Professor Lesley Barclay, director of the Northern Rivers University Department of Rural Health in NSW, is a leading proponent of the need to reorient maternity care around the needs of women and babies, and has plenty of first-hand experience of why this is particularly necessary for women living outside the major cities, especially Indigenous women from remote communities.

This coming Saturday, she will be speaking at the Australasian Medical Writers Association conference in Sydney.

Here is a sneak preview of her presentation:

“When women talk about what matters to them when it comes to childbirth, the issue they repeatedly mention is safety.

But their understanding of safety around childbirth is often quite different to how health systems and many professionals define it.

For women, a safe childbirth is not only about what occurs at the time of the birth. It also refers to longer-term issues, such as their social and emotional wellbeing in the weeks and month after the birth.

When women talk about safety, they are also thinking about the increased rates of depression and anxiety that manifest after operative birth or the consequences of wound infection on general health.

The Australian health system often makes it difficult for women to make wise choices around birth. Consider, for example, how the system defines childbearing as “obstetrics” and locates it physically and psychologically in acute care hospital services.

It is far more appropriate to speak of “maternity care”, which can be safely located in many locations.

For example, evidence shows for most women most of the time birth does not need to take place in hospital. Some women will only feel safe however, whether this is evidence-based or not, with specialist medical services and technology.

The term “maternity care” describes the range of services women need to enable them to safely and confidently ‘mother’. This incorporates their social and emotional needs. It puts them – rather than the professional or the service – at the core of the system.

Evidence shows maternity care can be provided by both midwives and obstetricians in public and private sector hospitals and can be safely provided at home.

Paradoxically, evidence also shows that safety from morbidity is less likely for Australia’s healthiest and wealthiest women cared for by private obstetricians in private hospitals. More recent epidemiological evidence shows as volumes of operative birth increases, deaths of mothers and infants are also increased by overuse of the very operation that was developed to save lives.

So where does choice fit in this repertoire of terms, locations, professionals, services and outcomes?

Safe birth should be the goal of choices offered to women and decisions taken by those who provide care for them.

Unfortunately, the choices some professionals offer or accept are self or income centered and ignore evidence. As a consequence of gender-located power historically, and a rapid increase in the numbers of more technically oriented professionals in recent decades, health services and costs do not reflect women’s needs or evidence.

The most important example of this is allowing caesarean birth to be a choice rather than only using this as the lifesaving emergency procedure it is.

Today, in many places around the world, including Australia, caesarean birth is rapidly becoming a life threatening procedure itself because of excessive use.

Epidemiological evidence from a number of countries, maternal death reviews and coroner’s reports now show the risks attached to using a major surgical procedure as a routine mode of birth.

Maternal mortality is between two and seven times higher for surgical than vaginal birth. One study of over one million women between 2001 and 2003 in Brazil found, compared to having a vaginal birth, women with CS were 3 times more likely to die in childbirth.

A large US study of 5 million births between 1998 and 2001 demonstrated that neonatal mortality for CS deliveries is nearly 3 times greater than for vaginal birth in women with no medical risk factors.

The physical, social and emotional morbidity attached to women who experience this mode of birth is not recognised therefore ignored within acute care hospitals but is evident in their homes and the community.

Research has identified that physical morbidity associated with CS is five to ten times higher than for women birthing vaginally. No less importantly there are also psychosocial consequences of surgical birth with women less satisfied, more concerned about the baby’s condition and fearful. Women delivering by CS report feeling less in control than women who have birthed vaginally.

Research also shows rates of post natal depression significantly different between women who birthed vaginally and the group of women who delivered either by planned or unplanned CS. There are also differences in parenting perceptions and behaviour between women delivering by CS and vaginally. Women who birth by CS evaluate their babies less favourably, are less likely to breastfeed and/or feed for a shorter duration.

Paradoxically, the choice to have a normal, safe, confidence affirming birth that is low cost and relieves pressure on hospitals is only available to a small minority of women.

This is not possible for Australia’s most vulnerable women and families, who, the evidence suggests, would benefit most. How many rural or remote living Aboriginal women can opt for a home birth attended by a skilful midwife?

Research associated with our NHMRC funded work in the Top End of the NT has shown that 1 in 10 remote living Aboriginal women in one large community avoid hospital services or skilled professionals because of the unacceptable risks to them of being evacuated from their community. One of the reasons they avoid large hospital birth is this takes them from families and other children for weeks at a time.

Other Australian women with more options are also taking this route, fed up with what they see as biased, self-interested advice and unacceptable risks of our current system.

To have real choices, one needs options and good information on which to base decisions. Better resourced women, with access to Internet searching, can chase evidence themselves, or question doctors, hospitals and midwives. They can try to weigh up the range of opinion they are likely to receive. It is hard to know at times where fact lies in the opinions you will generate through asking questions. H

However there are some ultimate arbiters beyond opinion. One of these is the impartial review of evidence provided by such as the Cochrane data base.

I saw to my great delight a writer (male and medically qualified) who also a Member of Parliament, recently quoting this source in a newspaper. His message, while aimed at indemnifying home birth midwives, was that home birth is safe.

He had gone to the Cochrane and reported back in his article that home birth is indeed safer at times than hospital birth when planned and supported by good hospital care for rare emergencies.

I wish the current president of the AMA, an erstwhile obstetrician, would be similarly correct with his claims that certainly are not recognisable as fact to those familiar with the evidence.

Choices for women are difficult when all they receive is highly partial and ill-informed opinion. Choices around birth are important or women will opt out of a system that does not meet their needs.

The Australian maternity system has been associated with increasing risks over recent years and is certainly much more expensive than it need be.

The Commonwealth aims to change this. Recent budget moves to allow midwives to claim for midwifery services and to increase choices for women will, evidence shows, reduce risks of physical and social morbidity. Location for birth similarly is a choice that women make that with good support systems will reduce cost, reduce morbidity and not increase deaths.

Should it be a matter of choice though for women to give birth via major abdominal surgery? Should we permit choice that means their babies avoid the process of vaginal birth that prepares them to live and breathe?  Should it be women’s or obstetrician’s choice that health pays or heavily subsidises the avoidable costs of unnecessary operations that prevent other necessary surgery being performed and add to waiting lists? I think not.

We need to recognise that operative birth is the option to use only when the risks associated with the alternative are unacceptable. This is not a matter of choice.”

That is one worrying implication from a study just published in the Medical Journal of Australia.

Researchers sought to examine the initial impact of the national bowel cancer screening program which offers faecal occult blood testing to those aged 55 or 65.

They reviewed the data on bowel cancers diagnosed between May 2006, when the program began, and June 2008 from a database involving 19 hospitals. The good news is that cancers detected through screening tended to be at an earlier stage than those diagnosed as a result of patients presenting for testing because of symptoms.

The worrying news for anyone concerned about equity is that almost two-thirds of the patients whose cancers were detected through screening were from wealthier backgrounds. Somehow, I don’t think this means that wealthier people are at increased risk of developing the cancer; it is much more likely to mean that the poorer groups are less likely to access screening.

Professor Ian Olver, ceo of Cancer Council Australia, has filed this analysis of the study:

“The recent report on the impact of bowel screening in Australia by analysing patients who present for surgery for colorectal cancer confirms the ability of the program to save lives.

As with studies from other countries, patients who are screened present with earlier stage disease which is more likely to be cured.

The study showed a disparity between low and high socioeconomic groups. Those from lower socioeconomic groups are less likely to have been screened.

Whilst this has been reported from other studies, potential solutions are not as well researched. It is known that certain subgroups like the culturally and linguistically diverse communities and Aboriginal communities will need culturally appropriate translations of information about screening. The access of remote populations may be an issue.

However what of the majority of people in lower socioeconomic groups? A recent American study has shown that educational level is a key factor, because it influences the provision of information about screening by healthcare providers (Ye J et al Cancer Epidemiol Aug 28 epub before press).

Clearly GP’s and other providers have an important role in encouraging participation in screening.

However, the major issue remains that given the proven ability of a bowel screening program to save lives, Australia still only has a one off bowel testing program rather than a full screening program.

There is no rescreening, which should occur every 2 years, and bowel screening kits are only mailed to 50, 55 and 65 year olds. Too many Australians, of all socioeconomic groups, are missing out on a program that could save 30 lives each week if fully implemented. It is urgent that the Government completes the role-out of bowel screening.”

Croakey continues:

The other worrying note from the study is the authors’ comment about the lack of evaluation of the screening program. They wrote:”…no resources have been allocated to determine the program’s ultimate impact on bowel cancer incidence or mortality”.

If true, this seems a remarkable oversight – to roll out a national program without having in place a proper evaluation process. Is this really the case?

There are many potential downsides to such simplistic messages.

You can read more about some of them in this article, published today in the SMH and online at the National Times, by Simon Chapman and Alexandra Barratt, from the School of Public Health at the University of Sydney.

Dawson contributed to the fatigue risk management guidelines which recently caused Queensland Health some media grief, and today he’s taken us well beyond those headlines.  Adelaide surgeon Guy Maddern also wrote about related issues in Crikey this week.

I particularly liked Dawson’s observation that:

“Fatigue risk management is the perfect example of what Tony Blair described as a ‘wicked problem’. That is, one for which the solution is complex, multi-factorial and will require thoughtfulness, flexibility and time. Successful fatigue risk management in health care will require exactly that.”

Using that definition, it seems to me that most problems in health are absolutely wicked.

Here at Croakey, we thought we’d do our bit to save the public purse by asking some relevant experts for their views about one particular recommendation, and the challenges surrounding its implementation.

This recommendation states (p97):

There should be a common national approach to evaluating all health interventions, with consistent evaluation of medical care, pharmaceuticals, prevention and population health interventions, medical devices and prostheses, allied health and complementary medicine. To use an example this might allow comparison of the relative efficacy of a medical intervention (gastric bypass), a pharmaceutical intervention (an anti-obesity drug), an allied health intervention (a structured program of exercises and diet management) and a population health intervention (a community walking program) in reducing obesity.

Of the experts contacted by Croakey, most liked the general thrust of the recommendation, although several cautions were sounded, and multiple barriers were identified.

Some of the cautions:

Jon Wardle (Qld Uni): The recommendation is certainly good in theory and worth pursuing – though is fraught in many practical ways. I see a well-intentioned measure heading for disaster.

Ben Harris-Roxas (University of NSW), when asked whether the recommendation should be progressed, gave “an emphatic ‘maybe’.” It sounds intuitively appealing but there will be substantial practical and methodological challenges.

Glenn Salkeld, School of Public Health, University of Sydney: It is worth agreeing upon a common set of principles for the evaluation of interventions and then consider the task of how best to evaluate the options. Without a clear articulation of the objectives of resource allocation (which must include the distributional consequences of resource allocation) we run the risk of measuring precisely the wrong thing in an evaluation.

***

Below, in no particular order, are the full responses to our informal survey:

1. Jon Wardle, School of Population Health, University of Queensland

What issues would need to be addressed to enable implementation? There are many barriers. The first is that there seems to be an underlying assumption that the generic nature of reactive pharmaceutical intervention for disease can immediately be transferred to the proactive/preventive treatment of disease. This casually ignores the many socio-cultural or other ‘non-health’ factors that affect the outcome of preventive health measures far more than acute treatments.

It also over-simplifies the methodological challenges in measuring the outcomes of interventions. Some may require a ‘whole-practice’ approach and not have readily identifiable markers of effect (I know of many menopausal interventions that have lower effect on single measures, but are superior on multi-factoral measures like ‘menopause scores’), or some may have patient-centred outcomes that may not be readily identifiable or comparable to clinical scores – but equally important in many aspects (for example the qualitative study of rheumatoid arthritis patients in Bristol that for the first time identified that fatigue associated with the condition, not pain, was the factor that most impacted their life – ‘clinical’ research had not previously explored this area). Of course people are individuals – some may respond better to diet than drugs, some vice versa.

Would a crude comparison make the intervention most effect for that individual unavailable as most other people did not see an effect? I would also suggest that it is not just health interventions that are measured. After all one of the most significant public health initiatives was seat belts – and that had bugger all to do with the health system!

The society in which we live predisposes the population to poor health outcomes (ie social isolation of suburbia; car-focused non-active transport; liquor licensing laws that encourage ‘super-pubs’ and subsequent binge drinking and violence over smaller, more social venues; urban planning that has reduced access to greengrocers, markets or other healthy and cheaper food choices in low SES areas; food safety laws that promote unhealthy options over fresher ones – for example national or processed over local or artisanal foods).

What impact might it have if it was implemented? The potential exists to stifle innovation in the development of health programs if the process is over-centralised or doesn’t deem it fit to focus on a number of similar interventions (ie why is the one ‘diet program’ chosen over another?). The bureaucracy of running it all may actually divert precious resources in the first place!

Do you think that it has any chance of being implemented? What might be some of the barriers? The barriers are too numerous to mention, and many of them involve internal politics, for example it assumes that one groups ‘walking program’ is the gold-standard, or which allied health profession will be chosen? Who will choose? In a sense this is being done already through broad health research funding agencies such as the NHMRC. A more prudent way to achieve this may be to develop research capacity in this new field through special funding rounds and later allow research to be funded on its merit. Although I would love to see the government fund research into each of those interventions my experience of grant rejection (we’ve all been there) makes me a little cynical and think there simply won’t be enough resources to do so.

Are you aware of any other countries that are already doing this? There are many attempts at doing similar things (NICE in the UK) but they are also share as many differences as they do similarities. Collaborations already compare such data already and we may be re-inventing the wheel.

Any other general issues that are worth raising? There are many factors that can affect health, in areas as disparate as transport or retail competition policy (for example it is pointless promoting to eat more vegetables if current retail policy competition means that the duopoly restricts access and affordability to nutritious foods – sorry a shameless plug for an article of mine coming up in ANZJPH). Many of the health issues of the future are particularly susceptible to the implementation of non-health policy and focus on this issue was sorely lacking. Some nations (including New Zealand) are investigating the role of “Health Impact Assessments” on new projects (such as housing estates) or policy and this is an area that should be explored further.

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2. Chris Del Mar, Dean, Faculty Health Sciences and Medicine, Bond University

This recommendation is a worthy objective. In particular some treatments are currently measured with quite different standards (esp complementary and alternative medicines, where ‘traditional use’ which can be recent, is considered an OK to licence, while other drugs need endless costly evaluation)

What are some of the issues that will need to be addressed to enable implementation? We need to facilitate randomised controlled trials more easily. Currently these are difficult to get done. Multiple ethics committees etc. In fact an RCT needs a higher standard of care than ordinary treatment (even if unproved!)

What impact might it have if it was implemented? People (patients and their doctors) should be encouraged to partner more in RCT evaluation of novel treatments. Currently this is seen as a ‘predator-prey’ relationship, which the trial funders are trying to make a buck for the shareholders, which is OK sometimes, but often there is a value to society by the RCT taking place and we all benefiting for the knowledge.

Do you think that it has any chance of being implemented? Yes, if we can change attitudes here.

***

3. Michele Kosky, Health Consumers Council WA

Great idea, let’s have treatment based on best evidence and most cost effective for patient and the funder. I think it would reduce the competing interests and the territory wars between the tribes of health professionals that we often witness and it could be graded so that the gastric banding, for example, becomes treatment of last resort with all its inherent risks. I think that the industry groups in health and the pharmaceutical industry will ensure this proposal does not happen.

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4. Carol Bennett, Consumers Health Forum of Australia

Is this recommendation worth pursuing? Yes, although it is obviously a goal or stretch target rather than something that can be quickly or easily achieved.

What are some of the issues that will need to be addressed? For common measures of efficacy, there will need to be common measures of patient outcomes which will need to include the experience of care – i.e. the degree to which health consumers felt the treatment matched their health needs rather than the degree to which the service provided matched some rigid standard of procedure.

What impact might it have if it was implemented? If health consumers were properly informed about likely outcomes from the full range of health interventions available, it would allow consumers to have greater control and ownership of their own health and well being. Obviously this would lead to a much more healthy community. At present, whichever procedural specialist you see, whether they be a surgeon or a gym instructor, they will be bias towards the efficacy of the services they provide.

Do you think that it has any chance of being implemented? What might be some of the barriers? This has very little chance of being implemented in the short to medium term primarily because existing health providers generally like to measure their performance against the efficacy of their agreed procedures rather than comparing real health outcomes for consumers. We need to make health outcomes for consumers the focus of evaluation, not the procedures that are currently used. A good model in the general practice setting is the Collaboratives program which focusses on health outcomes.

Are you aware of any other countries that are already doing this? Increasingly countries like the UK are looking to health consumer outcomes as the primary reference point for efficacy of any procedure or health intervention, but it still has a long way to go before it becomes a realised ambition as outlined in the recommendation of the NHHRC.

Any other general issues that are worth raising? While the goal may be a long way away, any step to provide better information to health consumers about the outcome of a range of possible interventions is to be encouraged and supported.

***

5. Public health physician George Rubin

What are some of the issues that will need to be addressed? National mechanism/s for conducting the reviews – a network of organisations under the auspices of NHMRC; methods agreed and developed …perhaps along the line of the evolution of systematic reviews

What impact might it have if it was implemented? Gradual shift of practice towards interventions of demonstrated effectiveness; hopefully a mechanism for ongoing assessment of interventions for which there is little or no evidence; reduction of interventions proven ineffective

Do you think that it has any chance of being implemented? What might be some of the barriers? Little chance. It will take a major organisational effort, will need a substantial budget (which could be saved by a successful program) and will involve substantial politics around what potentially gets dropped. More realistic to develop a program of comparative effectiveness measurement. Are you aware of any other countries that are already doing this? Health technology assessment organisations in NZ, Canada, US etc but unaware of comparative assessment programs

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6. Michael Moore, Public Health Association

I think that there is some merit in pursuing the recommendation. However, I do have some reservations about how the comparative research might be conducted and the prism through which such research might be constructed. Over the last decades preventive and public health has been the poor cousin in research because it is not simply about a gold standard double blind study with all confounding factors eliminated.

The medical and the pharmaceutical research methodology is likely to be more easily understood and therefore carry a favourable bias. I am not sure how these concerns might be met. A sensible study that wrestled and dealt with those issues has the potential to provide some serious insights into the most effective methods of dealing with obesity providing opportunity for governments to determine the most effective allocation of resources.

Implementation will be difficult as I suspect the funding of broad ranging research across different disciplines as this will demand is likely to be very expensive. However, it is possible and could be achieved by letting a tender to a consortium capable of crossing the barriers.

The complexity of obesity, the structural issues that drive it and the role of junk foods is probably a higher priority for research funds.

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7. Ben Harris-Roxas, Research Fellow, Healthy Public Policy Program, University of NSW

At time when we face increasingly complex health issues that are caused by multiple factors such as the way we live, work and take care of ourselves this may lead us further down the path to simple answers.

Also it’s unclear what methods might actually be used to compare interventions, e.g. cost-effectiveness studies, health technology assessment, etc. It’s not like issues of effectiveness will be examined independent of cost, so we should really be calling it what it is – a discussion about which intervention(s) should be funded based on their comparative cost effectiveness.

What impact might it have if it was implemented? I think it would tend to concentrate preventive activities even further on simple, well tested interventions that are closely tied to health outcomes, i.e. not complicated by other factors. This is not a bad thing in of itself, but it could stifle innovation and may only address the underlying issues at the margins.

Do you think that it has any chance of being implemented? What might be some of the barriers? It depends what the purpose of the “national approach” is. Will it be to ensure that only effective interventions get used or to decide that only a limited number of the most cost-effective interventions will be funded? Getting the states and the Commonwealth to agree on a common approach to this will be a minor miracle. The other issue is that the capacity to do health economic analysis is exceedingly weak at the state level and quite patchy at the Commonwealth level. The ability of drug manufacturers to demonstrate their products’ cost effectiveness is beter developed than, say, people developing population-based interventions, partly due to the nature of the interventions and outcomes but also because they are already doing cost-effectiveness studies for the PBAC/MSAC. The other problem is that it will favour one or two interventions as being the most cost-effective, when much of the emphasis in population health research is shifting to using complex interventions for complex problems.

Are you aware of any other countries that are already doing this? The UK’s National Institute for Health and Clinical Excellence (NICE) do this to a certain extent and the conventional wisdom is that they will only recommend that a drug or procedure gets funded if it costs less than £30,000/QALY.

If the “national approach” is only to set a minimum benchmark for cost effectiveness of interventions we may encounter a situation where

• costs grow rapidly (as currently occurs once drugs are apporved by PBAC or procedures by MSAC),

• there are increased inequalities in the health outcomes, and

• there will be concern about funding more and more interventions, suggesting that the benchmark threshold will have to be revised regularly.

A broader discussion is required about how much we are willing to pay as a nation and society for our health and how much we’re willing to invest in an average individuals’ health, but that’s too politically sensitive to contemplate in the forseeable future. If the purpose of the “national approach” is to ration services, and it would have to be at some level, this debate will have to occur.

Any other general issues that are worth raising? Transparency of the process will be important. Also, how do we circumscribe our consideration of effective interventions for health. For example, a recent meta-analysis of the lifetime effects of education on quality of life made a conservative cost estimate of between €98,000 and €168,000 for every QALY gained [Furnee CA, Groot W, van den Brink HM. The Health Effects of Education: A meta-analysis. European Journal of Public Health 2008;18(4):417-21.], and this didn’t quantify the effects such as the impact of education on mortality.

Education has a number of other positive impacts beyond direct health gains – should we be funding education as a cost effective health intervention?

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8. Wayne Hall, School of Population Health, University of Queensland

What are some of the issues that will need to be addressed if this is to be implemented? Something along the lines of the Pharmaceutical Benefits Advisory Council would need to be set up to evaluate major interventions in fields of high public health priority. Given the demands on expertise and time to do these analyses such an approach would probably have to be phased in.

What impact might it have if it was implemented? It would put the onus of proof on advocates of new approaches to provide evidence not just of their safety and efficacy but their cost-effectiveness compared to other similar interventions directed at the same risk factor or disease. It would make government think more strategically about funding for health care interventions rather than make piecemeal decisions about things one at a time (as we do with drugs with PBAC with limited capacity to revisit past decisions in the light of new interventions)

Do you think that it has any chance of being implemented? What might be some of the barriers? Barriers will be many: special interest groups (e.g. food industry, diet industry, pharmaceutical industry, health professionals with an investment in particular approaches); the economic costs to govt of implementing and scaling up such a system of evaluation; lack of data for economic evaluations etc etc

Are you aware of any other countries that are already doing this? NICE in the UK attempts to do something along these lines in so far as data permit for major areas of public health concern. Rob Carter from Deakin and Theo Vos at UQ are undertaking this sort of project at present for an NHMRC funded grant. Rob has done something along the lines suggested on obesity interventions and Theo something similar on alcohol.

Any other general issues that are worth raising? It’s an idea that needs to be seriously discussed and trialed in a couple of key areas of current public health concern, e.g. obesity

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9. Glenn Salkeld, School of Public Health, University of Sydney

What are some of the issues that will need to be addressed? Common issues – is there a common metric of health outcome that captures what matters? (ie the stated objectives of government health expenditure) Where does the information for the evaluation come from and is it valid and reliable? Who (an independent body or not) and what governs the assessment of the evaluation (is it regulation, legislation?) How does the process manage competing interests (of both buyers and sellers of health interventions/products)? What impact might it have if it was implemented? It would slow things down and allow time for proper debate on the best use of scarce resources. Depending on the responses to questions 1 & 2, it has the potential to shift resource allocation to a more transparent process (and hopefully move resource allocation to a more considered and defensible basis)

Do you think that it has any chance of being implemented? What might be some of the barriers? It will require a good deal of courage. It has worked in the pharmaceutical area because the only way to sustain large public expenditure that benefits the population and the sellers of medicines is to have an evidence-based approach to the selection and reimbursement of drugs. Without the public subsidy both sides lose. With a credible way to allocate money for medicines both sides gain. Are you aware of any other countries that are already doing this? The UK has the National Institute for Clinical Effectiveness (NICE) but that functions in the context of a more planned health service.

Any other general issues that are worth raising? Without a national approach to better resource allocation in health we will struggle to exert any control over who gets what health resources and how much. Doing nothing will only increase health inequalities.

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10. Les Irwig, School of Public Health, University of Sydney

My quick reaction is:

• Great idea!

• will need massive Govt funding to avoid the problem of RCTs being more likely for new pharmaceuticals.

• non-drug interventions used in the trials will need good descriptions – see Paul Glasziou’s recent paper in the BMJ on how poorly they are described currently in the lit

• need better consumer/patient involvement to define what endpoints are meaningful to patients and therefore should be measured in the trials

• pity they didn’t include diagnostic technology, for which far more trials should be done

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11. Lloyd Sansom, Chair, Pharmaceutical Benefits Advisory Committee

The Government is currently undertaking a Health Technology Assessment and one of the issues they are examining is the relationship between the various agencies particularly in regard to hybrid technologies and timeliness . With increasing applications of molecular targeted drugs, drug/device combinations it is important that we examine the situation to improve the efficiency of the process.

The PBAC submission to the review is here.  In view of the current review it would be inappropriate for me to make any other comment other than the submission

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12. Jon Jureidini, Adelaide psychiatrist and member, Healthy Skepticism

It could have a dramatic impact in some areas, but would require significant and often unpopular disinvestment. There would be some practical barriers, but the political ones will be stronger.

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13. Libby Roughead, School of Pharmacy and Medical Sciences, University of SA

Very often in health care we need implementation of a mix of strategies, not just one, so there needs to be a context in which this recommendation is considered. That being said if we only evaluate pharmaceuticals against pharmaceuticals, then we might not understand how that compares with other interventions which may be less or more effective – which I suspect is the issue trying to be raised.

If you look at the US Institute of Medicine’s top 100 priorities for comparative effectiveness, you will see that many of those are about gathering evidence for the mix of health care interventions – although I gather the top 100 priorities were opinion-based supported by a nominal group process rather than based on other data.

It is certainly a good idea to think about how public health dollars and practice and primary health dollars and care may be better integrated and how the evidence may integrate – we will always need both strategies (not just one or the other).

The challenge is creating the incentive for developing the evidence – it is work rarely done and we already have a challenge of evidence just within areas of health care. I suspect the starting point is to create the dialogue about what this means – as Croakey is doing.

The Indigenous Health Infonet is based at Edith Cowan University in Perth and funded primarily by the Australian Department of Health and Ageing’s Office for Aboriginal and Torres Strait Islander Health (OATSIH).

It is self-described as a “one-stop info-shop that aims to contribute to ‘closing the gap’ in health between Indigenous and other Australians by informing practice and policy in Indigenous health by making research and other knowledge readily accessible”.

Conigrave says: “It draws together a wide range of information and resources in relation to Indigenous health in Australia into an easily accessible format. It is a field that’s otherwise challenging to find information in, as so much is in the grey literature rather than in refereed journals.”

The project’s origins date back to 1981 but it’s undergone a number of evolutions since then and adopted its current name in 2000 when the project underwent a major redevelopment.

It’s well worth a look, and a bookmark.

The PM cited Australian research, recently published in the New England Journal of Medicine and reported in Crikey,  which found, he said, “that a commonly available treatment for fractures of the bones of the spinal cord was in fact no better than doing nothing at all”.

The PM said the Government was “keen to explore in conjunction with private health insurers and our research community” an NHMRC suggestion that treatments, therapies and devices which are not backed by evidence should be evaluated.

In the light of the PM’s enthusiasm for ensuring that health funding is well spent, I wonder whether he and his office are familiar with the work that was being done along these lines by the Royal Australasian College of Surgeons in evaluating surgical techniques.

Professor Guy Maddern, a surgeon who has been a driving force behind this work, writes of his great frustration at the Government’s apparent lack of support for the work:

“The recent publications in the New England Journal of Medicine describing the results of vertebroplasty highlight the problem of introduction of new surgical technologies.

Whenever a new procedure is assessed, particularly in its early stages, it is often difficult to prove that it is a superior step forward than existing technologies. This is in part because it is difficult to conduct the trials necessary to prove benefit.

Rather than rejecting a procedure because the evidence fails to be compelling, these two recent publications in the New England Journal of Medicine highlight the need for careful and assessed introduction of new technologies and procedures into surgical practice.

It is a great shame that the Australian Commonwealth Government does not greatly value assessment of procedures, particularly if they are not associated with a new Medicare item. While great efforts are put into assessing introduction of new drugs, substantial efforts are put into assessing new devices, much less effort and energy is put into the assessment of new procedures which often represent an alteration, which may be significant, of existing procedures.

It has been a great disappointment to the Royal Australasian College of Surgeons that the Commonwealth Government has not felt the need to continue to support the Australian Safety and Efficacy Register of New Interventional Procedures in Surgery.

This organisation, run by the College of Surgeons, attempts to look at new procedures that are introduced without the necessity for new Medicare item numbers. It may be that the alteration of a length of bowel, an angle of suturing or the use of existing devices in new and novel ways can bring enormous benefits but also potentially enormous harm to patients.

This desperately needs to be assessed and reported on, but explaining this to the Government at this time is a difficult and frustrating experience.

The reporting of this recent study highlights the difficulties in assessing new technologies but does not excuse the process from occurring. Hopefully it will provide further evidence to the health authorities that such activities are desperately needed within our health system.”

More info about the scheme is available in this British Medical Journal article.

Meanwhile, health policy analyst Jennifer Doggett has been humming some old tunes, and contemplating Todd Harper’s recent Croakey post calling for health warnings on alcohol labels. She writes:

“Elvis Presley almost certainty wasn’t thinking about public health when he sang his 1968 hit ‘A little less conversation, a little more action”.  However, the song has a message for Health Minister, Nicola Roxon, reported to be contemplating the introduction of alcohol health warnings, as recommended by the Preventive Health Taskforce.

Todd Harper, CEO of VicHealth, makes a case for more conversation about alcohol health warnings.  He argues that we need to talk more to drinkers about how we communicate alcohol and health information to them.

Certainly such conversations have their place.  Conversations can help governments considering the introduction of health warnings to gauge the response from the media, public health groups and the general community.  This is an important part of public health policy development.

However, what conversations won’t tell us is whether or not alcohol health warnings actually work.  For this we need data – independent, robust, replicable and measurable data. No amount of consultation with consumers, engagement with public health groups or advice from experts can substitute for this.

From the limited available evidence, the case for alcohol health warnings isn’t strong.   A comprehensive review of research into the impact of alcohol warning labels was undertaken by Professor Tim Stockwell (Director of Australia’s National Drug Research Institute) for the Canadian Government in 2005.  After examining a large number of studies he concluded that “….there is little or no measurable change in drinking behaviour and related harms as a result of the introduction of alcohol warning labels”.

In fact, there is a danger that warning labels could have unintended negative effects on those most at risk of alcohol-related harms. This is because they could increase the attractiveness of alcohol consumption among people seeking to undertake risky behaviours. In 2000 when the Australian and New Zealand Food Authority looked at this issue, it found that “there is considerable scientific evidence that warnings statements may result in an increase in the undesirable behaviour in ‘at risk’ groups.”

Of course, all this research has limitations.  In particular, the fact that most of the studies in this area have been conducted outside Australia makes it difficult to assess their relevance to the current debate.   Given these constraints and the lack of robust data from the Australian context, those advising the government on alcohol health warnings can only guess at their impact.

If we want more than guesswork from our public health policies we need to demand that they are based on evidence rather than opinion.  In the case of alcohol health warnings, this means we need a properly conducted, Australian-based trial.

Unlike many public health interventions, alcohol warning labels are a good candidate for a policy trial.  It’s hard to randomise exposure to quarantine laws or food safety standards, but relatively easy to control exposure to alcohol health warnings.

For example, we could take two cities of comparable size, say Sydney and Melbourne or Brisbane and Perth, introduce alcohol warning labels in one of them and not the other.   After a decent interval – 12 months at a minimum – we could measure whether there has been a change in the level or nature of alcohol-related harms in each city.  This would involve selecting a few measurable indicators, for example, alcohol-related admissions to hospital emergency departments and motor vehicle accidents involving alcohol, and measuring them both before and after the health warnings are introduced.  The impact on specific at-risk groups, such as young people, should also be measured to determine whether they respond differently to health warnings, compared with the general population.

Such a trial would not be perfect but it would give us more information about the impact of alcohol health warnings than we would get from any number of consumer focus groups, conducted around a table and a bowl of Minties.

If the Government is serious about promoting evidenced-based health policy, it should fund such a trial on alcohol health warnings.  After the trial’s completion, the data could be used by government, health groups and other interested parties to argue for or against their introduction.   Either way, this would be a conversation worth having.”

•Jennifer Doggett has previously worked on a youth alcohol campaign, partly funded by the alcohol industry

Last night he gave a public lecture in Sydney, which was attended by Croakey contributor and proud skeptic, Dr Peter Arnold, who has filed this report:

“With the exception of an unhappy homeopath, the audience at the Seymour Centre on Wednesday evening gave Simon Singh an enthusiastic reception at his Sydney University’s ‘Sydney Ideas’ talk.

Singh’s latest book, ‘Trick or Treatment’, co-written with Professor Edzard Ernst, Chair of Complementary Medicine at Exeter University, is unfortunately not available here in any quantity.  His previous book ‘Big Bang’ has been available since release in 2004.

Singh took the audience on a trip from the exposure of Chinese heart surgery, allegedly done ‘under acupuncture anaesthesia’, through a discussion of the rationale of controlled trials of purported remedies, whether ‘natural’ or discovered by pharmaceutical companies.

Reviewing the history of homeopathy, he demonstrated the need for properly conducted trials, even of the seemingly craziest theories. He illustrated one of these by referring to Fritz Zwicky, thought to be a real ‘nutter’ when he suggested the existence of dark matter, but since proven to have been correct.

Singh argued strongly against giving patients with serious illnesses false hope about possible cures, when the remedies were totally unproven.
Simon argued forcefully for the same rigorous testing to be applied to any proposed remedy, regardless of its source.

He then explained the background to his being sued by the British Chiropractic Association.

Unfortunately for all of us, even here in Australia, it seems that a libel action could be mounted in the UK for what we say or write downunder – the British courts have a global jurisdiction in these matters.

And the onus of proof is on the defendant!

Simon alluded to the campaign being mounted in the UK to have the law changed.

He concluded the evening answering questions about the practice of alternative therapies by some registered medical practitioners, justifying themselves on the grounds that it can’t hurt the patient and might just work.

The irony that people in the UK must be trained as vets to treat animals, but need not be trained as doctors to treat humans was not lost on the audience.

Our lonely homeopath, initially cheered on for her courage in coming forward, clearly had no understanding of the meaning of the concept of ‘meta-analysis’.

Quite failing to comprehend what this entails, she finally earned the derision of the audience as her ignorance unfolded through her interminable ‘question’ to Simon.

Chairman Professor David Day, Dean of Science, thankfully stepped up to the mike and put a stop to the rowdy exchange which had ensued.

The meeting concluded with (almost) unanimous acclamation for Simon.”

You can read more about Singh’s stoush with the chiropractors here, in the latest British Medical Journal.

Meanwhile, Michael Vagg, a member of Australian Skeptics, has written the following account for Croakey:

“The well regarded UK science writer Simon Singh published an article in The Guardian newspaper last year to coincide with Chiropractic Awareness Week.

In the article he wrote that the British Chiropractic Association (BCA) ‘happily promotes bogus treatments’ in that it recommends chiropractic treatment for conditions such as infantile colic and asthma.

Singh went on to detail the lack of scientific evidence to support these claims in his article.

He based much of the article on a book he had co-authored with Professor Edzard Ernst, a Professor of Complementary Medicine in the UK entitled Trick or Treatment: The Undeniable Facts About Alternative Medicine. The BCA, rather than backing up its claims of efficacy with scientific evidence, sued Singh for libel.

Events escalated after the preliminary hearing for the case took place in May of this year. The presiding magistrate Sir David Eady, was required to rule on the meaning of the objectionable words, and decided to interpret the phrase ‘happily promotes bogus treatments’ as meaning that Singh was alleging he could prove that the BCA knowingly and dishonestly promoted treatments which it knew to be ineffective. Neither Singh nor the BCA had understood the phrase to mean what the judge decided it meant.

The BCA appears to be angling for a court win similar to the decision of the USA Supreme Court against in the American Medical Association in 1990 where the AMA was forced to stop discouraging the public from using chiropractors.

This was on the basis of restraint of trade, rather than on the basis of convincing scientific evidence of the effectiveness of chiropractic.

A major libel payout against Singh would have an enormous negative effect on journalists reporting the steady stream of negative studies which have been published in high-quality journals for years now, many of them ironically funded by the National Centre for Complementary and Alternative Medicine (NCCAM) in the US.

Newsweek magazine recently reported that NCCAM has spent over $US2.5 billion over the last decade researched alternative medical treatments and has failed to have even one modality proven to be effective for a single condition or symptom at a level which would encourage mainstream adoption of the treatment.

After it appeared Singh might have to settle as his case had become unwinnable, the online community weighed in.

In early June a group of bloggers and scientists began inundating the Advertising Standards Authority with complaints about individual websites and the claims made thereon. The result was stunning. Within a week, bloggers had laid complaints against over 500 websites, and hundreds of them had been either taken down or modified.

The legal blogger Jack of Kent described it as the ‘Quacklash’. The regulatory scrutiny of treatment claims of chiropractic was dramatically increased, and the processing of the complaints lodged with the Advertising Standards Authority will probably lead to increased examination of the claims of chiropractic treatment to treat such conditions as infantile colic, asthma, frequent crying and ear infections.

The Sense About Science charity has launched a campaign entitled Keep Libel Laws Out of Science, and began with an online petition demanding changes to the British libel laws to protect scientific debate. At present the petition has over 12000 signatories, including celebrities such as Stephen Fry and Ricky Gervais, as well as a galaxy of scientists from the most eminent Nobel laureates to undergraduate students.

Encouraged by the support, Singh has announced that he intends to appeal the controversial preliminary decision, and will continue to fight the action.

For its part, the BCA has sent a circular to its members ‘strongly encouraging’ them to review their advertising materials and remove claims such as those subject to legal action. This has also been done by some other smaller professional bodies such as the United Chiroparctic Association and the McTimoney Chiropractic Association in the UK. The BCA has also published its scientific evidence in support of its claims. A typical response from medical professionals is found in Prof David Colquhuon’s Improbable Science blog here. Suffice to say that Simon Singh’s defence of Fair Comment is looking fairer by the week.

The overriding principle at stake in this imbroglio is that journalists should not be threatened with legal action (note that Singh himself was sued, not the Guardian) for making justifiable comments, particularly in an arena like scientific debate where the self-correcting process of aggressive peer review allows for a far more robust consensus of the truth to be arrived at compared to politics or economics.”