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    The current regulation of ‘low risk’ therapeutic goods is honesty-based – which is an open invitation for creative sponsors/manufacturers to apply for listings for products that they know do not have proof of efficacy.

    The TGA only check one in ten new listings, which means that sponsors only have a 10% chance of being picked up in a random post market audit.

    If the TGA asks them for ‘evidence’ all they do is put in new applications (using different names) with a 90% chance of escaping audit. They are therefore guaranteed to get a listing.

    The internet is now flooded with incorrect information on therapeutic goods, many of which are TGA approved goods, and consumer complaints are increasing.

    Consequently, there are hundreds of ineffective products that can claim to be “TGA approved”, and with no threat of legal action from recalcitrant sponsors, and complaitns system that lack teeth, it has become a free-for-all. Sadly, this means that thousands of practitioners are using ineffective, potentially harmful, products on some of our most vulnerable patients at sometimes great cost to their health and wallets.

    The TGA continues to focus on the ‘the industry’, with no transparency, contempt for complaints and no interest in consumer protection. You can drive a semi load of ‘low risk’ goods through the loop-hopes in the current regulation. It should be scrapped.

    There should be one system for all therapeutic goods.

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    I have just read Dr Harvey’s position paper in full and I have to say that I agree with him, although I would like to go further.
    I work for a company that markets listed medicines. My experience from the inside has shown me that the entire system needs to be overhauled.
    At present, we have some listed medicines that are, to be it bluntly, ineffectual rubbish, about which unsupportable claims are made. There are other listed medicines that in other parts of the world have the standing of registered medicines because they have the published peer-reviewed science behind them.
    In Australia it is close to impossible to get registered status for a natural medicine. The system is so biased in favour of the patented synthetics from big pharma that anything natural is locked out, regardless of how much evidence can be presented.
    This creates a situation in which some highly effective and safe natural medicines cannot be promoted for what they have been shown in published science to do.
    This is because what the Act classifies as ‘serious medical conditions’ are the exclusive preserve of registered medicines.
    Someone would have to be naive in the extreme to not see that the Therapeutic Goods Act was written to protect the interests of big pharma by denying both the public and doctors access to information. Truth and public interest are not considerations in the legislation.
    What I believe Australia needs is a classification for natural medicines that have been shown in published peer-reviewed science to be effective. This category should be able to make claims based on the evidence, regardless of whether the condition is ‘serious’ or not.
    The original intent of the medicines classification system was to require that medicines that were potentially dangerous needed a prescription and medical supervision. What it has morphed into is a system that protects the interests of big pharma by creating a closed shop.
    In summary, I believe there should be three classifications.
    1. Registered medicines that are prescription only because of the risk to the patient if they are used incorrectly.
    2. Medicines that are both natural and synthetic (currently registered non-prescription) that have published science on record with the TGA, but are low risk.
    3. Listed medicines that are not required to produce evidence and are low risk.
    Claims made in advertising should be on the basis of the evidence, not whether a condition is ‘serious’ or not.

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    Doctor Whom

    Pharmacists, who are trained in the scientific method, are some of the worst boosters.

    It’s possible to walk into a pharmacist shop in any suburb and see sales displays for slimming “potions” and all sorts of new age and old age woo woo cures.

    One doesn’t even have to go far to find a chemist doing homeopathy!


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