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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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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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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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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.

If you follow the process, no doubt you’ll know who trolls the internet leaving this statement anywhere someone criticises homeopathy;

“Real is scientific homeopathy like Conventional Allopathic Medicine (CAM). Evidence-based modern homeopathy is a nano-medicine bringing big results”

Firstly, wha??

Only one person can dish up quality woo like this. It’s Not-a-Doctor Nancy Malik of course. And what exactly is “scientific homeopathy”? Best you ask Dr Malik about that.

So given that it was WHAW, many science-based bloggers and tweeters took it upon themselves to make people “aware” that homeopathy is nothing more than an expensive placebo. In most cases, the liquid or sugar pills you buy from your pharmacist in fact contain nothing at all. Thus, the catch phrase of Ten23; “Homeopathy, there’s nothing in it”.

My best mate Richard Saunders did his bit, in the form of an epic slap-down story on Adelaide’s Today Tonight where Brauer “Natural Medicine” came in for a bollocking. As Phil Plait so eloquently put it, this story was unique for the token homeopath not the token sceptic, the latter being the usual way things work on commercial television. If you haven’t seen this video, take the 10 minutes to watch it – it’s great. Richard delivers some succinct and pointed sound bites which really bring the message home (and I’m not too coy to say I was sitting off camera coaching him for this part!).

But, like many sacred cows, homeopathy is an unsinkable rubber duck and despite 200 years and 200 clinical trials, there is still no evidence that homeopathy works (see how homeopathy works here). This leaves homeopaths mumbling excuses like “RCTs don’t work for homeopathy” or “one day quantum physics will solve it”.

Do not pass go, do not collect $200.

So it was with great delight that I opened my Australian Doctor email today to find an article by Paul Smith (whom I highly respect) with the headline; “National Health and Medical Research Council (NHMRC) declares: homeopathy ‘not efficacious’”. It’s a subscription based article so I can’t copy paste it here, but I can provide a summary.

“The NHMRC’s position is…it is unethical for health practitioners to treat patients using homeopathy, for the reason that homeopathy – as a medicine or procedure – has been shown not to be efficacious.”

This is currently a draft statement, apparently drawing on several issues; claims that “homeopathic vaccinations” are an effective substitute for vaccines, recent deaths (see here and here) in Australia where homeopathy was implicated and the findings by the UK Science and Technology Committee in 2010 which concluded that the UK National Health Service should cease funding homeopathy.

This is the first time the NHMRC has spoken out against homeopathy and the implications are significant. As Paul says;

“If the public statement is formally adopted by the council, the major health insurers – Medibank Private, HCF, NIB and MBF – will have to justify why it is using taxpayers’ money to fund “unethical” homeopathic treatments.”

Three billion dollars of taxpayers money is provided every year to fund private health insurance rebates by the government and this includes homeopathy. Should the NHMRC declare it “unethical”, health funds will be under pressure to pull funding for quack remedies like homeopathy.

It’s too early to tell at this stage if this will happen, since the statement is still a draft, but it is tantalising to think that science and rationalism could win this one.

I encourage the NHMRC to formalise this statement and declare homeopathy unethical and devoid of efficacy. Of course people will still be able to buy it, but at their own expense instead of that of the tax payer.

And maybe, just maybe, this will see the end of doctors prescribing it and pharmacists selling it. And wouldn’t that be a huge win for science and scepticism.

The full article (subscription required) can be found here

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I didn’t know this until out of curiosity I went to a website which has been heavily advertised over the last week on Australian television – the NPS website. I knew of this Australian government organisation since I follow them on Twitter but only after visiting the website did I discover they provide information on medicines for consumers and health professionals alike. Plus they are behind MedicineWise Week from January 30th – February 6th, 2011.

In light of the worldwide Ten23 campaign conducted all over the world this weekend – in fact every continent including Antarctica was represented – I thought I would pose as a consumer and search for information about homeopathy.

Like homeopathy itself, what I turned up was minimal and not very useful. I’ll explain more about this a bit later but first, as I was surfing around the NPS site, I found a press release about a survey of Australians’ knowledge of medicines.

Fifteen hundred consumers were surveyed and the results reported that 65% had used a prescription medicine in the last three months, 60% had used an over-the-counter medicine and 45% had used an alternative or herbal medicine.

When it came to alternative medicines and supplements, of those surveyed, less than half considered certain vitamins and herbs to be medicines: multivitamins (23%), echinacea (24%), fish oil (32%). Awareness of Chinese herbal remedies as medicines was slightly higher at 41%.

NPS clinical adviser Dr Danielle Stowasser said, “The first step to being medicinewise is knowing what is a medicine. Medicines include tablets, vitamins, herbs, eye drops, creams and gels. Medicines don’t just come on prescriptions but include things bought in a pharmacy, supermarket and other stores, and from naturopaths and herbalists.”

But thinking back to homeopathy, here’s where I began to get concerned:

Encouragingly, when asked where they would go to find accurate information about medicines, most respondents said a pharmacist (64%) and/or a doctor (60%). However, when asked if they did ask questions of their doctor or pharmacist the last time they received or purchased a medicine, 60% said no and 48% said they did not tell their doctor or pharmacist about other medicines they were taking.

Sixty four percent said they could get accurate information about their medicines from a pharmacist? I’m sure this is true for most conventional medicines – but I have repeatedly asked pharmacists about homeopathy and only once was I given an accurate description of what it is and what it does. ONCE. And in a certain pharmacy in Newtown, I have been (not so politely) shuffled to the door when asking too many questions of the shop assistants about homeopathy.

So, sadly in my experience, consumers cannot rely on pharmacists to accurately advise them on homeopathy.
So, I expected that a quick trip to the heavily promoted NPS website would do the trick. A search for “homeopathy” turns up one link to a generic page on complementary medicines where homeopathy is cited but not explained. A search for “homeopathic” turns up a link to a video which likewise doesn’t address homeopathy directly and in fact could even be construed as misleading. An excerpt from the transcript appears below:

“Manufacturers of non-prescription medicines sold in Australia must ensure that their products meet certain quality and safety standards, however when it comes to providing evidence of their effectiveness, they’re not tested as thoroughly as prescription and pharmacy medicines. The less thorough testing does not mean that these medicines don’t work, rather it means that the manufacturers don’t have to provide as much scientific evidence as they do for prescription and pharmacy medicines.

When you are choosing a traditional or herbal medicine obtain as much information about it and it’s use as you can.”

I doubt there would be any confusion that homeopathic “remedies” are not prescription medicines, but they could certainly be considered pharmacy medicines. After all, they are sold in pharmacies alongside the science-based remedies. So this video implies that since homeopathy – for all intents and purposes – is a pharmacy medicine, then it is tested just like prescription medicines.

Of course this is simply not true. In fact, some homeopathic remedies are exempt from the Australian Register of Therapeutic Goods (ARTG) which is a list of approved medicines and devices, because – in many cases – they are so dilute that they no longer contain active ingredients. Thus, there is nothing to regulate if there is nothing in the “medicine”.

The TGA website states homoeopathic preparations are exempt from the ARTG if :

“(they are) more dilute than a one thousand fold dilution of a mother tincture and which are not required to be sterile; and which do not include an ingredient of: a) human origin; or b) animal origin, if the ingredient consists of, or is derived from, any of the following parts of cattle, sheep, goats or mule deer.”

So unless you started with a mother tincture derived from animal or human sources, the government is not particularly interested in your product. And if it’s more dilute than 1000 times then they’re also not bothered. Makes sense I guess, since sugar pills and water with a dash of alcohol won’t do you any direct harm. (But, this does not mean they don’t do you harm.)

Even more bizarre is that when homeopathy is not sold through pharmacies, it is exempt from the TGA’s own advertising standards.

“A homeopathic product can carry claims which do not comply with the Therapeutic Goods Advertising Code and may still be listed in the ARTG. However, the label on the container and on the primary pack must include a statement to indicate that the indications have not been “approved” by the TGA.”

The description of homeopathy on the TGA website is also not very helpful to uninformed consumers.

“Homoeopathic preparation” is defined by the Therapeutic Goods Regulations as a preparation:

1. formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and
2. prepared according to the practices of homoeopathic pharmacy using the methods of:
   1. serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or
   2. serial trituration in lactose.

Wouldn’t it be much simpler to say “there’s nothing in it” (which they allude to further down the page anyway) and “there is no evidence that it works?“. Do they really think consumers are going to know what “sucussion” and “serial trituration” means? Like pretty much all of homeopathy, it’s goobledigook.

But, the facts remain that homeopathy is indeed listed on the ARTG, meaning it is assigned an official looking government number, which lends it legitimacy. For example, Brauer Natural Medicine Children’s Cold Flu Relief is listed as AUST L-132568. The fact sheet for this product states that all the ingredients exist at a 1000 fold dilution (1 µL in 1 mL)*.

Finally, a use for homeopathy. Photo courtesy of David Barwick

I found 37 listings for Brauer homeopathic “medicines” including childrens’ cough relief, hangover relief oral spray, and natural medicine burn cream. Interestingly, sleep and insomnia relief – (see left) the sleeping tablets popular amongst Ten23 overdose participants – are not listed on the ARTG since the active ingredients are diluted much more than 1000 times.

So whilst homeopathy is sold in pharmacies, many pharmacists don’t know what it is. They, like many consumers, think it is herbal (whilst it may have started out herbal, it’s certainly not by the time it gets to the shelf of your local chemist).

So what have I learnt in MedicineWise week? Firstly, the Australian government seems confused about homeopathy. I was unable to find a clear and concise explanation of what it is on their official websites, they appear to be bundling it in with pharmacy medicines, thereby implying that it works and further, they are lending it legitimacy by designating it official looking numbers on the official register of government approved Australian medicines.

No wonder the public remains confused. And no wonder it is left to the #ten23 campaign to increase awareness that, Homeopathy There’s Nothing In It.

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*The onus is on the user to verify the current accuracy of the information on the document subsequent to the date shown”. The sheet is dated accurate as at November 2006.

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In a spot check on about 400 products, 9 out of 10 were found to breach regulations. As a result a ”significant number” of products were removed from the Australian Register of Therapeutic Goods or ARTG, which currently lists 10,250 complementary medicines, including vitamins, minerals and herbal preparations. The breaches, largely relating to false claims of curative powers on labels, means the products can no longer be legally sold. Which products have been removed and precisely why, was not revealed by the TGA.

The complementary medicine business is worth over 4 billion dollars a year in Australia, but evidence that they work is not required by the TGA before they are assigned an official looking number and appear on the shelf of your local pharmacy next to aspirin and cough medicine.

Instead, the TGA operates a “self assessment” online registration system and undertakes post market reviews where approximately 25% of products are randomly selected for a review of their labels, product specifications and summary of evidence. Although the TGA website states “… evidence must be held by sponsors which demonstrates the indications and claims are true, valid and not misleading” the latest review indicates this is clearly not the case for the majority of products. A second issue is that even when products are removed from the listing, manufacturers can simply go back on line and re-register the product under a different name effectively getting it listed again in 24 hrs.

There are two types of drugs and clinical devices controlled by the TGA, those which have been evaluated for safety, quality and efficacy are designated a number preceded by “AUST R”. An example is antibiotics or hay fever medication bought over the counter at the chemist or even low risk products such as cough medicines. According to the TGA website, “The degree of assessment and regulation they undergo is rigorous and detailed, with sponsors being required to provide comprehensive safety, quality and efficacy data.”

On the flipside, “AUST L” are called listed products and include complementary and supplementary medicines such as homeopathy, ear candles and detox kits, many of which have not gone through clinical testing or indeed have any scientific evidence that they work (in the case of ear candles there is evidence that they cause harm). Listed medicines are considered by the TGA to be of lower risk than registered medicines, thus they are not assessed for efficacy by the TGA but only for quality and safety.

Clearly the problem here is the TGA’s reliance on “self assessment” as a means for determining a product’s efficacy. But it gets worse when you scrutinise precisely what they define as evidence for these products.

There are two streams of “evidence” accepted by the TGA, one being scientific and the other “traditional use”. Traditional use refers to documentary evidence that a substance has been used over three or more generations for a specific health related or medicinal purpose. Traditional therapies include Traditional Chinese Medicine (TCM), traditional Ayurvedic medicine, traditional western herbal medicine, traditional homoeopathic medicine*, aromatherapy and other indigenous medicines.

Further, there are also increasing levels of evidence within this, the greater your evidence the more claims you are entitled to make. For example, three independent written histories of use in the classical or traditional medical literature are acceptable and/or availability through any country’s government public dispensaries. So this includes chiropractic in Australia and homeopathy in the UK.

Recently the TGA announced a comprehensive review of the way it communicates regulatory processes and decisions to the public in an effort to improve transparency. The aim of the overhaul is multifaceted but one aspect is to ensure that the Australian public is better informed about the benefits and risks of therapeutic goods, including all medicines and devices. In particular the TGA aims to inform consumers that they do not test AUST L drugs, and as such cannot guarantee that they work as claimed.

So the TGA will continue to accept AUST L products for listing under the clearly flawed self-assessment programme and as a method for improving transparency, inform consumers that their system doesn’t really work. It’s also worth noting that as a consumer you are free to make a complaint about a TGA listed products, and if they agree the product has breached regulations, the complaints resolution panel will issue retraction orders to the company. However if the company chooses to ignore the sanctions, the TGA will not enforce them. Between 30 and 50% of companies called out for making false claims do ignore the sanctions and the TGA has never made a prosecution for refusing to comply. Another issue concerning transparency for the general public is they results of an investigation by the TGA do not appear on their website for up to 6 months. So a consumer searching the web has little chance of knowing that the product is making false claims.

This black hole where TGA complaints disappear was covered by ABCs Lateline programme earlier this year with respect to a Homeopathy website which claimed they could cure cancer and AIDS with water. When the story broke the owner of the website not only continued to ignore the sanctions but jumped the shark by publishing a response to the story replete with dozens of spurious links as to why their claims were correct.

One would hope that the review currently up for public comment will address and correct some of these issues. As it stands the burden is on the consumer to determine whether a product works or not, as an official looking AUST L number is no guarantee that the product does what it claims. And according to the recent review, 9 out of ten product don’t. Asking a pharmacist – which is where many of them end up – whether the product works can also be hit as miss and myself and Richard Saunders have experienced when enquiring of pharmacists about homoeopathy and being told it was “herbal”.

If you are in Australia you can submit comment to the review by February 11th. The panel are asking for submissions from health professional and the general public on topics such as about instances where it could have been useful for you to have had access to better information about your medicine, supplement or device and how you would like to have access to this information whether through your pharmacist or on the internet.

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Comment from the Sydney Morning Herald here
More from the Sydney Morning Herald here

* One wonders what defines “traditional homoeopathic medicine”. Perhaps it’s homeopathy prior to the “water has a memory” theory – a fairly recent invention – to get around that pesky Avogadro’s number which dictates that after a certain level of dilution there are no molecules of the active ingredient remaining. Homeopaths get around this problem by saying that the water maintains a memory of the original substance. But conveniently the water does not remember all the other things it has seen such as faeces, parasites, viruses and other nasties.

I’m soon to trek back to the US (for the third time this year) to attend a conference on BMAA and MND, a project I am enjoying working on immensely. I’ve written about this before over at Skeptic Zoners and talked about it on ABC Radio if you are interested to hear more details. No doubt I will have more to report from the picturesque Jackson Hole in Wyoming in early October when I meet with collaborators for the 7th Annual BMAA conference.

In the meantime, I have several manuscripts on the cusp of being returned for final review, after additional experiments were completed to satisfy reviewers’ comments. For a humorous take on how (not to) respond to these critiques, see PhD Comics Addressing Reviewers’ Comments, a copy of which is permanently taped in close proximity to my laptop.

I’m currently also in the midst of doing some research for another unrelated project (the details which I am unable to reveal just yet) and as such have been sorting through my stash of pamphlets, flyers and brochures collected from multiple trips to Mind Body Wallet festivals.

I just came across this one and simply had to share it. It’s a derivative of the old adage of “Things your doctor won’t tell you!!!” or “What the pharmaceutical industry is hiding!!!”. You know the type of screed that steals all the exclamation marks from the internetz.

It’s from a photocopied document entitled “Know Miracle II” which contains some garden variety woo about alkaline water curing everything. It then details how amazing this stuff is, and all the things it can cure. You know the phrase you couldn’t make this shit up? Well don’t worry readers, you don’t have to cause it’s already written here for you!

Okay, I won’t keep you in suspense any longer.  Enjoy. My comments follow in blue.

• Human bodies that have been been on Miracle-II (M-2) have been checked through esoteric programs via MD and naturopath….with the report, “Best results of any tests, regardless of age!”

Esoteric? Best results? Wha?

• Radionics machines find M-2 off the chart

Jibberish

• Independent university testing by NE Louisiana University five years ago determined that M-2 neutralizer neutralizes cobra venom and anthrax.

Citation needed

• World governments have contacted the formulator, taking samples home, in an attempt to break the formula….North Korea, China, the President and Health Minister of Liberia, and most recently, a team from Israel.

Jebus, all these scary governments have scary water with an alkaline pH? ARGHH.

But this one truly takes the cake.

• US Biological and Germ Warfare has contacted the formulator demanding he reveal the formula. His answer. “God told me not to tell anyone” still stands.

WTF.

There’s more, but I’m on the floor and unable to breathe.

Fran Sheffield runs the woo-fest website that is Homeopathy Plus! The same website that was the subject of a recent Therapeutic Goods Administration (TGA) investigation which found her website contained misleading information. Including such gems as “homeopathic immunisation” is as effective as vaccination and that homeopathy can treat cancer, AIDS and other terminal diseases.

Regular readers might remember her being responsible for the e-newsletter alerting us to the “homeopathy cures breast cancer study” which myself and David Gorski subsequently took to pieces. Sadly, only a few weeks ago this study ended being tabled as evidence for an EDM submitted by UK MP David Tredinnick (the one who believes blood does not clot under a full moon therefore surgeons do not operate) in the House of Commons. Thanks to the quick action of Simon Singh and Evan Harris, the EDMs were modified pointing out the utter fail that this study is, including the fact that one of the authors publicly dissociated herself from the study in a comment left on my blog.

As a result of an investigation into the HP! site, the TGA recommended Fran Sheffield publish a retraction in a prominent position on her website. But as is her want, she has refused to do so and since the TGA have no powers to enforce the ruling, so her website remains unchanged.

Following the finding by the TGA, Steve Cannane’s Lateline did a story where he interviewed Fran Sheffield about her reasons for not putting up the retraction. It was clear to me from the story that she sincerely believed the nonsense spouted on her website, thus saw no reason why she should conform with a TGA ruling to the contrary.

But it seems that since the TGA ruling and Lateline story, Fran has made even more outrageous claims and jumped the shark.

She even wrote a response on her website to the Lateline story where she Gish galloped references in support of homeopathy as an effective treatment for cancer and AIDS.

In her most recent flyer (below) for a seminar running in early August she claims homeopathy works for fractures (ummmm, okay), fear of flying (??), workaholism (huh?) and nose bleeds (I have one from reading this BS).

To be fair, she does get some things right. She says homeopathy works for hangovers – well sure it does, a nice big glass of water can be great for dehydration resulting from excessive alcohol consumption. And homepathy is good for plants – I add homeopathy/water to my plants water about once a week, they love it!

But seriously, Fran Sheffield, if I fractured a bone in my body, I reckon the first place I would go is a hospital, for some good old fashioned plaster – not run my leg under the tap. This information is wrong and dangerous. About the only thing homeopathy is good for is dehydration. And the TGA sits back doing nothing. Disgraceful.

Speaking of homeopathy for burns, Arnica Montana made these claims for the victims of the the Bali bombings and the Victorian bushfires back in February 2009.

A few weeks back on the Think Tank we heard the story of David Tredinnick, the UK Conservative MP who spent 700 quid of taxpayers money on astrology software. It turns out he believes in all kinds of woo, including  such tosh as, depending on the phase of the moon, “surgeons will not operate because blood clotting is not effective and the police have to put more people on the street”. He is also a big fan of homeopathy, and in response to the recent Committee on Science and Technology evidence checks findings about homeopathy, he submitted four early day motions (EDMs) to the House of Commons for consideration.

For those non UK readers, EDMs are motions tabled by Members of Parliament for debate “on an early day” (namely an unspecific date in the future). EDMs cover all manner of subjects that the MP thinks parliament should be made aware of and possibly debate. They can address serious matters such as climate change, or trivial events such as the Pidgeon Bombs EDM which was tabled in the 2003–04 session of the UK Parliament. This EDM concerned itself with a disclosure by MI5 that it had proposed using pigeons as flying bombs World War II. According to Wikipedia, the motion condemned the proposal, describing humans as “obscene, perverted, cruel, uncivilised and lethal”, and proposed that the House “looks forward to the day when the inevitable asteroid slams into the Earth and wipes them out thus giving nature the opportunity to start again”. (I realise this is Wikipedia but I sincerely hope this is true).

EDMs remain open for signature for the duration of the parliamentary session but are rarely ever signed by all 400 MPs and few make it to the floor for debate.

Despite the recent evidence check and the damning findings that the National Health Service should cease funding homeopathy, no further clinical trials of homeopathy should be conducted, evidence shows homeopathy doesn’t work, explanations for why homeopathy works are “scientifically implausible”, David Tedinnick was just busting to share some “new information” about homeopathy! So he tabled four EDMs, one citing “new research” concerning homeopathy as a effective treatment for breast cancer (which came out prior to the evidence check BTW) (EDM285), for depression (EDM286) and also insomnia (EDM287). Tredinnick also objected to the British medical association’s recent public statements that homeopathy is witch craft and calling for no further commissioning of, nor funding for, homeopathic remedies in the NHS (EDM284).

He cited published peer reviewed studies as evidence for his claims. One of them I happen to know very well, since I spent the better part of a Saturday back in February debunking the entire paper. The reason I did this was because Richard Saunders had received an e-alert from Homeopathy Plus! With a headline screaming “Homeopathy as good as chemotherapy for breast cancer and non-toxic!”. Which is a pretty extraordinary claim for some magic water. And also likely to be complete bollocks (I won’t keep you in suspense – it is).

EDM285 is reproduced below.

That this House welcomes the study published in the International Journal of Oncology, 2010 Feb; 36(2): 395-403 which revealed that homeopathic remedies have a beneficial effect on breast cancer cells; notes that researchers at the University of Texas conducted an in vitro study to determine whether products prescribed by a clinic in India have any effect on breast cancer cell lines; further notes that the researchers studied four ultra-diluted remedies, carcinosin, phytolacca, conium and thuja against two human breast adenocarcinoma cell lines, MCF-7 and MDA-MB-231 and a cell line derived from immortalized normal human mammary epithelial cells, HMLE; observes that the remedies exerted preferential cytotoxic effects against the two breast cancer cell lines, causing cell cycle delay/arrest and apoptosis; believes that the findings demonstrate biological activity of these natural products when presented at ultra-diluted doses; and calls for further research in this important area.

Yeah, I guess Tredinnick, like Homeopathy Plus either didn’t read the entire paper or doesn’t understand how to interpret the scientific literature cause this aint what I gleaned from the paper.

So the Twitterverse was mobilised to gather rebuttals to these 3 papers. Once Dr Evan Harris had my blog and Orac’s from Science Blogs in his sticky fingers, Dr Julian Huppert got straight onto composing a rebuttal. And it is a joy to read.

So let’s see what became of EDM 285 once it Harris and Huppert had gone to town on it.

EDM285A1 now reads like this:

Line 2, leave out from `403′ to end and insert `as an example of the failure of adequate scientific peer review because the paper provides no statistical analysis to support any conclusion, indicates that the experimental control, 87 per cent. alcohol solution, was itself toxic to the cell cultures, does not illustrate or explain the different chromatographic profiles of the solvent and the test substances, and does not provide sufficient data to allow proper evaluation of the study; notes that the lead author has retired and runs a homeopathy website which falsely claims that homeopathy is as effective as a conventional chemotherapy agent, Taxol, in treating breast cancer; further notes that one of the authors, Alison Pawlus, has publicly disowned the paper; regrets that isolated poor-quality studies are cited by proponents of homeopathy to endorse dangerous and exploitative cancer-curing claims in the face of overwhelming weight of scientific evidence against them; and agrees with the conclusions of the Science and Technology Select Committee’s Fourth Report of Session 2009-10, Evidence Check 2: Homeopathy HC45 that putting patients through pointless further clinical trials, and the spending of scarce public sector funds on research into homeopathy cannot be justified.’.

The comment about Alison Pawlus, listed as an author on the study publicly disowning the paper is derived from a comment she left on my blog where she stated;

“As an unintentioned co-author on this study, I feel obligated to respond….”

Alison went onto say “…I asked to not be included because I did not think it was a sound study…”

And

“I believe this study demonstrated changes in alcohol percentages on cells rather than the efficacy of homeopathic medicine.”

The amendments to the EDMs constitute a marvellous result and are testament to the dedication of Dr Evan Harris and Dr Julian Huppert. The fact that this message got out so quickly is also a credit to the power of the blogosphere and twitterverse. In fact, this was how I originally got my hands on the full text of this article, by tweeting for someone to source it for me. Thanks @xtaldave!

But David Tedinnick is not the only one who has jumped to conclusions about the findings of this paper. I already mentioned Homeopathy Plus! making a giant leap in logic from “cells treated in culture” to “homeopathy is better than chemo for cancer.” Many others have picked up this meme and run with it, despite the fact that not even the paper itself makes this claim.

The only reference to a common cancer drug appears buried in the discussion and states, “Interestingly, the cytotoxic effect of two of the remedies investigated in this study, Carcinosinand Phytolacca, appeared similar to the activity of 0.12 ?M paclitaxel (Taxol), the most commonly used chemotherapeutic drug for breast cancer, when it was tested in the two adenocarcinoma cell lines investigated in this study in parallel experiments (data not shown)”.

I repeat, DATA NOT SHOWN. Interesting that homeopathy sympathisers can go from this, to homeopathy can cure cancer. But then facts, evidence and science never really did interest them much. As for David Tredinnick, well it seems he is not much interetsed either, as revealed in a debate between him and Dr Simon Singh BBC Radio 4. You can listen to the audio here.

You can also read two great stories about the loonie beliefs of David Tredinnick from The Guardian by Nature’s @AdamRutherford here and The Lay Scientist’s @mjrobbins here.

The entire exercise was summed up by tweeter @paulNUK2010 who relected; “How to get your scientific papers peer reviewed by experts in the field – get David Tredinnick to cite them in an EDM #homeopathyEDMs”.

So very true.

As I said in my original blog post, the journal that published this tosh has an impact factor of 2.234 but a fail factor of 10^23.

Sadly, these amendments do not mean the loonie EDMs have been thrown out. We still need MPs to show their support by signing the amended versions.

If you live in the UK, please write to your MP here. You will find a form letter to use for a guide here.

Dodgy devices to be regulated 25-May-2010 By Michael East

THE manufacturers of shonky devices used by alternative therapists to carry out what they claim are diagnostic tests will soon have to provide clinical evidence that they work under new Therapeutic Goods Administration regulations.
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The changes, which will be introduced in July, are in response to growing concerns about the number of in-vitro diagnostic devices employed by alternative therapists.
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Among the products advertised on the internet is the “Hemaview”, which, according to its manufacturer, uses one or two drops of blood projected onto a video screen to diagnose “nutritional deficiencies, organ dysfunction and certain biochemical imbalances”.

Director of the Alfred Hospital’s department of haematology Professor Hatem Salem said users of the device were “pulling the wool over people’s eyes”.
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“The notion that one can diagnose all sorts of ailments by examining a drop of blood on a video screen is both ridiculous and plain stupid.”
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Currently the TGA is only able to regulate diagnostic devices included on the Australian Register of Therapeutic Goods, including those that test for HIV and hepatitis C, as well as those used in the home.
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However, many of the in-vitro diagnostic devices used by alternative therapists have been exempt from scrutiny because they are not considered medical devices.
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From July the makers of all in-vitro diagnostic devices will then be required to show clinical evidence that their products work but will have four years to fulfil the new requirements. They will also have to make clear to the public the potential risks of the devices.

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I’m afraid I’m sceptical. Required to show clinical evidence? To whom? Unfortunately the TGA does not have a very good track record of policing things like this.

Remember the homeopath who made all sorts of outrageous claims about magic water as a substitute for vaccination? Fran Sheffield of Homeopathy Plus! simply didn’t agree with TGA findings that her claims were misleading, so chose to ignore a ruling to remove such material from her website. And in an example of laughing in the face of the law, the day after she was exposed on ABC1′s Lateline programme by Steve Cannane, she jumped the shark.

In a post entitled; “Lateline: Can homeopathy safely protect against epidemic and infectious diseases? Can homeopathy treat serious diseases such AIDS and cancer?” she went even further, claiming that water could safely treat AIDS and cancer.

So, whilst I applaud this legislation in principle, how does the TGA, or other relevant health authorities plan to police it?

I regularly attend the Mind Body Spirit/Wallet Festival in Sydney where there is a plethora of snake oil salesman using Hemaview and collecting money hand over fist from gullible clients. It’s a perfect set-up; let us diagnose you with some allergy or somesuch and then when I reach over here, I have a bucket of powder for the special price of way-too-much which will fix you right up!

In NSW in 2008, legislation was introduced to regulate unregistered health practitioners, that is, those who are not already represented by a regulatory body like doctors or dietitians. Section 17 of the Code of Conduct states that a health practitioner must display the code and a document that gives information about where clients can complain to the Health Care Complaints Commission (HCCC) if necessary.

I have dutifully trotted off to the MB$ four times now, will my code clutched tightly under my arm and as yet, I have not once seen the code displayed. It’s now become a bit of a joke between my friends and as such, we have nick-named our futile search “Code of Conduct Bingo”.

This “festival” had enough quackery and snake oil to start a factory. (As an aside, one also has to wonder how much of the takings are declared to the tax department at the end of the four day love in). Make no mistake, a large amount of cash is collected, when you count up the magic scalar energy infused Fusion Excel Pendants for $150-$200 (available from Alibaba.com for 6 bucks a pop) or the $45 for a 20 minute reading with a psychic (queues last week extended half way across the exhibition hall). Or the dangerous and useless ear candles, which you can buy wholesale for 20 cents a pop, or pay about 15 bucks for three at the MB$ (after you pay your 16 bucks to get in). Or how about a $60 Power Balance Bracelet (available from Alibaba.com for between 50 and 80 cents).

In the two years I have been attending, I have not been aware of any representatives from relevant health bodies lurking around – this doesn’t mean they are not there of course. It would hardly make sense to walk around declaring your identity if you wanted to catch people in the act.

But certainly, I’ve been mistaken for such as person, at a Hemaview stand in fact. A colleague and I were asking for published evidence for the statement “clinically tested” which was splashed all over their stand, when the pamphlet he was holding was rapidly snatched out of his hand and the previously helpful assistant demanded, “are you Doctors?? Why do you want to know?…ARE YOU FROM THE TGA?”

Thou doth protesteth too much methinks.

It becomes very difficult not to lose your temper with these people, particularly when you know they are blowing it out their arse.

The first time I was exposed to a Hemaview/Live Blood Analysis person at the MB$, I was carefully shuffled away by my friend as my voice began to break and my ears to steam. It took him a good 10 mins to calm me down from the tidal wave of bullshit that had passed over me. You see, as a scientist I knew the terminology spewing from the representatives gob was real, but the deceit of peppering sciencey sounding words into a spiel about woo, to make it sound legitimate was too much for my science educated brain. She was right when she observed, just before I was escorted to the nearest corner, that I had been “affected by what she said”.

It’s just it was not in the way she presumed.

Another time at another Hemaview stand, I was with a nurse colleague when we were surreptitiously moved on with a nod the boss man. I guess he had twigged we were onto their profitable little scam.

It is interesting nonetheless, to observe the way woo-purveyors react to being challenged on their claims. After a fair bit of experience, I’ve come up with a theory. The ones who get angry and ask you to leave, are probably knowingly deceiving the punters. You might call them frauds or con men. The ones who genuinely try to answer your questions, even if their explanations are completely implausible and off with the fairies, are probably genuine, even if they are deluded.

It’s a bit like the psychics who spot you in the crowd, knowing who you are, and point out there are a lot of fake psychics here today.

I’M DEFINITELY NOT A FAKE, but look over there – he is!!!

So, personally, I am not confident this new legislation with have much of an impact of the alternative medicine industry. And it also seems odd that they are given four years to comply. Why so long? One thing is for certain though, the addition of legislation designed to clean up the industry will lend it unwarranted legitimacy. Imagine how happy snake oil purveyors will be to declare that their quantum energy box has been approved by the government.

The TGA is failing the Australian public. It’s a disgrace.