Thursday, July 27, 2006

This Is Not A Post About Tebonin's Efficacy

EoR has previously blogged about Big Altie Pharma's use of the legal process to suppress information it considers unfavourable.

It appears Schwabe Australia has achieved its goal.

Aiming to "help consumers make informed choices about these (non-prescription health-related) products", the [AusPharm Consumer Health Watch] founders worked out a process for gathering evidence on a product's effectiveness both from the product's makers and independently. They would then assess the strength of the evidence, and seek further comments before coming to a conclusion about the extent to which the claims made by the makers could be substantiated. But the website now faces an uncertain future after Schwabe Australia successfully took it to the Federal Court to suppress a report being prepared on the firm's herbal remedy for tinnitus, Tebonin. The site's 10 backers had already shrunk to three in the face of the growing legal threat, and the remaining trio are now preparing to capitulate after paying $15,000 out of their own pockets in an unsuccessful bid to oppose the temporary injunction banning publication of their report. It is understood the three are willing to agree on the injunction being made permanent in exchange for Schwabe dropping the case. The company had objected to the process by which the report was drawn up, as well as to its assumptions and conclusions.

As a result, it appears complementary medicines will continue to be listed by the Therapeutic Goods Administration under a notedly laxer system than pharmeceuticals.

According to the TGA, "most, but not all" complementary medicines are considered lower risk - meaning they only have to be "listed" on the register. While they still have to meet quality and safety requirements, they are not evaluated for effectiveness before they go on sale - in other words, there is no independent test to check if they are any good for whatever complaint the manufacturers are selling them for.

Consumer magazine, Choice, is also backing AusPharm.

Choice media spokeswoman Indira Naidoo said consumers "definitely want the TGA to crack down" on the sale of complementary medicines. "A lot of consumers do not realise that a lot of complementary medicines sold on the market do not have enough evidence, we believe, to support the claims made for them," she says. "They are very rarely asked to produce evidence and research material to support the claims they make about their products. Many consumers assume that because a product is available, that it does what it says. That's not the case."

Alties constantly complain about the pharmaceutical industry, citing suppression of unfavourable results, control of the market, and extending into various unsupported conspiracy theories, but it seems the alternative manufacturers are no better. If the evidence was there, wouldn't they be glad to show it?


  1. Anyone interested in this case can read the reasons for judgement at:

    Points of interest are:
    1. The judge accepted an argument by the company's inhouse doctor: "...different extracts of Ginkgo biloba or any other plant extract can never be the same in terms of efficacy and cannot be compared." (thus excusing Ginkgo product EGb761). This claim is contentious.

    2. The judge wasn't interested in the efficacy claims of the product because he said the public interest can be served through complaints to the Therapeutic Goods Regulations. However, here lies a Catch 22. The Therapeutic Goods Regulations panel cannot deal with a complaint if a proceeding has begun in court; or after a complaint has been made to the TGR, a proceeding begins in court, until after it has been finalised:

    Thus a company can stall criticism and enjoy a lengthy period to run promotional campaigns, while the court process creeps along.

  2. I've been reading (with more care) the judge's explanations - worth the trouble if you can bear it. Seems it is impolite/libellous to request confirmation of legitimacy of pre-clearance approval numbers endorsed on Big Altie's print advertisements. To question authenticity is apparently worse than fraud itself. Also having a link on your website to another website that carries paid advertising exposes you to the Trade Practices Act. Nasty.


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