Drug Company's Hearing Too Sensitive For Criticism

Tebonin Pharmacy PromotionOne of the marketing success stories in the world of herbal pills is the hype and advertising that has made Tebonin one of the big-time sellers. If you believe the ads, popping a Tebonin pill a day will relieve tinnitus (the ringing sound some people have in their ears), dizziness and even improve mental alertness. The promoters claim the drug, which is based on a patented extract from the ginkgo biloba tree, improves "impaired micro-circulation," reduces "free radicals" and "promotes optimum cell function."

According to the German manufacturer, Dr. Willmar Schwabe GmbH & Co KG, eight million pills are consumed every day. Schwabe, like so many companies in the herbal supplements sector, trades on its feel-good image. "From Nature, For Health," its website claims. That's the story the company wants you to hear. However, when a small group of Australian doctors and pharmacists, AusPharm Consumer Health Watch, drafted a report raising doubts about the benefits of Tebonin, they discovered a company that was not so warm and fuzzy. Soon after sending a copy of their draft report to the company, they were hit with a writ seeking an injunction that may bury their critical assessment forever.

Tebonin is already ranked as one of the top over-the-counter drugs in Germany and is widely available in the U.S., Japan and Europe. In April this year, Schwabe Pharma (Australia) Pty Ltd and its distributor, Natural Health Products Pty Ltd, launched Tebonin onto the Australian market. When major advertisements began appearing in the pages of Australian Women’s Weekly, New Idea and newspapers, AusPharm Consumer Health Watch wondered whether the scientific literature supported the claimed health benefits made in the gushing advertisements.

With their suspicions aroused, they drafted a report disputing that the pills are as effective as claimed. But controversy over the effectiveness of ginkgo biloba herbal products is nothing new. A 2005 review of clinical studies into ginkgo biloba, published in the Journal of Ethnopharmacology, concluded that "extracts are of little more use in the treatment of tinnitus than a placebo." (A placebo is an inactive pill used as a control in a trial to distinguish between the effects of the real drug and the reported effects of those who think they are getting the real thing.)

The three authors of the journal article, who were from the Department of Pharmacology and Toxicology at the University of Otago in New Zealand, concluded, "Treatments for tinnitus that do not have therapeutic efficacy not only waste money but can potentially prevent patients from seeking therapy that is efficacious. Furthermore, the unsupervised use of Ginkgo biloba extracts with other medications could lead to adverse side effects which are unnecessary and not justified in terms of therapeutic benefit." (Schwabe argues that their patented extract is different from other ginkgo biloba products. The company therefore claims the medical research disputing the efficacy of ginkgo biloba doesn't apply to its pills. However, this interpretation is disputed.)

While medical researchers debate the value of the extracts, the Australian companies promoting Tebonin wanted to prevent the publication of the AusPharm report. In early July, Federal Court of Australia Justice Andrew Greenwood granted a temporary injunction. While Greenwood envisaged the injunction would only be in force until a full trial, it now seems that the report will never see the light of day.

Justice Delayed Is Justice Denied

In their application, the companies claimed publication of the report would constitute "misleading or deceptive conduct" under the provisions of the Trade Practices Act and cause significant financial damage. They even wanted the court to restrain the group and its members from "otherwise engaging in criticism of the product Tebonin whether orally or in writing."

Central to the companies' claim was that the group should be treated as if they were a company engaged "in trade or commerce." It was ambitious argument. AusPharm Consumer Health Watch, like many community groups, is an informal group that is neither incorporated as a non-profit group nor as a company. Nor was there any evidence that it would gain any income from a report that would be published for free access on its website.

While agreeing that there was no "demonstrated discreet commercial arrangement between the operator of the site and a commercial party at present," Justice Greenwood claimed it didn't matter. As several of the principals in the group were also directors of for-profit pharmacy news and information websites that gained income from advertising, Greenwood suggested that in the future it was possible they could generate income from the AusPharm Consumer Health Watch report and website. To support this conclusion, he pointed out that one of the ten links from the group's website was to a for-profit website, Auspharmacist.net.au.

Greenwood optimistically decided that if the injunction were granted, the public interest could still be served by the government drug regulator, the Therapeutic Goods Administration, investigating the claims made in the draft report.

However, the simple act of the company serving a writ prompted seven of the group's ten founders to bail out. With the remaining three members having spent over A$15,000 out of their own pockets unsuccessfully trying to fend off the injunction, the prospect of burning tens of thousands more on an appeal or a full trial was too much to contemplate. Bowed and bloodied, the defendants have reluctantly proposed making the injunction permanent.

Donate to CMD!

What Justice Greenwood appears not to have understood was that as long as the matter is before the courts, the Therapeutic Goods Administration are obliged to sit on the sidelines. A regulation - known as Regulation 42ZCAJ - specifically prevents the agency from investigating a complaint, "if a proceeding has begun in a court about the subject matter of the complaint and the proceeding has not been finally disposed of." The Complementary Healthcare Council of Australia, which administers the self-regulatory code for herbal product marketers, won't investigate either, as long as the legal case is active.

Stopping the SLAPP-Happy

The Tebonin case illustrates how the legal system can work to the advantage of deep-pocketed corporations and why legal reforms are necessary to protect public interest advocacy groups. A group of public health professionals, who were only doing what the government regulator failed to do in the first place, have been deterred from raising legitimate questions over drug promotions. Greenwood's injunction has had the effect of forcing public-spirited citizens to surrender their legal rights, simply to clear the way for a government regulator to investigate whether the companies marketing claims stack up or not.

The only up-side to the injunction is that the heavy-handed approach of Tebonin's Australian promoters is likely to re-kindle debate over the need for legal reforms to protect public interest advocacy.

The Gunns 20The Wilderness Society in Australia, which is currently on the receiving end of a A$6.9 million SLAPP suit (Strategic Lawsuit Against Public Participation) brought by the logging company Gunns, argues for further legal protections in a recent report, Gunning for Change. (The Wilderness Society in Australia, which I worked for a little over a decade ago, and the Wilderness Society in the U.S. are unrelated groups). While the right of corporations to sue for defamation in Australian courts has been removed recently, Australian law still lags far behind that of the United States, where 25 states have passed anti-SLAPP statutes aimed at protecting the public right to participate in debate.

The infamous "McLibel" case launched by McDonald's, the Gunns 20 case in Tasmania, and now the Tebonin case all reveal the extraordinary fear that permeates the boardrooms of some companies. Their first reaction to public controversy seems to be to hit the speed dial button for their lawyers. It is an ultimately misguided response to questions being raised by citizens that care about the quality of the environment and public health.

Reading Justice Greenwood's judgment, one is left with the overwhelming impression that he missed the main game. If, as Tebonin's boosters claimed, the science was on their side, why were they so fearful of one small report issued by a small group in a far-flung corner of the planet? Or is it that the questions being raised were valid and had the potential to reach a far broader audience than a normal medical journal article ever would? And if that is the case, isn't that what democracy and science is supposed to be about - the testing of views and evidence by exposure to public debate?

Perhaps it is time that Schwabe dropped the "From Nature, For Health" guff from their website and substituted it with "From Schwabe, With Lawyers."


Bob Burton is the Editor of SourceWatch (www.sourcewatch.org) a project of the Center for Media and Democracy. SourceWatch is open to anyone interested in helping document and uncover public relations campaigns. SourceWatch volunteer contributors can help add to or edit the articles linked to above or any of the other profiles in the database. It's free to sign up, and we'd love to have you join us.

If you know of legal actions actions that have been threatened or taken against individuals or groups in Australia, please feel free to add to the list that is being compliled at SLAPP's in Australia.

An earlier version of this article was first published in the Australian magazine, New Matilda.

Comments

The case was recently settled on terms favourable to Schwabe Pharma (Australia) Pty Ltd and its distributor, Natural Health Products Pty Ltd. The settlement of the case now means that the Therapeutic Goods Administration and other bodies can investigate the concerns over the promotional claims. The court orders [http://esearch.fedcourt.gov.au/Esearch?showDoc=24867451 agreed to] included the following: 1. The respondents (and each of them by themselves, their servants or agents or otherwise howsoever) are permanently restrained from publishing on a website described as www.consumerhealthwatch.net.au or otherwise: (a) a report described as ‘Does Tebonin (Gingko biloba) provide relief in tinnitus?’; and/or (b) any document which is subsequently similar to the said report in purporting to critique as part of or emanating from a process of review of the product Tebonin applying the methodology as represented by the first respondent at a web page under the heading ‘About Us’ at a website described as www.consumerhealthwatch.net.au under the paragraphs bearing the headings ‘Background’ and ‘The Review Process’.

In November 2006 the Australian Complaints Resolution Panel determined that promotional statements about Tebonin made in print media and the internet breached the Therapeutic Goods Advertising Code. Schwabe Pharma Australia was requested to withdraw the advertisements from further publication and not use similar representations in the future. See also: Dowden J. Injunction impedes independent information Aust Prescr 2006; 29: 120. http://www.australianprescriber.com/magazine/29/5/artid/828 Harvey K. Injunction impedes independent information (letter). Aust Prescr 2007; 30: 33. http://www.australianprescriber.com/magazine/30/2/32/4#sub_471