TGA has lost trust on CMs: Harvey


Dr Ken Harvey has again taken aim at the CMs sector, labelling it “a market flooded with shonky products and unethical claims”.

And consumers no longer trust the TGA to protect their interests, he claims, writing in MJA InSight.

“Since 2002, there have been 17 government consultations and reviews concerning the regulation of complementary medicines,” Dr Harvey writes.

“A consistent theme has been the absurdity of a ‘light-touch’ regulatory system for perceived ‘low-risk’ products that involves no pre-market evaluation, trusts sponsors to obey the rules and has no timely or effective penalties for breaches of the regulations.”

He cited recently published TGA data on post-marketing reviews of listed CMs, over the year between July 2015 and June 2016.

408 products were eligible to have their compliance status assessed, and 80% were found non-compliant, mainly to do with labelling, advertising and evidence requirements.

“These appalling statistics, which have not improved over recent years, are a sad reflection of the sorry state of this industry,” he writes. “They are also the reason why many consumers no longer trust the TGA to protect their interests.

“Reform has been stalled by consistent industry opposition, changing bureaucrats, changing ministers, changing government and changing policy, the latest of which was the Abbott government’s agenda for cutting red tape.”

He calls for the implementation of recommendations made in the Sansom Review, particularly those around a list of “permitted indications,” sponsors to publish evidence supporting claims, and a disclaimer on product labels and promotion stating that efficacy claims have not been independently assessed.

Dr Harvey also took aim at the TGA: “In October 2016, the TGA organised the first of several ‘targeted stakeholder forums’ on complementary medicine reforms.

“The TGA ‘forgot’ to invite a representative from either Choice or Friends of Science in Medicine (both of whom had been invited to the 2015 forums). After last-minute representations, I finally received an invitation to represent both these organisations

“At this latest forum, there were 14 people representing the complementary medicines sector.”

Dr Harvey writes that it is disappointing that no TGA staff member accepted an invitation to discuss these matters at the Australian Skeptics National Convention.

“My own view is that it is crucial to open the debate about the government’s response to the MMD recommendations beyond Complementary Medicines –TGA hegemony and obtain greater input from civil society,” he says.

“For example, the current TGA proposed list of ‘restricted indications’ contains many problematic entries, while only two industry bodies are in favour of abandoning pre-approval of advertising; most other stakeholders believe it should be extended and made more effective.

“If the TGA (and the government) is to regain the trust of the community with respect to the regulation of complementary medicines, then a more open debate about reform options is required.”

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7 Comments

  1. Ian Carr
    08/11/2016

    Bravo, Dr Harvey. The “light touch” TGA approach is a free kick for health fraudsters. While there may be many companies with a sincere (yet un-evidenced) desire to help us all into mega-wellness through supplements, there are many examples of outright health fraud in operation due to the slowness and inflexibility of the TGA’s complaints system and the absence of meaningful penalties. A Note to the Federal Treasurer: In the current market, the TGA would be self-financing on fines alone, were it to impose realistic penalties.
    In the meantime, we have a pharmacy sector ethically compromised. A recent AJP news article seemed to suggest that the major retail growth for pharmacies was in vitamins and supplements.
    The good name of pharmacy has been co-opted to give credence to unproven, overhyped rubbish.
    Pharmacy students are given excellent grounding in Evidence Based Medicine, yet they have to endure a retail environment where, in most instances, they have to turn a blind eye to the promotion of expensive placebos.

  2. Daniel Roitman
    08/11/2016

    Well-put.

    Ultimately, the only real winners are the CAM industry stakeholders and pharmacy owners while the real losers are the general public who are regularly deceived by those they have entrusted with their health care.

  3. William
    08/11/2016

    TGA do not want to touch these products with a barge pole. In most of the world they are not regulated but have been drawn into the regulatory circle years ago.
    If the marketers of this rubbish want to continue to sell these myths then they should be forced to put the products through the same stringent tests to gain proper meaningful chemical, purity, stability and clinical data as ethicals.
    The real shame is the unsuspecting public who fork out a fortune on these products.

  4. Mimimomo
    08/11/2016

    There is no truth behind this CMs, poorly regulated. There should be an organisation check on this claim and to make sure the ingredient that they use are clean of any dangerous bacteria or etc and of high quality. They cost more that scientific medication and i feel sorry for the company who spend and put extensive time to get real medication on the market. Some make money at the end of the patent some don’t. SAD!!, this bogus claim by some company saying this herbs do this and that herbs do that and get to sell it on the market. I think is is unfair. There should be an NGO monitoring this claim and the quality for this CMS!!

    • bill smith
      11/11/2016

      Show me a medication that was tested on sick people with comorbidities, then tell me if they really work. I read a piece by a person who was 12 years editor of the NEJM. words to the effect of “I would not trust a drug company’s published research results as far as I could kick them”.

  5. Ron Batagol
    08/11/2016

    I agree with everything that Ken Harvey has written. Frankly, I don’t care whether or not they regulate all of these varieties of complementary “jungle juice” in U.SA, Canada or lower Moldova! I care what happens here! And the fact is, as Ken Harvey has indicated, we have an appalling lack of legislative monitoring and oversight of complementary medicine products with a whole range of questionable health claims, that are allowed to be made, so long as the makers of these products “swear on a legislative and bureaucratic bible” that they have evidence to support their claims. And when knowledgeable people with appropriate expertise such as Ken Harvey try to work within the legislative and bureaucratic processes to try to encourage a greater level of proof and justification for these products, nothing seems to happen!
    I have two major concerns over this lack of overview and monitoring. Firstly, by relying on these products instead of seeking proper medical advice, the sick, elderly and even children or infants may miss out on vital medical treatment for an undiagnosed serious medical condition ( think undiagnosed prostate disease, severe acute respiratory disease in infants and children , or a whole range of progressive serious medical conditions).
    Secondly, at a time when the health “movers and shakers” seem to agree that pharmacists should work collaboratively with doctors to assist with managing chronic illnesses within the community, their stocking and sale of these products creates a poor image and does nothing to advance the development of remunerated pharmacist involvement in managing a range of minor ailments and assisting in the management of chronic conditions within the community, as has occurred overseas.

  6. Dr Ken Harvey
    10/11/2016

    The TGA has now produced a consultation paper outlining options for giving the advertising system more teeth. I encourage AJP readers to respond to the options put forward in this TGA paper.

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