You are most definitely going to hear a lot more about this Danish study regarding back pain. The claim the researchers are making is very interesting. They present plausible preliminary evidence that a bacteria called Proprionibacterium acne seems to be present in some degenerated lumbar discs at rates well above chance. This is the same bug which is thought to cause good old spots, zits, blinders etc (the clue is in the name). They also report that a prolonged course of a common antibiotic (100 days was the duration chosen, rather arbitrarily perhaps) was able to significantly reduce back pain symptoms in patients with a particular type of MRI change on their scans.

These studies have been greeted with fairly fulsome praise from some quarters and more measured reporting from others. There has been talk of Nobel prizes. I wouldn’t disagree that if firmly established this could be the biggest advance in infectious diseases since Barry Marshall chugged a schooner of live Helicobacter Pylori on stage at a conference to highlight his and Robin Warren’s work on its link to gastric ulcers. Not many voices are being raised in reply.

Here are my comments about this work in no particular order

-The proposed mechanism is plausible, though there are some significant issues. P Acnes is a very low-virulence organism and its presence may well be incidental or an epiphenomenon. It can provoke inflammation with even a low-grade infection however, and this is perhaps the main appeal of the hypothesis.

-Establishing a causal relationship for an organism to cause disease is usually done by proving Koch’s postulates for the bug concerned. This hasn’t been done for P Acnes in LBP.

-Another reliable set of criteria for establishing causation is the Bradford Hill criteria, which is also far from being completed. More basic science will surely follow as a matter of urgency now this evidence has been published. Note that Marshall and Warren had mostly done all this groundwork by the time they advanced their hypothesis to public attention.

-The antibiotic used in the study was Amoxycillin combined with Clavulanic Acid. Clavulanic acid has been previously shown to have an anti-inflammatory action via its ability to inhibit pro-inflammatory cytokines. In other words, a large and well-established body of research suggests that the antibacterial action of the antibiotic may very well be irrelevant to its painkilling ability. I have several patients with chronic pain of various types whose pain is temporarily relieved for a few weeks by a stiff course of antibiotics.

-Extraordinary claims demand extraordinary evidence. The evidence presented by these researchers is fascinating and intriguing but most definitely not extraordinary. As well-conducted as this research has been, the idea that ‘40% of all chronic back pain can be cured’ is completely misleading and overblown. In fact, the research as presented does not in fact suggest a cure but just a reduction in average levels of pain.

-Even if one accepts the slightly patchy argument that a substantial chunk of chronic back pain is due to infection by P Acnes the proposed treatment is highly problematic. Overuse of Amoxycillin/Clavulanic acid is one of the major contributing factors to the rise of antibiotic-resistant superbugs. A prolonged course as described would leave you with nothing but a gutful of highly antibiotic-resistant flora. Serious superinfections from notorious marauders such as Clostridium Difficile would be inevitable. Such superinfections take weeks of isolation and barrier nursing to resolve. Not to mention the routine diarrhoea. You may well not fancy the idea of needing a faecal transplant to cure a life-threatening complication of your back pain treatment.

-There is no really practical way to tell yet whether any given individual would benefit from undertaking a trial of such experimental therapy. Chronic pain sufferers are incredibly easy to sign up for improbable treatments, and their interests need to be advocated for by subjecting any claim to a cure to serious scrutiny. I wouldn’t recommend this therapy to one of my patients unless I had a way of knowing I could offer them good odds.

So hold the phone to Stockholm. Proposed mechanisms of causation for chronic back pain have come and gone. This one is at least plausible, and gives a direction for further research. In the best tradtions of science, it allows one to formulate disprovable predictions. Although regular careful readers will be abl to detect the undertone of optimism and excitement in my appraisal, this proposed mechanism of long-term back pain has a long way to go before I’m going to call it revolutionary.

It’s not very often I’m completely lost for words. As a rehabilitation doctor, I’m very hard to shock and I can usually come up with at least a platitude for an given situation.

And then you see something like this.

Now I completely understand how easy it is to be taken out of context, or to make an off-the-cuff remark that seems insensitive, Been there, done that, got the dressing-down from the rightly aggrieved party.

But I really can’t say nothing when I see a major public figure like the Myer CEO say something so incredibly insensitive.

Allow me to point out to Mr Bernie Brookes that the NDIS if fully and adequately implemented will actually increase his customer base, rather then shrink it. The aims of the NDIS are to redistribute Australia’s considerable per capita wealth to allow around 400,000 of the most disadvantaged in our community a better shot at earning a living.

I simply can’t imagine how a wealthy middle-aged man like Mr Brookes who has climbed the corporate ladder and been a huge beneficiary of our generous tax and superannuation concessions to the top 10% of earners could gripe and rail against a measure which would bring his company a huge windfall. Not having to be out of pocket for so many everyday expenses (things which a healthy, English-speaking, well-educated man like Mr Brookes would not have ever thought about having to pay for) will bring hundreds of thousands of disabled consumers through the doors of stores like Myer. People with disabilities love quality coffee machines and LCD TVs like anybody else. It’s just that they can’t afford them because they’re too busy paying for services and equipment out of their pension to keep themselves out of hospital.

I have a one particular patient with a lifelong severe disabling illness which she has had since birth, who has now lived 10 years past her predicted life span, and shows every sign of going on longer than that. She has gotten her driver’s license and now has to fundraise to afford a modified car. I’d be happy to organize for Mr Bernie Brookes to give her one, if he is looking for a public gesture to make up for his unintentional but enormously offensive comment.

It would certainly be less expensive and more constructive than another round of advertising and PR advice.

Few readers would have seen this story yesterday in the Fairfax media – vitamin company Swisse has evaded an attempt by TGA to ban its appetite suppressant product by registering a new product with the exact same ingredient, an extract of Indian cactus. Oh, and Nicole Kidman has been named as the company’s US ambassador. But the fact that the story was buried in the business pages is no measure of its health-related importance. It has made it out into the news section today.

The Checkout team on ABC TV has already highlighted the problem of supplement manufacturers gaming the legislation using the very example reported in the SMH. This Indian cactus extract has no scientific validity as an appetite suppressant. Swisse is taking advantage of the loophole in the legislation that permits pseudomedicines to be promoted for their “traditional uses”. Just think about the implications of this story for a minute.

A swag of dodgy products have their listings on the ARTG cancelled by TGA due to the fact they don’t work and are being promoted in a misleading way. This is potentially annoying for Swisse, which has already sunk elephant dollars into hiring celebrities to endorse one of the cancelled products (I assume the celebrities didn’t seek Swisse out and offer their services for free because they are so convinced about the benefits of their various concoctions). One doesn’t need to be a PR genius to work out it would be a bad look to have Our Nic and the crew promoting stuff overseas that is banned at home.

Straight away, with no change at all to the ingredients or the formulation (presumably because they have warehouses full of the stuff ready to go) Swisse changes the label and is allowed to re-register the product because the approval for such products is done by a piece of software. Presumably the computer program involved lacks an irony detector.

As if that’s not absurd enough, check out what the effect of this “ban” will be. I promise I’m not making this up, but here is some advice from Swisse to their retailers, quoted directly from the information circular sent out to stockists.

WHAT DOES THIS MEAN FOR YOU, THE RETAILER?

The only impact brought about by this change is that from now, Swisse will sell you the product labelled and listed as “Hunger Control” rather than as “Appetite Suppressant”. This is not a new line of Swisse product, rather a new name for the same product.

You may continue to sell through existing stock of the Swisse Ultiboost Appetite Suppressant with its current name (and TGA listing) after the 4th April. The TGA has confirmed this.

WHAT DOES THIS MEAN FOR YOUR CUSTOMER?

Any customers that wish to purchase the Swisse Ultiboost Appetite Suppressant should be directed to purchase the Swisse Ultiboost Hunger Control instead. Customers can be told that Hunger Control contains the same formulation as the Appetite Suppressant, but has different labelling due to regulatory requirements.

So there you go. It stays on the shelves and can be legally sold until current stocks are exhausted while continuing to make the very claims that TGA has already decided are misleading for consumers. No ceasing, no desisting, just sales as usual.

As the business pages remark with approval, the expensive gamble of buying in celebrity clout has been costly but very effective for Swisse as a business. I strongly suspect the comparative pittance they pay their regulatory compliance department is worth much more to their operation. They have a superb working knowledge of how to operate within the clownish absurdities of our current regulations, and that gives the celebrities something to sell after all.

It was a sunny day outside the ward when Evelyn told the medical student she longed to die. She wasn’t being melodramatic, or even particularly emotional when she said it. It ruined the student’s day.

When recounting the conversation later, as part of an assessed case report, the student was concerned that Evelyn was clinically depressed and spoke about his shock at hearing an otherwise endearing and sweet old woman fervently wish for death, and express some regret at having lived so long.

I have worked with and around older Australians for a fair chunk of my career, and in my experience there is a place for rational suicidality to be expressed. The front page story of the Melbourne Age today has brought some welcome attention to the topic.

It’s not easy to talk about, but to live with significant disability, cognitive impairment, in poverty with few living friends or relatives is no picnic. The generation who are now in their mid-eighties were born in the early 1930s and were teenagers during the War. They were young parents during the Menzies era and well into middle age during the excesses of the eighties. They have seen the booming prosperity of middle Australia, and the introduction of Medicare right at about the time they were going to begin needing it. Unfortunately compulsory superannuation was still some years off, and the age pension was only ever planned to be necessary for a decade or so, given that the average life expectancy in the early 1980s was early 70s for men and a few years more for women.

Nobody planned for so many of them to live this long, with so many chronic conditions.

Many older Australians have been trapped by the changing social determinants of health, and now have been living for twenty years or more on the old age pension, with limited family contact, and an increasing burden of chronic disease. Many have escaped being taken by cancer or heart disease, at least for now. Osteoarthritis, visual and hearing impairments and torn or wasted muscles combine to limit them physically and cut them off from the immediate environment. The fear of dementia, or of becoming a burden to others is mounting. For some in this predicament, the decision to seek residential care is simply too overwhelming, and they choose to trust their luck living alone in accommodation which is no longer manageable or even safe.

I’m sorry if this is depressing, but if you spend any amount of time around the public hospital system these scenarios are only too familiar. They are not often openly raised (even with the patients it must be said) because the issues are complex and painful to contemplate.

It is in this context that I can certainly understand how it could be that someone like Beverley Broadbent could come to a decision in the full and clear light of reason that she no longer wanted to live.

I also have to say that I wouldn’t be the one who would give her the barbiturates.

Much of the research from the palliative care field such as this study on patients with motor neuron disease, this one on a patient with locked-in syndrome and this review of life satisfaction in tetraplegic people tend to support the view that social factors affect quality of life much more than health-related ones. Among survivors of failed suicide attempts, many are subsequently glad they made it, and would not attempt it again. Impulsive or crisis-related suicidality would have to be strenuously screened for. Do we have those tools yet? Are they reliable enough to be ethically justifiable to use in practice?

It seems reasonable to conceive that the more physically disabled a person is, the more dissatisfied they must be with their life. The problem is that the research largely doesn’t support this view, at least not in the most highly disabled groups. It seems that you can’t make generalisations about a person’s quality of life just by looking at their medical records. This is why I begin to feel uneasy when cases like Beverley Broadbent’s are discussed.

I wouldn’t disagree that she has agency over her own existence, and I am very well aware of the reasons that an older person could make a rational choice for suicide, I can’t see how this can be legally provided without dramatically changing the thinking involved.

A whole new set of pressures would be brought to bear on elders who are already vulnerable enough. We would have created the right environment where many would feel obliged to move on and distribute their assets where this had never been an option before. Let alone those whose families might actually come right out and say that to them.

How could we reliably distinguish between a case like Beverley Broadbent, who is clearly making a long-considered decision with rational forethought free from mental illness or social coercion, and another who hasn’t been through the same emotional and mental journey, or who may be getting a nudge along? And what about younger people who have survived into their 40s and 50s with conditions like cerebral palsy and spinal cord injury? They are experiencing similar physical and social disadvantage to the elderly, but at a much earlier age. Would they be allowed to apply as well?

Much, much more research is needed about any proposal for voluntary ending of a life in the absence of terminal disease. As a humanist, I support the right to choose an early and dignified exit from intolerable circumstances. As a doctor, and a pragmatist, I have a lot of trouble thinking my way towards a legal and social framework in which this could be ethically brought about.

We need to have a mature conversation about this. A conversation which respects shocking and awkward points of view. One which safeguards the well-being and rights of people even as they are choosing how to die. A compassionate, empathic but clear-eyed and well-informed discussion.

As a community we are living longer with disabling conditions, and the ranks of the isolated and infirm elderly continue to grow by the decade. We need research to inform an ethical and legislative debate about assisted dying and the courage as a society to think about whether and how we try to make it happen.

I do spend quite a bit of time banging on about evidence, plausibility and the like, but it’s nice to know I’m not the only one.

Dr Rachelle Buchbinder is Professor of Clinical Epidemiology at my old medical school. She has developed a formidable reputation for asking obvious and uncomfortable questions about various new and much-vaunted treatments. As she is Joint Coordinating Editor of the Cochrane Musculoskeletal Group I frequently read papers she has contributed to and I think she is one of the giants of critical thinking in musculoskeletal practice. Her most recent editorial in a big time journal returns to one of my pet bugbears – the lack of rigorous evidence for many surgical interventions which could be safely studied in randomised control tials (RCTs).

The trial under discussion was a meticulously done comparison between people with a torn meniscus cartilage in their knee and early signs of osteoarthritis who were randomly assigned to have arthroscopic surgery on it, or appropriate physiotherapy. The surgical procedure studied was meniscectomy, whereby the surgeon uses keyhole surgery to trim the torn meniscus cartilage, and ‘tidy up’ the cracked and worn lining cartilage. Most people would agree that it sounds like a reasonable thing to do in the circumstances. Certainly it is a frequently done procedure, with the study quoting a figure of more than 460,000 being done a year in the USA alone.

To cut to the important bit, the study showed that there seemed to be no additional benefit to the patient by 12 months following surgery. Even the people who were assigned to the physio group who then crossed over and had surgery (which was about 30% of them) did not fare any better.

The importance of establishing efficacy of treatments before they are offered widely is well understood for new drugs. Love it or hate it, Big Pharma spends elephant dollars on testing efficacy before releasing drugs onto the market. There are a few fairly common operations (including the one in the study) which would not see the light of a pharmacy shelf if they were assessed like medications, with benefits being weighed against risks.

So why do surgeons keep doing these procedures?

I will resist the troll’s answer that it’s just for the money. Orthopaedic surgeons can make a perfectly good living doing nothing but strongly-evidenced procedures. Really, they don’t need the money.

My guess is that studies like the above one don’t map very accurately to the real world because of the Hawthorne effect. Surgery provides a compelling reason to adhere to a physiotherapy regimen, and the social experience of surgery is well-demonstrated to have huge placebo effects. In the real world, if someone is in crippling pain, their motivation to stick with a physio program wanes easily. The siren song of a procedure with a nice rationale (‘get in, have a look and tidy up’) and fairly routine risks looks irresistable compared to slogging out the weeks and months of exercises with the sneaking suspicion that you are missing out on a short cut.

More subtly, the surgeon wishes to help, and is likely to be convinced by the patient’s sworn protestations of strict adherence to the physio program. Certainly this tendency is evident in the study, with fully a third of the group randomised to intensive physiotherapy crossing over the have surgery. The study population probably had a much better adherence to their exercises than a similar group of real-world patients. There is nothing left to do, it seems, but operate.

I wish to emphasise at this point that I’m not trying to say that people in this situation are foolish or weak for having surgery. More that the belief on everyone’s part that surgery will help is so overwhelming that even this very convincing evidence of lack of effectiveness will seem counterintuitive and somehow really hard to believe.

It demonstrates yet again the value of having organisations like Cochrane and academic clinicians like Prof Buchbinder to ensure that every risk patients take on is likely to be met with a reward.

I was notified today that last week’s article on chiropractic care of children and the related concerns about antivax CPD activities has resulted in a response from the Chiropractic Board of Australia (CBA). Much of the response we received was reproduced from other policy documents of the Board so in the interests of space I have selectively quoted from it below. The full text can be provided upon request by email.

First up, let me say I welcome the response from the statutory regulator to my piece. I raised what were for me some very concerning issues, and I can say that their response is reassuring in many places.

I suggested that CBA should decline to recognise CPD hours for activities found to be inappropriate and it seems that this what they are planning to do. To quote their response

The Board is investigating the CPD assessment and approval process and will report on its findings. The Board will revoke the approval of any course not deemed to be within the area of practice for a chiropractor or any course that fails to meet its standards.

It’s not mentioned whether that revocation would be retrospective, but one assumes it would be if the principle at stake is to be upheld. A very reasonable measure.

With regard to my call to emphasise the public health duty of chiropractors as an AHPRA-regulated profession, it is worth quoting again from their response.

While chiropractors may hold personal views as individuals about vaccination that do not align with the Board’s position, they must not allow their personal views to interfere with the care and advice of their patients.

Since the introduction of the National Scheme in July 2010, the Board has developed the standards that chiropractors must meet, including the Code of conduct for chiropractors, which clearly states that chiropractors have a responsibility to protect and promote the health of individuals and the community, and that they are expected to practise in a patient-centred and evidence informed context.

The code also states that, ‘chiropractors have a responsibility to promote the health of the community through disease prevention and control, education and, where relevant, screening.’2 The Board investigates concerns where this is not the case.

Advice about vaccinations falls outside of the expected area of practice for chiropractors. The Board expects chiropractors to refer patient questions about vaccination to other registered health practitioners who possess such training and expertise.

Half marks for that response, in my view. On the plus side, it states quite clearly that personal antivax beliefs are not to be pushed onto patients. If you get discouraged from being immunised by a chiropractor in their practice, they are breaching their professional Code of Conduct. Fair enough.

I am disappointed by their lack of outright endorsement of immunisation. You don’t need to possess anything but the meanest of intelligence to see the upside of it. In a previous article I highlighted the extraordinary achievement of polio eradication in India. This was largely achieved by providing purposeful, culturally-sensitive education about the basic benefits of mass immunisation. They already had the medicines to achieve it, but it was only when anti-vaccination misinformation was systematically countered that public health success was possible.

Surely that’s a bandwagon CBA should jump right onto! After all, it’s not like it’s a controversial or unconventional position. Every peak body remotely concerned with public health endorses it. It’s actually bipartisan political policy and has been for decades. No organisation apart from some of the tinfoil hat variety actually thinks that there is a problem with endorsing immunisation as a public health policy. Why do they need to be coy about their support?

With regard to chiropractic care of children, I cautiously welcome the posting of a new position statement on the CBA website. A selected highlight reads thus

Chiropractors receive extensive university training, including about caring for children. Like all health practitioners, chiropractors must take particular care to gain informed consent when managing the care of children and young people. This includes keeping parents/guardians informed with clinically relevant information relevant to the chiropractic management of children.

While individual chiropractors have their own beliefs and values, the Code of conduct for chiropractors makes it clear that those values must be secondary to the wellbeing of their patients and the promotion of health in their patients and the community. The Board expects chiropractors to offer balanced, non-biased health advice to their patients. When treating children and young people, this includes parents and guardians, as appropriate.

In maintaining good practice, practitioners should consider the balance of benefit and harm in all clinical decisions. Any care options or recommendations made to patients should be based on the best available information.

Again with the university training! I must say as a humble doctor, our university training is not regarded as nearly good enough for unsupervised practice. The average GP these days has worked in supervised practice for at least 4 years (usually longer) before being let loose on the public, and some specialty groups take even longer than that once the ‘extensive university training’ is completed. In medicine, it’s not unusual to spend the better part of a decade after graduation before commencing unsupervised practice. Hence the huge importance of postgraduate CPD in this debate.

It also appears the Board is happy that the university training is good enough to enable their graduates to provide ‘care’ for infants which has no scientific credibility, but utterly inadequate to permit them to draw the blindingly obvious conclusion that vaccines are good for kids. Puzzling.

The quoted segment refers to ‘best available information’ but this falls well short of my suggestion that no recommendation should be given that allows for such flimsily conceived ideas as birth subluxations, plagiocephaly treatment by chiropractic and the whole range of fanciful claims destroyed in the BCA v Singh case to prosper.

In another press release following last week’s article the Chiropractic and Osteopathic College of Australasia (COCA), which is the second-biggest professional organisation after CAA, drew attention to their unambiguous and strong statements about these areas which were exactly the sort of clear direction to practitioners that CBA could have chosen to give.

I can understand that CBA has no desire to get involved in the details of clinical decision-making, and is only charged with statutory regulation at a strategic level within the profession. I still find that they have left considerable room for some of their more reality-challenged practitioners to continue to get away with unscientific antics under their sleepy gaze.

So let’s wait and see what the Board’s CPD investigation finds out, and what their regulatory response will be. Many within and outside the chiropractic profession are hoping it will be a strong and clear message in support of the public health of Australians.

This weekend saw another exchange of views between chiropractors, the AMA and the Friends of Science in Medicine. It was set off by a number of stories by Amy Corderoy, the Health Editor at the Sydney Morning Herald, here and here and here.

In a nutshell, the issue was that government funding of chiropractic care for children under 14 was reported to have risen by 185% in four years. This prompted the AMA and others to question the advisability of this spending given the poor scientific evidence base for such care, as well as the potential for harm to children given that no clear benefit has been established. A particularly worrying point was the apparent tacit support of the Chiropractic Board of Australia for professional development courses run by opponents of mass immunisation.

The response from the Chiropractors' Association of Australia (CAA) can be found here. Predictably enough, the CAA has chosen to cast chiropractors as the hapless victims of a league of overpaid bullies representing unnamed but powerful medical interests.

What concerns me? The back story…

What particularly concerns me is the near-complete avoidance of any plausible effort to address the concerns raised by the AMA and FSM. The CAA release simply dismisses them as “purported concerns” and claims there is no evidence presented to back them up. According to one of the SMH articles,

National director of the Chiropractors Association of Australia Tony Croke said in the past 40 years no serious adverse health consequences of chiropractic had been recorded in a child.

Well, I have some news for CAA. It took me about a minute to find it on PubMed.

Here is one case. And here is another. Here is a whole systematic review of serious adverse events in children receiving chiropractic care, including some fatalities.

How about some more evidence to support the concerns raised in the SMH that chiropractic continuing professional development (professional education or CPD) actively supports presenters with an anti-vaccination agenda?

Here is a flyer for Tim O'Shea, a well-known antivax chiropractor. As you can see, it was advertised as “CAA Accredited”. Nimrod Weiner, the CAA’s current NSW Branch Secretary has regularly presented a “vaccination information” seminar that is packed with misleading inaccuracies. Chiropractors remain by far the largest professional group supporting the Australian Vaccination Network.

A paper presented at a major international chiropractic conference gives more cause for concern about the teaching of attitudes to immunisation in chiropractic training. (the abstract concerned is on page 63). This Canadian study demonstrated that positive attitudes to vaccination declined from 60% among first-year students (which is worrying enough you might think) to under 40% by fourth year and graduation. What is it about going to train as a chiropractor that could convince a third of those with pro-vaccination attitudes to drop their support?

Denial of public health responsibilities is unacceptable

If the CAA figure of 215,000 weekly visits to chiropractors is to be believed, the antivax activities of chiropractors may be creating a huge reservoir of underimmunised Australians. Preventable diseases spread quickly where such reservoir populations exist. For an AHPRA Board to tolerate the creation of such a massive threat to public health is frankly alarming. It’s not that hard to join these dots, yet the Chiropractic Board of Australia (CBA) seems unable to understand or accept that as a regulated profession, chiropractic shares the responsibility for maintaining public health.

Resorting to the PR technique of pretending to know nothing about immunisation isn’t good enough. The CBA has released a position statement advising that,

Patients have the right to make their own health decisions, but they need to be appropriately informed about the benefits and the risks to both the individual and the broader community associated with their health decisions.

Practitioners may often be asked to provide information not directly relevant to their competency or the scope of their practice; in such cases patients should be referred to someone with sufficient expertise in that field to have their questions or concerns addressed.

Advice about vaccination is not typically within the usual area of practice for a chiropractor. Current evidence indicates that preventative measures such as vaccination are a cost and clinically effective public health procedure for certain viral and microbial diseases.

The Board would clearly seem to have a direct and insoluble conflict of opinion with the likes of Tim O'Shea and the (soon to be renamed) Australian Vaccination Network, who both provide CPD resources to chiropractors.

Restoring credibility

In the interest of being seen as constructive, I’ll give some free advice to the CBA and CAA. Following these suggestions would go some way towards restoring some badly needed credibility for both organisations.

1. CAA should stop pretending that children have never been harmed by chiropractors, and should publicly retract their assurances to the contrary. After all, I’ve already pointed them towards some published evidence with a brief online search. I’m sure there’s probably more to find.

2. CBA should decline to acknowledge the CPD hours of those who have attended events which have a clear antivax agenda. It’s the least they could do now it is clear that CPD credit shouldn’t have been given to events which conflict with the Board’s clear directives.

3. Both CAA and CBA should acknowledge that chiropractors have a public health duty to participate in immunisation and recommend it to the general public. They should do this to prevent the creation of a large community who all are in contact with each other and have inadequate herd immunity.

4. CAA and CBA should encourage chiropractors to be educated about immunisation if they are of the opinion that it is not a particular area of expertise. Instead of giving their imprimatur to vaccine deniers, they could award CPD hours for undertaking online courses such as this one from the University of Pennsylvania.

5. Both organisations should acknowledge that the scientific rationale for treating children with chiropractic methods is substandard. The usual course for a responsible profession is that such treatments should be considered experimental, and not offered widely until compelling evidence of their safety and effectiveness exists. Neither should endorse treatment for children with the current state of the literature, since harm can exist, and benefits are not established.

This isn’t a turf war

It is quite clear that this is not a turf war. It never was. With just over 4300 registered chiropractors compared to over 91,000 registered doctors I don’t think we’ll be seeing doctors lining up at Centrelink due to chiropractors taking over any time soon.

Despite the protestations of CAA, this is very much a quality and safety issue. In large part it has been brought about by the ongoing denial of chiropractors that they have such responsibilities.

People like myself, the AMA, FSM and many others expect a lot of an AHPRA-regulated profession. We are not picking on chiros as much as we are holding them to the same standards we would expect of any health profession. I’m sure many rank-and-file chiropractors would welcome decisive leadership from the largest of their professional bodies to put these issues to rest.

The ‘blame game’ between Federal and State Health Ministers reached a new low overnight with Victorian Premier Ted Baillieu announcing that he had received ‘an extraordinary threatening letter’ from the Prime Minister which was apparently ‘accusing him of being unable to run the health system.’

Federal Health Minister Tanya Plibersek has given a scathing interview today announcing that she could ‘no longer allow the Victorian Government cuts to continue to affect patients in this way.’ So with gritted teeth and as much charm as she could muster, she has announced that the $107m budget cut for Victorian hospitals would be forestalled this financial year and the money taken from other Federal grants to Victoria.

From where I sit, as a humble clinician at the coal face of the system, this is about as graceless and humiliating a backdown as you could get. It is also a well-deserved one. Anyone who knows anything at all about running hospitals could have told you that with public money as scarce as it is, there are rooms full of very motivated people managing budgets down to the last dollar. Hospital administrators are obsessed with tracking how money is spent. To try and force such a big clawback through in the middle of the financial year was madness. To even try shows how out of touch they must be with conditions on the ground.

Let me give some examples. Elective surgery lists have been streamlined, remodelled and redesigned again and again so that cancellations due to bed unavailability can be minimized and hospital stays shortened. lists are planned well in advance, and surgeons are kept as busy as possible. Many surgeons have their leave planned for them, and adjusted minutely to ensure targets are kept on track. Imagine then having to tell them that for the next 4 months they will not have anything like full lists. Either the surgeon has to sit around and get paid for doing nothing, or they will go and find some of the work that beckons in abundance in the private sector. I know what I’d probably do.

Once the surgeons have found more work to do in other theatres, it is very difficult to get them back into the public hospitals. It relies hugely on the goodwill of the medical and surgical specialists concerned. Suddenly moving the planning goalposts in the middle of a financial year could have repercussions for elective surgery for months to come, and some of these specialists may be permanently lost to the private sector.

Now think about the nurses and allied health staff. Short term variations in ward workload are usually gotten around by forcing staff to take leave or not replacing sick staff. But bed closures are not actually cost savings unless nurses are not being paid, so sacking some or not employing casual staff is a given. Slashing elective operations like joint replacements is cost-effective in the medium term as rehabilitation staff like physios and occupational therapists can be dispensed with or their leave simply not covered. Then when you get some money again a few months later, you may have to deal with re-employing people who you just shafted badly a few months earlier, because they are the only ones with the skills and experience you need. They, too, may have departed the public system altogether in search of more secure employment.

So faced with such an abrupt and unexpected budgetary cut, what would you do if you ran a hospital? You would simply have to put off operations, close beds and lay off staff, and hope like hell that they came back to you when things picked up. There is no other way it could have been done to produce those savings in such a short time, with no preparation.

Nobody argues with the notion that health costs must be contained, and public money must be well-spent. Our health system is indeed needlessly complicated by Federal-State relationships and even by interstate rivalry. But the time and place to make big cuts is in the budgetary cycle so that these monolithic organizations can be allowed the chance to make good decisions. They need to be able to renovate, not amputate their services.

So when hospitals responded in the way they had to, it created a predictable and mighty backlash. One wonders what else Minister Plibersek thought might have happened? Certainly everything I’ve read from hospital executives in the media is consistent with my reasoning above. Any of them could have told the Feds what a bad idea this was, and what it was going to force hospitals to resort to.

A new study on diclofenac and cardiac risk suggests that the risk-benefit analysis for this commonly used non-steroidal anti-inflammatory (NSAID) should now be regarded as completely unfavourable. The implication of such a scientific judgement is that it should be withdrawn from sale altogether, as a public health measure.

Removing a drug from sale is advocated for various reasons from time to time. Some, such as dextropropoxphene seem to be effective, but are found to be no more effective than much safer drugs. Others, such as sibutramine turn out to have unforeseen risks which become apparent with widespread use outside of clinical trials.

Others are harder to understand. Lumiracoxib was a highly effective NSAID which in numerous patients of mine was effective at improving serious musculoskeletal pain where no other drug had been useful. It was, quite literally, a hope for some patients who had none otherwise. The problem was that 8 people out of the 60,000 who took it suffered significant liver damage. Of the 8 cases reported to TGA, 2 survived with liver transplants and 2 died so there was no disputing the seriousness of the liver damage.

The issue for my patients however was that none of them had abnormal liver function tests, and they couldn’t see how the drug should be denied them when they were quite happy to take on the 1 in 7500 chance of serious toxicity.

Isn’t this fair enough?

Fans of lumiracoxib were quick to point out the case of clozapine. Clozapine is a very potent anti-psychotic drug which caused tremendous debate in the mid-1990s due to its ability to improve severe chronic psychosis in previously untreatable patients. Its big drawback was that it had a habit of knocking off peoples' bone marrow and stopping it producing white blood cells. It does this at a rate of around 1 in 100 people who take it. When regulators moved to ban it from sale, they were met with requests from doctors and patients to waive their legal protections and keep taking it, as the patients whose lives were being changed remarkably for the better were arguing that they would rather risk death than go back to the nightmare they had been living before starting clozapine. A reasonable accommodation was reached whereby the drug company paid for the ongoing costs of regular blood tests to monitor the white cell counts and patients taking clozapine were given standard educational materials and asked to consent in writing to the treatment.

Commonly used antibiotics like flucloxacillin and amoxycillin/clavulanic acid have much higher rates and raw numbers of serious liver injury, but have never been close to getting banned. A supreme irony is that diclofenac itself killed more people from liver failure in its first 5 years of use than lumiracoxib ever did!

Beside these figures, simply banning lumiracoxib for a rare and potentially avoidable side effect still rankles as an officious overreaction.

The diclofenac data reported above has been known (at least in the circles I hang out in) for quite a while. Even the Daily Mail in the UK – hardly known as a beacon of common sense – reported this back in 2011 in quite a balanced way. The reason nobody is kicking up too much is that diclofenac is used overwhelmingly for short-term relief from acute musculoskeletal pain, and the additional cardiac risk doesn’t kick in unless you are using it consistently over the medium to long term. It also has quite a short half-life compared to many other NSAIDs, and thus even a daily dose will mean you’re spending most of the time throughout the day without high levels of it in your system. And there are many, many people who benefit from intermittent bursts of diclofenac where little else helps.

The well-characterised excessive cardiac risk of diclofenac should mean that discussions about this risk are built into long-term decision-making about treatments. Potentially risky treatments should be reserved for severe or recalcitrant diseases, and consumers should be kept fully informed. Banning a useful but risky treatment shortchanges consumers as much as allowing them to be exposed to an overly risky one. Informed consent shouldn’t be replaced by bureaucratic paternalism.

Happy New Year to all Convo readers! Here’s one in your eye to see in 2013.

But sadly, I predict that some of us may overindulge this festive season. I’m sure none of my intelligent and thoughtful readership would be so impious and impulsive as to overindulge. For those who may push the boat out too far, I offer the following information without prejudice or judgement, in a spirit of seasonal generosity..

Homeopathy

The Homeopathy Plus website is never short on advice about matters of worldly import. Apparently Nux Vomica and Carbo Vegetabilis are the remedies of choice. According to their website, Nux Vom is useful for headache or migraine following excessive consumption of alcohol; sensitivity to light, odours, or noise; nausea and vomiting; retching or ineffectual urging with vomiting or diarrhoea; and, undigested food sitting like a “rock” in the stomach. Those needing a dose of Nux vomica after over-eating will often say, “If only I could vomit I would feel better!” Sounds perfect for the holiday season! The plant used as a base for this remedy produces strychnine. Apparently When undergoing its homeopathic drug trials, some of the symptoms it produced, and so can treat (remember the Law of Similars), were symptoms similar to those of a hangover. During a homeopathic ‘proving’ ritual, undiluted base product is given to a group of people and the effects are observed and recorded (often in comical detail). I’m frankly gobsmacked that nobody died taking minimally diluted strychnine! Feeling hungover would be a positive relief after strychnine poisoning.

Carbo Vegetabilis on the other hand is made from carbonized vegetable matter. Exactly which vegetables are used to create the charcoal I couldn’t find out. I was thinking maybe I could make some out of diluting the burnt stuff in the bottom of roasting dish on Christmas Day. The homeopaths refer to this remedy as the ‘corpse reviver’. The TGA Advertising Code is very restrictive as it is, but I couldn’t find that necromancy is in fact a specific breach, so they can probably keep that claim going. The ‘indications’ listed on the website are positively melodramatic in their purple prose. Reach for the Carbo veg when there is indifference and apathy; extreme debility or collapse; coldness with an aversion to heat; difficulty in breathing, air hunger and desire to be fanned; unable to lie down – must be propped up; symptoms of heart failure and, extreme bloating, indigestion and belching. These last symptoms make it a useful prescription for over-indulgence, whether the person is at death’s door or not!

I am very indifferent and apathetic. I LOVE being fanned like you wouldn’t believe and often need to be propped up. I have been known to belch fit to make the windows rattle. Carbo Veg, where have you been all my life!

Traditional Chinese Medicine

Ok, so if homeopathy isn’t your bag, what about TCM? Check out Dr Shen’s herbal stuff. Apparently the cause of that overwhelming nausea and retching the next morning is not that the whisky has peeled back my stomach lining like cheap wallpaper, and paralyzed its peristaltic movements. It obviously is my ‘rebellious stomach qi’. Down boy, down. Good qi.

I must say though, there are some sensible types among TCM practitioners. Have a look at this non-story. They go to all the trouble of asking an acupuncturist how to beat hangovers, and the best advice she can offer is….eat some seaweed before the party so the seaweed soaks up the alcohol and you don’t get drunk. That’s outstanding. It really demonstrates why they need to have years of study and their own statutory Boards to regulate the TCM profession. Wouldn’t want knowledge like that ending up in the wrong hands…

How about some spirulina? All you do is put a heap of them in 2 big glasses of water to drink before going to bed, and have the same again in the morning. Genius.

In no particular order, here are a few more tips from altMD.com

-Acupressure

Point LI 4 (between the thumb and index finger) relieves headache and stomach ailments and the B2 points (upper edge of the eye socket) relieves headache accompanied by light sensitivity.

-Aromatherapy

The nausea of hangover may be relieved by drinking an aromatic cocktail of water, lemon juice, and a drop of fennel essential oil before breakfast.

-Imagery.

The hangover sufferer may visualize being on a ship in a stormy ocean. The ocean gradually becomes calm until the ship is gently bobbing in the water.

-Probiotics.

The bacteria Bifidobacterium bifidus is able to remove alcohol breakdown products. To fight hangover, naturopaths recommend taking B. bifidus before going to bed and again the following day.

-Supplements.

Taking 50 mg of vitamin B3 before going to bed may relieve hangover.

-Hydrotherapy.

Drinking a glass of water containing activated charcoal powder before going to bed may absorb alcohol in the stomach and reduce hangover symptoms.

So if you happen to chance upon me lying on the footpath near you tomorrow morning, with empty bottles of probiotics, fennel oil and berocca around, dark smudges around my mouth from the charcoal, with my fingers pressed over my eye sockets and chanting to myself “The ocean calms my bobbing boat”, please don’t call the police like any right-thinking member of the public would.

I’m just being open-minded.

The recent resurrection of the fluoride debate by a sitting LNP Member is just the latest example of pollies who alter reality to suit their particular brand of populism.

Perhaps Mr Woodforth wants to push his most fervently held ideological position onto the front pages before he loses his seat. Perhaps he thinks he can win the very marginal seat again by publicising wingnut theories which play well in his electorate. I’m not sure which depresses me more.

The tropes he repeats in that article, where fluoride is described as a ‘brain-altering chemical,’ go right back to post-war Europe.

IG Farben was a giant German company which made all sorts of industrial chemical products including dyes, photography materials, pharmaceuticals and agricultural chemicals. At its peak before the Second World War it was the 4th largest company in the world. Due to its intimate involvement in Nazi war atrocities, IG Farben was broken up by the Allies and Russians after the war and many of its senior management were tried for their crimes.

The light sentences handed out to these executives and strong links to other New World Order staples like the Rockefellers and Standard Oil, mean it has become the subject of a rich vein of conspiracy literature. The post-war history of IG Farben is a sorry tale of greed and power in its own right, and none of the people or groups involved come out of it with much credit.

So according to the ‘Conspiracy Planet’ website Farben had developed plans during the war to fluoridate the occupied countries because it was found that fluoridation caused slight damage to a specific part of the brain, making it more difficult for the person affected to defend his freedom and causing the individual to become more docile towards authority.

The gist of the fluoride conspiracy is that industrial chemical producers want to dump their fluoride-containing waste into the water supply. The benefit for them is that they get to cheaply dispose of waste products. The benefit to the various governments involved is that a population which drinks fluoride-containing water is much easier to control. The science which supports the health benefits of adding fluoride to drinking water has apparently been fabricated. To quote again from ‘Conspiracy Planet’ The ‘discovery’ that fluoride benefited teeth, was paid for by an industry that needed to be able to defend lawsuits from workers and communities poisoned by industrial fluoride emissions and turn a liability into an asset.

The problem for the cranks is that the science in favour of water fluoridation is very sound.

Even the seemingly strong argument that ‘mass medication’ is unethical or infringes human rights has been repeatedly struck down by courts all over the US.

Fluoride in drinking water in a dose range of between 0.6 and 1.2 parts per million (ppm) is able to reduce rates of tooth decay by between 20-40%. Communities with naturally occurring concentrations of over 4 ppm generally have their water treated to bring the concentration down. Excessive environmental exposure leads to the fluoride ions replacing calcium in teeth and bones. In teeth this only causes some discolouration but severe skeletal fluorosis can lead to brittle bones that are painful and fracture easily. Drinking water concentrations that lead to this severe effect need to be above 5ppm. Outbreaks of skeletal fluorosis have been linked to big volcanic eruptions, which can create atmospheric concentrations of up to 1000ppm for weeks at a time.

So having fluoride in the water at the standard doses allows for a huge margin of safety with what is still a very positive overall effect. A summary of the economic and public health benefits for Australia can be found here.

It’s ironic that a local MP with a background in fitness and bodybuilding is trying to leave a public health disaster as his political legacy. Mr Woodforth should wise up and learn some science instead of just googling conspiracy websites. Fluoride conspiracy theories are harder to kill than zombies, and just as brain-dead.

Every so often a new potential drug or supplement treatment bobs up in the literature and is worth looking into. The latest one to pique my interest is palmitoylethanolamide (PEA to its friends).

The article I saw was this one in my monthly edition of the Faculty of Pain Medicine’s professional journal. Here is a link to a full-text, free article which summarizes the state of play with PEA.

I thought it might be fun to go through with the help of my dedicated, thoughtful, intelligent and engaged readership a process of deciding whether I should start recommending it to my patients. For starters I’ll set out my thoughts which can then be critiqued and added to in the comments. Further evidence can be sought and discussed. We can also have a discussion about the threshold for deciding when to drop the objections and start using it in practice.

Are you along for the ride?

So here’s what I’ve done so far.

The above full-text article seems to me to do a fairly good job of setting out the rationale for thinking that PEA could be helpful for neuropathic pain. The first step I use in assessing a potential treatment that I haven’t heard about before is to check out the claimed mechanism of action to see if it’s plausible. So I go to PubMed and chuck in a fairly general search item, which returns a page like this. Scrolling down the linked articles, I am able to access several which give an account of the proposed mechanism by which PEA might have analgesic effects. The findings about PEA and its role in regulating proteins involved in signalling pathways of both pain and inflammation are part of wider research within a fairly mature field of inquiry. So the first step is achieved. Accepting that PEA might work as an analgesic compound does not seem to require any new science, and is completely compatible with what is already known about endogenous lipids. In fact, given its structural similarity to anandamide, which is one of the main endocannabinoid system regulators, it not only seems plausible but no surprise that it might be useful. Knowing how it is proposed to work can also enable us to make predictions about the sorts of pain that it might treat.

Having decided that it is indeed worth looking more closely, the next step is to look at the reported observations that form the basis of the deduction that PEA may be an analgesic. The initial study that prompted my interest was an observational case series involving several different types of neuropathic pain. I also can find case series with objective outcome data (not just patient self-reported outcomes) in Carpal Tunnel Syndrome, and chemotherapy-induced neuropathy,. Importantly, there is not just a single researcher’s name which keeps cropping up in all these papers. They are mostly from Italy, but there are some papers from other parts of Europe and the US as well. The presence of multiple sites of reporting helps to defuse the suspicion that this novel treatment is just a crank idea pushed by a couple of individuals with monomania.

What about randomized controlled trials of PEA? We have the supportive basic science and observational studies. The next step is high-quality RCTs to confirm efficacy versus placebo, and also head-to-head trials against other accepted analgesics.

Here we begin to stumble.

While the case reports and observational studies look good, there still remains a paucity of RCT data. Not surprising given that the ink is barely dry on most of the basic science and observational studies. I can find a small RCT of PEA vs ibuprofen for temperomandibular pain which has good methodology but a very small sample size (24 patients) which favours PEA. Another Italian pilot study used it for postoperative pelvic pain with some benefit. In this study PEA though better than placebo was not superior to celecoxib, which is the standard anti-inflammatory of choice for postoperative pain.

Does anyone think it’s time to head out and buy shares in PEA farms yet? Let’s discuss it!

The announcement on Friday last week that pregabalin (Lyrica) had made it onto the PBS is a huge relief for sufferers of chronic nerve pain.

It also means that the true cost of providing appropriate care to chronic pain sufferers can be better measured. Too many GPs and other doctors are forced to prescribe opioids for nerve pain when the evidence for their usefulness is known to be unconvincing. As previously mentioned in this column, long-term opioid therapy for non-cancer pain has limited benefits compared to the potential for reduced quality of life, even if the generally overstated risk of abuse and addiction is discounted. This is especially true for nerve pain, also known as neuropathic pain. The pain is simply generated in a way that opioid drugs don’t really influence.

In choosing to accept the PBAC recommendation to list pregabalin, we are finally seeing some movement on the issue of the scandalous undertreatment of chronic pain in Australia.

But Minister Plibersek and her bureaucrats have missed a big trick.

Gabapentin is an older drug with the same basic mechanism of action as pregabalin. It is out of patent and is manufactured by a number of generic manufacturers, including some Australian ones. Gabapentin will never be listed on the PBS despite its proven effectiveness because the company which originally held the patent is Pfizer. Pfizer also developed pregabalin, and will be the beneficiary of essentially all of the half a billion dollars that this listing will generate for it. There is no commercial imperative for them to reapply for gabapentin, which is what the current listing process demands.

However, if the Minister had insisted that gabapentin be listed alongside pregabalin, there would have been a cheaper alternative drug with the same mechanism of action, and which most experts agree is equally effective. Moreover, the financial rewards for treating neuropathic pain would not then all go to Pfizer, but would be split to include some home-grown generics.

It would have been a win all round. Doctors would have access to two first-line drugs instead of one to treat neuropathic pain. The PBAC could specify that gabapentin must be tried prior to pregabalin via the Authority system. Patients would have had the option of trying a different agent if they can’t tolerate the side effects of pregabalin (in our experience over the last four years of prescribing both drugs this happens a lot.) And finally the local generic drug manufacturers would get a share of the profit from treating locals more effectively. The total cost of treating neuropathic pain more effectively would arguably also be less, as for lower doses gabapentin is more cost-effective and better tolerated than pregabalin. The only losers from all this would be the Pfizer executives and shareholders.

So while I welcome with relief the news that pregablin will be available on the PBS, I can’t help thinking that we could have done better all around. We need both drugs to be available.

This article greeted my tragically decaffeinated gaze this morning as I fired up the computer at work. You’d have to be concerned about a senior drug and alcohol clinician like Alex Wodak saying something like ‘We’ve got a hell of a problem’ with prescription painkillers. Especially when that respected clinician writes for this very website!

As with all medical stories patients ask me about, I thought I’d find the actual source of the reporting. Turns out it was this report from the National Drug and Alcohol Research Centre (NDARC). This is a collation of the deaths in Australia related to opioid overdose over the last few years. It is worth looking hard at the methodology behind such reports, as they are not subject to the same peer review process as journal articles.

Before getting to the conclusions, my usual process is to check whether I even believe the assumptions the researcher has made. If some of them are a stretch, have they acknowledged this? Looking at this report, I see that there are some significant assumptions, and that there is a whole section, entitled ‘Notes on Findings’ with just such a discussion. So far, so good. The notes point out that there have been some changes in the way that overdose deaths are recorded, and that this may mean that between some states and some years, we may not be comparing apples with apples. Leaving these reservations aside, is it possible to get a better feel for the scope of the problem? Are we on the way to a public health disaster like the US?

I have to say I’m concerned about the rate of opioid-related deaths in Australia. But perhaps not as worried as I am about the road toll. The number of deaths from transport accidents in 2011 was 1,291, which represented a fall of 4.4 percent from 2010, and a full third of the total from a much smaller population in the early 1970s. This compares to 551 for opioid-related deaths in 2008, with projected rates of 612 for 2009 and 705 in 2010 awaiting formal confirmation. This also includes a fair chunk of deaths from heroin overdose, at rates that have been stable at a lowish level since the heroin drought of 2001 began.

The highest rate of deaths due to opioid overdose was during the late 1990s from heroin overdoses. Those peak rates were around double the number of deaths that we currently are recording, and are still well below the States where opioid overdoses rank just behind motor vehicle crashes as a cause of death in young and middle-aged adults. The US has around 14 times the population of Australia (311 million vs 22 million) but it has 60 times the number of overdose deaths (37,000 vs 612 in 2009).

So what do we have going in our favour? Stricter advertising and sales controls on prescription drugs for a start. More lenient marijuana and alcohol laws for another, though this is just my speculation.

On the other hand we have thousands of GPs who feel poorly equipped to know how to prescribe these drugs appropriately. We have minimal enforcement of opioid regulations except against those who are already using them legally. We have a lack of community awareness that the right to pain relief needs to be coupled with the responsibility of being an informed and disciplined consumer. We also have a real lack of awareness of the long-term health penalties that go with medium or high-dose opioid use, even for therapeutic purposes.

We have a resounding absence of leadership federally on the issue of centralized monitoring of opioid scripts and who is writing them. Despite much fanfare when announced the $5 million Electronic Recording and Reporting of Controlled Drugs system remains a spectral presence, the merest phantasm of a useful product. Such systems have been shown to be effective at reducing aberrant prescribing while not affecting legitimate pain patients, but it seems that even this basic and comparatively cheap measure is beyond our health bureaucrats to implement. It was supposed to begin in July, but it’s now October and we still don’t have any news about a rollout…

So while I don’t expect this very complex and nuanced problem to be fixed any time soon, it helps to know that we’re not as bad as some news columnists would have you believe. The solutions that will reduce the availability of trafficked prescription opioids are not overly complicated. They do however some money to be spent in an area where there is no real electoral payoff. They also require a culture change in education of health professionals and the community to provide accurate and nonjudgmental information about the potential benefits and harms of medium or long-term use of opioid anagesics.

Addicts, abusers and the anxious will always tend to prefer opioids because of the effects they can have on their brains. Some will demand them to treat pain even when they aren’t helping because they have been raised to believe that there should be a pill for every ill. Most people, in my experience, have a healthy attitude to painkillers. They want them to work when they take them, and they want to be off them when they aren’t necessary anymore. For the minority who can’t control their intake of prescription opioids, the answer is in having GPs who understand these drugs and prescribe them according to best practice, backed up by pharmacists who have the training and electronic capability to monitor their supply and spot those gaming the system for criminal purposes. Penalties for prescription drug trafficking should be harsher than for illicit drugs, to ensure that it becomes a high-risk decision for those better-organized criminal types looking for an easy buck. Potentially unpopular legislation is therefore part of the regulatory solution to the problem.

Simple, isn’t it?

I recently attended the Faculty of Pain Medicine’s Spring Meeting at Coolum. The Faculty has just launched a new online education initiative in conjunction with the Royal Australian College of GPs (RACGP) which aims to start closing the yawning gap in knowledge between the average health professional and the state of the art.

One of the really impressive things about the program is that is has deliberately been done without taking a cent from the pharma industry. Most of the $200K plus that it has cost has come from a grant from the Bupa Foundation, a charity which funds initiatives aimed at improving the health of the Australian population.

One the speakers at the weekend was Dr Jerome Schofferman from the US who researches and lectures on spine care and medical ethics. There is abundant research that doctors and other health professionals are as susceptible as everyone else to smart sales techniques.

Schofferman suggests that industry should be allowed to sponsor conferences and events, but they should be confined to the trade or exhibition area only. Branding on programs, speaker slides and in accommodation areas should be banned, and delegates should free to enter and leave the conference rooms without having to run the gauntlet of trade displays.

Incredibly, the medical-industrial conglomerates directly sponsor as much as 60% of continuing professional development (CPD) in the US, and Australia may well be similar. The Medical Board of Australia enforces mandatory participation in a CPD program, and every professional body runs their own. That’s a lot of education that somebody has to pay for if the current major sponsors are discouraged.

Given that it costs a heap and is compulsory, who should bear the cost? Travelling to conferences and staying at hotels is expensive and time-consuming. For those in private practice there is the double blow of not earning while away.

In Victoria, at least, there is an allowance that public hospital doctors can use to get refunds for such expenses. This has been a very useful tool in giving some freedom from industry-sponsored trips to big conferences, but it does not include GPs or private practitioners. The arrangements to relieve the CPD costs of nurses and allied health practitioners in the public sector are almost non-existent by comparison.

The Medicines Australia surveillance of pharma companies is one of the strictest in the world, and has been helpful in limiting the marketing of participating firms. A revised code is undergoing a lobbyist-led watering down process, but a simpler option is for pharma companies to just opt out of the Medicines Australia self-regulation framework. At present there’s nothing legally stopping them from doing so.

The marketing of health-related devices (implants, orthoses, gadgets) is still so loosely regulated it would make Big Pharma blush. Perhaps that’s a topic for another day.

What we need to counter the problem is for CPD provision by Colleges and Faculties to become more professional. The RACGP is already doing this very well. Industry sponsorship of CPD should be paid into a pool which is distributed according to educational priorities of learners, not commercial interests of sponsors. Marketing activities at conferences should be restricted to the trade and exhibition areas.

But the public health sector needs to do more to support the compulsory CPD needs of its employees as well. The more often that health professionals can attend non-commercial CPD sessions, the more likely they are to be getting good information rather than spin.

And finally, individual health practitioners of all stripes need to ensure that they don’t continue to encourage industry to spend on marketing disguised as education by being very choosy about what events they attend and how they interact with sales reps.

There are many guidelines which set out how ethical and mutually beneficial relationships with industry can be observed. I’d be interested to hear what other initiatives are out there to help separate CPD from industry influence. We owe it to ourselves and to our patients to seek them out and follow them.

The author is Chair of the CPD Committee for the Faculty of Pain Medicine and is currently helping organize a large scientific meeting for next year.

It’s been another interesting week for those who follow the literature on CAM.

To start off there is this article which is a big and well-conducted meta-analysis of Omega-3 supplementation in cardiac prevention. Even at a glance, it is apparent that the methodological niceties have been observed, since three very important comments are made up front. Firstly, the numbers are very big (over 68,000 patients in the studies analyzed). Secondly, they used 20 large studies for comparison and have included robust assessments of the heterogeneity of the studies involved. This is very important in a meta-analysis since in basic terms it accounts for the fact that different methodologies can give different answers, and different populations under study will also give variable results. Using fairly rarefied stats techniques one can compare across studies with some degree of confidence. The third piece of crucial information is to note that they have accounted for multiple comparisons. This is important because if you are performing lots of analyses, you will get some correlations as a matter of chance. The more comparisons, the more likely you are to come up with statistically significant correlations which disappear in subsequent studies. Any study which uses multiple regression techniques to get at hidden secrets in the data has to report that they have adjusted for multiple comparisons, and these authors have done just that.

So even before getting past the abstract, this looks like a credible study. It demonstrates pretty comprehensively that Omega 3 supplements aren’t effective at preventing cardiac problems like heart attacks, stroke, sudden death and arrhythmias. What makes this study more credible is that it has included both dietary and supplement studies. So whether you are getting your Omega 3’s from a capsule or from tins of tuna, it seems unlikely based on this very large and convincing study that they are doing much good.

The Cochrane Back Group has just released an updated systematic review of spinal manipulation therapy for acute low back pain (LBP). ‘Acute’ back pain by definition is pain which has been around for less than 6 weeks. The natural history of acute LBP is that 80% is better by 8 weeks, and half of the remaining patients get better over the next 8 weeks. This is a condition which has a high rate of spontaneous recovery over a couple of months no matter how agonisingly painful it is for the first couple of weeks. It is therefore not an easy condition to show a definite benefit for any proposed treatment. Unsurprisingly, there is no robustly evidence-based treatment for acute LBP apart from avoiding bed rest as much as possible. On the background of this lack of really effective treatments, manipulative therapists such as chiropractors and osteopaths have gained some acceptance while better evidence was awaited. The Cochrane acute LBP review of spinal manipulative therapy (SMT) was last updated in 2004. The new review includes 12 trials in addition to the 8 available in the previous review. The authors note that they included trials from the manual therapy, chiropractic and osteopathic literature in their search. Their conclusions deserve to be quoted in full..

“In this review, a total of 20 randomized controlled trials (RCTs) (representing 2674 participants) assessing the effects of SMT in patients with acute low-back pain were identified. Treatment was delivered by a variety of practitioners, including chiropractors, manual therapists, and osteopaths. Approximately one-third of the trials were considered to be of high methodological quality, meaning these studies provided a high level of confidence in the outcome of SMT.

Overall, we found generally low to very low quality evidence suggesting that SMT is no more effective in the treatment of patients with acute low-back pain than inert interventions, sham (or fake) SMT, or when added to another treatment such as standard medical care. SMT also appears to be no more effective than other recommended therapies. SMT appears to be safe when compared to other treatment options but other considerations include costs of care"

So that’s two strikes for two very popular and widespread CAM modalities. The third leg of the trifecta is this study in the prestigious Annals of Internal Medicine journal.

On the face of it, this looks to be a definite plus in favour of acupuncture for chronic pain conditions, but it simply isn’t what it appears. The abstract doesn’t report heterogeneity analysis, neither does it report adjusting for multiple comparisons. Both these deficiencies reduce your confidence in the strength of the conclusions. They are also just reporting pain scores, not pain-related disability or other functional goals. But let’s not quibble. Let’s suspend routine critical thinking and give them a pass on this. What are they actually reporting?

“Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.”

The actual effect size they are reporting as ‘modest’ is actually more like ‘negligible’ when talking about chronic pain. Although it might be statistically significant, it is too small a difference to be clincially signficant. They are reporting with a straight face that 80% or so of the benefit of acupuncture that they have been able to torture out of the data is in fact not due to the specific effects of putting the needle in.

Slap me if I’m being thick here, but isn’t careful placement of the needle into the strictly defined acupoint the whole thing acupuncture is meant to be about? If this was a Big Pharma drug trial it would be wipeout that would probably precipitate a marked decline in prescriptions.

If that is the best possible result they can get by disregarding the usual standards of a meta-analysis, I think I’ll be referring my patients for a cup of tea and a chat with my mum before I send them for acupuncture, since the majority of the benefit comes from having a charismatic and sympathetic listener.

PS. I’m kidding about the referrals bit Mum, not the other bit!

BREAKING NEWS

My copy of Pain has just dropped through the letterbox and it contains another 2 acupuncture-related articles of relevance. This one is a test of acupuncture analgesia on human experimentally-induced pain using both sham and real acupuncture needles. It showed no useful effect in any of the usual tests of effective analgesia.

The other was a very tightly designed RCT in acute LBP, comparing usual care with placebo acupuncture (ie placing needles in the ‘wrong’ spots), sham acupuncture (using retractable needles) and real acupuncture (done according to TCM principles). Regular readers will be able to guess the result.

Yep, you guessed it.

All 3 acupuncture arms did slightly better than the ‘conventional treatment’ arm, but not any better than each other. Confirming again that acupuncture is a strongly context-based treatment where the needles are essentially a prop.

The MJA this month leads with a startling statistic. Diabetes-related foot disease is apparently causing ‘a limb (to be) lost every 3 hours.’

As someone who works in amputation rehabilitation for a living, I think the data are more nuanced than just the scary headline. Let me start by saying that I don’t disagree with the authors of this article in their conclusions. The impact of foot disease in diabetics is a massive and costly problem which is currently underestimated and underfunded. The best evidenced-treatments such as custom footwear and multidisciplinary team care are not currently accessible for most diabetics, even in tertiary care. In our unit, following a major lower limb amputation operation, our patients have an average length of stay of around 6 weeks in rehabilitation. Some stay much longer, especially if they can’t return home. Preventive foot care may save some of these very expensive and prolonged hospitalisations, which can only be a good thing. The cost-effectiveness of these preventive interventions looks like a no-brainer when you examine the costs of amputation surgery and the subsequent lengthy rehabilitation that results. Even more so when the costs of moving amputees into long-term residential care are considered.

What does irritate me a bit is the seemingly irresistible urge for well-intentioned clinicians to stereotype amputees by the very language they use whenever the subject is discussed in the public domain. An amputation operation is almost always referred to in public discourse as ‘limb loss’. The commonest diabetes-related operations are partial foot and trans-tibial amputation, at the level of the middle of the foot, and the upper third of the shin respectively. Neither is even close to a whole lower limb. Both usually result in an amputee who, when fully rehabilitated, can function with reasonable independence compared to their state before the operation. The amputation operation in each case should be understood as a reconstruction of part of a limb to save life (if life is threatened) and to leave the amputee with a residual limb they can use. So rather than referring to an amputation as loss of a whole limb, it is much more inclusive and less stigmatizing to be accurate with your language, and don’t simply assume that having part of a limb is the same as not having one at all.

My own observation from the coalface, where I have been involved with amputation rehabilitation on and off for over a decade, is that while we may be doing more amputation operations than ever before, there are good reasons for this. Ten years ago, it was uncommon to have an amputee who was on kidney dialysis. In 2002 as a rehabilitation trainee in Geelong we had exactly 3 for the whole year, representing less than 10% of our workload that year. Now, at least half of our amputees are on dialysis. They have had longer and more complicated hospital stays prior to their amputations. It seems to me that diabetics are living longer while sicker, and this is why more of them are surviving long enough to undergo end-stage operations like lower limb amputations. The clinical and social role of the lower limb amputation operation has changed hugely in just the last decade, but it is still seen by many as an admission of medical defeat, and as a procedure where shame, disfigurement, disability and misery are inevitable. With appropriate rehabilitation (not always readily available outside metropolitan areas) this doesn’t have to be the case.

One of my mentors in rehabilitation once said to me, ‘You should be kind to amputees, because you won’t know them for long.’ A decade ago, the chances of surviving 2 years after a major amputation were only around 50%. The big killers were heart attacks and strokes, symptomatic of the blood vessels that had reached the end stage of their diabetes-induced deterioration. I believe we do much better than that these days, due to improvements in diabetes treatment, but at least as importantly because of more systematic preventive care for diabetics. But as the Australian type 2 diabetes epidemic enters its second decade, and goes into the truly expensive and overwhelming phase that has been predicted for a while now, the search is on to find smart and effective ways of delaying or preventing altogether some of these big-ticket consequences.

A Senate Committee report released nearly a year ago which recommended that the Federal Government stop using the PBS for political grandstanding has finally had a response from the Health Minister Tanya Plibersek.

Her response was deeply disappointing. It hints at a Cabinet willing to sacrifice the highest principles for short-term expediency.

Under the guise of ‘fiscal responsibility’ the Minister rejected all the recommendations of the Committee, preferring to continue the current policy of reserving the right to delay the listing of even low-cost PBS additions until the economic and political priorities of the moment seem favourable. It is worth remembering that this tactic was introduced last year by the Gillard Government, who insisted on deferring the addition of 7 new drugs until it suited them to put them on. This broke a bipartisan convention of pollies butting out of of the PBS approval process which had lasted since 1948. Through the tumultuous 1970s, the recession-hit 1980s, the economic rationalism of the 1990s and even the GFC of the last decade successive Governments followed the compassionate and humane course. All sides agreed that as soon as practicable after a drug was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) it should be available for subsidised use. Following the unprecedented cost blowout when Celebrex was introduced in August 2000, decisions regarding listing of a drug with an estimated cost of more than $10 million in any of the first four years on the scheme have been taken by Cabinet since 2001.

In the 20 years prior to February 2012, only 2 PBAC recommendations were rejected or indefinitely deferred by the Health Minister of the day. There was Nicotine patches in 1994 and Viagra in 2002. Both indefinite deferrals were because of very high expected cost, despite recommendations of cost-effectiveness to the the contrary by PBAC. In February last year, with the political imperative of a Budget surplus to produce, no fewer than 7 drugs were indefinitely deferred by then Health Minister Nicola Roxon. In the face of community, industry and political outcry, 2 of them were added to the PBS during last year, but the Committee could find no explanation as to why these were chosen and the others weren’t. Nary a soul from the Department of Health and Ageing could outline to the Committee a process by which the other drugs in limbo could progress their listing. A worrying precedent has been set.

The Senate Committee found that the antics of last year constituted a significant and concerning departure from usual policy. Claims by the Gillard administration at the time that it was a temporary change to the process were about as convincing as promises of imminent free elections by a Central American junta which has declared a state of emergency. And now Minister Plibersek has announced formally that this supposedly temporary enlistment of the PBS process to help with a short-term political goal is here to stay. As the submission from the Council of Social Service Networks put it

The PBAC is an independent statutory body established to provide expert advice to the Minister. Its advice is based on independent assessment made in the best interests of the community in terms of health, safety and cost…The Commonwealth Government is now politicising a process that used to have expertise, integrity and independence

The end result may well be that Australian patients will miss out on the best available medicines, as has begun to happen already in New Zealand. Mr Brendan Shaw from Medicines Australia testified to the Committee that

When you look at what has happened in New Zealand over the last 20 years, the industry has basically abandoned New Zealand. There are medicines available there. Some of the medicines available in New Zealand are forty years old and have become lesser used in Australia. Basically, a lot of the New Zealand market is now run out of Australia because of the commercial environment in New Zealand. Patients in New Zealand have to wait much longer for medicines than patients in Australia. There is various data that we are happy to provide you with that shows that New Zealand, in terms of access to medicines, is one of the worst countries in the OECD

Several other witnesses expressed grave concerns that the expertise of Cabinet was simply not sufficient to make the type of complex clinical and cost-effectiveness judgements that are the bread and butter of the PBAC. I can think of one very smart play which Cabinet will undoubtedly miss. They are currently waiting to consider a recommendation for a nerve pain drug called pregabalin. It must be listed as a matter of urgency because there is no comparable drug for a fairly common and severe problem. It will be expensive because there is no other PBS listed treatment for the same condition. There is an older drug in the same class called gabapentin which is only marginally less effective, better tolerated at low dose, will work in some patients where pregabalin doesn’t and is already off patent. Listing both drugs will work out cheaper than listing just pregabalin, and will arguably benefit more people with nerve pain. It will also spread the profit among several companies, including generic manufacturers, rather than just being a bonanza for Pfizer, which owns pregabalin. Of course, only someone like me who has been prescribing them both for the last 5 years week in, week out would realise this. That’s kinda the point of having ‘experts’ to advise you.

The availability of affordable, effective and safe medications has been a cornerstone of Australian life for more than 60 years. The PBS is a justly revered institution which has always been considered to be above the political turmoil of the times. I call on Minister Plibersek to look at the history and principles of the national monument her Government is threatening to deface, and stand up to her colleagues in defence of it. By the time she’s old enough to benefit from a strong PBS, it may have gone….

It’s been a really interesting month for those of us who follow the chronic pain literature.

The idea that higher brain processes such as attention, emotional functioning and even language can be affected by chronic pain processes has been around for a while. The evidence has been building for a few years that conditions which give rise to persistent pain affect the whole brain and spinal cord, but there have been 4 studies come across my desk this month which elegantly demonstrate unexpected facets of this idea.

The first comes from a group of German researchers who hypothesized that Complex Regional Pain Syndrome (CRPS) may cause a shift in the perceived midline as judged both with visual feedback, and in the dark. The perceived midline is an important measure of spatial awareness as it compares how closely a subject’s idea of where ‘straight ahead’ is with external reality. Conditions such as strokes which damage the parietal and temporal lobes tend to cause dramatic changes in the perceived midline, usually moving it to the left for reasons which needn’t detain us at the moment. The study is in pre-press and will soon be published in PAIN . In graphical form, here is what they found…

The practical consequence of this study is not obvious. It is profoundly important for understanding the rehabilitation of patients with such pain, as the implication of a shifted midline perception is that the brain is no longer paying attention to that sensory field. In extreme cases, this is called hemispatial neglect and is highly disabling. It is as if the high-level sensory and motor areas have written off any input from that half of the body and the space around it. This dovetails nicely with the clinical observation that in CRPS, constant sensory stimulation and movement of the painful area results in a better outcome. It also jibes nicely with the classic observation that many CRPS sufferers preferentially use their ‘good’ hand to do tasks, even if they have to cross to the other side of their body where the ‘CRPS’ hand could easily reach it.

A second nice study looked at visual attention. Psychological theory holds that perceptual processes give priority to objects in the environment which are assessed as potentially threatening. The evolutionary benefits of such a bias are obvious. If you are a dedicated arachnophobe like my middle son, you are always that first to spot a spider that others seem blind to. If you are thinking seriously about a buying a particular model of car, you seem to start coming across them everywhere. This group of Chinese neuropsychologists extended this reasoning to predict that subjects with a very high fear of pain should react more quickly to visual pain cues. What was particularly novel about their experiment was that it used flashcards with pain-related words on them, ie something of no visual threat value but requiring cognitive processing before the threat value was obvious. They used eye-tracking equipment to show that even without conscious effort on the part of the pain-fearing subjects, their eyes flickered more often towards the pain-related words or ‘health catastrophe’ words than did those with a low fear of pain.

Note that these were healthy adult volunteers, rather than chronic pain patients. This experimental finding is in line with the broader sweep of data that strongly support the idea that tackling fear of pain is a significant step towards normalising brain function in those who have chronic pain. Reducing attentional bias towards bodily pain or threats of pain has long been a major strategy for successful self-managers of chronic pain, but we are now really getting to grips with why that might be so.

The third study of interest involves what is probably the best-named test in the literature…the rodent gambling task. The researchers, this time from Portugal, were investigating another part of the brain thought to be impaired by chronic pain – the orbitofrontal cortex. The OFC is often injured in vehicle accidents, as it sits at the front of the skull right where the brain crashes against the ‘dashboard’ of the eye sockets in a front-on impact. Impaired output of the OFC tends to result in impulsive, emotionally-driven decision making without much reasoning or the ability to prioritize. It may also be significant in social cognition. The Portugese study showed that rats who had electrodes recording their OFC activity would make calculations of reward size, and tended to favour risk-averse, optimal gambling strategies when not in pain. In the presence of an inflammatory arthritis, there was a notable change in the activation of the OFC neurons, and the risk calculations went out the window in favour of a high-risk, high-reward game.

This pattern of performance is seen in humans with schizophrenia, gambling addiction and acquired brain injury of the OFC. The significance of this finding in humans with chronic pain is not known at this point but it is tempting to speculate that the propensity of pain patients to undertake desperate, extreme and usually futile efforts to cure their pain looks more understandable in the light of it.

The final paper up for discussion is this one in which the researchers suspected that people with a persistently painful body part would have no trouble recognising body parts visually, but that they would struggle to extract much abstract information about what they were seeing. Sounds weird? It makes sense if you consider that these people’s brains are likely to be paying less attention to their own painful body part. Our ability to observe and judge the movements of others seems to involve our brain comparing the visual input with how we would make the same movement. Think of the famous clip of the gymnast crashing into the vaulting horse, and your own brain will be running through the same movements…ouch! The reason we flinch is that we have pictured the same thing happening to ourselves. 2 groups of chronic pain patients were recruited, one group with long-term shoulder pain, the other with back pain. Participants were shown some abstract figures representing lifting motions and asked to judge the weight being lifted with various movements of the figures. The team found that, exactly as predicted, back pain patients had lots more trouble judging the weight being lifted by a figure that was using its back to lift, whereas shoulder pain sufferers were worse on the same task where a shoulder was involved, but not a back. For movements that the participants could easily perform themselves, their weight judgements were accurate.

So there you go. Having long-term pain can produce a very different lived experience to not having it, because the pain process can impact upon a number of systems which alter the way external and internal events are filtered and attended to. Maybe the pain experience is so hard to understand because those who have it are walking around with ‘pain goggles’ on that cause them to perceive reality quite differently without being aware of it. It’s an intriguing idea, and one which is proving a fertile field for new science to breed the next generation of treatments.

It’s about to get a lot harder to believe food advertising.

Ministers from Australian states and New Zealand with responsibility for oversight of food labelling met by teleconference at the end of last week. This anodyne piece of bureaucratic non-speak is what it looks like to have your consumer rights to truth in advertising quietly traded away to big business.

For those who, like me, knew nothing about this until it was too late, here is some background. Food Standards Australia New Zealand (FSANZ) is the trans-Tasman government body which has responsibility for ensuring that commercially sold food is manufactured safely and sold fairly. Part of that responsibility is monitoring the advertising claims made by manufacturers. It turns out that the food industry has decided that making health-related claims for food is a very effective advertising strategy, so they have doing a lot of it. So much, in fact that while FSANZ has evaluated and approved 115 specific health-related claims that manufacturers can use, there are simply hundreds more that it has not.

In Europe, the equivalent body has just banned over 1600 claims from being used in food advertising due to lack of adequate scientific evidence to support them. As of December 2012, it will become illegal for food companies to claim that probiotics ‘support the immune system’ or that tea can be ‘a great source of antioxidants’ or that Omega-3 fatty acids improve brain development in children. The European Food Safety Authority only approves around 10% of claims proposed by the industry. These claims and many, many others will continue to be made by Australian companies, because apparently our politicians are content for the general public to be fooled into buying products which don’t do what they claim.

Before the meeting on Friday, a coalition of health and consumer lobby groups including such heavyweights as the Cancer Council, National Heart Foundation and Choice strongly supported the adoption of new regulations which FSANZ has had on the table for three years. It is a regulator which has asked for the power to do its job properly, and address an epidemic of misleading advertising.

The Ministers however have crumbled like a shopping centre carpark.

What we get instead of demanding regulation of shonky advertising claims is less regulation, and reduced responsibility for FSANZ. The Ministers want FSANZ to come up with ‘pre-approved food-health relationships’ which will give companies the ability to say whatever they like about their product’s supposed health benefits as long as it meets this vague requirement. An example of how lame this is in practice is that of calcium and ‘bone health’. If your product had some calcium in it you could apparently claims it ‘promotes healthy bones’ with impunity without any requirement to show that it did.

Even worse than the dilution of labelling claim policing is the policy regarding new claims. Basically the Ministers have voted to sideline their own regulator, and only allow it to approve or strike down alleged health benefits AFTER the food hits the shelves.

Yes, you read that correctly.

You could bring out a new food product, and claim it did pretty much anything you could think of, and it would up to FSANZ to track you down and make you stop. This could take months or years, during which time the lies you told earlier would be all that people would remember once their brand loyalty was established. I bet the food company execs are pinching themselves. Corks would have been popping in corporate headquarters around the country after that meeting. It must have been quite a while since misleading advertising was given such a free kick.

The official term for this complete abrogation of consumer protection is ‘self-substantiation’. As evidenced by the European experience, manufacturers and regulators have very different ideas about what constitutes appropriate scientific evidence to support their claims. Based on their figures, 90% of health claims would have to be subsequently retracted by the food companies. Even with increased resources, FSANZ could not possibly keep up with the number of violations of the standards.

The end result of the reforms which a responsible regulator initiated 3 years ago is likely to be a complete advertising free-for-all. Companies will have to make increasingly outlandish claims to compete in a less regulated marketplace. The end result?

Bad news for the truth in advertising. Bad news for public health.

Regular readers will not be surprised that the MJA articles on CAM teaching in universities have not gone unnoticed by this column. Ian Musgrave has done a typically thorough job highlighting one of the most misleading aspects of the arguments presented in the 2 pieces, I feel there are a few more that need pointing out.

With a hat tip to Sean Rintel’s excellent piece on Olympic memes and also recognising that these debates can easily degenerate into namecalling and unhelpful discussion, I thought adding some memes might help lighten the tone a bit. For ease of reference to the group of authors who contributed to the editorial, I will refer to them collectively as the Apologists.

CAM in Universities

The Apologists begin by making a number of justifications for their support of ongoing teaching of aspiring CAM health practitioners in higher education. They assert that
the real benefit of an appropriately mentored and approved university education is the exposure of students to the biomedical sciences, epidemiology and population health, differential diagnosis, safe practice and critical appraisal

They leave out the bit about students then being taught about herbs that don’t work, treatments such as Bowen Therapy, iridology and applied kinesiology which have never been subjected to any serious research and subluxations that don’t exist. There is no point asking students to begin by respecting biomedical science only to have them ditch it when it disagrees with the ideology of the treatment you want them to provide. Intellectual integrity demands that health professions have a consistent approach to science. Either disregard it, or embrace it. Don’t make up ‘sciencey’ jargon just to sound clever or serious.

They also try to justify the need for university level education in such areas because removing these programs will not diminish clinical demand but may decrease the educational rigour of these courses, to the detriment of patients. This reads like a barely veiled threat. I don’t agree that there is no way to reduce public demand for quackery. A better educated public and appropriately enforced regulations for the industry would go a long way towards reducing a demand that is not as high as CAM proponents would like to think (there will be more about this in another post to come). They seem to argue that the general public should be hostage to practitioners who want to do things their way regardless of whether they are actually helping their patients or not. Fund us to do what we want, or we won’t be held responsible for what we do seems to be the implied threat.

The Apologists go on to hail universities as institutions which
conserve the diversity of ideas in the community, and that this is as important to the survival of knowledge as genetic diversity is to the survival of species

I see. We do seem to be getting along OK without university departments of phrenology, bloodletting, miasmas, leeching and mesmerism. There was a time when they were taken very seriously but their extinction is entirely appropriate within universities. Better stuff came along which more closely approximated reality. Maybe they are sometimes used as examples of historical and sociological curiosity but this is not essential to the survival of medical knowledge. Neither is the persistence of such outmoded belief systems such as herbalism, homeopathy, chiropractic and similar vitalistic approaches.

They go on to opine that Authoritarianism, supernaturalism, corporatism, irrationalism and political correctness have been identified as the enemies of ideas and considered to be synonymous with enemies of universities. I wouldn’t disagree, but in what parallel universe do they propose that scientific healthcare is more authoritarian, mystical, corporatist, irrational and politically correct than CAM? Followers of chiropractic, homeopathy, TCM and nutritionism are famously authoritarian. If you don’t believe me, try lurking on a forum where they are discussed, and then make a polite and well-reasoned criticism of the founder of the movement in a thread. Try explaining to a naturopath in your local pharmacy or health-food shop that although a decade ago we thought glucosamine might have been good for joint pain, we now don’t think so because large, well-conducted studies showed it wasn’t. Do I really need to provide examples of CAM being irrational? Or supernaturalist? An entire branch of CAM is called Energy Medicine and this purports to provide healing by manipulating an unseen ‘biofield’ which is undetectable by physics. Mind you, physics can detect the tiny electromagnetic energy from Voyager 1 which is only about 17 billion kilometers away from us putting out information from a transmitter that is not much more powerful than an average light bulb. So it’s not as if we wouldn’t find it if it was there. Similarly for the supposed ‘meridians’ of acupuncture. Despite all the efforts of proponents, there has never been a clear demonstration of what meridians actually are, or indeed whether they exist. Supernatural? Irrational? Is it just me who can’t figure this line out?

The Relationship of CAM to Science

The Apologists then head off into a vaguely postmodern exegesis about sociology and science. See what you make of this argument… _Indeed, it is not melodramatic to point out that if Friends of Science in Medicine were to succeed in their stated aims, they would achieve a dystopia – a medical ‘1984’ where only one way of knowing the body in health and illness is permitted in public discourse. Well, for starters, it IS melodramatic to call FSM dystopian. Allow me to also point out that FSM are not talking about public discourse, they are talking about university training of health professionals. The logic of this argument rests on an assumption that scientific knowledge is not special. If you want to accept this argument, you must also conclude that knowledge obtained by the scientific method is just culturally determined opinion. Karl Popper and other philosophers have made a convincing case that scientific truths are more trustworthy than mere opinion because they can be verified by anyone with the means to do so, regardless of culture. Importantly, scientific beliefs can be disproven by anyone who can show that the chain of reasoning and experimental verification is flawed. FSM are calling for the removal of taxpayer funding for the training or health professionals in improbable or disproven treatments. They continue to support the investigation of any and all potentially useful treatments. If research suggests it works, then it should be taught. Doesn’t sound much like 1984 to me.

Biological Plausibility

I would suggest that readers of a delicate disposition who are easily offended by the egregiously illogical should look away now.

The Apologists then go on to demand a truly remarkable and bizarre concession. Citing biological plausibility as an explanation for accepting a lack of evidence in conventional medicine over complementary medicine is flawed. Biological plausibility depends on contemporary biological knowledge and we should not dismiss an association because it may be new to science or medicine.

It appears we are being asked to abandon what is nothing less than a fundamental tenet of science here. Science proceeds from the known to the unknown. If you want to introduce new knowledge it has to be explained in terms of what is already known. You can go on to expand, demolish or reinterpret the current knowledge as you please but you must first master what we already know and be able to explain it. You can’t just hand in a note from your mum asking to be excused from this. You can’t just sit there like Canute and wave away the ocean of biological science that exists. The onus of proof is on the scientist making the claim to new knowledge. It’s not the obligation of everybody else to believe it because someone thinks it may be true.

Conclusion

Having already treated logic like the unfortunate cop in Reservoir Dogs, the Apologists then quote Voltaire in the conclusion.

Voltaire of course, being famously a champion of sceptical rationality and a scourge of those who would fool themselves and others. As the wreckage and debris of the irony meter begins to float down from the atmosphere, they make the stunning assertion that These courses clearly develop critical thinking. With the greatest of respect I submit that if that is their goal, they are failing miserably. It is university-trained chiropractors who are the largest professional group supporting the antivaccine movement, and who espouse belief in imaginary causes of disease. It is university-trained naturopaths who fail to be critical of the welter of disproven treatments such as applied kinesiology, herbal remedies, iridology and Bach flower remedies they are trained to dole out. It is university-trained TCM practitioners who continue to do small, poorly-powered pilot studies of acupuncture in areas where large, well-conducted studies have shown it doesn’t work. It is their professors who are asking for the conventions of science to be dispensed with so their papers will have ‘better’ results.

These, then, appear to be the best and most compelling arguments that can be put in defence of the current position of CAM in academia. A dog’s breakfast of post-modernism, paranoid futurism and pathological science. It is disappointingly likely that these arguments will simply continue to be trotted out without much development every time this issue is raised from now on. The MJA has given the Apologists an elevated platform to make their case, and I can’t help but think they have fumbled the opportunity.

I have just attended the 15th World Congress of Pain Clinicians, and while there, I went to a session chaired by one of the unsung heroes of evidence-based medicine, Prof Andrew Moore from Oxford University. As somebody who has to work continuously to avoid forgetting everything I know about statistics, I love hearing talks by people who make it all seem very clear.

Prof Moore is part of a group based in Oxford who have been instrumental in improving the quality of research in pain medicine. The philosophy of this group is to work to ensure that all patients who participate in clinical trials have their altruism honoured by ensuring that their data is collected in such a way that it can continue to be analysed years after the study is completed. If the data is collected in a consistent way by all studies in a particular field then the results can be pooled and analysed as if it was all one enormous study.

This is important for a number of reasons, not least because enormous studies are incredibly expensive and hard to organise. An equally important but less obvious reason is because in small studies involving, say 40-60 participants, statistical analysis struggles to overcome the effect of random events. The end result is almost always that small trials of individual drugs versus placebo tend to vastly overestimate the positive effect of the drug in the trial. Prof Moore’s classic paper explaining this dilemma can be found here.

The Oxford group has recently produced an outstanding summary of all the evidence related to drugs used to treat acute pain. Unfortunately, paywall issues mean that I can’t link directly to the paper. I can however link to the reference page which you can find here. They reviewed over 350 individual studies involving more than 45,000 patients over a 50 year period. The end result was a very similar ‘league table’ to this one which is some of their earlier work.

Seeing this sort of work gives some idea why science-based health professionals are hard to impress. A single study of a treatment, even if flawlessly conducted, is not enough evidence to be convincing. The effect of the treatment needs to be huge if even a medium-sized study is to show an absolutely clear effect. As if this is not hard enough to achieve, if the same treatment is studied using different methodology for the trial the results may be wildly divergent. Consistent use of the smartest study designs means that there will be fewer avoidable aberrant results reported. The signal will be coaxed from the noise more quickly.

It can be a bitter experience to eventually realise that the ‘promising treatment’ you’ve learnt how to use was actually less effective than the old faithful stuff. It can even be very expensive and embarrassing if your hospital has shelled out a big pile of clams to fund equipment and training. A venerable adage among surgeons is that you don’t want to be the first one doing a particular procedure, or the last. But in the end, a systematic review of carefully collected and curated evidence remains the best way to decide whether treatments work, and we take them very seriously.

Such changes of evidence-based opinion occur all the time in medicine, and properly designing studies helps to weed out ineffective treatments at the earliest possible opportunity once they have entered practice. More subtly, having lots of data points means that patterns can emerge which helps you target a treatment to the people who will benefit the most, and avoid foisting it onto those who cannot benefit from it.

Statistics is hard because our brains are easy to fool. The answers may be surprising or feel wrong. This doesn’t excuse us from having to know how it works. Unlike politics or the law, medical opinion does not rely just on logic and debate, but on a consensus derived from some complicated figuring out. Once settled, it requires that you not only show we are wrong, but explain how we went wrong in the face of a mountain of well-collected data and accurate interpretations of reality.

Homeopaths in the UK are about to find out what it’s like to be properly regulated….and they don’t like it. Consolidation of existing regulations by the Medicines and Healthcare products Regulatory Agency (MHRA) will come into force in July 2012 despite a vigorous campaign by supporters of homeopathy. While the details of the regulations take a little effort to get your head around, there are a couple of good summaries of the situation, particularly on the UK Parliament website.

Consolidation of the regulations in this way does nothing more dramatic than bring homeopathy products under the same restrictions as other products that make therapeutic claims.

This a big problem for homeopaths because the situation in the UK is that there are only 5 appropriately qualified pharmacies under the regulations which can dispense the four dozen or so formally registered potions that can be legally sold.

All other homeopathic prescribing and supply not involving a face-to-face consultation with a registered homeopath will be unlawful after July 1 2012.

The thousands of unregistered homeopathic preparations that are not included in the regulations (equivalent to our TGA Registered products) will no longer be legal for sale. Even for the handful of legal preparations, supply without a face-to-face consultation will cease. All online sales will be illegal, and even phone ordering will have to cease.

Note that all this has occurred without the law being changed. The implication is that since the Medicines Act was introduced in 1969, it has never been properly enforced with regard to these products. The MHRA has been very firm in responding to the campaign against the changes, and has emphasized that this is not a new law, or even an amendment to existing laws. It is merely a decision to treat all therapeutic products the same, removing the anomalous status of fanciful homeopathic remedies like Dolphin Sonar or Berlin Wall that has existed for over forty years.

Homeopaths affected by the new interpretation of the Medicines Act really have no recourse with legislation either, as MHRA has made it clear that any change to existing UK law to allow sale of these products would directly contravene EU law. This would require a massive legal and political process that would take years, and require political will that does not exist for any other issue short of national security issues.

The regulatory measures will of course only succeed if they are enforced. It is heartening to those of us who value consumer protection that the privileged position of homeopathic remedies is being ended, but one fears the MHRA may be in a similar position to our own TGA. Open flouting of minimal regulations without fear of meaningful sanction such as happens here could be possible. Companies in Australia that run afoul of regulations can afford to take a calculated risk that their profits will far outweigh any puny attempts by TGA to bring them to book. Much like choosing to cop a parking fine occasionally because paying for car parking may work out more expensive if done regularly.

Supporters of homeopathy in Australia may call for statutory regulation of altmed professions but I must say this is the type of evidence-based, low-cost regulatory reform that makes most sense. Homeopathy as such has not been made illegal. It has just been stopped from fleecing consumers by selling unregulated products and making unfounded claims about them.

Medical doctors are often accused of paying little attention to dietary interventions for many diseases. On the other hand, dietary fads and commercial supplements are frequently based on little, if any, reliable clinical evidence.

It should make all parties to this conversation pleased that an article is in press in the prestigious journal Pain which reviews the scientifically supported ways you can alter your diet to improve specific pain problems.

The findings are preliminary in many cases but are scientifically robust and point the way forward to some interesting possibilities for interventions.

Omega 6/Omega 3 ratio A number of factors have led to a dramatic change in the ratio of these 2 crucial fatty acids in the average diet of affluent countries. Omega 6 fatty acids are highly important in immune function, but can contribute to inflammation. Omega 3 fatty acids by contrast have a well-established anti-inflammatory effect. An ideal ratio of these 2 in the diet is thought to be as close to 1:1 as possible. The average citizen of a developed country like Australia has a typical ratio of 10:1 or worse. This is why people who suffer from inflammatory joint pain (which includes rheumatoid arthritis and lupus arthritis) tend to benefit from boosting their Omega 3 intake. Note that joint and muscle pain which is not caused directly by inflammation does not respond to this intervention. This includes the common form of arthritis due to ‘wear and tear’ (osteoarthritis) which often has very little inflammation.

Magnesium and polyamine depletion Long-term chronic pain results from a number of irreversible changes which occur within the spinal cord and brain. One of the single most important of these microscopic events is the activation of NMDA receptors which normally are in a closed state. Activation of large numbers of NMDA receptors in the spinal cord has the effect of amplifying dramatically any incoming pain information, or transforming non-painful stimulation into a pain signal.

Drugs which selectively block NMDA receptors are very powerful and effective analgesic drugs. Their use is limited to specialised pain clinics due to their potential for significant side effects if not very carefully used, and their highly variable outcomes.

A class of molecules known as polyamines (some of which rejoice in unfortunate names such as spermine, cadaverine and putrescin) is known to have an enhancing effect on open NMDA receptors, making it harder to turn down the gain On pain signals. There is convincing evidence in rats that diets high in polyamines increase chronic pain sensitivity, and conversely that removing them from the diet results in reduced pain. Some of the most polyamine-rich foods include wheat germ, rice, mango, pumpkin, beef, pork and chicken. Soybeans, mushrooms, and green tea leaves also have high levels. There are only a couple of studies which look at how practical and tolerable these diets are for humans, but given how difficult NMDA blocking drugs are to use in practice, this deserves vigorous investigation.

The transformation of a closed NMDA receptor to an active one depends on the removal of a magnesium ion which blocks the channel in the nerve cell membrane within the receptor protein. High doses of magnesium given intravenously are effective for short-term treatment of some types of chronic pain. The authors of this article speculate that ensuring adequate levels of magnesium in the diet may be important for ensuring that as many NMDA receptors as possible remain closed. Personally I would have no problem with this recommendation, as 3 foods which are very high in magnesium include chocolate, bananas and avocado. The science however is fairly thin.

Flavonoids Given that there are over 5000 compounds in this group in plants, it is hardly surprising that some of them may have pain relieving properties. Perhaps the most robust evidence at this stage favours soy and possibly cherries as leading contenders to have useful effects in the real world. While there is not enough evidence to make firm recommendations, diabetics with painful peripheral nerve damage and people contemplating surgery with a risk of nerve damage might benefit from getting stuck into soy products if they find them palatable enough to stick with long-term.

Caffeine The news is not completely good for the coffee and chocolate brigade however. Caffeine consumption is rising worldwide, and apart from the very well-recognised caffeine withdrawal syndrome, there is also evidence that several first-line pain drugs including amitriptyline, carbamazepine and even paracetamol may be much less effective in the presence of even low doses of caffeine. Caffeine junkies should stay below an intake that causes withdrawal headaches and remember that they may not be able to depend on paracetamol as much as they can when they aren’t heavily juiced on java.

So there you go, foodies. Apart from the obvious advice to eat a varied diet and get plenty of exercise, there are possibly a few promising, low-cost and easy to understand dietary interventions to help with chronic pain. The next few years should lead to some further proof-of-concept studies and then hopefully to firmer recommendations.

Reference: Bell RF et al. Food, pain, and drugs: Does it matter what pain patients eat? PAIN (2012), http://dx.doi.org/10.1016/ j.pain.2012.05.018

(Note this is unfortunately behind a paywall)

As a kid I can remember my Dad going off to Rotary meetings and coming back talking about how polio could one day be eradicated. He and his decidedly uncool and stuffy Rotarian buddies did some serious fund-raising for it in the town where I grew up. They have stuck at it since. I imagine they are now feeling incredibly proud of their efforts, as that great milestone may soon be achieved.

I also have met quite a few polio survivors professionally, a couple of whom are way younger than you might expect because they caught the disease overseas. I can only imagine how they are going to feel when their children, grandchildren and great-grandchildren are forever put beyond the reach of the virus which blighted their own lives.

A staggeringly important article passed almost unremarked yesterday in the Fairfax press. Norman Gillespie and Gustav Nossal wrote a short piece which summarises how close we are to finally eradicating polio. The stakes are high. If we allow polio to re-emerge it will, they say, “constitute the most expensive public health failure in history.” A motley amalgam of Rotarians, NGOs, scientists, bureaucrats, politicians and community leaders has brought the world to the brink of a stupendous public health achievement, only for it to be threatened with failure when their fingers are almost closing around the prize.

Since 1988, when there was 125 countries left with endemic polio, we are now down to 3. Two of those, Pakistan and Afghanistan, have suffered a combination of natural and military adversities which have derailed the public health efforts of authorities.

The other remaining endemic country is Nigeria. The story here is more complicated. Public health infrastructure is not superb, but it is at least as functional as its neighbours. The main problem in Nigeria is that there are communities where local religious leaders have bought into anti-vaccine conspiracy theories. The general facts are outlined here.

Purely religious objections to vaccinations as such are uncommon in most of the world, and the difficulty in Nigeria, and to a lesser extent in Pakistan and Afghanistan, seems to be due to an anti-Western ideological bias as well. Having said that, I would add that if mass vaccination programs are decided upon and planned by a central authority, such as WHO or UNICEF, they clearly need to be administered according to local sensitivities and culture. This was beautifully demonstrated in India (which passed 12 months without a new case of polio in January this year) where ambassadors such as Bhagwath Chandrasekhar and committed culturally-appropriate education programs have reversed the previous anti-vaccine propaganda. Perhaps the immunisation campaign has not been as effectively handled in Nigeria. Certainly the use of a vaccination program for intelligence purposes in Pakistan is a cynical ploy which might yet delay the success of polio eradication in the holdout areas.

Achieving a polio-free India is a monumental step to eradicating this appalling disease. Finishing it off is now just a matter of political will, skillful diplomacy and money.We cannot allow complacency, opportunism and scare-mongering to let it fail.

The Channel 9 Mornings program this morning ran a story about a Christian couple who claim to be able to cure cancer by the power of prayer. Not surprisingly, for those who missed it, there is no acknowledgement of the segment on the show’s website, as such claims made by people who are not registered health practitioners are a breach of the NSW Code of Conduct for unregistered Health Practitioners.

To say that airing such a segment is irresponsible would be putting it too mildly. There is enough misinformation and fearmongering about cancer treatment as it is without having a highly popular and well-regarded show give a free kick to such claims. Such simple-minded tomfoolery also stigmatises cancer patients since the obvious implication is that they have cancer because they are not morally worthy, or in some way deserve to have it.

People are perfectly free to follow their religious urges wherever they lead them, but they do not have the right to make unsupported and implausible claims about serious illnesses being curable by prayer or other supernatural means. That’s not just my opinion. It’s the law. Both under the NSW Code mentioned above, and the TGA Advertising Code, you are expressly and specifically forbidden from claiming to cure cancer, HIV or other serious illnesses.

By failing to provide any disclaimer or critical response as part of the story, it is possible (I am no lawyer!) that Channel 9 has itself breached the TGA Code by providing what is essentially an advertorial for these so-called healers. There is a precedent for such a finding by TGA.

Around lunchtime, the following information appeared on the official Twitter feed of the show

Today we had a young couple on claiming faith healing can cure cancer. Tomorrow medical science hits back, GP Dr Penny Adams with her view.

This looks to me like damage control. Medical science should not have to “hit back” as if there is a genuine debate to be had. There is no contest. Faith healing is not a proven treatment for serious illness, as its adherents have never produced any useful or convincing evidence to suggest that it is. Chemotherapy works the same regardless of the religious beliefs of the recipient, because it is based on sound science.

In this day and age it is utterly remarkable that there are TV producers who are willing to risk breaching serious laws that have significant consequences to allow sincerely misguided so-called “healers” free advertisements in the guise of genuine information. Remarkable….and depressing.

I await with interest the regulatory action that one feels is inevitable given the blatant flouting of specific prohibitions against claiming to cure cancer. Lack of such action by Channel 9, the Healthcare Complaints Commission, TGA or the Australian Communications and Media Authority would be even more remarkable and depressing.

The debate in society about marriage equality for same-sex couples has many facets. Until now though, health arguments have not been to the fore. The Melbourne Herald Sun ran with a story about some doctors who have founded a group called Doctors for the Family to lobby against amending the Marriage Act. It isn’t easy to find the submission they have made to the Senate Committee which sets out their objections but you can find it linked to here.

I have to say up front that it seems clear to me that their submission relies heavily on the social authority of the medical profession, as it is very thin on health-related evidence. The first piece of research they cite is this report which is commissioned study by a Professor of Law. It is quite evidently NOT a piece of peer-reviewed evidence. I also note that this report was commissioned and funded by the Australian Christian Lobby, so its appearance in a submission with a supposedly evidence-based healthcare approach raises the reasonable suspicion that Doctors for the Family is just another of the many religious groups which oppose the amendment on ideological grounds.

The next study they cite is this one. I only have access to the Abstract but it sounds like it is a study comparing teens living with step-parents with those living with both their biological parents. There is no mention of gay parents in the Abstract. The quote included in the Senate submission looks like it has been cherry-picked from a study which is not really about same-sex parents. This is pretty disingenuous. From a technical point of view, this study is a post hoc interrogation of a large database, and therefore is a retrospective cohort study. Such studies cannot be used to do anything other than determining correlations, and generating hypotheses for further study. They are not the final word about anything.

Most of the other references were to news stories or opinion pieces, apart from the truly spectacular selective quoting of some US research which was presumably done because it allowed them to quote alarming rates of sexually transmitted infections amongst gay men in that country. Oddly though, the submission refers to the press release, not the original paper. Trying to use this data to generalise about the health risks of actually being in a stable, loving and long-term relationship with a same-sex partner simply does not follow. For one thing, Doctors for the Family seem happy to completely ignore the cataclysmic rates of HIV among African heterosexual men and women. For another, they also seem content to ignore the significant body of research which has already been done into gay parenting. The consensus view is that same-sex couples make no better or worse parents than any other type of family arrangements.

This appears to constitute the entire ‘medical’ argument against marriage equality. No doctor, nurse, physio or in fact any science-based practitioner would accept a new treatment based on such a poorly argued presentation of research. Apart from the obvious appearance of ideological bias in using a non-medical, non-peer-reviewed piece of research funded by a lobby group as a primary source, the other studies presented make no tenable case whatsoever that there are health risks to either the same-sex parents or their offspring.

The submissions presented by the Australian Medical Student Association (AMSA) and by Psychologists for Marriage Equality (PME) are much better analyses of the health implications which are relevant to the debate. Changing a social institution as fundamental as marriage requires careful consideration of all relevant information. It is hard enough to be across all the things you need to know to have an opinion without having to see poor science masquerading as credible information. They have a perfect right to their own opinions but they have to make do with the same scientific facts as everybody else. Doctors for the Family are trying to hijack the credibility of science, while being disingenuous about their religious beliefs.

It’s been a pretty tough week for supporters of alternatives to medicine. First up, the Therapeutic Goods Administration (TGA) released a draft for public comment of its much-anticipated consultation document on the evidence required to support indications for listed medicines. This could well be the single most revolutionary consumer protection step in the regulation of non-prescription products since the Therapeutic Goods Act itself.

The draft document outlines a system whereby the manufacturer of a product which makes therapeutic claims would be required to provide the TGA with an “expert report” on the claimed benefits of the product. There are also guidelines as to what constitutes an appropriate “expert”. To the relief of consumer advocates and supporters of scientific healthcare, the TGA has spelled out in detail that the “expert” must be a university graduate of at least a three year bachelor’s degree, with at least five years of clinical work, or a PhD with relevant expertise.

Does this seem excessive? It seems reasonable and sensible to have at least one person with at least a rudimentary amount of training and experience supporting the claims made for products which are making their manufacturers billions of dollars a year. Lord knows, the average punter in the street already thinks this is the case, and they are usually indignant when told it isn’t so.

The reaction from Big Supplement has been predictably apocalyptic. The CEO of the Complementary Healthcare Council of Australia (CHCA), the peak industry body, Ms Wendy Morrow was quoted in one article in the medical press as saying: “If it’s adopted in the way that it’s drafted, there won’t be an industry to worry about. If you don’t have a health degree, according to this, you can’t be an expert.”

If you have a massive industry that is built upon widespread noncompliance with even the shrivelled fig leaf of regulation that currently exists, the public are probably much better off without it. It seems as if this parasitic and lazy behemoth has grown so accustomed to making easy money that even a very reasonable and long-overdue reform looks like a full frontal assault. They seem surprised and offended when their customers get sick of being treated like mugs.

Oh, and I would consider someone with a bachelor’s degree and five years of experience to be just beginning to be reasonably competent in a healthcare-related field. I would be genuinely intrigued to find out what CHCA’s preferred definition of an “expert” would include.

The second hair in the throat for CAM supporters this week is an excoriating exposure of the failures of one of their icons. The National Centre for Complementary and Alternative Medicine (NCCAM) is a huge research establishment founded by the political intervention of a pair of powerful Iowan senators, Tom Harken and Berkely Bedell. It has been around in its current form since 1999 and has an annual budget of $US130m. Its funding has steadily increased over the last decade, despite overall NIH funding declining during the same period. Surely this must mean that it is producing outstanding results? After all, even NASA – the greatest and most undeniably successful organisation in American science – has just had its budget gutted.

In an editorial for the very prestigious Journal of the American Medical Association (JAMA) this month, Dr Paul Offit goes through a litany of negative results and improbable research funded by NCCAM, and by any standard of academic merit, it is impossible to conclude that NCCAM has anything other than ideological value. Unfortunately the full article is behind a paywall, but the following is a fair sample of it…

“many studies funded by NCCAM lack a sound biological underpinning, which should be an important requirement for funding. For example, NCCAM officials have spent $374 000 to find that inhaling lemon and lavender scents does not promote wound healing; $750 000 to find that prayer does not cure AIDS or hasten recovery from breast-reconstruction surgery; $390 000 to find that ancient Indian remedies do not control type 2 diabetes; $700 000 to find that magnets do not treat arthritis, carpal tunnel syndrome, or migraine headaches; and $406 000 to find that coffee enemas do not cure pancreatic cancer. Additionally, NCCAM has funded studies of acupuncture and therapeutic touch. Using rigorously controlled studies, none of these therapies have been shown to work better than placebo. Some complementary and alternative practitioners argue reasonably that although their therapies might not work better than placebos, placebos may still work for some conditions.”

The real problem from a scientific point of view is that if a mountain of evidence shows that improbable therapies don’t work, this fails to result in CAM practitioners abandoning these treatments.

Dr Offit continues: “Several studies have shown that garlic does not lower low-density lipoprotein cholesterol, St John’s wort does not treat depression, ginkgo does not improve memory, chondroitin sulfate and glucosamine do not treat arthritis, saw palmetto does not treat prostatic hypertrophy, milk thistle does not treat hepatitis, and echinacea and megavitamins do not treat colds. Moreover, some studies have found that megavitamins increase the risk of cancer and heart disease. Because the vitamin and supplement industry is not regulated by the US Food and Drug Administration (FDA), negative studies have not precipitated FDA warnings or FDA-mandated changes on labeling; as a consequence, few consumers are aware that many supplements have not delivered on their claims.”

Sound familiar? Pretty similar to here really.

Given the massively funded research effort over more than a decade that has led to no net value to the community, and the determination of the industry to keep flogging their patent cures until the sheriff runs them out of town, I don’t see that there is a baby in the bathwater that we would miss even if it were all to go down the plughole.

The popular internet meme First World Problems makes often bitingly ironic statements about things which are really irritating and sometimes infuriating, but only from a position of self-involved privilege. Without being ironic or satirical, here are three problems which I see regularly in my professional life that are due to the success of first world medicine. If you overtake society’s readiness to deal with new problems, there can be heartbreaking results.

1. Ageing with a disability

People with serious spinal cord injuries, traumatic brain injuries and major developmental disabilities never used to survive into middle age. Life expectancy for Down Syndrome individuals is a good example. People born with this condition live twice as long now as they did in the 1980s.Survivors of spinal cord injury similarly have vastly improved survival rates and quality of life now compared to the 1970s and earlier periods. More and more disabled adults are getting older with their disability and their carers are ageing too.

Because the main carers of highly disabled children and adolescents are their parents, health care professionals are seeing more older adults with caring responsibilities for disabled middle-aged children. I cared for a lady who discharged herself very early from the rehabilitation ward following her fractured femur when she heard her 55 year old disabled son was not doing well in respite care. She herself was not going well, but she felt that even coping poorly herself was preferable to her son’s needs not being met. For many of these individuals who are ageing with a disability, their usual means of maintaining their independence are eroded by ‘wear and tear’ conditions like tendon injuries and arthritis. They experience a double blow to their ability to cope, and they may go from fairly independent in their own place to nursing home level care needs in a few months.

2. Being the parent of a very premature baby

Expectant parents want nothing but the best for their children, and do all they can to ensure it. Despite all the precautions that parents can take, premature and unwell babies are still being born, and they need very invasive and prolonged medical intervention to survive. When this happens, all of the usual parental expectations are out the window, and a whole new perspective is needed.

The emotional turmoil that some new mothers suffer trying to recover from a birth, while also trying to comprehend what is happening to their newborn child in ICU can hardly be imagined. The days and nights turn into weeks of slow progress and complications. Some of the complications are inevitable due to the child’s condition, but many are due to the care they receive, including oxygen toxicity, tracheal damage from breathing tubes, nasal and throat injuries from feeding tubes. It is a terribly helpless experience, to watch your tiny child through the perspex, without being able to hold, comfort and nurture him.

As younger and sicker babies survive, the stories of these extraordinary parents become almost commonplace, yet each is a triumph of hope, tenacity and love which those in the world without access to these resources will never know.

3. Hanging on at home

The recently announced Aged Care reform package shows that politicians and bureaucrats alike are very well aware of the ageing population. They are also incredibly desperate to avoid large numbers of institutionalised elderly people in Government-funded care. The orthopaedic rehabilitation ward on which I work helps to provide an environment where people can try to recover to their previous level of ability, but the sad fact of the matter is that most of those over 75 years old who have a major fracture do not achieve their previous level of independence. A significant number of them were barely managing. Their families may demand that we ‘stop them going home’ because they are worried sick about their mum, dad, or auntie and haven’t been able to persuade them to accept help or move into more secure accommodation.

In an audit of our patients I did a couple of years ago, far and away the biggest contributing factor to very long lengths of stay in the ward was looking after people who couldn’t bring themselves or their families to make a decision not to return home. Putting extra social work time into these patients did not significantly change this, because the ultimate decision had not gotten easier. We now have the Transition Care Program, which is specifically set up to provide safe and appropriate accommodation for elders who are at this threshold, and who need more time to properly come to terms with choosing whether to up sticks and move or fight on in their own home.

Modern medical care and a first-world lifestyle are adding years to life and saving lives that would otherwise be cut short. It cannot foresee what those years will be like. Health professionals both in hospitals and the community are dealing with incredibly complex emotional and social situations like these in rapidly increasing numbers.

Are we wrong to find them agonising and difficult dilemmas?

I don’t think so. Yes, we are privileged to have access to the medicine which makes them happen, but the human struggle is written in all languages and by all people. The details may vary, but the solutions to these problems all require compassion, communication, social justice and deep thinking. Sometimes the answers can be as complicated and confusing as the questions.

I have become aware due to my own diligent research on the internet (literally hours and hours) about a massive conspiracy by greedy and unscrupulous engineers. I am talking about the fearsome, faceless safety-industrial complex I call Big Seatbelt.

They have managed, under the guise of “public safety”, to get it made mandatory in all states and territories of Australia to wear these dangerous devices, which maim and harm thousands of people every year while the so-called ‘Safety Engineers’ and their corporate masters in Big Seatbelt rake in the profits. There are whole companies who do nothing but make and install seatbelts which we are powerless to stop. Look at this graph which shows a reduction in serious injury and death from 1981. Think it shows seatbelts “work”? Well, deaths and serious injuries were coming down anyway, due to better cars and roads as well as healthier people who could survive accidents better.

When I was younger I had heaps of traffic accidents. They were almost like a rite of passage. I don’t remember anyone getting harmed. There’s no real evidence that anybody much got injured on the roads in the 1950s and 60s. It’s almost like the medical-safety-industrial complex wants us to forget how great things were on the roads before the crushing weight of mandatory belting up was forced on us.

There are even articles in medical journals about the severe and appalling injuries you can sustain from seatbelts, but I don’t see any doctors speaking out. Guess why? Yep, they’re only looking up from having their snouts in the Big Pharma trough for long enough to gulp down more swill from Big Seatbelt. To quote from a major Australian study:

Children restrained by a lap-only belt, or young or small children restrained by a lap-sash belt are more likely than those in recommended child restraints, to suffer a specific cluster of injuries referred to as the lap-belt syndrome including tears and perforations to the intestine and its mesentery, injuries to abdominal organs such as liver, pancreas, kidneys, and spleen and fractures, distraction or dislocation of the mid-lumbar spine and spinal cord injuries (1,2).. More recently, reports of serious neck and cervical spine injuries due to the sash portion of adult lap-sash belts have also been described (5,6).

Our right to be at liberty is under threat from the Government, the Police and politicians who keep us enslaved to seatbelts. We need a Campaign for Unrestrained Travel to ensure that all the facts are heard.

We’re not anti-seatbelt, we’re pro-choice.

People, that is those who are not already brain-dead drooling puppets of Big Seatbelt and their shills, need to wake up and make up their minds not to be told what to do. Mothers need to follow their instincts in deciding whether to belt up their children. I put a restraint on my child once, and it was like he was afraid of me for days afterwards. To quote Jeff Jacoby from the Boston Globe

Already the government confiscates the largest part of your income, controls what you can watch on TV, decrees the curriculum your child must study, tells you what to do with your trash, decides what contraceptives you’re allowed to buy and may throw you in prison if you enlarge your house without permission. A compulsory seat belt law may be only a minor encroachment on our freedom compared with the ones we’ve already accepted. At least let us resist the minor encroachments.

So join me in spreading the word about these fiendish and dangerous devices. Sure they’ll try to tell us that their “science” shows these hellish and cruel restraints save lives. Sure they’ll tell us that by chaining ourselves into the car we’re contributing to the good of society. I don’t buy it, coming from those with so much money invested in it. And neither should you. If these arguments are good enough for anti-vaccination groups who can collect for charity, then they are good enough for my Campaign for Unrestrained Travel. Donations open next week.

The tragic case of Penelope Dingle’s death from a potentially treatable cancer was the subject of a moving ABC Australian Story. Following a coronial inquest, the case continues to make headlines with Penelope’s sister Toni Brown suing homeopath Francine Scrayen who allegedly advised against pursuing conventional treatment in favour of alternative therapies.

The merits of these allegations will be debated at length in other places, but I want to focus on the fairly obvious question I have posed above. Registration by the Australian Health Practitioner Regulation Agency (AHPRA) has been debated for naturopaths, homeopaths and others of their ilk. Proponents argue that standards of training and practice will be improved by statutory regulation. Opponents argue that AHPRA regulation would give consumers false confidence in the efficacy of CAM modalities.

According to the Coroner’s report:

While I accept the evidence of Sylvia Neubacher to the effect that making such a representation went beyond the Australian Homeopathic Association Code of Conduct and that the Association has attempted to provide accountable structures to ensure that homeopathic practitioners are qualified and have medical and professional standards which would provide a safeguard to consumers, I have serious reservations about any efforts to register or otherwise legitimise homeopathy or other similar alternative forms of medicine. While I do not agree with the proposition that such alternative medical regimes should be outlawed, unless and until their supporters can provide appropriate and sufficient science base, any apparent legitimisation of these regimes could provide mixed messages for vulnerable and often desperate cancer suffers.

I could hardly agree more. This point of view is exactly consistent with common sense and ethical obligations. Consumer choice is only a valid argument when both alternatives are viable. Providers of health care have more responsibility not to mislead their customers than call centre workers.

It seems sadly true that Penelope Dingle would not have been saved by seeing a registered CAM practitioner, as the Coroner concluded that it was ultimately her own choices, made in the framework of “misinformation and poor science” that lead to her needlessly untimely and agonising passing. Living in an environment of uncritical acceptance of ersatz medical treatments and antagonism towards conventional medicine was the real reason that she made the choices she did. No amount of sanctioning individual practitioners will change that, or prevent it happening to others.

If we are to learn anything from this whole pitiable saga, perhaps it should be that we need to create a public discourse where desperate and scared patients are not given false choices. Banning therapies is usually an ineffective last resort. Far better to educate the average punter to avoid outright scams and for official bodies to avoid lending the illusion of gravitas to absurd therapies. For better or worse, Australians trust their public institutions. Government bodies like universities and regulatory agencies must be worthy of this trust, and effectively protect the public from misinformation and the susceptibility of some well-intentioned practitioners to fall for traps that more scientific souls have learned the hard way to avoid. There is no national professional register of Nigerian email scammers or psychic hotline providers. Why would we need one for homeopaths?

An interesting snippet from The Age today. It seems that the Federal Government of the day in 2005 was warned that its proposed $226m dial-in hotline, known as healthdirect Australia would not reduce Emergency Department demands and might in fact increase it, based on the experience elsewhere.

The idea of being able to get rapid access to an experienced clinician on demand seems reasonable on paper. The drawbacks only become apparent when one thinks it through a bit further. Imagine you are the nurse or GP on the end of the line, and someone who may be scared, distressed or just not very good at explaining things is on the line. You have a duty of care to give safe and responsible advice. You may not be able to get a really clear picture of what is going on. So what are you going to do? Of course you’re obliged to advise the caller to seek further help, because you can’t see what’s going on, you can’t examine the patient and you feel responsible for ensuring that there is not a serious problem that is being missed.

The evidence presented in the journal Emergency Medicine Australasia suggests that in fact the idea that EDs are being overcrowded by patients who should see their GP instead is a myth. Attempts to solve the problem of ED overcrowding by increasing remote triage or diverting patients to GP superclinics or bulk-billing centres are therefore pointless. ED demand has boomed in the last decade in Australia, and neither population growth or the ageing of the population accounts for it.

The trouble is, once it’s in the policy of both major parties and the bureaucrats who advise them, not to mention that the Commonwealth has sunk nearly a quarter of a billion dollars into it, the pollies have to say it is working well. Both the current Health Minister and her predecessor have made public statements supporting the concept, despite the fact that the evidence-based view from the troops on the front line is that it is not helping at all. Before it was introduced here in 2005, almost identical schemes in New Zealand and the UK had completely failed to improve the same problem so this cannot have been much of a surprise.

You can’t help but get the feeling that the experts who advised the Health Minister back in 2005 would much rather have had the $225m to spend on other ways of improving their services. The money would have gone a long way.

The MJA this month leads a themed edition with an editorial on the public health and social consequences of persistent pain which makes sobering reading. For my own part I am well aware of this, as I spend most of my working life (when I’m not pinching the time to write these columns of course) working with sufferers of various types of pain.

There are many barriers to adequate treatment for pain-related problems, and it is an area of medicine where Australia spends shamefully little on research. In the UK, Europe and the US there are many basic science labs researching pain-causing conditions. There are clinical research institutes and academic departments of pain management. In Australia….tumbleweeds. A few committed and charismatic individuals have been able to convince the universities and governments to fund their research, but there is no co-ordinated national framework to even begin addressing the problem. The Pain Management Unit where I am based, which was the first in Victoria, did not have a secure long-term funding stream until last year. That meant for more than a decade we were solely dependent on the goodwill of the CEO and executive of the organisation as we raided the budget of our parent department on an essentially ad hoc basis. According to the Australian Institute of Health and Wellbeing’s 2005 figures, musculoskeletal pain constituted the single largest disease non-fatal burden in adults. It is a public health and economic problem that is rivalled only by mental health and cardiovascular disease when you look at the disability it causes. It’s hard to believe that so little has been seriously done at a government level to address it.

As difficult as it has been for us to get our service funded, it has been even harder for those we serve. First-line nerve pain drugs like gabapentin, pregabalin, duloxetine and amitriptyline are not on the PBS for this indication. Pregabalin is not even on the PBS at all. One of the cornerstones of drug management of pain is the opioid class, which is subject to so much social repugnance and misinformation that many choose not to even try them. Others may be forced onto them because more effective and less potentially harmful treatments are denied them by geography or lack of infrastructure, due to decades of underinvestment in pain services. Poorly treated pain sufferers are probably second only to cancer patients in their vulnerability to outright quackery for these reasons as well. Serious pain management expertise can improve the lot of most of those who manage to get to see someone, but this expertise is only available to relatively few. In the absence of something more effective, desperate people turn to improbable measures.

Australia is a wealthy, first-world society with a strong economy and an identity built on helping others through adversity. The underbelly of this identity can be a suspicion and scapegoating of those not perceived to be pulling their weight. If I was trying to fake my way onto a pension, I would certainly not pretend to be a chronic pain sufferer. If you look at the figures it’s not a lifestyle you would choose at all.

The Friends of Science in Medicine is a loose collaboration of doctors and other scientists and concerned citizens who have chosen to speak out on the topic of where science belongs in medicine, and where pseudoscience belongs in society. Much of that discussion has taken place on this very website.

It seems odd that the role of scientific understanding in medicine should even need to be defended, given the extraordinary progress that has been made in the last century with medical technology. The scientific approach to the study of medicine has given more benefit to humanity in the last two centuries than any other form of health knowledge in the last two millenia. Perhaps scientific medicine is a victim of its own success at some level.

Galileo remarked in the 1600s that the goal of science is not to open the door to ultimate wisdom but rather to set limits upon infinite error.There are a million and one ways to be wrong about the human body and the ways that it functions. There are only a few ways to be right. The precise demands of human physiology are remarkably invariable from one human to another, because there are only a handful of ways to defy the improbable odds of being able to maintain existence in this hostile universe. Let alone be self-aware and morally good on top of that! The more detailed the knowledge that science gives us about biology, the more it constrains the possibilities of other proposed states of being in the universe. Homeopathy, Qi life energy, biofield energies, chiropractic subluxations, phrenological bumps and the four humours are just a handful of examples of ways to be wrong about the body that have not been compatible with the rapidly evolving body of scientific biology.

Accumulating facts is not good enough to be scientific, however. As the French mathematician Henri Poincare pointed out

Science is facts; just as houses are made of stones, so is science made of facts; but a pile of stones is not a house and a collection of facts is not necessarily science.

A scientific approach generates facts into hypotheses, which are then tested rigorously and discarded if they fail. A pleasing ideological worldview is no substitute for being able to very closely approximate objective reality. For the science-based health practitioner, a cherished therapy will be ruthlessly jettisoned no matter how painfully if the evidence demands the sacrifice. For most doctors this happens every couple of years throughout their career. I can think of several treatments within my own speciality of Pain Medicine which I have stopped using in the last couple of years, and I expect that in five years I will be treating chronic pain patients differently to the way I do now. I can quote at length the strengths and weaknesses of the evidence supporting all the therapies I currently ask my patients to agree to, and I wouldn’t expect them to settle for less than that. I’m not sure yet which parts of what I currently accept as fairly true will have to be junked in the face of better research, but I can’t wait to find out.

Having an organisation like FSM to kick-start a public debate about the value of science in healthcare is invaluable. The science-based health care community has not done very well in the last couple of decades at sharing with the public at large the excitement, frustration and genuine hope of doing real science. We have not explained as well as we perhaps could have why the scientific approach is not perfect, but better than every other system we’ve tried to date. One of the greatest strengths of science is its unselfishness, and its honesty. Self-examination and self-correction is built into the system. We know that the things we have discovered by a disciplined adherence to scientific principles will always be right until something better comes along. The ideas of clinical trials for medications and quarantine for infectious diseases have been around since the great medieval Arab physician Ibn Rushd and are no less correct now than they have always been. In science-based medicine, once you’re right, you stay right. That doesn’t mean we can’t learn something by trying to prove you wrong.

Pseudoscience is fundamentally sterile and unproductive, based more on charismatic personalities, unchanging eternal ‘truths’ and unreliable anecdotes. I have a patient whose back pain was fixed by falling down some stairs while dropping her grand-daughter off at playgroup. That doesn’t mean I have started shoving my other patients down the steps to fix them. It’s just an interesting yarn. DD Palmer started chiropractic based on a similarly improbable cure. Ignaz von Pelczy did the same in starting iridology. No useful research breakthroughs have changed the fate of humanity from either field since.

So to the extent that FSM can get the media and the general public thinking about how much they might value science as opposed to pseudoscience in their healthcare it can only be a good thing. That’s why I stopped sitting on the sidelines of the debate and signed up when I found out about them.

The recent Swisse Vitamins flap has led to another round of discussions about advertising terminology for supplements and over-the-counter (OTC) health products.

To briefly summarise, for those up the back, Swisse have been ordered by the Complaints Resolution Panel of the Therapeutic Goods Administration (CRP) to stop using the terms “clinically proven” or “independently tested”, as well as its “Tired? Stressed? You’ll feel better on Swisse” tagline.

The order from the CRP has been contested by Swisse, who have published on their website a list of the evidence they rely on to support their claims. The case hinges in large part upon the scientific credibility of this evidence, which will no doubt be given a thorough going-over in other forums. It also raises the issue of what these commonly used advertising phrases actually mean.

‘Clinically Proven’ sounds like a very strong recommendation indeed, and clearly tests well with focus groups, as it is an industry favourite. The average punter would assume that it means something like ‘scientifically legit and definitely effective. Used all the time in medical practices.’ The TGA itself has gone as far as to publish guidelines back in 2008, for the benefit of advertisers and the general public. To quote them precisely:

the Panel considers that its use in advertising should not even be contemplated unless unequivocally supported by robustly designed, published, peer-reviewed clinical trials which have been conducted upon the actual product being advertised or an identical formulation (as a minimum). Even where such evidence is available, the claim must also reflect the weight of all available evidence and not just the specific research being relied upon.

This clearly implies that having one or two small studies with positive outcomes is not good enough to justify the term, and furthermore, that these couple of studies with Product X can’t be quoted without mentioning the more numerous or better-conducted studies which show it doesn’t work. The use of ‘Clinically Proven’ on a product ought to be a guarantee of rigorous testing and use in the clinic, but unfortunately it is so debased and frequently applied that it really is virtually meaningless. Hence why CRP put out a guideline about it. Like so many other warnings and directions the watchdog has put out, it has been ignored by many in the industry. A quick trawl through the CRP Complaints Register shows that the term has cropped up in misleading advertisements for everything from anti-snoring devices to stress-reliving herbal supplements and back pain devices.

‘Independently tested’ implies that there is some type of arm’s length arrangement between the company selling the product, and the people doing the research. In practice, this usually means a university team doing the research which may or may not be directly funded by the company concerned. Such arrangements are common with Big Pharma products, and high levels of integrity are fundamental to good science being carried out. Full disclosure of funding sources is expected all the way through the peer review process, and is also expected to be acknowledged at conferences or in journals where the data may be publicised.

Swisse’s cause was not helped by the disclosure 2 days ago that the current CEO’s father was one of the academics who oversaw some of the research at Swinburne University in Melbourne which was funded by Swisse and is also used by them to support their claims of effectiveness. Such as an obvious potential conflict of interest as is quoted in the Swisse case does not automatically invalidate the research, but full disclosure ought to have been made at all stages of handling that data so outsiders can judge for themselves the strength of the evidence with all the facts to hand. With no guidance from CRP as to exactly what constitutes a valid claim of ‘independent testing’, this phrase is going to be headache for consumers for some time yet.

Truth in advertising is a long-term societal principle which must balance commercial interest with the public good. Big Pharma are prevented in this country from advertising directly to the public but the performance of those in the healthcare industry who are allowed to advertise in this way must improve substantially if consumer protection is the goal.