Healthy Skepticism Library item: 20564

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

Corderoy A
War of words on potions and pills continues
The Sydney Morning Herald 2013 May 12
http://www.smh.com.au/national/health/war-of-words-on-potions-and-pills-continues-20130511-2jely.html

Abstract:

Views on complementary and alternative medicines – as many and varied as the products themselves – include strong opposition to the way products can be marketed without external evaluation.

Full text:

Ken Harvey may well be a sucker for punishment. That’s not my assessment – it’s his.
“No one in their right mind would spend the time or effort needed to complain about these products,” the Adjunct Associate Professor in the school of public health at La Trobe University says.
He’s talking about complementary and alternative medicines. And he has complained about them – a lot. In the past three years he has made 43 complaints to Australia’s drug regulator, the Therapeutic Goods Administration (TGA), about dodgy products.
Of the complaints that have been assessed by the TGA’s complaints resolution panel, all have been upheld.
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Of the nine yet to be assessed, a third have been waiting more than a year.
Harvey estimates he spends between two and four hours preparing each complaint.
That’s a lot of time, and a lot of waiting. In the process he has become the last line of defence against all manner of products which are marketed with little evidence of efficacy.
Harvey says the current system lets dodgy medicines on to the market too easily, with companies allowed to “list” products on the register of therapeutic goods without external evaluation.
“The end result is a market flooded with shonky products, making it very difficult for consumers, and health professionals, to pick the small amount of evidence-based wheat from the voluminous hype-driven chaff,” he says.
The world has a long history of salesmen selling a cure for whatever ails people. And today, as in the past, business is booming.
“It’s no secret that it’s a $2 billion business and there are more than 250 companies in Australia selling these products,” says Nick Williams, a healthcare consultant at Roy Morgan Research. About 7 million people are swallowing a huge range of products from fish oil to multivitamins and echinacea. Some have been used for centuries. Early clinical trials indicate that a few have the potential to be developed into effective treatments.
Williams is fascinated by the different motivations people have for using complementary and alternative medicines.
“One of the things that emerges is that people who are using complementary medicines aren’t necessarily interested in evidence of efficacy,” he says. “Consumers like to feel in control of their own wellness, they are mostly influenced by word-of-mouth advocacy from trusted friends.”
An interesting trend is emerging in the data with a slight decrease in people saying they have purchased “herbal products” or natural medicines, while vitamins, minerals and supplements – generally produced by bigger companies, with bigger marketing budgets – have increased.
Sales through health food shops have declined and the big supermarkets and pharmacies have grabbed a larger share.
A quick look at the numbers from two of the biggest Australian brands, Swisse and Blackmores, shows between them in 2011 they spent almost $50 million on marketing. But Swisse chief executive Radek Sali says the company’s overall marketing budget is small compared with budgets for other consumer goods.
He points to a Nielsen list of top advertisers for last year. It is filled with companies like McDonald’s, Nestle, and, ironically, Jenny Craig.
“People aren’t eating healthily, and health and wellness should be our top priority,” says Sali.
Wellness is a noble goal, but one that’s hard to pin down, and test.
Almost all evidence reviews, and national health bodies, say there is no credible evidence vitamin use will help otherwise healthy people stave off disease.
And when you do produce an evidence-based natural medicine, selling it is costly and difficult, says Craig Weller, the managing director of Flordis, a natural medicine company.
“You can get these products to market quite easily in Australia, but the biggest problem is there are many disreputable companies out there who will make the same claims based on no evidence,” he says.
“They will make the same claim but might be using a different part of the plant, or a different plant.”
Australia has a dual regulation system. High-risk products, such as prescription medicines and some over-the-counter and complementary medicines, are independently assessed by the TGA before being registered. By contrast low-risk products that contain pre-approved ingredients are listed without assessment.
Weller says to get a product registered costs about $300,000 and takes about three years. But imitator products are then listed without jumping through any hoops and at much lower cost.
Weller is dismissive of claims that vitamins and supplements are needed for overall “wellness”.
People are getting ripped off,” he says. He estimates only about 1 per cent of the complementary and alternative medicines sold in Australia are evidence-based.
So how did we get here? In 2001 the federal government introduced the system of “self-assessment” for certifying that low-risk complementary medicines satisfied the regulatory requirements that allowed them to be ‘‘light-touch’‘ listed.
Another major blow occurred when the Health Department ordered a recall of vitamins produced by Pan Pharmaceuticals, only to be sued by the company and lose the case. Some industry participants believe the episode may have had a chilling effect on the TGA.
By 2008, 90 per cent of products reviewed were found to be non-compliant with regulatory requirements.
“In this context, the available evidence indicates that the regulation of complementary medicines in Australia has been of limited effectiveness,” a 2011 Auditor-General’s major review found.
Bruce Arnold, a law lecturer at the University of Canberra, wonders whether the TGA has the legal power, resources or will to deal with a hugely expanded industry.
Arnold says part of the problem is that misleading claims about benefits could in theory be dealt with by the TGA or the Australian Competition and Consumer Commission, but in practice just fall through the cracks.
“Companies just need to tick the box that their products aren’t harmful, but there’s no enforcement that they actually work,” he says.
Recently, the government has been chipping away at the problem. Legislation before Parliament will allow the health minister to intervene and remove products from the federal register.
The Department of Health has also created a panel to review private health insurance subsidies – which are partially funded through taxpayer rebates – for a limited number of alternative therapies.
Ana Lamaro, from the Australian Homeopathic Association, is furious about the review.
She argues that the structure of medical science is not suited to assessing the holistic, overall health support provided by homeopathy.
Further, that when mainstream scientific bodies such as the Cochrane Collaboration have reviewed the evidence, they have targeted areas with the weakest research.
“One has to question the motivation for taking such an approach,” she says.
She believes the way the private health insurance review has been set up means it will not support the homeopathic approach.
It might be the only point on which Lamaro and John Dwyer, president of Friends of Science in Medicine, would agree.
Dwyer says the insurance review is vital, not for the sake of saving some of the estimated $90 million the government spends subsidising alternative treatments, but because removing the subsidy will send a message to the community that these treatments have been rejected.
“The really important thing will be the chief medical officer of the nation telling the community that there is no credible evidence for this. That’s never happened before,” he says.
But Dwyer says the review itself will not be enough, and so do Arnold and Harvey.
They argue products listed through a light-touch regulatory process should be labelled as not tested by the drug regulator. And when lies are discovered, they should be actively prosecuted.

Named and shamed
(August 2012 to now) – Swisse Ultiboost Appetite Suppressant – Blooms Curcumin 600 Plus with enhanced BioP absorption – Fat Eliminator – Energy Slim – Undoit Plus – Colocap Balance – BergaMet Mega – Quicktrim Suppress & Burn – Reducta Fatblaster Tablets
Source: TGA