Sunday, March 25, 2012

Unsolicited advice for the new Queensland Government

[Full post on other blog.]

Last night in Queensland, the Liberal National Party (it could only happen in QLD), won in a landslide, led by Campbell "Can Do" Newman, son of Federal Politicians and with 13 years distinguished service as an Engineer in the Army.

One of the candidates I graduated with from school, 40 years ago has a very successful legal practice, I'm an underemployed I.T. consultant.

I sent him this unsolicited advice [On ICT and Healthcare]
Not very original of me I know, but I hope it gives a useful insight to them.

Systemic Quality and "The Iron Triangle" of Quality, Cost and Schedule.

[Full post on other blog.]

The work on Safety and Quality systems by James T. Reason and Charles H. Perrow redefined the world of Quality, showing up in acceleration Safety in Aviation post-1970.

But what do you call this approach?

I'd like to suggest, "Systemic Quality".

Perrow called them "Normal Accidents" and Reason "Organisational Accidents". Both were talking about System created Accidents. Where multiple events, not individuals, are the cause of unintended poor outcomes. But neither coined a term for this approach to Safety and Quality.
My reasoning for the naming is:
Name the approach after the cause addressed, Systems create the problems, so it's Systemic Quality.
The text below is adapted from a piece on suggesting Medicine become a Modern Profession, like Aviation.

What Dr W. Edwards Deming understood so well is that Quality, Process Improvement and Performance Improvement are linked through the same fundamental:
Deliberate, focussed review of work outcomes with intentional Learning and Adaption are necessary for, and common to, all three.
This is enshrined in Deming's P-D-S-A (Plan-Do-Study-Act) cycle, which he called the Shewhart Cycle.

Systemic Quality through its design and nature improves Safety, Performance/Productivity and Economic Performance/Profitability.
Something that Apple Inc knows and Microsoft, the long-time market leader, does not.

EBM's and RCT: Doubt, Scientism and unquestioned Ideologies

update 8-Apr-2012: Quotes from "Evidence-Based Medicine: Neither Good Evidence nor Good Medicine" by Steve Hickey, PhD and Hilary Roberts, PhD.

  • The current approach to medicine is "evidence-based." This sounds obvious but, in practice, it means relying on a few large-scale studies and statistical techniques to choose the treatment for each patient. Practitioners of EBM incorrectly call this process using the "best evidence."
  • Significant Does Not Mean Important...
  • Large trials are powerful methods for detecting small differences.
    • Now, tiny differences - even if they are "very highly significant" - are nothing to boast about, so EBM researchers need to make their findings sound more impressive.
    • They do this by using relative rather than absolute values.
    • Suppose a drug halves your risk of developing cancer (a relative value). Although this sounds great, the reported 50% reduction may lessen your risk by just one in ten thousand: from two in ten thousand (2/10,000) to one in ten thousand (1/10,000) (absolute values). 
    • Such a small benefit is typically irrelevant, but when expressed as a relative value, it sounds important. (By analogy, buying two lottery tickets doubles your chance of winning compared to buying one; but either way, your chances are miniscule.)
  • There is a further problem with the dangerous assertion implicit in EBM that large-scale studies are the best evidence for decisions concerning individual patients.
    • This claim is an example of the ecological fallacy, which wrongly uses group statistics to make predictions about individuals.
    • There is no way round this; even in the ideal practice of medicine, EBM should not be applied to individual patients.
    • In other words, EBM is of little direct clinical use.
  • As we have mentioned, EBM restricts variety to what it considers the "best evidence."
    •  However, if doctors were to apply the same statistically-based treatment to all patients with a particular condition, they would break the laws of both cybernetics and statistics. 
    • Consequently, in many cases, the treatment would be expected to fail, as the doctors would not have enough information to make an accurate prediction.
    • Population statistics do not capture the information needed to provide a well-fitting pair of shoes, let alone to treat a complex and particular patient.
    • As the ancient philosopher Epicurus explained, you need to consider all the data.
  • A doctor who arrives at a correct diagnosis and treatment in an efficient manner is called, in cybernetic terms, a good regulator. 
    • According to Roger Conant and Ross Ashby, every good regulator of a system must be a model of that system. Good regulators achieve their goal in the simplest way possible.
    • In order to achieve this, the diagnostic processes must model the systems of the body, which is why doctors undergo years of training in all aspects of medical science.
    • In addition, each patient must be treated as an individual.
    • EBM's group statistics are irrelevant, since large-scale clinical trials do not model an individual patient and his or her condition, they model a population-albeit somewhat crudely.
    • They are thus not good regulators.
    • Once again, a rational patient would reject EBM as a poor method for finding an effective treatment for an illness.
  • Diagnosing medical conditions is challenging, because we are each biochemically individual.
    •  As explained by an originator of this concept, nutritional pioneer Dr. Roger Williams,
    • "Nutrition is for real people. Statistical humans are of little interest."
    • Doctors must encompass enough knowledge and therapeutic variety to match the biological diversity within their population of patients.
    • The process of classifying a particular person's symptoms requires a different kind of statistics (Bayesian), as well as pattern recognition.
    • These have the ability to deal with individual uniqueness.

The Friends of Doctors espouse an uncritical Ideological belief in a simplistic doctrine:
Evidence Based Medicine is the only source of Good Science and hence Good Medicine.
All else is, by definition, irrelevant, invalid and, at worst, quackery.
Which is a variation on Scientism, "the universal applicability of the scientific method and approach".

In 1898 you might've excused a Great Expert from declaring "We know everything and have invented everything" [paraphrased] - but in the 21st Century, for anyone to have the arrogance and hubris to make universal/absolute statements that are not dissimilar is unbelievable.
Doubly so, if like FoSiM, they hold themselves up as Great Experts (Professors with many awards and decades of experience).

I have a very specific objection to the FoSiM position, roughly, EBM/RCT's are OK as far as they go, but are far from being the only thing:
Evidence Based Medicine (EBM) and Randomised Double-blind, placebo Controlled Trials (RCT's) are NOT definitive in themselves, they are far from the only source of valid evidence to support clinical practices and treatment.
While the underlying Science is necessary, a lot more is needed to arrive at safe treatments consistently delivered in Practice.
RCT's are a necessary, but not sufficient, way to gather evidence, but can never provide proof. Popper's "falsification" notion says theories can never be proven, only disprove with 1 counter-example. The source of the economics/finance term "Black Swan" - something completely new and unexpected.
Why would a group of eminent persons go out of their way to make themselves look complete fools, espousing an entrenched and immovable position that is obviously flawed?

The only reasonable answer I can come up with is:
They are fighting a Turf War and using EBM/RCT's as an overwhelming strength with which to beat-up their opponents. But if the opponents start to provide RCT's, then they can either play "Change the Rules" or "Move the Goal Posts" to force the opponents to waste time and resources.
The unreasonable explanation is these folks are uncritically and intractably wedded to the Ideology, "EBM and RCT's are everything".

So, if RCT's are a good experimental methodology and EBM beats the pants off what Establishment Medicine was doing 50 years ago, why isn't that the end of it?

There are two headline problems and a lot of "fineprint" to uncover with RCT's.

The headline summary is: EBM based solely on RCT's are fatally flawed - they completely ignore real-world Service Delivery and Patient Safety issues.
  • Good Practice does not automatically flow from "Good Science".
    • Just delivering good enough service, treatment and medicine, economically to all people in a population is a major challenge to which the underlying "Science" is at best tangential, at worst, irrelevant.
    • Practitioners like "Dr Death" of Bundaberg amply demonstrate the "Knowing, Doing Gap", let alone the "Potential vs Actual" service delivery problem.
    • For the worst doctors, efficacy of treatments is completely irrelevant. Patient Safety is of prime importance and absent if Safety and Quality systems are inadequate or absent.
  • Treatments and Medicines need to be Safe and Effective. RCTs only seek evidence for one half of the equation - efficacy.
    • RCT's do not, nor seek to, establish the real-world safety of treatments/medicines. It takes years of treatment and many iatrogenic injuries and deaths to establish a good view of Patient Safety. Then a judgement needs to be made if Efficacy trumps Safety or not.
    • Drugs like Vioxx, "linked to thousands of deaths", are the predictable and inevitable outcome of unquestioning acceptance of the Ideology of "RCT's and EBM is the only One True Base for Medicine".
RCT's, or more properly, Randomised Double-blind, placebo Controlled Trials sound pretty impressive. What could possibly be wrong with them?
Let's go back to the full name and pick it apart.
  • "Randomised Double-blind". Why? Because people can bias experimental results without knowing.
    • This sort of experiment is very sensitive to bias, accidental or systemic, throwing doubt onto the results of every Controlled Trial.
    • Psychological effects on experimenters and subjects is exceedingly subtle and complex, to say "there can be no bias because we know everything about doing this" is supreme arrogance. That there have been many significant effects uncovered in the last 50 years suggests that many more will be uncovered in the next 50 years.
      • The simplest of biases comes from the difference between the target population and the testing population.
      • The most subtle is the genetic differences in populations between countries. What works in Africa, may not in Asia or European countries, and vice versa.
    • The Elephant in the Room for RCT's is One Team, One Environment, One Test.
      • There is an iron-clad law of Quality: You cannot test your own work.
      • With experiments, this translates to, you cannot validate or check your own experimental data.
      • As a minimum, RCT's need to be Triplicated in diverse contexts with diverse populations to address even this simple type of bias.
  • "Placebo Controlled Trials". Why? Because "mere suggestion" has very powerful healing effects.
    • The baseline controlled against is never "no treatment" but a "sham treatment".
    • The reason "Controlled" trials are needed is because if people think they are getting treatment, their bodies start to heal themselves. It's a powerful enough effect that it cannot be ignored - it's enough to overwhelm normal statistical analyses.
    • Here's the nasty secret RCT-base EBM doesn't discuss: Nobody knows the mechanism of the Placebo Effect. Because its named, people think its explained.
    • So what if we don't know the exact mechanism, we've developed effective treatments for a century or more without knowing exact mechanisms?
      • But that's the whole point of RCT-backed EBM, to be very exact about what works, and how it works. Who's to say the efficacy of a large fraction of treatments/medicines who's can't be doubled or tripled by "tweaking" the placebo effect.
      • The secret is nastier: whatever the Placebo Effect mechanism is, it cuts both ways. It can promote or retard healing. Without knowing the mechanism(s), RCT results have all the validity of home-made magic potions. Is there something that normal research teams do that modifies the action of treatments but isn't replicated in normal Practice? Nobody knows - everyone pretends, without any certainty, the effect has been compensated for, which is wishful thinking, not Good Science.
      • This is a central contradiction of RCT's used for EBM: it gives the appearance of Science because there are number with a lot of decimals and many fine, complex statistical analyses, but its all smoke and mirrors to disguise the truth, "We really don't know what's going on, but are pretending its All Good."
  • In a Controlled Trial, drugs are tested alone. This is necessary to get "clean data" and verifiable, trustable results. It also isn't how drugs are used. Drugs are used in combination with many things, which are specifically untested in RCT's.
    • Drug interactions, especially increased side-effects, are a major problem with new drugs.
    • With the increasing numbers of drugs, treatments, supplements, exotic foods and traditional medicines in use, it isn't possible to test new drugs against all expected use-cases, let alone against all possible combinations.
    • EBM quietly overlooks that Controlled Trails, while presenting valid single-drug data, provide no evidence about real-world usage. Each patient is a new experiment.
  • What does a failed treatment experiment look like? When RCT's don't cut it?
    • Iatrogenic Injuries and deaths...
    • Proponents of EBM don't go near this, it just wouldn't look good in Journal. Of course, the papers are already published and the Trials shutdown, there is no way to go back in time and add those problems to the RCT when published. Each patient is a new experiment.
  • The reasons our species thrives and survives are many, but part of it is the constant genetic mixing from parents. We each have very individual physiologies - making us tolerant and sensitive to 'chemicals' in very individual ways. 
    • Controlled Trails make two exceeding dangerous and simplistic assumptions:
      • The trial and target populations correspond well enough. Until the trial is validated in practice, how can this assumption be validated? Each patient is a new experiment.
      • Individuals won't react outside the bounds seen in the trial. All the trial data needs to be reduced into simple dosage instructions "xx mg/kg body weight". How does your  treating Physician discover you are either exceptionally tolerant or sensitive to this new challenge to your system? Each patient is a new experiment.
      • Of course, we just don't mention abreactions, anaphylaxis and allergic reactions in Trials, or devise methods to avoid foreseeable problems. Each patient is a new experiment.
    • Individual sensitivity to drugs is not constant over time. For example, dosage of opiates needs to be reduced over time as liver function reduces with days spent in bed. Each patient is a new experiment.
But wait, there's more...
  • The bane of all experiments are Errors, Mistakes (in Design and Execution) and incorrect/incomplete models leading resulting in "knowledge gaps" - things that should be done, that aren't.
    • Systemic and systematic errors in methods, skills, execution can't be detected within the originating team. Like every individual, we cannot see ourselves from the outside. We need others to check our work, we are perceptually blind to our mistakes and problems/faults.
    • Normal RCT experiments fail basic Quality Systems design:
      • there have to be checks built into the process to validate "production".
      • This normally requires a separation of Design, Execution and Data Analysis.
    • Again, I think Triplicated Controlled Trials are the minimum requirement for this methodology. It is trying for Perfection when Service Delivery is so severely flawed and defective that it makes new Trials mostly irrelevant. For the next ten years, if we just did what is known to work, everywhere and all the time, that would provide orders of magnitude improvement in Patient outcomes.
  • Human Nature drives fraud, intellectual and commercial, it can never be eliminated from Science. medical or not, it can only detected and controlled. When the commercial rewards are high, the drive is much stronger and methods employed more subtle and devious. It becomes intentional, organised activity, not "rogue individuals" and "opportunistic amateurs".
    • Because there is so much at stake, both in human lives, pain and suffering and money, you'd think that extraordinary efforts would be made to prevent and detect all types of fraud and rigged results.
    • But you' be wrong. Major drug RCT's aren't subject to strict independent fraud checking. Just the usual and quaint "peer-reviewed academic journals".
    • What this says about the gullibility and naivety of Medical Science is debatable, but they are sorely lacking in insight and a sense of public duty.
In summary:
Medical Science uses RCT's because it's the best thing they've got, but belief in them "should be held lightly", they are not infallible nor free of serious deficiencies.

Evidence Based Medicine is a good servant and a poor Master. The emphasis must be on Medicine, not 'Evidence', on providing good patient care and outcomes. Chief of which is focussing on Patient Safety, not the glittering bauble of "efficacy". "First, do NO harm"...

Saturday, March 24, 2012

Friends of Doctors: What the figures say...

An analysis of the 11-March-2012 members list of "Friends of Science in Medicine":

  • They can claim 28 'Friends' outside the field or their parent body and who still work.
Calling the group "Friends of Doctors" is far more accurate.

Note: A full count of members of the parent Organisation, "Australian Skeptics" is not possible without a public membership list (4,000 subscribers are claimed to "The Sketpic").

The organisation's own analysis, (494 members, 25-Feb-2012) is:
Of the 494 individuals were a total of 226 (45%) medical doctors (212 Australian, 14 Overseas) and other disciplines (243 Australian, 25 Overseas).
My analysis:
  • 502 unique names,
  • 1 duplicate record, "Prof Jon Emery"
  • 123 with title "Dr"
    • 2  declare or publicly state membership of the parent Organisation, "Australian Skeptics"
    • 92 MD, MBBS, MBBCh, Physician, Psychiatrist, RN, Dentist
    • 4 retired
    • 6 "medical" research in entry
    • 14 other Health related
      •    1 Anatomy
      •    1 Biochemistry
      •    1 Gender, Health and Ageing
      •    2 Genetics
      •    2 Neuroscience
      •    1 Nutrition and Dietetics
      •    1 Optometrist
      •    2 Pharmacist
      •    1 Prosthetics & Orthotics
      •    2 Veterinary Surgeon
    • 5 non-health related
      •    1 Chemistry
      •    1 Computational Physicist
      •    1 Economics
      •    2 Science writer
  • 334 with title "Prof" (including A/Prof)
    • 4 FoSiM Executive members
    • 34 Emeritus or retired
    • 165 MBBS, MD, BMedSci, FRACP, FRCP, FANZCA, FRACGP, Obstetrics & Gynaecology, Medical Oncology, Psychiatry, Pharmacy/Pharmacology, RN
    • 131 remaining:
      • 26 work in a "Dept/College/School/Faculty of Medicine"
      • 16 Psychology
      • 9 Biological Sciences, Biology
      • 8 at  Meical Research Institutes, "Walter and Eliza Hall Institute of Medical Research", "Baker IDI Heart & Diabetes Institute", "QLD Brain Institute", "Women's and Children's Health Research Institute"
      • 6 Microbiology
      • 6 in a NHMRC unit
      • 6 Physiology
      • 5 work in a "Faculty/School of of Health Sciences"
      • 5 Biochemistry or Biomolecular, Molecular Science
      • 4 Immunology
      • 4 Cancer research
      • 3 Exercise and Nutrition Sciences, Nutrition and Dietetics
      • 2 Veterinary Science
      • 2 Genetics
      • 14 other Health related areas
        • Clinical Epidemiology and Biostatistics
        • Cognitive Science, Cognition and its Disorders
        • Experimental Ophthalmology
        • Health Economics
        • Human Movement Studies
        • Human Variome Project
        • Medical Technology and Physics
        • Mental Health
        • Mother and Child Health Research
        • Deaf Studies and Sign Language
        • Optometry and Vision Sciences
        • Paediatrics
        • Public Health, Biostatistics
        • Reproductive Biotechnology 
        • Sex, Health and Society
    • 15 in non-health areas
      • Anatomy and Histology
      • Applied Ecology
      • Australian Museum
      • Australian Studies
      • Climate Science
      • Computer Assisted Research Mathematics and Applications
      • Earth Sciences
      • Environmental Management and Ecology
      • Law (2)
      • Pianist/composer
      • Social and Economic Modelling
      • Special Education Centre
      • Statistics
      • Tropical Crops and Biocommodities
  • 41 not "Dr", "Prof" or on the Executive.
    • 7 declare or publicly state membership of the parent Organisation, "Australian Skeptics"
    • 17 are in Medicine/Medical Science or allied disciplines (Pharmacy, Nursing, paramedic)
    • 18 "non medical" vocations [counts not given].
      • health/biology related
        • Critical Care Dietitian
        • Musculoskeletal Physiotherapist
        • PhD Candidate, Environmental Futures
        • PhD candidate, Psychophysiology
        • Physiotherapist, Private Practice
        • Registered Psychologist
        • Senior Health Content Producer, Choice
        • Veterinary Services
      • 8 non-health related
        • Information Technology 
        • MSc(Astronomy) BSc(Finance & Economics) 
        • Science, eLearning Officer
        • legal researcher, solicitor
        • science writer/editor/creative director

Tuesday, March 20, 2012

Censorship in 300 words or less. What's up at Fairfax?

An article in the Fairfax media entitled "Homeopathy | Alternative Medicine | Ian Gawler" drew my attention. I went to the effort of registering and making a comment. It didn't appear, having been "moderated", presumably breaking the Fairfax Rules for Commenting on articles and blogs :-
... any comments that can be reasonably considered offensive, threatening or obscene will not be allowed.
  • Do not post material that may incite violence or hatred.
  • Gratuitous abuse - be it of the author, subjects of the story or other commentators - will not be accepted.
  • Please keep your comments relevant to the discussion at hand.
  • Do not use the comments section for commercial purposes or spam.
Herewith my comment and the original article...


First, this is an ideological debate. Nobody is going to be convinced by anything written here, but I'll make an effort.

You are conflating and confusing Science and Medicine. One is about Theory and Knowledge, the other is a an Applied Performance Discipline.

"it is strange that Western medicine is so on the nose with so many people."
No, the Science may be good, but the Practice and Delivery are often appalling, if not deadly. Check the Medical Error Action Group site. If Aviation were run like Medicine, we'd have 20+ 747's crashing every year in Australia.

"Why do people believe in ..."
Because they get compassion, care and concern from the practitioners. Ever waited 12 hours in an ER? It's not about the patient or good care.

"So how do we strive for truth?"
A Question based on a false assumption: people are looking for care, not data.

"How can the state deal with such popular therapies when there are
questions over efficacy?"
Because it's not about the Absolute Theoretical Potential of treatment, but the reality of Delivered Service, like "Dr Death" and others named by the QLD Commission of Inquiry, there is often a huge gulf.

"What is the role of freedom and hope in this equation?"
People already vote with their feet and wallets, use these market forces. Establishment Medicine is hugely subsidised ($50+B/yr), yet a large fraction of people choose to pay more and go elsewhere.

That would seem to be a comprehensive market failure of a whole Industry/Profession.

As taxpayers and voters, why do we accept this woeful state of affairs?

Potions, pills and promises
March 19, 2012
OPINION: Dick Gross

Beliefs in the promises of untested cures are as resilient as any faith.  Trust in "alternative medicines" is sufficiently widespread that it is now a significant industry.

At the same time, a group of eminent scientists "Friends of Science in Medicine" have received worldwide attention for their attempt to remove alternative medicine from university courses.

This debate touches upon the nature of belief.  I am not a medical practitioner but merely an observer of faith.  Epistemology or the study of knowledge looks at the role of faith when we can't be sure of things.  Because we cannot know about creation or death we inevitably turn to faith.  As members of the laity, most people cannot know about the cause or cures of our woes.  We take cures, orthodox or alternative, believing as we must, in the advice of our practitioners.

Advertisement: Story continues below
Where science is silent on an alternative medical practice, practitioner and patient alike must embark on a journey of faith.  Some practices such as Vitamin D pills are put under scientific scrutiny and survive.  Vitamin D, therefore, is no longer an alternative treatment for it has been given the green light by medical science.  Other treatments are either untested or fail scientific scrutiny and yet are resiliently popular.  Newspaper front pages were full last week with an attack on the efficacy and indeed the legitimacy of homeopathy. I have never been persuaded by homeopathy, the use of highly diluted medications, and it was no surprise to me it was being attacked as nothing but a placebo.

Even the great Steve Jobs was initially a believer in the untested.  There is evidence that his life could have been extended if he did not waste months trying unproven cures when his cancer was first spotted.  Valuable months were eaten up while he played around with severe diets and non-mainstream treatments.  This is the ultimate paradox – one of science's greatest promoters may have died prematurely because he turned his back on science.

How is it that a rational scientist can harbour in the same mind the two conflicting schools of science and alternative non science?  It happened with Isaac Newton (who dropped his maths, moved from Cambridge and repaired to London to pursue all sorts of weird beliefs) and it may have brought down Steve Jobs.

So how can we of the less lofty minds hope to resist the blandishments of untested cures especially when not only do alternative medicines hold out vaulting hope but don't give us the unvarnished truth?  The Therapeutic Goods Administration in December 2010 found that 90 per cent of alternative medicines breached advertising rules.

It must be conceded that science has its problems.  Over selling by Big Pharma, unexpected side effects, burst breast augmentations, medical negligence and over servicing are real issues.  Yet it is strange that Western medicine is so on the nose with so many people.  Why is it that we are still so prone to belief in therapies that have not been subject to the implacable scrutiny of science?
Science struggles to win hearts and minds.  It has struggled in the carbon debate and still struggles to win the creation debate in many parts of the world.  For me, a fan of science and a devotee, this is a mystery.

Epistemologists would argue that the adherence to untested therapies is not just faith but is augmented by the human weakness for hope.  Hope is a bedrock human quality.  The phrase "faith, hope and charity" exemplifies the importance of hope in the traditional perception of human emotions and demonstrates why faith, built on hope, will be a human weakness until the end of time.

The sceptic within me rails against, not just faith, but false hope.  I despair when those with hearing impairment worship and offer plastic ears at the Portuguese shrine of Santo Ovido (the patron saint of hearing problems) when cochlear implants exist.  I boil with anger when parents refuse to have their kids inoculated on the basis of unscientific claims.  They are undermining public health.  I despair to see the billion-dollar alternative pill and potion industry flower in the absence of scientific testing.

In a great article, psychiatrist Tanveer Ahmed on the National Times site argued that alternative medicine is the superstition of this age.  His argument is that in a society where religions and their pastoral care are in decline, alternative therapies seem to hit the mark.

As an articled clerk in 1980, my firm acted for a group of alternative therapists dealing with some negligence cases.  We also helped negotiate with the government on the registration system for the practitioners.  Clearly the state grappled with the issue of efficacy at the time and came up with the idea of vocational licensing.  It looked, however, to me more like an anti-competitive device rather than a genuine consumer protection measure.

As last year was ending, a story broke about one of Australia's most eminent alternative therapists.  Ian Gawler contracted cancer at the age of 24.  After the amputation of his leg he seemingly contracted a secondary cancer, which it was claimed was cured by a "self help program with key principles: good food, positive attitudes, meditation and loving support".

From that moment a virtual industry has grown around Ian Gawler including four bestselling books among them You Can Conquer Cancer using techniques such as meditation.  Relaxation is great but whether we can relax our way to a cancer cure is another thing.

Two oncologists, Professors Lowenthal and Haines have written a scathing attack on the Gawler claims. In it they allege that the secondary cancer that was supposedly cured by the Gawler method was in fact tuberculosis or some other lung infection.  No biopsy was taken (as was the practice in those far off days) so no one can know for sure.  These are credible men who confront the science of life and death daily and have seen cancer victims financially exploited by hope merchants and their orthodox treatment delayed.  Their attack has come and gone and been the subject of insufficient discussion and debate.

So how do we strive for truth?

What do we invest our medical faith in?

How can the state deal with such popular therapies when there are questions over efficacy?

What is the role of freedom and hope in this equation?

Over to you . . .

Friday, March 16, 2012

The Accountability Paradox: Personal Consequences and Blame

[Full post on other blog.]

A recent piece in The Journal of Patient Safety, "An NTSB for Healthcare, Learning from Innovation: Debate and Innovate or Capitulate" by experienced, highly-competent Aviators and Medicos prompted me to ask a question about on the subject of Dr Brent James, Chief Quality Officer of Intermountain Healthcare:
The NTSB only recommends, the FAA makes sure those things (and more) are done.
As a regulatory and compliance organisation, the FAA is able to hand out "direct, personal consequences" - and make them stick. [Natural Justice suggests proportionality as well].

Any Aviation Professional who repeats, or allows, a Known Error, Fault or Failure will be discovered and will suffer the consequences. [Hence would a medical version need two bodies?]
Dr James kindly responded to me and I was gently reminded of James Reason's "Blame Cycle" [below] and Dr James own comments on the 2001 ABC's Health Report, "Minimising Harm to Patients in Hospital":
Norman Swan: So remove the culture of blame, sort out the legal liability problems, without ignoring the fact that there will be the odd rogue doctor or rogue nurse who needs to be sorted out. What we should be seeing here, we haven't really emphasised it up till now, is that most of the problems that occur when injuries occur, are system problems, the hospital, the management, the organisation of the hospital, rather than an individual going wrong?

Brent James: Exactly. We know that the individuals will have problems. How do we create an environment in which it's easier to do it right, and hard to fail? That's the real issue. It's an institutional responsibility not an individual responsibility. The next thing that we need is an organisational structure. In the United States we're calling them Patient Safety Officers, and in the Institute of Medicine Report we asked that all care delivery groups appoint Patient Safety Officer, usually from existing personnel, usually a good clinician.
My central concern with the NTSB-for-Medicine proposal is the necessity for the organisation to not be a "toothless tiger", to have the power to cause change, but simultaneously engender a "Safety Culture" where Openness and Transparency are the norm and individuals do not feel threatened by the system.
Audit reports and Commissions of Inquiry into major failures (QLD) say what's wrong, but have no powers to cause change. They are equivalent to the NTSB, but lack the ability of the FAA to implement, to cause or require necessary change and to check that it is done.

Reason's "Blame Cycle", and my own more extreme "Blame Spiral", require Dr Demings' exhortation to "Drive out Fear" be scrupulously and systemically be applied.

How can these two conflicting objectives be achieved? I've no experience in this.
This is The Accountability Paradox:
For real change in the system, any person who repeats, or allows, a Known Error, Fault or Failure, must be held personally liable (including criminally if they caused death or severe injury/disability),
BUT if that is perceived as the Primary Role of the compliance and governance organisation, then it will be ineffective, instead it will engender the "Blame Cycle" as a minimum.

Some references to Prof. Reasons' "Blame Cycle":
"Diagnosing “vulnerable system syndrome”: an essential prerequisite to efffective risk management" (2001, Qual Health Care 2001;10:ii21-ii25 doi:10.1136/qhc.0100021) and
"Managing the Risks of Organizational Accidents" [1997].

The "Blame Spiral": How a blame culture destroys Projects and what to do about them.

[Full post on other blog.]

James T. Reason has a very well developed model of the "Blame Cycle", e.g. "Diagnosing “vulnerable system syndrome”: an essential prerequisite to eVective risk management" (2001, Qual Health Care 2001;10:ii21-ii25 doi:10.1136/qhc.0100021) and "Managing the Risks of Organizational Accidents" [1997].

It is based on:
  • The Fundamental Attribution Error: misidentifying the root cause of an event (a person who chose to do it, rather than a multi-factorial Organisational Error).
  • A "Person Model" not "Organisation Model" of errors, and
  • if informed, people will just stop making mistakes.
  • [and there is much more to it than this]
The remedy to the "Blame Cycle" is creating a "Safety Culture" which is where, in Deming's words, "Drive out Fear", is conscientiously and consistently practised.

All of which is correct, but doesn't explain three things:
  • Why after around 25 years of writing, research and implementations by Reason and Perrow and around 75 years since H.W. Henrich's "Industrial Accident Prevention, A Scientific Approach" (1931) are Blame Cultures still the norm, rather than the exception, even in High Safety environments like Healthcare. Aviation and space flight (e.g. NASA) seem to be leaders in the implementation and practice of the "Safety Culture" approach.
  • After more than a century of definitive, proven Management Science theories, why does the Default Management Style, of which the "Blame Culture" is one aspect, still prevail? It isn't just that better techniques/systems aren't known or aren't practiced, but that organisations revert from their good practices. World leaders, like Kodak and General Motors, stop their successful practices and go back to known worst practices and suffer terminal decline. How can this be so in a rational, well-informed world?
  • Individuals in teams and projects start out with good intentions and high hopes, only to end up mired in the tarpits of Blame. How can this happen over and over again? What is the common, systematic element, or where are the payoffs?

James Reasons' "Blame Cycle" is detailed, correct and useful, but misses two important points clearly seen in I.T. Projects:
  • The interaction of Blame with the non-rational, uninformed "Default Management Style", and 
  • the psychological dimension: the predictable reaction of individuals, groups and organisations to Blaming in circumstances that can spiral out of control.
Simplistic Safety and Quality systems, based on formulaic, inflexible action/response "protocols" not only cannot cope with the complex, variable everyday challenges of systems with intangible, undefined Outcomes, but push the organisation down the "Blame Spiral" into Toxic collapse and overwhelm.

Demings' exhortation of "Drive out Fear" is the solution, but must be imposed from the top down. This requires determination and consistency of purpose all through the management chain. Along with the identification and elimination of perverse incentives and outcomes.

Monday, March 12, 2012

Friends of Science in Medicine: What's the Agenda?

The more research I do, the more amazed I am at the Agenda of "Friends of Doctors and Maintaining the Status Quo".
  • "Inconvenient Truths" are simply ignored or edited out by FoSiM. Would you expect less of these folk with their doctrinal attitude and blinkered views?
    • In "Doctors, Nurses Often Use Holistic Medicine for Themselves", it is reported that in the USA around 25% more Healthcare Professionals than the general population (76% vs 63%). Should as the FoSiM stance implies, they all be drummed out of the Profession? Or do they know what they doing and actually look after themselves in the best possible ways?
  • All the medicos on the FoSiM executive are well respected and highly accomplished doctors, researchers or science communicators, in their own fields. But none is expert in, nor has published in a respected 'high-quality' Journal on the validity of, EBM or RCT [not that I've found]. They are at best, "well meaning amateurs", not expert in a highly technical, very contentious and contested area of Statistics and Theory and Philosophy of Science. That they haven't provided reasoned, comprehensive rebuttals of Drs. Penston and Millers' work is proof of this. That they don't even cite this debate, stretching back at least a decade suggests to me either a lack of intellectual rigour or research, wilful ignorance or a disregard of more "inconvenient truths". None of these options "covers them in glory" or supports their arguments.
  • Fundamentals are ignored by FoSiM:
    • "Show us the Data!" FoSiM are violently and implacably opposed to "CAM" (presumably Complementary and Alternative Medicines), roundly criticise and vilify therapies they do not approve of and loudly call for all Alternative Medicine/Therapies to be justify themselves with EBM and RCT, so beloved by FoSiM. Only no data are provided to suggest this is warranted, only opinion and non-peer reviewed articles. Compared to Establishment Medical and Hospital practice and outcomes, are alternative methods etc unsafe enough to be called into question? No data, no case...
    • This is an argument first and foremost about Patient Safety, then Quality of Care and lastly about Effacy of treatment, therapies, medicines. But there is no definitive data for the outcomes of Establishment Medicine, despite them consuming consuming 10-15% of National GDP in mature, western economies to use as a baseline in discussing Effacy:
      • The only estimates of Medical and Hospital avoidable fatalities and Adverse Events (serious Injury), are horrifyingly high (4500 deaths/yr in Australia). The real problem is the non-collection of hard-data but that there is no outcry within the Profession to correct this. If FoSiM were interested in better Healthcare and better Patient Outcomes, this would be on top of their list.
      • Despite the 550+ page report of the 2005 Queensland Public Hospital Commission of Inquiry, where's the evidence of change in Queensland Health? Or any real transparency or hard-data recording and reporting?
      • Could "Dr Death" of Bundaberg be repeating, right now? Absolutely, and without being reported, actioned or with any personal consequences to those involved.
      • The Medical Error Action Group keeps collecting and reporting new deaths from the same causes. In Engineering or Aviation, this systemic failure of the Profession and its Professionals would not only not be tolerated, but those repeating, or allowing, Known Errors, Faults and Failures would be ejected from the profession and would face criminal charges. The folks who designed the World Trade Centre were not charged because they took into account all known failure modes in the early 1960's. Any Engineer who, since 2001, designs a tall building that is not survivable from large jet aircraft impact, would be criminally liable.
    • Science is not Practice. Substantially more than a few studies is needed to convert some Theory or data into reliable, repeatable Real World Practice. We know this, because it is being done intentionally and deliberately by at least one significant Healthcare System in the world, Intermountain Healthcare, Utah. Dr Brent James has spoken and written extensively about their work and results. As well, he and his team have published many papers on their results (using Real World hard-data) in peer-reviewed Journals. This is not idle speculation, assertion nor dogmatic belief. In Australia, we've know publicly about this since the ABC's Health Report interviewed Dr James in 2001: "Minimising Harm to Patients in Hospital".  A 2009 New York Times Story, "Making Health Care Better", about Dr James and Intermountain highlights their systemic and systematic approach, and that it needs constant attention and work. A letter to an under-performing Obstetrician by Dr Ware Branch, head of the Quality Committee, is quoted.
      • “You are perfectly right to question the data,” Branch wrote. “We have been found incorrect in numerous cases.” But for all its politeness, Branch’s letter was also pointed. With it, he attached a list of every elective induction the obstetrician had done recently and invited him to identify any that had been incorrectly classified. Branch also enclosed statistical profiles of other, similarly busy obstetricians. They performed fewer C-sections and had shorter delivery times. The letter’s final section included the following:
        “Lastly, quality improvement is a process, not an event. In part it works by finding variation and drawing attention to it, as has happened with you and others in this effort. And well-done quality improvement is not punitive; it’s educational. It is also worth noting that those docs determined not to learn, never do.” [my italics]

      I can't imagine any hospital I know in Australia either writing to that Obstetrician in the first place, nor responding to them in this way. Shouldn't this be what the FoSiM should be advocating for? Real, Enduring Change?
  • There is a well-known, perfect model for how to create an Industry-wide Quality and Safety Culture, in one of the most cut-throat profit-driven businesses ever: Aviation.
    A recent piece in The Journal of Patient Safety, "An NTSB for Healthcare, Learning from Innovation: Debate and Innovate or Capitulate"  by both experienced, highly-competent Aviators and Medicos makes a very strong case for in both describing the systemic problems (the figures on waste, fraud and over-servicing are horrifying) and for outlining a solution:
    • Adopt what is known to work in Aviation, and
      has been proven to be Cheaper, Safer and Better on every metric for coming up to 2 decades by Intermountain Healthcare with their "Do it Right, First Time" Quality approach.
    • Isn't it odd that the self-appointed, self-proclaimed "experts in all things Medical", the FoSiM, haven't suggested this approach nor flagged that our Hospitals and Medical system are far from World's Best Practice.
    • Instead of seeking to improve their own failed Profession, they are seeking to attack and discredit "The Competition", or at least those that they can identify and target.

Friday, March 9, 2012

First, Do no harm: Patient Safety and the central fallacy of the "Friends of Science in Medicine" position.

"First, Do no harm"... Or so the Hippocratic Oath is presumed to begin.

The Dwyer/Marron "Friends of Science in Medicine" campaign against the teaching, insurance/reimbursement-for and ultimately practice of Alternative Therapies and Medicines of which they, and they alone, do not approve, is based on a central fallacy:
People are much safer being treated by the Medical Establishment not using Alternative Therapies and Medicines, but exactly the reverse is true. 
The number of Patient Injuries and Fatalities from 'standard' Medical and Hospital care and treatment is more than 1,000-fold greater than Alternative Therapies and Treatments, even on the flimsy data we do have on Establishment Healthcare. Why isn't there good data on our $50B/year spend of Public Money? That's another story.
This debate is "all about Evidence", as in hard-data, but Patient Safety and Quality of Care must be examined first before any debate on Effectiveness can even be started.
The flip-side is the erroneous logic that "Good Science" is somehow causally linked to "Good Patient Care", but FoSiM ignore the Golden Rule of Execution: 
Science and Knowledge don't deliver outcomes, Practice does.
Before the Dwyer/Marron group can argue against any Therapy, Treatment or Medicine, by its own strict rules ("there must always be very strong Evidence"), it must:
Show us the Data! As complainants, the onus is on the Dwyer/Marron group to prove their case, not for everyone else to justify their existence to their satisfaction (which, being undefined, will never be forthcoming.)

Where is their Evidence, the "Good Science" they want from everyone else, to demand any changes? If the modalities they are so implacably and virulently opposed to are harmful, then there must be plenty of irrefutable Evidence, not mere anecdote or self-selected collections/surveys, to support their case. If there isn't already enough, the group should go and create some definitive studies, given their self-confidence it should be extremely easy to do so.  It should take them no time at all to collect and publish some statistically robust studies in a well recognised, peer-reviewed Journal.
The worst logical trick and intellectual swindle played by the Dwyer/Marron group is their conflation and confusion of terms:
  • A slew of unrelated practices are strung together in one long line of gibberish, with no distinction between recognised, well-controlled modalities and others, with all presumed to be 'equivalent'.
    If the Dwyer/Marron group cannot, or will not, distinguish between a piece of crud and a gem, what relevance or vracity do their arguments have? None whatsoever, they fail their own test of "Good Science", which requires correct, unassailable logic, not sensationalist tabloid anti-logic, innuendo and guilt-by-association.
  • In Australia, there is a trivial and essential differentiator between all Medical Therapies, Practices and Medicines:
    • Is there a AHPRA Registration Board? and hence
    • Do Practitioners have a Medicare Provider Number?

    The failure of the Dwyer/Marron group to make this simple and essential distinction invalidates all their arguments, because:
    • just who are they vociferously and ferociously objecting to?
    • The properly certified, regulated and trained Practitioners, approved and controlled by expert Government bodies, or
    • the unregulated, unregistered minority?
  • For the Dwyer/Marron group to disagree with Government Policy and Processes is their Democratic right.
    For them to not understand the way these decisions and processes are changed is via Lobbying and the Political process is both ludicrous and naive.
    The best outcome they can have by attacking Alternate Therapy and Medicine Practitioners is to create a media spectacle and feel righteous and self-satisfied with themselves.
    Without ever once having the possibility of effecting change, because they are lobbying the regulated, not the regulators - the only people in the system with the power to implement their desired changes are being ignored by the Dwyer/Marron group.
Whilst the Dwyer/Marron group and their FoSiM purport a wish "to foster Good Science in Medicine", their actions and statements belie a rabid bigotry, bias and prejudice.

Even in their Constitutions' statement of Object, they don't define or elaborate on their terms:
  • "Good Science" is a vague, ill-defind term. To quote Shakespeare's Macbeth:
    "it is a tale told by an idiot, full of sound and fury, signifying nothing".
  • There are "scientific methodologies" (hypotheses, test, result) and "(apparently) good or valid studies/experiments" with "strong evidence", but "Good Science" is at best a lay-person's term, not something any Professional in the field would use.
  • Likewise, "Medicine" is a broad church...
    There is no definition ever offered for FoSiM's frequently used acronym, "CAM", presumably "Complementary and Alternative Medicine". This has some mysterious meaning only known to the Inner Sanctum of the Dwyer/Marron group. I expect it falls in the category of "I know it when I see it", a throughly undisciplined, non-rigourous and unscientific methodology - because it is inexact, ill-defined and non-repeatable.
I like the Richard Dawkins definition: "There is no alternative medicine. There is only medicine that works and medicine that doesn't work."

Where does that leave the Dwyer/Marron definition of "CAM"?
Invalid and irrelevant, like the rest of their bluster, assertion, dogma and prejudice parading as "the opinion of experts", because they can provide no test or Evidence to show, as Dawkins says, "what works and what doesn't".

The very real risk they face with their simplistic and naive thinking is that if they ever construct testable definitions, then a good deal of their own Establishment Medicine would be found wanting. Not an outcome most Medical Practitioners would embrace.

It comes down to this:
The Dwyer/Marron group have no documented process or methodology to define the Alternative Therapies and Medicines of which they, and they alone, do not approve. They have a loose, informal, self-referential definition: "Good Science, it's what we say it is".
They are self-appointed experts and judges, without credentials, special expertise or relevant experience, who are presuming to force their opinions, biases and prejudices upon the rest of us.
Whenever they cry "Show us The Evidence" or "That's not Good Science", all they are displaying is their own ignorance, ineptitude and biases.

Thursday, March 8, 2012

Australian Medicine as a Failed Profession. #1

Australian Doctors practice medicine as if it was a cottage-industry craft supported by a 'Guild', not as a modern, accountable Profession practised for the Public Good.

Guilds limit new entrants, protect and control 'the secret craft knowledge' and vigorously defend their turf. A monopoly on the practice designed for restraint-of-trade, not the benefit of clients nor the community.


  • We are entering the second decade of the doctor and specialist shortage here. Australia has more than enough resources to be producing a surplus and exporting to the world the best doctors around, like the Scottish once did for 'Engineers'.
    • How can there be a shortage? It's not because its not needed nor not possible here.
    • Why aren't doctors picketing every Parliament in the land on behalf of their patients and the wider community? Letting known dangerous conditions for patients and doctors continue is neither Ethical nor Professional behaviour.
  • It's now more than a decade since "Minimising Harm to Patients" was broadcast here and the US Institute of Medicine released "To Err is Human: Building a Safer Health System" yet the critical first steps, gathering hard data, are not being practiced in Australia. Real Change can only be based on hard data, not abstract or distant  'scientific evidence'.
    • Dr Brent James showed with hard data, not statistical inference or speculation, that Patient Injuries (unintended results of "system errors") were 80 times (eighty!) more prevalent than Adverse Events (due to human error or omission). Sentinel Events are a subset of Adverse Events that are undeniable and result in catastrophic outcomes for the patient.
    • Where's the hard-data from Hospitals and GP's on one of their most critical Performance Indicators: Patient Injuries?
    • The Profession can't claim ignorance of these results nor their irrelevance. So why haven't doctors and their Professional Associations been very strong activists for this necessary reform?
    • One of the surprise results of Dr James work, again backed with the strongest proof, was "it's at least 20% cheaper to Do it Right, First Time". Why aren't Australian Doctors overwhelmingly lobbying all Parliaments for this reform, especially in Hospital systems?
  • Five plus years on from "Dr. Death" in Bundaberg, is anything different? Is there any excuse for that?
    • The Commission of Inquiry into Queensland Health (QH) determine just one of the root causes was the inability of QH to retain locally trained doctors. Why hasn't that been remedied? As a major, critical Public Health issue, why aren't doctors and their associations taking the strongest actions industrially and politically with both State and Federal Parliament to rectify this on behalf of those in their care?
    • Could Jayant Patel happen again? It seems, "yes". Could he be hired again, allowed to practice in the same way, poor patient outcomes go unnoticed and unremarked, and the nursing staff who raising the alarm be comprehensively ignored and worse? After five years there is no public evidence that QH has addressed these issues, and yet the doctors and their associations remain quiet and action-free. Why the lack of activism and public action? Why is the Medical Profession silent on this issue? [And if the answer is a provable "No" as against "trust us, we've changed", why isn't that known?]
    • In most states, Jayant Patel's deliberate harming of patients is not a crime. Where is the outcry and outrage from the Medical Profession? After more than 5 years, the absence of any concerted efforts by doctors and their associations to have this oversight corrected is not accidental. This non-action is now deliberate. Why are doctors and their associations not advocating for the strongest, most reasonable protections possible for their patients?
    • Jayant Patel was only charged for a very small proportion of his injuries and deaths because of an antiquated legal notion, direct causality. We know that Patel killed, maimed and injured many times the number the DPP was able to charge him with. The statistics on his trail of carnage are unassailable, yet no legislative changes have been made or proposed. In one of the Engineering Professions, evidence like this would cause a practitioner to lose their license to practise and might be accepted as evidence in criminal proceedings. [I don't have legal advise on that]. Why is the Medical Profession silent on this issue when statistical analyses are at the very heart of their holy-of-holies Standard of Evidence, Randomised Controlled Trials (a.k.a. Placebo controlled double-blind randomised experiments)?

What does a modern Profession look like?
Aviation as a perfect model.

A short excursion into theory:
 In Project Management, there is the "Iron Triangle", explained as "Good, Fast, Cheap: pick any two".
[Alternatively, the "Iron Triangle" comprises: scope, schedule and cost constraints with no explicit mention of Emergent Dimensions like Safety and Quality.]

This piece of received wisdom says that Economic Profitability, Job Performance and Product/Process Quality are competing dimensions, to optimise one of them, others have to be sacrificed.

This just isn't so.

It only appears that way if a) you examine a single project (in the short-run) and b) your Project Methodology doesn't include the last half of Demings' cycle (Plan - Do - Review - Act to improve system).

Dr Deming's proven Quality Theories rely on two fundamentals which you might recognise from the Scientific Method:
  • Be inquisitive, examine your own performance, look for insights into your work and outcomes, self-examination is the precursor to insight, and
  • try to constantly improve both your knowledge and practice, to consciously learn both from your failures and successes.
This "conscious, deliberate learning" mindset is a necessary condition for constant improvement in all three aspects of the Iron Triangle: Profitability, Performance and Quality.

It's a long-run, not short-run, effect. It doesn't appear within a single project, but after the execution of many. The most important part of every project is the Analysis/Learning phase after it, the Project Review.

For cottage-industry crafts, where you only practice "as learnt" skills without deliberate improvement or correction, the veracity of the "Pick any two" ideology is both obvious and unbreakable.

For modern Professions practising "Do it Right, First Time", the saying is trite and wrong.

Back to Aviation, a modern Profession where, in most but not all countries, "Do it Right, First Time" is pervasive and firmly embedded in the culture and practice of each discipline and speciality, as well as in the governance of the whole Industry and its component parts.

More importantly, there is free, public data on the performance of the Industry.

Page 11 of the EASA's 2010 Annual Safety Review, has a powerful chart [Fig 2-1] showing how the Industry has progressed/improved and some words that should make the Australian Medical Profession both ashamed and envious:

The data in Figure 2-1 show that the safety of aviation has improved from 1945 onwards. Based on the measure of passenger fatalities per 100 million passenger miles flown, it took some 20 years (1948 to 1968) to achieve the first 10-fold improvement from 5 to 0.5. Another 10-fold improvement was reached in 1997, almost 30 years later, when the rate had dropped below 0.05. For the year 2010 this rate is estimated1 to have stayed at 0.01 fatalities per 100 million miles flown.

The accident rate in this figure appears to have been flat over recent years. This is the result of the scale used to reflect the high rates in the late 1940s.
Another Canadian resource site, with an inspiring graph on the improvement in Aviation Safety says:
Up to the early 1970s the number of fatalities increased with some proportionality with the growth of air traffic. By the 1970s, in spite of substantial growth levels of air traffic, fatalities undertook a downward trend. This is jointly the outcome of better aircraft designs, better navigation and control systems as well as comprehensive accident management aiming at identifying the causes and then possible mitigation strategies.
This isn't isolated or peculiarly European: 
The reason for these massive, on-going improvements is the detail and seriousness of incident investigations. Notably, while commercial "Air Carriers" have improved their Safety and Operations by several orders of magnitude while being profitable in a cut-throat industry experiencing a 1,000-fold increase in services delivered, "General Aviation" has improved, but by only approximately 5-fold.
The difference isn't in the technology, training available or processes/procedures detailed. It's the Professional "Right First Time, Every Time" approach.

The crash in early 2009 into the Hudson River of US Airways 1549, piloted by  Capt. "Sully" Sullenberger, was dramatic, widely reported, and resulted in no fatalities and only a handful of injuries.
Yet it led to 35 "Recommendations" by the US official investigator, the NTSB (National Transport Safety Board). Think how different this is to Australian Medical practice: even injuries resulting in permanent disabling of patients, like the 2010 preventable and foreseeable injury to Grace Wang, a repeat of prior Errors, led to news reports, but no obvious investigation and certainly no consequences for anyone involved.

These NTSB "recommendations" will be implemented, will be checked upon by a regulatory body [the FAA] and failure to do so will result in proportional, direct, personal and organisational consequences.

This is completely at odds to the 550+ page report by the 2005 Queensland Public Hospitals Commission of Inquiry, triggered by Jayant Patel and others, where the Recommendations are optional, their (timely) implementation won't be checked, nor will there be consequences for anyone repeating these Known Errors, Faults and Failures.

One of the reasons for this cultural change in Aviation and resulting the on-going improvement of Safety, Quality and Performance in Aviation is the theoretical work of two men:
NASA uses Perrow [PDF] as a basis for its Safety programmes.

Prof. Reason seems to have retired from Academe, but is still listed as an advisor to "The Texas Medical Institute of Technology (TMIT)".

James Reason's work is well known in the medical community: it was used by Dr Brent James and colleagues in the remarkable turnaround and improvement of Intermountain Healthcare, reported in "Minimising Harm to Patients".
On the wikipedia page on "The Swiss Cheese Model", a large number of pieces in "Further Reading" are medical.

Where this ends is a 2012 article published in "Journal of Patient Safety", available on the TMIT site, "An NTSB for Healthcare, Learning from Innovation: Debate and Innovate or Capitulate", where the authors, Medicos and Aviators and authors of 100 medical papers, call for applying what is known to work in Aviation to Medicine.

An idea that seems long overdue, although they don't go as far as suggesting the second, necessary, pillar of the Aviation system, the US FAA or UK's CAA, a regulatory and compliance organisation (also responsible for provision of common services, like Air Traffic Control). These organisations are charged with first implementing and on-going checking of NTSB recommendations, bringing direct, personal consequences to those not complying.

Without "accountability", recommendations and findings have little likelihood of being fully and consistently practised.

Economic and medical risks threaten the national security of America.
The spiraling costs of United States' avoidable healthcare harm and waste far exceed those of any other nation. 
This 2-part paper, written by a group of aviators, is a national call to action to adopt readily available and transferable safety innovations we have already paid for that have made the airline industry one of the safest in the world.
This first part supports the debate for a National Transportation Safety Board (NTSB) for health care, and the second supports more cross-over adoption by hospitals of methods pioneered in aviation. 
A review of aviation and healthcare leadership best practices and technologies was undertaken through literature review, reporting body research, and interviews of experts in the field of aviation principles applied to medicine.
An aviation cross-over inventory and consensus process led to a call for action to address the current crisis of healthcare waste and harm. 
The NTSB, an independent agency established by the United States Congress, was developed to investigate all significant transportation accidents to prevent recurrence.
Certain NTSB publications known as "Blue Cover Reports" used by pilots and airlines to drive safety provide a model that could be emulated for hospital accidents.
An NTSB-type organization for health care could greatly improve healthcare safety at low cost and great benefit.
A "Red Cover Report" for health care could save lives, save money, and bring value to communities. 
A call to action is made in this first paper to debate this opportunity for an NTSB for health care.
A second follow-on paper is a call to action of healthcare suppliers, providers, and purchasers to reinvigorate their adoption of aviation best practices as the market transitions from a fragmented provider-volume-centered to an integrated patient-value-centered world.

Friends of Science in Medicine: Irrelevant #2

The Dwyer/Marron Friends of Science in Medicine, finally have a public website where we can learn a little more about them.

Their constitution lists their "Objects" as:
to foster Good Science in Medicine [my capitalisation]
Their home page states:
We are currently campaigning:
"to reverse the current trend which sees government-funded tertiary institutions offering courses in the health care sciences that are not underpinned by sound scientific evidence"
I'm not aware of any usage of "to foster" that translates into attacks and calls for banning properly instituted and checked activities... Buts that's a side-show to the real game.

The Dwyer/Marron group choose to ignore multiple Elephants in the room, hospital deaths, medical adverse events and patient injuries in favour of a campaign that's been termed "a witch hunt", and even if completely successful would achieve so little as to be farcical.

The only fact I can present in support of this is: There are no facts.

Which in itself is a complete failure of Governance and Safety/Quality systems of the Australian Medical system and Profession.

What's the ratio of fatalities to Adverse Events (AE's), those caused by Human action or inaction?
We've no idea...

An early Australian report is summarised as: 18,000 fatalities due to AE's at a cost of $2B/year :
The total costs (health, economic and social) of adverse events are significant. Studies in recent years that have identified the magnitude of the economic and social cost:
  • The Quality in Australian Health Care Study (QAHCS) found that 16.6% of hospital admissions were associated with an Adverse Event, and that 18.5% of these Adverse Events resulted in permanent disability or death. This equates to approximately 18,000 deaths that are attributable to Adverse Events. The estimated annual cost of Adverse Events to the Australian healthcare system is AUD$2 billion. [Wilson RM, Runciman WB, Gibberd RW, Harrison BT, Newby L, Hamilton JD. The quality in Australian Health Care Study. MJA. 1995;163:458-471]
Dr Ross Wilson, the author, is quoted in the media ten years later, as saying that "things are likely the same" because we still don't have figures being reported and collated.

In 2009, the SMH reported a government study or report estimating "Hospital errors claim the lives of 4550 Australians a year". A more acceptable figure? But it's still in line with the near 20,000 "Adverse Events" Dr Wilson estimated.

We do know, from the 2002 "Second National Report on Patient Safety Improving Medication Safety"  that GP visits include "400,000 of these thought to involve adverse drug events." (around 0.25%)

The much weaker figure, "Sentinel Events" is discussed in an AIHW (Australian Institute of Health and Welfare) document, "Sentinel events in Australian public hospitals 2004–05". They describe "Sentinel Events", and their need as:
there are occasions when patients suffer harm that is unexpected and unintentional. Sentinel events represent a very limited range of serious events, which can provide a ‘window’ into the vulnerabilities and safety of the health care system.
This report analyses 130 events that caused or had the potential to cause serious harm to some of those patients.
We've no information if the "Sentinel Event" causes identified in the AIHW report have been eliminated in all Hospitals and Health systems. But why would they be after only five years? It's not like people are dying needlessly every day, is it? [apologies for using sarcasm.]

The responsibility for collecting and reporting "Sentinel Events" was devolved to the states.

Sadly, from the AIHM website, which you'd expect to be definitive, it appears that only WA and Victoria have taken up Sentinel Event collection and reporting.

WA reports 1 Sentinel Event in 10,000 patient separations, and that they'd achieved a 10% improvement in the year. The WA figures (96 events or 0.01% of separations) don't exactly tally with the AIHW figures for patient separation. The WA figures report 0.96M separations in WA of 2.3M population. For the whole 22M Australian population, it would be 9.1M separations, versus the 8.5M reported by the AIHW.

This seems to demonstrate a convincing, overpowering view by administrators of the other Hospital systems that such data is unnecessary and not useful... A very disturbing view to me.

What's the ratio of "Sentinel Events" in hospitals to Adverse Events?

From the estimates available this is 130:18,000, or about 140:1, possibly worst case because the definition of "Sentinel Event" is still being refined and increasing.
Which is why the "Sentinels" were chosen, as "canaries in the coal mine". Simple to measure and quickly and easily show if things are getting better or worse...

We know from the hard-data reported by Dr Brent James around 1999, that the ratio of Adverse Events to "Patient Injuries" is 80:1 (eighty times).

If we are conservative in our assumptions and use the WA Sentinel Event rate (0.01%), a lower ratio of Sentinel to Adverse Events (1:100) and a lower ratio of Adverse Events to Patients Injuries, then the 8.5M patient separations reported by the AIHW for 2009-2010 (costing $33.7B for Public Hospitals),
resulted in:
Sentinel Events: 850 (÷ 10,000)
Adverse Events: 85,000 (* 100)
Patient Injuries: 4.25M (*50)
 More in keeping with Dr Wilson's estimate, would be an SE:AE ratio of 20:1, giving:
Sentinel Events: 850 (÷ 10,000)
Adverse Events: 17,000 (* 20)
Patient Injuries: 850,000 (*50)
Which is still an incredible figure indicating a massive, needless waste of money, not to mention the impact of unnecessary injuries and treatment upon patients.

The Irrelevance of Friends of Science in Medicine:

The Dwyer/Marron group make no claims for the numbers of Patient Injuries, nor their severity, attributed to their foes, "Complementary and Alternative Medicine" (CAM).
Are they claiming figures of 1,000,000 injuries and a few thousand fatalities: in the ball-park of known good estimates for Medical and Hospital systems?
If they aren't then:
  • They should say nothing until they go out can get some hard-data on the actual injury and fatality rates.
    • Unfortunately, a single media appearance by Lorreta Marron exposing and shutting down one uncertified backyard operator, while preventing a few injuries, does NOT constitute research or evidence.
    • Friends of Science in Medicine need to apply their own standards to themselves.
      Without strong evidence, what anyone says is completely irrelevant, misleading and potentially harmful.
  • Estimates of use of Alternative Medicine and Therapies in the general population vary between 40-60%. How many visits and treatments does this translate into? NOT anywhere close to the 100M/year visits to GP's? What about the total patient injury rate via CAM?
    • Even the anecdotal evidence doesn't support the view that there are close to the same number of patient injuries as from doctors and hospitals.
    • Get some data before you criticise everyone else.
If even a guesstimate (that's a valid Engineering term and process) put the total Patient Injuries by CAM at 10% of mainstream Medical and Hospital, I'd be very surprised.

And if fatalities were even has high as 1,000th of the known, preventable deaths in Hospitals, I'd be astonished. Do we lose as many as 5 people to certified, registered Alternative Therapy practitioners in a year? You'd have to make some outrageous assumptions to even get there.

So why do these people want to shine a light in an area where the total potential for harm and injury is not even a rounding error in the statistics of the practices they are so virulently supporting?

The irrelevance and hypocrisy of Dwyer/Marron and their The Friends of Science in Medicine is that they know full well the scale and scope of the preventable failures of mainstream Medical and Hospital system, but they then choose to "raise Cain" about areas of relative inconsequence. What's going on?

My message to the Dwyer/Marron group:
Practice what you Preach and Get your own house in order first.