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8 Comments

  1. 1

    jp

    The TGA in 2003 was prepared to go through the complementary medicine manufacturing industry with a fine tooth comb following adverse reactions to Travacalm (a herbal based anti-nausea medication) produced by Pan Pharmaceuticals.

    It became known as the Pan Scandal and for weeks our newspapers were filled with lists of thousands complementary medicines that had been removed from the shelves of health-food shops, chemists and supermarkets. The entire complementary medicine industry was thrown into disrepute. The TGA showed no concern for third party business.

    In 2008 Australia’s largest Federal Court settlement to date, saw Pan Pharmaceuticals paid $55 million from the Commonwealth.

    Now, 6 years on from the Pan scandal, we have a situation where a herb is being substituted with less active ingredients and the TGA is doing nothing. Ginkgo biloba is a well studied herb with evidence supporting its effectiveness in certain cognitive conditions. The adulteration of this herb has been known since at least 2005.

    Consumers are now left wondering whether the products they have consumed in a hope to enhance their health have had any affect at all, or worse, could they be tainted and potentially negatively impacting their health.

    Reading between the lines, this suggests that the TGA is once bitten, twice shy and has chosen to protect the financial interests of third parties over the financial and health interest of consumers.

    Who makes these decision? What is the criteria?
    Either the decision to the severely disrupt the pharmaceutical and complementary medicine industry in 2003 was wrong and ill-conceived or, the current decision, to ignore the public and protect the industry is wrong and ill- conceived.

    A consistent and transparent decision making process should be the minimum standard the public should expect from the agencies empowered to protect them.

    Reply
  2. 2

    Ken Harvey

    The TGA said,

    “While presented as a consumer interest matter, this issue appears to have been raised to allow certain companies to attempt to gain a commercial advantage by claiming other products are not meeting standards that are not actually part of Australian regulatory requirements”.

    I resent and reject this implication by the TGA. In the course of protracted correspondence about this FOI request the TGA have asked whether I would gain any pecuniary benefit from my inquiry. I stated that I would not. I have no financial arrangement, consultancy or any other relationship with companies producing complementary medicines.

    The fact remains that adulteration of Ginkgo biloba has been known to be a common problem since at least 2006. Neither the TGA or industry has taken any action on this matter until my original FOI request was made. Neither the TGA or industry has spelled out the date when sponsors will be required to implement a test equivalent to USP Identification Test B. Meanwhile, consumers are being financially disadvantaged by products that are misleading, deceptive and not true to label and sponsors who source genuine (more expensive) Ginkgo are being disadvantaged in the market place.

    For the TGA to say that, “no products breached applicable Australian standards at the time of testing” is a sad reflection of the failure of the TGA to set appropriate standards for the quality of herbal medicines. Other countries, such as Germany, have done this long ago.

    Dr. Ken Harvey
    Adjunct Senior Research Fellow
    School of Public Health | La Trobe University

    Reply
  3. 3

    peter

    The TGA in this instance seems to be prepared to protect the companies selling adulterated or substandard products, since it is not prepared to publish the results of the testing of ginkgo products. What a disgrace! My understanding is that the TGA exists to protect the public, not to collude with fraudsters, which in effect is what seems to be happening.
    Perhaps, because the adulterated products are not killing anyone, then they are not particularly concerned. But what other body is there to ensure that the people who benefit from ginkgo are not being ripped off? Ginkgo is an important herb for some people.

    Reply
  4. 4

    Jonathan Wardle

    Adulteration and quality issues are one area in which current regulations are woefully inadequate. To their credit, the TGA has implemented a regulatory framework that is world-leading, though this is sadly reflective of the world’s failure to understand the complexity of CAMs than an opportunity to rest on our collective laurels.
    The TGA is probably correct in focusing on issues of GMP in its initial development of guidelines, as these were the issues that directly affected public safety at the time, though now these seem in place it needs to address the issue of therapeutic quality as well. As Ken Harvey rightly points out, this is an area other nations have already moved towards. Even are wine-growers are more proactive in quality control of natural products. If it’s good enough for our alcoholic indulgences, surely it’s good enough for our medicines?
    The development of appropriate policy and procedures is essential. The TGA does in many respects seem ‘once bitten, twice shy’ about complementary medicines but not creating policy is not the answer. In fact I have already written that the reason the TGA was bitten in the first place was its failure to pre-empt CAM policy requirements and when these became necessary it had to fumble, making policy and rules up on the fly, with disastrous consequences (http://www.crikey.com.au/2008/08/19/pan-fiasco-was-entirely-preventable/).
    The fact is that CAM has enormous potential in Australian healthcare, but until appropriate regulations and policy are in place, it will be unable to live up to this potential.

    Jon Wardle
    School of Population Health, University of Queensland

    Reply
  5. 5

    ron batagol

    Ken Harvey wrote:

    On 01/10/2009, I received a letter from the TGA refusing my FOI request on the grounds that the documents contained information that:

    * could adversely effect business (of third parties) if disclosed;
    * if disclosed could prejudice the future supply of information from industry.”

    Now, let me see if I understand this- TGA had found that a random sample of 20 Australian herbal products containing Ginkgo biloba had failed United States Pharmacopoeia (USP) Identification Test. Ken Harvey writes to request the brand and sponsors names of the 20 products tested and the identification of those products that passed and those that failed USP Identification Test. After a lot of stonewalling, he gets the reply he can’t get that information under FOI, because such information could adversely affect business (of third parties) if disclosed; and, if disclosed could prejudice the future supply of information from industry.

    So, what’s the plain, simple take-home message from all of this? I think it goes something like this-

    If you make a dodgy product, the Regulator won’t tell anyone, because it may affect your Business, and, (wait for it folks!)- if they do tell anyone, you might stop co-operating with the said Regulator- (not that it appears that co-operation to date has been what you might call a roaring success, since apparently some manufacturers seem to be still out there making and selling said dodgy products!)

    Now, I wonder why the Monty Python Ministry of Silly Walks suddenly spings to my mind at this point!!!!

    You’re right Ken -it’s absolutely blood outrageous!!

    But, hey- then again, what else do you expect from a National Health Regulator that turns a blind eye to the continued peddling of shonky homeoprophylactic “vaccines” around the countryside!

    Ron Batagol

    Reply
  6. 6

    Natural Health Products

    Natural Health Products (NHP) is the Australian sponsor of a German-made Ginkgo biloba product called Tebonin EGb 761, which complies with the strict German Commission E standard as well as the World Health Organisation standard.
    Our product was one of the 20 tested by the TGA and we would like to see the results made public.
    Tebonin EGb 761 is the result of a 27-step process of extraction and standardisation. During the proprietary production process, the compounds that contribute to the product’s efficacy are enriched by a factor of up to 100, while any components that don’t contribute to the efficacy are eliminated – resulting in the highest quality product. A tonne of the raw Gingko biloba leaves yields just 20kg of EGb 761.
    EGb 761 consists of 24 per cent flavones glycosides, six per cent terpene lactones and less than 5ppm ginkolic acids, as required by the German Pharmacopoeia (DAB) monograph.
    A study published in the Journal of the American Medical Association showed that Tebonin EGb 761 was in a class of its own among Gingko biloba products. Meinhard Kieser, co-author of the study, wrote: “Previous research comparing EGb 761 against other extracts showed that only EGb 761 increased activity in all areas of the brain.”
    Tebonin EGb 761 has over 600 published studies to support its many applications. Currently Tebonin is sold on the Australian market to help improve mental performance, cognitive function, micro circulation and help relief the symptoms of tinnitus and vertigo. Tebonin is also used in many other countries as a first line treatment for more serious health issues.
    Clearly Ginkgo biloba adulteration is a public interest issue because consumers have a right to know what products are adulterated
    and what are not. Equally, this is also an issue for sponsors that source the more expensive genuine herb.
    John D. Waitzer
    Managing Director
    Natural Health Products.

    Reply
  7. 7

    rachaeldunlop

    I have made complaints to the TGA about the Homeopathy Plus website with respect to homeoprophylaxis. After several months and no correspondence, I found my complaint in the too hard basket of the CRP classified as “not in our jurisdiction”. The TGA is about as useful as an ashtray on a motorbike in my experience.

    Dr Rachael Dunlop (PhD)

    Reply
  8. 8

    Ken Harvey

    John D. Waitzer, Managing Director, Natural Health Products (NHP) said:

    NHP is the Australian sponsor of a German-made Ginkgo biloba product called Tebonin EGb 761, which complies with the strict German Commission E standard as well as the World Health Organisation standard.

    Agreed!

    Currently Tebonin is sold on the Australian market to help improve mental performance, cognitive function, micro circulation and help relief the symptoms of tinnitus and vertigo.

    I do not agree that all these indications are supported by good evidence!

    There is good information about the use of Ginkgo online at Medline Plus (U.S. National Library of Medicine), see: http://www.nlm.nih.gov/medlineplus/druginfo/natural/patient-ginkgo.html

    This evidence-based monograph states: “There is conflicting research regarding the use of ginkgo for tinnitus. Additional well-designed research is needed in order to resolve this controversy” and “A small amount of poorly designed research reports benefits of ginkgo for the treatment of vertigo. Additional study is needed before a recommendation can be made.”

    See also: http://www.sourcewatch.org/index.php?title=Tebonin

    Dr. Ken Harvey
    Adjunct Senior Research Fellow
    School of Public Health | La Trobe University

    Reply

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