Address by Professor Warwick Anderson to the ANZICS / ACCCN Intensive Care Annual Scientific Meeting - October 2012

Adelaide Convention Centre
Opening plenary session, 1-3pm Thursday 25 October 2012

It’s a pleasure to join you today with Professor Rubenfeld for this opening plenary session of the conference.

I acknowledge the Traditional Owners of the land on which we meet, the Kaurna people and pay my respects to their Elders, past and present.

I also acknowledge the important and extremely demanding work you and your colleagues perform every day and every night in our hospitals. Delivery of healthcare is one of the noblest professions. Providing optimal health care involves the application of established and new knowledge, and established and new technologies. This is nowhere truer than in your work.

You will all know that NHMRC is Australia’s major funder of health and medical research. It is perhaps less widely appreciated that NHMRC is equally committed to ensuring that the results of research are translated from the bench to the bedside. My main focus today will be on how we are pushing to accelerate the uptake of high quality research findings into practice to improve patient care.  I will discuss NHMRC’s renewed emphasis on this role.

I will also talk about money.  As we consider what the future holds, we are used to hearing that it will be a carbon constrained future. It also looms as a cost-constrained future, as governments struggle to reconcile growing demands on the public purse with slower growth in their revenues. I will argue that this will increasingly challenge health care providers to ever more rigorously apply spending priorities based on evidence and ethics.

Better knowledge, better care

NHMRC was established 76 years ago last month. In its first year it had 30,000 pounds to distribute to researchers. Seventy five years later, in 2011, we invested $788 million dollars in medical research. 

Billy Hughes, then Minister for Health and Repatriation, who served earlier as Prime Minister, said ‘research must be actively pursued and developed, and as fast as new knowledge is acquired it must be applied’.

We now call this research translation, but I’m afraid that we are not doing it anywhere near as well as we should. We know this, because we have funded research to assess our performance.

Published in the Medical Journal of Australia earlier this year, the Caretrack study, led by Professor William Runciman with co-authors Tamara Hunt, Natalie Hannaford, Peter Hibbert, Johanna Westbrook, Enrico Coiera, Richard Day, Diane Hindmarsh, Elizabeth McGlynn and Jeffrey Braithwaite, interviewed more than 1000 adult Australians to determine the percentage of health care encounters during 2009 and 2010 at which they received care in line with evidence-based or consensus-based guidelines.

The study found that such care occurred at a disappointing average of only 57% of eligible encounters. The best practices complied with more than 80% of indicators, but the worst came in at the low thirties. Compliance ranged even wider across conditions, from 90% for patients with coronary artery disease to just 5% for those with severe hypertension.

Although the methodology of that study was first rate, I know that interview-based findings have to be viewed as more indicative than conclusive. However, when viewed in light of a similar study in the US which found an average 55% compliance, it indicates very strongly that we have a problem.

As taxpayers, Australians are funding health and medical research through NHMRC and other public research institutions but that research is being underutilized in the sense of it informing the treatment Australians receive as patients.

To address this problem, in August this year we initiated the NHMRC Research Translation Faculty. Australian researchers supported by NHMRC are a major and under-utilized resource for research translation. They generate the knowledge, and many are in positions from which they are able to directly influence practice and policy and the training of future practitioners and policy makers.

There is clearly strong interest in fulfilling this role among our researchers. Their response to our invitation has been outstanding. More than 2,500 have volunteered to join the Research Translation Faculty, which will focus on three related objectives:

  • Identifying the biggest gaps between research evidence and health practice
  • Recommending action to address those gaps
  • Identifying and putting forward a case for a major targeted call for research in these areas.

It is critical that the Faculty works with NHMRC and the relevant peak bodies to articulate and implement research translation solutions. We need to understand why these gaps exist and do something about closing them.

I’m feeling particularly positive today after attending the Research Translation Faculty’s inaugural symposium in Melbourne yesterday.

In addition to the Faculty’s contribution, NHMRC’s Centres of Research Excellence program provides unique opportunities to improve the evidence base and research capacity in selected fields and to ensure rapid and successful translation of evidence into new policy and practice. The CRE program enables researchers to collaborate across institutions and with professionals in clinical settings.

A most recent example relevant to your speciality is the CRE for Patient Blood Management in Critical Illness and Trauma, led by Professor David Cooper of Monash University. NHMRC has provided $2.5 million to establish this CRE which will provide infrastructure and project support for clinical trials and other research focussed on improving outcomes for the 10% of blood transfusion recipients who have immediately life-threatening conditions.

A randomised controlled trial of iodine supplementation in pregnancy to enhance neurodevelopment in children – University of Adelaide

  • This study was led by Professor Maria Makrides
  • Aim of the study was to find out if any benefits are to be derived by expectant mothers taking iodine supplements
  • Iodine supplements are promoted as being beneficial for the health of expectant mothers, but this claim has apparently been made without sufficient scientific evidence to support it
  • Professor Makrides believes the messaging on iodine’s health benefits is largely coming from industry

A randomised controlled trial of the effect of hydrocortisone on mortality in critically ill patients with septic shock – University of Sydney

  • This study is being led by Professor Bala Venkatesh
  • This study aims to find out whether adult patients admitted to the Intensive Care Unit with septic shock who are given hydrocortisone compared to placebo (a dummy solution), will have an improved rate of survival 90 days later
  • About a quarter of people who suffer septic shock that is not rapidly reversed, will die.
  • There is no agreement amongst doctors around the world about whether treatment with or without low dose steroids improves the overall recovery and survival in patients with septic shock.

Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial - University of Sydney

  • This study is being led by Professor Craig Anderson
  • An initial study by Professor Anderson investigated whether lowering the blood pressure of patients suffering acute cerebral haemorrhage can reduce haematoma expansion and consequently improve outcomes
  • Having established ‘proof-of-concept’ that lowering BP may improve outcomes, Professor Anderson and his team went on to try and establish the effects of the treatment on major clinical endpoints in patients with of intracerebral haemorrhage

I want to particularly acknowledge the great work that ANZICS Clinical Trials Group has done – and is doing – in devising and implementing research targeted at improving the care of around 140,000 patients each year in more than 180 ICUs in Australia and New Zealand. Since 1994 it has grown to become a world-leading critical care research network of more than 60 ICUs and more than 350 clinicians and researchers.

I particularly commend the CTG on its collegial ethos and its commitment to research directed at patient-centred outcomes, translation of research into clinical practice, and to the education and training of clinical researchers.

Translation of research into commercial returns

AccessDeloitte study

In 2011, the value of commercialisation estimated from NHMRC R&D conducted since 1970-71 was $6.1 billion. Comparing this to NHMRC R&D expenditure over the same period ($8.5 billion) yields a commercialisation benefit to cost ratio of 0.72:1. That is, the financial benefits from commercialisation alone would almost be enough to recoup the dollars the NHMRC spends on research before assessing any of the health benefits.

Medicines Australia/Australian Bureau of Statistics (Catalogue 5368.0)

In 2010-11 the value of pharmaceutical exports from Australia was nearly $4 billion – far greater than our exports of cars (~$2.75 billion) and wine (~$2.2 billion). Our key markets for medicine exports are Asia (41%), South Africa (20%) and Europe (16%).

Evaluation of Development Grants Scheme

This evaluation, conducted over December 2011 to March 2012, was intended to assess the economic, health and industry outcomes flowing from NHMRC investment in Development Grants, including benefits accruing to the Australian Government, industry and the wider community.

This report found that the Development Grants scheme has had and continues to have a range of positive outcomes, in particular:

  • Creation and commercial exploitation of intellectual property.
  • Investment in new and existing Australian biotech firms.
  • Investment from overseas biotech firms.
  • Translation of research into health outcomes.
  • Relationships between researchers and business which generally extend well beyond the initial grant period.
  • Acquisition of commercialisation skills by researchers.

Completed NHMRC Development Grants that illustrate significant outcomes

1) Prof Ian Wicks, Development and pre-clinical evaluation of G-DSF inhibitors for inflammatory joint disease

  • At completion of grant: Proof of concept achieved and initial commercial partners plus investment established.
  • Since completion of grant: Picked up by CSL. Further research as basis for clinical trials.

2) A/Prof Ted Maddess, Wireless objective visual field testing for glaucoma diagnosis

  • At completion of grant: Established basis for further clinical trials and commercial partner secured.
  • Since completion of grant: Product to market 2010.

One member of the new Faculty we heard from yesterday was Professor Rachelle Buchbinder, Director of the Monash University Department of Epidemiology at the Cabrini Hospital.

In 2009 Rachelle captured the attention of the then Prime Minister, Kevin Rudd, with her work to assess the efficacy of vertebroplasty as a treatment for spinal fractures in osteoporosis patients. When her team compared the outcomes for patients who received the cementing treatment with others who received a placebo, they found no significant differences.

Since 2005 the procedure had been listed on the MBS, costing taxpayers up to $1500 per treatment. Prime Minister Rudd cited it as an example of how there were savings to be made in the MBS. That research was translated into an outcome when vertebroplasty was subsequently removed from the subsidised treatment list.

Another recent example of research translation which delivered cost savings without compromising patient care was the study led by Professor John Myburgh of the George Institute and the University of New South Wales, a former chair of your CTG. By showing that saline solution worked just as well as albumin as a fluid replacement treatment in critically ill patients, that research has eased some of the pressure on albumin supplies and contributed to cost savings for ICUs here and overseas.

Which brings me to my second theme for this presentation.

Tougher times, tougher decisions

Governments acknowledge their role in providing the best medical care for all citizens. This is both a public responsibility and a political imperative. But just as the great momentum of medical research and its translation pushes more treatment options into clinician’s hands, governments are facing a much tighter fiscal outlook than has been the case in recent years.

We all know about the chronic high debt and deficit problems being faced by many developed economies, and the austerity regimes being imposed to restore their budgets. Thankfully, Australia and New Zealand do not face such chronic fiscal problems, but our contemporary challenges are nonetheless daunting.

And the challenge will not diminish in coming years. This is not a road hump: it is the beginning of a hillclimb.

I draw from comments by Australia’s Treasury Secretary, Dr Martin Parkinson, in a speech he gave in Canberra in August.

He noted the rising community demand for government provision of what economists call 'superior goods'. These include aged care, health, disability, education and social welfare. And growth of this demand will accelerate in coming decades as the population ages.

Dr Parkinson’s comments come at a time when the nation’s taxation base is weaker than Treasury had forecast in the mid-2000s. A proportion of revenue then was due to what they now realize was a temporary bubble in the economy. Commonwealth tax receipts are thus expected to remain around $20 billion per annum lower than pre-GFC projections, leaving a widening gap between the demands the community places on government and what the community is prepared to pay to fund government.

Closing that gap would require governments to raise more revenue and achieve significant savings. Dr Parkinson said, and I quote: ‘The public will need to make thoughtful decisions about what it wants government to provide, and how it expects these things will be provided’.

This is an appropriate point for me to outline NHMRC’s funding profile.

 You will note the steep change in funding between 2005-06 and 06-07, in the middle of last decade when Treasury’s outlook was buoyed by what it now identifies as a bubble. That rise from $448 million to $643 million amounted to a 43 per cent increase.

As the slide shows, our funding faltered slightly in the two following years but has since recovered to the incremental rate of increase that has been the historical norm. It is important that this trajectory be maintained, notwithstanding the tough Budget decisions facing governments in the years ahead.

Bringing the Budget back to balance makes sense. Maintaining support for medical research which delivers savings in the form of reduced healthcare costs, and returns in the form of commercial developments, also makes sense. The focus thus falls onto cutting current expenditures, and getting better value for money.

The removal of MBS support for vertebroplasty following Rachelle Buchbinder’s work is a case in point. It was an evidence-based move but nevertheless it earned the Government some bad press, not least from an ABC current affairs segment in which a patient and a practitioner complained about the removal of what they saw as an entitlement.

Another example is the decision in the May Budget to institute a review by the Chief Medical Officer of the Private Health Insurance Rebate as it applies to natural therapies or complementary medicines. The results of the review are scheduled to take effect from January 2014. From that date private health insurers will only be able to pay benefits for natural therapy services which the review has found to be clinically effective.

Evidence based, but bound to upset many voters.

Following recommendations from the Pharmaceutical Benefits Advisory Committee, the Government has also recently instituted higher standards for the prescription of synthetic infant formulae for infants with cow’s milk protein intolerance. The committee noted the rising incidence of prescriptions of amino acid formulae before a protein hydrolysate formula was tried. Protein hydrolysate formulae are suitable for the management of a significant number of children with these conditions, and amino acid formulae are significantly more costly.

Evidence based, but bound to upset many voters with babies, not to mention some GPs and paediatricians.

We can expect many more incidences in which support for less effective solutions is withdrawn in favour of evidence-based solutions that have greater impact, or less costly solutions which do not disadvantage patients. In this cost-constrained future we will need to apply more rigorous standards to justify public expenditure.

To do this, health practitioners will have to accept even greater responsibility to be fully aware of the range of treatments available for their patients, and to acknowledge their embodied costs. This not only raises the bar on the existing reality that health practitioners must continually upgrade their knowledge base, but also speaks to their professional ethics.

We are used to dealing with ethical challenges that can arise due to the necessary involvement of private sector companies which supply medicines, machines and other tools of the physician’s trade.

As we deal with tighter budgetary limitations, ethical challenges are also more likely to arise as physicians seek to do their best for patients in desperate situations, or to promote the use of costly treatments which lack a sound evidence base. The temptation is to use shortcuts or take advantage of loopholes in the system.

An edgy example is the recent pressure from some practitioners to provide naltrexone implants as a treatment for opioid-dependent patients.

Naltrexone is registered for both opioid detoxification and maintenance treatment, though not listed on the PBS for these uses. Oral naltrexone is licensed and PBS-listed only for treating alcohol dependence.

While naltrexone implants may currently be legally manufactured by a licensed facility, until they are evaluated and approved for registration by the TGA they may only be used under certain exemptions applying to clinical trials and to the provision of unapproved products under the Special Access Scheme.

Some practitioners have successfully sought to take advantage of this dispensation to gain approval to treat their patients with naltrexone implants. This is an example of what I mean by taking advantage of loopholes in the system.

Apart from the cost considerations, this is by no means a proven therapy. It is still an experimental therapy, and as such should be subject to oversight by an ethics committee as a controlled trial, rather than as a routine treatment.

To gather evidence on the efficacy and safety of a novel treatment requires research and that takes time. Then the results of the research have to be assessed and reviewed to inform the development of guidelines for the application of the treatment.

It is understandable that this can frustrate practitioners who, for whatever reason, are keen to make the treatment available. Even more understandable is that patients who may benefit from the treatment become impatient patients, putting pressure on their doctors to bend the rules.

The emergence of research into the comparative effectiveness of treatments offers a framework to inform ethical decision making. Comparative effectiveness is not primarily a measure of cost effectiveness, but it is not quarantined from cost considerations. NHMRC is now spending around $30m a year on comparative effectiveness research, up from $2 million in 2004.

In conclusion, I was intrigued by the theme of this conference: ‘ICU: it’s not all black and white’.

At first I wondered if this was a cunning insertion by our Kiwi colleagues to remind us of their reasonably successful rugby team.  Perhaps it was an acknowledgement of the shades of grey on the heads of those of us taking part. Or even a reference to a popular contemporary novel that I have yet to find time to read.

I remind you of Billy Hughes’ exhortation in 1936 that ‘research must be actively pursued and developed, and as fast as new knowledge is acquired it must be applied’.

At around 57%, we are definitely in a grey area on this performance measure. Through the Research Translation Faculty and other programs, NHMRC is committed to pushing our performance up into the black.  I urge you to redouble your efforts to join us in this quest.

Thank you for the opportunity to address you today. I look forward to your questions.