Please don’t do your own research on immunisation; you’ll get it wrong

Michael Vagg, Deakin University

Pauline Hanson has become the latest politician to flirt with the fringe view of immunisation denial. Of course, like all thoroughly modern anti-vaxxers, she claims to be about choice and empowerment rather than denial of the overwhelming scientific consensus.

Of all the weasel words immunisation deniers use, I get most infuriated by the “do your own research” trope.

You don’t need to. Unless you’re a senior research scientist with your own lab, a posse of postdocs and serious wad of cash, we don’t need your help.

What Senator Hanson appears to mean is that she wants average people who find misinformation on the internet to be allowed to disagree with decades of rigorous, serious scientific effort. Unlike so many of my medical colleagues, I make an effort to keep up with goings-on in the anti-vax movement so I am grimly aware of the depths of hubris and folly that inform the “research” you so easily find when you innocently Google for vaccine information. The average person with high-school science knowledge and healthy faith in human decency has no chance.

Someone who has limited time and attention would not possibly bother to wade through the byzantine details of how Andrew Wakefield’s fraud was uncovered and the scurrilous ongoing attempts to smear Brian Deer, the investigative journalist who brought it to light.

Only a dogged student of human nature would have the stomach to watch videos featuring the pseudoscientific ramblings of the supposed intellectual leaders of this wretched movement. Yet many of us have done this for you. Trust me, there is no wisdom or learning in these cranks.

Only the real enthusiasts would have watched with bemusement last month as the Chiropractors’ Association of Australia (CAA) had a public spat on their own Facebook page with the AV-sN, Australia’s leading anti-vax organisation. CAA finally got around to demanding the removal of a link from AV-sN website endorsing their chiropractic philosophy of opposing immunisation. Their public statement read in part:

It has come to our attention that the Australian Vaccination-sceptics Network contains a link to the CAA National website. We have requested that they remove this link to our website as a matter of urgency.

The Chiropractors’ Association of Australia (CAA) does not support the views promoted by the Australian Vaccination-sceptics Network.

The former president of the anti-vaxxers then further embarrassed CAA by turning up in the comment section and lamenting:

More and more chiropractors are speaking out against their governing body trying to tell them that they must ignore basic chiropractic philosophy of the power that made the body heals the body in order to gain acceptance from mainstream medicine. When will the CAA understand that mainstream medicine’s only concern is to maintain their own authoritarian monopoly and destroy any and all competitors?

I’ve previously documented how CAA has been providing anti-vax speakers at official learning activities approved for professional development by their regulator, but you won’t find this information on the front page of your Google search. As recently as 2015, the CAA National Conference featured several speakers with links to the antivax movement. But again, the background briefing needed to appreciate the importance of this is not available to any but the most hardcore anti-vax-watchers.

I could go on and on in this vein, but I’ll spare you. Suffice to say that everywhere you get suspicion and hostility about immunisation you also get shoddy thinking and misrepresentation of plain facts. You get routine denial of reality and genuinely unhinged discourse. Science becomes The Enemy. Ideology trumps evidence.

There is no worthwhile political debate to be had here. Giving such deformed pseudoscience any media oxygen at all is reckless. It is unworthy of a serious aspirant to political power. By parroting the coded messages of the anti-vax movement, and encouraging hesitant parents to “do their own research” Senator Hanson is enabling an unspeakable industry to thrive. Make no mistake, there are hucksters both big and small raking in money by manufacturing hostility towards one of the greatest gifts our benighted species has managed to give itself.

All these cretins want is the chance to get unwary, perhaps vulnerable parents in front of their finely tuned propaganda.

What Senator Hanson has just done is give them a flood of fresh eyeballs to sell to.

Michael Vagg, Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist, Deakin University

This article was originally published on The Conversation. (Reblogged by permission).  Read the original article.

New evidence gives supporters of chiropractic a headache

Michael Vagg, Deakin University

A paper was published and much discussed online recently, which demonstrates all the problems that I – and other critics – have with the way research is done and interpreted in the world of chiropractic.

The study looked at the effect of chiropractic neck manipulation on people who have migraines.

On the face of it, the article concerned looks like a pretty fair and well conducted study. Despite the methodological difficulties of randomisation and blinding of participants with manual therapies, a genuine effort was made as part of the study design to allow for this.

The trial was a three-armed study comparing chiropractic spinal manipulation (CMST) with a sham manual therapy and a group who continued with their usual care.

Although the deliverers of the manual therapy would know what they were providing, a level of blinding to treatment allocation was possible. It was refreshing to see as well that they had checked to confirm that the blinding of subjects was maintained throughout the study. This is extremely important in assessing the validity of a study, and as the authors point out

The importance of our successful blinding is emphasized by the fact that all previous manual-therapy RCTs on headache lack placebo._

The outcome measures chosen were reasonably fair and representative of the group studied. The statistical analysis was conventional enough. They had performed power calculations using a reasonable comparator, which again increases confidence in the validity of the results and shows they were taking the methodology seriously.

The robustness of the methodology is likely the reason it was included in the European Journal of Neurology – a solid, second-tier journal with a credible reputation.

I would not quibble with the summary of their conclusion, published in the paper’s abstract, that said:

It is possible to conduct a manual-therapy RCT with concealed placebo. The effect of CSMT observed in our study is probably due to a placebo response.

This is the correct scientific interpretation of the data. If it was a drug trial, we would conclude there was no pharmacologically relevant effect within the parameters shown, and it would be considered a negative study.

How very different then is the analysis of the same study by chiropractors. The Chiropractors’ Association of Australia (CAA) mentioned it in their press release titled saying “chiropractors welcome latest evidence of headaches”. The relevant quote is:

A paper published in the European Journal of Neurology in September 2016 was the latest in a series of papers to confirm the effectiveness of chiropractic health care in treating people with migraines. The study of 104 people in Norway found that Migraine symptoms were substantially reduced as a result of chiropractic treatment.

Critical reporting of this study, such as found on the website of the American Council on Science and Health, throws up some interesting conversations and interpretations in the comments section.

While I don’t generally read online comment sections (apart from this column naturally) it’s worth making the effort in this particular case. The author of that piece has made the same basic epidemiological arguments as I have above, and come to the correct conclusion that it is a negative study.

One of the commenters accuses the author of deliberate bias and makes the following piquant observation:

To show how much spin this “article” has the title could have been: Have a Migraine? Skip the meds, sham and Gonstead CSMT both effective. more than medical care.

This commenter appears to be making the same error of interpretation as the CAA. The point of a three-armed study is to differentiate between the effect of any intervention in the study (due to placebo responses) and the improvement due to simply being observed in an artificial situation (known as the Hawthorne effect).

If a treatment is genuinely efficacious, one expects to see three divergent curves with: a minor improvement in the no-intervention group; a larger improvement in the sham intervention group; and a clearly larger improvement in the true intervention group.

A treatment which lacks effectiveness will produce results in which the two intervention groups are indistinguishable. That is exactly what this study returned. Observe the graphs for yourself.

The graphs that tell the story. European Journal of Neurology

Note carefully that the authors of the original study are careful to claim the only conclusion that can be drawn is that it is feasible to conduct a manual therapy study in a single-blinded fashion.

They made no claims about the efficacy of the intervention apart from the fact it was equivalent to sham, and in fact are explicit about the fact they believe the treatment effects were all placebo. Outright claiming the opposite is a new peak of disingenuousness for supporters of chiropractic.

Another characteristic of treatments which do not have efficacy is that the more rigorous the study, the more the claimed effect disappears into the statistical noise. To be definitive about a lack of efficacy, a much larger study would be needed.

The results above would not inspire me to spend a couple of million dollars on a study with 200 people in every arm. Results like this over the years have killed off hundreds of medications which were being developed by Big Pharma.

Academic chiropractors are in the invidious position of trying to establish that an ideologically-based treatment system has a scientific basis. They should be careful what they wish for when conducting rigorous studies, as they may find their fondest beliefs being dashed on the rocks of reality.

Michael Vagg, Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist, Deakin University

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.

NHMRC fluoride paper: relax, Australian citizens, your pineal glands are safe

Michael Vagg, Deakin University

When not being forced to waste their time and formidable expertise researching furphies like wind turbine syndrome or homeopathy, the National Health and Medical Research Council (NHMRC) can get on with producing exemplary public health statements like their newest one on water fluoridation.

Begun in 2014 in response to this sort of conspiracy-mongering, the NHMRC has collected an overwhelming weight of evidence in support of the safety and benefit of adding tiny amounts of fluoride to drinking water supplies.

This document is a draft released for public comment. I would love to be able to read the public submissions they are going to get. None of the favoured conspiracy claims are supported.

It most emphatically did not find any evidence that fluoride lowers IQ, as suggested by a badly done and even more badly reported paper from 2012.

Neither did it find any support for the idea that fluoride at levels obtained by current fluoridation practices caused significant dental fluorosis, such as brittle or discoloured teeth from excessive fluoride being incorporated into teeth.

Still less was there any support for fluoride acting as a mind control agent!

The draft paper sets out in excellent prose the value of its work and how it has been done. It is easy to understand and reading through it, I was struck by how well the considerable scientific grunt work had been made to sound easy and logical. In particular, the couple of pages the authors have devoted to their methodology is outstandingly clear and easily understood.

Sections are also included on the ethics and cost-effectiveness of water fluoridation, distilled into useful factoids such as:

• For every A$1 spent on fluoridation, A$7-18 is saved in dental treatment costs
• Over the last 25 years in Victoria, around A$1 billion dollars has been saved in treatment costs and reduced absenteeism
• Stopping water fluoridation would increase health inequality in the nation as a whole.

I would recommend the NHMRC fluoride paper as a public document for anyone with an interest in the issue, or indeed as a basic study of how to do public health policy. Most people I suspect will just go about their lives secure in the knowledge that sensible, reasonable public health professionals are making good decisions in the national interest.

Or at least, that’s what we would be thinking given that we are apparently docile and obedient from all the fluoride accumulating in our pineal glands…

Michael Vagg, Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist, Deakin University

This article was originally published on The Conversation. Read the original article.

 

Please can we give up on complementary, alternative and ‘integrative therapies’ now?

Michael Vagg, Deakin University

A purportedly serious publication in a serious forum that was published this week has given rise to a bunch of breathless CAM-related headlines in my news feed. CAM being Complementary and Alternative Therapies.

I presume that this is what the authors and their employer wanted, as the supposed good news story is in fact one of the most blatant examples of quackacademic confabulation I have seen in ages. By this I mean that all is not what it appears with this review.

Firstly, the article in question was not prepared as an original research article. This is important, as some of the headlines seem to claim this is “new evidence”.

Look at the table of contents in the journal. It is part of a “CME Credit” symposium. This is an exercise where the editor invites summary articles on behalf of the journal from experts in a field to create what is supposed to be an uncontroversial and impartial review of the state of consensus opinion based on the literature in any given field.

Busy doctors read the review and complete some questions, then claim the learning time for their professional development. I am responsible for a lot of this sort of thing in my professional life, so I know that they are not always peer reviewed and can sometimes go off the rails if the expert panel is not carefully chosen. They are most definitely not considered a means of introducing new findings.

The article is apparently the first in a “Pain Medicine Symposium” to be offered over several editions of the journal. I would have expected to see a few names I recognised from the American Academy of Pain Medicine or the International Association for the Study of Pain, or maybe even the American Pain Society among the authors. But did I?

Nope.

They all came from the National Centre for Complementary and Integrative Health (NCCIH). The lead author is an epidemiologist, and the co-authors include a naturopath with publications about echinacea and colds, a chiropractor (who at least has published about yoga and pain), a cardiologist who works in the regulatory affairs part of NCCIH and a statistician. Not exactly representative of mainstream opinion within the specialty of pain medicine I would submit.

Not to worry, I thought. There might be something to learn so let’s dive in. They start out reasonably enough sketching out some basic facts about the huge societal impact of persistent pain in the United States, which is similar to most countries. They nominate a few selected treatments: acupuncture, spinal manipulation, massage, meditation, “natural product supplements” and yoga, Tai Chi and qigong which all get lumped together, though they are in fact wildly different in practice and contradictory in theoretical concept.

After then setting out a few plausible-sounding excuses for what follows, which constitute the barest academic fig leaf to cover their sectarian belief systems, they also go on to specifically exclude cancer pain from their review. Why? I can guess. Even sincerely deluded cranks have some vestiges of conscience and wouldn’t stoop to taking advantage of cancer patients. (Or would they?)

Having cherry-picked the topics and modalities that have thrown up the most randomly positive studies over the years, they then set out a steady stream of mostly negative studies which they somehow conclude support their argument that there is some useful clinical evidence for some of the therapies.

The Science Based Medicine blog has set out an excellent critique of the methods and results of the review. But the authors would not have gotten this paper published even in an invited slot without the mandatory disclaimers about the shortcomings of the studies. These are worth looking at in detail. First:

The trial samples tend to be white, female, and older, with very few, if any, minority group participants; as such, the generalizability of the findings to the breadth of patients seen by primary care physicians in the United States is still unresolved.

Ummm, I can resolve it. They aren’t at all generalizable, since the world does not consist entirely of elderly white female people. Next caveat:

Often, the trials reviewed were small, with fewer than 100 total participants. Small trials are prone to more variability and to false-negative results.

No kidding. This is a well-known problem. If you combine the results of lots of small, bad trials you don’t reliably get closer to the truth. So why, after hundreds of trials and tens of millions of research dollars are we still getting acupuncture studies with a couple of dozen participants?

A false-negative result is one in which a real treatment is inappropriately rejected by the results of the study. However, an underpowered study is also far less likely to be reliable if positive. Doing underpowered studies using variable study designs is the exact opposite of what savvy research funders require. You don’t want to waste buckets of cash doing studies which can’t be compared or assimilated down the track to get you closer to the truth.

Given that they admit their analysis is entirely of suspect positive results from poorly-designed underpowered studies, it hardly seems worth discussing any further. But we will look at the next caveat the authors put forward:

In many of the trials in which the statistical superiority of a given complementary health approach was reported, it was not clear if the differences vs the control group were clinically relevant.

In plain English, this means you would not notice the benefit of the treatment in real life. Maybe the treatment helps but it’s not worth bothering with even if it does help. In pain medicine this is all-important, as we are currently on a crusade to reduce the prescribing of drugs such as sustained-release opioids and benzodiazepenes in situations where they have poor efficacy and significant risk. We have a couple of decades of research showing that small, short-term reductions in pain intensity are not associated with improved quality of life or health status.

For most complementary approaches, there are no standard treatment protocols or algorithms, and in the case of dietary supplements, no rigorously established dosages and products; as such, trials of a given complementary approach rarely compare the exact same intervention.

This is the bald truth. There is no standardisation of therapies, no quality control of products, nothing at all but spin and fervent belief. The situation with acupuncture for example is nicely summed up by Paul Ingraham of the Pain Science blog:

the most favourable evidence available is also the oldest, weakest and the most biased, and even that evidence is underwhelming, benefits that barely register as clinically significant — much ado about not much, even if it’s actually real, which no better study has ever confirmed.

So to recap, NCCIH released a statement for the press as if this represented new research, when their employees actually published a CME activity rehashing mostly old data, that by their own admission drew from highly unreliable studies and even if accurate was not generalizable to the population as a whole.

Never even mind that some of the therapies are conceptually exclusive of each other and biologically implausible. The press release of this through-the-looking-glass piece of “research” was then widely distributed to inform the public of the exact opposite of what the data presented actually showed. This apparently represents the pinnacle of quality in CAM research. It’s certainly the most expensively-funded.

I will be closely watching with interest the next part of the Pain Medicine Symposium from Mayo Clinic Proceedings. I hope the editors were mortified to see the opportunism with which the solid reputation of their publication was exploited by the media beat-up that followed. They have let their readership and their academic integrity down badly with this review. I can hardly believe they will embarrass themselves so badly again.

Michael Vagg, Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist, Deakin University

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.

Is the Chiropractic Board of Australia doing enough to protect consumers from pseudoscience?

Michael Vagg, Barwon Health

In this column two and a half years ago, I took the Chiropractic Board of Australia (CBA) to task for abdicating its responsibility to keep the public safe by waving through questionable activities that some chiropractors have taken part in. It drew this response from the Board, which I thought was a bit lukewarm at the time.

I resolved to wait and see whether they lived up to their public commitment. Maybe they would surprise me with their rigorous approach to protecting the public from the so-called “fringe” elements of the profession. I say “so-called” because some of the views that cause concern emanate from positions of considerable influence with chiropractic ranks.

I have not been the only one with these frustrations. An article by A/Prof Ken Harvey in the MJA Insight publication last year highlights some more direct action he has undertaken in an effort to drag chiropractors kicking and squealing into line with the same professional standards that seem so routine to other groups.

When followed up some months later it is clear little effective action has taken place. More than half of the misleading claims were still present in the complained-of websites. Only one of the ten clinic websites reported to CBA had removed the claims. The misleading and unprofessional claims that the CBA is tasked with regulating are still there, five years after it was first highlighted to them, and seven months after the CBA announced its intention to start getting serious.

The CBA Communique from its June 2015 meeting says:

The Board holds ongoing concerns about advertising by the profession that may be seen as misleading and deceptive. In particular, there have been a number of concerns raised about chiropractors’ advertising that indicates that there may be a lack of understanding of evidence and evidence-based practice.

Worryingly, the CBA’s credibility problem goes beyond advertising regulations. By continuing to lend its gravitas to some of the continuing professional development (CPD) activities that attract approved hours, I would suggest the CBA itself may end up looking like it has problems understanding the concept of evidence-based practice.

Here is an example of an activity approved by the CBA via their delegated authority to the Chiropractors Association of Australia (CAA). It specifically says on the website offering these online modules:

The Paediatric CPD Program is approved in Australia (by the CAA on behalf of AHPRA).

One of the modules on offer in this program is on Craniosacral Therapy. Craniosacral Therapy is an entirely made up and ineffective pseudo-therapy based on what “evidence” exists in the literature. It is implausible and has no credible reason for being promoted as a treatment for anything. To allow practitioners to offer it is entirely inconsistent with a commitment to evidence-based practice.

Here is another howler CBA might rather forget. Obtained by the medical media website 6minutes.com.au, it shows the CAA National approving CPD hours on behalf of CBA for chiropractor Tim O’Shea’s visit to Australia a couple of years ago. Note that CAA specifically pointed out that they were happy for him to use the Board’s imprimatur in his marketing.

CBA subsequently overturned the approval for claimable CPD hours after an investigation prompted by outrage from the more science-based chiropractic community and negative media coverage.

The CBA’s previous inability to professionally manage an investigation of an injured child has not been forgotten either. The failings of that case, including inappropriate public discussion of the highly confidential AHPRA report I have detailed previously.

Just have a look at the slap-downs being handed out by the other AHPRA Boards. Bear in mind also that the chiropractors disciplined by the Board so far have only been disciplined for advertising code breaches. The inappropriate treatment that they actually may be providing, if their advertising is anything to go by, has received little attention.

These ongoing frustrations within the profession have resulted in the formation of a new professional organisation based on professionally progressive ideals. The early signs are positive that this organisation may provide leadership and representation that is more in alignment with what the rest of the scientific health-care community expects from their colleagues in the 21st century. Whether Chiropractic Australia can influence the Board to take a similarly progressive stance against pseudoscience in their profession remains to be seen. It is a daunting and perhaps forlorn task but I wish them well in their efforts.

So after five years of hollow threats and effete regulatory action, the Chiropractic Board of Australia has “written to every chiropractor registered in Australia via the newsletter to remind them what is legal, and what the Board expects” according to the current Chair in a media release. They have also set out at length in their newsletter the standard to which they wish to hold their profession.

I guess it’s just too bad for the public if average chiros treat this latest “campaign” by their supine regulator with the same unresponsiveness they have shown for the last five years. Reform-minded chiropractors might prefer to see a few outrageously unprofessional colleagues temporarily put out of practice pour encourager les autres.

I think when one looks at the efforts of the CBA over the last couple of years, it’s hard to be confident that the public’s interests are being adequately protected. The reluctance of the fractured chiropractic profession to go along with even the most basic self-regulation standards seems intractable with a light touch. The strongest enforcements by the CBA have been brought about by public shaming from the media or within their own profession. As it stands they are the Caspar Milquetoast of regulators.

They could at least have a go.

Michael Vagg, Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist, Barwon Health

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.

 

Can the ACCC ‘target the source’ of misleading labelling?

Michael Vagg, Barwon Health

Regular readers of this column will know that I’ve been less than complimentary about the effectiveness of the Therapeutic Goods Administration (TGA) in its efforts to regulate advertising of non-prescription products.

I am therefore delighted to give some credit when good news breaks. The Australian Consumer and Competition Commission (ACCC) has succeeded in a Federal Court action to have misleading packaging of Nurofen products banned.

The manufacturer Reckitt Benckiser (Australia) Pty Ltd has three months to remove all its misleadingly packaged Nurofen products from shelves. This outcome has taken five years from the time CHOICE magazine awarded Nurofen a Shonky Award for the labelling. The TGA first ordered them to withdraw the claim in 2011.

Following a final TGA review in 2012 which backed up the original finding, Reckitt Benckiser effectively dared the TGA to force them to change their ways. It was announced in March this year that following the failure of the TGA to get an outcome, the ACCC would pursue it using their consumer protection powers.

Today’s outcome is entirely predictable, from a scientific point of view. There was never any merit to the claim that ibuprofen could in any way be said to “go straight to the site of pain” any more than a sprinkler system in a high-rise building goes straight to the cause of a fire.

So why didn’t Reckitt Benckiser change their branding when ordered to?

My guess (and I emphasise this is speculation) is that they understood that there has never been a prosecution by TGA under the Therapeutic Goods Act 1989 because the derisory penalties aren’t worth paying good public money to enforce.

Once Reckitt Benckiser have paid their lawyers and costs, I’m guessing they will be well in front after selling the offending products for four years longer than they were supposed to. They have also had four extra years to gather marketing data and optimise their plan for rebranding.

It was inevitable that they were going to have to change their indefensible labelling, but why jump until you’re about to be savagely pushed?

Another example of the contempt in which the TGA is held was in 2013 when Swisse vitamins had an “appetite supressant” product banned by TGA only to re-register the exact same pills as a “hunger control” product. They only made the change after the TGA threw everything they had at them. Yet it was as easy as that to shrug off all the bluster the regulator could work up.

The example Reckitt Benckiser has set in defending its misleading and unfair consumer strategy with Nurofen will be noted by other companies, and the lesson will not be lost on them if they are next in the ACCC’s sights. The tactic is to fight in the courts for as long as the ACCC has the will to spend taxpayers’ money in order to buy time to plan the exit strategy and get a few more months or years of benefit from the dodgy claims. Milk the cash cow until the law closes in, then cop it sweet and move on.

Australian consumers will continue to be ripped off and fleeced as long as we are represented by a TGA which has not been given the tools to do its job. Neither side of politics is very interested in legislative change because the big players are just fine with it how it is. The real problem is that the same legislation that makes the TGA a tough-but-fair sheriff as far as prescription drugs and devices go also renders it flabby and supine enough to be unable to seriously hamper the sales targets of the non-prescription sector.

The foxes of the health-care industry may not be directly in charge of the hen house, but no holes in the wire are getting fixed without them giving the nod.

Michael Vagg, Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist, Barwon Health

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.

 

Is the medical marijuana debate even worth having?

By Michael Vagg, Barwon Health

Given the recent thawing in political attitudes in New South Wales and Victoria towards so-called medical marijuana, one could be forgiven for assuming that the medical care of certain individuals is being disadvantaged by the lack of access to THC (tetrahydrocannabinol) products. One of the most frequently cited reasons for legalising marijuana for medical use is its efficacy for chronic pain.

By way of background, there is no dispute scientifically that molecules derived from marijuana (cannabinoids) are involved in pain signalling. The class of biological molecules that activate this system are called endocannabinoids and their biological activity is very complex. The sheer complexity of these actions is essentially the problem with finding suitably safe and effective medications for pain. There is an enormous amount of crossover from pain regulation into other brain functions such as motivation, memory, appetite and thermoregulation (body temperature control). The basic science is complex, and clinical trials to date have been disappointing. This usually suggests we have more to learn before a treatment is ready for adoption. When we have the clinical pharmacology of a drug nailed down, the results in trials are usually clear cut successes.

If you want a slightly technical but very accurate and balanced view of the current state of the evidence regarding the risks and benefits of cannabinoids in pain, you can read these lecture notes. If you don’t have the time or inclination, the summary of the serious literature is as follows:

• The evidence supporting efficacy in neuropathic pain or any type of chronic pain is mixed, and the basic question of whether it really works is a long way from settled.
• The most generous estimate of the effect size for THC-derived products in clinical trials to date is small. Simply put, THC-derived products are about as useful as paracetamol for pain.
• There are significant concerns that lifetime consequences can occur from periods of exposure to THC-derived products, particularly in adolescence and young adulthood.
• Currently available prescription products such as Sativex do not have evidence supporting their efficacy in pain conditions that would qualify them for serious consideration. They do have evidence of side effects and potential harm, like all prescription drugs.

The situation regarding hemp oil and other “cottage industry” products is even less encouraging. There is no compelling evidence that stronger preparations are better for pain relief than the relatively less potent ones available on prescription. The quality and safety of such products is unregulated and does not deserve any sober consideration as a useful treatment for pain. They may be highly regarded by connoisseurs but they don’t even approach the benchmarks for ethical prescribing.

Is more research needed? Yes, I think much more research is needed into endocannabinoids to identify more promising targets for new drugs. Do we need any more trials looking at hemp oil or other currently available forms of cannabinoids? Not really. We would probably get better value for increasingly scarce research dollars by looking at other more promising treatments.

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.

Acupuncture, zombie fish and Humpty Dumpty

By Michael Vagg, Barwon Health

“When I use a word,’ Humpty Dumpty said in rather a scornful tone, ‘it means just what I choose it to mean — neither more nor less.’

’The question is,’ said Alice, ‘whether you can make words mean so many different things.’

’The question is,’ said Humpty Dumpty, ‘which is to be master — that’s all.”

Lewis Carroll, Through the Looking Glass

My daughter is a huge Katy Perry fan, and thus it came to my attention that the songstress had tweeted about eating acupuncture-treated sushi and loving it. Naturally, my antennae were twitching at the suggestion that there were integrative fishmongers out there. What next, I thought, reiki-treated wagyu? Reflexologized spatchcock? Quinoa harvested by shamans with planetary tuning forks, perhaps?

Now, I’m all for eating healthily, and I’d also like to make it clear that it seems Katy had not gone out of her way to insist that the fish had been needled prior to consumption, but rather that some top Japanese fishmongers like to use acupuncture needles to treat the tuna and salmon to keep them fresh.You can see some video of the practice here.

Far from using the ancient wisdom of acupuncture to balance the qi and bring perfect health and amazing vitality to empowered and health-conscious aquatic consumers of the deep, the needles are used to disconnect the brain of the fish from its spinal cord, effectively letting it continue breathing with brain stem reflexes only to oxygenate the flesh while being transported. The more upmarket way to get fresh fish in Japan is to have it filleted while still alive, such is the value placed on freshness. Clearly this is not a practice that has much appeal for diners not culturally attuned to such cruelty. I’m not totally sure that the needling is much more humane, despite it being given the soothing euphemism of “kaimin katsugyo” which translates as “living fish sleeping soundly”. The fish with needles sticking out of them are packed in seawater-soaked cloths for transport, and are said to expire peacefully during the transport to the restaurant, where chefs and diners swoon at the exquisite flesh.

I’m intrigued though that this use of acupuncture needles for a purpose that clearly has absolutely nothing at all to do with health and wellbeing is even called acupuncture. It illustrates one of the fundamentally irritating and illogical things about acupuncture in general ,ie which form of it is the real acupuncture?

If the underlying premise of Traditional Chinese Medicine (TCM) acupuncture is about balancing yin and yang with a view to manipulating the flow of qi along meridians, then why is there also Japanese acupuncture, which uses shallow needle insertions, Korean acupuncture which concentrates on the hands and auricular acupuncture, which was invented by a Frenchman in 1957? If meridians were real, and acupuncture works in the manner claimed by any of these schools with diametrically opposed opinions, then there must be a winner if they are put to the test. Why hasn’t that happened? Where are the crossover studies from TCM proponents showing head-to-head comparisons with Korean or Japanese techniques? Where are the basic science studies demonstrating in animal models (since animals apparently have meridians as well) why Korean acupuncture has it right, and TCM has been doing it wrong all these years?

Part of the frustration of trying to take acupuncture seriously (which I do, that’s why I’m always annoyed about it) is that the definition and supposed theoretical model cannot be defined in a meaningful way. As Humpty Dumpty points out rather scornfully, ‘acupuncture’ seems to mean whatever you can do with an acupuncture-like intention. As a wonderful example of the genre, this study was an instant classic when it was published in 2009. The authors can’t admit it was a resoundingly negative study. Instead they want more research into the possible mechanisms of ‘toothpick acupuncture’ since it seemed more effective than their best-practice TCM version. Similarly, the popularity of ‘laser acupuncture’ is testament to the fact that complete lack of plausibility and rationale for a treatment is no barrier to widespread use if you get the feels right.

So let’s be clear, zombifying fish to give them a prolonged death is no more acupuncture than using toothpicks, lasers, electrodes, tong ren hammers or needles to restore health. There is no genuinely accepted definition of the term. There is just a bunch of sectarian splitters.

Michael Vagg does not work for, consult to, own shares in or receive funding from any company or organisation that would benefit from this article, and has no relevant affiliations.

This article was originally published on The Conversation. (Republished with permission). Read the original article.

Are pharmacists are trustworthy as they’d like us to believe?

By Michael Vagg, Barwon Health, 12 September 2014

Pharmacists are consistently held up as among the most respected and trusted of professionals. They fulfil an important role within the health professions of being the gatekeepers of medication dispensing and the link between the community and their medication use. For more than one hundred years, there has been a very clear and ethical distinction between doctors (who prescribe medications) and pharmacists (who sell them). That way, the argument goes, doctors have no direct financial interest in drugs they prescribe, and pharmacists have no direct financial interest in recommending any of the drugs on their shelves directly to patients. So far, so good.

There has been a bit of role creep over the years, with calls from some doctors to be allowed to sell their own concoctions directly to their patients, as well as a much more concerted push by pharmacists to play a bigger role in health care, including providing immunisations and health checks direct to consumers. Naturally this is of concern to GPs as such proposals have the potential to fragment primary care even further. Not to mention taking the critical role of diagnosis and putting it into the hands of those who are underqualified, underinsured and undersupported to handle it.

What concerns me particularly is not so much that these health checks will take work away from GPs. If anything I suspect they will increase GPs workloads, sorting out the advice already given to patients by wannabe GP enthusiasts like pharmacists and their associated naturopaths. This month’s Skeptic magazine from Australian Skeptics highlights the problem quite well.

I think it’s time for pharmacists to decide if they want to keep the trust placed in them by the community to give sound advice. If they want to remain a trusted source of advice they need to lift their game and get all the ear candles, homeopathy, magnets, herbs and supplements out of their shops, along with the iridologists and other fairground ‘health professionals’. In short, they need to start acting like they deserve the trust and respect that is accorded them. We have heard nothing of the training and CPD requirements for pharmacists who want to diagnose and treat patients, let alone how they will be insured. I would want to see all this detail before I let my croupy baby or breathless grandmother within a bull’s roar of a pharmacist’s diagnostic skills.

The protectionism involved in the business of running pharmacies is breathtaking. Like dentists, only pharmacists are legally allowed to profit from running pharmacies, and they have defended this with all the bitterness and vitriol you might expect from a group who know they are onto a good thing. Health Minister Peter Dutton seems all for the pharmacists’ ambitions and has been on the media trail vowing not to wind back their protected status.

So it seems the pharmacists will have all they want. I wonder if they deserve it? I hope they take the opportunity to lift their game as a profession and use their protected status to raise standards, not profits. A good place to start would be to stop advertising and selling shonky devices and products that would be considered fraudulent in any other context. Too hard? Then get out of the expanded responsibility game for good.

Michael Vagg does not work for, consult to, own shares in or receive funding from any company or organisation that would benefit from this article, and has no relevant affiliations.

This article was originally published on The Conversation. (Republished with permission). Read the original article.

Fluoride conspiracies + activism = harm to children

By Michael Vagg, Barwon Health, 2 September 2013.

I’ve discussed in an earlier piece the origins of fluoride conspiracy theory in post-war Europe. Other articles on The Conversation have set out the science behind our understanding that optimising levels of fluoride in drinking water is a safe and effective intervention (albeit one with a modest effect size) for the good of public health.

What I didn’t put into that earlier piece was a few personal anecdotes. The SMH article was completely consistent with them, so I might as well add my bit of anecdotal colour to the debate.

The region where I live has been one of the last in Victoria to add fluoride. This has partly been for logistical reasons, but also because the region is home to one of the better organised and more vociferous anti-fluoridation groups. In fact, my Letters to the Editor of the local paper pointing out the numerous factual errors of these groups ended up getting me personal nasty replies from the Editor herself, along with solemn and binding commitments on her behalf never to publish my ill-formed opinions again.

As a Pain Specialist, many of my colleagues are anaesthetists, and they have for years never looked forward to the paediatric dental lists here. So many children getting general anaesthesia for multiple extractions due to decay. The children wake up dazed, in pain, crying, vomiting and bleeding. Even though they bounce back pretty quickly afterwards, it’s not a very rewarding job to do. Anaesthetic trainees rotating down from big city hospitals where they rarely see such lists are about the only ones who benefit from such a cavalcade of needless misery. The risks of general anaesthesia are not to be idly contemplated for children, and far outweigh the virtually nonexistent risk from fluoridation.

Since fluoridation was introduced to Geelong in 2009, my colleagues are much happier, as severe dental abscesses requiring tricky anaesthetic techniques are much less common, and tend to mainly come from areas in the region which still aren’t fluoridated. A quick chat with one of our local dentists confirmed they had the same belief. The rate of kids needing GAs for dental work is approaching that of their metropolitan counterparts, though the list remains disappointingly long.

The other anecdote I wanted to share was that one of my colleagues who had worked in Europe for a few years went away with 3 children under the age of 6, who were the same age and social demographic as our own children. When they returned from living in a non-fluoridated European city 3 years later, 2 of his 3 children had needed dental treatment under GA and all 3 had fillings compared to none of any of their peers in our social circle who stayed in Australia. That’s a nice little case-control study right there, as if any further anecdotal evidence was needed to add to the overwhelming scientific evidence for fluoride optimisation.

So again, please don’t buy into fluoride conspiracy-mongering. Let’s not voluntarily give up the advantages of access to first-world public health measures because of manufactured scare campaigns. Maybe many anti-fluoride activists are sincere and reasonable people at heart. They certainly seem to hold their views with conviction. It’s just that on this issue, they couldn’t be more demonstrably wrong. The consequences of their misguided support for non-fluoridation are causing direct and measurable harm to children who deserve better than wilful ignorance and ersatz health consciousness.