Introduction by Croakey: In 2015, when The Australian Competition and Consumer Commission (ACCC) instituted proceedings in the Federal Court of Australia against the makers of the analgesic, Nurofen, for labelling its range of identical Ibuprofen formulations as being specific to various types of pain, chair of the ACCC, Rod Sims said,
The ACCC takes false or misleading claims about the efficacy of health and medical products very seriously.”
It’s a phrase the author of the post below would like to see put to use more often.
Robin Brown, who has a long history of working in government accountability and consumer advocacy, writes that consumers expect that health professionals who offer, recommend, or refer for any therapeutic good or service, do so with at least some evidence of efficacy – and that they will carry their professional ethics into any business activities outside clinical practice.
Here, Brown explores some of the grey areas for health practitioners who wish to use complementary, unconventional or emerging therapies. The Medical Board of Australia is currently developing guidelines, with the aim of clearer regulation of doctors who provide such treatments.
Brown writes that this is an area that is ripe for the regulators of all the health professions.
Robin Brown writes:
Efficacy is the extent to which an intervention does more good than harm under ideal circumstances (“Can it work?”).
Services and goods provided for therapeutic or health maintenance purposes can be seen as falling into one of five categories – those for which there is:
- Good evidence of efficacy
- Limited evidence of efficacy
- No evidence of efficacy
- Evidence of inefficacy
- Evidence of risk to health
The principle of evidence-based services and goods is fundamental to the Australian health system. Thus, Australian consumers would generally understand that our accredited courses for health professionals* deliver training to enable them to provide services, and to provide or use goods which, at the time of the course, fall into the first of the above categories or possibly the second.
In their continuing professional development, practitioners would be expected to learn when services and goods move from one category to another as a result of new research.
As well as “Can it work?” there are other considerations to be taken into account in determining an appropriate therapeutic intervention. An intervention might meet the efficacy standard, but practical factors might mean it is not effective (“Does it work in practice?”).
In addition, the efficiency of an intervention, that is its effectiveness in relation to the resources it consumes (“Is it worth it?”), must be taken into account.
Communicating efficacy: consumer expectations and health professionals’ obligations
Consumers would generally expect that any health professional* would provide a service, or use or provide a good, that fell into the first category above (or possibly the second), and that was effective and efficient**.
The Medical Board of Australia’s code of conduct, Good medical practice: a code of conduct for doctors in Australia states that doctors should provide ‘treatment options based on the best available information’.
Section 8 of the code states obligations in relation to advertising, including that good practice involves ensuring information ‘is factual and verifiable’, ‘making only justifiable claims’ and ‘not exploiting patients’ vulnerability’.
The Medical Board is in the process of developing guidelines for medical practitioners on “Complementary and unconventional medicine and emerging treatments” defining these as,
any assessment, diagnostic technique or procedure, diagnosis, practice, medicine, therapy or treatment that is not usually considered to be part of conventional medicine, whether used in addition to, or instead of, conventional medicine. This includes unconventional use of approved medical devices and therapies.”
Under the guidelines, medical practitioners would be required to make clear to a consumer, the evidence or otherwise of efficacy of any complementary or unconventional medicine or emerging treatment the consumer might be considering using or obtaining, or which practitioners themselves might consider offering or recommending.
The difficulty with alternate and unconventional and emerging treatments is the profile often looks like:
- Can it work? – There is often little or no evidence, or no research has been undertaken. Because no patent protection is available, any company can free-ride on any investment in research any other company might undertake.
- Does it work in practice? – There is likely to be even less systematic evidence, apart from that of practitioners and consumers who hold energetic and passionate beliefs in the usefulness of these kinds of care. This can be supplemented by misinformation on the internet.
- Is it worth it? – Again, though there may be no evidence, many consumers believe their expenditure is worthwhile.
The definition of unprofessional conduct in the National Law that regulates registered health practitioners, includes the following:
(d) providing a person with health services of a kind that are excessive, unnecessary or otherwise not reasonably required for the person’s wellbeing
(h) referring a person to, or recommending that a person use or consult, another health service provider, health service or health product if the practitioner has a pecuniary interest in giving that referral or recommendation, unless the practitioner discloses the nature of that interest to the person before or at the time of giving the referral or recommendation.
Arguably, if guidelines governing complementary and unconventional medicine and emerging treatments are enacted, it would, in effect, mean that it would be unprofessional conduct for a medical practitioner to offer, recommend, suggest or refer in relation to:
- Any of the 17 services the National Health and Medical Research Council (the NHMRC 17***) found to have inadequate evidence of efficacy and which now may not be covered by health insurance, and
- Any service or good which falls outside efficacy category 1 or 2.
It also seems appropriate that the principles applying to medical practitioners in relation to “complementary and unconventional medicine and emerging treatments” should apply to all health professionals and certainly to all health practitioners registered under the National Registration and Accreditation Scheme by AHPRA.
Practitioners providing services or supplying goods separately from their registered practice – ethical issues
Health professionals (including registered health practitioners) often have businesses separate from their practices. (h) above seems to permit a registered practitioner to sell or be involved in selling a “health service or health product” separately from their registered practice provided they disclose their interest.
Currently health practitioners are perhaps not constrained from “d) providing a person with health services of a kind that are excessive, unnecessary or otherwise not reasonably required for the person’s wellbeing” if they are not providing such services to a person as part of their registered practice, even if the person is a client of their registered practice.
It seems unlikely, however, that a consumer, whether or not a client of a particular health professional, perhaps especially a registered practitioner, would expect health professionals to set aside their professional principles when, separately from their practice, they offer goods and/or services.
For example, a client of a dietitian could reasonably expect that, if the dietitian had a business selling food products, they would not offer a food product which had been found by nutritional science to contribute to poor nutrition – or at the very least, they would advise clients that the product had nutritional disadvantages.
Likewise, a consumer could reasonably expect that goods offered for sale for therapeutic purposes in a pharmacy, would only be in efficacy categories 1 and 2, or at the very least to be advised if a good did not fall into those categories.
The Pharmaceutical Society of Australia (PSA) has in fact said:
The supply of homeopathic products is in contravention of the PSA Code of Ethics for Pharmacists. The Code of Ethics, recognised by the Pharmacy Board of Australia, states that pharmacists should only “supply or promote any medicine, complementary medicine, herbal remedy or other healthcare product where there is credible evidence of efficacy and the benefit of use outweighs the risk.”
Psychologists must abide by a code that prevents them from engaging in multiple relationships with clients so they may only provide services and/or goods separate from their psychology practice to persons who are not their psychology clients.
If a person who is a psychologist, or indeed is any kind of health professional, has a business that is completely separate from their health practice, selling goods or services that consumers could perceive to have therapeutic or health maintenance value when there is no evidence for such value, is it enough that normal consumer law prohibits misleading and deceptive practices?
Such goods or services may be sold, but claims of therapeutic or health maintenance value may not be made. Many would argue that an ordinary businessperson selling such goods and services is only legally and ethically obliged to ensure no incorrect information or impression is conveyed about the goods or services.
Others would argue differently, but there is perhaps a clearer ethical obligation if the seller is a person known to consumers to be a health professional. Because consumers invest a particular trust in them it might be argued that it is incumbent on health professionals to assist consumers to make adequately informed decisions about the therapeutic or health maintenance value of goods and services.
Because of this trust, consumers are likely not to take the steps they would normally take to inform themselves about goods and services and the competitiveness of pricing.
If the seller’s status as a health professional is completely obscured it might be argued that no special obligations apply, but one might reasonably expect that the seller’s personal ethics should result in their adhering to their professional ethics anyway. In many cases, especially in small communities or if the health professional had a high public profile, it would not be possible to completely obscure a professional status.
These issues are further explored in an appendix, here.
The placebo effect can no doubt be therapeutically useful. Many people using one of the NHMRC 17 services have benefited from it, and no doubt many people buying vitamins and supplements and herbal preparations which have no nutritional or pharmacological value to them are benefiting from the placebo effect.
The problem is discriminating between a useful placebo effect and an inefficient use of national resources and a waste of consumers’ money.
Making money selling goods and services that are useless, therapeutically and for health maintenance, is clearly unethical and should be unlawful even if advertising and labelling is not misleading or deceptive.
Surely it is unfair, and surely it is unjust enrichment. Surely it offends the principle that “no one should be benefited at another’s expense,” a principle that is at least as old as Roman law “nemo locupletari potest aliena iactura”.
A costly business, in need of regulation
The issue of health professionals, endorsing, promoting or selling unproven therapies is significant in individual and community terms. Individuals are at risk of spending money they cannot afford, on useless goods and services, and perhaps delaying efficacious therapy or at worst not receiving needed therapy at all.
The cost to the community is also enormous. On some estimates at least 3 billion dollars are spent on vitamins, supplements, herbal preparations and the like with no therapeutic or health benefit, and there is probably quite significant spending on the NHMRC 17.
This amounts to significant allocative inefficiency and thus welfare loss. This is ironic given the amount the nation spends to produce health professionals of the highest standard. The productive capacity involved could be used on genuinely valuable therapeutic and health maintenance goods and services, or in some other welfare improving manner.
Uninfluenced by vested interests, the Productivity Commission could be expected to make useful recommendations if given a reference. The ACCC should take more actions like the Nurofen action. The TGA should act, but it is perhaps politically unable to do what is necessary.
The other health practitioner boards, especially the Pharmacy Board, should provide guidance similar to that which the Medical Board is developing. State and territory health service/complaints commissioners should utilise the National Code of Conduct for Health Care Workers to the greatest effect possible.
*The term “professional” is used here to cover both health service providers who are registered practitioners in the National Registration and Accreditation Scheme and unregistered providers regulated by the National Code of Conduct for Health Care Workers. There would be many kinds of providers in the latter category whom many would not regard as professionals, but some, such as dieticians and counsellors, would be seen as professionals by most consumers.
**Consumer expectations was the basis for which Commission Hayne recommended a statutory best interests test for mortgage brokers. “Consumers expect mortgage brokers to act in their best interests – so the law should say this”. There are a number of regulatory concepts that apply to financial service providers that perhaps are appropriate for health professionals. These are discussed in an appendix to this paper.
***Alexander technique, aromatherapy, Bowen therapy, Buteyko, Feldenkrais, Western herbalism, homeopathy, iridology, kinesiology, naturopathy, pilates, reflexology, Rolfing, shiatsu, tai chi, and yoga.
Robin Brown is Deputy Chair of ACCESS2 and was head of the Consumers’ Federation of Australia during the 1990s during which time, with Philippa Smith and John Wood he founded the Consumers’ Health Forum and served on its inaugural General Committee. He has served as a consumer representative on many policy advisory and regulatory bodies including the Public Health Committee of the NHMRC and others in the health area. He is currently a member of the Dental Board of Australia and the ACT, Tasmania, Victoria Psychology Board. This article is written in a private capacity and the opinions and views expressed are the author’s own. It does not reflect the views of either of these boards or the Australian Health Practitioner Regulation Agency.