Health Care Complaints Commission v Le

Peer opinion

1. In determining whether the alleged conduct amounts to unsatisfactory professional conduct the Tribunal must determine whether the conduct fell below the standard expected of a practitioner of equivalent level of training or experience to the Respondent.
2. To this end, the Commission sought the opinion of a general practitioner, Dr Simon Young, who was asked to consider the Practitioner's treatment of the patients to whom the Complaint relates.
3. The Respondent submitted that, although there were aspects of Dr Young's opinion which support the Respondent's clinical approach in dealing with the patients referred to in the complaint, the Tribunal should approach Dr Young's evidence with caution for a number of reasons.
4. First, it was said that Dr Young's opinion was furnished on 10 August 2023 before the Respondent's evidence in reply was served and so his opinion did not reflect all the evidence in the matter. It was argued that therefore, less weight should be attributed to his opinion. It was submitted that the Commission could have sought a supplementary or additional report from him but did not.
5. Counsel for the Commission informed the Tribunal that Dr Young had considered the additional material provided after the date of his report and it did not cause him to alter his opinion. On this basis alone, it appears that nothing would have been gained by the Commission seeking an additional report.
6. However, the Respondent did not seek to examine Dr Young to challenge his opinions, either based on the additional evidence or the contents of his report. This fact plus the fact that in submissions, apart from the general comment that because his report did not mention the later material it should have less weight, counsel for the Respondent did not point to one area or issue which, had it been considered by Dr Young, would have made a difference to his opinion or caused the Tribunal to take a different approach to the evidence.
7. We do not accept this challenge to Dr Young's opinion.
8. Next, it was argued that Dr Young, in considering the Respondent's conduct in relation to the patients, exceeded the basis on which the opinion was sought because some of his comments could be seen as going to the Respondent's character rather than his conduct. We do not agree. Many of Dr Young's opinions and comments which drew the Respondent's criticism are directly relevant to issues to be determined by the Tribunal. For example, Dr Young was criticised for opining that the Respondent adopted a "slavish" adherence to prescribing CC cream and it was said his report therefore lacked balance. An aspect of the Commission's complaint against the Respondent was that he adopted the use of CC cream as a first line treatment even when other conventional treatments had not been tried. It was also the Commission's case that the Respondent steered his patients away from conventional cortico-steroid treatment in favour of his CC cream.
9. Much of the criticism of Dr Young's opinion rests on an acceptance of the Respondent's evidence and assertions. It will be for the Tribunal to assess the evidence including that of the Respondent and determine whether the Commission has established the Complaints and the particulars supporting them.
10. While Dr Young uses somewhat flamboyant words to describe the Respondent's conduct such as "grandiose" and "dogged", his opinion on the standard expected of a general practitioner of equivalent level of training or experience to the Respondent was not challenged. The characterisation of the Respondent's conduct, if necessary, will be a matter for the Tribunal having considered the evidence and forming its own conclusions about the evidence and its effect.
11. We do not accept that the matters to which the Respondent refers serve to reduce the weight to be attributed to the Dr Young's opinion nor do we find his opinion was unbalanced.
12. We propose to rely on his opinion as to how the Respondent's conduct, the subject of the complaint, is measured against the expected standard.

COMPLAINT ONE The practitioner is guilty of unsatisfactory professional conduct under section 139B(1)(a) or (I) of the National Law in that the practitioner has: i. engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or ii engaged in improper or unethical conduct relating to the practice or purported practice of medicine.

Patient A 1. On or around 28 October 2020, the practitioner failed to conduct an adequate and appropriate initial assessment of the lump on Patient A's left foot. 2. On or around 28 October 2020, the practitioner misdiagnosed Patient A's left foot lesion as a chronic solitary dermatitis nodule caused by habitual trauma. 3. Between 28 October 2020 and 8 February 2021, the practitioner inappropriately prescribed CC cream, when he should have prescribed an evidence-based treatment such as mild cortisone cream and moisturiser. 4. On or around 28 October 2020, the practitioner failed to obtain adequate and appropriate informed consent from the patient prior to prescribing CC cream in circumstances where CC Cream was not TGA approved nor a conventional treatment for eczema. 5. Between around 9 December 2020 and 8 February 2021, the practitioner inappropriately continued to prescribe CC cream after Patient A reported itchiness and the lesion on her foot became progressively worse.

1. In Patient A's statement, she said that in 2017, she noticed a raised lump on her left foot which was very small, about 1 centimetre, it was not itchy. It was "a little bit pinkish with black around it". She said it was not painful but a few years later, after her child threw a toy which landed on her foot, it became painful to touch. She went to see her doctor. Her usual general practitioner recommended that she see a skin specialist, however Patient A said that her neighbours told her that the Respondent treated skin conditions and so, she decided to consult him.
2. The patient did not say in her statement that the lump had been itchy before seeing the Respondent nor did she say she had been picking at it.
3. Patient A said that at her first consultation with the Respondent he said; "it's just a lump", gave her cream to put on it and told her to cover it with a band aid every time she applied the cream. She said: "He had two creams, yellow and red. He gave me yellow cream the first time". Patient A could not remember how many times a day the Practitioner told her to apply the cream, she thought maybe three times. She said that the Practitioner did not tell her the name of the cream or where it came from although she said her friends in the neighbourhood told her he made his own cream. The Patient said that at the end of the appointment, she got the cream from the receptionist and paid about $20 or $25 for the cream. The patient said that the tube was white at the bottom and yellow at the top. She could not remember if there was any writing on the tube. The cream inside was yellow.
4. Patient A said that after two weeks the lump began itching. When she consulted the Respondent about the itching, he said to her that it was the band aids, not the cream, making it itch. He told her to swap the yellow cream for the red cream and told her it was stronger than the yellow cream. He told her to put the cream on and around the lump. She said he told her there would be no need "to cut" the lump because it would disappear with the cream. As with the yellow cream, the patient purchased the cream from the receptionist. This time, she said, the tube was white at the bottom and red at the top. The cream inside was red.
5. Patient A followed the Respondent's advice. The itchiness became worse and she saw "so many reddish things around the lump that make me itchy", so much so that after a month she returned to the Respondent who told her to stop using the red cream and resume the yellow cream. The Practitioner told her it was not the cream making her foot itchy. Again, the patient purchased the cream from the receptionist.
6. The patient said that despite following the Respondent's advice the itchiness continued and she returned to see him and, again, the Respondent said it was not the cream causing the itch and suggested that she wear socks and wondered whether the cause of the itch was dietary. The Respondent told her to use the red cream again. The itching became worse. She stopped seeing the Respondent and returned to her own general practitioner who then referred her to a dermatologist who treated the lump.
7. As will be discussed later, the Respondent's notes in relation to the consultations with Patient A are scant and lack adequate detail. In his written reply to the complaint, the Respondent sets out in considerable detail the conversation he had with Patient A about his use of CC cream including that he told her that treatment using a corticosteroid was "gold standard". He said the patient told him that lesion was itchy and she had been scratching it and he told her to stop doing that because it would not heal.
8. The Respondent's reply contains details of the subsequent consultations with Patient A which do not appear in his notes.
9. During his evidence before the Tribunal, the Respondent used Patient A's notes to refresh his memory of events that occurred during the consultations and it could not be said that he had a clear, independent recollection of his interactions with Patient A. Commonsense would dictate that in a practice such as that operated by the Respondent with many, many patients presenting with skin conditions, he would not have a perfect memory of what was said in any particular consultation outside what was written in the notes.
10. Even so, the Respondent's written reply to the complaint does not mention him asking the patient what treatments she had tried before coming to him to address the lesion. He asserted, however, in his evidence that she had tried mainstream treatments without success before coming to him.
11. In short, we do not accept that the Respondent's recollection of the events in the consultations with Patient A is reliable, not because he is not being truthful but because of the frailties of recollection with no document to assist his recollection.
12. Patient A's unchallenged account of what occurred during the consultation, where it is relevant to proof of a particular supporting the Complaint is, in our view, more reliable an account of what happened than the Respondent's.

Failure to conduct an adequate and appropriate initial assessment

1. Patient A's first appointment with the Respondent was 28 October 2020. The Respondent's records for that appointment do not include the patient's medical or family history. He noted "no reg med" but there is nothing in the notes about how long the lump had been present, whether the patient had tried other medication for it or whether she had tried steroid based medication.
2. The notes record: Traumatic nodular lesion on left dorsal 8mm with pih and excoriation Rx. Clarkr (sic) comp occlusive dressing.
3. The Respondent said that, while there is no note of it, he recalled asking the patient whether she had used steroids to address the lump.
4. Dr Young noted that while Patient A's statement reflected that the Respondent gave her advice about the use of the creams and covering the site, other than a reference to "occlusive dressing" none of this is found in the Practitioner's notes in relation to this patient.
5. Dr Young referred to the Medical Board of Australia's Good Medical Practice: A Code of Conduct for Doctors in Australia in considering the Respondent's medical records in which it says: Maintaining clear and accurate medical records is essential for the continuing good care of patients. 6. This includes: Keeping accurate, up-to-date and legible records that report relevant details of clinical history, clinical findings, investigations, information given to patients, medication and other management. 7. The litmus test of 'good enough' medical records is: ...ensuring that the records are sufficient to facilitate continuity of patient care.
6. Dr Young noted that the Respondent did not record a diagnosis although the Respondent later said that it was a "chronic solitary dermatitis nodule caused by habitual trauma". Dr Young said that not recording a diagnosis, of itself, indicates that his records were deficient and demonstrated a lack of clinical rigour. He said that the notes show an inadequate assessment, containing only a description without a history. He said that when seeing a patient for the first time, at a minimum, the record should reflect how long the lesion had been present, when it first appeared and any past or present skin, hair or nail conditions.
7. In failing to make a record of "targeted history" and formulating a provisional diagnosis together with observations at the initial consultation, the Respondent fell well below the expected standard.
8. We find this particular established.

Misdiagnosed Patient A's lesion

1. As Dr Young noted, the Respondent's notes in relation to Patient A contain no diagnosis. The Respondent later offered the diagnosis of "chronic solitary dermatitis nodule caused by habitual trauma" because he said the lump had recently become larger and was itchy. We note that the patient's unchallenged evidence was that the lump only became itchy after she began using the CC cream prescribed by the Respondent.
2. Dr Young said that "chronic solitary dermatitis nodule caused by habitual trauma" is not a known diagnosis although "nodular prurigo" produced results from a search of a dermatology website. However, the search said that the hallmark of nodular prurigo is itch. If the evidence of the patient is accepted that the lump was not initially itchy, then Dr Young did not believe the Respondent made an accurate diagnosis of the condition. There is nothing in the Respondent's notes about "habitual trauma" nor does the website refer to it as being part of the condition.
3. Dr Young noted that when Patient A returned to her usual general practitioner, he diagnosed her as having a dermatofibroma which is a common condition and fitted the history given by the Patient. When the patient's usual general practitioner referred her to a dermatologist, Dr Zagarella, for further treatment, he too diagnosed her condition as a dermatofibroma with acute contact dermatitis caused by applying the CC cream to the dermatofibroma.
4. Patient A was not challenged on her account of the condition of the lesion on her foot when she first attended on the Respondent and there is no reason to doubt the accuracy of her version of events, in particular, that the lump was not itchy until she started using the CC cream.
5. We also accept that the diagnosis ultimately offered by two other practitioners of dermatofibroma was both conventional and fitted the patient's history of how long the lesion had been present and its location.
6. We accept that the Respondent misdiagnosed Patient A's condition and find this particular established.

Inappropriately prescribed CC cream

1. It is alleged that between 28 October 2020 and 8 February 2021, the Respondent inappropriately prescribed CC cream for Patient A and he should have prescribed an evidence-based treatment such as a mild cortisone cream and moisturiser.
2. The Respondent, in reply, did not admit that the prescription of CC cream was inappropriate because, he said, other treatments used by the patient before consulting him had been unsuccessful. There is nothing in the notes which indicates any discussion about what had been previously tried, and for reasons discussed, we do not consider the Respondent's recollection of the consultations particularly reliable and are not persuaded that the Respondent and the patient discussed what treatments, if any, had been tried before.
3. Dr Young said that a competent general practitioner, given the history of a longstanding lump (the Patient said it had been there for three years) that had become painful after a recent trauma, would have prescribed simple treatment such as mild cortisone cream and moisturiser and reassessed the lesion once the effects of the trauma had subsided. In his opinion, the Respondent's management of the patient's lesion by prescribing CC cream was inappropriate and fell significantly below the expected standard.
4. We find this particular made out.

Failing to obtain adequate and appropriate informed consent from the patient prior to prescribing CC cream in circumstances where CC cream was not TGA approved nor a conventional treatment for eczema.

1. Dr Young noted that the Practitioner did not obtain written consent or document any discussion with Patient A about the source of the cream or that it was not TGA approved before prescribing it for her.
2. However Dr Young said that adequate and appropriate informed consent does not necessarily have to be in writing.
3. In his opinion, for there to have been adequate and appropriate informed consent, the Respondent would have informed the patient that CC cream was not an evidence-based or mainstream medication, what was in it, why in the Respondent's opinion it was a better option over other evidence-based and mainstream medications, how much it would cost compared with other medications and that he had a financial interest in the sale of CC cream. All that having been discussed, the Respondent should have recorded that the patient was content to use the CC cream.
4. There is nothing in the Respondent's notes for Patient A that reflects that kind of discussion with her about using CC cream.
5. The Respondent said that although he had not recorded anything in the patient's notes about consent, he nonetheless had a specific recollection of discussing with Patient A whether she had used steroids before on the lesion and discussing the use of CC cream.
6. The patient, in her statement, said that the Respondent told her nothing about the cream or where it came from, but she knew from her friends that he made it. She makes no mention of discussing the pros and cons of using a cortico-steroid cream or that CC cream was not TGA approved.
7. We do not accept that the Respondent did have a discussion with the patient about CC cream other than as Patient A said, and we are satisfied that the Respondent did not obtain informed consent from Patient A before prescribing CC cream for her.

Inappropriately continued to prescribe CC cream after Patient A reported itchiness and the lesion became progressively worse.

1. After the initial consultation on 28 October 2020, in which the Respondent prescribed CC cream, the notes for the following consultation on 9 December 2020 record: "Nodule not much smaller rx. Trial Clark con BD may need excision
2. On 1 February 2021 the Respondent's notes record: Nodular lesion left foot got worse with occusive (sic) dressing and dermatitis from adhesive.
3. He recommended an "open dressing with clark conc qid".
4. At the final consultation on 8 February 2021 the notes record that the lesion was smaller and "surrounding dermatitis fully resolved". He prescribed "clark av" to be used four times per day.
5. Dr Young said when the Respondent's notes show the patient's skin condition worsening after the prescription of CC cream, in failing to consider other more likely causes of the patient's worsening condition, the Respondent displayed poor applied professional knowledge and skills.
6. Dr Young was also critical of the Respondent attributing the worsening condition to contact dermatitis from the band aid and poor patient hygiene at the lesion site. He said that a competent general practitioner in these circumstances would have logically concluded that the itch was contact dermatitis caused by the CC cream and ceased using the cream and treated it with a short course of topical corticosteroid cream. In these circumstances, he said that the Practitioner's conduct fell significantly below the expected standard.
7. Accepting the patient's history that the lump only became itchy after the application of CC cream and worsened despite the Respondent's prescription of CC cream, there is significant force in Dr Young's criticism of the Respondent in not considering other causes of the patient's condition. In persisting in prescribing the cream without considering other causes of the worsening condition, the Respondent's conduct fell significantly below the expected standard.
8. We find this particular made out.

PATIENT B 6. On or around 14 August 2020, the practitioner failed to conduct an adequate and appropriate assessment of Patient B at the initial consultation. 7. On or around 14 August 2020, the practitioner inappropriately prescribed CC cream to treat the patient's severe eczema where it was not clinically indicated. 8. Between 19 August 2020 and 5 November 2021, the practitioner inappropriately continued to prescribe CC cream to Patient B where there were other, evidence-based, less expensive alternatives available which would not have placed Patient B at risk of mercury toxicity. 9. Between 14 August 2020 and 5 November 2021, the practitioner failed to obtain adequate and appropriate informed consent from Patient B's parent/s prior to prescribing CC cream in circumstances where CC cream was not TGA approved nor a conventional treatment for eczema. 10. Between 14 August 2020 and 24 December 2021, the practitioner failed to appropriately liaise with the dermatology team at the Childrens' Hospital Westmead in relation to Patient B's treatment and condition at any time. 11. The practitioner inappropriately prescribed CC cream, a mercury containing compound, to Patient B in circumstances where there was no evidence that it was safe for use in children and the risks associated with mercury toxicity were well known.

1. Patient B was born on 9 August 2019. When he was five months old, he spent between 13 December 2019 and 17 January 2020 at the Children's Hospital Westmead for management of erythroderma. While in hospital, it was discovered that he had other health conditions including acute hepatic dysfunction, poor weight gain, a suspected underlying genetic disorder and a zinc deficiency. After his discharge from hospital, Patient B attended the Children's Hospital Westmead dermatology outpatient clinic
2. He was brought to the Practitioner by his parents on 14 August 2020. The Respondent had 11 consultations with the child until 24 December 2021. During the time he was consulting the Respondent, Patient B also attended the dermatology outpatient clinic on 29 January, 2 July and 21 October 2020, and 16 June, 22 September, 18 November and 15 December 2021.
3. At the time of Patient B's first consultation with the Respondent, the dermatology team had reduced the child's treatment to moisturiser only.
4. The Practitioner's notes of the first consultation with Patient B observe that he had spent 26 days in hospital and added: …"first few days due to skin cond then developed adverse rxn from paracetamol with liver failure."
5. He notes that the child had a biopsy and that steroids had been tried in hospital which did not help. He observed that the child's whole body was inflamed, raw red with excessive peeling.
6. The Practitioner prescribed an antibiotic and Clark compound and noted the instructions to "apply a generous amount of Clark Compound to the rash…three times a day".
7. He reviewed Patient B on 19 August 2020, noted "good improvement" and again prescribed the CC cream.
8. On 5 September 2020, the Respondent's notes record the mother telling him by phone that she had taken the child to her general practitioner who advised her to stop the cream. She told the Practitioner that the child's whole body was inflamed. He advised her to bring the child in straight away. The Respondent's notes record "inflamed skin still most of body skin but no skin shedding." The notes record that the Respondent prescribed CC cream to be applied three times a day and that he might try "clark concentrate if not much improved".
9. The child was reviewed on 12 September 2020 and CC cream was prescribed to be applied three times per day.
10. On 10 October 2020, the Respondent noted that the parents had run out of CC cream and ceased using it because they had no money. He provided the cream on credit. In the following consultations, the Respondent recommended Clark Concentrate cream.
11. Over the next 12 months, the Respondent continued to prescribe CC cream, sometimes in the concentrated form.
12. On 13 October 2021 the following is recorded: Has been using Clark concentrated over a year Parents and specialist a bit concer (sic) about mercury toxicity rx. Blood tests Will discuss intensive program for psoriasis treatment after blood tests. May add antibiotic and pulse top (sic) steroid Parents happy to cont with Clark Conc for now
13. As previously mentioned, at the same time as Patient B was being seen by the Respondent, he was being treated at the Children's Hospital Westmead dermatology clinic. The Respondent said that the mother had shown the dermatologist at the hospital the CC cream which led the specialist to express concern. The dermatologist at the Children's Hospital Westmead rang the Respondent on 21 November 2021 and discussed his concerns about mercury toxicity from use of the cream. He made a follow up call in February 2022.
14. Some six weeks later, on 5 November 2021, the blood test results for Patient B were returned and showed a high level of mercury in his blood - 343nmol/l. The normal range for blood serum mercury is less than 60. The Respondent's notes record advice to "stop CC cream for 1 month and repeat the blood test".
15. Patient B's last consultation with the Respondent occurred on 1 July 2022. The notes record that the child's blood serum mercury level was 75, down from the earlier high of 343. The Respondent's notes indicate he advised the parents to "stay off Clark Conc for now".
16. The Practitioner prescribed CC cream in both its regular and concentrate form for this child for a period of about 14 months.
17. When the spectre of mercury toxicity was raised as a concern by the Westmead specialist, the Respondent did not cease the use of the cream but continued its use for a further six weeks until the blood test results were returned.
18. The dermatologist at the Children's Hospital Westmead made a complaint about the Practitioner's treatment of Patient B (and also of Patient C to whom we will refer) and said after noting that these two children, who had both attended the hospital, were being treated for eczema by their general practitioner with a topical mercury-based cream and that he had discussed it with a paediatric toxicologist: Our side (Dermatology) this signifies a significant deviation from standard practice -From the toxicologist side, he suggested that if it is continued for long periods in other patients, it signifies substantial risks of harm (due to possible long term consequences of high serum Mercury). Discussed with Dr Le who suggested safety studies were being performed and suggested he would continue prescribing. The main issue of concern is ongoing prescriptions of these creams that could potentially cause hard if continued long term.
19. Dr Narendra Gunja, expert paediatric toxicologist, prepared a report for the Commission. He said that mercury is a foreign substance to the human body and that the accepted level of mercury in children (who do not consume fish or seafood) is under 10nmol/L.
20. Dr Gunja said: Mercurochrome (merbromin) is an organic mercury salt, and prolonged usage can cause a variety of effects, depending on extent of exposure. These effects include fatigue, insomnia, weight loss, dermatitis, blood disorders and impaired kidney function. Neurological effects have been reported affecting both the central and peripheral nervous systems - peripheral neuropathy and paraesthesia affecting the limbs, and neuropsychiatric disorders. Dermatological effects, when these compounds are applied to the skin, include rash and dermatitis, sometimes exacerbating the conditions for which they are being used. Mercury absorption is increased when applied to non-intact skin, such as in eczema or dermatitis. Long-term risks of ongoing mercury exposure in children is poorly characterised. However, studies from settings where children predominantly have a seafood diet provide some insight into these risks - mainly related to neurodevelopmental impairment from chronic mercury exposure. For these reasons, manufacture and sale of mercury-containing thermometers and skin products are banned (or restricted) in some European countries and the USA
21. We turn then to the particulars of complaint about the Respondent's treatment of Patient B.

Failure to conduct an adequate and appropriate assessment at the initial consultation

1. When the Medical Council received the complaint about the Respondent from the dermatologist at the Children's Hospital Westmead, a s150 Panel Enquiry was convened. In the course of that hearing, the Respondent was asked about his records for Patient B.
2. He agreed that in relation to Patient B nothing was recorded in the notes about allergies, family and social history and medication. The Respondent said that, at that time, he was still working to improve his record keeping. It became clear in the course of the Respondent's evidence to the Panel, that the sole source of information in his notes about Patient B and, in particular his stay in hospital, came from the parents and not from correspondence from the hospital or discussion with his treating dermatologists.
3. Dr Young was asked to comment on whether the Respondent had conducted an adequate and appropriate assessment of Patient B. He prefaced his comment by noting that he does not expect "textbook assessments" from general practitioners and is happy with a "good enough" assessment. In his opinion a comprehensive assessment would include: Atopic history rash distribution age of onset Associated symptoms reduced sleep, itch, irritability, poor feeding, failure to thrive and developmental delay. Identified triggers. Previous eczema treatments, including frequency of treatments. Previous skin infections MRSA, VZV, HSV, Molluscum contagiosum, coxsackievirus Zinc or Vitamin D deficiencies (rare) may compound eczema severity.
4. Dr Young said that the Respondent's description of the child's skin was "respectable".
5. He said however the Respondent did not, in his opinion conduct an adequate and appropriate assessment of Patient B at the initial consultation because while he had some information about what had occurred at the Children's Hospital Westmead, he needed additional history of which steroid/s and which moisturisers had been used and the frequency of use.
6. Dr Young said that a competent general practitioner would have established that the child was continuing under the care of the Children's Hospital Westmead dermatology clinic and would have communicated with the specialists there as to their care of the child. He added that he should have obtained the child's notes from the hospital especially since he was aware that there had been a biopsy which, had he obtained the results, would have revealed information that, in Dr Young's opinion would have made a diagnosis of atopic dermatitis/eczema less likely. The Respondent would also have been made aware of the child's zinc deficiency.
7. It was submitted that the Respondent was reliant on the information provided to him by Patient B's parents who did not tell him he was in the continuing care of the hospital. No reason was advanced as to why the Respondent, understanding that the child had a long history of being treated at the hospital, did not make the enquiry for himself.
8. The Respondent said that he understood from the parents that previous mainstream treatments had failed which is why the parents brought Patient B to him. When asked in oral evidence why he had not sought the child's records from the Children's Hospital, he said he did not need them because he knew "what was wrong".
9. The Respondent acknowledged that this child clearly had complex needs but did not accept that it was appropriate to take a common practice approach to the treatment of Patient B's skin condition.
10. In Dr Young's opinion, the Respondent's did not conduct an adequate and appropriate assessment of the child at the initial assessment and fell below the expected standard.
11. We find this particular made out.

7 Prescription of CC cream not clinically indicated and inappropriate on 14 August 2020

1. Dr Young said that it was clear that when the Respondent first saw Patient B, the child was having a severe eczema flare up. He said a peer general practitioner would have considered wet dressings, topical corticosteroid cream and bleach baths, either at home or in hospital, through communication with the child's usual treating team. He said that a peer general practitioner would not prescribe an expensive, non-evidence based non-mainstream cream to Patient B and would not prescribe a cream containing an antifungal when there was no evidence of fungal infection in the eczema or a concurrent fungal infection.
2. He concluded that the treatment was not clinically indicated or appropriate and in so doing, the conduct fell significantly below the expected standard.
3. The Respondent maintained that he was consulted because those mainstream treatments had not worked for the child and therefore, to prescribe CC cream was both indicated and appropriate. He said that he had prescribed the cream because he had achieved "very positive results … in thousands of other cases…". It was submitted that the proof of the appropriateness of the treatment is shown in the photos of the child which show an improvement "at least initial(ly)".
4. Whether there was an initial improvement, the Respondent did not explain why for this child a cream containing an anti-fungal element was clinically indicated or appropriate or indeed why a further trial of mainstream treatments such as wet bandaging in the first instance was not tried.
5. In failing to do so, the Respondent's conduct fell significantly below the expected standard.
6. We find this particular made out.

8. Continued to inappropriately prescribe CC cream
9. The Commission complains that the Respondent continued to prescribe CC cream for Patient B for an extended period when other evidence-based, less expensive alternatives existed which did not carry the risk of mercury toxicity.
10. There is no doubt that the Respondent was aware of the potential for mercury toxicity from the outset when he started prescribing CC cream for his patients. His said that in the early years of his use of the cream, he conducted blood testing on about 50 patients before during and after the use of the cream and said he did not see raised mercury levels of concern, even with prolonged use. He thus concluded that it was safe to use long term. He could not recall whether any of the patients tested at that time were children and if so, their ages.
11. He said: From the beginning, I have been cognisant of the concern about raised blood mercury levels of patients using topical merbromin. After monitoring mercury levels of around 50 patients before, during and after completion of treatments, I have concluded it is safe to continue to use merbromin compound at the concentration of 0.43%. That patient pool did not demonstrate mercury toxicity.
12. The Tribunal notes that when prescribing for Patient B, the Respondent did not restrict the prescription to the CC cream which is the cream containing .43% merbromin. According to his notes, at least between 9 December 2020 and 3 March 2021, the Respondent prescribed the concentrated version of CC cream. After a trial of Clark AV from March 2021, the Respondent's notes of 31 March 2021 state: "Clark AV not helping. Parent has gone back to Clark Concentrate".
13. On 13 October 2021, the Respondent's notes refer to the concern about mercury toxicity conveyed to him by the child's parents and after indicating that blood tests will be undertaken the note reads: Parents happy to cont with Clark Con for now
14. As we have said, with the Respondent's knowledge and acceptance, Clark Concentrated cream was used on Patient B for a further six weeks until the blood test results returned.
15. As to his prescription of the cream to Patient B over a considerable period of time, in his response to the Medical Council, the Respondent said: 33. When prescribing Clark Compound to any paediatric patient, I recommend it be used topically two to three times a day depending on the severity of the disease. Treatment course is one month, subject to review. Clark Compound is intended to treat eczema, i.e. long term remission. It is not intended for ongoing use to control symptoms of eczema, as in the case of topical steroids
16. Notwithstanding that recommendation, in this case, the Respondent prescribed CC cream in various concentrations for the child over a period of 14 months. His notes do not indicate that his continued prescription was subject to a "review" of the patient's condition.
17. At the s150 hearing, when asked whether he considered stopping the prescription of CC cream to Patient B to whom he had prescribed it for more than a year, the Respondent said: …if the patient use the cream for a year, should be a concern or should them to stop. …have patient to use the - the cream for many years, but they use it like an on and off, like a symptom management, the same when they use steroid. They put it on a few days, the lesion goes away, this stuff, it come back. So also, that's kind - that - a group of patients I had been checking the level and I know it sounds so - doesn't cause any significant or concern in mercury level as well, so that's why I don't - at the moment, when that child, I just - and that child hasn't come very regularly, when they said they'd been using for a year, I just think that's good enough to check the level and decide after, but I don't think at the moment, I need to stop the Clark cream treatment straight away. (emphasis added)
18. The Respondent continued and said that based on his past testing, he was confident that there was no risk in "over the limit" toxicity when the cream is used in long or short term, but when the child's blood serum levels of mercury were notified to him, he thought it was a good idea to do blood testing.
19. Despite his own recommended practice, it seems that the prescription of CC cream continued over this long period.
20. Dr Young said that peer general practitioners would not have prescribed an expensive, non-evidence based, non-mainstream cream to the patient. Instead, he said that they would prescribe regular moisturisers and appropriate topical corticosteroids. As an adjunct to that, he said a peer general practitioner would use wet dressings and bleach baths.
21. In continuing to prescribe CC cream, Dr Young said that the Respondent's conduct fell significantly below the expected standard.
22. We find this particular made out.

9. Failure to obtain adequate and appropriate informed consent
10. There is nothing in the Respondent's notes to show that he discussed the use of CC cream with Patient B's parents. In his written reply to the complaint, the Respondent said that before prescribing CC cream, he made the parents aware that the cream was not mainstream medication. He added that the parents were "aware that I developed, compounded and sold the cream at my clinic" and said that they would therefore have been aware that he had a financial and commercial interest in the sale of the cream.
11. Dr Young did not consider that the Practitioner had obtained adequate and appropriate informed consent and referred to the matters which, in his opinion must be covered for adequate and appropriate consent to which we have earlier referred. He said that the factors included in the discussion about consent and the fact of consent should be recorded in the notes (which they are not). He said that this failure falls significantly below the expected standard.
12. Again, the absence of a note of any kind, and the broad-brush evidence of the Respondent about what he said in general when obtaining consent and of what the parents of Patient B "would have been aware", makes it impossible to determine to what extent the Respondent explained the matters necessary for adequate and appropriate informed consent. We do not accept the Respondent's assertion that because the parents paid money to the receptionist to purchase the cream, it would have been sufficient for them to glean that he had a financial and commercial interest in selling the cream.
13. We cannot find that the Respondent did in fact provide all the elements necessary for adequate informed consent. In failing to do so, we accept that his conduct fell significantly below the expected standard.

10. Liaison with the dermatology team at the Children's Hospital
11. The Respondent said that he did not liaise with the practitioners at the Children's Hospital Westmead because they did not refer the child to him and the parents did not tell him the child remained under their care.
12. The Respondent's evidence was to the effect that he did not need to know what had been done at the Children's Hospital Westmead because the mainstream treatments they had recommended had not worked and the parents came to him for him to treat the child, and, it followed, to treat the child with CC cream in its varying forms.
13. Dr Young said that a peer general practitioner would have respected the Children's Hospital team's efforts and attempted to work as a team through appropriate communications. He said "a curious clinician" would have obtained all hospital medical records which would have enabled him to see that they were considering a diagnosis of psoriasis. Instead, Dr Young said, the Practitioner chose to treat Patient B ignoring the dermatology team at the Children's Hospital and in this, his conduct fell significantly below the expected standard.
14. We find this particular made out.

11. Continued to prescribe CC cream where there was no evidence it was safe for use in children and he well knew the risks of mercury toxicity
12. As we have already set out, the Respondent said that he had considered mercury toxicity arising from use of merbromin, however, after testing patients early in his use of the cream, he was convinced that there was no risk of toxicity from the use of CC cream whether in the long or short term. We note however that this comment was made in relation to the 0.43% cream. He gave no evidence about whether he had considered the risk of mercury toxicity at higher concentrations.
13. When prescribing the cream containing merbromin to a child, the Respondent's recommendation was that it be for short term use or longer after review.
14. Dr Young said: … I am highly critical of Dr Le using an unresearched mercury containing compound for over twelve months in an infant leading to raised mercury levels that infant [Patient B], and with a clear demonstrated drop in these levels when the CC was ceased. This evidence supported by toxicologist Associate Professor Naren Gunja in his letter dated 7 August 2023 (Tab 11) who states that the elevated mercury level was due to the application mercury based skin cream to non -intact skin.
15. We cannot help but agree. Here, the Respondent, having been notified of concerns about mercury toxicity in this little boy both by the parents and in a phone call from the treating dermatologist at the Children's Hospital at Westmead, did not immediately stop using the cream, did not apparently tell the parents about the risks of its continued use and prescribed the cream in its concentrated form because "the parents were happy to continue" using it.
16. When asked why he continued to prescribe the cream for use after being notified of the concern for mercury toxicity, the Respondent said that, in his opinion, the benefits of using CC cream outweighed the risks of mercury toxicity.
17. We find this particular made out.

Patient C 12.Between 15 October 2021 and 26 January 2022, the practitioner inappropriately prescribed CC cream to Patient C where it was not clinically indicated. 13.Between 15 October 2021 and 26 January 2022, the practitioner failed to appropriately manage Patient C's itchiness, a symptom of his eczema, by not prescribing topical corticosteroids or other evidence-based treatments such as bleach baths. 14.The practitioner inappropriately continued prescribing CC cream to Patient C after 28 October 2021 in circumstances where he was aware that another of his paediatric patient's serum mercury levels were elevated following use of CC cream, where there was no evidence that it was safe for use in children and the risks associated with mercury toxicity were well known. 15.From around 1 December 2021, the practitioner failed to refer the patient to a specialist dermatologist in circumstances where Patient C's condition had not improved after the first six weeks of home treatment and his parents were struggling with the treatment regime.

1. Patient C was 7 when his parents brought him to see the Practitioner on 15 October 2021.
2. At the first consultation, the Practitioner noted that the child had inflamed excoriated patches over his whole body, some weeping. He indicated infected eczema. The Respondent prescribed CC cream.
3. The notes under the heading management said: Apply generous amount of Clark Compound to the rash, itchy skin, rough skin areas, ie affected areas three times a day.
4. When the Respondent next saw the child on 30 October 2021, he noted that the child's skin was no longer weeping. He prescribed CC cream.
5. The Practitioner's note of a consultation on 20 November 2021 recorded that the condition was not improved and to change to Clark concentrated cream.
6. On 21 January 2022, the notes suggest a trial of another formulation of CC cream "Clark AV" but on the next consultation on 26 January 2022, the Practitioner noted that the child's condition was not improving and to return to using Clark Concentrated. This was the last consultation with the Practitioner in relation to Patient C.
7. The Respondent had provided his CC creams in its various form to Western Sydney University (NICM Health Research Institute) to conduct a safety study of 60 adults.
8. In his statement to the Commission the Respondent said of the testing: …the researchers concluded that all the four formulas of Clark Compound, including the merbromin compound, are safe with no apparent adverse reactions or side effects and minimal risk of toxicity or systemic reaction.
9. The report from NCIM was received by the Respondent in December 2021. It contained the following: Reviews assert that the foetal development in utero and the development of infants early in life are at particular risk of poisoning from methylmercury (Bose-O'Reilly et al., 2010); a concern heuristically generalised to other organic mercuries. … In the interest of caution, it would be advised that infants, and pregnant or breastfeeding women avoid topical merbromin. It is surprising that this restriction is not placed on the existing merbromin product available in Australia, unless some data has been provided to the regulator which could allay our concerns … (emphasis added)
10. The Respondent was in possession of this report when Patient C was under his care. Days before he first saw Patient C, the Respondent had been informed of the mercury toxicity in Patient B's blood serum.
11. When blood tests were performed on Patient C at Westmead Children's Hospital, they revealed that as at 15 February 2022, he had serum mercury levels of 79nmol/L.

12 Inappropriate prescription of CC cream between 15 October 2021 and 26 January 2022 where not clinically indicated.

1. The Respondent said that he prescribed the cream because mainstream treatments had not been successful.
2. Dr Young said that a peer general practitioner would not have prescribed the CC cream. He said the prescription was not clinically indicated or appropriate at the initial consultation and to do so was conduct that fell significantly below the expected standard. He said that there was no clinical indication to prescribe a cream containing an antifungal component when there was no suggestion of a fungal infection.
3. We find this particular made out.

13. Failure to manage the patient's itchiness, a symptom of eczema, by not prescribing topical cortico-steroids or evidence based treatments
14. Although the Respondent prescribed antibiotics for the child during his treatment of him, he continued to prescribe CC cream and did not try or suggest to the parents that other treatments should be considered.
15. His notes show that while under the Respondent's care, the child's condition did not significantly improve. There are notes indicating that the child was scratching and picking at the lesions and the Respondent suggested occlusive dressings.
16. Dr Young pointed out that there were adjunct treatments available to address skin itchiness such as moisturisers, topical corticosteroids, wet dressings and bleach baths.
17. He said to fail to manage the child's condition and to continue to prescribe CC cream was conduct which fell significantly below the expected standard.
18. We find this particular made out.

14. Continuing to prescribe CC after 28 October 2021 when he was aware of elevated mercury levels and where there was no evidence it was safe to use in children.
15. On 13 October 2021, the Respondent had been alerted to the possibility of mercury toxicity in Patient B arising from his use of CC cream. This was confirmed by the blood tests on 5 November 2021. On 21 December 2021, the Respondent received the report from NICM to the effect that the use of CC cream was not safe in infants.
16. The Respondent said in his evidence to the Tribunal that he "thinks" he advised Patient C's parents about the risks of elevated mercury levels through using CC cream. There is nothing in the notes which suggests the parents were so advised.
17. When the concerns about possible mercury toxicity in Patient B were brought to his attention by the dermatologist at the Children's Hospital Westmead, the Respondent said that he would continue to prescribe CC cream but would monitor patients by blood tests. He did not have any blood tests conducted on Patient C.
18. Neither when he received the results of Patient B's serum mercury levels nor when he received the report from NICM, did he stop prescribing CC cream for Patient C.
19. In his response, the Respondent said that the prescribing was not inappropriate, and that the prescription of CC cream was indicated and beneficial.
20. The Respondent said that after being made aware of Patient B's serum mercury levels, he "requested" that the patient had a blood test. There is nothing in the notes to indicate that a blood test was recommended, a referral for blood testing was made or that there was a conversation between the Respondent and the patient's parents about it.
21. Dr Young was also asked to express an opinion on the appropriateness of the Practitioner continuing to prescribe CC cream between October 2021 to 26 January 2022 without monitoring his blood serum levels of mercury in light of the discovery on 28 October that Patient B's serum mercury was elevated.
22. Dr Young said: I believe a competent GP would have changed their prescribing to avoid harm on learning that a treatment caused raised mercury levels. In Dr Le's case, being the manufacturer of the cream, ceasing the cream's manufacture would have been appropriate. He did not consider the balance of benefit and harm in a clinical-management decision. Dr Le's continued use of CC Cream after the discovery that his paediatric patient [Patient B] had an elevated serum mercury was medically negligent - he risked harm and injury to future patients.
23. Dr Young said that in doing this the Practitioner's conduct fell significantly below the expected standard.
24. We agree and find this particular made out.

15. Failure to refer Patient C to a dermatologist
16. The Respondent's notes for Patient C reflect that the child's parents were struggling to implement the treatment regime recommended by the Respondent, in particular in using occlusive dressings on the child's lesions.
17. Dr Young said that the Clinical Practice Guidelines developed by the Royal Children's Hospital Melbourne suggest that a general practitioner should consider consulting with a local paediatric team when: Deterioration of moderate or severe eczema despite compliance with correct treatment(s) for 6 weeks or more There is concern that the child's carers are not able to provide appropriate eczema treatments and are unable to access outpatient supports.
18. Dr Young said that after six weeks of unsuccessful general practice management and when it was noted that the parents were not coping with home treatment, the Respondent should have referred the child to a specialist dermatologist.
19. In failing to do so, he said the Respondent's conduct fell below the expected standard.
20. We find this particular made out.

CONCLUSION

1. Unsatisfactory professional conduct is defined by s 139B(1) of the National Law as: (a) Conduct significantly below reasonable standard Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of that practitioner's profession is significantly below the standard reasonably expected of an equivalent level of training or experience. …. (l) Other improper or unethical conduct Any other improper or unethical conduct relating to the practice or purported practice of the practitioner's profession.
2. Whether established conduct falls significantly below the standard reasonably expected of a practitioner of equivalent level of training or experience is an objective evaluation against the standards of the profession generally. Here, the unchallenged opinion of Dr Young as it relates to the Respondent's conduct against the expected standard, is persuasive and the Tribunal is satisfied that the Respondent is guilty of unsatisfactory professional conduct.
3. The Commission further asserted that the conduct was improper and unethical.

Improper and unethical

1. The assessment of whether a practitioner has engaged in improper or unethical conduct must be read in the context of s 139B(1) that is relating to the practice of the practitioner's profession. In Health Care Complaints Commission v Sare [2018] NSWCATOD 190, the Court considered the dictionary meaning of both improper and unethical. The Court accepted (at [31]) "improper" as bearing the meaning "not in accordance with propriety of behaviour…" and "unethical" as "contrary to moral precept, immoral …".
2. In Office of Local Government v Toma [2015] NSWCATOD 21 the Tribunal held: 25. Applying these authorities, I do not need to state an exhaustive definition of improper or unethical conduct. Rather it is enough to here note that the expression encompasses conduct which, viewed objectively, would be regarded by reasonable persons as falling below the standards of conduct to be expected of Councillors, in that it has a tendency to bring into disrepute the civic office held by Councillors, or the Council, or both. In Dallas Buyers Club LLC v UNet Limited (No 3) [2015] FCA 422 at [5] Perram J said, aptly for present purposes: The difficulty in locating where a line is to be drawn is a well-known problem in legal discourse. But here, as in other contexts, it is best answered not by seeking to find where the line is but instead by asking which side of the line one happens to be on. 26. In my opinion the conduct I have found and which the Respondent has not contested clearly falls on the wrong side of the line. It reduces public confidence in the institution of local government. It amounts to improper and unethical conduct."
3. While the Tribunal is satisfied that the Respondent's conduct in relation to the three patients to whom the Complaint refers was significantly below the expected standard, we are not satisfied that his conduct was also improper and or unethical. We make this finding understanding the trenchant criticism by Dr Young of the Respondent's continued prescription of a cream in which he had a financial interest. However, we are satisfied that the Respondent's conduct sprang from an unshakeable conviction that the cream he developed and produced represented help when other treatments had not worked. That belief led him to conduct himself in a way which we have found constituted unsatisfactory professional conduct, but it does not amount to either unethical or improper conduct in the practise of medicine.

COMPLAINT TWO

1. The practitioner is guilty of unsatisfactory professional conduct under section 139B(1)(a), (i) or (I) of the National Law in that the practitioner has: 1. engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or 2. failed to disclose a financial interest in recommending that a person use a health product; and/or 3. engaged in improper or unethical conduct relating to the practice or purported practice of medicine.

General prescribing/compounding issues 1. The practitioner inappropriately continued prescribing CC cream to patients after 28 October 2021 when pathology results showed that Patient B's serum mercury levels were elevated following treatment with CC cream.

1. The Respondent contended that the elevated serum mercury levels in Patient B related to his treatment of Patient B. He said his treatment of Patient C with CC cream was not implicated in Patient C's elevated serum mercury levels. The Respondent did not give any evidence which would assist in understanding what was the distinction between the treatment of Patient B and Patient C which would reflect concern for mercury toxicity only in Patient B. Certainly, the view of the toxicologist and dermatologist from the Children's Hospital Westmead did not support this assertion and we reject it.
2. The Respondent continued to prescribe CC cream to patients until orders were made by the Medical Council in August 2022 which prevented him from doing so. It is not to be assumed that the Respondent would have stopped prescribing the cream notwithstanding the results of Patients B and C's serum mercury tests (which clearly threw doubt on his claims that the use, even long term use, of the CC cream was safe).
3. Dr Young described the Respondent's insistence on continuing to prescribe CC cream for patients against the evidence of both infant patients having high serum mercury levels as "medically negligent" and he risked harm and injury to his patients.
4. We agree. This particular is made out. 2. The practitioner failed to disclose his pecuniary interest in CC cream when prescribing and supplying it to patients contrary to clauses 10.12 and 10.13 of the Medical Board of Australia's 'Good medical practice: a code of conduct for doctors in Australia'.
5. The preamble to this section of the Code says: A conflict of interest in medical practice arises when a doctor, entrusted with acting in the interests of a patient, also has financial professional or personal interests, or relationships with third parties, which may affect their care of the patient.
6. The Code continues and says that good medical practice involves: Declaring to your patients your professional and financial interest in any product you might endorse or sell from your practice …
7. There can be no doubt that the sale of a cream produced by the Respondent to patients to whom he prescribed it, represented a financial interest in the product which the Respondent was obliged to disclose.
8. His financial interest in the CC creams was not indicated either in his account of what he discussed with the patients in obtaining their consent nor in the written consent documents developed for his patients after the complaints to the Medical Council.
9. The Respondent said that the patients purchasing the cream from his receptionist would understand that he had a financial interest in the sale. There was nothing further said to support this assertion. We do not accept that this would be a necessary conclusion from the transaction and even if it were, would be, in our view insufficient to discharge the Respondent's obligation of financial transparency.
10. Dr Young regarded this as conduct which fell significantly below the expected conduct.
11. This particular is made out.
12. The practitioner breached the Medical Council of NSW's `Complementary Health Care Policy', including by: 1. failing to ensure that his prescribing of CC cream did not discourage the use of evidence-based treatment; 2. failing to provide patients with an objective account of the risks, benefits, efficacy and cost of CC cream.
13. The stated aim of the policy is to assist practitioners providing complementary health care to meet professional standards of practice. As background, the Policy states: Medical care is based on evidence-based research which evaluates methods of assessment, investigation and treatment for their efficacy, safety, quality and cost-effectiveness. Complementary health care involves the provision of care, or aspects of care, which have not been scientifically validated in this way. The Council is concerned about any of these practices which cause direct, indirect or financial harm to patients
14. Of particular relevance to this matter is s3 which states that practitioners should only act in their patients' best interests, ensuring that the use of complementary medicine does not interfere with, discourage or replace the use of evidence-based care if this may adversely affect a patient's health.
15. The Commission contends that the documents provided to the Respondent's patients show that he discouraged evidence-based treatment in preference for CC cream.
16. The Respondent said that a significant percentage of his practice involved patients with skin problems. He said that patients would come to him through word of mouth and through social media. While he had no social media profile himself, he said a patient of his had about 100,000 followers and she spoke about his treatment of skin conditions, particularly using CC cream on her social media platform. Patients often came to him specifically asking for CC cream. The bulk of his patients seeking help with skin problems have eczema or acne. About 40 or 50% of the patients he sees with eczema are babies and small children.
17. The Respondent said that of his patients with skin conditions only about 10% leave the consultation with a prescription for a steroid cream, with the balance choosing CC cream.
18. The location of the Respondent's practice includes patients whose first language is not English. The documents provided by the Respondent to his patients are written in English.
19. The Respondent said he gave his patients with eczema a document which says: Even though steroids are the most widely used form of treatment for eczema, its only help is reducing inflammation (hence reducing symptoms of eczema). On the other hand, steroids will weaken the skin's immune system and make it harder for the body to kill germs. Furthermore, steroids also impair the skins ability to repair and regenerate. (bolding in the original)
20. This is followed by a heading in much larger font: How does Clark Compound Help with Eczema Treatment?
21. The document then lists the benefits and advantages of CC cream.
22. The Respondent's evidence was that he provided this document at the consultation and said that it was the patient's "choice" whether or not to be treated with CC cream or mainstream treatments.
23. The reader of the document would, in the Tribunal's view, be left in no doubt that the Respondent's preference lay with CC cream. Patient A's unchallenged evidence was that the Respondent told her to use the cream and directed her to the receptionist to buy it. She said he did not tell her what it was or where it came from, although she had been told he made it himself. She says nothing of being asked to make a choice between CC cream and steroids.
24. To the extent then that patients were given the document and the choice of treatment, the Tribunal accepts the contention that the document clearly preferred CC cream over mainstream treatments and would have the effect of deterring patients from using them.
25. Section 5 concerns the necessity for informed choice and providing the patient with sufficient information which should, among other things: (a) providing advice about all of the available treatment options, their risks, benefits and efficacy, as supported by evidence-based research. (b) providing an objective account of the risks, benefits, efficacy and cost of any recommended non-evidence based investigation or treatment.
26. The Commission relied on the documents provided by the Respondent to patients of his practice.
27. Although there was no consent document given to Patient A or the parents of Patient B, the Respondent said that he discussed with them their treatment options and told them that CC cream was of his own invention and making. While we have not accepted that he did have such a conversation, even in his evidence to the Tribunal about what he said, the Respondent did not mention any risk of mercury toxicity.
28. The Respondent said that after he received the complaint in relation to Patient B, he produced a consent form, a copy of which was in Patient C's notes and is dated 15 October 2021, which we note was after the Respondent had been notified of concerns about mercury toxicity in Patient B.
29. The document reads: I understand that Clark cream treatment is based on the principle of strengthening, repairing and regenerating skin barrier - a joint research with Western University Sydney - is not conventional and has not yet been TGA approved. In addition, treatments using anti-inflammatory ointments - either topical corticosteroids or non-steroidal anti-inflammatory ointments such as pimecrolimus, coal tar - to reduce the itch), dietary changes, ultraviolet radiation therapy (phototherapy) and oral medication steroid, immunosuppressants, biologics etc..] remain the gold-standard and mainstream treatments for eczema-, There is growing evidence that allergens introduced into the body through .the skin [in eczema patients] can lead to the later development of food-allergy asthma and hay fever. Aggressively treating eczema in children and taking steps to restore normal skin barrier function may lower the risk of future development of these (food allergy, asthma and hay fever-conditions" (bolding in the original)
30. We observe that there is no reference there to any risk to the patient in using mercury based products.
31. The Tribunal is satisfied that even when he well knew that there was a risk of mercury toxicity associated with use of CC cream, it was not included in the consent form.
32. The Tribunal accepts that both particulars of this complaint are made out.
33. The practitioner failed to comply with the Pharmacy Board of Australia and Medical Board of Australia's `Joint statement on compounded medicines', dated 24 November 2017 by prescribing CC cream: 1. where an appropriate commercial alternative product was available; 2. where there was insufficient evidence to support the cream's intended use based on recognised therapeutic standards.
34. The Pharmacy Board of Australia and Medical Board of Australia's Joint statement on compounded medicines notes that unlike medicines to which the Therapeutic Goods Act applies, compounded medicines are not subject to rigorous assessment of efficacy, safety and quality. Thus additional considerations apply. Under the heading "Good Practice" the statements says: 1. A compounded medicine should only be prescribed by a medical practitioner and prepared by a pharmacist where it is clinically indicated and if: an appropriate commercial product is unavailable, or a commercial product is unsuitable.
35. If a compounded medicine is considered, good practice indicates that the medical practitioner and pharmacist should determine whether the compound is safe and appropriate for human use: 3.1 whether the substance(s) in the compounded medicine is suitable and approved for human use,
36. The Respondent referred to his product as "unique" and sitting apart from commercially available treatments for eczema. However, the overwhelming evidence before the Tribunal was that cortico-steroid creams were appropriate for the treatment of the conditions represented in these three patients. Dr Young's evidence was that those creams are readily available commercially and are less expensive than CC creams. He added that any treatment that caused raised mercury levels in the patient was not in his opinion suitable for human use. We must agree.
37. As to whether there was an evidentiary basis for the cream's use, the Tribunal is satisfied that there was scant evidence. Although the Respondent spoke of the cream being subject to "safety testing", as the Commission pointed, out the testing was not conducted on children and the testing was done to determine skin sensitivity to the product not whether it caused raised blood serum mercury levels. There was no evidence in the testing that the product was safe for children and, indeed the results of the NICM testing was to the contrary i.e. that it was contraindicated in infants and pregnant women.
38. Further, the conclusion of the NICM research testing in 2019 was that more work needed to be done to determine if the cream has significant clinical effects.
39. The predominant, if not sole, basis on which the Respondent based his statements of the effectiveness of the cream was anecdotal and in circumstances where he did not continue to test his patients for mercury toxicity.
40. The Tribunal finds this particular made out. 5. The practitioner engaged in bulk manufacture of CC cream, contrary to the Therapeutic Goods Regulations 1990 (Cth), Schedule 5, Item 6 and Schedule 8, Item 1.
41. The Respondent admitted this particular. In April 2017 the Respondent received a letter from the Pharmaceutical Unit of NSW Health in which was set out the substance of an earlier conversation with the Respondent and Ms Dolan the author. Ms Dolan noted that the Respondent had admitted he was manufacturing the cream in bulk which was prohibited. He was informed: As a medical practitioner you may extemporaneously compound a therapeutic substance but only when labeled in an individual patient's name in accordance with Appendix A of the Poisons and Therapeutic Goods Regulation 2008, in the same manner as a pharmacist, with the name and address of the premises from where is has been compounded
42. The Respondent continued to manufacture the cream in bulk to the extent that he always had a quantity, as much as 1 kilogram already prepared. In his evidence he attempted to cast his manufacture as being personal to the particular patient even though a tube was available to the patient as soon as the consultation was concluded. The concession that the Respondent did breach the rules regarding bulk manufacture as alleged in this particular is properly made.
43. The Tribunal finds this particular made out.

Complaint Three The practitioner is guilty of professional misconduct under section 139E of the National Law in that the practitioner has: (i) engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration, and/or (ii) engaged in more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of the practitioner's registration.

PARTICULARS OF COMPLAINT THREE The particulars of Complaints One and Two and repeated and relied upon both individually and in combination.

Professional misconduct

1. Section 139E of the National Law defines professional misconduct as unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration or more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of the practitioner's registration.
2. In Chen v Health Care Complaints Commission [2017] NSWCA 186 at [19]-[20], the Court characterised professional misconduct: "19. … The term 'professional misconduct' does not have a specific meaning; it is merely a category of 'unsatisfactory professional conduct' which is sufficiently serious to justify suspension or cancellation. … 20. There is no category of unsatisfactory professional conduct which is not capable, depending on the circumstances, of giving rise to professional misconduct and hence engaging the power of either suspension or cancellation of registration. The only requirement is that it be 'sufficiently serious' to justify such an order, a characterisation which must depend upon an evaluative judgment made by the Tribunal. … Each case will depend upon an evaluative judgment to be made by the Tribunal as to the nature and seriousness of the conduct. …"
3. A finding of professional misconduct does not necessarily dictate cancellation or suspension of the practitioner's registration, however by its terms it clearly speaks to serious conduct.
4. The Tribunal is satisfied that the Respondent's conduct in the treatment of all three patients is of sufficient seriousness to amount to professional misconduct.
5. In relation to Patient B the Tribunal points to Respondent's conduct in failing to liaise with the dermatologists at the Children's Hospital Westmead to determine what treatments had been tried, in failing to obtain any documentation from that hospital, in particular the biopsy report and in continuing to prescribe CC cream to Patient B where there was no evidence that it was safe to use in children and after being told of concerns about mercury toxicity is, of itself, of such seriousness as to amount to professional misconduct.
6. Equally, in relation to Patient C, to prescribe CC cream for him knowing of the serious concern of mercury toxicity in the Patient B's blood, and in not informing the parents of that risk nor in ordering blood tests, this too amounts to professional misconduct.
7. The Respondent's single minded and unswerving belief that CC cream could succeed where other mainstream treatments had failed is reflected in his treatment of Patient A where there is no evidence that he discussed with her what, if any previous treatments she had used on the lump, that he did not obtain her informed consent to use his cream and when the area around the lump became itchy after using the cream, did not stop and consider whether the continued use of the cream was appropriate.
8. Further it caused him to not offer or recommend those mainstream treatments for these patients but discouraged his patients from using them in preference for using CC cream which had no scientific basis that it was effective amounts to professional misconduct.
9. The Respondent elected to have the Complaint determined in two stages. Thus, having determined the Complaint made out and that the Respondent is guilty of unsatisfactory professional conduct and professional misconduct, the balance of the hearing as to what protective orders must flow from those findings will be adjourned to another date.

Orders 1. Pursuant to s139E of the Health Practitioner Regulation National Law (NSW), the practitioner is guilty of professional misconduct. 2. The proceedings are listed for hearing on 25 February 2026 to determine the orders which are necessary to protect the health and safety of the public.

I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales. Registrar

Amendments 13 November 2024 - Paragraph 2 & 6 corrected to Campsie Health Care Medical Practice DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 13 November 2024