Your health, your choice

More and more New Zealanders are seeking health care away from conventional medicine. But do they know what they are getting? In a series of articles we examine the frameworks within which the different medical traditions operate, look at the medicines and the practitioners, check the statistics, talk to Western-trained doctors who offer complementary alternatives and find out why patients want a different choice.

By GEOFF CUMMING

Look at my hands," says Professor Jihuai Gao, holding out his palms. They are as wrinkle-free as his baby face. "My skin is very good but I'm 54."

Professor Gao's elixir of youth is a mushroom. Six capsules a day of an extract of lingzhi mushroom will, he says, calm the mind, purify the blood, enhance the immune system and combat the ageing process.

Gao, a mycologist based at Crop and Food in Mt Albert, has spent 20 years identifying the properties which make lingzhi the "cure-all magic mushroom" of Chinese herbal medications. He found ingredients useful for fighting cancer, blood diseases, asthma and impotence which, using a patented extraction process, he sells as highly concentrated capsules.

Because the extracts have not undergone the exhaustive trials required for registration as medicines in New Zealand, he cannot make therapeutic claims about them and they are sold as health supplements at up to $120 a bottle.

While Gao's research is grounded in science, publication in the International Journal of Medicinal Mushrooms doesn't hold quite the same sway with Western doctors as the British Medical Journal or The Lancet. But word of mouth works wonders. The capsules are sold in 10 countries and last year Gao's company, Alpha Healthcare, sold 50,000 bottles in New Zealand alone.

Most clients are referred by doctors to Alpha outlets in Auckland, Rotorua, Wellington, Christchurch and Dunedin. Gao says a growing proportion are referred by European doctors who have read the literature he sends with samples.

"In the first three years it was very slow - doctors could not understand what natural medicine was good for. But as they try it in different patients they see the results."

Crop and Food is building a new laboratory so Gao can further his research into natural extracts including kiwifruit, which has a number of therapeutic ingredients, cancer-combatting shellfish byproducts and a mushroom which may allay Alzheimer's. He believes research into traditional Maori medicines could throw up similar potential breakthroughs with huge economic benefits for New Zealand.

"Natural medicine is very good for health because Western medicine has more side effects. Western and natural medicine combined together are very good for curing diseases."

But that state of happy co-existence is as elusive as a cure for cancer. In an age of nanotechnology, the mysteries of the human body continue to defy science. Patients are increasingly searching out alternatives but the barriers between conventional and "complementary" medicine are crumbling only slowly. One in four GPs may use complementary techniques but most place their faith in a science which does not provide all the answers.

The two camps circle each other like punch-drunk warriors in full body armour, each seizing opportunities to probe the other's Achille's heel. For every expose of new age quackery, an approved medicine or therapy has disastrous side effects. For every "breakthrough" trial there's a charge of drug-company bias or flawed research. It's a debate of ever-increasing circles: the more we learn, the less certainty for the consumer.

The two sides even differ on what divides them. Internet websites such as Quackwatch in the United States and Second Opinions in Britain rail against the lack of science behind alternative therapies and cures. For this phalanx, the dividing line is the evidence - or more correctly, evidence-based methods (EBM) - and its stance is summed up in a Quackwatch commentary: Is Complementary and Alternative Medicine a UFO?

"Complementary and alternative medicine [CAM] are methods for which efficacy and safety are unproven or disproven. If and when proven to be effective, they cease to be 'alternative' and become EBM."

But for alternative therapists, the dividing line is philosophy, says Ken McIver, research director for the Charter of Health Practitioners, an umbrella group of natural therapies.

"On the one hand is the philosophy that you have to go in and control things - this part's rotten, you have to cut it out. But the philosophy from the natural healing point of view is to promote the body's own healing ability.

"The approaches are different but we are asked by those in power to conform to the crisis paradigm," says McIver, an acupuncturist with a PhD in biological medicine.

In a bid for credibility, alternative medicines are increasingly undergoing clinical trials. At the Auckland Medical School's clinical trials research unit, present trials include a natural weight loss product and the use of honey for healing leg ulcers.

"We are evidence junkies," says co-director Dr Anthony Rogers. "Whether it's got reliable evidence is the key - not whether it's got a conventional or alternative label."

Worldwide, more than 4000 trials have been carried out on CAM treatments but the jury is still out on whether they work. Some invite more scepticism than others but there are things that science simply cannot explain, say proponents - and their patients.

Research findings are published in industry journals and by agencies dedicated to alternative medicine research but reports in conventional medical journals are few and far between. Most are rejected because they fail to satisfy rules of conventional research on issues such as sample size. But alternative practitioners say techniques such as randomised control trials fail to acknowledge natural medicine's holistic approach and often throw up invalid results.

In an article in the British Medical Journal, Richard Nahin and Stephen Strauss of the US National Centre for Complementary and Alternative Medicine explained the limitations of traditional scientific methods in evaluating acupuncture.

"There are hundreds of small studies examining the efficacy of acupuncture needling alone for treating asthma, pain, hypertension or nausea. Yet in real practice, acupuncture needling would be just one of an arsenal of interventions used by a licensed acupuncturist."

As Hamilton medical herbalist James Hart points out, research is hugely expensive and can take years, with no guarantee of a favourable outcome. While drug companies can recoup costs by charging high prices for their patented artificial compounds, alternative medicines which are natural substances cannot be patented.

There is therefore little incentive to do CAM research, particularly when products can be sold in New Zealand as dietary supplements without proof of whether they work.

Picton doctor Keith Welch had no time for such excuses in a submission to a Government discussion paper on complementary medicine: "The randomised control trial (RCT) is the only acceptable method for evaluating any form of medical treatment. Claims that CAM cannot be evaluated in this way should be treated with the utmost contempt.

"Science is a universal philosophy. I am very worried by a trend developing where CAM practitioners claim that it is too expensive for them to conduct RCTs."

But Dr Stewart Jessamine, technical specialist with medicine registration agency Medsafe, says it takes 15 to 17 years and hundreds of millions of dollars to clear the research hurdles to register new medicines. The barriers include toxicology tests on animals and clinical trials on the equivalent of "3000 patient years - for instance, 1500 patients for two years".

Nevertheless, scientists continue to explore the alternatives. A study published in February in the Journal of the Royal Society of Medicine found arnica, a homeopathic remedy, ineffective in treating carpal tunnel syndrome, a painful condition of the hand and fingers. Homeopaths soon found flaws in the sample size and dosage schedule and said they would never prescribe arnica for the condition anyway.

But published trials showing homeopathy to be superior to conventional medicine in treating hay fever have been condemned as equally flawed.

The health media is awash with claim and counter-claim. Hard on the heels of the Journal of American Medical Association's advice that we should all take a multivitamin a day came the scare about multivitamins causing cancer.

Alternative practitioners also recite the mantra that while (almost) no one dies from taking health supplements, thousands die each year from reactions to prescribed medicines.

A US study of 548 pharmaceutical drugs approved since 1975 found nearly one in five had serious or life-threatening side effects discovered only after they came on the market.

Yet the mainstream media trumpet claims from orthodox medicine while spreading misconceptions about alternative therapies, says McIver of the health practitioners' charter. "The media will seize on one line in a research trial such as 'vitamin C thins arteries' but they rarely come out and retract."

While McIver is critical of manufacturers who make unsubstantiated claims about natural remedies, he argues that medical journals trot out one-sided and biased "research".

"With any new drug, you have to look at where it has come from and who paid for it. There are physicians paid to authorise reports created by pharmaceutical spin doctors - that's a corruption of what I call science."

The British Medical Journal agrees that the links between drug companies and the medical profession - and medical publications - have gone too far. In a special edition in May, it condemned the dependence of medical journals on pharmaceutical advertising and the misleading content of much advertising. Editorial coverage was even more valuable to the industry - and journals competed to publish research breakthroughs - but drug-company-funded trials were often manipulated to produce favourable results.

The BMJ noted that research and development previously undertaken by governments has been replaced with industry funding. "Finding senior medical researchers or clinicians without financial ties to pharmaceutical companies has become exceedingly difficult."

It called on doctors to distance themselves from pharmaceutical-company sponsorships, gifts and free lunches. "Twisted together like the snake and the staff, doctors and drug companies have become entangled in a web of interactions as controversial as they are ubiquitous."

Six weeks later, the New Scientist published research claiming drug-company sales reps have only a small impact on what doctors prescribe. Watch this space.

In an article last year in the New Zealand Medical Journal, Auckland GP David Hopcroft criticised the standard of references used in medical advertising to influence doctors' prescribing habits. Hopcroft examined 123 references in 38 advertisements and found four in 10 were either inaccurate or inappropriate.

Hopcroft has formed a company to promote evidence-based advertising to GPs, saying doctors reject most pharmaceutical advertising as a waste of money.

"There are fantastic products coming through with very good evidence to support them - if you want me to change my prescribing habits give me a good reason rather than all these gimmicks."

If doctors can't rely on what pharmaceutical firms tell them, where does that leave patients? New Zealand is the only country other than the United States that allows direct-to-consumer advertising and Health Minister Annette King supports doctors' calls for it to be banned.

The Researched Medicines Industry has revised its code of practice to make the ads more balanced and informative after a survey found nearly a third breached the Medicines Act. The code also covers conduct between drug companies and health professionals which chief executive Lesley Clarke describes as "beyond reproach".

But while scepticism is increasing about the integrity of Western medicine, the alternative is an unregulated fairground of exotic potions and therapies.

In January, the medicines safety authority Medsafe ordered the withdrawal of 11 Chinese herbal remedies after tests revealed they contained scheduled medicines and toxic substances. One was said to contain 4 per cent arsenic; others were linked to severe kidney damage and urinary tract cancer.

In April, Australian and New Zealand authorities recalled hundreds of dietary supplements with ingredients manufactured by Pan Pharmaceuticals, which had its licence suspended because of serious quality and safety breaches.

While only one product, Travacalm, was found to have caused adverse reactions, an audit found cross-contamination between human and animal drugs, products containing traces of metal and evidence of "systematic manipulation and misrepresentation of quality control data".

But Government moves to ensure the safety of therapeutic goods have met with anguished outcry. One proposed remedy, soothingly labelled harmonisation with Australia, would merge Medsafe with Australia's Therapeutic Goods Association in a transtasman regulatory body. Advertising rules will be clarified and all supplements will need to be registered. Medsafe's Stewart Jessamine says there are too many loopholes in the law as it stands, with consumers misled by the claims surrounding many products.

The changes will allow firms to make therapeutic claims about products if they have evidence that they work but manufacturers say the process will be so expensive that useful products will simply be removed from shelves, narrowing the options for consumers.

It is still unclear whether products which don't make therapeutic claims will be legally saleable under the new regime.

Calls to further protect the public, by providing for the registration of all natural healthcare practitioners in the Health Practitioners Competence Assurance Bill, have been rejected by the Government. As the law stands, anybody can hang up their shingles and call themselves what they like, says Jessamine.

But further changes are in the wind. A ministerial advisory committee is considering submissions on a wide-ranging discussion document which may lead to registration.

The Ministry of Health is also developing a website so consumers can study the evidence on whether complementary treatments work or not.

But attitudes towards the reform process sum up the chasm between the sectors.

Quackwatch founder Stephen Barrett, in an analysis of the advisory committee's draft report: "The committee appears to be dominated by proponents of irrational CAM methods. ... It should be replaced by a science-based committee that focuses on consumer protection."

McIver of the health practitioners' charter: "The committee was a charter initiative but is dominated by the conventional medical sector. The whole thing has been subverted."