Show and tell: conflicts of interest undeclared for clinical guidelines

TRANSPARENCY AND MEDICINE – A series examining issues from ethics to the evidence in evidence-based medicine, the influence of medical journals to the role of Big Pharma in our present and future health.

Today Bebe Loff and colleagues discuss the lack of adequate management of conflicts of interest among experts generating clinical guidelines in Australia.

Clinical guidelines are increasingly used to establish practice standards and are relied upon by governments when making decisions about allocating health-related funding. But the public has little basis for assuming that the recommendations of the range of medical groups around Australia that develop these guidelines are free of outside influence.

Last year, the National Heart Foundation (NHF) renounced a $330,000 deal it had with McDonalds that permitted the company to display the Foundation’s “Tick of Approval” on its menus. While the arrangement was always controversial, it was also unsurprising.

Corporate dollars (usually emanating from multinational pharmaceutical companies rather than global food chains) have long supported the work of professional medical associations such as the NHF and clinical researchers. They have also often topped up the wages of doctors.

Your general practitioner is probably writing with a pen provided by a drug business, and next year he or she may have their trip to a medical conference in Greece heavily subsidised by a different drug company. There’s nothing inherently sinister about such support, and often important medical breakthroughs are achieved because of it.

But there’s a problem in Australia surrounding the lack of disclosure of such money and how the perception of conflicting interests is managed.

Clinical guidelines

Late last year, we published an article in the Medical Journal of Australia (MJA) looking at one particular example of how conflicts of interest are managed in one area of medicine – the development of clinical guidelines.

While many ordinary people may have never have heard of clinical guidelines, they are vital documents that assist doctors to quickly decide the appropriate care and treatment to give patients. So guidelines probably touch every one of us in some way, whether we are in the GP consulting room or on the operating table.

They’re also increasingly used by health authorities and government funders to ensure that care is standardised across the sector. And their importance will only grow in future as consistency will be used to both maintain quality of care and keep costs down.

Lack of clarity

Individuals who sit on the panels that draft guidelines, and the professional medical associations that sponsor their development, are reputable experts. But panel members and professional medical associations also receive support from pharmaceutical companies and other corporate entities. And because guidelines contain recommendations for commercially marketed drugs and medical devices, they are vulnerable to bias.

There’s no suggestion that guidelines are being deliberately biased through panel members or sponsoring institutions solely recommending a drug made by a company that offers them a speaker’s fee or research grant.

But influence can be subtle and insidious.

In the United States, for instance, the pharmaceutical company Eli Lilly sponsored a conference in 2003 that resulted in their very expensive drug for infections being placed on clinical guidelines for intensive care patients. Further research showed the drug to be less effective than thought, but the cost had already been accrued.

While a situation of this nature hasn’t arisen yet in Australia to our knowledge, it’s concerning that of all the guidelines we reviewed on the National Health and Medical Research Council’s (NHMRC) Clinical Guidelines Portal, only 15% had conflict of interest statements that listed the financial support offered to panel members.

Where guidelines did contain such statements, an even smaller percentage had details of the amounts given or explained the way potential conflict was managed by the panel or institution sponsoring the guideline in question.

Engendering transparency

To fix this, the nature of any support (financial or otherwise) from corporate interests to institutions and individuals, as well as the processes to manage conflicts needs to be disclosed on guidelines for which they are responsible. Some medical associations do make such disclosures, but they are exceptions rather than the norm.

While this issue has been debated in both the United States and the United Kingdom extensively, it’s seldom debated in Australia.

The United Kingdom has a central, public authority to develop all clinical guidelines. While this ensures that the institution is free of potential conflicts, processes are still required to manage conflicts of individuals sitting on drafting committees.

Professional medical associations do important work – they advocate for research into serious health problems; they educate both the community about staying well and doctors about the best treatment or procedures to use. And, in developing clinical guidelines, they undertake a vital service that governments haven’t seen fit to fund comprehensively.

But we must have confidence that the medications recommended in clinical guidelines, which taxpayers subsidise through the Pharmaceutical Benefits Scheme (PBS) to the tune of billions of dollars, are proposed for reasons of efficacy and not because of the intermingling of corporate money and medical research.

The perception of a conflict can be just as damaging to community confidence as the conflict itself.

When your doctor uses an expert guideline to help decide what treatment to give you, you should feel confident the guideline authors have disclosed conflicts of interest and that these have not affected the content of those guidelines.

That way, your doctor can be confident in the guideline’s advice, and you can be confident in your doctor’s advice.

This is the third part of Transparency and Medicine. You can read other instalments by clicking the links below:

Part One: Power and duty: is the social contract in medicine still relevant?

Part Two: Big debts in small packages – the dangers of pens and post-it notes

Part Four: Eminence or evidence? The ethics of using untested treatments

Part Five: Don’t show me the money: the dangers of non-financial conflicts

Part Six: Ghosts in the machine: better definition of author may stem bias

Part Seven: Clearing the air: why more retractions are good for science

Part Eight: Pharma’s influence over published clinical evidence

Part Nine: Insight into how pharma manipulates research evidence: a case study

Part Ten: Why data from published trials should be made public

Part Eleven: Open disclosure: why doctors should be honest about errors