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There has been lots of talk recently in the Australian media about CAM in universities. A new lobby group known as Friend of Science in Medicine was recently established to get the discussion going about whether this is a good thing. (Full disclosure, I recently added my name to the 400-long list of doctors, scientists and concerned citizens who are worried about pseudoscience creeping into universities).

The discussion has ruffled some feathers and I think this is a good thing. As I said in a comment on The Conversation, what is wrong with us looking at these courses and determining if what they are teaching is evidence-based? If we find there is nothing wrong, then we can carry on our merry way.

Yet, some CAM peeps don’t seem to see it this way. Some have been behaving as if they are being persecuted. Some are claiming that taking CAM out of unis puts the public at risk as practitioners are more likely exposed to shonky teaching (I haven’t seen any evidence for this, but as usual I’m willing to look at it if it’s true).

But this misses the point that it doesn’t matter where you teach it, if it’s nonsense outside of a university it remains nonsense when taught in one. Teaching homoeopathy or tactile therapy in a university environment won’t make it work. To see how homeopathy works, go here.

The argument got rather heated on Twitter recently with Prof Kerryn Phelps jumping in the mix. I had quite a long conversation with her, which remained mostly civil (if not a little strained) until I suggested we weed out the stuff we know doesn’t work or exist, such as subluxations in chiropractic and homeopathy.

The response I got was odd to say the least and I’m still unsure exactly what she was getting at. See the screen shot below (read from bottom up).

Some people suggested this was an example of the No True Scotsman fallacy, which I kinda agree with. More simply, it appears to say “don’t mention homoeopathy, even we’re embarrassed by that”. If you have another idea, please leave a comment.

Someone else called “SkepNurse” also posed the question to Prof Phelps regarding which CAM she would unequivocally say was not worth pursuing any more, either because it can never work or has been proven not to. She posted these tweets on Jan 26th and is still awaiting a direct answer.

Anyway, I’d been poking around for information on whether homeopathy was taught in universities as a stand alone course, and I hadn’t found any evidence. CAM practitioners had confirmed this as well, pointing out that it was a requirement to enter Bachelor of Health Science (Complementary Medicine) at Charles Sturt University but was not taught as a separate subject.

Well, they were wrong.

Homeopathy is taught as a stand alone course subject at a publicly funded university in NSW as part of Southern Cross University’s Bachelor of Clinical Sciences. They offer introductory homeopathy and clinical homeopathy. It is also offered as a service in the health clinic

There is even a prize offered at SCU.

The Warren Brauer Memorial Prize – Homoeopath Dispensary to the value of $500

Awarded to the Naturopathy award graduate who has exhibited a high level of proficiency in the understanding and application of homeopathy.
Donated by Brauer Natural Medicine Pty Ltd

SCU is a publicly funded university who received $32 million of federal funding in 2011. Thus, public funding is going towards the teaching of nonsense in Australian Universities.

When I’ve previously written about public funding for homeopathy in Australia the most I could do was speculate about how much it might cost the tax payer. It’s complicated because our public health system does not directly fund homeopathy as health care, but it does supplement private health funds (which do cover homoeopathy) and also some doctors/gps will prescribe recommend it.

This is the first evidence I have found that tax payers funds directly fund this nonsense. And what a waste of money it is.

I’ve written to SCU to ask for their course outlines for both classes. Let’s hope I get them so I can get a better idea of exactly what they teach.

With continued pressure from FSM, this conversation will likely continue for some time. I would like to see the first casualty be these courses at SCU.

This comment on The Conversation has really summed up this debate for me so far. It’s from Didier Nave, an ex-herbalist of 25 years and the following excerpt speaks volumes;

Time to face the facts. The data is coming in and its not looking good. It’s clearly showing that what we do is not much better than placebo. So the question is do we have the humility to accept the evidence and dump these theories. I doubt it….Have i seen the industry contest or reject its own stupidities like live blood analysis or “detoxing” when it can’t name one toxin that its methods supposedly detox? No, it embraces them instead.”

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To see how The Dean of the School of Health, Professor Iain Graham, defends woo in his uni, see Mick Vagg’s post here.

There’s more info on woo in public and non-public facilities here.

Thanks to Loretta Marron for assisting with research.

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More interesting reading on the current debate (and for healthy discussion in comments) see two recent articles from The Conversation;

Alternative Medicine Can Be Sientific Say Besieged Academics

Pointing The Bone At Chiropractic Quackery Lessons From the UK

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If you’re interested in signing your name to FSM, you can find their Facebook page here

To see the investigation of woo in universities from The Skeptic magazine (and written by Tim Mendham with research from Jo Benhamu) go here (pdf).

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But this morning I had reason to leap out of bed at the ungodly hour of 05:30 to hit the computer and report on some very good news.

Our government has gone done something good and given that this doesn’t happen very often, I reckon it’s worthy of a pre-dawn blog post.

The news, which was brought to my attention by Fuzztwin on Twitter, reports on changes to the current childhood immunisation schedule to include three new vaccines and increase the incentives for parents who complete the schedule, effective 2013.

From http://www.heraldsun.com.au/news/more-news/inject-children-or-lose-money/story-fn7x8me2-1226205382138

Chickenpox or varicella which as not previously been covered by the schedule (and hence was an out-of-pocket expense for parents wanting to vaccinate against chickenpox) will now be included.

Also new is vaccinations for meningococcal C and pneumococcal.

The new schedule brings the number of infectious diseases covered by the schedule to twelve.

Importantly, reports indicate that the number of shots kids will be required to get will actually be reduced however, since there will be new combination vaccines used.

According to a report in The Herald Sun a new combination vaccine will cover measles, mumps, rubella and chickenpox in one shot and will be administered at 18 months replacing the previous MMR given at 4 years. The number of visits will increase however, owing to the new scheduled shot at 18 months.

There are also changes to the incentive scheme for parents and this is where it gets interesting (well, for nerds of legislation like me).

Under the current maternity immunisation allowance scheme introduced in 1997, parents receive two one-off payments totalling $258 if they complete the vaccination schedule. This will be scrapped under the new system and replaced with three payments of $726 each, paid at one, three and five years. If kids are not fully vaccinated, then the $2100 will be withheld. (This is part of the current family tax benefit part A end-of-year supplement so it’s not an entirely new benefit).

From http://www.smh.com.au/national/tax-threat-to-parents-who-dont-have-their-children-immunised-20111124-1nwwx.html

Health Minister Nicola Roxon said: “We know that immunisation is fundamental to a child’s lifelong health and that’s why we want to make sure that children are immunised at the right time.

“We want all Australian kids to grow up healthy, and immunisation is essential to that.”

What is not mentioned in any of the news stories is whether this effects the current options for conscientious objectors. Under the current system, you can still get the maternity immunisation allowance even if you don’t vaccinate, if you identify as a conscientious objector (CO). Excerpt from the Centrelink website which administers the payment:

a recognised immunisation provider (e.g. your doctor) signs a letter or form saying that:

• they have told you about the benefits and risks of immunising your child and you have a conscientious objection to immunising your child (your provider should complete a Health Insurance Commission Immu-12 form),

• immunising your child with a particular vaccine is medically contraindicated (your provider should use the Health Insurance Commission Immu-11 form),

• the child has a natural immunity to the disease, or

• the vaccine is not available,

• you or your partner are a member of the Church of Christ, Scientist and you have a letter from an official of the Church advising that you are a practising member of the Church.

This is certainly going to be the bit the anti-vaxers are interested in. The news stories appeared overnight (at least one was published at 12:00) so we have yet to see a reaction from Meryl and her buddies. But you can expect some major *head asplosions* on this one, guaranteed. Particularly since Meryl had previously claimed she has some sort of influence when it comes to vaccination policy. It seems she might have missed this one.

This is not the only piece of good news in this story either. Reports also detail a new pertussis awareness campaign in the form of mail-outs to warn parents about the dangers of the current epidemic and advise on ways to protect their kids.

This is a direct response to campaigning by the McCaffery family who lost their baby Dana in 2009 at 4 weeks of age in the grips of a pertussis epidemic. The family was never warned about the risks of pertussis or that they needed, as parents and carers, to get boosters, since the effectiveness of the vaccines wanes over time.

From the Age:

Ms Roxon said the aim of the whooping cough campaign was to raise awareness, particularly among parents planning pregnancies and others to be aware of the dangers to infants and the need to have vaccinations at two months, four months and six months after birth.
.

But the vaccinations do not provide lifelong protection from whooping cough and children should have booster shots at age four and then during teenage years, Ms Roxon said.

.

”Whooping cough is not just a childhood disease, as adolescents and adults can account for half the cases in the community.”

Overall, this is a step in the right direction by the Australian Government and I applaud Nicola Roxon for (finally) taking action. The introduction of the chickenpox vaccine is also a welcome addition to the schedule, since it costs as much to get as the current maternity immunisation allowance (~$200) making the incentive seem moot.

It’s still early in Australia, and since this story only broke overnight, I wait with interest for the response of the anti-vaxers. I’ve also searched, but to no avail, for a government media release, as I’m keen to find out if any changes have been made to the CO conditions.

One suspects they will remain in place, at least in some form, since they are necessary for kids with genuine medical reasons for not vaccinating, but given that the maternity immunisation allowance scheme is to be scrapped, it appears they will at least need to be migrated, if not re-drafted.

I await with interest.

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Update: the government statement about changes can be found here

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The document was released by the TGA in response to an FOI for Infringement Notices and Enforceable Undertakings issued by the TGA against sponsors on the ARTG.

In other words, someone was trying to find out which companies who have products on the Australian Register of Therapeutic Goods and have been issued with infringement notices for unspecified breaches.

In April this year the TGA began a transparency review so consumers would be better informed about their practices. If this is the result then they’re doing it wrong.

I lold.

Download a copy of the form here.

As someone on Twitter said

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The story concerned a study in progress from well known anti-vaxer Judy Wilyman (for more background see Dave the Happy Singer’s blog post).

ABC Science presented her views in a completely credulous fashion omitting any context that she has lectured with the sometimes-president of the AVN Meryl Dorey and has close affiliation with the AVN. (In response to my complaint about this lack of disclosure, the ABC apparently asked Ms Wilyman if she was affiliated with the AVN and when she said no, they were satisfied with her response).

As you’ll see below, they have also taken out of context my complaint that her views should have been reported along with a declaration that she does have anti-vaccine affiliations to say I don’t think her views should have been reported at all. This was not what I was trying to say and I don’t think my complaint conveys this (it’s reproduced below so you can decide for yourself – let me know in the comments if you think it does).

Overall, I am extremely dissatisfied with this response. I wouldn’t care if her piece was presented as opinion – but it was presented as science with comments from Prof Booy (one wonders why he keeps getting quoted in such articles – it only serves to boost the legitimacy of the anti-vaxer and does nothing for his reputation).

It also comes off as rather patronising in my opinion, beginning with addressing me as “Ms” when my correspondence was from “Dr”. You’ll also note below that ABC neglected to address my comment about an internal ABC memo which stated that any material or interviews which involve the AVN or affiliates must be published in context so that readers are aware the information is not based on evidence.

I think this was a rather important point which the ABC decided to gloss over.

There is much more to say on this, but I am currently at a conference which has been going for 12 hrs so far today and I haven’t had dinner yet. I’ll get back to this later.

Thanks to Ken and Carol for the tip-off to this poster. I’ve annotated it for the ABC just so they can understand.

To: Audience & Consumer Affairs
From: Rachael Dunlop
Subject: ABC Science HPV story
Date: 14/10/11 17:20

Below is the result of your feedback form. It was submitted by Rachael Dunlop
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ABC program: ABC Science

Response required: true

Date of program: 131011

Contact type: Complaint

Location: NSW

Subject: ABC Science HPV story

Comments: Yesterday ABC Science online published an article questioning the safety of the HPV vaccine.

The PhD student interviewed is a well known anti-vaccine campaigner who is affiliated with the Australian Vaccination Network.

The AVN was investigated by the HCCC in 2010 who issued a public warning about their website here

In short: The Commission?s investigation established that the AVN website:

• provides information that is solely anti-vaccination
• contains information that is incorrect and misleading
• quotes selectively from research to suggest that vaccination may be dangerous.

Indeed the ABC issued a warning to staff in July 2010 stating that “it’s vital that programs provide adequate context to ensure listeners clearly understand the AVN is a lobby group”.

Why were the affiliations of Wilyman not made clear? A declaration should have been published stating she is an anti-vaccine lobbyist.

Perhaps a better headline for this story would have been “Evidence for HPV vaccination questioned by anti-vaccine campaigner”. That this anti-vaccine nonsense was published on an ABC science website is a disgrace.

Network – ABC Online
RecipientName – Audience & Consumer Affairs
Referer – Complaint
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My comments in bold (more comments to come)

Dear Ms Dunlop

That’s Dr to you thanks

Thank you for your emails regarding the ABC Science story ‘Evidence for HPV vaccination questioned’, published on 13 October.

In accordance with the ABC’s complaint handling procedures, your correspondence was referred to Audience & Consumer Affairs, a unit which is separate to and independent of program making areas within the ABC. The role of Audience & Consumer Affairs is to investigate complaints alleging that ABC content has breached the ABC’s editorial standards (available here: http://abc.net.au/corp/pubs/edpols.htm).

Yeah, thanks for that, but that was where I sent my email you dolts. See
To: Audience & Consumer Affairs
From: Rachael Dunlop
Subject: ABC Science HPV story
Date: 14/10/11 17:20

I also want to add here that our initial complaints were made on Twitter to @ABCScience and the editor of the latter, @ScienceNewsGeek (Darren Osborne).

I did this (a copy of my email to Darren can be found here), I also made a direct complaint to Audience and Consumer Affairs which is addressed in this post.

Contrary to what Darren said about “a few days” I did not hear back regarding my direct email to him. I tweeted to him a few days later to enquire about the status of my direct complaint and was told that apparently all complaints had now been sent on. This was despite the fact that I had already complained to ABC Audience Liaison. I received this (unsatisfactory) response from Darren when enquiring further about this;

Anyway, on with the “defence” of this nonsense by Audience and Consumer Affairs.

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I understand you believe the story should have disclosed the affiliations of Judy Wilyman, one of the interviewees whose views it reported, and that she is an “anti-vaccine lobbyist”.

In addition, I understand you believe it was irresponsible and disgraceful for the story to report her views.

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Taking my comments out of context much? Yeah I see what you did there clever Consumer Affairs Peeps.

In context, I said presenting her “anti-vaccine nonsense” as if it were science with no disclaimer to indicate she has an anti-vax agenda was “totally irresponsible” and “absolutely disgraceful” particularly in the context of a recent resurgence of vaccine preventable diseases. I think I made this quite clear.

Judy Wilyman can say what she likes when it presented as opinion but you presented it as science when it was a purely a grab bag of anti-vax canards thinly disguised as science.

This was clear as day to anyone who has done their research, which apparently ABC Science has not (and is not willing to do so, beyond asking Judy Wilyman herself – see below).

Oh wait! But someone in the comments has. They Googled “Judy Wilyman” and “Meryl Dorey”and got a link to an Australian Vaccination Network blog post describing when they gave talks together. Actually the same link I provided you in my original complaint. Did you not see it?

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The ABC Editorial Policies do not contain a specific standard requiring disclosure of information about interviewees.

Maybe not, but there was this memo which YOU distributed to YOUR own staff in July 2010 following the public warning about the AVN issued by the HCCC

Excerpt from internal ABC memo sent July 28th 2010 following the HCCC public warning

However, the manner in which factual content – including information about interviewees – is presented is subject to the accuracy standards set out in section 2 of the Editorial Policies:

“2.1 Make reasonable efforts to ensure that material facts are accurate and presented in context.

This was kinda my point – you didn’t do this

2.2 Do not present factual content in a way that will materially mislead the audience. In some cases, this may require appropriate labels or other explanatory information.”

^^^ ummmm this?

In light of your concerns, Audience & Consumer Affairs has reviewed the story, considered information provided by ABC Innovation (the division responsible for the ABC Science website), and assessed whether these editorial standards were met in the presentation of information about Ms Wilyman.

Ms Wilyman was described in the story as someone “who is completing a PhD on the Australian government’s vaccination policy at the University of Wollongong” and “who has a Master of Science in population health”. These descriptions were accurate. As well as quoting from and paraphrasing Ms Wilyman’s views, the story included a direct link to the paper in which her views were outlined in detail.

I note your view that Ms Wilyman is an anti-vaccine campaigner and is affiliated with the Australian Vaccination Network (AVN). Audience & Consumer Affairs has found no evidence indicating that Ms Wilyman has particular affiliations which needed to be disclosed in the story in order for readers to make their own judgements about her claims. We have found no evidence indicating that Ms Wilyman is a member of the AVN, and ABC Innovation has advised that Ms Wilyman has denied being a member of or having any affiliation with this group. (translation – are you anti-vaccination? No? Okay then, thanks!)

In our view, readers were provided with sufficient information about Ms Wilyman to form their own conclusions, and the manner in which she was presented was not materially misleading.

Nonsense.

While we are satisfied that the relevant editorial standards were met, please be assured that your comments about Ms Wilyman and the AVN, and your view that it was irresponsible for ABC Science to report her view…

Again, it was irresponsible to report her views without context and since when has science been about “views” and not evidence. ABC Science – WE DON’T NEED NO STICKIN’ SCIENCE!111),

…have been noted and conveyed to ABC Innovation management. Thank you for bringing your concerns to the ABC’s attention.

Yours sincerely

Simon Melkman
ABC Audience & Consumer Affairs

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Do some stinkin’ research ABC. Cause this nonsense make ABC Science seem like an oxymoron.

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From the ever dangerous and delusional Homeopathy Plus! who would be funny if they were a Poe (they’re not). For the complete crazy go here.

BTW, the reason I’ve had a busy week was because of a post on Mamamia which went well a little bit mental. I been kept busy responding to comments. So far I’ve been called a liar at least three times, usually by people hiding behind anonymous handles. Brave eh? Thanks so much to everyone else who has jumped in to help me.

Mind you Mia Freedman came out today and slapped the anti-vaxers down with this comment.

Anti-vaxers using dirty tactics? Who’d have thunk it…

I did a pre-record for next week’s Mamamia TV with her today.

Also on the panel was Sam de Brito, Sarah McDonald, the head of GetUp! and the editor of Cosmospolitan Magazine (sorry, I fail to remember their names). You can watch it on Foxtel next Friday at 21:15 or on the Mamamia website after it’s aired.

Enjoy your weekend!

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The Pharmacy Guild of Australia and Blackmores have agreed that the Gold Cross endorsement of the Blackmores Companions range of complementary medicines will be withdrawn.

The mutual decision has been taken in view of the strong level of public concern about the proposal, based on some media reporting of the endorsement which was ill-informed and inflammatory.

The last thing the Guild would ever want to do is deplete the credibility of community pharmacists, or damage the trust in which they are held by Australians. That trust and confidence is of paramount importance to the Guild and to our Members.

The Gold Cross endorsement arrangement with Blackmores was entered in good faith, with absolutely no intention of undermining the professionalism and integrity of  articipating pharmacists. There is not now and never would be any direction from the Guild for pharmacists to be involved in unprofessional, unethical or clinically unsound conduct. The idea that community pharmacists would take part in commercial “upselling” without regard to their professional standards is offensive to our profession and rejected by the Guild.

However, perceptions are very important, and it is overwhelmingly clear that the public perception of this endorsement was damaging to the reputation of community pharmacy. Both the public, and sections of the broader pharmacy industry expressed strong concerns about the proposal.

The Guild has listened to these concerns and accepts – mutually with Blackmores – that the best course in all the circumstances is to withdraw the endorsement arrangement. The Guild regrets any damage done to the image of community pharmacy and will do everything possible to ensure the public maintain their trust in community pharmacists as the custodians of medicines and the Pharmaceutical Benefits Scheme.

The National President of the Guild, Kos Sclavos, said: “We entered this arrangement in good faith, but we have now agreed with Blackmores that the furore that has been created is doing damage, and must be dealt with before it further damages community pharmacists and the patients they serve. The only alternative is to cancel the endorsement, and this has been done. I add my personal apologies for any distress this has caused to pharmacists.”

Gold Cross, a fully owned subsidiary of the Guild, had agreed to endorse a range of Blackmores products, which meant that the range of four Companions products would have the Guild’s Gold Cross on their packaging.

Additionally, an optional prompt containing clinical information for the patient to consider in relation to one product of the Companions range was to be available through the dispensary IT programs, on a pilot basis. The software pilot was not intended to commence until at least November, and will now not proceed.

Blackmores products are well-established, and marketed by one of the best known and respected names in evidence-based complementary medicine. Many doctors, pharmacists and other health professionals make recommendations for these types of products frequently.

Blackmores developed this range of four to be available exclusively through pharmacies so that consumers would always obtain the appropriate information and advice.

Contrary to some media reports, there was never any compulsion whatsoever on pharmacists to sell these products, nor was there any direct incentive to any pharmacist to sell them. At all times, community pharmacists would continue to be free – and indeed expected – to exercise their professional and clinical judgement in relation to these products.

Media inquiries: Greg Turnbull 0412 910 261

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I mean most of them already stock homeopathy and woo like ear candles and holographic wrist bands, a lot have in-residence naturopaths and iridologists. But now there’s yet another way to rip off consumers by selling them stuff they don’t need, this time when they’re trying to get a prescription filled*.

It has just been announced that the Pharmacy Guild and Blackmores have joined forces to upsell you Blackmores supplements when filling a prescription. It’s all explained in the video below but basically now when you go to a pharmacist to get a script, a computer programme will match your medication to a Blackmores product, then the pharmacist will attempt to upsell you, by saying you need it if you’re taking that medication.

What a sweet deal between the Pharmacy Guild – the organisation who essentially manage the business side of pharmacies – and what a great little earner for Blackmores. The only people who are in line to get ripped off in this partnership are the consumers who will likely get sold expensive and unnecessary supplements. As Dr Ginni says in the video below, it’s the equivalent of saying “do you want fries with that?”.

It pains me to think that pharmacists exploit their status as one of Australia’s most trusted professions by doing crap like this. Do they really care about their patients anymore or are they only interested in lining their back pockets?  (The previous statement was made in frustration. Thanks to @pakili1987 for pointing out that this will not translate into a boon for individual pharmacists. It’s a ruling made by the Guild and many of them fervently disagree with it).

And they’ve really picked their timing on this haven’t they. Are they hoping we wouldn’t remember the recent TGA audit of CAM which found ninety percent of complementary medicines didn’t comply with regulations? Out of 31 selected for random audit;

• 22 were found to have manufacturing and/or quality issues
• 20 medicines had labelling issues or breaches which may mislead consumers
• 14 did not have adequate evidence to substantiate claims made about the medicines

That so many products failed to even satisfy quality or manufacturing standards has led for calls by the TGA to label supplements with “untested”. And why not. Consumers have a right to know they’re buying something that probably does nothing and in some case may even be harmful.

According to The Age;

“Obtaining evidence of efficacy of listed complementary medicines has been a difficult issue,” the audit report said.

“While most products are safe, if often ineffective, Australian research last year identified 39 reports of adverse events associated with such products, including four deaths over the previous two years.”

“Official inaction on the efficacy issue has been blamed on the Government’s reluctance to pay for tighter policing of the remedies, but also on pressure from industry leaders, including, Marcus Blackmore who rejects the disclaimer idea.

ORLY.

As for the Pharmacy Guild, never mind that our products don’t comply with TGA rules for safety and manufacturing, let’s gets our white coated “trusted” friends to push ‘em on consumers anyway! What the hey! BUY OUR SHIT!

Disgraceful.

I remember one of the first things I ever did when becoming an active skeptic was sit with Richard Saunders and write an open letter to the pharmacists of Australia asking them to stop selling quackery. That was three years ago and instead of things getting better they only seem to be getting worse.

Well done Pharmacy Guild of Australia for taking the piss out of consumers and bringing your “trusted” profession into disrepute again. Shame on you.

*BTW I am uncertain this is a brand new idea. I’ve certainly had pharmacy staff attempt to upsell me supplements when being prescribed antibiotics but it only happened once and it was a long time ago. I presume this new deal means the upsell will now be exclusively Blackmores – what I don’t know is if means it will be more common place.

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QUICK UPDATE: From an article in Fairfax this morning.

“He said it was the first time the Guild’s computer system, which is used by about 70 per cent of members, would prompt pharmacists to discuss complementary medicines with patients. The system has been used to alert pharmacists to potential drug interactions or medication compliance issues.”

What a dirty money grabbing exercise this is. Worse than I previously thought.

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UPDATE: I was informed last night that the TGA has listed 13 dodgy devices on the ARTG in the past week. Seven are holographic devices, five are ‘energy patches’ and another is a TENS device. Amongst the “energy patches” are Lifewave, (yes those make-shit-up, nanotechnology homeopathic pieces of gauze) and holographic energy bracelets, (see Power Balance) called CieAura.

Regular readers would know by now that the process of getting a product listed on the ARTG is based on an honesty system where sponsors type in their product, select the ingredients from a pre-approved list, pay a fee (< $1000) and bing! Get an official looking L number for their product and a listing on the official government list of medical devices. I can’t say this often enough (and perhaps I should, given that I’m probably tipping sponsors off to ways around the TGA) but you don’t need to provide evidence up front. You just have to say you possess it.

I’ve blogged about this before.

That CieAura would make it onto the ARTG is just embarrassing given that they’re just a copy of PowerBalance who were chased out of Australia earlier this year by the ACCC (the TGA did play a role). And Lifewave? You only need to Google them to find links to scam websites and other dubious activities. Plus, they are homeopathic (so there’s nothing in them) and they are non-transdermal (so they don’t transfer anything into your system) so what exactly do they do then? Precisely.

Fortunately, there has been some good news this morning about this debacle. I’ve been informed that The Lifewave patches have been cancelled from the ARTG and the CieAura holographic bracelets are under investigation. I’ll keep you posted. In the meantime let’s continue to play whack-a-mole with the TGA, mischievous sponsors and the TGA. Cause until the legislation is changed, this process will continue unabated.
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An article from Australian Doctor described how a complaint against the makers of Nurofen – an ibuprofen based pain killer – were directed to stop claiming their product could “go to the site of pain”.

According to the article:

Reckitt Benckiser Australia Pty Ltd was ordered by the TGA’s complaints resolution panel to withdraw a television advertisement for Nurofen that claimed the product “targeted relief from pain” and “goes straight to the source of pain”.

However in a statement, Reckitt Benckiser said it did not agree with a number of the sanctions imposed by the TGA panel and therefore,

Nurofen advises that consumers will continue to see the familiar branding of the Nurofen target and messages of Nurofen working at the site of pain. This branding includes TGA approved claims on packs that Nurofen provides targeted relief from pain.

Sigh.

Of course Reckitt Benckiser are by no means the first company to essentially flip the bird and say “get stuffed we’ll do what we want” to the TGA. Indeed, today’s statement follows a damning audit of the TGA’s management of complementary and alternative therapies released recently, which essentially described the TGA as having no teeth to enforce rulings against companies who do the wrong thing. Mick Vagg has covered some of the details here.

The audit came after a review of a random sample of listed products – “listed” meaning supplements, vitamins, (some) homeopathic preparations and other products classified as “low risk” including 31 types of ear candles, which found over ninety percent of products breached TGA guidelines. This review was from 2009/2010 and the one 5 years prior to this found over seventy five percent of products breached guidelines.

Out of the 31 products which were selected for the 2009/10 review, only 3 were found to fully comply (I’ve blogged about this previously here). Of the rest, 22 were found to have manufacturing and/or quality issues, 20 had labelling issues such as non-compliance with labelling requirements and/or breaches which may mislead consumers, 12 included incomplete and/or inappropriate information, and 14 did not have adequate evidence to substantiate claims made about the medicines.

Let’s go over that again.

• 22 were found to have manufacturing and/or quality issues
• 20 medicines had labelling issues or breaches which may mislead consumers
• 14 did not have adequate evidence to substantiate claims made about the medicines

When it comes to consumer protection this is a pretty poor report for the TGA.

As a result of these failures, a significant number of products were removed from the Australian Register of Therapeutic Goods (ARTG).

It’s worth noting however that Nurofen is a registered drug, not a listed one (for the difference see my post here) so stricter rules apply when it comes to regulation of what’s in it and whether it works. With AUST L (listed) drugs, for example, companies or “sponsors” are not required to present evidence of safety and efficacy before they are rubber-stamped for sale by the government. However AUST R (registered) drugs – of which Nurofen is one – are.

Indeed AUST L drugs are considered low risk by the TGA, so have a soft-touch system of registration. To apply for an official number you go online, select from a list of pre-approved ingredients, describe what your product does, state you have evidence for your claims in your possession (but no need to produce it!) pay a fee and voila! Bob’s your uncle.

The fact that most consumers don’t know this was the basis for the recent call to label CAM in Australia with the disclaimer “This product has not been tested”. You can imagine how this went down with the industry.

However, advertising rules for L and R drugs are essentially the same – basically you can’t make claims which you can’t substantiate and if you do, the TGA can order you to remove them. Whether this be from a website – as has happened several times now with Homeopathy Plus! – or a television commercial, as is the case for Nurofen.

Once a complaint about a product is received (and the TGA relies on consumers to make complaints as they are not pro-actively seeking products which breach guidelines), the TGA will preside over it and if it’s upheld, direct the company to remove the offending material and/or publish a disclaimer. But, as has been known for some time and was also highlighted in the recent audit and on Lateline, approximately thirty percent of companies ignore these sanctions. And they can, because the TGA has never in its history enforced them. Ever.

From the audit:

Due to the very low financial penalties currently available (a maximum of $6,600 for individuals and $33,000 for corporations) for advertising offences in the Act and other investigative priorities for the TGA, it is not cost-effective for the TGA to initiate a formal investigation of an advertising breach with a view to preparing a brief of evidence for consideration of prosecution by the Director of Prosecution.

It has never been cost-effective for the TGA to initiate a formal investigation of an advertising breach with a view to preparing a brief of evidence.

In other words, the cost of prosecuting a company outweighs the fine, so it’s not worth it and it’s never been done. This of course makes the TGA the laughing stock of drug manufacturers. If you read between the lines of the Nurofen press release you can see it loud and clear:

Nurofen advises that consumers will continue to see the familiar branding of the Nurofen target and messages of Nurofen working at the site of pain…

Well of course they will. I mean $33,000 is a pittance for a large Pharma company anyway. It’s laughable to think this would be a deterrent to making some claims that might not be “quite right” but sound pretty good in marketing terms.

Homeopathy Plus! also declined to comply for similar reasons, saying they didn’t agree with the TGA’s findings that homeopathic immunisation is ineffective against polio, meningococcal, cholera, whooping cough and other serious diseases. They’ve since gone onto claim homeopathy can cure breast cancer, treat meningococcal disease and radiation poisoning. Jumped. The. Shark.

To go back to the TGA’s findings about Reckitt Benckiser, the complaints resolution panel found that;

reasonable consumers … would conclude that the active components of the product travelled specifically to areas of the body affected by pain — in this instance, the part of the head affected by a headache

Which I think is a fair call. But this is not how pain killers work. To say they are “targeted” is just nonsense.

Yet, this is not the first time Nurofen have been called out for shonky advertising. Indeed last year they were honoured with a 2010 Choice Shonky Award for a very similar thing;

From the Choice website;

Nurofen has … a range of caplets for migraine, back, tension headache and period pain. Yet a closer look at the ingredients shows they’re identical from product to product. So does the back pain version somehow magically go straight to your back – and only your back – as soon as you’ve swallowed it? Could you, say, choose to treat only your back pain while keeping your headache? The answers are no, no and definitely no.

As long as the TGA has no teeth to enforce dodgy claims and advertising breaches I expect we’ll see this type of behaviour continue. And even if they were to fine companies for breaches, 33,000 or 6,600 bucks is a pittance to most drug companies – whether CAM or science-based. There seems little deterrent to stop when there’s money to be made and no-one’s gonna stop you anyway.

In my opinion this is about consumer protection and if the TGA fails to do that, then I wonder what good they’re doing at all.

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I get emails. And recently I was reminded of one I got back in June which somehow slipped from my consciousness. With all the negative attention Nimrod has been receiving of late the response from some authorities has been, “we can’t respond unless someone reports him.” Indeed, last month, chair of the Chiropractic Board of Australia urged people to make a formal complaint against Mr Weiner after Australian Doctor posted audio of his two-hour public lecture on the dangers of vaccination.

So I went back through my emails and found a complaint from Dr John Cunningham, forwarded to me and submitted to AHPRA (then passed onto the Chiropractic Council of NSW) on April 4th, 2011. Dr Cunningham received the following response on May 31st, 2011 (my emphasis).

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Really? So it’s okay for a registered health professional to disseminate false, misleading and dangerous information under the guises of “it’s my opinion”? But what if the evidence says the opposite, which in this case it most certainly does.

If you take a look at the references Weiner uses in the 4 pages of anti-vax rhetoric posted on his website (which was the subject of Cunningham’s complaint), and his 2-hr long lecture on “18 reasons to not vaccinate” (pdf of references here) you’ll find a grab-bag of some of the most prominent anti-vaxers. He cites all my favourite loons including the AVN and their previous publication “Informed Choice”, Not-a-doctor Andrew Wakefield, Viera “parsnip box” Scheibner, Joseph Mercola, Whale.to and Vaccine Information Service Australia or VISA (amongst others).

There’s a glass and a half of crazy right there.

Weiner also drags out the some of the old favourite canards of the antivaxers. See the following paragraph as an example of vaccines cause everything;

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“Other conditions linked to vaccination include pervasive developmental disorder (PDD), Asperger’s syndrome, eczema, encephalitis, Guillain-Barre syndrome, convulsions, seizures, anaphylaxis, thrombocytopenia, optic neuritis, ocular palsies, retinitis, deafness, otitis media, ulcerative colitis, bowel disease, Crohn’s disease, headaches, dizziness, hearing and vision problems, arthritis, arthralgia, learning disorders, chronic fatigue, diabetes, multiple sclerosis and more.”

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He doesn’t provide a reference for these claims.

And as usual, Weiner beats the dead horse of vaccines = autism

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“After years of denying a link between vaccination and autism, on November 9, 2007 the US government in Court of Federal Claims admitted that vaccines can cause autism.”

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The reference Weiner cites for this claim is David Kirby writing for the Huffington Post in 2008. Kirby is also the author of “Evidence of Harm” a book detailing the personal stories of parents of children who have autism who went onto establish the advocacy group SafeMinds. So there may be a conflict of interest in what Kirby has to say.

There also *may* have been some advances on our understanding of the evidence against a link between vaccines and autism – which have occurred since 2008, both in the courts and in the lab.

But despite the fact that Weiner claims to base his information on the latest science, he uses outdated references, claims Wakefield’s work is “sound” and uses scary language that has no basis in science.

There’s more…

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Robert Mendelsohn, MD writes: “My suspicion, which is shared by others in my profession, is that the nearly 10,000 SIDS deaths that occur in the U.S. each year are related to one or more of the vaccines that are routinely given to children.”

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My suspicion? So you don’t have any evidence for that then? The reference for this statement is simply Mendelsohn. Ibid:250 which makes no sense to me. In any case, Mendelsohn is well known for his “unusual ideas”.

For example, he has opposed water fluoridation, immunization, coronary bypass surgery, licensing of nutritionists, and screening examinations to detect breast cancer. He has a listing on Quackwatch and whale.to.

The spurious claims about vax go on for 4 pages and at last check they were still there. (I’m actually surprised it is still up given the criticism Weiner has been under of late. Perhaps his cognitive dissonance is so strong that he thinks he is right. Sadly, I suspect this is the case).

But whether Weiner thinks he is right and that vaccines are bad “in his opinion” is irrelevant when it comes to his role a health care professional, especially when dealing with kids. Remember he’s a pediatric chiropractor dealing with kids as young as one-day-old.

And science is not formed via opinion, it’s based on evidence and there is no evidence for just about everything he claims (even chiropractic subluxations actually).

The fact that the CCNSW thinks it’s okay says a lot about their responsible approach to chiros under their jurisdiction and patients.

This story was covered in Australian Doctor today and rest assured, we have not seen the last of the Weiner files. More to come very soon.

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It all came to a head last week when his anti-vaccine “rants” were covered by our national media when The Australian newspaper and Radio National both took him to task over his public anti-vaccine lectures. The stories came after Australian Doctor published the audio of his talk online, against his wishes but in what they say was in the public interest.

Why is it in the public interest? Because Weiner gives talks to parents, pregnant mothers and young mums and effectively scares them into not vaccinating. Also, he’s the Vice President of the Chiropractors Association of Australia (CAA) NSW branch of whom Australian Doctor have previously accused of “fundamentalist ideologies” and “pseudoscientific dogma”. He’s also on the board of the Australian Spinal Research Foundation where he contributes content for the newsletter. So effectively, he’s a high profile chiropractor.

But leading up to the bad news week for Weiner was a heck of a lot of work behind the scenes. I thought it might be interesting to track the chronology of events which resulted in him getting pwned all over the media. Hopefully, it will give readers an understanding of the value of grass roots scepticism and how a little bit of investigation, like asking questions at the Mind Body Wallet Festival or spending two hours in a chiropractors clinic can result in exposing dangerous quackery. And anti-vaccine quackery is particularly dangerous.

Let’s begin.

November 14th, 2010. My mate Richard Saunders came across this flyer at the Newtown Festival last year where Newtown Community Chiropractic had a stall. He twitpicked it and we decided to go along (Richard didn’t end up going – we can’t remember why).

November 25th, 2010. Meryl Dorey sends out warning to chiropractors as part of her newsletter

December 4th, 2010. I attended the 2 hr free seminar with a friend and blogged it here the same day. Or watch it on the YouTube (thanks to the kind soul who made it).

March 8th 2011. A journalist from Australian Doctor contacted me as part of researching a feature on CAM published as Exploring the Alternatives (I eventually wrote a guest editorial). He was curious about chiropractors and their views on vaccination and knew I had been to listen to Weiner. He booked to go along to the seminar in March. He recorded the seminar, identified himself as from Australian Doctor and asked Weiner if he could post it on-line. Weiner declined.

(Note: according to the Australian Doctor article – which is paywalled – Weiner claims he’s done five years of a medical degree. I was unable to confirm this).

Literature handed out at Nimrod Weiner's December 2010 seminar

To provide you with some context for what happened next, chiropractors were copping it around this time for treating babies.

March 18th 2011. The first stories about a chiropractic clinic at a Victorian University treating babies and kids appears in national newspaper The Australian. Spearheaded by Loretta Marron, academics and health professionals including Simon Singh and Edzard Ernst petition the government to close the clinic down.

March 28th 2011. The British medical journal covers the story

April 27th 2011. Australian Doctor are the first to link chiropractors with the anti-vaccine group the AVN revealing that 130 of professional members of the AVN are chiropractors. This includes clinics run by the CAA president Simon Floreani, the association’s treasurer Taylor Vagg and board member Anthony Croke.

“Mr Floreani….insisted AVN was a valuable resource for patients: “For me it’s about critical thinking. You are only going to get one biased side of the debate from the medical profession. Can you trust the claims that the vaccines are safe when one-fifth of all deaths are related to medical error?

“The AVN has links and resources to an enormous amount of information that you don’t find elsewhere. As a registered health professional, your role is to help patients. I don’t think [of the AVN] as anti-vaccination. It is more pro-choice.”

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May 28th 2011. More bad publicity for baby-cracking chiros, where Marron says, “I would not have written a submission if the chiropractors were treating adults for lower back pain,” she says. “Pediatric chiropractic is a form of faith healing and it should be in theology, not health science.”

July 2nd 2011. A feature story on chiros treating kids appears in The Australian with another “pro-choice” chiropractor, Warren Sipser. (note: this the same one who commented in an article which Meryl Dorey went onto refer to as “vaccination is akin to rape with full penetration.”

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The decision sparked a reaction from the anti-immunisation movement in Australia, with one sceptic, paediatric chiropractor Dr Warren Sipser, saying the judgment was “dangerous” and some children could have severe reactions.

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18 reasons to not vaccinate. Literature from December 2010 seminar

July 11th 2011. The CAA sent a media alert out to their members about damage control, directing their members to send all media enquiries to a PR firm.

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“We wish to alert you to an article that may be appearing in this weekend’s edition of The Weekend Australian…..As always, we continue to make every effort to mitigate negative press that at times is being played out in the media, as well as our attempts to generate positive media..”

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July 23rd, 2011. A bunch of concerned citizens and some members of SAVN attended Weiner’s talk. They were “…criticised by the audience for doing such dreadful things as pointing out errors made by the speaker.”

July 24th 2011. I received a call from a journo who was investigating how widespread anti-vaccine beliefs were amongst chiropractors. The story was published a few days later.

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“Of the (AVN) network’s 198 professional members, 128 are registered chiropractors. Many are members of the professional body the Chiropractor’s Association of Australia, or CAA.”

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August 8th 2011. After obtaining legal advice, Australian Doctor posts the audio of Weiner’s talk online with commentary, even though Weiner did not agree to it. They state; “… we believe it is in the public interest, particularly given Mr Weiner’s profile within the chiropractic profession.”

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We…reported on accusations against the Chiropractors Association of Australia – the profession’s peak body – that it has turned its back on science to peddle “fundamentalist ideologies” and “pseudoscientific dogma”. The CAA has strenuously denied the claims.

On the issue of vaccination, it says the profession’s role is to educate the public on health issues – the risks and benefits of vaccinations is just one of those issues. So here we offer a talk on vaccinations given to members of the public by Nimrod Weiner…..vice-president of the NSW Chiropractors Association of Australia and ..on the board of the Australia Spinal Research Foundation, a self-styled scientific research body.

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August 15th 2011. Another journo, again from The Australian newspaper emailed to ask me about the Australian Doctor audio, since he knew I had blogged about the talk. A story entitled “Call to probe anti-vax rant” was published on August 17th (seen by approximately 128,985 people) where Weiner’s comments were described as “outrageous” by the Australian Medical Association who called on the CAA to intervene.

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Mr Weiner declined to comment, referring questions from The Australian to a PR company, which said the Chiropractors Association of Australia (NSW) had no position on vaccination and “any comments that Nimrod Weiner may have made would be his private opinions, not those of the association”.

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August 18th 2011. The following day, the story appeared on Radio National on the back of Australian Doctor audio and The Australian newspaper article.

August 19th 2011. Another critical article appeared in the press

Interestingly, shortly after these national stories broke, a link on Weiner’s website to his vaccine talks was showing a 404 but it could be found in Google cache. Today, as I was researching to write this article I again found the page, but it appears an attempt to hide it has been made, as indicated by the “_offline” text at the end of the url. You can still get the page though if you do some digging, but it has been moved thus breaking all previous links.

I guess the question now is will Weiner continue to give these seminars. According to this screenshot he has previously charged for the seminars.

UPDATE: Another critical article appeared in Australian Doctor today, where the Chiropractic Board of Australia is calling on people to complain about Weiner;

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The chair of the chiropractic board is urging people to make a formal complaint about high-profile chiropractor Nimrod Weiner over his public seminar on the alleged dangers of vaccines.

Phillip Donato stressed that chiropractors had a duty under the profession’s code of conduct to provide up-to-date, evidence-based information. He said: “It appeared at the very least he is misinformed and may be providing misleading information to the public. We would encourage notifications so that we can have a look at the case properly.” Australian Doctor understands that notifications have already been made.

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Indeed a complaint made to AHPRA then passed onto the Chiropractic Council of NSW was dismissed in June this year. The complainant flagged anti-vaccination material on Weiner’s website as being in breach of section 10.2 of the Code of Conduct for Chiropractors, which states; “good practice involves: c) understanding the principles of immunisation against communicable diseases.”

The complaint was dismissed on the grounds that “The Council considered that Dr Weiner was entitled to put his opinion forward and that this did was not in breach of the Code.”

I don’t think we’ve seen the end of this saga. I’ll be sure to keep you posted.