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We're spending billions on 'wellness' crap. Why?

The alternative medicines industry rakes in billions, but consumer protection has gone missing. The regulator doesn't have the power or the money to do its job ... and powerful interests like it that way.

The next time anyone tells you to try some spiffing product guaranteed to improve your health and your wellbeing, remember this: it’s not your wellbeing they’re interested in.

The wellbeing schtick is about the notion that health should be about more than the absence of disease. Being normal isn’t good enough. So a vast global industry, now worth an estimated $US1.5 trillion ($A2.36 trillion) annually, exists to supply a market with stuff that only a few years ago we didn’t even know we needed.

That’s four times the amount the Australian government collects in tax. It’s equal to the entire gross domestic product of Malta, Albania. North Macedonia and Cyprus combined.

The McKinsey company of global management consultants published a report in 2000 that surveyed the range of benefits that consumers sought from the alternative health and wellness market. They identified six main areas:

Health. This doesn’t mean absence of disease. It doesn’t involve being ordinarily healthy. Here, “health” covers personal health tracking gadgets, various services and a global inundation of miracle pills and potions.

Fitness. Personal trainers, running shoes, lycra, gym subscriptions.

Nutrition. How much money should we have to pay for people to tell us to eat fruit and vegetables, ease off the grog, cut down on salt and consider a Mediterranean diet? Not good enough, according to McKinsey: “Now consumers want food to help them accomplish their wellness goals in addition to tasting good.” Apparently this is different from what humans have been doing for the past 300,000 years or so without fad diets, diet coaches and special supplements.

Appearance. “Primarily relates to wellness-oriented apparel (“athleisure”) and beauty products (skincare and collagen supplements), but also includes service-oriented offerings like non-surgical aesthetic procedures.”

Sleep. “Now goes beyond traditional sleep medication, like melatonin, to app-enabled sleep trackers and other sleep-enhancing products.”

Mindfulness. “Has gained mainstream consumer acceptance relatively recently, with meditation-focused apps and meditation-oriented offerings.” What mindfulness actually is remains unclear.

How much money?

A 2019 study published in the British Medical Journal estimated that 50% of the Australian population had used complementary medicines in the previous 12 months. About half of that was for vitamins and mineral supplements.

Complementary Medicines Australia, the industry lobby group, claims a higher figure of 70%. The organisation also claims revenue (for 2020) of $5.6 billion, although that includes exports of $1.1 billion. On that basis, the domestic market would be worth around $4.5 billion.

But according to Ibis World, a business research company, industry revenue in 2022 was $3.5 billion, down 10.7% on the year before. Overall, the alternative therapies industry is in medium-term decline, falling by an annual average of 4.9% between 2017 and 2022.

That would still have been enough to treat 62,000 hospital inpatients or to fully fund 38,000 standard GP consultations.

Complementary Medicines Australia allocated its figures to four main categories:

  • Vitamin & dietary supplements: $3.1 billion;
  • Sports nutrition: $1.31 billion;
  • Herbal/traditional products: $0.76 billion;
  • Weight loss: $0.43 billion.

Over the industry, the lobby group said, companies enjoyed a profit margin of 10.8%. This compares with net profits in 2022-23 of 8.35% for the supermarket giant Coles; 2.25% for the private hospital operator Ramsay Health Care; and 5.94% for Blackmores, the alternative medicines company, which had a bad year .

Every pharmacist is extensively trained in the safe and effective use of medicines, but most of the shelf space in any community pharmacy is stacked with products that have little or no evidence behind them and are unlikely to work. This chart shows why: the pharmacy owners make an enormous amount of money from them. “Natural health” products account for over a third of all pharmacy sales of over-the counter medicines.

On top of that are the sales in supermarkets, convenience stores and online.

A large survey (2,019 participants) published in 2018 found around 53% of Australian adults used complementary medicines. Users were more likely to be female, have a chronic disease diagnosis, no private health insurance, a higher education level, and not be looking for work.

Older people seem to use more. A 2020 survey by researchers at Monash University of people over 70 found three-quarters used complementary medicines. Women were much more likely to do so than men (82.3% to 64.6%). So were people with depression and osteoarthritis.

Why this is important

There are many ideas about the benevolence of alternative medicine which are widely accepted and dangerously wrong.

One is that these products and services are natural and therefore healthy. Not true. This is a highly industrialised, commercialised field. Products, including herbal medications, are highly processed.

Another is that they can do no harm. Even many doctors think this: that if the product has no effect, it can’t do any damage.

Let me illustrate. In the early 1990s, when AIDS was killing large numbers of gay men, a prominent Sydney naturopath with a substantial gay clientele convinced his patients that HIV did not cause AIDS, that the drugs did, and that the appropriate treatment was to administer bitter-melon enemas.

Some of that man’s patients had access to the gay community media and spread his message until it became a major force against effective HIV treatment.

The antiviral drugs then available did not control the infection for the long term but they gave several extra years of life. In many cases this was enough to allow us to benefit from the decisive breakthrough when it appeared in 1996.

That naturopath deprived his patients from that chance of life. I knew several of them. They were credulous and, perhaps, stupid; but their trust should not have cost them their lives.

Since then, some restrictions have been placed on the marketers of alternative medications, forbidding them from making claims about curing serious illnesses, such as cancer. But the changes would not have affected what that naturopath told his clients in his consulting rooms and it would not have prevented them spreading that message throughout a vulnerable and panicked community.

The politics and practice of voodoo medicine

Edward Albert Christian George Andrew Patrick David Saxe-Coburg-Gotha, who briefly became known as King Edward VIII, was particularly fond of three things: (a) an unattractive American called Wallis; (b) an even less attractive German called Hitler; and (c) homeopathy.

Enthusiasm for the third option was entrenched in the royal family. Edward’s brother, King George VI, was a true believer. Elizabeth II was patron of the Royal London Homeopathic Hospital and its director, Peter Fisher – one of the nation’s top quackocrats – was her personal physician. But there has been no more fervent devotee than the present incumbent, Charles Philip Arthur George.

His incessant lobbying of ministers in Labour and Conservative governments for more funding for homeopathy and other alternative therapies was only revealed when The Guardian obtained a cache of his letters (they quickly became known as the Spider Letters because of the handwriting). One of the most notorious was written to Tony Blair, asking for a delay to the implementation of a  quite mild set of EU rules on the sale of herbal medicines.

Blair replied warmly, saying he had consulted with people recommended by the prince and now agreed with them.

“The implementation as it is currently planned is crazy,” Blair wrote. “We can do quite a lot here: we will delay implementation for all existing products to 2011; we will take more of the implementation on ourselves; and I think we can sort out the problems in the technical committee – where my European experts have some very good ideas.

“We will be consulting with your contacts and others on the best way to do this – we simply cannot have burdensome regulation here.”

Charles ... voodoo monarch
As Prince of Wales, one of his Duchy of Lancaster businesses was Duchy Originals, which sold quack herbal and ‘detox’ remedies. False claims of efficacy led to censures of the prince himself from the Medicines and Healthcare products Regulatory Agency and the Advertising Standards Authority.

Those regulations were indeed delayed by six years.

Imagine Charles’s dismay, then, when in 2018 his pet hospital (now renamed the Royal London Hospital for Integrated Medicine, which is his preferred name for alternative therapies) the National Health Service refused to fund any more homeopathy. After all, he’d only reopened the place in 2005 after a refurbishment costing £20 million (that’s $A61 million in today’s dollars).

“Sadly,” he wrote, “we have been witnessing the relative decline of some homeopathic services in different parts of the United Kingdom.”

Homeopathy is based on the idea that an illness can be treated by administering a diluted form of the poison that caused it. So hayfever treatments can take a pollen sample, then dilute it in water so many times that the final product comprises one part in a million of the original compound.

Because the water is shaken during each dilution, proponents claim it retains a memory of the original compound, even though none of it is likely to be present in the product administered to the patient.

In 2015, Australia’s National Health and Medical Research Council published an exhaustive study of the evidence for homeopathy. It concluded:

“Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective.

“Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness.”

A Powerball customer’s chance of winning is hundreds of millions to one against, but at least there is a chance. With homeopathy, there is no chance.

In Australia, at least, homeopathy was already on the way out. A 2018 survey found its use was down to 3.4% of the adult population. That’s still 660,000 people, but far less than the 2.4 million going to a chiropractor or the four million going to a massage therapist.

The Department of Health released a review in 2015, headed by the Chief Medical Officer, on whether various natural therapies should continue to be covered by private health insurance. In 2012 Tanya Plibersek, then health minister in the Gillard government, ruled that “the Private Health Insurance Rebate will be paid for insurance products that cover natural therapy services only where the Chief Medical Officer finds there is clear evidence they are clinically effective.”

The review was clear: “Such clear evidence has not been found.”

Iridology ... one of 14 quack remedies targeted
The subsequent Liberal government moved slowly on the matter but, from April 2019, 14 fringe therapies finally lost funding: Alexander technique, aromatherapy, Bowen therapy, Buteyko, Feldenkrais, homeopathy, iridology, kinesiology, naturopathy, Pilates, reflexology, Rolfing, Shiatsu, tai chi, Western herbalism and yoga.

It wasn’t the end of the story. Greg Hunt, the Liberal health minister, set up a review of the review. This has an advisory panel that has met twice a year since 2019 to see whether any new evidence can be found. Their report, expected early next year, will go to the NHMRC for further review together with reports from other advisory committees.

Eventually, something will land on the desk of the present health minister, Mark Butler. None of this stuff is likely to result in any actual meaningful regulation. Consumer protection is not on the agenda.

This perfidious industry continues apace. Losing private health cover meant public – that is, government – money is no longer being used; but it’s a small advance. The public’s money still flows in torrents into their bank accounts. Spot the difference.

Nor is consumer protection on the agenda for the plethora of products sold, usually for high prices, which have – at best – no guarantee of quality, safety, efficacy or cost-effectiveness. The mainstream pharmaceutical companies show this evidence not because they want to, but because they have to. The alternative providers get away with doing almost nothing.

So we have over two million people using aromatherapy oils, 1.8 million using herbals, 1.5 million using flower essences and – even now – 1.3 million people using quack homeopathy products.

In 2000, the federal government decided that alternative medicines were too widely used to continue to be left outside the regulatory system. Senator Grant Tambling, Parliamentary Secretary for Health, introduced a system which, the ABC reported, would “ensure the products are analysed for safety and that they are capable of treating the ailments they claim to.”

If that was the aim, it was not the result. Tambling stressed that the new system had been negotiated with the industry and had their approval. But that’s not the way to get serious and effective regulation. Companies do not agree to policies which protect the public but which will cost them serious money and perhaps endanger entire businesses. If governments do not have the guts to enforce such changes, nothing of consequence will occur.

A South Australian survey found 49% of the sample “believed (erroneously) that [these products] are independently tested by a government agency such as the Therapeutic Goods Administration before being sold …

“Most (74.8%) believed that these products were tested for quality/safety/side-effects; 21.8% believed that these products were tested for what they claimed to do; and 17.9% for efficacy/strength/effect.”

In all of this, they were mistaken.

Quality, safety, efficacy

These are the three basic aims of medicines regulation, here and worldwide. If a system does not ensure these, it fails in the most basic way.

Quality: Does the description on the label match what’s in the bottle?

Safety: Will the product harm the people who use it? And if there is potential harm, is that justified by the benefit to the consumer?

Efficacy: Does it work as claimed?

Quality is a serious issue, largely unaddressed. An example: in 2003, when I was the health policy officer at the Australian Consumers’ Association (Choice), I organised testing of all the brands of

echinacea that were available in Australia. The tests were done by a specialist unit within Sydney University’s pharmacy school.

None of those products, the scientists concluded, contained enough of the known active ingredients to have any clinical effect.

The industry responded angrily and, without any evidence, claimed that there are other active ingredients that we don’t know about. All those products stayed on the shelves. The regulator did nothing.

American investigators found similar problems there. A report in the Journal of the American Medical Association (JAMA) said: “Echinacea samples available for purchase in Denver in August 2000 did not reliably contain the labelled species.”

Safety is another serious issue.

Despite the assumption that these products are inherently benign, safety is also a major issue, and also largely unaddressed.

A key area of concern is that if these products actually do have a clinical effect, they may interact with prescription medicines, with potentially serious results. One major Australian study revealed that over half of respondents did not tell their GP that they were using alternative products.

This table, published by the federal government’s Australian Prescriber journal, lists the products in which dangerous interactions are of most concern:


Efficacy. Do these things work?

Let’s look again at echinacea: a common claim is that it cures colds. But a high-level systematic review by the highly respected Cochrane Collaboration concluded that the evidence does not support the claim.

The National Center for Complementary and Integrative Health, part of the US government’s National Institutes of Health, reported: “Taking echinacea might slightly reduce your chances of catching a cold. Echinacea has not been shown to shorten the length of a cold. There isn’t enough evidence to show whether echinacea is helpful for other health conditions.”

It's not just echinacea. This sort of finding is not universal but it is usual. The tantalising thing about this whole area is that there are, for some of these preparations, indications that significant benefit could be likely – but only if the problems of poor manufacturing, and a massive lack of research into both what may be effective and why, are addressed.

Echinacea is just such a product. It’s touted as an immunity booster, but there is no evidence on just how it might interact with the extraordinarily complex human immune system. And we need far more research into the active ingredients: how that may work, and how that may work together and within the body.

But the industry is not interested either in spending the money, or in the risk of getting answers it doesn’t want.

Who’s there to protect you?

The head of Complementary Medicines Australia, the industry lobby group, once told me that the products sold by his clients obviously worked because so many people bought them. Well, a lot of people bought thalidomide.

Consumer protection, particularly in healthcare, doesn’t usually work like that. A huge global network of regulators has arisen to protect national populations from harm.

The protections that are now standard around the world have their origins in two landmark events – the Nuremberg trials of 1945 and 1946; and the thalidomide scandal of the 1960s.

The cruel and useless Nazi experiments on human subjects in the death camps were, and were seen bymost nations, as the lowest point in the history of medical science that must not be allowed to happen again.

A tablet that Nazi doctors thought might stop soldiers bleeding from their wounds was administered to prisoners who were then either shot through the neck or chest or had their limbs amputated without anaesthetic. The tablet didn’t work.

Experimental bone marrow transplants were carried out without anaesthetic.

Mengele and twins at Auschwitz
At Auschwitz, Dr Josef Mengele infected prisoners with typhus, sewed twins together to create conjoined twins, cross-transfused the blood of opposite sex twins to change their respective sexes, experimented on twins’ genitals and attempted to attach the urinary tract of a seven-year-old girl to her own colon.

Thalidomide was first developed in the 1950s by a German company, Mäurer & Wirtz, which now makes perfumes, to develop new antibiotics. The firm was established by Hermann Wirtz, a former member of the Nazi Party; he appointed a chemist, Heinrich Mückter, who had managed to escape prosecution for war crimes for his experiments on concentration camp prisoners. Mückter, in turn, hired Dr Martin Staemmler, a leading proponent of the Nazi eugenics program, as head of pathology; Heinz Baumkötter, the chief medical officer at the Sachsenhausen concentration camp; and Otto Ambros, a chemist and Nazi war criminal.

Thalidomide was first marketed as a sedative, then as a treatment for flu and for morning sickness and insomnia during pregnancy. It had never been tested on pregnant animals or pregnant women before being widely sold. A member of the committee that later investigated the tragedy, Dr Widukind Lenz, commented: “The papers published in 1956 … on animal experiments and … on clinical experiences with thalidomide have so little scientific value that in my opinion they should not have been accepted for print.” 

By the time the scandal ended, more than 10,000 babies had been born with limb defects, typically with hands and feet growing straight out of the trunk. The drug was quietly withdrawn in 1962 but the full extent of the scandal remained hidden until a Sunday Times investigation in 1972 led to a tenfold increase in compensation being paid to victims.

The eventual result of those two appalling episodes was the Helsinki Declaration of 1964 by the World Medical Association. That declaration has been updated and extended many times; various countries and organisations have produced their own variants. Broadly, though, the international rules now governing human clinical research make three fundamental ethical demands:

The interests of the person subject to the experiment must always be put ahead of the interests of any other people later on. It is not acceptable to sacrifice people now for the sake of real or imagined benefit later on.

The question being researched must be worth asking. Junk research, like that of the Nazis, has no place. The potential outcome of the research must be proportionate to the risk to the research subject.

The subject must be informed of the nature, purpose and risk of the research and must give free and meaningful informed written consent before the project can proceed. But the responsibility for clinical research remains with the investigator, never with the subject.

How mainstream medicines are regulated

Today, all clinical research must be approved by an approved ethics committee. Drug trials begin with in-vitro testing in the laboratory showing the effect of the compound on  human cells; if this initial stage is successful, it is tested in relevant animal models: rats and mice account for 95% but can also include other animals whose organs and systems more closely resemble those of humans. These include ducks, woodchucks, dogs, macaques and, occasionally, chimpanzees.

Only then, when theoretical safety and efficacy has been proved at that level, can human trials begin. These are in three stages: initial safety studies, typically involving around 15 or 20 people; stage two safety and dosing trials, with perhaps a hundred participants; and final stage three efficacy trials with 500 to 1500 participants.

Only then can the new drug, and the trial results, be submitted for approval to the regulator, in our case the Therapeutic Goods Administration. (It’s perhaps worth noting that the US Food and Drug Administration didn’t ever get around to licensing thalidomide, which saved American mothers and children a world of sorrow.)

This system is expensive, but not as expensive as the big drug companies claim. A key independent study, published in 2017, found the median cost of a trial program was $US48million ($A74 million), though it varied from $US28million to $US69million ($A43 million to $A106 million).

“Overall, the estimated costs are modest for establishing the benefits that will guide the treatment of thousands to millions of future patients,” the researchers noted. “The costs-per-patient for these trials are sometimes similar to what pharmaceutical companies charge for these same drugs to treat a single patient or a handful of patients after marketing approval.”

Alternative medicines slip through the net

The regulations introduced 23 years ago created a new category specifically for these products. Instead of being ‘registered’ on the Australian Register of Therapeutic Goods, they would be ‘listed’. Proof of efficacy is not required and, in almost all cases, safety and quality is assumed.

Companies have to promise that they hold such evidence but, in the few cases this is asked for by the TGA, it is frequently found to be of poor quality, inconsistent with marketing claims or non-existent.

A scathing 2011 report by the Australian National Audit Office found:

“The regulation of complementary medicines came to public attention in Australia when the Department of Health and Ageing reported in late 2010 that, based on 2009–10 data, as many as 90% of products reviewed were found to be non‐compliant with regulatory requirements, despite the system of self‐assessment by sponsors. Among the medicines the TGA reviewed, 31 were selected at random, for which the following compliance issues were recorded (with a number of products recording multiple breaches):

  • 20 medicines had labelling issues such as non‐compliance with labelling requirements and/or breaches which may mislead consumers.
  • 12 included incomplete and/or inappropriate information on the Australian Register of Therapeutic Goods (ARTG).
  • 22 were found to have manufacturing and/or quality issues.
  • 14 did not have adequate evidence to substantiate claims made about the medicines”

The report concluded:

“In this context, the available evidence indicates that the regulation of complementary medicines in Australia has been of limited effectiveness.”

Also in 2003 a widely used product claimed to treat travel sickness was found to be contaminated. A number of people became ill.

The manufacturer, Pan Pharmaceuticals, was a major supplier of alternative medicines, including such things as Fat Blaster and Horny Goat Weed. The TGA inspected the plant and found many problems: it took action and suspended the company’s license, announcing:

“219 products manufactured and supplied in Australia by Pan Pharmaceuticals Limited have been identified for immediate recall. These products have been cancelled from the Australian Register of Therapeutic Goods for quality and safety reasons. The company has also had its approval to supply its range of export products (approximately 1650) cancelled.”

The regulator’s action was appropriate and timely. A manufacturer of medicines that cannot do so safely should not be in business.

In 2005 and 2008, the company pleaded guilty to several criminal charges, including manufacturing and supplying counterfeit medicines and negligently inflicting grievous bodily harm. It was fined a total of $13 million.

But the law, in the end, was on the company’s side, not the regulator’s. The TGA was sued in the federal court, accused of acting outside its statutory powers and undertaking a “vendetta” against Pan’s boss, Jim Selim.

Mr Selim was awarded $55 million in personal damages and a group of alternative-medicine companies which had used Pan’s services got a further $67.5 million.

The TGA’s capacity to protect consumers was seriously damaged but there has been no attempt by any subsequent government to ensure it has the legal powers we all thought it had.

Is there a way out of this?

Yes, but we’re unlikely to take it.

There is quite enough money being made in the alternative therapies area to fund all the research needed to make this industry scientifically reliable. The full array of clinical trials will seldom be needed, if ever. Properly designed efficacy trials, with a control arm as well as an active-treatment arm, are well within these companies’ financial reach.

Sometimes this could lead to a patent for a particular application, meaning a period in which the company commissioning the research would have a monopoly. It could even contemplate listing on the Pharmaceutical Benefits Scheme.

In most cases, patents will not be possible. Research would need to be funded broadly, across all the companies marketing that particular entity.

But they won’t do anything unless they’re forced into it by strict government action. It should be made illegal, after a reasonable period, to sell something that hasn’t got this evidence behind it. That would mean large quantities of jars disappearing from the shelves and, probably, some companies going broke.

Meanwhile, successive federal governments have shown no real interest in any aspect of the alternative therapy market. Those who will oppose such change will be far more vocal than anyone who supports it.

And so the most potent force in public policy – inertia – wins again.



 



 

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