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Tinnitus 'cure' ads banned

Wed 22 November

A widely promoted ginkgo product, Tebonin, has had its advertisements banned after claiming it provided relief from tinnitus.

The decision by the Therapeutic Goods Administration is vindication for evidence-based healthcare advocates whose report on the Tebonin claims was suppressed by litigation from the manufacturer.

Schwabe Pharma has now been instructed to withdraw its advertisements for Tebonin and to stop making claims that the ginkgo product is supported by extensive scientific evidence.

 
Consumer advocates have been successful in challenging the promotional claims made for the ginkgo biloba product for tinnitus.
 

Dr Ken Harvey, one of the authors of the suppressed AusPharm Consumer Health Watch report said the TGA decision was welcome, but the difficulties his group encountered showed the process of challenging scientific claims for OTC products was flawed.

“This case … shows the current system has grave defects. There is a need for an independent, transparent, one-stop-shop for complaints about [TGA] listed products,” said Dr Harvey of the School of Public Health at Latrobe University.

Dr Harvey and his colleagues faced legal bills of more than $15,000 after the manufacturer took out an injunction on their report into the evidence base for Tebonin’s claims.

He said the current system allowed questionable products to continue advertising while crucial data was kept secret due to “commercial-in-confidence” considerations.

And industry bodies such as the Complementary Healthcare Council took no action against inappropriate promotion, he noted.


22 November 2006
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Latest Comments

  • This report is misleading.

    The CHC/TGA ruled that certain words had to be changed. It did not ban the advertisements, per se.

    Also, Schawbe continues to offer copies of scientific papers to anyone who asks for them.

    I asked and I received.

    I also question the conclusion reached by both the Cochrane Collaboration and AusPharm.

    So far as I have been able to determine, the Cochrane Collaboration looked at Ginkgo biloba in general, not Schwabe's patented extract EGb 761.

    To compare raw or generic Ginkgo biloba with EGb 761 could be likened unto comparing willow bark with Aspirin.

    You can chew willow bark all day and say that it does not relieve pain, but to say that Aspirin does not relieve pain is obviously ridiculous.

    I believe that the same thing has happened with the treatment of Ginkgo biloba and EGb 761.

    Schwabe has sent me reports that come to hundreds of pages, most of which have been published in reputable journals.

    Several of the studies make a point of mentioning that EGb 761 is very different to raw Ginkgo biloba and even other preparations made from Ginkgo biloba.

    To accept the position of the Cochrane Collaboration and AusPharm that EGb 761 does not work would be to call scores of reputable scientists and doctors either incompetent or liars.

    I believe that, in a spirit of fairness and a search for the truth, both the Cochrane Collaboration and AusPharm should look specifically at EGb 761.

    Unless these dozens of scientists and doctors are either all fools or liars, the evidence is overwhelming that EGb 761 does everything that Schwabe claims of it.

    Posted by Carl D. Thompson 5/12/2006 4:44:06 PM

  • I do not believe that the 6 minute report was misleading.

    I encourage those interested in this issue to read the full determination from the link provided above.

    The independent Complaint Resolution Panel (CRP) who investigated alleged breaches of the Therapeutic Goods Advertising Code by Schwabe Pharma Australia Pty Ltd concluded that promotional statements about Tebonin (EGb761):

    1. Were not correct and balanced;

    2. Were likely to arouse unwarranted and unrealistic expectations of the products effectiveness;

    3. Misled directly or by implication or through emphasis, comparisons, contrasts or omissions, and

    4. Presented scientific information in a manner that was not accurate, balanced and not misleading.

    Accordingly, Schwabe Pharma were requested to withdraw the advertisements, including the website material, from further publication.

    A recent New Zealand review [1] summarised the present state of knowledge about Ginkgo biloba extracts for tinnitus as follows: “Some clinical trials have yielded positive results, however, these studies are few and have been limited either by design flaws, the small size of the significant effects, or else the results have not been published in peer-reviewed journals and therefore the quality of the research is not assured. By contrast, the two most systematic clinical trials, both double-blind and placebo controlled, and published in respected peer-reviewed journals, have yielded negative results and suggest that Ginkgo extracts are of little more use in the treatment of tinnitus than a placebo”.

    Finally, well conducted clinical trials of Ginkgo biloba use standardised extracts of the herb. EGb761 contains 24% ginkgo flavone glycosides and 6% terpenoids while LI 1370 which was used in the largest double-blind, placebo controlled trial mentioned above (with a negative result) contained 25% ginkgo flavone glycosides and 6% terpenoids.

    References.

    1. Smith PF, Zheng Y, Darlington CL. Ginkgo biloba extracts for tinnitus: More hype than hope? J Ethnopharmacol. 2005; 100: 95-9.

    2. Drew S, Davies E. Effectiveness of Ginkgo biloba in treating tinnitus: double blind, placebo controlled trial. BMJ 2001; 322: 1–6.

    Posted by Dr. Ken Harvey 6/12/2006 12:47:47 PM

  • All I can state is that I have just started my 6th box of tebonin. It has reduced the intensity of my tinnitus greatly but not taken it away. I stopped taking it after box 4 and the tinnitus just kept increasing each day for a 2 week period, and I restarted. Whether it works by mental or physical, I will continue to take it until something better comes on the market. (I also take Magnesium cramp bark formula with the tebonin as recomended by the natrupath at the shop).

    Posted by Errol Rains 23/12/2006 9:58:43 PM

  • This is a very important subject, truth and the customer must come first. Suppressing valid reports is unacceptable.

    Posted by Fred Schwacke 6/03/2007 8:26:00 PM

  • I would just like to say that i had used Tebonin before for a period of 3 Months.

    It seemed to reduce the effect but i was not too sure.

    However i stopped taking it and have now noticed that the Ringing in the Ears is definately worse than before.

    (stopped for 6 weeks now)

    So on this trial basis i truly believe that Tebonin does work to a certain extent and i will be returning to it as of Tomorrow.

    THANKS TO THE INVENTOR!!Fred Schwacke

    Regards

    Vernon

    Posted by V A MacDONALD 16/05/2007 3:41:00 PM

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