Health Care Complaints Commission v Hart

Peptide Complaint

1. In 2013 Dr Hart and two other people set up an online peptide clinic called Peptide Clinics Australia Pty Ltd (the Peptide Clinic). The Peptide Complaint concerns two groups of patients. Twenty-two of the patients (the Peptide Clinic Patients) particularised in the complaint bought peptides online through the Peptide Clinic. The second group of seven patients (the Other Patients) saw Dr Hart in person at one of two medical clinics where he practised. Dr Hart prescribed these patients with peptides as well as other hormones and compounds including testosterone, Metagenics supplements, vitamins D and K2 and DHEA.
2. Dr Hart had no particular interest in peptides before setting up the Peptide Clinic. For most of the 29 patients to whom he prescribed peptides he did so "without an appropriate level of training". We made the following finding as to Dr Hart's knowledge and training at [131] of the Stage 1 decision: "Dr Hart said that before setting up Peptide Clinics he had scoured the literature to see if there was some evidence of the benefits of peptides and no evidence of harm. Even if there was no high quality evidence of benefits, Dr Hart anticipated that evidence might emerge in the future. The articles he read and the courses he attended were not based on randomized double blind placebo controlled (RDBPC) studies. His 'evidence' that peptides work was said to be supported by the fact that people were re-ordering them and secondly WADA had banned many peptides for athletes."
3. Dr Hart designed a questionnaire which the Peptide Clinic Patients completed online. That questionnaire was deficient in several respects: 1. it inaccurately stated that the use of peptides had "been proven to be safe and very effective provided certain diseases are not present, overdoses are not consumed and possible side effects are checked"; 2. it discouraged patients from identifying certain contraindications, by asking patients to self-report only "uncontrolled" heart disease or "uncontrolled" diabetes; 3. it asked patients to identify their interests using vague terminology such as "anti-aging", "fat loss/weight loss", "injury repair", "muscle building", "anti-anxiety/confidence", "safe enhanced tanning", "increased libido" and "insomnia relief".
4. Dr Hart reviewed the questionnaire after a patient had completed it online. As long as the person did not identify any of the contraindications such as "uncontrolled diabetes" and the substances were consistent with the person's "interests", such as "muscle building" he wrote a prescription. Significantly, none of the peptides or other hormones and compounds Dr Hart prescribed to any of the patients identified in the Peptide Complaint were prescribed for an appropriate therapeutic purpose or need.
5. The scripts were sent to a compounding pharmacy which sent the substances to the person who had ordered them. If a person completed a second or subsequent order, Dr Hart did not check the date of the previous order and the amount prescribed to calculate whether there had been an over-supply. He did not turn his mind to the risk that his patients may be abusing or re-selling peptides. Between them, the Peptide Clinic Patients and the Other Patients received approximately 500 courses of peptides or hormones.
6. These arrangements meant that Dr Hart did not take a proper history from any of the Peptide Clinic Patients; he did not clinically assess them; none of the patients provided informed consent; and, apart from Patient E, Dr Hart did not monitor any of the patients to see if the substances were having the desired effect or were causing any side effects. Dr Hart continued with these arrangements irrespective of whether: 1. he was prescribing the Peptide Clinic Patient with the same peptide or a different peptide on a subsequent occasion; (e.g. Patient V) 2. the Peptide Clinic Patient asked for and was prescribed very large amounts of peptides; (e.g. Patients G and I) 3. the Peptide Clinic Patient reported a reaction to the peptide; (e.g. Patient D) or 4. the Peptide Clinic Patient asked for numerous "overlapping" peptides - that is multiple peptides which were intended to have the same effect.

Anti-aging Complaint

1. This complaint concerned Patient AE, an 82-year-old woman with dementia and depression who weighed 39kg. She initially came to see Dr Hart accompanied by her adult son and daughter. Dr Hart treated AE in accordance with what he called the "functional medicine approach" to chronic disease. We summarised Dr Hart's treatment of Patient AE at [149] of the Stage 1 decision: "… In accordance with those theories, Dr Hart suggested that the main cause of dementia was low-grade neurological inflammation. He was looking for the triggers of the inflammation such as environmental and nutritional factors. He ordered a pelvic and breast ultrasound, bone density study, coronary artery calcium CT scan, cone beam dental CT scan and various pathology tests. He recommended that Patient AE undergo a colonoscopy, take various drugs and vitamins and have her home tested for the presence of electro-magnetic fields. While he acknowledged that dementia cannot be reversed, he thought these interventions could potentially change the rate of progression of dementia."
2. Notwithstanding Dr Hart's interviews with the Medical Council of New South Wales (the Medical Council) on 2 September 2016 and 28 August 2017 and the audits of his practice in July 2017 and April 2018, he continued to practise medicine which was not accepted by mainstream medical teaching. In his written statement of 21 July 2020 at par 16, Dr Hart acknowledged that his care of Patient AE was not supported by evidence-based medicine - that is, clinical practice that incorporates the best evidence from well-designed studies.
3. Dr Hart engaged in improper and unethical conduct by failing to tell Patient AE about a conflict of interest. Dr Hart received a 10% to 30% rebate from pathology and supplement providers when patients purchased goods and services from those providers.

Tribunal's powers

1. Under s 149A(1) of the National Law, the Tribunal has various general powers including the power to reprimand Dr Hart or to impose conditions on his registration. In addition to those general powers, the finding of "professional misconduct" triggers the Tribunal's discretionary power under s 149C(1)(b) to suspend or cancel his registration: 149C Tribunal may suspend or cancel registration in certain cases [NSW] (1) The Tribunal may suspend a registered health practitioner's registration for a specified period or cancel the registered health practitioner's registration if the Tribunal is satisfied - (a) the practitioner is not competent to practise the practitioner's profession; or (b) the practitioner is guilty of professional misconduct; or (c) the practitioner has been convicted of or made the subject of a criminal finding for an offence, either in or outside this jurisdiction, and the circumstances of the offence render the practitioner unfit in the public interest to practise the practitioner's profession; or (d) the practitioner is not a suitable person for registration in the practitioner's profession. …
2. An order may provide that an application for re-registration may not be made until after a specified time: National Law, s 149C(7). The HCCC submitted that that time should be 5 years. Dr Hart submitted that it was not appropriate to cancel his registration for any period.

Legal principles

1. The relevant legal principles were summarised by Wright J in Health Care Complaints Commission v Dr Della Bruna [2014] NSWCATOD 31 at [88]: "… (1) In the exercise of its functions under Subdivision 6 of Division 3 of Part 8 of the National Law, the protection of the health and safety of the public must be the Tribunal's paramount consideration - s 3A of the National Law. (2) Disciplinary proceedings against members of a profession are intended to maintain proper ethical and professional standards, primarily for the protection of the public but also for the protection of the profession - Health Care Complaints Commission v Litchfield (1997) 41 NSWLR 630 at 637. (3) The public interests served by protective orders include, indirectly, the standing of the medical profession and the maintenance of public confidence in the high standards of medical practitioners - Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91]. (4) Protective orders also involve an element of deterrence or, to put it more positively, encouragement to other practitioners to recognise the importance of complying with professional standards and the risks of failing to do so - Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91]. (5) Although the specific purpose for which the Tribunal makes orders is protective of the public interest and not punitive with respect to the practitioner, that is not to deny that such orders may be punitive in effect and that punitive effect may be relevant in formulating a protective order - Lee v Health Care Complaints Commission [2012] NSWCA 80 at [20] citing Director General, Department of Ageing, Disability and Home Care v Lambert (2009) 74 NSWLR 523 at [83]."
2. Soon after Wright J summarised these principles, the Court of Appeal confirmed that protecting the health and safety of the public "… includes protecting the public from the similar misconduct or incompetence of other practitioners and upholding public confidence in the standards of the profession": Health Care Complaints Commission v Do [2014] NSWCA 307 at [35]. In 2017, the Court of Appeal commented on the relevance of the time period which the Tribunal may fix before a practitioner may apply for a review of a cancellation order: Chen v Health Care Complaints Commission [2017] NSWCA 186 at [88] Payne JA (with whom Basten and Leeming JJA agreed) "The Tribunal was permitted by s 149C(7) to identify a period of time during which a re-registration application could not be made. Doing so indicated the seriousness, from the Tribunal's perspective, of the conduct. A practitioner wishing to challenge that period may do so by way of appeal. Contrary to the appellant's submission, a time fixed under s 149C(7) does not necessarily mean that the Tribunal has formed a view that things will have changed by the end of the period which has been fixed. The Tribunal is permitted by s 149C(7) to make clear in its orders the seriousness with which it views the conduct of the practitioner reflected in the complaints which have been proven. Such an order plays a part in the general deterrence reflected by the order."
3. Dr Hart's counsel highlighted the fact that the Medical Council had lifted the suspension on Dr Hart's registration on 25 July 2019. The Medical Council was satisfied at that time that it was not appropriate for Dr Hart's registration to be suspended either to protect health and safety or in the public interest: National Law, s 150(1). Instead, the Medical Council allowed Dr Hart to continue to practise subject to conditions. That decision reflects the Medical Council's view of the evidence at that time. We must decide what orders to make based on the evidence at the date of the hearing - 20 May 2021. That evidence includes Dr Hart's oral evidence at both the Stage 1 and Stage 2 hearings.
4. Applying the legal principles outlined above we will make findings about two relevant matters: the seriousness with which we view Dr Hart's proven misconduct and the risk, if any, to the health and safety of the public if Dr Hart continues to practise with conditions. Dr Hart's age is not relevant to the issue of the protective orders we should make.

Seriousness of the conduct

1. Dr Hart was instrumental in setting up the Peptide Clinic. He did not have an appropriate level of knowledge and training to prescribe peptides to any patient. For the Peptide Clinic Patients he designed a seriously flawed questionnaire and did not perform the most rudimentary steps in caring for his patients. Those steps include taking a proper history, clinically assessing the patient, only recommending treatments when there is a therapeutic need, obtaining the patient's informed consent and monitoring their progress.
2. Dr Hart did not even take the very basic precaution of checking to see whether a previous prescription would have been exhausted before prescribing further courses. That practice in relation to prescriptions for Patients A, B, C, D, G, H and I, meant that there was a high risk that these patients were abusing or on-selling peptides. That conduct demonstrates a complete disregard for patient safety. Dr Hart's treatment of the Other Patients at his clinics, including his prescription of vitamin and mineral supplements and testosterone, was not of the same order of seriousness, but was still very concerning. The conduct continued over a period of 5 years and involved approximately 500 courses of peptides or hormones.
3. In relation to the Anti-Ageing Complaint, Dr Hart admitted that he recommended inappropriate investigations and treatment for Patient AE and prescribed drugs without a therapeutic purpose for doing so. Even after being interviewed by the Medical Council about the Peptide Complaint, Dr Hart continued to practise medicine which was not evidence based. In the case of Patient AE, this conduct is extremely serious because of her vulnerability - she had dementia, was depressed and was severely underweight.
4. Dr Hart did not inform Patient AE of a conflict of interest in that he received a 10% to 30% rebate from pathology and supplement providers such as Nutrisearch, Metagenics and Nutripath when patients were referred to those providers, and purchased goods and services. His failure to do so is made worse by the fact that he did not disclose this conflict to Patient AE even after the Medical Council drew his attention to the conflict of interest provisions in the Code of Conduct in September 2016 (Medical Board of Australia, "Good Medical Practice: A Code of Conduct for Doctors in Australia" (March 2014) at 8.11). This misconduct is moderately serious.

Risk to health and safety of the public if Dr Hart continues to practise with conditions

Current conditions and employment

1. Dr Hart was first registered on 1 January 1995. Since 25 July 2019, he has been registered subject to conditions including that: he not possess, supply, administer or prescribe peptides; he practise in a group practice where there is always one other registered practitioner on site; he treat no more than 25 patients in one day; and he be subject to 'category B supervision'. Since September 2019, Dr Hart has been employed part-time by two group practices - one in Coffs Harbour and the other in South Grafton. He has participated in extensive further education and training. He is committed to acquiring knowledge relevant to the practise of medicine.

Compliance with conditions and character references

1. With two inconsequential exceptions concerning the number of patients treated in one day, Dr Hart has complied with the conditions on his registration for the last 20 months.
2. His supervisors, who are other general practitioners in the practices, have provided regular reports which do not raise any issues of concern. References from practice managers, fellow practitioners, supervisors and a patient are supportive and express positive opinions about Dr Hart's care of patients, knowledge and commitment.
3. Dr Bruce Watts is a senior GP in the Coffs Harbour practice. He provided a reference dated 18 June 2020, eight months after Dr Hart had joined the practice. Dr Watts noted that, in that time, Dr Hart's prescribing practices had been "very straight forward and cautious". He was impressed with Dr Hart's interest in and knowledge of the metabolic management of aging and dementia, and the assessment of complex cases of unexplained fatigue, weakness and chronic illness. He said that Dr Hart "is passionate about researching the science… and trying to change outcomes for people".

False and misleading statements

1. At [22]-[35] of the Stage 1 decision we documented several examples of statements that Dr Hart made to the HCCC or the Medical Council which were false or misleading. He attempted to mislead the HCCC by providing information which suggested that Peptide Clinic patients could easily telephone him or email him directly. He attempted to give the impression to the HCCC that there was reliable data showing that certain peptides inhibit the functional deficits of aging. He misled the HCCC by claiming that Patient K had benefitted from using Melanotan because he had not reported any untoward symptoms or side effects when there had been insufficient time between scripts for any side effects to become apparent. He attempted to mislead the HCCC about his reason for prescribing SARMs s22 Forte to Patient H for a second time.
2. Dr Hart also falsely claimed that he was "closely monitoring" Patient S. At the Stage 1 hearing, he initially maintained that when he wrote those words to the HCCC in 2016, he actually thought he was closely monitoring that patient. The following day Dr Hart clarified that he first became aware that his treatment was inadequate around the time of the s 150 hearing before the Medical Council in September 2016.
3. Dr Hart repeatedly made statements in relation to Patients A, B, C, F, I, M, O, P, Q, R, T, U, V and X to the effect that these patients "appeared to be deriving benefit from the treatments". He conceded in his oral evidence that he had no way of knowing whether the patients were deriving any benefit.

Failure to practise evidence-based medicine even after Medical Council interview

1. On 2 September 2016, Dr Hart attended a hearing before the Medical Council convened under s 150 of the National Law. We made the following findings at [36]-[38] of the Stage 1 reasons for decision: "… At that hearing, Dr Hart agreed that there were no randomised clinical trials supporting the use of peptides for muscle growth, weight loss or improved sleep. He also accepted the proposition that without substantial clinical trial data, it is very difficult to predict side effects. He agreed not to prescribe peptides because he now understood that the evidence supporting their efficacy was not good enough. However, even after that hearing, Dr Hart continued to prescribe dehydroepiandrosterone (DHEA). DHEA is not a peptide. It is a hormone naturally produced by the adrenal glands that helps make testosterone and estrogen. The HCCC questioned Dr Hart about continuing to prescribe DHEA after his lawyer assured the Medical Council in September 2016 that he would only prescribe substances where there was good evidence supporting their efficacy. Dr Hart said that the reason he prescribed DHEA was that there is more evidence of its possible benefits. Dr Hart also continued to prescribe other substances for which there was no good quality evidence of their efficacy." (Emphasis added.)
2. After the s 150 hearing in September 2016, Dr Hart knew that he must follow Australian guidelines and practice evidence-based medicine. Nevertheless, he subjected Patient AE to a battery of tests about which the HCCC's expert witness, Dr Carter, was highly critical. Those criticisms are summarised at [152]-[170] of the Stage 1 reasons for decision.
3. We have noted Dr Hart's failure to disclose a potential conflict of interest with Patient AE even after the Medical Council brought the matter to his attention. Dr Hart could not offer any reason to the Tribunal for failing to do so.

Understanding and insight

1. As to his insight, Dr Hart's mentor, Dr Watts, reported that Dr Hart freely admits that his prescribing was inappropriate and that he would never be involved in anything like that again.
2. At the Stage 2 hearing, Dr Hart relied on a document entitled "Dr Hart Reflection 2021". He wrote that document as part of an Education Plan developed by his insurer's (Avant Mutual's) Risk Advisory Group. He began by stating that he had thought deeply about how his attitudes and knowledge base had led him to make poor decisions when practising medicine. He proceeded to give some reasons, not excuses, for his conduct. These reasons, on which Dr Hart was cross-examined, and his evidence at the Stage 1 hearing, demonstrate that his understanding and insight remain deficient.
3. Firstly, and most significantly, Dr Hart explained his participation in the Peptide Clinics as being motivated by a desire to ensure that people seeking peptides receive a quality-controlled supply and be screened for contraindications. He said he thought it was safer for him to prescribe peptides online than for people to buy them in gyms where there was no assessment of the patient. At the hearing on 20 May 2021, Dr Hart asked rhetorically whether he should have just ignored the evidence that was available and not have improved the level of safety for patients.
4. We asked him why he embarked on the Peptide Clinics venture after practising orthodox general practice medicine for 13 years. Initially he could not articulate a reason other than to say that he thought it was a good idea at the time. He then repeated the supposed safety benefits. When prompted, Dr Hart mentioned financial remuneration but added that this was a secondary consideration as he was only working on Peptide Clinic patients after hours and on weekends.
5. In the reflection document, Dr Hart explained his conduct, in part, by reference to the fact that he viewed himself as a researcher as a result of his university studies in exercise physiology. When setting up the Peptide Clinic he had tried to be innovative. He agreed that he was taught to practise evidence-based medicine when studying to be a doctor and throughout his placements before being registered. Nevertheless, he relied on information obtained from overseas organisations which was not evidence based. His interest in research is obvious but it does not explain how he convinced himself that despite the lack of high-quality evidence supporting the therapeutic use of peptides, he should nevertheless prescribe them.
6. Dr Hart also mentions the fact that he had been "de-trained" as a medical practitioner as a factor contributing to his mistakes. In the reflection document Dr Hart wrote that after graduating, he worked for 13 years as a GP in a practice that had a very narrow client base - 17-25 year old Japanese travellers. He says he became "de-trained" in the broad range of skills and knowledge that is required for general practice work. When setting up the Peptide Clinic he sought training with un-recognised overseas postgraduate medical training institutions and practitioners that, at the time, he believed were innovative and up-to-date. He says he now realises that many of the treatments propounded by these organisations were not proven. In our view, Dr Hart's involvement with a narrow patient cohort for 13 years does not provide a credible reason for his subsequent poor decision-making.
7. We were concerned that despite the fact that Dr Hart has had considerable time to reflect on his conduct, he continues to identify patient safety as one of the motivations for embarking on the Peptide Clinics business. In fact, as we have found, Dr Hart's failure to perform the most rudimentary steps in caring for a patient showed a complete disregard for their safety. Of lesser concern, but still significant, is Dr Hart's limited insight into the reasons for his conduct. He partially explains his conduct by reference to his interest in research and previous narrow areas of practice. We appreciate that Dr Hart is attempting to understand how he made such poor decisions but in that process he has failed to acknowledge that there is no reason other than his own lack of knowledge and understanding.
8. Dr Hart characterised his conduct as having made a bad decision; as having thought it was a good idea at the time and as the worst decision of his life. He continues to lack insight into the motivation for setting up the Peptide Clinics business, the extent to which he was providing appropriate medical care and the potential risks to patients, including Patient AE. That misguided mindset continues to influence Dr Hart's thinking.
9. Examples of his mindset include misleading the Medical Council by saying there is reliable data showing that certain peptides inhibit the functional deficits of aging; justifying prescribing DHEA by claiming that there is more evidence of its possible benefits than for peptides; and expressing gratitude in his reflection document that no patients were harmed. When questioned about this comment, he agreed that he had no idea whether any patient had been harmed.
10. We are not critical of Dr Hart's passion for research. We are critical of his strong inclination to practise medicine outside accepted guidelines. That inclination is exacerbated by two factors. First, he did not explain the lack of evidence or the known risks so that he could obtain properly-informed consent from each patient. Secondly, he did not follow up to see if any issues had arisen or there was a risk of on-selling peptides.

Conclusion

1. Dr Hart has performed satisfactorily while being subject to the conditions imposed by the Medical Council including Category B supervision. He has the support of various colleagues, supervisors and patients. However, the seriousness of the misconduct including the complete disregard for patient safety; his inclination to practise medicine outside accepted guidelines; his limited insight as to his motivation; the false and misleading statements he made to the HCCC and the Medical Council and his failure to change aspects of his behaviour despite being alerted to his deficiencies persuade us that there would be a risk to the health and safety of the public if he continues to practise, even with conditions. These matters together with confidence in the standards of the medical profession require that Dr Hart's registration be cancelled. Because of the seriousness of the misconduct, he cannot apply for re-registration for two years.

Orders 1. Pursuant to s 149C(1) of the Health Practitioner Regulation National Law (NSW), Dr John Hart's registration is cancelled. 2. Pursuant to s 149C(7) of the Health Practitioner Regulation National Law (NSW), Dr John Hart may not seek a review of these orders under Division 8 for two years from the date of these orders. 3. Dr John Hart is to pay the costs of the Health Care Complaints Commission as agreed or, failing agreement, as assessed under the Legal Profession Uniform Law Application Act 2014 (NSW).

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 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: 09 June 2021