Disease definitions linked to pharmaceutical companies
A few weeks ago, ABC Radio aired a frightening item stating one in 10 Australians has “chronic kidney disease”, CKD, and most don’t know they have it. The story prominently featured fear of early death, and the salutary tale of a young man who belatedly discovered advanced kidney disease needing medical attention. What the ABC story didn’t reveal was that the definition of kidney disease has been dramatically and controversially expanded in recent years by experts and organisations with direct links to pharmaceutical companies.
The broad new CKD definition arose in 2002 from a partnership between the United States National Kidney Foundation and Amgen, a big drug company. Experts arbitrarily set the disease cutoff at half the “normal” kidney function of a young adult – a controversial decision that automatically declared almost half of the elderly as “diseased”, because kidney function changes as we age.
As it happens, many of the people labelled under this definition of “chronic kidney disease” will – bizarrely – never experience any kidney disease. As one British kidney charity explains, “often CKD is only a very slight abnormality” and many of the elderly people classified as having CKD may have “normal ageing of their kidneys”.
Despite a decade of criticism of this broad definition of CKD, drug-company-funded organisations have strongly defended it. In 2012, a group of experts reaffirmed it: more than half of them also had financial ties to drug companies or device makers.
CKD is not an isolated case but an example of a much bigger problem in medicine affecting all of us. Disease definitions are being expanded and diagnostic thresholds lowered so relentlessly that many of us with mild problems or at very low risk of future illness are being unnecessarily labelled as sick, and the rules are often being changed by people with egregious conflicts of interest.
A diagnosis can transform our life’s narrative, or that of our loved ones, forever. Sometimes this is valuable, as in the case of the young man featured in the ABC Radio story. But if a diagnosis is unnecessary, it will not only do more harm than good, it will waste precious health resources that could be much better targeted towards the genuinely ill.
In 2013, an international team of researchers, including myself and colleagues from Bond University and the Australian National University, decided to scrutinise the little-known panels of experts who review and change the definitions of human disease. We examined the influential panels of doctors in the United States who had made recent changes to 14 common conditions, including high blood pressure, Alzheimer’s and attention deficit hyperactivity disorder, and we published results in a leading open-access journal, PLOS Medicine.
We found most panels expanded disease definitions, while just one panel narrowed a definition, and none reported on the potential downsides of turning more people into patients. Close to 75 per cent of panel members were working for an average of seven drug companies or device makers – as speakers, consultants, advisers or researchers – and often they worked for the very same companies benefiting directly from panel decisions that declared wider populations in need of the treatments they offered.
These findings don’t prove that ties to drug companies cause experts to expand definitions, but they do reveal serious conflicts of interest.
Among the expert panel that in 2003 first announced the broad new category of “pre-high blood pressure”, 80 per cent of panel members were working for an average of 12 drug companies each.
Among the experts that in 2011 described “pre-dementia” and suggested a possible “pre-clinical” version of Alzheimer’s, more than half of the experts had ties to an average of five companies each.
“Pre-disease” labels affect many millions of people previously regarded as healthy and can be highly controversial.
Certainly, early detection can often be a good thing, saving lives if deadly disease is caught early and nipped in the bud. But it’s a double-edged sword. Many of us diagnosed with pre-disease – whether its pre-diabetes, pre-dementia or pre-osteoporosis – will never actually progress to suffer any genuine illness but will experience the harm of unnecessary tests and treatments without gaining any benefit.
Other examples from the study include the recent loosening of criteria for diagnosing ADHD and depression. For ADHD, the changes make it a little easier for adults to be diagnosed. For depression, changes make it easier to diagnose someone who recently lost a loved one – a change critics argue might medicalise people going through normal grieving. In both examples decisions were made by psychiatric panels on which more than half the members had ties to drug manufacturers selling drugs for ADHD and depression respectively.
Clearly mental illness can be debilitating and efforts to destigmatise and prevent it are laudable. But the ever-lowering thresholds for a diagnosis jeopardise the legitimacy of these labels, pushing resources at people with mild or transient difficulties that could be better spent on those with serious mental disorders.
These newly expanded definitions are not abstract or obscure. They appear in guidelines for doctors, they determine where health resources flow, and they ultimately affect whether your doctor decides to classify you as healthy or sick. And the newly expanded conditions are heavily promoted through a suite of marketing strategies – including the 30,000 pharmaceutical industry-sponsored “educational events” for Australian doctors every year, which happen inside hospitals, hotels and restaurants.
So what can we do to reduce our risk of an unnecessary diagnosis? One of the world’s leading medical journals, The BMJ, is currently publishing a series of articles on common conditions that have been controversially expanded, and you may find reading about these examples engenders a more healthy scepticism towards disease labels.
The definition of gestational diabetes – which is diagnosed in pregnant women – was changed in 2010, causing almost a tripling of the numbers of women defined as sick. According to the new rules, almost one in five pregnant women should now be considered as suffering gestational diabetes, and critics are concerned this could put many women and babies at risk of unnecessary medical interventions.
Another article argues millions of the people diagnosed with mild high blood pressure may be taking blood-pressure medicines unnecessarily, as there is no good evidence the drugs benefit this group of people. Their work adds weight to calls from other experts who say we should consider raising the threshold at which blood pressure is considered abnormal – a rare and radical proposal to de-medicalise, which could mean tens of millions among the population are transformed from patients back into people.
An article on ADHD in The BMJ series advocates a new approach entailing much more time and caution before a diagnosis is given to a child, while another calls for doctors to be sceptical about “chronic kidney disease” and cautious about using the label. Osteoporosis is another example where the characteristics of a young person have been arbitrarily designated as “normal”, automatically labelling a huge proportion of older women as “diseased”.
There is growing concern in the medical community about this trend and it is more acute among GPs. Some are even starting to take action.
A group in Britain has recently set up a special standing committee within the Royal College of General Practitioners to formally try to address the problem. In Europe there is now a new movement among GPs – with the awkward title of “quaternary prevention” – which explicitly aims to protect its patients from medical labels and unnecessary treatments that bring more harm than good.
Globally, several organisations, including the World Health Organisation, are contemplating new rules for the expert panels that change disease definitions. They hope to encourage these panels to look at the harms as well as the benefits of lowering diagnostic thresholds and turning more people into patients.
All of these reforms will take a lot of time to kick in, and as time ticks away we are likely to see more specialist groups trying to expand their medical turf. The safest bet may be a double shot of healthy scepticism next time you hear someone say one in 10 people suffers with a disease though most don’t know they have it.
This article was first published in the print edition of The Saturday Paper on Jun 20, 2015 as "Lucrative diagnosis". Subscribe here.