Health Care Complaints Commission v Hart

The standard

1. Section 3.1 of the Code of Conduct provides general guidance about providing good patient care: In clinical practice, the care of your patient is your primary concern. Providing good patient care includes: 3.1.1 Assessing the patient, taking into account the history, the patient's views, and an appropriate physical examination. The history includes relevant psychological, social and cultural aspects.
2. In the same document at 4.5, the Medical Board of Australia sets out the expectations of medical practitioners about obtaining informed consent to medical care: Informed consent is a person's voluntary decision about medical care that is made with knowledge and understanding of the benefits and risks involved. Good medical practice involves: 4.5.1 Providing information to patients in a way they can understand before asking for their consent.
3. Prof Carter, a clinical endocrinologist, expressed the view in his report that an appropriate assessment involves taking a full history, not just administering the questionnaire and occasionally examining a patient in his rooms. Prof Carter noted that Dr Hart asked about "uncontrolled diabetes mellitus" in the questionnaire but that was not adequate. The history should have included questions about diabetes, glucose intolerance, musculo-skeletal injuries, carpal tunnel syndrome and oedema (in relation to growth hormone secretagogues and insulin-like growth factor 1).
4. Dr Hart's evidence was that in 2014 he did not realise that CJC-1295, a synthetic analogue of growth hormone releasing hormone, could aggravate type 2 diabetes. In his view, there may be a temporary increase in insulin resistance but eventually there would be an improvement. Any aggravation would be minor and temporary.

History

1. For the majority of patients, who were not seen face-to-face, the history was merely the information provided by the patient on the questionnaire. For example, Patient S recorded that he was taking Lexapro 10mg. When responding to the HCCC, Dr Hart wrote a summary document noting that Lexapro was a treatment for mild anxiety or depression. He went on to express the view that "it did not appear to impact his regular lifestyle or activity." Dr Hart had no information about the extent of Patient S's anxiety or depression, or the effect the drug was having on his lifestyle.
2. Patient X recorded on the questionnaire that he had asthma. Dr Hart's view was that there was no problem prescribing peptides in those circumstances. He was not aware of any clinical data about the effect of taking peptides on a patient with asthma. He did not ask Patient X any follow-up questions or tell him that there was no quality data on this subject.
3. One aspect of obtaining an accurate history is obtaining information from the patient's regular GP. Patient R was 74 years old and weighed 100kg. He provided his GP's address in the questionnaire but Dr Hart did not contact him. Dr Hart admitted that it was improper to write scripts for large quantities of three peptides for an elderly patient without contacting his GP.
4. Patient Z's goal was to lose body fat. He had previously commenced testosterone injections two or three times a week. Dr Hart did not communicate with his previous GP before prescribing more testosterone.
5. Dr Hart did not obtain an adequate history from Patient S, X, R or Z or from any of the other patients.

Assessment

1. The only "assessment" Dr Hart undertook for the patients he did not see face-to-face was reviewing the questionnaire before prescribing the substances. For example, Dr Hart prescribed Thymosin Beta 4 for muscle repair without knowing whether Patient A had any torn muscles or other injuries. He prescribed these products solely based on Patient A's stated goal and the absence of any contra-indications on the questionnaire.
2. Many of the patients for whom Dr Hart prescribed peptides for fat-burning were not overweight, or Dr Hart had insufficient information to determine whether they were overweight. For example, Patient B weighed 90kg. The summary Dr Hart prepared for the HCCC described him as "mildly overweight" at 90kg. Dr Hart agreed that he did not record Patient B's height. Patient G weighed 91kg and Patient V weighed 103kg. In the summaries to the HCCC, Dr Hart described both these patients as being of normal weight. He did not know how tall either of them was. There is no rational basis for these conclusions.
3. Patient Q was a 53-year-old man weighing 115kg. Dr Hart agreed that at that age and weight he may have been at risk of heart disease. However, as Patient Q did not record any information indicating heart disease on his questionnaire, Dr Hart did not inquire further. Dr Hart agreed that Patient Q needed a proper assessment before prescribing peptides and he did not make that assessment.
4. Dr Hart admitted that he knew in 2014 that he was obliged to conduct a proper assessment of each patient. He acknowledged that he did not believe, even at the time, that he was conducting a proper assessment or adequately monitoring any of the patients.

Informed consent

1. Prof Carter expressed the view that written informed consent is mandatory given the paucity of information relating to peptides and the potential for side effects. Dr Hart admitted this particular in writing. We find it to be proved.

The standard

1. According to Prof Carter, it would have been appropriate to monitor each patient periodically to assess the benefits or otherwise of the peptides. Depending on the peptide prescribed, Dr Hart should have assessed for adverse reactions such as aggravation/development of glucose intolerance, carpal tunnel syndrome, joint abnormalities, gynaecomastia and skin lesions.

Monitoring

1. When prescribing the same or similar peptides for a second or subsequent time, Dr Hart did not ask the patient whether the peptides were achieving the desired results or whether they were producing any untoward symptoms or side effects. He admitted that he assumed that because the patient was re-ordering, there was no need to ask these questions. He did not monitor any patient for side effects.
2. Dr Hart prescribed CJC-1295/Ipamorelin combo 160mg to Patient D in June 2015. On 22 November 2015, Patient D emailed Peptide Clinics saying "after injecting in the abdomen my skin has become irritated very quickly." The support team referred the email to Dr Hart. Dr Hart responded to Patient D saying that he "might have developed an allergy to the peptide". He recommended stopping for three months and then starting again with two days off per week. When Patient D ordered more of the same peptide less than three months later, Dr Hart wrote the prescription for a quantity of four because that is the quantity Patient D had requested. The support team sent out the same standard instructions that had been provided to Patient D previously. Dr Hart admitted that the recommendations in his email were inconsistent with those instructions and that this was very poor medical care.
3. Dr Hart wrote three scripts for multiple peptides in a single month for Patient A. On 12 May 2015, Dr Hart prescribed Thymosin Beta 4 - 30mg (10 weeks). Further scripts for bremelanotide 20mg (up to 66 doses) and CJC-1295/Ipamorelin combo 80mg (up to 26 weeks) were prescribed 8 days later on 20 May 2015. On 31 May 2015, Dr Hart prescribed Thymosin Beta 4 45mg (18 weeks) and IGF-1LR3 5mg (up to 10 weeks). Throughout the rest of 2015, Dr Hart continued to prescribe the peptides that Patient A requested and that were consistent with his stated "goals". Because Patient A had not reported any "untoward effects from his initial use of peptides", Dr Hart said he "appeared to be deriving benefit from the treatments".
4. In the summary to the HCCC about Patient A, Dr Hart wrote that Patient A's "administration of peptides was substantial, however his treatment regime remained appropriate and was closely monitored by me". Dr Hart now concedes that he did not monitor Patient A. He wrote the scripts without reviewing previous scripts, several scripts were for quantities in excess of what Patient A could safely use in the time frame and he did not know what effects, if any, Patient A was deriving from the peptides.
5. In February 2016, Dr Hart prescribed various peptides to Patient G including four quantities of SARMs s22 Forte 15mg (3000 mcg/ml). If Patient G had injected this peptide in accordance with the instructions emailed to him, it would have lasted one year. Three months later, in May 2016, Dr Hart wrote another script for SARMs s22 Forte in a quantity that should have lasted another year.
6. For Patient I, Dr Hart wrote scripts for 8 quantities of SARMs s22 Forte 15mg on 5 February 2016. That amount should have lasted 20 weeks. A week later, on 12 February 2016, Dr Hart wrote another script for 8 quantities of the same peptide. He admits that he did not check the frequency or quantity of previous orders and assumed that Patient I was not experiencing any untoward effects. Dr Hart wrote the second script because Patient I ordered it, it was consistent with his stated goals and no contra-indications were recorded on the questionnaire. He did not monitor Patient I.
7. Dr Hart prescribed Patient V with various peptides over a 2-month period in 2015. Fourteen months later, in May 2016, Patient V ordered SARMs s22 Forte, a peptide he had not previously ordered. Dr Hart said that he would have reviewed Patient V's new questionnaire before writing that script. When he was told that the only questionnaire on the record was the 2015 questionnaire, Dr Hart said he assumed that if the questionnaire had not been updated, nothing had changed. It is apparent from this answer that Dr Hart did not require each patient to complete a new questionnaire even after 14 months had elapsed. That fact reinforces our finding that he was not assessing or monitoring this patient adequately.
8. Dr Hart maintained at the hearing that he saw Patient W regularly and monitored his progress although he conceded that his notes were too brief. He saw this patient at his Sydney CBD practice following a shoulder injury. Prof Carter expressed the opinion that Dr Hart did appropriately monitor this patient and Patient E.
9. Dr Hart did not adequately monitor or follow up with any of the 29 patients apart from Patients E and W, after first prescribing.

The standard

1. The Code of Conduct sets out the expectations of medical practitioners. At 3.2.7 the Code states that good medical practice involves: Only recommending treatments when there is an identified therapeutic need and/or a clinically recognised treatment, and a reasonable expectation of clinical efficacy and benefit for the patient.
2. A central issue in the proceedings was whether Dr Hart accepted that he had prescribed the peptides "without an appropriate therapeutic purpose". Dr Hart's solicitors wrote to the HCCC on 1 July 2016 attaching a list of the peptides he had been prescribing, the effect of the treatment and the dosage instructions. Based on that summary and his oral evidence, Dr Hart admitted that, other than in relation to the peptide AOD-9604, he failed to provide appropriate care to each patient to whom he prescribed the peptides. However, he believed, both at the time and now, that: 1. the prescribed peptides were largely able to achieve the desired effect or goal (such as fat breakdown, fat burning, muscle tissue growth, enhanced libido and enhanced tanning) however, he knew at the time that there was no high quality data supporting that view; 2. exceptions to that general claim are Follistatin 314R and mechano growth factor (MGF) which were not particularly effective; and 3. the recommended dosages were appropriate.
3. "Therapeutic use" is defined in s 4 of the Poisons and Therapeutic Goods Act 1966 (NSW) as having the same meaning as in the Therapeutic Goods Act 1989 (Cth). Section 3 of that Act relevantly defines "therapeutic use" to mean "use in or in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons". Dr Hart says he now understands and accepts that there was no therapeutic purpose for prescribing peptides to any of the 29 patients.
4. Below we summarise the evidence about the efficacy of peptides given by Professor Carter, a clinical endocrinologist. We agree with that evidence. We have also included a summary of Dr Hart's former and current understandings.

AOD-9604

1. For AOD-9604, Prof Carter said: "This peptide is a synthetic fragment of human growth hormone (GH) and has developed primarily to assist fat and weight loss when taken in conjunction with a diet and exercise program. Clinical trials of this agent for weight loss was [sic] ceased in February 2017 because of lack of efficacy. Numerous safety studies have been performed which were published in relatively obscure journals. They were sponsored by the peptide manufacturer and the articles were written by authors who appeared to have a financial interest in the drug and thus had a conflict of interest. I am unaware of any clinical studies which have indicated clinical benefits regarding fat/weight loss consequently the clinical use of this peptide is not evidence-based. It is not possible to comment definitely regarding the safety of the peptide due to lack of clinical data."
2. Prof Carter added that there are no accepted therapeutic standards for the dosage and duration of treatment because of a lack of clinical data. He concluded that there is no credible reason to prescribe AOD-9604.

CJC-1295

1. Prof Carter concluded that the safety, quality and efficacy of CJC-1295 have not been established and that there are no clinical indications for prescribing it in normal adults. "This peptide is a synthetic analogue of growth hormone releasing hormone (GHRH). It acts on the GHRH receptors on the pituitary gland to stimulate endogenous GH synthesis and secretion. There are only limited published clinical trials relating to this peptide and the findings are variable with some reports indicating an increase in muscle strength in normal adults but others [sic] studies showing no effect. There are insufficient clinical studies to allow comments on safety but as the mechanism of action is via an increase in GH secretion, there are well recognised side-effects of injections which include oedema, carpal tunnel syndrome, abnormalities in glucose metabolism (including aggravation of underlying diabetes), arthralgias and gynaecomastia."
2. Dr Hart prescribed CJC-1295 if the patient requested it and their "interest" or "goal" was muscle tissue growth, fat-burning or anti-aging. He believed that if this peptide was used in combination with exercise, the person would recover faster. He agreed that there had been no independent trials of this drug and that if the person was doing a lot of exercise, it may be difficult to prove that CJC-1295 was contributing to muscle tissue growth and fat loss.

Follistatin 315

1. Prof Carter concluded that there are no demonstrated benefits of Follistatin 315 in humans. "This peptide has a theoretical mode of action by inhibition of Myostatin (which inhibits muscle growth). Thus, theoretically, it could stimulate muscle growth but there are no clinical trials (with or without results of benefit) using this peptide and in particular no reports of systemic administration of the peptide. There may possibly be an experimental role in treatment of patients with particular muscle wasting conditions but there is a paucity of data in this regard."

GHRP-2, GHRP-6, hexarelin and ipamorelin

1. Prof Carter concluded that although growth hormone (GH) injections have proven benefits in GH-deficient individuals, no significant beneficial effects have been documented when used in adults without GH deficiency. There are no clinical indications for prescribing GHRP-2, GHRP-6, hexarelin or ipamorelin in normal individuals. "These four peptides are GH-releasing peptides which stimulate GH release from the human pituitary via a mechanism independent from stimulation of the GHRH receptor on the pituitary. GHRP-2, Hexarelin and Ipamorelin are all synthetic peptide analogues of GHRP-6…"
2. Dr Hart agreed that no quality research had been conducted on the efficacy of these peptides. He considered that ipamorelin promotes muscle tissue growth and repair, particularly in people who are also exercising.

Human chorionic gonadotropin (HCG)

1. Prof Carter said that HCG is a high-quality peptide and when used appropriately has good safety and efficacy. However, it has no recognised clinical indications with respect to weight loss or fat loss. "HCG is a hormone that acts via the luteinising hormone (LH) receptor on the gonads and it has some well-recognised indications for usage in the management of infertility or hypogonadal problems."
2. Dr Hart said that he believed, at the time, that HCG in conjunction with a low-calorie diet could reduce body fat. However, while he may have believed that, he knew that there was no good quality evidence to support that belief.

Insulin-like growth factor 1 (IGF-1 LR3)

1. Prof Carter concluded that IGF-1 has been proven to be effective in IGF-1 deficient patients, but not in normal adults. "IGF-1 is a hormone produced predominantly in the liver following stimulation by GH. Almost all of the biological effects of GH are mediated via the stimulation of IGF-1 production. The IGF-1 peptide prescribed by Dr Hart is produced by a recombinant DNA technique and when used in appropriate doses would appear to be safe."
2. Dr Hart prescribed IGF-1 for muscle tissue growth and repair. He acknowledged that in 2014 there was no quality research supporting its use.

LGD-4033 and SARMs s22 Forte

1. Prof Carter concluded that there are currently no clinical indications for prescribing SARMs. "SARMS are selective androgen receptor modulators which bind to androgen receptors throughout the body resulting in stimulation or inhibition of androgen (e.g. testosterone) production. There are limited data that indicate SARMS are used to increase muscle protein synthesis and to decrease muscle atrophy. Many of the studies are small and have been performed by the manufacturer (raising the question of conflict of interest) and there are insufficient data to comment on the safety quality and efficacy of these peptides in clinical situations, particularly in normal adults."
2. In 2014, Dr Hart was not aware of any proven clinical benefits, but he considered that SARMs were effective in promoting muscle tissue growth and repair.

Mechano growth factor (MGF)

1. Prof Carter concluded that there are no studies in humans on which to base any comments regarding the efficacy or side-effects of prescribing MGF for muscle tissue growth or repair. "MGF is a variant of IGF-1 which is derived from muscles rather than the liver. It is thought to increase muscle mass by increasing the rate at which damaged muscles repair and regenerate. There are some data which indicate that MGF does not have the systemic effects of IGF-1 and thus does not aggravate glucose intolerance. Its effects are thought to be specific to muscles."
2. Dr Hart agreed that in 2014 there was no quality research supporting the use of this peptide.

Melanotan II

1. Prof Carter said that very limited clinical studies, plus an extensive body of anecdotal evidence, suggests that Melanotan II is very efficient at inducing a generalised tan. "Melanotan II is a synthetic analogue of alpha melanocyte stimulating hormone and it acts by stimulating melanocytes in the skin and thus increases generalised tanning."
2. Prof Carter also quoted an online report issued on 9 November 2015 by the Victorian Department of Health and Human Services titled "Health warning on Melanotan-II and other products not approved" which stated: "Melanotan-II is a product not approved by the Therapeutic Goods Administration and is known to produce significant side-effects, including abnormal tanning of moles and freckles which may interfere with skin cancer diagnosis."
3. Prof Carter expressed the opinion that before prescribing this product it would be important to undertake a full skin examination of underlying skin lesions, particularly those that are pigmented.
4. Dr Hart prescribed Melanotan II to assist with tanning and for libido enhancement and appetite suppression. He agreed that no quality research has been undertaken. He also admitted that, contrary to Prof Carter's recommendation, he did not do a skin check on any patient or refer them to a skin specialist before prescribing Melanotan II. He disagreed with the view expressed on the Victorian Department of Health's website, that using Melanotan II may interfere with skin cancer diagnosis.
5. Dr Hart appears to have misunderstood Prof Carter's evidence. He was not saying that Melanotan II causes malignancy, merely that the use of Melanotan II may lead to abnormal tanning of moles and freckles which would make diagnosis of skin cancer more difficult. That is the reason for undertaking a full skin examination of the underlying skin lesions, particularly those that are pigmented.

Oxytocin

1. Prof Carter concluded that, apart from use in childbirth and lactation, there are no clinical indications for prescribing oxytocin. He did not accept the validity of Dr Hart's reasons for prescribing oxytocin which were "to enhance confidence and reduce feelings of anxiety, which can assist with weight loss". "Oxytocin is a hormone produced in the hypothalamus of the brain and is important with respect to labour and lactation. It is synthesised and the commercial preparations are of high quality and would appear to be safe. ... There are no good quality clinical studies relating to oxytocin administration with respect to effects on calmness and anxiety and any reported benefits were either not significant or of borderline statistical significance only."
2. Dr Hart agreed that there was no quality research supporting the prescribing of oxytocin to enhance confidence and relieve anxiety.

Bremelanotide (PT-141)

1. Prof Carter said: "Like Melanotan II, Bremelanotide is an analogue of alpha melanocyte stimulating hormone... It is prescribed for the treatment of male and female sexual dysfunction but I am unaware of any high-quality clinical trials demonstrating effectiveness."
2. Dr Hart prescribed this peptide "to enhance libido" and had no doubt that it worked. However, he admitted that he should have confined himself to prescribing substances with high quality evidence to support their use.

Thymosin Beta 4

1. Prof Carter said: "This peptide is involved in cell proliferation, migration and differentiation and plays a role in wound healing. There are very few clinical trials demonstrating benefit from the use of this peptide and the major trials (with small numbers of patients) relate to use with corneal ulcers and in chronic full thickness cutaneous skin ulcers. There is no clinical evidence that the use of the peptide prophylactically is beneficial with respect to muscle injuries and there are no convincing data to suggest that it should be routinely used for wound healing. Based on a paucity of clinical data, it would appear that the peptide is safe and of high quality, but there are very few data confirming efficacy with respect to wound healing."
2. Dr Hart prescribed this peptide to promote blood vessel, cell and skin cell regeneration and migration, resulting in more rapid and effective injury and wound repair.

Examples of peptides prescribed with no therapeutic purpose

1. In August 2016, Dr Hart wrote a summary of his treatment for the purpose of responding to the peptide complaint. He wrote that he considered Patient A to be a suitable patient for peptide treatment to assist him in pursuing his health and lifestyle interests. On 8 April 2016, Dr Hart had prescribed Patient A with 3 quantities of oxytocin (each expected to last 30 days) for the first time. He does not know why he wrote that script and agreed that there was no stated goal, much less a therapeutic purpose, for doing so.
2. As with Patient A, Dr Hart agreed that there was no therapeutic purpose for prescribing oxytocin to Patient G on 29 December 2015 or for prescribing Melanotan II to Patient K.
3. Patient T indicated that his interests were "anti-aging, muscle building, fat loss/weight loss, safe enhanced tanning, injury repair and increased libido." Because these interests effectively covered the field, Dr Hart prescribed everything he asked for.
4. Patient F presented complaining of poor energy levels and gastrointestinal pain and discomfort. After a series of tests, Dr Hart suggested various vitamins (D3 and K2) and supplements as well as Melanotan II.
5. Patient W was 49 years old and had difficulty recovering full use of his shoulder. On 14 April 2014, Dr Hart diagnosed Patient W with adult growth hormone deficiency and issued a prescription for NutropinAq (somatropin). Dr Hart acknowledged that none of the tests he ordered suggested that Patient W was deficient in adult growth hormone. While he did not have a "laboratory deficiency", Dr Hart said he had symptoms that were consistent with a deficiency. He acknowledged that there was no quality evidence that a rotator cuff tear would benefit from peptides.
6. Dr Hart treated Patient Z, who was 53 at the time. He reported taking numerous medications including DHEA (dehydroepiandrosterone), metformin, oxytocin, testosterone cream and clomiphene 50mg. Dr Hart tested Patient Z's DHEA levels, which are known to decline with age. He accepted that there is no high quality evidence supporting prescribing DHEA in healthy adults.
7. In September 2015, Dr Hart prescribed clomiphene 50mg for Patient Z. That medication is used to increase testosterone production in men. Dr Hart agreed that there was no clinical indication to prescribe this peptide. He says it was prescribed on a trial basis, as a substitute for testosterone cream, to see if it would help Patient Z's low energy, mood and low libido. He admitted that he did not record that reason in his notes. On 28 January 2016, Dr Hart prescribed testosterone cream again without ordering a blood test to ascertain his testosterone levels. When Dr Hart did request a blood test a month later, Patient Z's testosterone was above the normal range. Dr Hart said that he wrongly thought that the optimal range was higher than the normal range.
8. Patient E completed the online questionnaire on 7 April 2015 when he was 39 years old. He indicated that he had suffered from a shoulder injury and had undergone surgery in 2014 and 2015. He consulted Dr Hart in his surgery on 9 April 2015 reporting neck tension and pain. He had had a plate removed seven weeks earlier and his shoulder had not fully recovered. Patient E was looking for alternatives to surgery.
9. Dr Hart tested Patient E's testosterone level thinking that low testosterone may be preventing his shoulder from healing properly. The results of the testosterone test were 28 nmol/l. That reading is considered to be at the upper end of the normal range for a person of his age, but Dr Hart said he mistakenly compared the level against what he expected for a healthy 20 year-old. He prescribed testosterone even though Patient E was not androgen deficient. In his statement of 10 March 2020, Dr Hart suggested that there was a clinical basis for prescribing testosterone to Patient E. He now accepts that there was no clinical basis for doing so.
10. Dr Hart also prescribed metformin for Patient E. He had read that it reduced the conversion of testosterone to estrogen so he thought it would help a patient to recover from an injury. He now accepts that it has no clinical basis for the treatment of muscle injuries.
11. We find Complaint 5, particulars 6 and 7 to have been proved, that is, there was no clinical basis for Dr Hart to prescribe testosterone propionate or metformin to Patient E.
12. In accordance with the evidence, particularly Prof Carter's opinion, Dr Hart prescribed each of the substances listed in the 29 complaints without an appropriate therapeutic purpose.

Prescribing multiple peptides which performed the same function

1. In relation to Patient A, it is alleged that Dr Hart failed to provide appropriate care and treatment in that he prescribed multiple peptides which performed the same function, namely: CJC-1295, hexarelin, IGF-1 LR3, ipamorelin, MGF and SARMs.
2. Dr Hart agreed that both SARMs and CJC-1295 were prescribed for muscle building but said that they each used a different mechanism to achieve that goal. Dr Hart regarded these treatments as appropriate, but took no steps to determine whether the creams were actually achieving Patient A's goals. Dr Hart also conceded that while he regarded each peptide as safe individually, he was not aware of whether the four peptides would react together. He maintained that different mechanisms of action give additional effects although he conceded that there was no quality data to support that opinion.
3. The first time Dr Hart wrote a script for Patient B was on 25 September 2014. He prescribed CJC-1295/Ipamorelin combo 20mg, SARMs s22 20mg and AOD-9604 24mg. Dr Hart acknowledged that by writing scripts for multiple peptides he did not know which one, if any, was responsible for any change. He repeated that the "mechanisms of action" were different for each one. Three weeks later, Patient B asked for the same three peptides and Dr Hart wrote a prescription for them. He did not know whether Patient A was abusing these peptides and did not turn his mind to the wisdom of prescribing them. Six months later Dr Hart prescribed GHRP-2 in combination with two other peptides. He admitted that he did not know what effect these combinations were having on Patient B.
4. Dr Hart also prescribed multiple peptides to Patient G. While he said he thought about the dangers of prescribing so many peptides in high doses, he did not act on that thought. He said he was aware that it was a prolonged course but he assumed that Patient G, and other patients, would not take more than the recommended dose.
5. Patient L expressed interest in muscle building. On 19 October 2015, Dr Hart prescribed CJC-1295/Ipamorelin 20mg cream, MGF 10mg cream and SARMs s22 Forte 50mg cream. Dr Hart knew that there is no evidence that these peptides have a cumulative effect. He did not mention that to Patient L.
6. Patient AA first consulted Dr Hart on 17 June 2014 and informed him that he had previously used steroids. Patient AA returned for a second consultation a month later. During a third visit on 7 August 2014, Dr Hart said he planned to test Patient AA's testosterone levels because steroid abuse can suppress testosterone production. The patient's goal was to increase fertility. Dr Hart admitted that he did not check for testicular atrophy or sterility. Patient AA's testosterone level was 22.6 nmol/l on 19 August 2014. Dr Hart prescribed anastrozole, an aromatase inhibitor which inhibits the production of estrogen from androgens. Anastrozole is normally used to treat breast cancer in post-menopausal women. Dr Hart agreed that there was no clinical purpose for prescribing that drug. He said he thought it was based on something he had read from overseas.
7. At a consultation on 22 October 2014, Dr Hart wrote a plan to consider SARMs. On 16 December 2014, he prescribed clomiphene with no therapeutic purpose for doing so. Dr Hart also accepted that there was no therapeutic purpose for treating Patient AA with metformin in 2015.
8. On 8 August 2016, Dr Hart prescribed a form of testosterone, Reandron 1000 by injection 0.3ml twice a week. He denied that this was an excessive dose, saying that he gave smaller doses rather than one big dose. We agree with Prof Carter's evidence that this dose was clearly excessive. The normal dosage is 4ml corresponding to 1000mg Reandron (testosterone undecanoate) every 10-14 weeks. Dr Hart's dose is 1.5 times the 10-weekly dose and double the 12-weekly dose.
9. Patient AB reported fertility issues and sleep apnoea. Dr Hart prescribed vitamins D3 and K2. He agreed that there was no therapeutic purpose for doing so. He also prescribed clomiphene, a substance used to make testosterone, and planned to order a clomiphene stimulation test (CST) to see whether clomiphene was effective. On 21 October 2015, Dr Hart wrote that there were no symptomatic changes on CST. Prof Carter's evidence was that there was nothing to indicate that Patient AB was deficient in testosterone. Dr Hart accepted that there is some controversy about how to calculate testosterone deficiency but that, in any case, it was not appropriate for him to trial Patient AB with testosterone.

Inadequate training

1. For most of the 29 patients, it was alleged that Dr Hart failed to provide appropriate care and treatment by prescribing certain medications "without an appropriate level of training". Prof Carter's evidence was that the level of training required to prescribe the peptides Dr Hart was prescribing should be equivalent to that of a clinical endocrinologist.
2. 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. There were other major gaps in Dr Hart's knowledge and competence. Prescribing testosterone to Patient E when he was not androgen deficient is one example. In accordance with Prof Carter's opinion, we are satisfied that Dr Hart prescribed the specified medications without an appropriate level of training. In particular, although Dr Hart did not admit these particulars, we find Complaint 7, particular 3(g) and particular 6(g) to have been proved (that Dr Hart prescribed IGF-1 LR3 and SARMs s22 Forte for Patient G without an appropriate level of training).

Signing the prescription

1. For Patient F, it was alleged that Dr Hart prescribed Melanotan II on certain dates and in certain quantities, without signing the prescription provided directly to the patient in his own handwriting. It was also alleged that even though Dr Hart saw Patient F face-to-face, he failed to provide a complete prescription to him, contrary to the Poisons and Therapeutic Goods Regulation 2008 (NSW) and NSW Health's "Criteria for Issuing Non-Handwritten (Computer-Generated) Prescriptions".
2. Dr Nespolon concluded that Dr Hart had used computer-generated scripts with no handwriting on them. Dr Hart's evidence was that he was unable to say whether he failed to provide a complete prescription to Patient F
3. There was insufficient evidence about these particulars. We find Complaint 6, particular 1(e) and particular 2 (that Dr Hart did not sign the prescription provided directly to Patient F in his own handwriting when prescribing Melanotan II and that he saw Patient F face-to-face but did not provide a complete prescription) not to have been proved.

The standard

1. The Medical Board of Australia's Code of Conduct ("Good Medical Practice: A Code of Conduct for Doctors in Australia", March 2014) sets out the expectations of medical practitioners about treating themselves and those with whom they have a close personal relationship. At section 9.2.2, the Code states that good medical practice involves "seeking independent, objective advice when you need medical care, and being aware of the risks of self-diagnosis and self-treatment". The Medical Council has elaborated on the Code in a publication titled "Guideline for self-treatment and treating family members" dated 2 December 2014. The guidelines state that: "Medical practitioners should not initiate treatment (including prescribing) for themselves or members of their family."
2. Dr Hart prescribed himself CJC-1295/Ipamorelin, LGD-4033 and SARMs s22 Forte on four occasions between 30 July 2014 and 6 March 2016. He claims that he was not treating himself; he just wanted to see what happened when he took peptides. He admitted that he did not prescribe them for a therapeutic purpose.
3. We find this complaint proved.

Inadequate medical records

1. The HCCC alleges that Dr Hart is guilty of unsatisfactory professional conduct under section 139B(1)(b) of the National Law. Section 139B(1)(b) provides that: (b) Contravention of this Law or regulations A contravention by the practitioner (whether by act or omission) of a provision of this Law, or the regulations under this Law or under the NSW regulations, whether or not the practitioner has been prosecuted for or convicted of an offence in respect of the contravention.
2. Under cl 7(1) of the Health Practitioner Regulation (New South Wales) Regulation 2010 (NSW) (repealed): 7 Records relating to patients (1) A medical practitioner or medical corporation must, in accordance with this Part and Schedule 2, make and keep a record, or ensure that a record is made and kept, for each patient of the medical practitioner or medical corporation.
3. Schedule 2, clause 1 provides that: 1 Information to be included in record (1) A record must contain sufficient information to identify the patient to whom it relates. (2) A record must include the following: (a) any information known to the medical practitioner who provides the medical treatment or other medical services to the patient that is relevant to the patient's diagnosis or treatment (for example, information concerning the patient's medical history, the results of any physical examination of the patient, information obtained concerning the patient's mental state, the results of any tests performed on the patient and information concerning allergies or other factors that may require special consideration when treating the patient), (b) particulars of any clinical opinion reached by the medical practitioner, (c) any plan of treatment for the patient, (d) particulars of any medication prescribed for the patient. (3) The record must include notes as to information or advice given to the patient in relation to any medical treatment proposed by the medical practitioner who is treating the patient. (4) A record must include the following particulars of any medical treatment (including any medical or surgical procedure) that is given to or performed on the patient by the medical practitioner who is treating the patient: (a) the date of the treatment, (b) the nature of the treatment, (c) the name of any person who gave or performed the treatment, (d) the type of anaesthetic, if any, given to the patient, (e) the tissues, if any, sent to pathology, (f) the results or findings made in relation to the treatment. (5) Any written consent given by a patient to medical treatment (including any medical or surgical procedure) proposed by the medical practitioner who treats the patient must be kept as part of the record relating to that patient.
4. Dr Nespolon, the general practitioner who gave expert evidence, expressed the view that there were no clinical records provided that would comply with the requirements of these regulations. We find these particulars to have been proved.

Summary of findings in peptide complaint

1. We find each of the 32 complaints in the peptide complaint filed on 2 October 2019 to have been admitted or proved apart from: 1. Complaint 5, particular 1(d) and Complaint 23, particular 1(e) (that Dr Hart did not adequately monitor and/or follow up with Patient E and Patient W whilst prescribing these drugs); and 2. Complaint 6, particulars 1(e) and particular 2 (that Dr Hart did not sign the prescription provided directly to Patient F in his own handwriting when prescribing Melanotan II and that he saw Patient F face-to-face but did not provide a complete prescription).

Unsatisfactory professional conduct - knowledge, skill, judgment and care

1. For Complaint 1 of the anti-aging complaint, the HCCC alleged that Dr Hart is guilty of unsatisfactory professional conduct under section 139B(1)(a) of the National Law. Under that provision, the conduct must demonstrate that the knowledge, skill or judgment possessed, or the care exercised, by Dr Hart in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. The conduct listed includes recommending or prescribing certain treatments, drugs and vitamins and failing to obtain Patient AE's informed consent.

Improper or unethical conduct

1. Complaint 2 of the anti-aging complaint is that Dr Hart engaged in "other improper or unethical conduct relating to the practice or purported practice" of medicine in breach of s 139B(1)(l) of the National Law. The HCCC alleged that 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. Dr Hart admitted this complaint.

Professional misconduct

1. Complaint 3 of the anti-aging complaint is that Dr Hart is guilty of professional misconduct under s 139E of the National Law in that he has: 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
2. The HCCC alleged that when the instances of unsatisfactory conduct in the peptide complaint are considered together with the instances of unsatisfactory professional conduct in the anti-aging complaint they amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of Dr Hart's registration. Dr Hart admitted this complaint.

Functional medicine

1. Patient AE, an 82-year-old woman with dementia, presented with her son on 17 October 2018. Dr Hart recorded that she was complaining of worsening tiredness and shortness of breath on exertion. She weighed 39kg and was depressed.
2. Dr Hart provided a number of articles by Dr Breseden (and others) which he considered at the time provided a "compelling case" for applying the theories of functional medicine to patients with cognitive decline. 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.
3. Dr Hart said he thought it was his role to assess the various guidelines both in Australia and overseas before deciding what was best for his patients. He said it takes 13 years from when scientists first discover something for it to be accepted by the medical community. He thought that he should be up to date with the latest findings and apply them in his practice. Dr Hart said he now understands that he needs to practise medicine in accordance with the guidelines and standards referred to throughout this decision and the collective opinion of relevant experts. He referred to those guidelines generically as "the standard of care".
4. When asked when he became aware that he was not following the relevant standard, he said it was a "process over time". When the Medical Council suspended his registration in 2019, he said he realised that he was at risk of complaints if he did not follow the guidelines even though they are decades behind the times. In our view, Dr Hart has always known that he was not following the so called "standard of care". He knew he was practising outside the standards expected of medical practitioners but he did not stop doing so until his registration was under threat.

Expert evidence

1. Prof Carter provided a report dated 11 November 2019 which was updated on 13 March 2020 and again on 17 March 2020. With a few minor exceptions, he found Dr Hart's treatment of Patient AE to be significantly below the expected standard and to invite his strong criticism.

Coronary artery calcium CT scan

1. Patient AE had experienced multiple vascular problems and had had two stents inserted. Dr Hart ordered a test to measure her coronary artery calcium score (CACS). He thought that if her vascular health was worsening, whatever was causing the dementia might have been the problem. Dr Hart conceded that he did not communicate with Patient AE's cardiologist and that, in hindsight, the CACS scan was not necessary. Since 2018, he has re-acquainted himself with current "standard of care" principles.
2. Prof Carter noted that Patient AE was seeing a cardiologist for heart disease and it was inappropriate to order this scan as the result was not going to alter her clinical management. In accordance with Dr Hart's admission and Prof Carter's expert evidence, we find that this investigation was inappropriate.

Pelvic and breast ultra sound

1. When recommending these procedures, Dr Hart was contemplating whether Patient AE should be prescribed hormone replacement therapy (HRT). At the time, he considered it to be appropriate clinical practice to offer HRT to an 82-year-old woman. He acknowledged that screening for breast cancer usually stops at 75 and that there were no clinical signs or history of abnormal breasts. Nevertheless, he wanted to give Patient AE "an abundance of care" and said that ultrasound is a more accurate screening tool than manual examination. He said he would not suggest pelvic and breast ultrasounds now because he would not consider offering HRT to an 82-year-old woman.
2. Prof Carter expressed the view that there were no clinical indications to suspect any underlying pathology. Consistently with that view, we find that these procedures were not clinically indicated.

Bone density testing

1. According to Prof Carter, bone density testing was inappropriate because Patient AE was already being treated with Prolia for osteoporosis. The result of any bone density testing would not have altered her clinical management.

Cone beam dental CT scan

1. Patient AE had no teeth of her own. Dr Hart ordered this procedure because he thought inflammation could be present in the teeth sockets. He said that there are usually no symptoms of inflammation but a scan can reveal infected bone in the cavity. He would not recommend this procedure now, but at the time he was trying to identify as many things as possible that were contributing to Patient AE's cognitive decline.
2. Prof Carter expressed the view that there were no clinical indications for ordering this scan. Consistently with that view, we find that this procedure was not clinically indicated.

Pathology tests

1. Dr Hart ordered several blood tests in an attempt to identify possible causes of fatigue and inflammation. He gave evidence that if heat shock protein 27 was elevated, that showed that cells were under stress and he could use that as a marker of improvement. Copper and zinc levels can also be a marker of inflammation. In Prof Carter's opinion, the tests for heat shock proteins, copper and zinc were inappropriate. In a later report dated 13 March 2020, he added that tests for sex hormone levels, insulin, leptin and parathyroid hormone (PTH) were not clinically indicated.
2. We agree with that view and find that the ordering of those tests was not clinically indicated. In the absence of expert evidence from Prof Carter or an express admission from Dr Hart in relation to the remaining pathology tests, we find the particular not proved for any other tests.

Recommending a colonoscopy

1. This allegation is that Dr Hart recommended that Patient AE undergo a colonoscopy and that he failed to obtain sufficient details of results and timings of a previous colonoscopy.
2. Prof Carter's opinion was that a colonoscopy might have been indicated in view of the past history of colonic polyps together with Patient AE's low weight and intestinal symptoms. However, Dr Hart should have obtained information about the timing and outcome of previous colonoscopies before subjecting Patient AE to a further colonoscopy.
3. In fact, Dr Hart had merely suggested that Patient AE go back to her GP and ask for a referral to the surgeon for a colonoscopy. He did not recommend that Patient AE undergo a colonoscopy. We find this particular not proved.

Geovital screening

1. It is alleged that Dr Hart recommended that Patient AE obtain a Geovital screening for man-made electromagnetic radiation in the absence of any proven medical benefit. According to Prof Carter, there is no proven benefit with respect to preventing the progression of dementia.

Failure to obtain informed consent

1. It is alleged that Dr Hart failed to obtain adequate informed consent from Patient AE regarding the investigations and medications he recommended. Dr Hart agreed that Patient AE did not have sufficient cognitive function to understand the detail of what he was suggesting. She signed a general consent form coming into the practice, and her son signed the specific consent form for hormone replacement therapy.
2. Prof Carter's opinion was that Dr Hart had obtained adequate and informed consent for some aspects such as prescribing of triiodothyronine (T3) and the sex hormone therapy. However, there was no evidence of informed consent being obtained for the significant number of investigations which were extremely unlikely to have influenced Patient AE's clinical management.

Inadequate clinical records

1. It was alleged that Dr Hart failed to maintain adequate clinical records that comply with s 7 and Sch 2 of the Health Practitioner Regulation (New South Wales) Regulation 2010 (NSW) with respect to the care and treatment of Patient AE.
2. Prof Carter initially gave evidence in his 11 November 2019 report that he did not believe that Dr Hart had maintained adequate clinical records of his consultations with Patient AE. In particular, the reasons for prescribing medications and supplements were not given. Later, the HCCC gave Prof Carter screen shots from the computer program used by Dr Hart. Despite that further information, Prof Carter was not able to see where Dr Hart had recorded primary problems with Patient AE. He could see little evidence that the plan of management was specifically oriented to Patient AE. Rather, Dr Hart appears to have taken a generic approach. Prof Carter concluded that: "Although the screen shots indicate that Dr Hart had recorded significant clinical notes, they are not in a form that would allow another doctor taking over (Patient AE's) care to understand what were her primary problems, why the numerous investigations were undertaken and why all the types of medications/supplements were commenced."
3. We agree with Prof Carter that the notes would not allow another doctor to understand why he was ordering the numerous investigations and why each of the medications and supplements were commenced. However, although Dr Hart's reasons for treating Patient AE were fundamentally flawed, the notes did reveal the assessments Dr Hart had made and his management plan. The information collected and the plan developed were not standard practice, but they were amply recorded. This allegation is not proved.

Conflict of interest

1. It is alleged that Dr Hart failed to 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 purchased goods and services from those providers.
2. A conflict of interest is defined in the Medical Board of Australia's Code of Conduct at 8.11: "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."
3. The Code of Conduct states at 10.12.3, that good medical practice involves: "Informing patients when you have an interest that could affect, or could be perceived to affect, patient care."
4. Dr Hart admitted this part of the complaint. He did not tell Patient AE that he received these rebates. He also acknowledged that when he was before the Medical Council in September 2016, the relevant parts of the Code of Conduct were brought to his attention. Despite that, he did not inform Patient AE of the conflict. He could not offer any reason to the Tribunal for failing to do so.
5. We find that this conduct amounts to "other improper or unethical conduct".

Summary of findings in anti-aging complaint

1. We find each of the three complaints in the anti-aging complaint filed on 16 April 2020 to have been admitted or proved apart from: 1. that part of Complaint One, particular 1(a) relating to pathology tests other than for heat shock proteins, copper, zinc, sex hormone levels, insulin, leptin and PTH; 2. Complaint One, Particular 1(b) (that Dr Hart recommended that Patient AE undergo a colonoscopy); and 3. Complaint One, particular 1(f) (that Dr Hart failed to maintain adequate clinical records with respect to his care and treatment of Patient AE).

Orders 1. In relation to the application for disciplinary findings and orders made on 21 October 2019, we find the subject matter of the complaints to have been admitted or proved apart from: 1. Complaint 5, particular 1(d) and Complaint 23, particular 1(e); and 2. Complaint 6, particular 1(e) and particular 2. 1. In relation to the application for disciplinary findings and orders made on 16 April 2020, we find the subject matter of the complaints to have been admitted or proved apart from: 1. that part of Complaint One, particular 1(a) relating to pathology tests other than for heat shock proteins, copper, zinc, sex hormone levels, insulin, leptin and PTH; 2. Complaint One, particular 1(b); and 3. Complaint One, particular 1(f).

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: 08 April 2021