Healthy Skepticism Library item: 7061

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Burton B.
Regulator finds advertising of complementary product "misleading".
BMJ 2006 Dec 2; 333:(7579):1141
http://www.bmj.com/cgi/content/full/333/7579/1141-b

Abstract:

The Australian regulator of the drug industry has found that the company Schwabe Pharma (Australia) breached standards for media advertisements when it promoted the complementary medicine Tebonin.

Tebonin, which is an extract of ginkgo biloba, is manufactured by the German company Dr Willmar Schwabe, which claims that eight million Tebonin pills are consumed globally each day.

In July, the company’s Australian subsidiary managed to suppress publication of a report by AusPharm Consumers Health Watch, a watchdog made up of pharmacists and academics (BMJ 2006;333:116, 15 Jul).

Before the injunction preventing publication was granted, the watchdog forwarded a copy of its report to Australia’s drug regulatory authority, the Therapeutic Goods Administration (TGA), for investigation by its complaints resolution panel.

The administration did an audit to assess whether the evidence provided by Schwabe supported the approved indications for the product, but it has refused to release the audit because it is “commercial, in confidence.”

In November, the panel determined that it was “misleading” of the company to claim that the overwhelming scientific evidence found the extract was effective in relieving the symptoms of tinnitus. Instead, it concluded that the evidence only supported the claim that Tebonin may provide relief from the symptoms.

The panel also found misleading the company’s claim that “scientific evidence for Tebonin is extensive, unequivocal, of exceptional scientific quality, and not subject to any serious question.”

Despite upholding key elements of the complaint, the panel recommended only that the advertisements be withdrawn.

The Complementary Healthcare Council of Australia, the body that represents the complementary products industry, also found that an advertisement for Tebonin breached a provision of its self regulatory code of conduct by not including the name of the manufacturing company. But the council didn’t share the regulatory authority’s concern that the claimed scientific benefits of the supplement were being overstated.

One of the complainants, Ken Harvey, from the School of Public Health at La Trobe University, believes the case highlights excessive secrecy and serious flaws in the existing regulatory system.

“It shouldn’t take a complaint from the public for the TGA to discover that the evidence for a product doesn’t support the marketing claims. Nor is simply requiring the withdrawal of the advertisement an adequate response to consumers being misled,” he said.