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The Therapeutic Goods Administration responds …

Last night I emailed the public affairs unit of the Department of Health and Ageing about the recent Croakey articles on the Therapeutic Goods Administration.

Below is my request, and the response.

From Croakey

Dear public affairs

Croakey has recently run several articles related to the TGA generally, and comp medicine regulation, and TGA media management. This is the most recent post and it links back to the previous articles.



I am very keen to publish a response or responses from the TGA to the matters raised.

• If there are any factual errors in any of the posts, please point these out

• if the TGA would like to respond to any of the specific concerns/questions raised or more broadly, this would be welcome

• if Kay McNiece or McNiece Communications would like to respond to the post on media relations issues, this would also be very welcome.

If anyone from the TGA would like to discuss this request, I’d be very happy to chat.

Melissa

***

The TGA responds

Kay McNiece, Media Adviser, TGA, writes:

Thank you for the opportunity to respond to your articles on the regulation of complementary medicines in Australia.  The TGA welcomes public scrutiny and debate.

There are 10,000 complementary medicines listed with the TGA on the Australian Register of Therapeutic Goods.

In general these products are considered to be low risk due to the nature of the ingredients they contain.

Listed medicines may only contain pre-approved low-risk ingredients and must not make claims nor impute that they provide benefit for the treatment or prevention of serious illness.

To ensure the safety of preparations used in complementary medicines, certain restrictions are applied including dosages and labeling. For example, herbal ingredients containing caffeine require label warnings.

Unlike many other countries in the world Australia ensures that complementary medicines are manufactured safely and only contain approved, low-risk ingredients.

This is not the case in the US, Europe or New Zealand where the controls on manufacturing quality, ingredients and claims that operate in Australia do not apply.

There are strict advertising rules about making health claims and sanctions, including removal from the Register or criminal charges, can be laid by the TGA.

Unlike higher risk registered medicines, listed medicines are not evaluated for efficacy before entry on the ARTG and consumers should be aware that the TGA regulates these products for safety but cannot guarantee if they work.

Consumers should also be reminded that while the effectiveness of complementary medicines is not evaluated by the TGA, the manufacturing quality and the ingredients are. Consumers should therefore avoid purchasing complementary medicines over the Internet, or from other sources if they do not have an Aust-L number showing that they have been listed in the ARTG.

Because of the low risk of listed complementary medicines, the TGA considers it appropriate for sponsors to apply to be on the Register on-line but sponsors of Listed medicines are required to hold evidence in support of claims made for their products and to produce this to the TGA for review upon request. If this is found to be inadequate, the TGA can take appropriate regulatory action.

In response to community concerns about the listing of complementary medicine, the TGA recently convened a working party of consumers and industry representatives to ensure that all parties are clear about their regulatory obligations and to explore ways of strengthening compliance.

Further information can be found here: How complementary medicines are regulated in Australia

Comments 9

  1. Rorschach says:

    In general these products are considered to be low risk due to the nature of the ingredients they contain.

    Erm, seeing that this is the Therapeutic Goods administration we’re talking about here, it’s not exactly about whether these products might harm you, but surely it should be about whether they have any, you know, therapeutic benefit beyond the placebo effect ?

  2. ron batagol says:

    I agree. Indeed, I have previously, on a number of health websites and in various articles, expressed my ongoing concerns over parents relying on herbals and homeopathics for treating their young children, thereby neglecting proper medical review and assessment, when, often, as we know only too well, potentially fatal childhood conditions such as pneumonia or meningitis may insidiously creep up and take over in a matter of hours or days. Indeed, in one of my articles 5-6 years ago, referring to a tragic case resulting in a fatality, which had resulted in a subsequent Court Case I suggested that that:” At the end of the day, this sort of dereliction of parental care, however laudable the motives, almost borders on a form of criminal neglect in their duty of care to their children!”

    I concluded with the suggestion that I still believe is as valid today as then, namely :”I believe that T.G.A should give serious thought to giving official endorsement and legal proclamation to the restriction of the use of herbal and homeopathic medicines in children under 12 years of age, unless under direct medical supervision, with the exception of vitamin, mineral and nutritional supplements, where these are appropriate for paediatric use”.
    And, Yes, I did write to TGA, and, of course, got the usual predictable wishy-washy reply. In 2009, I even wrote to the Office of the Federal Health Minister, albeit specifically with regard to homeopathic medicines for children and infants being approved for marketing, and received a reply from the Office of Complementary Medicine, which, quite frankly would have done credit to Monty Python’s Ministry of silly Walks! Amongst many other statements supporting the status quo, it stated:” Australia has a risk-based system for the regulation of medicines, including complementary medicines”.
    Oh really? What about the risk of parents neglecting proper medical care when it is needed? After all, we take legislative steps to protect our children form many of the other daily hazards that may befall them, so why not simply restrict the sale of herbals and homeopathics to adults and children over the age of 12 years?

    Ron Batagol

  3. ozziejack says:

    I’d like to make a couple of comments about complementary medicines here. They seem to get far more scrutiny and criticism than conventional pharmaceuticals, and yet, as many are painfully aware, the side effects of many mainstream pharmaceuticals can be devastating. Unfortunately, such is the financial, legal and political clout of the pharmaceutical companies that these findings seem to be swept under the carpet until it is absolutely proven time and time again that a particular drug is dangerous. Then it is removed from the market place. (of course many $m made in the meantime). I’m really concerned that the push against complementary medicines may be indirectly supported by Big Pharma – they have most to lose from a cheap, effective alternative treatment. In terms of placebo effect, what the hell. The mind is a very powerful aid in treatment that certain sectors of the industry don’t want harnessed because they can’t sell anything if it is. What would you rather, taking a weak herbal treatment (perhaps a bit of placebo effect cutting in as well) or taking a pharmaceutical drug that later caused alzheimers? Let’s hope that we don’t end up with a corrupt body as exists in the USA for approval of drugs.

  4. Quoll says:

    This research on bias in media stories regarding herbal medicine and pharmaceutical trials in the English speaking world supports your perception I think ozziejack. A negative bias is what they found for herbal medicines. With an unrealistically positive bias regarding pharmaceuticals.

    Herbal remedy clinical trials in the media: a comparison with the coverage of conventional pharmaceuticals

    http://www.biomedcentral.com/1741-7015/6/35

    Probably a majority of even ‘new’ drugs are often derived from natural sources, often traditionally used herbal medicines or natural products from numerous different continents and cultures.
    The diversity of herbal medicines reflects both the significant and important biodiversity of the natural world and the cultural and experiential diversity of human societies across just about all ecological circumstances over millenia.
    Rather than a problem to be wiped away, this diversity should be seen as a strength and base from which future developments in medicine will certainly occur.
    Which is likely to provide new insights into both our own and the general biology of living things on planet earth.

    Humans are not standardised and environments and cultures vary as well, which is reflected in the diseases any particular people or communities are most likely to suffer from.

    Concerns about fly-by night and marketing scams appear to be reflect a general issue in our modern consumer driven industrialised societies and a planet full of humans. Anything for a buck. Utilisation or exploitation of all natural resources or peoples ignorance and weaknesses for personal gain. Perhaps there’s an element that have and will always be that way, no matter what any one tries to do. That’s a broad cultural trait across many fields.

    Herbal medicine in particular has managed to exist across virtually all human cultures since prehistoric times, and has only recently been taken over by, or made to become an ‘industry’, rather than the local diverse and almost universal cottage industry and social role it has played. Although it still fulfills that role for many of the poorest and most marginal including indigenous people around the world.

    Despite the negative press, the basic application of modern scientific research clearly indicates that many natural medicines could be of value in a wide range of circumstances.
    New information and insight on herbal medicines continues to arise in scientific journals, and the vast array of articles, books and texts on herbal medicines, that can trace itself back to the some of oldest extant texts of any sort in both the eastern and western traditions, continues to grow.

    Thing is also that historically used cheap or readily available natural products do not lend themselves to monopolisation through IP or other instruments per se, and the necessity or ability to demand royalties by anyone.
    Funding for clinical research needs a somewhat different approach.

    Many people evidently feel they benefit from their own use of a range of herbal medicines, and many may not, but for most reasonable people their subjective experience counts for something, even if it is apparently completely dismissed by others. It doesn’t count for everything, but it is surely one of the most basic aspects of human experience to be sensitive to our own feelings and senses and respond to them both consciously and not.

  5. Alexa says:

    I support the concerns of health consumer advocates with regard to the quality, safety and labelling of complementary medicines. However, I urge them to broaden their activities to consider the question of access.

    Even if all consumers were happy to access only conventional medicines (and of course many aren’t), conventional medicine is not able to provide any solutions for some medical conditions and diseases and can only help others giving substantial side-effects.

    There is evidence that complementary medicines can play a part in many medical conditions and diseases, including those that conventional medicine isn’t yet able to help. Such evidence isn’t always well covered in professional or media publications.

    Reasons for resistance to their use can include a belief that it is exploitative. However, I suggest that because there are some quacks and charlatans does not mean that all those involved in complementary medicine fit that bill. I wonder if some of the passionate detractors are letting some personal experience cloud their judgement.

    On the other hand, there are many people with financial and reputational vested interests who wish to see complementary practices and medicines be abandoned. I note that complementary medicines can’t be patented and sales are therefore much less profitable. They compete with some patented medicines.

    Quality evidence to get scientific registration of complementary medicines is expensive. There is not enough profit in such medicines to encourage most businesses to fund the required research. If consumers are to benefit from complementary medicines, it is therefore up to philanthropists and governments to fund it. Some recognition is given to that by the TGA process of listing traditional medicines and the US government funded research.

    Complementary medicine often becomes conventional medicine once such research has been done. Some complementary medicines and practices can replace conventional practices which have substantial side-effects.

    I urge those who are lobbying on behalf of health consumers to respect the right and judgement of those who wish to access complementary medicines. They should continue to insist that quality, safety and labelling of complementary medicines are protected. I hope that they will also advocate for continued access as well as funded research.

  6. Mick Vagg says:

    Like their counterparts in the clinic, defenders of CAM on internet forums never seem to bother checking the facts and just trot out the same recycled, disproven arguments.
    To whit
    @ozziejack so-called complementary medicines receive almost no regulatory oversight, and in fact this conversation is part of an attempt to bring the same level of regulatory attention to bear on them as on co-called conventional products. There exists a gaping double-standard in Australia in this regard. The difference is that pharmaceutical companies accept that they must have science to back up their claims, and manufacturers of other products squeal loudly and think someone is picking on them when they are asked to do the same.

    @quoll There is no space to deal with the gaps in logic of much that you say, but we agree on a couple of points including that cultural and local factors determine patterns of disease and wellness in populations. There’s even a whole science called epidemiology which is devoted to this idea. However you seem to be saying that we shouldn’t try to stop fraudulent or ineffective products being sold to consumers becasue “there’s an element that have and will always be that way, no matter what any one tries to do. That’s a broad cultural trait across many fields.” I disagree with the sentiment that we should not try to prevent the public being taken in by those who see an easy buck in doing so. The consequences of this being allowed to happen are too high when you’re talking about ppl’s health.

    Both Quoll and Alexa make the same incorrect statement that you can’t patent natural products. Here’s an experiment you can try. Email Blackmore’s and try to get them to tell you what is in some of their products, like I have done and they will claim it’s patented, protected information. Same goes for the Bioeffectives range. So it appears that at least some ‘natural medicines’ can be patented and marketed with quite profitable results.

    Alexa also trots out the weary old ‘complementary to usual care’ canard. There have been a number of studies looking at whether this works in practice and they have tended to conclude that the same results are obtained in terms of clinical outcomes, with more expense to whoever is paying. Just what you would predict would happen if ineffective treatments are added to usual care. Here is an example
    http://1.usa.gov/jUtCE5 and another http://1.usa.gov/ig3whO

    Note that in the second of these two references some forms of CAM were publicly funded and costs rose significantly in the public sector, but were reduced in the private sector, presumably because they could then justify not funding such treatments or received fewer claims.

    Alexa’s second last paragraph is missing an important proviso. CAMs may become accepted treatment not once the research is done, but once the research supports their effectiveness. Most proposed ‘conventional’ treatments fail to achieve this when subjected to rigorous evaluation, so it is unsurprising that hardly any CAMs do either. What is most surprising is the insistence of the presence of a conspiracy when in fact these implausible therapies are being treated no differently to any ‘conventional’ treatment making the same claims.

  7. Quoll says:

    No, you’re wrong in many ways it seems to me MV.

    Commenting primarily on other commentors and making a broad and general smear about an imaginary class of people rather than actually addressing points raised. Such as the data contained in the research I posted that demonstrates for an equivalent clinical trial outcome, there’s a significant negative bias against herbal medicines in the media of the English speaking world.

    Herbs and natural products can not be patented.
    Patents are not intended to protect simple discoveries of nature either.

    Products that use ‘special’ or ‘secret’ processes for production or formulation can have those specific methods or processes protected by patent or trade secret.
    The natural substance or raw herb that might be responsible for the activity of the product can not be patented as such.
    Anyone else can take up production and sale of the same herb in another product.
    It’s a well known and widely documented aspect of the industry.

    You seem to be particularly ill-informed on the nature and substance of patents and selling products.
    Patenting does not protect information concerning anything.
    In fact it is entirely about disclosing the information publicly so that legal rights to limit other people’s use, production and sale of the ‘invention’ can be enforced, or royalties demanded.

    A patent is a public description and declaration of ownership over an ‘invention’, not a secret or simple discovery of a natural phenomena or substance.

    I believe it is the case that no-one can sell anything in Australia, particularly for human consumption, and not disclose the ingredients to the customer. Unless it’s GM food of less than 1% or something.
    Or it is protected by a trade secret, but these expensive and difficult for anyone but a very large corporation with more influence than should be possible I’d say (Coca-cola has a trade secret, maybe KFC).

    Sounds like you’ve been fobbed off, and perhaps understandibly so if the tone of your queries were as vexacious as your commentary seems.

    “I disagree with the sentiment that we should not try to prevent the public being taken in by those who see an easy buck in doing so.”

    Did anyone suggest that?

    Are you suggesting that some sort of centralised Orwellian health-police state committee and buraeucracy decides from now on (year zero) what every single human can and cannot say, do or consume in regard to their own bodies and health despite their own experiences and information?
    Is this now the only saviour for humanity?
    In what other way could society come to ‘control’ this situation as you seem to be suggesting?

    A well informed populace with access to as much sound information and public discussion of the whole field and issues arising are far less likely to be suckers, including to pharmaceutical business interests. Vioxx anyone?

    Actually I’d argue that in the broad as more patronising and socially controlling elements (generally by government) seem to have grown within Australian society over my life time (40+ yrs), people have become more and more stupid, selfish and gullible and prey to manipulations from all sorts, including pharmaceutical companies.
    Not to mention unhealthily fatter with greater chronic illness of both body and mind.

    My argument is exactly that people are more and more likely to end up as suckers when they are cultivated to accept that they are too stupid and ignorant to ask questions, know or make decisions for themselves.

    Such a broad a general social phenomena seems to have developed here in more recent times, we being the worlds biggest suckers to Nigerian emails, and amongst our polatical, sporting and business ‘elites’ to pathetic get rich and ridiculous marketing scams (Firepower etc) … we’ve become a pack of largely more ignorant suckers and fools driven by self-obsession I think generally.

    Fiddling around trying to ban people using herbs is merely a distraction from deeper underlying problems that relate to social and cultural norms and development.
    Which also dismisses the significant historical contribution that herbal medicines have made to the very idea of drugs and modern medicine, or the potential future contributions.

    Although it seems almost impossible for those with entirely mechanistic and reductionist views of human life to understand. People generally do better, healthwise, the greater their rights, information and the level of self-determination they have in life, along with the basics of life – food, friends and family, satisfactory housing and a clean environment.
    I agree with Sir Michael Mormot that the major drivers of poor health outcomes are actually outside the realm of medicine generally.
    Now there’s an epidemiologist I listen to MV.

  8. rheaseo25 says:

    The increasing number of people patronizing alternative may be caused by the expensive med or by the increasing awareness for natural solutions.

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