The New South Wales Civil and Administrative Tribunal recently explored how a general practitioner’s 'unshakeable conviction' in the efficacy of his self-manufactured 'Clark Compound' cream (some iterations of which contained mercury) lead him far outside the bounds of acceptable and appropriate professional conduct.
This article was written by Hannah Shiel and Isabelle Yates for the Australian Health Law Bulletin.
With the Tribunal finding the bulk of allegations against Dr Tuan-Anh Le proven, including allegations that he knowingly exposed child patients to a risk of mercury toxicity, it is somewhat unsurprising that he was found guilty of professional misconduct.
However, the case highlights an unresolved question about the extent to which genuine intent can shield medical practitioners from allegations of impropriety and unethical conduct. At a time where many practitioners are integrating elements of 'complementary healthcare' into their practice, patients and the general public are in need of further reassurance that harmful misuse of these modalities will be acknowledged and dealt with regardless of a practitioner’s intentions.
Introduction
In Health Care Complaints Commission v Le1 (Le), the Health Care Complaints Commission (HCCC) alleged that Dr Tuan-Anh Le, a general practitioner, was guilty of both unsatisfactory professional conduct and professional misconduct in relation to his treatment of three patients to whom he prescribed a skin cream which he developed and manufactured himself. The New South Wales Civil and Administrative Tribunal (the Tribunal) considered not only whether Dr Le’s conduct fell significantly below the expected standard, but also whether his conduct was improper and unethical. The Tribunal found that the particulars of all three complaints against Dr Le were made out, except for the allegation that his conduct was improper and/or unethical.
The decision raises questions about how the regulatory framework will contend with harmful misuse of 'complementary health care'.2
Ultimately, the growing influence of 'complementary' or 'alternative' health care adds impetus to clarifying what the public should expect from medical practitioners, and clearly recognising the failure to provide evidence-based treatment as a breach of the duties of a medical practitioner.
Background and context
Dr Le is a GP who owned and consulted from BHC Medical Centre in Lakemba, New South Wales and also consulted at Campsie Health Care Medical Practice.3
Dr Le developed 'Clark Compound Cream' (CC cream) in about 2000. CC cream was never approved under the Therapeutic Goods Act (TGA). CC cream contains the active ingredients merbromin (also known as mercurochrome) which is a topical antiseptic, and terbinafine hydrochloride, which is a topical anti-fungal. It also contains a sub-therapeutic amount of a steroid. There are four different formulations of CC cream, including 'standard', 'concentrated', 'AV' and 'Herbal' variations. The 'AV' and 'Herbal' formulations do not contain merbromin. Dr Le manufactured CC cream in his rooms, and prescribed and sold it to patients for various skin conditions.4
The HCCC alleged that Dr Le was guilty of unsatisfactory professional conduct and professional misconduct pursuant to ss 139B and 139E respectively of the Health Practitioner Regulation National Law 2009 (NSW) (the National Law).5 The HCCC relied on a peer opinion from Dr Simon Young (GP) regarding Dr Le’s treatment of Patients A, B and C.6
The facts
The HCCC’s first complaint related to Dr Le’s treatment of three patients:
- Patient A, a 32 year old woman who was not a regular patient of Dr Le,
- Patient B who was 12 months old when first brought to Dr Le by his parents, and
- Patient C, who was 7 years old when brought to Dr Le by his parents.
Patient A noticed a raised lump on her left foot in 2017. She consulted with Dr Le who told her to use the CC cream on the lump and cover it with a band-aid every time she applied the cream. Patient A said that, after 2 weeks of using the CC cream, the lump began itching. She consulted with Dr Le again, who told her that it was the band-aids causing the itching, not the cream. He gave her a different formulation of the cream which he said was stronger. Patient A followed Dr Le’s advice and the itchiness continued to worsen. She returned to see him twice more as her symptoms did not improve, and on both occasions Dr Le advised that it was not the cream making her foot itchy. Patient A eventually stopped seeing Dr Le and returned to her usual GP who referred her to a dermatologist who subsequently treated the lump.7
Patient B was brought to see Dr Le by his parents in 2020 when he was just over 12 months old. He had a history of erythroderma for which he was hospitalised at 5 months old. He also had other health issues, including acute hepatic dysfunction, poor weight gain, a suspected underlying genetic disorder and a zinc deficiency. He was under the care of the dermatology outpatient clinic at the Children’s Hospital Westmead at the time he was first seen by Dr Le.
In his first consultation, Dr Le noted that Patient B had an inflamed, raw red, peeling rash to his whole body. He prescribed an antibiotic and CC cream. Dr Le continued to prescribe CC cream to Patient B over the following 12 months, and the skin inflammation was noted to be ongoing. Dr Le noted in his consultation record in October 2021 that Patient B’s parents and a treating specialist were concerned about mercury toxicity from CC cream. He ordered blood tests and prescribed ongoing use of CC cream. In November 2021, Patient B’s blood test results showed a mercury level of 343nmol/l — the normal reference range is below 60nmol/l. Dr Le recommended stopping CC cream for a month and then repeating blood tests.
The dermatologist at the Children’s Hospital called Dr Le in November 2021 and February 2022 to express his concerns about mercury toxicity from use of CC cream. Patient B’s last consultation with Dr Le was in July 2022, and his mercury levels were down to 75. The dermatologist at the Children’s Hospital made a complaint about Dr Le’s treatment of Patient B (as well as Patient C, discussed below).8
Patient C was brought to see Dr Le by his parents in October 2021 when he was 7 years old. At the first consult, Dr Le noted that he had patches of infected eczema over his whole body and prescribed CC cream. Dr Le saw Patient C three further times, and noted no improvement on any of these occasions but continued to prescribe CC cream.9
The second complaint against Dr Le related to his alleged failure to disclose his financial interest in CC cream before recommending it to his patients, and general prescribing and compounding issues related to his manufacture and prescribing of the CC cream.10
The third complaint alleged that Dr Le was guilty of professional misconduct under s 139E of the National Law.11
The decision at hearing
Dr Young’s opinion
Solicitors for Dr Le submitted that the Tribunal should approach the peer opinion of Dr Simon Young (GP) with caution on the basis that his report strayed into commentary on Dr Le’s character rather than conduct. It was also submitted that his report was finalised before Dr Le’s evidence in reply was served, that it did not reflect all the evidence in the matter and should be given less weight.12
The Commission advised that Dr Young had considered the additional material provided by Dr Le after the date of his report, and it did not cause him to change or revise his opinion. Furthermore, the Tribunal noted that Dr Le’s advisors did not seek to examine Dr Young based on the additional evidence provided after his report was finalised or on the opinion expressed in his report. The Tribunal did not accept this challenge to Dr Young’s opinion.13
Dr Le’s submissions raised criticisms of Dr Young’s descriptions of Dr Le’s 'slavish' adherence to prescribing CC cream, and his 'grandiose' and 'dogged' conduct, arguing that these characterisations indicated a lack of balance in his report. The Tribunal noted that Dr Young’s verbiage was 'flamboyant' in some instances, but concluded overall that his opinion was of the standard expected of a GP of equivalent training or experience to Dr Le.14
Overall, the Tribunal was not persuaded by submissions that Dr Young’s report should be given less weight, and resolved to rely on his opinion.15
Findings on each of the complaints
Complaint one
The first complaint alleged that Dr Le was guilty of unsatisfactory professional conduct under s 139B(1)(a) or (l) of the National Law on the basis that he engaged in conduct significantly below the reasonably expected standard, and that he engaged in improper or unethical conduct in relation to Patients A, B and C.
In relation to Patient A, the Tribunal found all particulars of the complaint established, namely that Dr Le failed to conduct an adequate and appropriate initial assessment, that he misdiagnosed Patient A’s lesion, that he inappropriately prescribed CC cream, that he failed to obtain adequate and appropriate informed consent from the patient prior to prescribing CC cream, and that he inappropriately continued to prescribe CC cream to Patient A.16
Dr Young, with reference to the Medical Board of Australia’s Good Medical Practice: A Code of Conduct for Doctors in Australia,17 opined that Dr Le failed to maintain adequate records for Patient A, including failing to record a diagnosis for her lesion.18 The Tribunal found that Dr Le failed to record a 'targeted history', a provisional diagnosis, or observations at the initial consultation and thus fell well below the expected standard.19
Further, it was Dr Young’s opinion that, in order for Dr Le to have obtained adequate and appropriate informed consent, he would have had to inform the patient that CC cream 'was not an evidence-based or mainstream medication', the cream’s ingredients, the comparative cost of CC cream and other treatments, and that he had a financial interest in the sale of the cream.20 Having disclosed all this information, if the patient consented to use of CC cream, Dr Young said Dr Le should have then recorded this in his notes. The Tribunal found that Dr Le had failed to obtain this standard of adequate and appropriate informed consent from Patient A for use of the CC cream.21
The Tribunal also found all particulars of the complaint in relation to Patient B established, namely that Dr Le failed to conduct an adequate and appropriate initial assessment, that he prescribed CC cream when it was not clinically indicated and was inappropriate, that he continued to inappropriately prescribe CC cream, that he failed to obtain adequate and appropriate informed consent from Patient B’s parents regarding the prescription of CC cream, that he did not liaise with the dermatology team at the Children’s Hospital Westmead, and that he continued to prescribe CC cream when there was no evidence it was safe for children and when he knew the risks of mercury toxicity.22
The Tribunal noted Dr Le’s assertion that the parents of Patient B 'would have been aware' that he had a financial and commercial interest in the sale of CC cream because they knew he developed and compounded it. However, this was deemed insufficient to establish the extent to which he disclosed the information necessary to obtain adequate and appropriate informed consent (as per the matters outlined by Dr Young in relation to Patient A).23
The Tribunal found all particulars of the complaint in relation to Patient C established, namely that he inappropriately prescribed CC cream when it was not clinically indicated, that he failed to manage Patient C’s eczema-related itchiness with evidence based treatments, that he continued to prescribe CC cream when he was aware of elevated mercury levels and where there was no evidence it was safe for children, and that he failed to refer Patient C to a dermatologist.24
Dr Le advised the Tribunal that, after he received the complaint relating to Patient B, he created a consent form for CC cream. A copy of this consent form appears in Patient C’s notes and is dated after Dr Le had been informed about the concerns of mercury toxicity in Patient B.25 The form indicates that CC cream is 'not conventional and has not yet been TGA approved'.26 The Tribunal noted that, although Dr Le had been made aware of the concerns about mercury toxicity in Patient B, the consent form he developed did not mention this as a risk.27 This was found not to meet the standard for 'informed choice' as set out in the Medical Council’s 'Complementary Health Care Policy', which requires that practitioners provide 'an objective account of the risks … of any recommended non-evidence based … treatment'.28
The Tribunal further noted the unchallenged opinion of Dr Young, being that Dr Le’s conduct fell significantly below the standard reasonably expected of a GP of equivalent training and experience.29 The Tribunal was satisfied that Dr Le was guilty of unsatisfactory professional conduct under s 139B(1)(a) of the National Law ('Conduct significantly below a reasonable standard').
The Commission also asserted under s 139B(1)(l) of the National Law that Dr Le was guilty of unsatisfactory professional conduct because his conduct was improper or unethical. Ultimately, the Tribunal was not satisfied that Dr Le’s conduct was either improper or unethical, emphasising that, while his conduct was significantly below the expected standard, it was motivated by an 'unshakeable conviction that the cream he developed and produced represented help when other treatments had not worked'.30
Complaint two
The second complaint, relating to general prescribing/compounding issues, alleged that Dr Le was guilty of unsatisfactory professional conduct under s 139B(1)(a), (i) or (l) on the basis that his conduct fell significantly below the reasonably expected standard, that he failed to disclose a financial interest in recommending that a person used a health product, and that he engaged in improper or unethical conduct.
The Tribunal found the particulars of this complaint were made out, including that Dr Le inappropriately prescribed CC cream, failed to disclose his pecuniary interest in CC cream to his patients, failed to comply with the Medical Council of NSW’s 'Complementary Health Care Policy', and engaged in prohibited bulk manufacturing of CC cream. The Tribunal did not address the allegation of improper and unethical conduct in relation to the second complaint, presumably relying upon the previous reasoning regarding the first complaint.31
Complaint three
The third complaint alleged that Dr Le was guilty of professional misconduct under s 139E of the National Law because he had engaged in instances of unsatisfactory professional conduct which was sufficiently serious (either independently or considered together) to justify suspension or cancellation of his registration. The Tribunal was satisfied that Dr Le’s conduct in the treatment of all three patients was sufficiently serious to amount to professional misconduct. In particular, the Tribunal drew attention to Dr Le’s continuing prescription of CC cream to Patients B and C even after becoming aware of concerns about mercury toxicity, and his recommendation that Patient A continue to use CC cream even after her lump became itchy.32
Dr Le elected to have the complaint heard in two stages, with this decision confirming the finding of professional misconduct pursuant to s 139E of the National Law, and the proceedings adjourned to 25 February 2026 to determine the necessary orders.33
The implications
Although the Tribunal is yet to make orders in Dr Le’s case, the initial decision raises three salient issues.
Firstly, the Tribunal dismissed the assertion that Dr Le’s conduct was improper or unethical for the purposes of s 139B(1)(l) of the National Law. The decision extracts a passage from the Office of Local Government v Toma34 (Toma) in which the Tribunal held that improper and unethical conduct:
The Tribunal’s reference to the construction of improper and unethical conduct as an objective standard in Toma becomes somewhat puzzling in light of their subsequent emphasis that Dr Le’s conduct was motivated by his 'unshakeable conviction' that the CC cream was effective and therefore did not amount to unethical or improper conduct. This rather seems to suggest a subjective construction, under which a practitioner’s conduct cannot be improper or unethical if it is driven by a genuine belief that it is beneficial and appropriate for a patient.36 It could reasonably be argued that Dr Le’s conduct (knowingly exposing children to a risk of mercury toxicity, for instance) fell afoul of the Toma standard of improper and unethical conduct, yet the Tribunal’s reasoning on this point was not elucidated any further.37
The Tribunal has previously considered the meaning of 'improper' and 'unethical' in HCCC cases. In Health Care Complaints Commission v Kesserwani38 (Kesserwani), the Tribunal held that 'the use of the word ‘or’ in s 139(1)(l) suggests that the words unethical and improper should be read disjunctively and do not carry the same meaning' but noted that there may be overlap in their meanings.39 Further, the Tribunal took the view that 'unethical' conduct implies that the conduct falls short of the professional standard and that conduct has been performed 'subjectively in a way that is morally dubious or unprincipled'40 (emphasis in original).
This accords with the Tribunal’s emphasis in Le that Dr Le’s conduct was motivated by sincere belief that he was acting in his patients’ best interests. However, as the Tribunal noted in Kesserwani, 'improper' and 'unethical' are to be read disjunctively for the purposes of s 139(1)(l) of the National Law, and the lack of subjective moral opprobrium does not dispose of the issue of impropriety.
The Tribunal has held that 'improper' conduct is an objective standard.41 Professional disciplinary proceedings have adopted the High Court’s consideration of the term 'improper' in R v Byrnes.42 In that decision, the High Court held that impropriety does not depend on a person’s 'consciousness of impropriety', but rather comprises the breach of standards reasonably expected of someone with that person’s duties, powers and authority.43
Taking this definition, the question remains — how could Dr Le’s conduct in relation to Patients A, B and C, and in prescribing and manufacturing CC cream generally, could not be deemed improper, even if it was not unethical? In drawing attention to Dr Le’s subjectively genuine intentions, the Tribunal followed the reasoning expounded in previous HCCC decisions that unethical conduct is a subjective test. However, the reasoning behind finding that his conduct was not improper remains opaque and indeed difficult to understand in light of the construction of impropriety in the decisions of Toma and R v Byrnes.
Indeed, it may be that findings of impropriety are more readily made in cases involving inappropriate financial/commercial dealings by medical practitioners. Notably, the Tribunal found in 2024 that a practitioner had engaged in improper and unethical conduct after he continued treating relationships with two patients after entering into commercial/employment relationships with them.44 However, Dr Le was also found to have failed to disclose his pecuniary interest in CC cream when prescribing it to patients, yet the Tribunal did not mention this in considering the allegation of improper and unethical conduct.
The outstanding issue of impropriety in Le raises questions about how the contentious topic of complementary health care will be handled in future, noting that there are sure to be more regulatory cases pertaining to its use. The Tribunal found that Dr Le breached the Medical Council of NSW’s 'Complementary Health Care Policy' by failing to ensure that his prescribing of CC cream did not discourage use of evidence-based treatment and by failing to provide his patients with an objective account of the risks, benefits, efficacy and cost of CC cream.45
This policy, which emphasises that '[m]edical care is based on evidence-based research', was implemented in a background of the Council’s concern about complementary health care practices causing 'direct, indirect or financial harm to patients'.46 Given the Tribunal’s findings, it is uncontroversial that Dr Le caused at least one, if not all, of these types of harm to his patients. If impropriety is to be understood by reference to the standards expected of someone with the relevant person’s duties, powers and authority, surely the Council’s policies are apt source material to determine the duties of a medical practitioner such as Dr Le.
Concluding remarks
Complementary health care no doubt has its place in meeting the needs of particular patients. However, as more medical practitioners start offering treatments and modalities that could be considered complementary health care (utilising terms such as 'alternative', 'holistic', or 'functional'), the regulators must keep pace with monitoring concerns about direct, indirect or financial harm to patients. Section 139(1)(l) of the National Law provides a mechanism to moderate the boundaries of acceptable and appropriate conduct in the context of this shifting landscape of medical practice (or purported medical practice).
It is possible or even likely that most practitioners offering complementary health care have a genuine belief in the benefit of these modalities as Dr Le did. However, when harm comes to patients as a result of misuse of complementary health care practices, findings of impropriety have the potential to reinforce that the duties of medical practitioner are governed by an objective standard, notwithstanding the practitioner’s subjective beliefs, and that the public is entitled to expect that they will not breach these standards.
To read the full article and gain further insights into this case, click here.
1 Health Care Complaints Commission v Le [2024] NSWCATOD 171; BC202415425.
2 In their 'Complementary Health Care Policy' the Medical Council of NSW defines 'complementary health care' as the provision of care, or aspects of care, which have not been scientifically validated 'based on evidence-based research which evaluates methods of assessment, investigation and treatment for the efficacy, safety, quality and cost-effectiveness'. Medical Council of NSW Complementary Health Care Policy Policy version 3 (2015) 2 www.mcnsw.org.au/sites/default/files/dd15_43664_policy_-_complementary_health_care_-_version_3_finalised.pdf.
3 Above n 1, at [2].
4 Above n 1, at [3]–[5].
5 Above n 1, at [1].
6 Above n 1, at [13].
7 Above n 1, at [24]–[35].
8 Above n 1, at [69]–[89].
9 Above n 1, at [135]–[45].
10 Above n 1, at [175]–[76].
11 Above n 1, at [216].
12 Above n 1, at [14]–[15].
13 Above n 1, at [17]–[18].
14 Above n 1, at [19]–[21].
15 Above n 1, at [22]–[23].
16 Above n 1, at [24]–[68].
17 Medical Board of Australia Good Medical Practice: A Code of Conduct for Doctors in Australia Code (2020) [10.5] www.medicalboard.gov.au/codes-guidelines-policies/code-of-conduct.aspx.
18 Above n 1, at [40]–[41].
19 Above n 1, at [42].
20 Above n 1, at [56].
21 Above n 1, at [60].
22 Above n 1, at [69]–[134].
23 Above n 1, at [122]–[23]. See further, above n 1, at [56] for the elements Dr Young outlined would be necessary for Dr Le to disclose in order to obtain adequate and appropriate informed consent for the use of CC cream.
24 Above n 1, at [135]–[68].
25 Above n 1, at [202].
26 Above n 1, at [203].
27 Above n 1, at [204]–[5].
28 Above n 2, at 3.
29 Above n 1, at [170].
30 Above n 1, at [174].
31 Above n 1, at [175]–[216].
32 Above n 1, at [217]–[24].
33 Above n 1, at [225].
34 Office of Local Government v Toma [2016] NSWCATOD 21; BC201600952.
35 Above, at [25].
36 There is an ongoing debate as to whether it is inherently unethical for medical practitioners to prescribe complementary or alternative treatments that are not evidence based. See, eg, M Pirotta 'Is it ethical for medical practitioners to prescribe alternate and complementary treatments that may lack an evidence base? — Yes' (2011) 195(2) MJA 78; and J Dwyer 'Is it ethical for medical practitioners to prescribe alternative and complementary treatments that may lack an evidence base? — No' (2011) 195(2) MJA 79.
37 Except for reference to the consideration of the meaning of 'improper' and 'unethical' in Health Care Complaints Commission v Sare
[2018] NSWCATOD 190; BC201811394 in which the Tribunal considered the dictionary definitions of both terms.
38 Health Care Complaints Commission v Kesserwani [2020] NSWCATOD 65; BC202005413.
39 Above, at [25].
40 Above n 38, at [26].
41 Health Care Complaints Commission v Liu [2016] NSWCATOD 133; BC201609064 at [54].
42 Above, at [54]; R v Byrnes (1995) 183 CLR 501; 130 ALR 529; [1995] HCA 1; BC9506451 (Byrnes).
43 Above, Byrnes, at 538.
44 Health Care Complaints Commission v Pincock [2024] NSWCATOD 89; BC202408700 at [114]–[22].
45 Above n 1, at [186].
46 Above n 2, at 2.
