TGA effectiveness questioned

A number of recent decisions by the Therapeutic Goods Association, the body tasked with establishing and maintaining a “national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods”, have been criticised as being ineffective or neglectful of the needs of consumers.

The ongoing saga of the supposed ‘weight loss’ product SensaSlim and its management has taken a turn, with Ken Harvey, the subject of defamation cases from the company, revealing that the company’s UK operation is selling the product, sourced from Australia, via a number of international web sites.

Harvey shows that monies paid for ordering this product from a UK-based web site go to Liana Emberg, based in the Gold Coast, who is alleged to be associated with Peter Foster, who in turn has been previously convicted of fraud and recently named in Federal Court orders obtained by the Australian Competition and Consumer Commission (ACCC).

Harvey says “It seems unconscionable that, despite Federal Court orders and the recent determination by the TGA’s Complaints Resolution Panel … this product continues to be promoted and exported internationally from Australia by the people behind this scam.”

Harvey goes on to ask “Why cannot the TGA use its powers under section 30(2)(e)) of the Therapeutic Goods Act 1989, ‘Registration or listing may be cancelled if the goods do not conform to an applicable advertising requirement’, to remove this product from the Australian Register of Therapeutic Goods (ARTG) and thus make the continued sale and export of SensaSlim illegal?”

It has also been revealed that the TGA has listed 13 suspect devices on the ARTG in the past week. Loretta Marron, who has spent years tracking down such devices, says that seven are holographic devices, five are ‘energy patches’ and another is a transcutaneous electrical nerve stimulation (TENS) device.

Among the ‘energy patches’ are Lifewave, a “non transdermal adhesive patch” (basically a piece of gauze), and holographic energy bracelets called CieAuru, which are similar to the Power Balance wristbands recently proved to be useless and consequently withdrawn from the market following action by the ACCC.

The process of having a product listed on the ARTG is based on an honesty system where sponsors type in their product, select the ingredients from a pre-approved list and pay a fee (<$1000). The result is an official looking L number for the product and a listing on the official government list of medical devices. No evidence to prove the efficacy of the product is required.It may, however, be that the Lifewave patches have been cancelled from the ARTG and the CieAura bracelets are under investigation. In the meantime, such people as Marron, Harvey and organisations such as Australian Skeptics play what Skeptics vice president Dr Rachael Dunlop describes as “a continuous game of whack-a-mole with the TGA”.The third issue concerns Nurofen, an ibuprofen based pain killer, which the local distributor, Reckitt Benckiser Australia, claims “targets relief from pain” and “goes straight to the source of pain”.In fact, the product does attack pain, but across the body rather than targeting specific sites. Choice gave a Shonky Award last year to Nurofen for its various versions, all claiming to target different parts of the body but all containing the same ingredients and dosages.

A complaint was lodged with the TGA’s Complaints Resolution Panel against the makers of Nurofen and, according to Australian Doctor magazine, Reckitt Benckiser Australia was ordered by the Panel to withdraw a television advertisement for Nurofen’s targeted pain relief.

“However”, the magazine says, “in a statement, Reckitt Benckiser said it did not agree with a number of the sanctions imposed by the TGA panel and therefore: ‘Nurofen advises that consumers will continue to see the familiar branding of the Nurofen target and messages of Nurofen working at the site of pain. This branding includes TGA approved claims on packs that Nurofen provides targeted relief from pain.’

Basically, the company has simply ignored the TGA’s directive.

A recent audit of the TGA’s management of complementary and alternative therapies essentially described the TGA as having no teeth to enforce rulings against companies who do the wrong thing.

In its defence, the TGA says that the relevant legislation will not empower it to do more than make directives, many of which, as the SensaSlim and Nurofen cases indicate, are ignored by some in the alternative and ‘traditional’ medicine industries.

As Dunlop says, “It’s worth noting that Nurofen is a registered drug, not a listed one, so stricter rules apply when it comes to regulation of what’s in it and whether it works. With AUST L (listed) drugs, for example, companies or ‘sponsors’ are not required to present evidence of safety and efficacy before they are rubber-stamped for sale by the government. However AUST R (registered) drugs – of which Nurofen is one – are.”