Homeopathy fraud gets a free pass

The regulation of homeopathy marketing is woefully inadequate, experts say

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Have you ever walked into a pharmacy looking for a homeopathic remedy? The Medical Republic did – but only to prove a point.

An exhaustive search of the vitamins and supplements aisle did not reveal any homeopathic concoctions. It was only at the cold and flu section that we found, nestled between over-the-counter preparations, what we were looking for.

To those who believe in science, homeopathy, by its very definition, can provide no therapeutic benefit whatsoever, besides a placebo effect. In homeopathy, substances are diluted to the point where there is close to zero probability that a single molecule of the original ingredient will be contained in the final product.

The 200-year old principle underpinning homeopathy is the “like cures like” or the “laws of similar”, first propagated by German physician Samuel Hahnemann. One example of homeopathic logic is the use of trace amounts of onion to alleviate allergic rhinitis. Large doses of the chemical irritant in onion causes watery eyes, but in tiny doses it relieves this symptom, according to the Australian Homeopathy Association.

But this is unlikely to be obvious to your average consumer when faced with homeopathic product packaging. Emblazoned across the label of one particular product we found were the words, “Kids cold”. The box contained 10 lozenges for “temporary relief from cold and flu symptoms, headache, fever, stuffy and runny nose, sneezing”. But each ingredient – including Kali Bichromium, Pulsatilla and Allium Cepa, among others – was diluted to 30c. This means that one drop of each substance was diluted in 99 drops of water and this process was repeated 30 times.

There is no possibility that this product – or any similar homeopathic product – could relieve cold symptoms, according to Dr Ken Harvey, an Adjunct Associate Professor at Monash University.

And there is every possibility that a parent might accidentally select this product for their sick child instead of consulting a GP. “It is really magical thinking to think [homeopathy is] going to do anything,” says Dr Harvey.

“People are simply not aware that homeopathy has nothing in it and doesn’t work and is not medicine,” says Rachael Dunlop, post-doctoral medical researcher and vice president of Australian Skeptics. “People presume – and rightly so – that if they walk into a pharmacy and pick up something off the shelf, it is going to work.”

Yet despite claims by homeopathy practitioners that “nanodoses” can be biologically active, this view is not supported by scientific evidence.

In March 2015, the National Health and Medical Research Council concluded there were no health conditions for which there was reliable evidence that homeopathy was effective. The report was based on 57 systematic reviews and 176 individual studies.

The US Federal Trade Commission went further, initiating a crackdown on dishonest advertising of homeopathic products. The commission, which has a similar role to the Australian Competition and Consumer Commission (ACCC), ordered homeopathic companies to state explicitly on product labels that there is no scientific evidence the product is effective.

The move raised the hackles of the American Institute of Homeopathy. Its rebuttal statement, which was mocked as “comedy gold” by one US physician, claimed that homeopathic efficacy had been demonstrated in “hundreds of state-of-the-art double-blinded, randomised, placebo-controlled studies, many in peer-reviewed journals”.

Despite the mounting evidence that homeopathy is ineffective, the market is flooded with homeopathic products. Australians spent around $8 million on homeopathy in 2009, according to the World Health Organisation.

“[If you look up Australian homeopathy suppliers online] you will find hundreds and hundreds of them all making misleading claims,” says Professor Emeritus John Dwyer, president of Friends of Science in Medicine. “The market is awash with very profitable products that do not benefit Australians and actually send them the totally wrong health message.”

The darker side to false advertising by homeopathy companies, of course, is the risk that consumers will forgo standard medical treatment. “We know that the outcomes of homeopathic practice have in some instances had fatal results and there have been extremely sad coronial inquests and, in one case, criminal charges,” says Ian Freckelton QC, a professor of law and psychiatry at Melbourne University.

In 2005, Perth woman Penelope Dingle suffered a needlessly painful death from bowel cancer after spending around $30,000 on homeopathy remedies and forgoing medical care. A toddler named Gloria died in 2009 in Sydney from untreated eczema when her parents replaced homeopathy for conventional treatment. The parents were found guilty of manslaughter.

The regulatory problem

So could, and should, Australia be doing more to prevent similar tragedies occurring?

Unfortunately, false and misleading homeopathy advertising often falls between the cracks in the regulatory framework in Australia.

As therapeutic goods, homeopathy products fall under the purview of the TGA. But the TGA does little to actively regulate the industry because it views homeopathy as “very low risk”. As such, homeopathic goods need not be registered or listed on the Australian Register of Therapeutic Goods, unless they refer to the treatment of any form of a disease, disorder or condition. While homeopathy companies must comply with the Therapeutic Goods Advertising Code 2015, there are “no effective penalties for Code breaches” such as fines, says Professor Harvey.

Regulation is largely complaints-driven. The TGA outsources complaint handling to an independent Complaints Resolution Panel made up of stakeholders and attended by the TGA. This panel deals with complaints on a case-by-case basis and can ask companies to withdraw specific pieces of advertising. The TGA can take further action to enforce advertising controls but, in the case of homeopathy, the market is essentially self-regulated.

“There’s an assumption that if [homeopathy] hasn’t got anything in it, it doesn’t need to be regulated properly because it isn’t a medicine,” explains Professor Harvey, who sits on the complaints panel.

The complaints process is achingly slow, taking an average of 149 days for each issue to be resolved.

“Australia has … an overloaded and under-resourced complaint system,” says Professor Harvey. Last year, the panel received 146 complaints for complementary medicines (62% of all complaints) and found almost all were justified.

Over the past decade, the panel has asked at least 11 individual homeopathy companies to withdraw advertising following complaints. A cursory look at the websites of each of the sanctioned companies revealed that more than half (by our count) were still making misleading claims. The worst examples included suggestions that homeopathy could reverse autism, act as an effective first-line treatment for burns, aid in healing post-surgical wounds, treat fibromyalgia and ear infections, bronchitis, tonsillitis and ringworm in children.

Another internet search revealed that four out of eight companies recommended by the Australian Homeopathic Association as go-to retailers were misleading the public on their websites, including promoting homeopathy for children with ADHD, eczema, colds and flu, as well as one website presenting homeoprophylaxis (homeopathic immunisation) as an option to parents who did not wish to vaccinate their children.

Professor Harvey says this figure matches the complaint panel’s own statistics for 2015-16, which showed that in 40% of cases advertisers simply fail to comply with the requests of the panel.

“In reality, the industry really snubs their nose at the TGA,” says Professor Dwyer. “There have been many situations where product advertising was said to be fraudulent and they just changed the name of the product, they didn’t change the product. And the Complaints Resolution Panel – the TGA – really doesn’t have any teeth to hurt industry.”

Much of these criticisms of the regulatory process are uncontroversial and are, in fact, acknowledged by the government’s own Review of Medicines and Devices Regulation – Stage Two Report, which describes the complaints system as “overly complex and slow”. “The current sanctions and penalties … are insufficient… and should be enhanced to incentivise greater compliance,” the July 2015 report states.

The ACCC

A major obstacle to reining in homeopathy advertising is that two regulators operate in the same space and neither want to make homeopathy their problem. The ACCC, like the TGA, is responsible for making businesses comply with consumer protection laws.

The ACCC has significantly greater powers than the TGA to pursue legal action under the Competition and Consumer Act 2010. But the ACCC’s portfolio includes a broad range of industries, including banking and telecommunications, and only the “big picture” cases can be launched in the therapeutic goods space, says Professor Dwyer.

The ACCC has only ever successfully enforced penalties on a homeopathy company in one instance. Last year, Homeopathy Plus was ordered by the Federal Court to pay $115,000 in fines for false or misleading claims about using homeopathic remedies as an alternative for pertussis vaccine.

“The ACCC is concerned when representations about medical treatments are unable to be supported by scientific evidence,” a spokesman told TMR. However, “the ACCC is unable to pursue all matters that come to its attention”. The specific regulation of therapeutic products was more aligned to the roles of other agencies, he added.

But the TGA also backed away from any suggestion that it might become more active in regulating homeopathy advertising.

“The TGA is not a generalist consumer rights regulator,” a spokeswoman said. “Where appropriate, broader aspects of product promotion including fraudulent non-therapeutic claims, financial loss or unacceptable business practices may be referred to the appropriate national or state/territory regulator.”

The ACCC and the TGA are handballing homeopathy regulation back and forth between them. No one wants to catch the ball, says Professor Harvey.

There appears to be general agreement that the current system for regulating fraudulent advertising by homeopathy suppliers is completely inadequate. But the wheels of bureaucracy grind slowly. The Review of Medicines and Devices Regulation, which is leading the reform into the advertising complaints system, is now in in its third year. The Review, commissioned by the Government and chaired by Emeritus Professor Lloyd Sansom, will make recommendations about simplifying the regulation of therapeutic goods.

For some, the process is taking too long. “I really don’t think we need another review. It’s really about getting cracking on just putting some robust systems in place,” says Dr Justin Coleman, Queensland GP and commentator. “Everyone agrees the system is broken.”

But there is much disagreement over how the system should operate. One suggestion – which has received wide support – is to follow the footsteps of the US. Placing a disclaimer on homeopathic products to make it clear that homeopathy has no scientific basis is a “step in the right direction”, says Dr Coleman.

“[Labelling] will absolutely help people become aware that these products are actually not medicine,” says Ms Dunlop.

Dr Coleman suggests extending this model to include a set of standard claims that homeopathy manufacturers can make about their products. “Then if the advertiser wants to use more claims than that then they [would need to be] pre-approved,” he says.

Dr Bastian Seidel, president of the RACGP, says more comprehensive reform is required. “Labelling alone is not going to be good enough in my opinion.”

Health professionals, especially pharmacists, must take responsibility for communicating the problems with homeopathy.

“It is your professional obligation to make the customer or the patient aware of what the benefits are and what the pitfalls are,” Dr Seidel says.

The review’s stage two report called for the entire therapeutic goods complaints system to be disbanded and a new, centralised body with greater powers to be established. The TGA’s consultation, which closed in December, revealed strong opposition to this recommendation.

Professor Harvey and Professor Dwyer interpreted the proposal as the TGA positioning itself to take over the role of managing advertising complaints by abolishing the Complaints Resolution Panel and the Code Council and acquiring similar powers to the ACCC.

A TGA spokeswoman confirmed that the TGA taking over the complaints role was under consideration, along with an outsourced model.

Professor Dwyer says the TGA should not take charge of managing complaints as there is very little confidence in the TGA’s ability to protect consumers. “There are no details about how [the TGA] would do a better job and they are very, very close to industry and they appear to be influenced by industry,”  Professor Dwyer says, adding the TGA has an “unhealthy dependence” on registration fees from businesses. “There is also concern that the TGA lacks a consumer protection culture … has failed to address long-standing problems and is not transparent about the outcomes of complaints it currently handles.”

Dr Coleman cautions against disbanding the Complaints Resolution Panel. “It really hasn’t been given a proper go. If the TGA complaint panel was given reasonable resources, I think they could do a good job.”

One example of underfunding is the lack of support for a RACGP member to sit on the panel, which has meant that GPs have not been represented.  “It’s not the RACGP’s job to pay someone to do that job,” Dr Coleman says. “It seems crazy that the national body can’t find even a bit of money to pay a clinician to sit on the panel.”

A radical idea, proposed by Professor Harvey in his submission to the TGA and supported by Professor Dwyer and Dr Coleman, is to send a senior enforcement manager from the ACCC to the TGA to oversee the new system and change the TGA’s culture. This would keep the best of the old system (the code council and the complaints panel) while fixing the flaws, such as the lack of power to enforced determinations, Professor Harvey argues.

The ACCC did not respond when asked whether they would be interested in performing this function. A TGA spokeswoman said, by way of response: “The TGA has an established, productive relationship with the ACCC. This issue is being considered more closely by the TGA in the context of the Expert Review of Medicines and Medical Device Regulation. In the interim, the TGA will continue to work closely with the ACCC as needed to ensure regulatory coverage.”

So in the meantime, there is seemingly no limit to what homeopathy can purport to do.