Laurie Ferguson (Reid, Australian Labor Party, Shadow Minister for Consumer Affairs) Share this | Link to this | Hansard source

I seek to raise the issue of the abuse of power which a few pharmaceutical companies have engaged in and the seeming inability of the regulator to adequately respond. During the June Senate estimates hearings, my colleague Senator Forshaw raised the issue of the marketing of the over-the-counter tinnitus relief drug Tebonin. Unfortunately, the responses from the TGA and the Department of Health and Ageing were inadequate to say the least. The Tebonin pack and current promotional materials state that Tebonin, containing a unique extract of ginkgo biloba, has been shown, through clinical research, to be an effective treatment for a range of conditions, including tinnitus and vertigo. A number of consumer advocates, including Dr Ken Harvey and Mark Dunn, were concerned about the marketing and claims made. AusPharm Consumer Health Watch sought to publish a paper refuting the claims made by the drug maker. Unfortunately, the manufacturer took out a court injunction which prevented the publication of their analysis.

The paper, which has now been published, makes the following claims. The authors of a number of recent scientific reviews have not been convinced that ginkgo biloba provides more relief for tinnitus than a pill without active ingredients—in other words, a placebo. The Australian suppliers of Tebonin were approached and asked to supply information about the efficacy of Tebonin. A thorough research of the scientific literature was then conducted by AusPharm Consumer Health Watch, and the papers found were also reviewed. The TGA was contacted to determine what claims for Tebonin were listed on the Australian Register of Therapeutic Goods and whether these claims had been submitted to independent verification.

The Australian distributors provided two papers to support their claims that it provided relief and/or was an effective treatment for tinnitus. One paper was published back in 1997 and in their opinion was of poor quality. The other paper was published in 2000 and provided an uncritical review of earlier work. Both papers came to conclusions that differed from more recent independent reviews.

Schwabe Pharma Asia Pacific Pty Ltd provided three additional papers published in 1997, 1999 and 2002. In the reviewing author’s opinion, the statistical analysis of the 1997 paper was poorly performed and the author’s conclusion that it provided greater relief than a placebo was not justified. The 1999 paper reported a trial that administered Tebonin intravenously in hospital followed by oral treatment. In their opinion, this research is not relevant to the treatment of tinnitus with an over-the-counter product. The 2002 paper was a review of earlier studies and concluded:

Overall, the results of these trials are favourable to ginkgo biloba as a treatment of tinnitus, but a firm conclusion about its efficacy is not possible. At present, the body of evidence is small. More trials are needed to test the therapeutic value of ginkgo biloba for relieving tinnitus.

Tebonin will cost consumers approximately $30 to $80 per month to use, although this will vary depending on the dose and the place and time of purchase. In the reviewer’s opinion, a product that appears to be no more effective than a placebo does not offer value for money.

After a long and protracted complaints process, which was greatly delayed by court proceedings, the Complaints Resolution Panel, who investigate alleged breaches of the Therapeutic Goods Advertising Code, found that the website and print advertisements were in breach of sections 41(b), 42(a) and 42(c) of the code. The CRP has no jurisdiction over similar complaints about statements on the product pack, packet insert, pharmacy posters et cetera. The CRP requested Schwabe Pharma Australia Pty Ltd in accordance with subregulation 42ZCA1(1) of the Therapeutic Goods Regulation 1990:

(a)

to withdraw the advertisements, including the website material, from further publication;

(b)

to withdraw the implied representations that the scientific evidence for Tebonin is extensive, unequivocal, of exceptional scientific quality and not subject to any serious question, and that Tebonin is supported by an overwhelming positive body of evidence;

(c)

not to use the representations in (b) in any further advertisement unless Schwabe Pharma Australia Pty Ltd satisfies the panel that the use of the representations would not result in a contravention of the ... Act ...

In a letter to my office, Dr Ken Harvey argued:

While this outcome vindicates those who submitted the original complaints, the need to submit the complaint to three different bodies, the delays involved due to litigation and the varied responses of individual regulators highlight a number of deficiencies in the regulation of ‘listed’ therapeutic products. These include:

1.

Regulation 42ZCAJ of the Therapeutic Goods Regulations which meant that the complaints had to be set aside pending resolution of litigation ...

2.

Commercial-in-confidence considerations of the Office of Complementary Medicines of the Therapeutic Goods Administration concerning claims made on the product pack, package insert and ARTG—

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