Healthy Skepticism Library item: 18376

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: news

Creswell A
Untested remedies get TGA tick: Australian Register of Therapeutic Goods
The Australian 2010 July 10
http://www.theaustralian.com.au/news/health-science/untested-remedies-get-tga-tick-australian-register-of-therapeutic-goods/story-e6frg8y6-1225889563855

Full text:

GOT any aches and pains? How about stress? If the answer to either of those is yes — and, let’s face it, we’d be talking most Australians here — then the Australian Register of Therapeutic Goods is the place for you.

Though few Australians would have heard of it, the register is the officially sanctioned list of all the pills, potions, contraptions and devices that are allowed to be sold for health-related conditions. Its 50,000-plus entries cover the gamut of tried and trusted treatments: everything from paracetamol to chemotherapy, and from bandages and antiseptic wipes to height-adjustable trolleys and artificial joints.

But for those seeking something a bit more outre, the register offers more, so much, much more.

Along with dozens of herbs and potions promising to “nourish the fei” or “tonify the qi”, transform “turbid dampness”, nourish the blood or harmonise the “middle jiao”, peculiar gizmos are there aplenty. Try magnets.

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Some magnets offer to stimulate “energy meridians to aid stress relief”, while others claim to produce “a weak magnetic flux field . . . to potentially provide comfort or localised temporary relief of minor aches and pains”.

Or you can fork out for an “electro-acupuncture testing device” that measures the electrical resistance of the skin, in turn offering “the precondition for a bio-electronic regulation diagnosis”. Say what?

If you prefer to keep things a bit more bread-and-butter, you can go in for a spot of ear-candling, which involves sticking a hollow candle into the ear and lighting one end (hopefully not the end inside the ear), which claims to consume the build-up of ear wax, even though independent tests have never shown it to do anything other than burn the candle.

Needless to say, all of the above are denounced by experts as unproven at best and examples of bizarre pseudo-scientific babble at worst.

But under the present oversight arrangements, all can — and many do — lay claim to being “Therapeutic Goods Administration approved”.

It’s not a new problem but it has been thrust back into the spotlight by the federal government’s move last week to canvass options for stiffening the regulation of advertising and promotion of therapeutic goods, something critics have been calling for with increasing urgency.

Parliamentary secretary for health Mark Butler last week released two linked documents, one a position paper calling on the industry to develop stronger and more unified principles underlying their existing codes of conduct that place limits on the promotion of products to doctors and other health professionals.

“Doctors and other health professionals should prescribe drugs or medical devices because of the benefit to their patients, not because they could receive an incentive or a gift,” Butler says.

“If the industry cannot provide the tough self-regulation that consumers deserve, the Gillard government will have to bring in legislation.”

A second document, a consultation paper issued by the TGA, outlines plans to tighten advertising rules for therapeutic goods or products, which at present are different according to whether the product is available over the counter or by prescription only, and whether the advertisement appears in traditional media, online or in-store.

However, advocates of tougher regulation and a more effective complaints handling process are not confident the processes outlined are heading in the right direction.

Critics such as the Consumers Health Forum say advertising — typically print or broadcast commercials, although increasingly it takes more subtle forms — is but one aspect of promotion, which ranges from drug-branded pens sent to doctors to the provision of luxury trips and even cruises.

As such, they say one code should be devised to cover it all, with one complaints and appeals system to replace the present kaleidoscope of processes run by different industry bodies.

Ken Harvey, adjunct senior lecturer in public health at La Trobe University and a longstanding critic of the existing systems, has already sent the government a response that questions its faith in industry self-regulation, which Harvey says has “proven to be weak and self-serving”, as well as an apparent lack of plans to consult consumers and health professionals about the changes.

Harvey also challenges a “focus on the promotion of so-called ‘higher-risk’ medicines and medical devices to health practitioners, which ignores the fact that most of the problems in this area come from the promotion of ‘lower-risk’ complementary medicines and medical devices to the general public”.

Harvey says he is regarded as a serial complainant after bombarding the TGA, the peak pharmaceutical industry body Medicines Australia and the Complaints Resolution Panel, which handles complaints on the promotion of over-the-counter products, with files detailing alleged infringements in recent years.

He says while the CRP diligently processes complaints and often upholds them, it “has no power . . . with the result that 40 to 50 per cent of sponsors thumb their nose; requests for retractions weren’t obeyed, requests to desist weren’t obeyed.

“The TGA should step into the breach, but the TGA is a black hole that tells no one anything, and there’s no evidence they do anything, although they tell people they do,” Harvey says.

Another critic is former Australian Skeptic of the Year Loretta Marron, who says the lax oversight means “the internet is now flooded with incorrect information on therapeutic goods, many of which are TGA-approved”.

“The old drover’s dog can get an application approved,” she says. “The two victims of the self-regulatory system are consumer health and truth.”

She and Harvey contend much of the problem with the so-called lower-risk complementary therapies — for example, the array of herbal treatments such as FatBlaster and Xantrax that claim, on flimsy evidence, to help people lose weight — is that TGA listing implies official approval that the product works, when no such appraisal is made.

In contrast to prescription-only drugs, over-the-counter treatments such as these can be listed on the ARTG for a reduced fee, with the only proviso being that sponsors hold evidence supporting the claims made for the product (which are only allowed to be general in nature).

But random checks to verify such evidence is held cover less than one-third of products, and the evidence can still be little better than questionable.

Harvey says the regulation and complaints system is malfunctioning partly because the advertising complaints process is being asked to pick up the pieces caused by the TGA’s failure to police claims properly at the outset, a task for which any advertising complaints process is ill-suited.

The complementary medicines industry accepts the system can be improved, but supports a self-regulatory approach.

Wendy Morrow, executive director of the Complementary Healthcare Council, says the “regulatory system is working, but there are issues with parts of it; the best example is the length of time a complaint takes to move through the system.”