senior level within the World Organisation of Family Doctors, WONCA, which represents groups representing more than half a million family doctors worldwide.

The proposal arises from the Preventing Overdiagnosis conference series, which is supported by The BMJ, and will this year take place in Sydney, December 5-7, co-sponsored by the World Health Organisation.