Broadening the definition of 'disease' may be good business for drug companies but can leave ordinary people worse off

Last September one of my blogs reported on a piece in the British Medical Journal in which journalist, authors and patient advocate Ray Moynihan alerted us to the potentially unhealthy links between the pharmaceutical industry and doctors who set health policy. Specifically, Mr Moynihan’s concern was the definition of disease is being widened, and this is often pushed by doctors who have clear financial conflicts of interest.

In this week’s BMJ, Mr Moynihan writes again about this issue [1]. And again, his piece makes for uncomfortable reading.

A main thrust of Moynihan’s piece is that the criteria used to define ‘illness’ are widening to the extent that virtually every older adult is classified as having at least one chronic [long-term] disease. But, as he points out “Yet a growing scrutiny of the seemingly well meaning march of medicalisation suggests we may sometimes be pushing boundaries too wide, and setting treatment thresholds so low, that people with mild problems or modest risks are exposed to the harms and costs of treatment with little or no benefit.”

Moynihan points to several examples of clear conflicts of interest here, where doctors who set health policies regarding what constitutes disease have financial links from drug companies that benefit from the broadening of disease criteria.

For example:

• Of 12 members of the panel that created the controversial diagnostic category “pre-hypertension” [this ‘diagnosis’ is given to people who do not have raised blood pressure but are deemed to be at risk of it] in 2003, 11 received money from drug companies.
• 11 of the 12 authors of a 2009 statement on type 2 diabetes were heavily conflicted, with authors working as consultants, speakers, or researchers for an average of nine companies each.
• Within the field of sexual dysfunction, drug company employees join their paid consultants to design diagnostic tools to identify and then medicate millions of women with a disorder of low desire that may not even exist.
• Of the panel members responsible for producing the Diagnostic and Statistical Manual of Mental Disorders, 56 per cent of panel members had financial ties to drug companies, although for some panels, including that for mood disorders, the figure was 100 per cent.

The problem, according to Moynihan, is not just confined to financial conflicts of interest, either. Some doctors can push ‘pet theories’ too.

There is call in some quarters for panels to be free from individuals with clear conflicts of interest. There is no reason why this cannot be done, though as pointed out in Moynihan’s piece, it’s generally easier to find a conflicted individual than a non-conflicted one. This observation is made by Sidney Wolfe, who works at Washington, DC based organisation Public Citizen (which has long pushed for such a clean up in the area). Wolfe notes that because old panels are “constantly broadening the numbers of people defined as ill and recruiting millions of people to drug treatments that may not benefit them.”

He cites as an example the situation with cholesterol, where people in good health have lipid levels defined as “above-optimal,” which can lead some doctors to prescribe unneeded cholesterol lowering drugs. Others have observed that treatment thresholds have now become so low that in some cases hundreds of people at low risk of future illness need to take medications for a year, in order for one of them to avoid a heart attack or stroke.

Although not mentioned in Moynihan’s piece, it is worthy of note of the nine members of the National Cholesterol Education Programme (NCEP) in the US that set desired cholesterol limits in 2004, all but one had financial conflicts of interest (which, by the way, were not declared at the time the guidelines were published).

The solution to all this would be to form panels free of individuals with conflicts of interest. Some bodies, including the National Institutes for Health in the US, bars conflicted individuals from panels that set policy on defining disease. There’s also call for panels to set policy that is genuinely evidence-based, and include appraisal of the social consequences of any change in policy.

In this piece, I think Moynihan does a very good job of highlighting an hugely important issue in medicine right now: the fact that healthy people can be labelled as ‘sick’ and in need of treatment, despite little or no evidence that they will benefit. Of course, treatment is never without risk. We have the possibility therefore that the ever-broadening of what constitutes ‘disease’ may be good business for drug companies, but leave ordinary individuals worse off.

References:

1. Moynihan R. A new deal on disease definition. BMJ 2011; 342:d2548