Med Writing (evidence-based)

Justin takes a keen interest in encouraging  health practitioners to judiciously use what we know works, rather than enthusiastically embracing what we wish would work.

He only occasionally produces his own research, preferring to sit back comfortably and collate all the hard work done by other people. He likes quality evidence about interventions that really matter and shows surprising disinterest in the latest, sexy medical fads and crazes.

Below are a few selections from before 2014. For more recent articles, see blog posts.

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Pharma payments to doctors should be transparent
TGA Advertising Code needs tiger teeth
Archie Cochrane
Naked Doctor strikes again
Naked Doctor
Confessions of an ordinary doctor in a Centre of Excellence

Pharma payments to doctors should be transparent

Here are a couple of selected sections from the full document (pdf), published on the RACGP website.

Royal Australian College of General Practitioners (RACGP) response to:

Transparency Model Consultation and Discussion Paper

Drafted by Dr Justin Coleman, RACGP representative on the Medicines Australia Transparency Working Group.

September 2013

Summary

The RACGP commends Medicines Australia for inviting a range of interested parties onto the Transparency Working Group (TWG) and for producing a discussion paper which reflects a balanced summation of where these parties agreed and disagreed. The RACGP representative on the TWG felt that this consultation process was effective and fair.

Overall, the RACGP supports the discussion paper, with the specific provisos that in section 5.2, Alternative 2 is selected for Reporting thresholds, and also that the cost attributed to each doctor attending a sponsored event does include the full cost of that event (i.e. includes non-hospitality and non-function costs).

We support Alternative 2 for 5.2 i

I.e. For calendar year 2015, payments or other transfers of value less than $10 do not need to be recorded or reported. Payments or transfers of value of greater than $10 must be recorded but do not need to be reported unless the aggregate amount paid or transferred to the healthcare professional recipient exceeds $100 in a calendar year.

We believe it is appropriate that if a doctor accepts payment (or transfers of value) of more than $100 from the one pharmaceutical company in the one calendar year, then this should be recorded on the transparency register. We accept that, for practical reasons, it is reasonable to exclude the requirement to record payments valued at less than $10.

We note that this transparency model in no way restricts the doctor accepting such payments; it merely serves to make the payments transparent. A doctor who wishes to avoid their name ever appearing on the transparency register may still accept an unlimited number of payments of less than $10, and also accept up to $99 from any number of pharmaceutical companies in each calendar year.

We do NOT support Alternative 1 for 5.2 i

I.e. For calendar year 2015, payments or other transfers of value less than $25 do not need to be recorded or reported. Payments or transfers of value of greater than $25 must be recorded and reported.

We believe that the distinction between Alternatives 1 and 2 impacts on GPs more than any other group of doctors, and so we take particular interest in the wording of this section5.2.

GPs account for the largest group by volume visited by pharmaceutical representatives, although the amount spent per doctor is smaller than for the medical specialties. We believe that an exemption for recording payments less than $25 will result in the overwhelming majority of visits by pharmaceutical reps to GP surgeries ‘flying under the radar’. This potential loophole is large enough for this type of interaction to remain virtually unrecorded.

Given the ability to divide the per capita cost during a surgery visit by the number of people who partake in lunch (or similar), one can imagine that it would be easy to ensure the catering costs fell to $24 or less per head. It also appears that non health-professionals may be included in the denominator; there does not appear to be any clause which would stop, for example, a $95 lunch for two doctors and two practice nurses or other staff being divided by four, which would therefore go entirely unrecorded against the doctors’ names, even if the same company provided lunch on a regular basis.

Alternative 1 would be considerably cheaper for industry compliance because the majority (in number, not value) of doctor payments would be exempted. This Alternative 1 would make the recording tasks for pharmaceutical reps far easier—virtually non-existent as far as GP practice visits are concerned—but could defeat one of the main purposes of the transparency system.

After all, a large part of the public benefit deriving from the transparency code rests on improved insight into interactions between doctors and pharmaceutical representatives who are promoting one particular therapeutic product over another. The higher $25 recording threshold would still capture payments to speakers and ‘key opinion leaders’, but would miss most of the smaller payments, which nonetheless are known to influence prescribing patterns.


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TGA Advertising Code needs tiger teeth

A slightly edited version appears as the TGA formal submission on the RACGP website here (pdf)

TGA Consultation: Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public.
This submission has been prepared by RACGP representatives Dr Justin Coleman and edited by Dr Jane Smith

The Royal Australian College of General Practitioners (RACGP) takes a keen interest in the regulation of advertising of therapeutic goods. General Practitioners (GPs) are responsible for around 85% of medical prescriptions in Australia and are regularly involved in discussions with patients around over-the-counter medications whose advertising and promotion may well have influenced the patient’s purchasing decision.

We note that very few, if any, of the proposed reforms would directly or indirectly result in any financial gains or losses to the average GP, and as such we can confidently argue that our position is free of any pecuniary ‘vested interest’ and that our sole concern is the health and safety of our patients—in effect, the Australian public.

Our concerns for consumers (our patients):

• Currently, consumers are frequently being misled by direct-to-consumer advertising claims

• Misleading claims include some for which the TGA has already completed its decision (e.g. reprimand for ‘Nurofen targeted relief’)

• Many other alleged misleading claims are ‘stuck’ somewhere in the slow-grind TGA process (for example, the majority of complaints referred to the TGA by the CRP over the past three years have not been finalised.)

• The ‘vitamin and supplement’ industry thrives on claims of therapeutic efficacy which can be shown to be false or exaggerated. This industry is so lucrative that it is profitable to make a false claim to increase market share for as long as possible, then deal with any TGA complaint at a later stage. The time course including the pre-complaint sales, the first complaint, the drawn-out TGA case and appeals, the eventual reprimand, and finally the delay in taking any action on that reprimand, can be years. Meanwhile, the profits far outweigh any financial penalty, and by the time the company complies by withdrawing the claims, it is time to move onto a new advertising campaign anyway.

• Although consumers are free to spend their money in whatever way they see fit, we believe that people are particularly vulnerable when it comes to products which purport to promote health or relief from suffering. False advertising claims for health products have potentially far more serious consequences to individuals than do false claims for most other consumer goods purchased.

• Purported weight-loss agents and relief from chronic painful conditions such as arthritis are particularly prone to fanciful claims.

• Advertising claims using evidence-based terms such as ‘scientifically shown to…’, ‘clinical evidence’ or ‘tests have proven’, should require the company to demonstrate that the understood, scientific meaning of these words actually applies in their case. Besides any direct misleading, this lazy appropriation of scientific terms by marketing divisions also waters down the public’s understanding of the meaning of such terms when they are applied correctly. This is particularly important in light of the ongoing struggle of the medical profession to continually ‘clean up its own back yard’ by debating and applying evidence to its own therapeutic interventions.

Our concerns with the current TGA code:

• The RACGP strongly affirms the regulatory role of the TGA, and we believe that role requires strengthening.

• The current Therapeutic Goods Advertising Code 2007 was written six years ago and is in great need of revision. The complex set of regulations and codes require updating, simplification and strengthening.

• Broadly speaking, the code, and the process of handling complaints under the code, is considered almost ‘toothless’. The long delays, the light punishments, and the lack of timely, firm action when reprimands are ignored, have led to a situation where large companies can merely ‘factor in’ a potential TGA complaint into their promotional budget.

• TGA code revisions should be more frequent and in each case designed to reduce the ‘wriggle room’ for companies who aim to avoid sanctions.

• The upper limits on penalties for confirmed breaches of the code should be increased. In particular, penalties for ignoring or unreasonably delaying compliance with a reprimand should be severe. Penalties for companies who repeatedly breach the code should also be severe enough to make them fastidiously avoid subsequent breaches.

• The media is rapidly changing, and advertising regulations must be extended to include all forms of media including online and subscription media, pay TV and social media (where sponsored campaigns are concerned).

[For all eight proposals, see RACGP document. I have included here just proposal 6, which received the most media attention]

Proposal 6: Advertising directed to health professionals

We support option 2 (Update the exemption for health professionals in section 42AA of the Act to only recognise health practitioners regulated under the Health Practitioner Regulation National Law.)

As it stands, the Therapeutic Goods Advertising Code 2007 categorises complementary and alternative medicine (CAM) practitioners such as naturopaths and homoeopaths, alongside medical practitioners and other health professionals who are registered with AHPRA. Thus, the advertising exemptions which apply to AHPRA-registered practitioners (who are considered to have sufficient expertise to judge each claim on its merit) also currently apply to CAM practitioners.

It is very common—usual practice for some groups—for companies to promote products with no evidence of efficacy (supplements, herbal and homeopathic remedies) to CAM practitioners who in turn dismiss the need for ‘scientific evidence’. Such practitioners then on-sell the product to consumers. This relationship is substantially distinct from that between AHPRA-registered health professionals and their patients, and is more akin to wholesalers advertising to direct-to-consumer distributors. We believe that CAM practitioners should therefore not be exempt from the Code, but should instead be subject to the same regulations as concern direct-to-consumer advertising.

We have noted current social media campaigns and petitions against this option by CAM practitioners and at least one company which sells vitamins and ‘natural therapies’. We would point out that both groups have significant financial interests in this matter, although it is not entirely clear why those CAM practitioners who signed the petitions feel so strongly about their right to receive advertising which is exempt from the TGA safeguards against false claims.

We also believe the wording of the petitions themselves inaccurately reflects the actual TGA reforms proposed and has instead been deliberately distorted so as to gain maximal outraged support. For example the title of the most-signed proposal is ‘Stop the proposal that may delete Naturopathy’ an outcome which is an entirely unsustainable claim. In all the petitions we have seen, no reasonable reader could guess that the issue at hand is limited to the advertising of goods; instead, the petitions warn about encroachments on the interaction between the CAM practitioner and their client.


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How Archie Cochrane flipped the medical world on its head

I love the story of how Archie Cochrane, founder of the Cochrane collaboration, first gained notoriety as a very junior staff member at the massive Department of Health in London. This was recounted to me by his friend, another great Scotsman, health economist Prof Gavin Mooney, who died in tragic circumstances last Christmas.

At a Department of Health clinical meeting, the young Archie Cochrane was presenting slides from a Randomised Control Trial on outcomes after heart attacks following rehabilitation either while remaining a hospital inpatient or after early discharge home. London’s ‘Who’s Who’ of learned physicians nodded sagely as Archie showed the crucial slides where the hospital outcomes—represented in red—outdid the blue columns of home-based rehab outcomes across nearly every parameter. A couple of supportive comments, no questions.

Then the young epidemiologist pretended to look flustered. ‘I’m terribly sorry. I seem to have mixed up the red and the blue.’ He had deliberately flipped the slide labels. All the better outcomes were in fact in the home-based, early discharge group. Needless to say, chaos erupted as suddenly a hundred audience members grilled him on every possible dubious aspect of the study design!

Best-practice or common-practice?

Until that time, there had been no reason for a London physician to doubt that an intensive, expensive, high-tech hospital stay would improve health outcomes. It made perfect sense, and a whole bunch of highly intelligent, caring physicians had spent their careers ensuring that such a system existed. Where it wasn’t affordable, public and charity funds were sought to ensure more people could get longer hospital stays.

This was best-practice care, in the same way that bed rest for back pain, monthly breast self-examinations, and PSA tests to detect prostate cancer have been understood by clever and well-meaning people to be fairly obvious best care.

Sometimes our medical interventions are wrong, even when tens of thousands of medical practitioners believe they are doing the right thing. This was true and will ever be so. Our mistakes from the past must remind us that we are making mistakes right now.

The art of discovering nothing

Full credit to all those anonymous doctors and researchers who unwrapped these anomalies. History rightly lauds those who discovered ‘something’; Alexander Fleming and penicillin. But I also dip my hat to those who discovered ‘nothing’. Bloodletting doesn’t work. Arsenic doesn’t work. Keeping kids with polio in hospital back straighteners for a year of their lives doesn’t work. In many cases, our patients would be better off if we chose not to act.

I have a particular interest in those aspects of medical practice which don’t work, or actually cause harm. This interest is an attempt to balance the important and exciting work of discovering new stuff with the un-sexy hard-slog science of analysing those times where we have over-reached and over-enthused. The best of our medical predecessors started this process and we must continue it; this is why we are a science and not merely a tradition.

Two hundred years ago, the French physician Phillipe Pinel cared enough about the damage his colleagues were doing to his psychiatric patients to observe “It is an art of no little importance to administer medicines properly: but, it is an art of much greater and more difficult acquisition to know when to suspend or altogether to omit them.”

It took a young epidemiologist Archie Cochrane to highlight the flaws in obstetric practice which should ideally have already been obvious to the world’s leading obstetricians and their institutions. And these were not minor flaws. Obstetrics units in one part of the world were teaching methods which had already been shown in another part of the world to increase deaths, and vice versa.

Archie didn’t do the research himself; his genius was to collect, collate and analyse all the available evidence—and, importantly, reject the shoddy stuff: the anecdote and the meaningless trial—so that obstetricians and their departments could make informed decisions as to how to get the best outcomes. Archie never delivered a baby nor managed a single maternal complication, but his legacy would probably have saved more lives than any doctor listening to his slide presentation in London.

When less is more

I believe that medical practice, if left unchecked, naturally tips the balance towards overtreatment. The paradigm promoted by industry, the media and some doctors, particularly the sub-sub-specialists, is that the only important news is a new invention, new drug, robotic surgery, more MRIs. That the best doctor is always the one at the cutting edge. That the best diabetologist for my grandmother is the one who has just spent two years in America learning the finer points of subcutaneous insulin infusion pumps.

I live life at the blunt edge. I hang around the guys mopping up after the party has swept through, cleaning the debris after the enthusiastic early-adopters have already moved on to the next big thing. I embrace the unexciting.

And let’s face it: only one in a thousand new ideas, interventions or medications leads to a true paradigm shift in health outcomes, so the early-adopters make a lot of mistakes. The typical ‘promising treatment’ may help some people to some extent, but we need to take the time to find out exactly who and in what circumstances. An intervention which works brilliantly for patients with extreme illness in hospital may do far less for the majority of patients whose illness is just one strand in the complex tapestry of their lives.

Although evidence-based medicine is certainly not sufficient on its own, it is a necessary condition if we want to actually improve health outcomes. Archie Cochrane reminded us that we must judiciously apply what we know works, rather than enthusiastically embrace what we wish would work.


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Naked Doctor strikes again

When the Naked Doctor bared all in January, the world stood up to watch.

Health gurus and fellow sceptics from all over the planet sent wolf-whistles of encouragement, while others posted a raspberry—or Bronx cheer, depending on country of origin. Stripping back some of the excesses of medicine is clearly a debate whose time has come.

Naked Doctor found friends in the expected places—HealthNewsReview.org, and the BMJ’s Richard Lehman —but also discovered some small, dedicated organisations with overlapping aims.

The Australian Institute for Patient and Family Centred Care plugs away at patient-centred medical care. The Slow Medicine movement is a bit like the Slow Food one, except even healthier. The folk at Healthy Skepticism beat Naked Doctor to a title which pretty neatly sums up the aim of the whole shebang. And the American College of Physicians—admittedly, not a recent Naked Doctor discovery—is climbing on board, big time, with a push to save $200 billion a year on excessive testing.

Interestingly, some commentators suggested that Naked Doctor is exposing himself to his clothed colleagues while ignoring the excesses of the alternative medicine industry. As to the former charge, there is nothing indecent about subverting a medical practice when new evidence suggests it is unhelpful to our patients. That’s what good doctors get paid to do, by a health system which can ill afford the alternative.

As for ignoring complementary and alternative medicine (CAM), the charge sticks. The lack of evidence for diagnosis and treatment is a pandemic of overwhelming proportions in CAM. Naked Doctor chose to limit entry into the strip show, where the audience at least knows the rules. He doesn’t envy those on the stage next door, attempting to peel back the layers to reveal the ghost within. He watches with interest the ongoing debate about whether those charged with that very task—CAM academics—warrant their university tenure.

Naked Doctor thanks his many emailers and tweeters for suggestions for this updated list. Enjoy the show


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The Naked Doctor on Croakey: profiling overdiagnosis and overtreatment.

Naked Doctor aims to encourage discussion and awareness of the opportunities to do more for health by doing less. It is a compilation of articles, books and other works that highlight overdiagnosis and overtreatment.

Introducing the Naked Doctor: When is ‘no action’ the best action?
The modern doctor seems to have an intervention for every occasion. He or she wears a magician’s coat of surprises, each more incredible than the last. Hidden pockets contain pills, scalpels and lasers, with sophisticated medical tests providing the performance instructions.

At its finest, the medical method is impeccable; type I diabetes was a rapid death sentence prior to insulin and accurate blood sugar tests. Sometimes, though, the heavy clothing creates it own problems. Tests point to the wrong diagnosis, treatments cause harm and the promised magic fails.

Some failures are a consequence of bad luck and random variation. But the closer we study these problem areas—applying the scientific method—the more we find predictable patterns emerging. Many tests and interventions fail because they should never have been used in the first place.

The Naked Doctor probes the places in medicine that would be better stripped bare. Places where the correct option is to do nothing. The ‘doctor’s bag’ accompanying a home visit before the second world war contained no medication which would be considered of any use today, and quite a few dangerous poisons. The physician would have been of more use turning up empty handed—or, given the lack of latex gloves and infection control, perhaps not turning up at all. The modern example of cancer screening via whole-body CT scanning offers as much protection as the emperor’s new clothes, and the guileless emperor would be better off naked.

Naked Doctor’s old anatomy professor Norm Eisenberg used to claim ‘only half of the stuff we teach you in this medical course is true. The problem is, we don’t know which half!’

Luckily, various health professionals and journalists around the globe dedicate themselves to steadily peeling back the covers. Naked Doctor exposes their disrobing of over investigation and overtreatment. We invite you to watch, and to contribute.       Read the Naked Doctor list of relevant articles and books on Croakey website


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Confessions of an ordinary doctor in a Centre of Excellence

When Willie Sutton was asked why he kept robbing banks, he replied ‘Because that’s where the money is!’ Sutton’s law was the logic behind my giving Indigenous health a go in my fourth year as a doctor. I’d been taught how to fix diseases, so I looked for the biggest bank of health problems. Figuring that my own country was a good place to start, I threw a dart at a map of the Simpson desertand hit Tennant Creek. I was pretty much right on the money.

I loved Tennant Creek, although in the fifteen years since I have met few others who share my enthusiasm. The town’s modest tourist motto is ‘Stay the night!’ because most don’t. But, as a GP registrar working at the Aboriginal-controlled health service for two years, the work was extraordinarily exciting, endlessly challenging and gave me great medical freedom. There were health problems in abundance, but also a resilient and generous local Aboriginal community. I couldn’t have asked for a better entrée into general practice.

Having never been the type to impress my hospital superiors with my knowledge of medical minutiae, I soon discovered that working in a remote Aboriginal community suited my temperament. My natural tolerance for uncertainty and keen ability to embrace chaos (not how my wife would phrase it) had occasionally been considered a hindrance by supervising consultant physicians.

Yet, suddenly, I was amongst people who recognised these traits as a boon. The locals didn’t want referrals to the best plastic surgeon in town; they wanted me to lance their carbuncle with whatever was handy, while they supported a peritoneal dialysis bag over their head and told me stories about their ancestors. If Sutton’s law led me into Aboriginal and Torres Strait Islander health, it was the Warumungu and Walpiri mob who encouraged me to stay.

In my subsequent years in and out of the NT, many have assumed I must have been paying off some scheme for recidivists, requiring desert-based penance for the sins of incompetence at my city job or over-borrowing from my bank. I vaguely denied the former, and suggested my meagre salary proved Sutton’s law should not be taken literally. Even so, I have been shocked to hear a couple of people whine, ‘What’s wrong with treating us whitefellas?’

To the profession’s credit, no doctor I’ve ever met has questioned why someone would want to work at the bottom of the health ladder, although quite a few wouldn’t be seen down that end for quids. And to be fair, I wouldn’t wish it on them.

If you’re a perfectionist whose job satisfaction depends on excellent outcomes, and expect patients to follow your ten-point postoperative manifesto, then frankly, apply elsewhere. Although a brief exposure to Indigenous health won’t do your perspective any harm, anything more than a dabble is likely to lead to frustration, depression and, ultimately, sweeping statements at cocktail parties that, despite everything you’ve done, the whole situation is hopeless.

Instead, the truth is that Indigenous health is an exciting place to be. Once you accept that many poverty-related social risk factors are beyond your control, it allows you to then concentrate on the things you can change, and there are plenty of those.

Take, for example, the steep curve at the top of the cardiovascular risk graph. Because most risks are multiplicative rather than additive, then altering one factor has huge effect. If your brief interventions reduce smoking rates by 10% from a baseline of 60%, or increase compliance with cardiovascular medication by a quarter, the gains in healthy life-years will be legion. While others are bemoaning the futility of trying to tackle the complexities of the ‘Aboriginal problem’, you will literally be saving lives. Unlike those operating in transplant units, you will never be handed a score sheet, but this is commonplace in primary health care—which is why we invented epidemiologists.

General practice and primary health care are undoubtedly ‘where the money is’ in Aboriginal and Torres Strait Islander health, even if only figuratively until the bean-counters catch on. The hospital sector does what it can, but no ‘cutting edge’ intervention can hope to match basic primary care when it comes to putting a dent in morbidity statistics. I now like to describe myself as being at the blunt edge of medicine, which is possibly why I don’t get asked to cocktail parties.

All of which leads me to my confession.The medical knowledge required in Aboriginal and Torres Strait Islander health care is really pretty simple. Just don’t tell my employer. It’s not brain surgery, and doesn’t often require any gadget invented since the glucometer. Simple folk like me can learn it on the job and keep up to date without ever seeing a drug rep to hear about the latest nanotechnology delivery systems. My favourite, sexiest drug is still metformin, which is older than most of my patients.

Mastering the medical knowledge is easy; its delivery is the complex part. The doctors I know who have mastered the art of Indigenous health have combined excellent communication skills with a drive to engage their patients. Doctor-patient trust is the key, and nowhere else in medicine does it open more doors.

I believe Aboriginal and Torres Strait Islanders have a particu­larly keen sense when it comes to detecting lack of respect, perhaps honed by two centuries of frequent practice. But, if you are prepared to listen and learn, and to make genuine efforts at communication, the work becomes immensely satisfying.

For the past five years I have worked in Brisbane at the Inala Indigenous Health Service, soon to become the South East Queensland Aboriginal and Torres Strait Islander Centre of Excellence. The Centre of Excellence will have twice the space of our current, cramped clinic, and generous resources for research and teaching.

 But even when I am sitting in my excellent room doing excellent consultations, I’ll spare a thought for my colleagues plugging away in remote communities and under-resourced city clinics. Because everyone who steps into the adventurous world of Indigenous health becomes a part of something meaningful, something big.

 They have chosen a marginal place where ordinary doctors at the blunt edge of medicine can do extraordinary things.


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One Response to Med Writing (evidence-based)

  1. David says:

    Research shows that is it 2 key demographic factors which best change aboriginal outcomes: the less rural the better, and the more miscegenation the better.

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