Healthy Skepticism Library item: 8703

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Publication type: news

Cole L.
Natural justice
Medical Observer 2007 Mar 2
http://www.medicalobserver.com.au/displayarticle/index.asp?articleID=7515&templateID=105&sl=1

Full text:

Serious questions are being asked about government regulation of the complementary medicine industry. Lara Cole investigates.

FEELING like you’re coming down with a cold? There’s echinacea.

Want a natural treatment for osteo­arthritis? Glucosamine.

Depressed? We’ve all heard of St John’s wort.

For a large number of Australians these natural therapies are more likely to be the first thing they try before going to see their GP.

They’re part of an overwhelming range of alternative products that line the walls of pharmacies and health food stores across the country.

A consumer research study by Cardinal Health in 2004 showed 74% of the population had taken a vitamin, mineral, herbal or nutritional supplement in the previous 12 months.

In all, that’s believed to add up to more than $1 billion in sales of natural remedies a year in Australia.

But evidence for the effectiveness of these remedies is wildly different.

Many studies have cast doubt on whether echinacea fights colds and much research has pointed to the dangerous psychoactive effects of St John’s wort.1,2

But glucosamine is the new poster child of alternative therapy, with a Cochrane Review finding it more effective than placebo.3

These significant differences in efficacy and safety have prompted calls from the medical and scientific professions for more evidence-based criteria for complementary medicines.

Some have the Therapeutic Goods Administration (TGA) firmly in their sights as the key to tightening up what they see as lax regulations for registering complementary medicines.

The TGA allows complementary medicines to be listed without the same burden of proof as registered medicines because they are considered “low risk”.

Although complementary medicines listed must meet quality and safety requirements, the TGA does not evaluate their effectiveness.

So products might be harmless, but there’s no official requirement to show that they actually work. Is this reasonable public policy – even if the government doesn’t underwrite the complementary healthcare industry as it does with pharmaceuticals?

BUSTING THE MYTHS
Retired Queensland scientist Loretta Marron is putting the TGA to the test.

Every month she goes to the post office with a thick parcel of research addressed to the TGA. She spends hours researching and debunking the claims of many so-called natural therapies.

Her work has identified 700 weight loss and detox products, which she claims have no evidence to support their effectiveness. In fact, she’s found the most common ingredient in most is caffeine equivalent to about a cup of coffee.

For all the complaints she has made to the TGA, Ms Marron says she has only managed to have two upheld, and both of the products involved are still being advertised today.

“The TGA is failing both the public and the pharmacies badly because it’s listing products that simply don’t work.”

University of NSW professor of medicine Lesley Campbell has added her voice to the growing group of experts supporting tighter evidence-based criteria.

“People are so suspicious of drugs, which have to meet incredibly vigorous standards, but if you go and put a bit of stuff in a bottle you don’t have to prove it’s effective in any real way,” Professor Campbell says.

But with figures showing nearly 60% of the population believe alternative medicines are fairly effective, it will take a lot to change public sentiment.

“Only when we have the public on side will there be the political will to force tighter restrictions on natural therapies,” she says.

And she argues that the scientific community needs to drive this change.

“They need to put their money where their mouth is to inform the public… who can put pressure on the TGA to clean up their act.

“It shouldn’t have to take another [Pan Pharmaceuticals] scandal.”

The TGA defends its existing system as “robust and appropriate”.

In a statement supplied to Medical Observer, it says: “Australia regulates complementary medicines as medicines, unlike many other countries where they are considered foods and subject to basic food standards.”

The TGA listing process
COMPANIES wanting to list a product on the Australian Register of Therapeutic Goods fill out an electronic application form.

Listed medicines may only contain ingredients previously approved by the TGA.

Like tax declarations, once on the list companies face random and targeted reviews. If requested, they must provide evidence to support claims.

Listed medicines can only carry claims for health maintenance and health enhancement, and refer to non-serious, self-limiting conditions.

An advertising code binds companies to be socially responsible, truthful, appropriate and not misleading.

If safety concerns about a product are raised, the TGA’s complementary medicines evaluation committee automatically examines it.

In 2002 this process led to a recall of all products containing kava (a Polynesian shrub) after the death of a woman who used a medicine containing the product.

But this example backs claims made by medical leaders, such as AMA president Dr Mukesh Haikerwal, who dispute the concept that if a product is natural it’s harmless or “low risk”.

“Just because something is so-called ‘natural’ it doesn’t mean it’s therefore devoid of side-effects and problems,” he says.

“Anything claiming a medical benefit should have similar rigour [to pharmaceutical medicines] applied to it.”

Professor Campbell fears reliance on natural therapies prevents many people from seeking appropriate treatments.

“In the area of metabolic medicine there are only a couple of legitimate drugs for weight loss and they get a real pasting. But then I look around and see people wasting their money on these other things and believing in them – sometimes dangerously so – without any control whatsoever. It’s very frustrating.”

Dr Haikerwal believes the size and financial clout of the complementary industry is part of the reason the push to tighten regulations is failing.

But Complementary Health­care Council of Australia exe­cutive director Dr Tony Lewis (PhD) defends the current regulations as both safe and cost effective.

“There might be minor arguments from time to time about particular products, but overall the industry very strongly supports the process of listing,” he says.

“It keeps the costs down and recognises the reality and low-risk nature of complementary medicines. There are built-in safeguards, and the materials used are regularly reviewed.

“In fact, Australia’s the envy of a lot of other countries because not only does it deliver a good solid performance on the product but the system is relatively cheap and prevents delays.”

EVIDENCE-BASED
Dr Vicki Kotsirilos is a supporter of complementary medicine – but she only incorporates evidence-based therapies such as acupuncture and hypnosis into her Melbourne general practice.

As a practising GP and member of the TGA’s complementary medicines evaluation committee, she has a box seat at this debate.

And she says there’s more to it than whether there is or isn’t existing evidence for a product.

While Dr Kotsirilos backs evidence-based practice, she sees inherent problems with demands for more stringent evidence requirements for all therapies.

“Many complementary medicines have been around for hundreds and sometimes even thousands of years,” she says.

“We’ve got a large amount of traditional use, but the problem with scientific evidence is there hasn’t been a lot of funding for complementary medicines, certainly not for the size and quality of the study you’d need.

“However, even when there is a lack of research it doesn’t necessarily mean it doesn’t work. If you were to regulate complementary medicine based just on evidence, it could mean we’d be depriving the public of some complementary medicines that may be useful but not yet well tested and researched.

“Also, they would still need regulating for safety and quality issues via the TGA anyway.”

Instead of stamping down on such products simply because they are not evidence based, Dr Kotsirilos believes the TGA’s current regulation system is adequate, but more thought may need to go into other ways of controlling complementary medicines.

She suggests more highlighting of products that have been properly evaluated. This could be done through public education and better labelling.

There are some moves in this direction. Late last year the NHMRC was awarded $5 million to investigate a range of alternative medicines.

While this research is unlikely to put an end to the work of Loretta Marron, it may well result in supporting evidence for existing TGA-listed complementary medicines.

But Professor Campbell says mainstream medicine should also take an honest look at what it might be doing wrong.

“We’ve got to clean up our own act to make the medical area more appealing. If we improve the attractiveness of our own attempts, we won’t be pushing patients into the arms of alternative therapists.”

REFERENCES
1. Kligler B. Echinacea. American Family Physician 2003;67:77-80,83;
Linde K, Barrett B, Wölkart K, Bauer R, Melchart D. Echinacea for preventing and treating the common cold. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD000530. DOI: 10.1002/14651858.CD000530.pub2.
2. Linde K, Mulrow CD, Berner M, Egger M. St John’s Wort for depression. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD000448. DOI: 10.1002/14651858.CD000448.pub2.
3. Towheed TE, Maxwell L, Anastassiades TP, Shea B, Houpt J, Robinson V, Hochberg MC, Wells G. Glucosamine therapy for treating osteoarthritis. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD002946. DOI: 10.1002/14651858.CD002946.pub2.