Tag Archives: quackery

Pseudoprofundity

by Tim Harding

Most skeptics are familiar with the term ‘pseudoscience’, which means non-scientific activities masquerading as science. Examples include astrology, alchemy, so-called ‘alternative medicine’ and ‘creation science’.

Less well-known is the term ‘pseudoprofundity’, which means claptrap masquerading as profound wisdom. Deepak Chopra springs to mind, when he uses pseudoprofound terms such as ‘quantum healing’ and ‘dynamically active consciousness’.  

‘Love is only a word’ is a more general example of pseudoprofundity which Daniel Dennett calls a ‘deepity’ – the pretension of depth. This is a phrase which sounds like it contains a great depth of wisdom by virtue of being perfectly ambiguous. The philosophical blogger Jonasan writes that on one level it is clearly false that love is only a word. ‘Love’ is a word, but love itself is not (the inverted commas are important). The fact that ‘love’ is a word is also trivially true. We are thus left with a statement which can either be interpreted as obviously false or trivially true.  Jonasan notes that by failing to exercise our powers of analysis on this statement we end up thinking about both meanings together, rather than separating them and perhaps seeking clarification about which meaning is intended. This gives an illusion of profundity.

Stephen Law has pointed out that you can also achieve this effect without the need for an ambiguity in meaning. Ordinary trivially true platitudes such as ‘death comes to us all’ can be elevated to the level of profound insight if enunciated with enough gravitas. Likewise, one can take the other side of Dennett’s deepities – that of self-contradiction – and use it without even needing the trivially true side. Law again gives us one of the finest examples in ‘‘sanity is just another kind of madness’. It sounds profound doesn’t it? Except that sanity cannot be a form of madness because they are defined as opposites.

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Government decision not to ban homeopathy sales from pharmacies is a mistake

The Conversation

File 20180508 46356 1fu8iho.jpg?ixlib=rb 1.1
Evidence homeopathy works is pretty clear: it doesn’t. From http://www.shutterstock.com

Bruce Baer Arnold, University of Canberra

Last year a review into pharmacy in Australia recommended homeopathic products be banned from sale in chemist shops across the country. This was a sensible recommendation, given pharmacists are trusted scientists in the community and science tells us homeopathic products simply don’t work.

In the government’s recent response to this review they “noted” the concerns of the reviewer, and have chosen not to adopt it. Here’s why that is a mistake.

What is homeopathy?

Homeopathy involves extreme dilution of a compound that is claimed to be therapeutically effective, and uses the concept of “like cures like”. For example a fever might be treated with a compound used to induce fevers, in the belief the diluted active ingredient will have the opposite effect and cure the fever.

Products tend to contain the equivalent active ingredient to a single molecule within an Olympic-size swimming pool. Practitioners of fact-based medicine have understandably indicated that any effect of the product could only be attributable to the placebo effect (it works because you believe it works) or because the product contains alcohol or a similar base.


Read more:
No evidence homeopathy is effective: NHMRC review


Most pharmacists probably abhor such treatments lacking evidence, given they go through years of rigorous university training, are heavily regulated and have a strong professional ethic. But it makes the cash registers clang.

These days pharmacies also sell jelly beans, lipstick, energy bars, vitamins, teddy bears and sunglasses – as well as prescription medications. This, unfortunately, is business practice.


Read more:
Discount chemists are cheapening the quality of pharmacy along with the price


Pharmacists are trusted scientists. From http://www.shutterstock.com

Business v health care

Pharmacies have a special status as businesses, along with many actors in the health system. Successive governments have grappled with tensions around service delivery, standards and competition.

They’ve also had to grapple with a very strong industry body, the Pharmacy Guild (stronger than the Pharmaceutical Society). Much of the review reflects agreement between them. In responding to the review the government has flicked the homeopathic hot potato to pharmacy owners:

Professional standards have been designed for use by individual pharmacists to assess their own professional practice. They are intended to serve as guidance for desired standards of practice. However, it is the sole responsibility of the individual pharmacist to determine, in all circumstances, whether a higher standard is required. It is equally their responsibility to meet that standard and ensure that consumers are provided with the best available information about the current evidence for, or lack-of efficacy in, offered treatments and therapies.

So given the government has not banned homeopathic products from pharmacies, we could hope for restriction under Australian Consumer Law. They can, for example, prohibit sale of products that lack the purported constituents or qualities. But this has yet to happen with homeopathy, as it’s considered misleading but harmless.

The government is putting the onus on consumers to ask the pharmacist “does this work?”, and only the exceptional customer will ask.

If consumers wish to purchase therapies without a proven effect, they should be able to do so from venues that sell incense sticks and similar “wellness” paraphernalia.

They should not be available for sale in an industry necessarily regulated by government and trusted by the community.

It’s time for the Guild and Society to take a stand and reject sale by their members of products that by definition do not work. If pharmacies want status, they have to skip the junk products dollar. The government should help.


The ConversationRead more:
Pharmacists are trusted medical professionals, so they shouldn’t sell remedies that lack evidence


Bruce Baer Arnold, Assistant Professor, School of Law, University of Canberra

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

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Science or Snake Oil: can a detox actually cleanse your liver?

The Conversation

Nick Fuller, University of Sydney

This is the first article in our new ongoing series Science or Snake Oil. Articles will look at the claims for a product and decide whether they are supported by science or lacking in evidence.


The human adult liver weighs about one-and-a-half kilograms, making it one of the largest organs in the body. It is responsible for a range of functions. It helps break down fats, carbohydrates and proteins into substances the body can utilise.

The liver acts as a storage unit for these substances (including vitamins and minerals) and supplies the body with them when they need it. For example, when your blood sugar level drops, the liver will release stored carbohydrate (glycogen) to rectify the problem.

It also acts by metabolising toxins into harmless substances or by eliminating toxic substances from the body. Clever marketing has led us to believe it is the food that contains toxins and, hence, following a diet that eliminates certain foods and taking over-the-counter products that “cleanse” your liver of “toxins” will detoxify the liver.

Can the liver be ‘cleansed’?

We have a misconception we can “cleanse” the body by following a “detox” diet.

This is a complete fallacy. To explain this process one must first understand exactly what a toxin is. A toxin is a harmful substance that enters your body from the environment. Examples include carbon monoxide from motor vehicles, bisphenol A (BPA) from consumer plastics, and heavy metals such as lead and mercury. Toxins can also include drugs and poisons.

However, substances are only toxic based on the quantities in which we ingest them. The situation in which “detoxification” is required is when someone is being treated in a hospital for a dangerous level of a substance that is life-threatening.

The liver is otherwise working to eliminate unwanted substances in the body through our faeces and urine. These are the toxic byproducts from the metabolization of foods. For example, excessive amounts of protein can be dangerous to the liver.

Many over-the-counter products claim to “clean” your liver of “toxins”. But does the liver really respond to an over-the-counter product that claims to “detoxify” or “heal” its function?

Most of these products contain the active ingredients from Silybum marianum (known as milk thistle) and Taraxacum officinale (known as dandelion). Many of the formulations also contain other ingredients such as selenium, phosphatidylcholine, amino acids, artichoke leaf, green tea leaf and turmeric root, to name a few.

Several companies produce a range of liver detox or liver cleanse products with varying quantities and ingredient compositions. But how strong is the evidence to show these active ingredients actually help with liver repair?

Some popular liver detox brands.
Screenshot, Chemist Warehouse

Milk thistle

Milk thistle extract (standardised to 80% silymarin) is the most commonly marketed herb claimed to “detoxify” the liver. Silymarin is the active ingredient in milk thistle. The use of milk thistle for treatment of various diseases dates back to Dioscorides, the first-century Greek physician.

In more recent times, it has been used to treat liver disease. However the majority of studies that have been conducted are of low-quality study design, so its purported efficacy is still questioned.

There is some evidence to suggest milk thistle (usually accompanied by other substances) is beneficial for improving blood cholesterol, insulin resistance and inflammatory markers in the body. There is no evidence, however, to suggest milk thistle “detoxifies” the liver – which many of these products claim.

Caruso’s liver detox active ingredients as per their website.
Screenshot, Caruso’s

Dandelion

Dandelion’s therapeutic use dates back to the tenth century for liver and spleen disorders.

Since then, the medicinal use of the plant has been tested for a range of diseases. But the evidence is contradictory, or based on poor study design with incomparable results.

Of greater relevance is that the majority of research investigating the efficacy of this flower extract has been tested only in animals. Similar to milk thistle extract, there is no evidence to suggest it helps to eliminate toxins or detoxify the liver, and hence serves no benefit for such a proposed indication.

A healthy liver

To have a well-functioning liver you simply have to eat healthy foods and limit your consumption of substances, such as alcohol, that cause it to work harder. Excessive consumption of any one particular food may contribute to an increased load on the liver.

Therefore, a healthy, well-balanced diet based on national guidelines is the best liver “cleanse” available, rather than spending disposable income on over-the-counter products that are not backed by scientific literature supporting such claims.

Complementary medicines are one of the largest growing markets in the world. Governing bodies must continue to incentivise companies to conduct innovative research to support the specific claims accompanying their products. It’s imperative companies are transparent in their advertising claims so consumers know what they are spending their money on from both an efficacy and safety point of view.

Evidence for approved ingredients should not be generalised from product to product. This is because the evidence supporting one such product is made up of a unique combination of ingredients and dosages. The most recent review of the regulatory framework for complementary medicines is available on the Department of Health website.

The ConversationNick Fuller, Research Fellow, Clinical Trials Development and Assessment, University of Sydney

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

 

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Traditional Chinese Medicine at RMIT: roll up and start a new life in woo

Victorian Skeptics

RMIT Open Day TCM 2015

by: Mal Vickers

Imagine you’re in the midst of the stress of VCE and facing those life-changing questions: What do I do with my life? Which university course should I do? You’d want accurate and reliable information, right?

Sadly I witnessed an audience of impressionable, aspiring young people who were considering career moves being given poor information by an Australian university.

In August 2015, I sat in on RMIT’s Open Day presentations promoting a degree courses in Traditional Chinese Medicine (TCM). By the look of the demographic in attendance, most were Year 12 students. About one quarter looked to be the parents, with a few possible mature-age students and one known skeptic, MOI.

Young people are going to be exposed to misleading information and dubious advertising in society, that’s a given. As a society, we’re already taking up a lot of valuable educational time in teaching science and critical thinking…

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Should scientists engage with pseudo-science or anti-science?

The Conversation

Rod Lamberts, Australian National University and Will J Grant, Australian National University

The ABC’s flagship science journalism TV programme, Catalyst, has riled the scientific community once again. And, in a similar vein to Catalyst’s controversial 2013 report on the link between statins, cholesterol and heart disease, it has now turned its quasi-scientific attention to a supposed new peril.

Its “Wi-Fried?” segment last week raised concerns about the ever-increasing “electronic air pollution” that surrounds us in our daily lives, exploiting a number of age-old, fear-inspiring tropes.

There are already plenty of robust critiques of the arguments and evidence, so exploring where they got the science wrong is not our goal.

Instead, we’re interested in using the segment as inspiration to revisit an ongoing question about scientists’ engagement with the public: how should the scientific community respond to issues like this?

Should scientists dive in and engage head-on, appearing face-to-face with those they believe do science a disservice? Should they shun such engagement and redress bad science after the fact in other forums? Or should they disengage entirely and let the story run its course?

There are many of examples of what scientists could do, but to keep it simple we focus here just on the responses to “Wi-Fried” by two eminent Professors, Simon Chapman and Bernard Stewart, both of whom declined to be a part of the ABC segment, and use this case to consider what scientists should do.

Just say no

In an interview about their decision to not participate, Chapman and Stewart independently expressed concerns about the evidence, tone and balance in the “Wi-Fried” segment. According to Chapman it “contained many ‘simply wrong’ claims that would make viewers unnecessarily afraid”.

Stewart labelled the episode “scientifically bankrupt” and “without scientific merit”. He added:

I think the tone of the reporting was wrong, I think that the reporter did not fairly draw on both sides, and I use the word “sides” here reluctantly.

Indeed, in situations like this, many suggest that by appearing in the media alongside people who represent fringe thinkers and bad science, respected experts lend them unwarranted credibility and legitimacy.

Continuing with this logic, association with such a topic would mean implicitly endorsing poor science and bad reasoning, and contribute to an un-evidenced escalation of public fears.

But is it really that straightforward?

The concerns Chapman and Stewart expressed about the show could equally be used to argue that experts in their position should have agreed to be interviewed, if only to present a scientifically sound position to counter questionable claims.

In this line, you could easily argue it’s better for experts to appear whenever and wherever spurious claims are raised, the better to immediately refute and dismiss them.

On the other hand, if scientific experts refuse to engage with “scientifically bankrupt” arguments, this could send a more potent message: that the fringe claims are irrelevant, not even worth wasting the time to refute. So this would mean they shouldn’t engage with this kind of popular science story.

On the third hand, their refusal to engage could be re-framed to characterise the experts as remote, arrogant or even afraid, casting doubt on the veracity of the scientific position. So to avoid this impression, experts should engage.

But wait, there’s more.

Participation in these kinds of popular science shows could also tarnish the reputation of the expert. But not appearing means missing the opportunity to thwart the potential harm caused by fringe, false or non-scientific claims.

And what about an expert’s obligation to defend their science, to set the record straight, and to help ensure people are not mislead by poor evidence and shonky reasoning? Is this best done by engaging directly with dubious media offerings like “Wi-Fried”, or should relevant experts find other venues?

Should scientists engage anti-science?

Well, this depends on what they think they might achieve. And if one thing stands out in all the to-ing and fro-ing over what scientists should do in such cases, it’s this: the majority of proponents both for and against getting involved seem convinced that popular representations of science will change people’s behaviour.

But there is rarely any hard evidence presented in the myriad “scientists should” arguments out there. Sticking with the Catalyst example, there is really only one, far-from-convincing, study from 2013 suggesting the show has such influence.

If you really want to make a robust, evidence-based decision about what experts should do in these situations, don’t start with the science being discussed. In the case of Catalyst, you’d start with research on the show’s relationship with its audience(s).

  • What kinds of people watch Catalyst?
  • Why do they watch it?
  • To what extent are their attitudes influenced by the show?
  • If their attitudes are actually influenced, how long does this influence last?
  • If this influence does last, does it lead people to change their behaviours accordingly?

Of course, we applaud the motives of people who are driven to set the scientific record straight, and especially by those who are genuinely concerned about public welfare.

But to simply assume, without solid evidence, that programmes like Catalyst push people into harmful behaviour changes is misguided at best. At worst, it’s actually bad science.

The ConversationRod Lamberts, Deputy Director, Australian National Centre for Public Awareness of Science, Australian National University and Will J Grant, Researcher / Lecturer, Australian National Centre for the Public Awareness of Science, Australian National University

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

 

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

The Conversation

Michael Vagg, Barwon Health

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

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

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

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

The CBA Communique from its June 2015 meeting says:

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

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

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

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

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

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

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

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

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

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

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

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

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

They could at least have a go.

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

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

 

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Denialism

Denialism is a person’s choice to deny certain particular facts.  It is an essentially irrational belief where the person substitutes his or her personal opinion for established knowledge. Indeed, one of the hallmarks of denialism is a failure to recognise the distinction between opinions and facts.

Denialism should not be confused with modern scientific skepticism, which is the challenging of beliefs that are unscientific, irrational or based on insufficient evidence.  Instead of denying facts, modern skeptics test claims by analysing whether they are supported by adequate empirical evidence. Denialism is the a priori rejection of ideas without objective consideration.

The philosophical skepticism of the Academic Skeptics and Pyrrhonists in Classical Greece (which was quite different to modern skepticism) consisted of doubting whether there can be any knowledge or facts at all, rather than denying particular facts.

Science denialism is the rejection of basic facts and concepts that are undisputed, well-supported parts of the scientific consensus on a subject, in favour of radical and controversial opinions of an unscientific nature. For example, the term climate change denialist is applied to people who argue against the scientific consensus that the global warming of planet Earth is a real and occurring event primarily caused by human activity. 

The term evolution denialist or ‘creationist’ is applied to people who argue against the fact that life on Earth has evolved from earlier forms, instead of having been created by a supernatural being in its current form.

Other instances include Holocaust denialism, AIDS denialism, vaccination denialism, and Flat-Earthism. The various forms of denialism present the common feature of the person rejecting overwhelming evidence, often with attempts to deny the existence of a scientific consensus or alternatively to allege a conspiracy theory to fake or conceal the evidence. Denialism is commonly one of the foundations of quackery and other varieties of woo.

The motivations and causes of denialism include irrationality, religion and self-interest (political, economic or financial), beliefs in conspiracy theories or even defence mechanisms meant to protect the psyche of the denialist against mentally disturbing facts and ideas.

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Age Editorial

Victorian Skeptics

We seem to be riding a wave of mainstream support for a Skeptical / rational view of health policy. The following is an editorial from The Age Newspaper of 22/12/15. The highlights are entirely down to us!

Well done, THE AGE !

______

The_Age_logo.svg

You cannot argue against the science

The science is clear. It is beyond argument. It is accepted. For hepatitis C sufferers, there is no dispute, only relief. The federal government announced yesterday that drugs to combat the disease will be placed on the Pharmaceutical Benefits Scheme. The drugs can cost a patient $100,000 but, for Australia’s 230,000 sufferers, they will now be accessible for the PBS co-payment cost of $37.70, or $6.10 for concession.

According to Health Minister Sussan Ley, 10,000 new cases are diagnosed each year. She hopes that the drugs will not only halt the spread of Hep C, an infectious virus that attacks the liver…

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“Letter to the Editor…”

Victorian Skeptics

FRIENDS OF SCIENCE IN MEDICINE FRIENDS OF SCIENCE IN MEDICINE

We’re pleased to re-post, with the kind permission of the authors, the following letter. It was published in The Australian newspaper on 18/12/15.
[We note with interest that at the time of posting The Australian is running with this issue on the front page.]

The government is struggling to find savings and about to make real inroads into pathology services, prescriptions and other valuable medical benefits of proven effectiveness. The Treasurer asks for suggestions as to where alternative savings might be made, so here are three.

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What’s in your herbal medicines?

The Conversation

by Ian Musgrave and Michael Bunce

Many people take herbal medicines, including traditional Chinese medicine (TCM) thinking they are doing something positive for their health. Ironically, in many cases they may be doing just the opposite.

Have you ever wondered what is actually in the herbal medicine products you buy? Has the herb on the label been replaced with another herb? Have pharmaceuticals been snuck in?

Making sure that a tablet claiming to have 500 milligrams of paracetamol really does contain 500 milligrams of paracetamol is relatively easy, there are established assays to measure paracetamol routinely. But how do you test for herbs?

Most herbal medicines are pills or powders that have removed all trace of structure we would normally use to identify plants, and many plants have no chemical signature that is able to definitively identify them. And what about all the other possible contaminants and adulterants that could hide in the complex brew of chemicals from herbal medicines?

Our research, which has just been published in the journal Nature Scientific Reports, goes a long way to answering that.

For the first time, our group of researchers from Curtin University, Murdoch University and the University of Adelaide have combined some of the most cutting-edge and sensitive analytical techniques to screen a set of traditional Chinese medicines available in Australia.

We used a three-pronged approach, combining DNA sequencing, toxicology and heavy metal testing to elucidate the true composition of 26 TCMs purchased at random from the Adelaide Markets; most were either for colds and flu’s or for general wellness.

What did we find?

Summary of the contaminants in traditional Chinese medicines (TCMs) tested in this study that contained toxic metals, undeclared or illegal contents as determined by DNA, toxicological, and heavy metal screening methods. Each TCM tested is represented in the diagram as a tablet; blue shading on tablets indicate AUST L listed medicines, red shading are not-listed with the TGA regulatory body. TCMs deemed non-compliant
for DNA (green), toxicology (pink) and heavy metals (yellow) or a combination thereof, are represented within the Venn diagram. 
Coglan et al.,Sci Reports 2015

Nearly nine in ten of these medicines had some form of undeclared substance in them as either adulteration or contamination. Sixteen of TCM’s had more than one contaminant or adulterant.

While around half of these medicines were not listed with the Therapeutic Goods Administration (TGA), and should not have been available for purchase, contaminants were found in both TGA-listed and non-listed medicines. These adulterants/contaminants included pharmaceuticals and toxic heavy metals.

Plant and/or animal DNA from species not listed on the labels were also found. The most concerning finding was snow leopard DNA (snow leopards are an endangered species), which was detected in one medicine. DNA from pit viper, frog, rat, cat and dog was also detected in several medicines.

Among the pharmaceuticals found were paracetamol, antihistamines, anti-inflammatories and antibiotics, and stimulants such as pseudoephedrine. Of particular concern were drugs such as warfarin, which have significant potential for harm if not taken under medical supervision, and ephedrine, which is banned in Australia.

Significant levels of toxic heavy metals such as arsenic, cadmium and lead were found in over half the medicines. In at least four of these medicines following the directions on the label would expose you to over ten times the TGA’s regulatory limit for heavy metals in medicines.

What does this mean?

Herbal Medicines. Megan Coglan

Are the levels of undeclared materials in these products adulteration or contamination? In adulteration, the material is added deliberately. In contamination, the material is added inadvertently, for example, through unclean workplaces or herbs grown on contaminated soil.

Whether a compound is a result of deliberate adulteration or contamination has different regulatory implications. It can mean the difference between banning a substance or cleaning up the workplace.

It can be tricky to decide which is which. In TCM materials, for instance, heavy metals or toad venom may be added as part of the treatment. However, by looking at the patterns of materials we found, we can get some hints.

One TCM claiming to enhance weight gain with appetite stimulation contained pharmaceutically relevant levels of the drug cyproheptadine, a known appetite enhancer.

In another, ephedrine was found without any evidence of DNA from plants of the Ephedra genus, suggesting that in both cases the drug was deliberately added.

Intriguingly, high levels of arsenic were often found with similar levels of lead. Lead arsenate has been used as a pesticide, and the high levels may come from persistently contaminated soils.

What this means is that you should be very careful about choosing and purchasing TCMs. Definitely avoid any medicine that does not have an ARTG listing (it should have a number like AUST L 123456 on the front of the bottle). But even medicines with these AUST L labels are no guarantee of safety.

This also highlights the importance of informing your health practitioner if you are taking TCMs as adulterants might interact with conventional medication to cause adverse effects.

What are the regulatory implications?

Unlike countries such as the United States, where many herbal medicines are regulated as dietary supplements, in Australia, herbal medicines are regulated through the TGA as medicines.

TGA-regulated medicines can be approved as either “registered” or “listed”. Most herbal medicines are classified as “listed”. Unlike registered medicines such as paracetamol and warfarin, the evidence required for approval is much less stringent.

In many ways it is an honour system, where the herbal medicines sponsor says there’s no evidence of harm, and they hold documentation that shows this. Mostly, the evidence is historical, claiming that people have been using it for generations without evidence of harm. As well, if the compounds are on the TGA’s list of “generally recognised are safe” materials extensive safety testing is not required.

The TGA uses post marketing follow-up to check for compliance with the “listed” medicine regulations. This follow-up consists of random surveys as well as targeted surveys from concerns raised by consumers.

In Australia, nearly 2,000 new herbal medicines are registered each year.
In a TGA survey in 2012-2013, 145 complementary medicines were tested. Around 83% of complimentary medicines surveyed were deemed to be non-compliant, with 6% failing due to product composition, formulation or manufacturing.

Using a combination of new molecular approaches, our survey found a much higher level of adulteration and contamination in TCMs than found in the TGA’s surveys. Adding DNA ingredient screening to the TGA’s armoury of analytical methods would help ensure that undeclared ingredients are not included in the herbal medicines we consume.

And Finally:

The herbal medicine industry is a billion dollar international industry, with products travelling all over the world.

Globally, we need a better auditing “toolkit” to ensure consumers of herbal medicines, as well as people testing their efficacy, are not being misled.

This research, we think, provides a roadmap to more effective regulation of the herbal medicine sector.

* The results of our screening have been passed on to the TGA, which is following this up.

The ConversationIan Musgrave, Senior lecturer in Pharmacology

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

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