Drug company’s hearing too sensitive for criticism

The chances are that while flipping through the pages of Australian Women’s Weekly, New Idea or a newspaper during May you came across gushing advertisements for the complementary health pills, Tebonin.

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 improves impaired micro-circulation, reduces free radicals and promotes optimum cell function.

What you haven’t heard is that a group of doctors and pharmacists, AusPharm Consumer Health Watch, were so sceptical that they drafted a report disputing that the pills are as effective as claimed. Nor are you likely to hear why they came to that conclusion.

Tebonin is a product based on an extract from the deciduous tree ginkgo biloba, which has been patented by the German company, Dr. Willmar Schwabe GmbH & Co KG. In Australia, Tebonin is imported by Schwabe Pharma (Australia) Pty Ltd and distributed by the Gold Coast-based company, Natural Health Products Pty Ltd.

Controversy over the effectiveness of ginkgo biloba herbal products is nothing new, but the Australian companies sought an injunction from the Federal Court of Australia to prevent the publication of the AusPharm report. In early July, Justice Andrew Greenwood agreed. While the injunction was intended as only a temporary measure until a full trial, it is likely to have the effect of burying the report forever.

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 or 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 websites, Greenwood suggested that in the future it was possible they could generate income from the report and website. To support this conclusion he pointed out that one of the ten links from the group’s website was to one of the for-profit websites.

Greenwood optimistically decided that if the injunction was granted the public interest could still served by 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 $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.

What 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 under their act 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 Health Council, which administers the self-regulatory code for herbal product marketers, won’t investigate either as long as the legal case is active.

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.

The Wilderness Society, which is currently on the receiving end of a $6.9 million legal action brought by the logging company Gunns, argues for further legal protections in a recent report, Gunning for Change. While the right of corporations to sue for defamation has been removed recently, Australian law still lags far behind that of the United States, where 25 states have passed legislation aimed at protecting the public right to participate in debate.

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.

References :

Tebonin website

Justice Andrew Greenwood’s judgement