WE NEED TO TALK ABOUT...SCIENCE AND ETHICS

We need to talk about …science and ethics.  I am not persuaded that we have the relation between science and ethics clear.  Committees established to ensure that medical research is ethical should surely do that – no more and no less.  Instead, research ethics committees quite happily make judgements about the scientific integrity of proposed research. 

Back to the beginning.  When research ethics committees were established by Lovell and McCaughey in Australia under the NHMRC umbrella, they were to have lay people, lawyers, ethicists and clergy on them as well as members from the research community. Ethics are not the same as science. Society has an ethical code, give or take, and that is understood as well by lay members of these committees as it is, or better, than the research workers. 

The ethics committee were to be multiple and local.  They were to represent the view of the local community in assessing whether research should go ahead and under what conditions of informed consent, safety, ethical integrity and confidentiality.  Their job was to review the ethics – not the science, not the financials, not what is now known as ‘governance’ (by which is meant all the liability, contractual, public resource use matter pertaining to the research). 

Not only was reviewing the science not their job, the committees were not constituted to do it even if they wanted to.  They were not like NHMRC project grant review panels. And yet in the most recent documents about how eastern Australia is now moving to an arrangement whereby one ethics committee can review a multicentre trial for conduct anywhere in Australia, the documents speak of ‘mutual acceptance of ethical and scientific review’ of multi-centre clinical studies by any one accredited Human Research Ethics Committee.

The defenders of this faith assert that scientific members of an ethics committee can make the necessary scientific assessment of research proposals, or call on mates (I presume) who can help.  The clergyperson, the lawyer and the lay people on the committee are disenfranchised form this discussion.  Secret scientists business, it would seem.

Research that lacks scientific integrity, because it is poorly thought out, wastes people’s time, has sample sizes that are inadequate or is in other ways weak (and there is a lot of stuff that masquerades as research that matches these criteria) simply should not be done – it is unethical. It is unethical to invade people’s privacy because a study is fatally flawed.  That ethical call can be made by a scientific review committee, composed of scientists from all relevant disciplines.  Those projects that are scientifically sound are the only ones that should go to an ethics committee for further assessment.

There are lots of reasons why this ideal arrangement does not work in practice everywhere – staff shortages, ethics committee members suffering from delusions of grandeur, and administrative ignorance about the nature of ethics, to say nothing of pharmaceutical companies rattling the pill bottle about how, after a decade of development, their latest product cannot be held up by such trifling impediments as ethical review.

Is this arrangement good enough?  No. Could it be changed?  Yes – by insisting that scientific and ethical review be separated.  Not so hard after all.

Ethicists vital to avoid repeating horrors of past*

I recently visited an exhibition entitled Deadly Medicine in New York. It is about eugenics.  It disabuses the viewer of all delusions about the past moral purity and ethical rectitude of both medicine and public health. It is about our professions’ misguided involvement in the eugenic movement in the 1930s. Little by little it slipped and slid from banal rhetoric about preserving genetic purity to the enormity of Auschwitz-Birchenau. And the medical and public health professions were deeply, deeply complicit.

Excavating the foundations in 1966 for the twin towers of the World Trade Center, produced nearly 1m cubic metres of landfill. It was dumped into the nearby waters of the Hudson to extend the southern tip of Manhattan to form Battery Park City.  The New York Museum of Jewish Heritage was built on the site, a 26 metre-tall granite hexagon representing the six million Jews lost in the Holocaust and the six points of the Star of David.  Now, within sight of the waterfall memorials to the lost of 9/11, it shares an emotional bond with its sinister madness. It is heavy with grief and shock.

It is in this darkly serious place that Deadly Medicine, an educational exhibit from Washington DC, is displayed.  A late winter afternoon is probably not the psychological moment to see such an exhibit. 

Eugenics was a concept that received international endorsement from the scientific community in the early part of the 20^th century.  The eugenics movement in Germany, with which the exhibit is principally concerned, began with sterilization of feeble minded men and women out of concern that racial purity was at risk if they reproduced.  The nation felt the immense loss of healthy young men in World War I. ‘Eugenics advocates in Germany,’ reads the exhibition brochure, ‘included physicians, public health officials, and academics in the biomedical fields, on the political left and right.’

Eugenics were absorbed into the Nazi ideology and enshrined in German law by 1935.  World War II led many who had opposed eugenic euthanasia to now endorse it ‘for the good of the Fatherland’.  The killing of children was expanded to adults in 1939 and ‘patients in private, state and church-run institutions’ were especially vulnerable.  From January 1940 to August 1941 70,000 such people were killed using carbon monoxide in gas chambers ‘disguised as showers’.

Paediatricians helped sort children with rickets or developmental problems into those who should be euthanased.  Few of the doctors suffered as a result of their involvement in the eugenics program and the relation between Hitler and organized medicine was strong.  One psychiatrist was tried for war crimes and executed.  Paediatricians, psychiatrists, physicians and others who participated in the death panels went from strength to strength.  Eugenic theoreticians, with their statistical data and scientific notions of genetics and natural selection who subscribed to the prevailing Darwinian orthodoxy, prospered once the war was over. Pathological specimens taken from the dead were studied for years beyond the end of World War II. Business as usual.  

Medical people helped with the gas chambers, initially reserved for those who had an infirmity or deformity.  The slide into their use as a means of exterminating millions of Jews occurred slowly and methodically, often with medical advice.  Heinrich Himmler saw them as a less traumatic way of ridding the world of Jews because his SS troops were disturbed by having to shoot over 1 million Jews in the open air as part of the Russian campaign.  Then followed the mass extermination of Jews using the Zyklon-fed gas chambers.  Nazi doctors helped selected the fittest subjects for labour rather than immediate death.

We have elaborate checks and balances to maintain the ethical standards for research in Australia.  Ethics committees are frequently pilloried because they impede (so it is said) the progress of science with their picky questions.  But we have no countervailing institution to keep medicine and public health practice on an even keel. 

The message of history suggests that we need to take this more seriously than we do.  It is not the bold leap into ethical error that we need to fear.  It is the slow shift, especially as the professions seek to curry favour with the power brokers in society – politicians, drug companies, the health bureaucracies to name three groups.  Grade report?  We could do a lot better – and should.  We must never forget.

*Printed in the Australian Doctor on 3 February 2012

WHO WILL PAY FOR PUBLIC HEALTH?

Public health, whatever else, concerns the health of the public.  It takes an interest in the well community whereas the health care system concentrates on general practice, emergency services, and hospital beds (and waiting lists for those beds) for people seeking to be as healthy as they can, but who are at present, sick. 

Public health supports clean and safe environments, immunisation, a secure and safe food supply, health education, healthy children, occupational health and safety, among others.  It takes a dim view of tobacco smoking, excessive eating and drinking, unsafe driving and conditions that send people crazy. Latterly, given the rise of obesity and diabetes, it has promoted changes in the community such as cycle-ways, green spaces, non-isolationist urban design and paths - all of which make it easier to exercise, easier to avoid cigarette smoke and easier to work out which foods to buy.  It has a broad reach and for something that consumes less than 2% of the health budget has done pretty damned well.

While several aspects of public health can be best developed locally, as the healthy cities movement of two decades ago showed, there is a big chunk of it that is state-wide.  It is unlikely that a mass media project conveys important messages only for a region of, say, NSW.  True, with Indigenous health, public health must take a local approach.  But even in that case, there are public health matters, such as housing policy, that require state-wide action. A moment’s reflection on flu epidemics supports the view that other public health problems require a national (if not international) public health response. 

For a secure public health future, we need policy and a strategy that links the federal to the local via the states and territories. That strategy could set goals.  The Preventative Health Taskforce, leading to the establishment of the Australian National Prevention Agency, provides an excellent national focus for public health.

With the decentralisation of the public hospital system as part of national health and hospital reform, great care is needed to ensure that we do not stuff up public health.  It is easy to neglect.  State-wide and national things can easily get run down.  I spoke with Tommy Thompson (the then Secretary of the US Department of Health and Human Services) in 2001 shortly after 9/11 and the anthrax scare was in full swing.  He was shocked to discover how run down the US public health services were, incapable of rising to the challenge.  Big investments in public health followed as part of the massive move to improve homeland security.
I am not suggesting we are facing an equivalent challenge to anthrax in the mail system, but we do face problems that cry out for public health energy, ranging from environmental concerns to Indigenous health, through childhood obesity, to the blindly ignored alcohol abuse problem in Australia.  Policy and strategy are needed. 

SHOULD WE REWARD ‘EFFICIENT ACTIVITY’ WHILE NOT MEASURING OUTCOMES AND CONSIDERING OTHER ASPECTS OF HEALTH CARE?

I have always been a case-mix sceptic, and while my views on it have, like my ageing brain, softened with time I remain worried about aspects of it.  Let me share my concerns with you.

First, though, I congratulate the recently-appointed Independent Hospital Pricing Authority (http://www.ihpa.gov.au/internet/ihpa/publishing.nsf/Content/draft-pricing-framework) on their pricing framework discussion paper entitled Activity based funding for Australian public hospitals: Towards a pricing framework. It is superbly written (I found only half a dozen typos and generally good grammar in the summary, both of which are exceptional in public health documents these days) and much more importantly it shows openness, seeking responses to clear and important consultative questions in the development of its argument.  Admittedly one might expect something pretty good from a group with such lavish resources: three consultant groups are identified on the cover and the budget from the Commonwealth is non-trivial. 

The problems that the national efficient price addresses are real and deserve attention. 

There is a complex background, both direct and indirect, to current deliberations.

Variations in medical and surgical service frequency from one place in Australia to another comparable locality, together with variations in procedure rates between private and public systems, have attracted criticism. This has stemmed especially, but not exclusively from outstanding health economists such as Geoff Richardson, for decades, but eliciting ineffectual ho-hum responses. 

Add to these variations in practice (400 hysterectomies per annum here versus 200 there for as many women of the same age and social class that make no epidemiological sense and reflect the preferences of providers of these services) to other fluctuations, say in regard to cardiac interventions between the public (low) and private (high) systems, and you have another cause for worry.  What on earth is going on?

These variations are the background to another, more formidable, problem namely the variations in cost that occur in the treatment of comparable conditions among hospitals.  These are also wild.

No one should be surprised therefore that the National Health and Hospital Reform Commission looked to activity-based funding (ABF) as an attempt to address this latter variability. 

ABF seeks to standardise payment for comparable services and only to pay as much as the service, efficiently rendered, costs.  In passing, it is hard to see how it could do much for the variations on procedure rate between public and private systems, or from one locality to another, but never mind.

The goal is to determine a set of efficient prices for providing health services that could be applied nation-wide.  Give or take, the Commonwealth would like to pay the same efficient price to hospitals in Melbourne, Adelaide, Perth, Brisbane and Sydney for hernias, deliveries, and by-pass procedures.   

Does that efficient price take account of what happens to the patient?  Not directly, but then we have been indifferent for ever to what comes out of the health system so you can hardly pick on ABF.  Archie Cochrane, the twinkle-eyed epidemiologist who promoted the randomised controlled trial and whose memory is perpetuated in the Cochrane Reviews of evidence-based medicine, spoke of an encounter with a man working at a crematorium.  Somewhat surprisingly the man expressed strong satisfaction with his job.  “So much goes in,” he said, and then with glee, “but so little comes out!”  Cochrane thought of suggesting he find employment in the British NHS.

We don’t, and have never had, generally measured health outcomes from mainstream clinical services.  Several specialties have done so, including orthopaedic surgery (they can tell you what happens to patients with different hip prostheses) and special medical services like renal dialysis and transplantation but system-wide we don’t know for sure.  ABF is a step - no more - in that direction.

But - not everything hospitals do can be reduced to activities that could be costed using the ABF model.  The document acknowledges that, but when fundamentalism gathers momentum find a bunker - and there are ABFundamentalists on the prowl. One recently proclaimed that teaching could be subject to ABF - an efficient price could be struck for teaching based on number of students and time spent with them.  Quality?  Outcome? Inspiration? Pass rate?  Passion?

Fortunately the Commonwealth recognises the distinctive need of rural hospitals that serve nursing home functions. Where services are different in style to those in larger centres they have spoken, but in hushed terms and with few specifics, about ‘block grants’ for these additional services.  The multimillion dollar investment of public health services in research and education may be supported through block grants as well, though Details-Lite is the name of the guessing game here, too.

Much more needs to be heard from the Commonwealth about these mystical cargo vessels called ‘block grants’.  Fundamentalists have a reputation for ignoring facts that do not fit with their ideology and it is conceivable that concerns about outcomes on the one hand, and R&D capability and workforce development on the other, could be brushed aside in a stampede of glazed-eye enthusiasm.  Where that leaves regional and rural hospitals, together with larger hospitals committed to research, innovation and workforce development is anyone’s guess.

My personal interest as an academic is selfishly invested in R&D. But I have a deeper concern and it is this: what is ABF going to do, if anything, to promote the humanity of what we are aiming to do for the Australian community through our provision of health services?  I believe that if we give over health care to systems of reimbursement that are determined on the basis of technical process - activity - we will damage not only health care but the values of our society. 


By all means let’s apply ABF where it fits, reserving a goodly portion of public financial support for rurality, regionality, R&D, and rewards for superior outcomes.

2012 SCIPPS CONFERENCE

Positioning Chronic Disease Care and Management in the Current Health Reform Context

Date: Wednesday 14 March 2012
Time: 9am – 4pm
Venue: University House, Corner Balmain and Liversidge Streets, The Australian National University, Acton, Canberra

This conference follows on from three roundtable discussions held in November 2011 which focused on the following significant Serious and Continuing Illness Policy and Practice Study (SCIPPS) findings:

·         the complexities of co-morbidity;

·         the economic impact of chronic disease on individuals and families; and

·         community support for effective health literacy and self-management.

For more details on SCIPPS click here.

For further information about the Conference contact: Mier Chan on mier.chan@anu.edu.au or 6125 6803.