There exists a level of glycaemia defined by WHO as ‘intermediate hyperglycaemia (IH).’ Over the last 20 years, however, the term ‘prediabetes’ has dominated both the scientific literature and the media. At the PODC in 2014, this author argued that the epidemic of ‘prediabetes’ was a classic example of overdiagnosis, driven by the agendas of professional associations and the medical-industrial complex. This presentation will update the literature on ‘prediabetes,’ and report evidence from a recent piece of investigative journalism supporting this contention.
The definition of IH recognised by WHO is based on a glucose tolerance test, and termed Impaired Glucose Tolerance (IGT). In 2005, the prevalence of IGT in US adults was 13.7%. Successive changes to the diagnostic criteria applied by the American Diabetes Association (ADA) included:
Using fasting plasma glucose–based criteria (‘Impaired Fasting Glucose’ (IFG));
Lowering the cut–point for IFG from 6.1mmol/l to 5.6mmol/l;
Adding a category based on levels of glycated haemoglobin (HbA1c); and
Lowering the cut–point of HbA1c from 6.0% to 5.7%.
Defining ‘Pre–Diabetes’ as comprising any of these 3 abnormalities.
Other bodies have not adopted these changes, and generally oppose the use of the term ‘Pre-Diabetes,’ mainly because most such people never progress to develop diabetes. But the consequence of these successive changes is that the prevalence of ADA-defined ‘Pre-Diabetes’ in US adults, is now 33.9%, or 84 million people. In China, using the WHO criterion of IGT, this proportion is 8.3% (82 million adults). With the ADA criteria, however, the prevalence is estimated to be 50.1% (493 million adults).
The American Diabetes Association publishes annual Standards of Care, advising weight loss and physical activity as the mainstay of management. In 2007 it started recommending using metformin to treat high-risk people with ‘Pre-Diabetes’ whose measures did not respond to such treatment. More recently, however, the recommendations have included use of a range of more expensive drugs. All such treatments would be ‘off-label,’ as none has been approved for such use by the US Food and Drug Administration.
In a recent article in Science, Piller has reported the origin of the ADA’s use of the term ‘Pre-Diabetes.’ He describes a meeting in 2001 between the Public Relations chief of the ADA and its then Chief Scientific Officer Richard Kahn to explore ways to engage the public in taking seriously slight elevations of glucose levels. At a meeting at the National Institutes of Health, they came up with the idea of using the little-used term ‘Pre-Diabetes’ in place of IFG and IGT in all their literature.
The article also used the Open Payments database to explore Conflicts of Interest among the ADA advisers. One senior clinical academic, who has authored studies, such as ACT NOW and STOP DIABETES, of off-label treatments has received $5million from pharmaceutical companies for research funding and $1.3million in consultation fees and travel between 2013 and 2017. Furthermore, during the period covered by this database, 41% of the authors of ADA Standards of Care received at least $10,000 in funding from pharmaceutical companies.
Objectives To document the corporate drivers of the epidemic in pre diabetes.
Method Literature review and interviews with key informants.
Results The term pre diabetes was coined at a 2001 meeting between public relations experts and a scientist working for the American Diabetes Association. Many of the panel who advise on standards of care for the American Diabetes Association have substantial funding from the manufacturers of the drugs recommended for off-label use.
Conclusions There is new evidence supporting the contention that the ‘epidemic of pre diabetes‘ is at least in part commercially driven.
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