The Tribunal finds allegations 1, 2 and 4 proven, and in respect of each allegation finds that the conduct is unprofessional conduct within the definition in s 5 of the National Law, namely professional conduct that is of a lesser standard than that which might be reasonably expected of the health practitioner by the public or the practitioner's professional peers.

The proceeding is listed for an administrative mention on 30 October 2017, by which date the parties are to advise the Tribunal in writing of proposed consent orders and directions in respect of submissions on determinations. If the parties ask that the matter be listed for hearing, they are to advise available dates for Counsel and any witnesses in December 2017 and January and February 2018.

1. This case is about Dr Bassam Abi Haila's conduct as a registered medical practitioner in 2013 and early 2014, in particular his prescription of testosterone and human growth hormone (hGH) to adult male patients, while working at an 'anti-ageing' clinic.
2. It highlights the risks for medical practitioners, particularly junior medical practitioners, in working in such clinics at the fringe of medical practice, and where the medical practitioner is likely to come under intense pressure to prescribe.
3. In 2013, Dr Abi Haila was a junior doctor in his third year after graduation. He had completed internship and residency years at Ballarat Base Hospital and was, at the time he worked at the clinic, a medical registrar at Box Hill Hospital. At the date of hearing, Dr Abi Haila was still only three years into four-year general practitioner training.
4. He worked one day a week at the clinic which was owned by a dietician and personal trainer, who referred patients to Dr Abi Haila. By the time he saw them, they had had an initial consultation, completed a questionnaire and blood test results had been obtained. The questionnaire had at the end the following declaration:

I declare to the best of my knowledge the information given is correct and that I know of no reason why I should not have hormone replacement therapy. I hereby acknowledge that I assume all responsibility for my participation, activities and use of hormone treatment.

1. In most cases, the blood tests showed hormone levels within the normal range. In all but one case, the patients were under 50. Dr Abi Haila did not order repeat blood tests before prescribing and did not obtain specialist opinion from an endocrinologist or an andrologist.
2. Testosterone and hGH are both Schedule 4 poisons, which means that a medical practitioner must not prescribe them unless he or she has taken all reasonable steps to establish that a therapeutic need exists for that poison.
3. The Medical Board of Australia (the Board) alleges that Dr Abi Haila has engaged in unprofessional conduct and/or professional misconduct within the meaning of the Health Practitioner Regulation National Law Act 2009 (National Law) by:
   • Prescribing testosterone to four patients without proper clinical justification
   • Prescribing the hGH Somatropin (product name SciTropin A) to six patients without proper clinical justification
   • Failing to adequately record his medical treatment of six patients
   • Failing to appropriately clinically manage certain of his patients, in particular by failing to obtain the opinion of a suitably qualified specialist before initiating treatment.
4. Dr Abi Haila contends that the Board has not proven the allegations made, in particular the allegations that he prescribed testosterone and/or hGH without proper clinical justification, and should have sought specialist opinion.
5. He agrees that he prescribed testosterone and/or hGH to each of the patients as alleged. He maintains, however, that his prescription of testosterone and/or hGH to the patients concerned was appropriate. His prescribing criteria were:
   • Levels of testosterone and IGF-1 that were on the lower side of the normal range
   • An age of no less than 35
   • Symptoms of 'andropause' or male menopause: namely low libido, reduced exercise tolerance, lack of energy, increased fat, dysthymia and erectile dysfunction
6. He believed that the patients would obtain a benefit from the treatment. In each case, he said, the patients were fully informed of the risks and benefits and gave informed consent. He prescribed low starting doses and short term prescriptions. He had prescribed testosterone and/or hGH to 14 patients in total but had refused to prescribe to 7 patients.
7. Dr Abi Haila said he recognised that that there was a potential for his work at the clinic to be controversial or to attract attention from regulators. In late 2012, before starting work at the clinic, he sought advice and received counselling from Mr Chris Falcke, Senior Drugs and Poisons Officer, Drugs and Poisons Regulation, Department of Health.
8. At the hearing before us, he acknowledged that that the patients referred to him were seeking hormone treatment. While working at the clinic, he felt under increasing pressure to prescribe, leading to a decision to stop working there. But he maintained that his prescribing was appropriate and said he would not have done anything differently.
9. It was submitted on behalf of Dr Abi Haila that the central question in this case is whether 'andropause' is a real medical condition.
10. We disagree. The questions for us are whether the Board has proven the allegations made and whether Dr Abi Haila has behaved in a way that constitutes unprofessional conduct or the more serious professional misconduct.
11. Relevantly, Dr Abi Haila did not record a diagnosis of 'andropause' for any of the patients. Nor did he record any other diagnosis.
12. In any event, the opinion of all three expert witnesses in this case was that 'andropause' (as opposed to the recognised gradual decline in hormone levels as a man ages or true clinical deficiencies confirmed by repeat testing) has not been accepted as a medically valid concept. Further, none of them would have prescribed testosterone and/or hGH in the particular circumstances here. And other explanations for the symptoms reported were open, such as mood disorders.

1. The Board makes four allegations against Dr Abi Haila. They are set out in full, with their particulars, in the discussion below.

That between on or about 5 April 2013 to on or about 15 January 2014, Dr Abi Haila engaged in unprofessional conduct and/or professional misconduct within the meaning of the definitions of unprofessional conduct and/or professional misconduct in section 5 of the National Law in that he prescribed Testosterone to his patients, Patient 1 and/or Patient 2 and/or Patient 5 and/or Patient 6, without proper clinical justification.

Allegation 2: prescription of human growth hormone

That between on or about 25 March 2013 and on or about 15 January 2014, Dr Abi Haila engaged in unprofessional conduct and/or professional misconduct within the meaning of the definitions of unprofessional conduct and/or professional misconduct in section 5 of the National Law by prescribing Somatropin to his patients, Patient 1 and/or Patient 2 and/or Patient 3 and/or Patient 4 and/or Patient 5 and/or Patient 6, without proper clinical justification.

That between on or about 29 January 2013 two on or about 15 January 2014, Dr Abi Haila engaged in unprofessional conduct and/or professional misconduct within the meaning of the definitions of unprofessional conduct and/or professional misconduct in section 5 of the National Law in that he failed to adequately record his medical treatment of his patients, Patient 1 and/or Patient 2 and/or Patient 3 and/or Patient 4 and/or Patient 5 and/or Patient 6.

That between on or about 29 January 2013 to on or about 15 January 2014, Dr Abi Haila engaged in unprofessional conduct and/or professional misconduct within the meaning of the definitions of unprofessional conduct and/or professional misconduct in section 5 of the National Law by failing to appropriately clinically manage certain of his patients.

1. Under s 196 (1) of the National Law, after hearing a matter about a registered health practitioner, the Tribunal may decide that the practitioner has no case to answer and no further action is to be taken in relation to the matter or may decide one or more of the following:
   • The practitioner has behaved in a way that constitutes unsatisfactory professional performance
   • The practitioner has behaved in a way that constitutes unprofessional conduct
   • The practitioner has behaved in a way that constitutes professional misconduct
   • The practitioner has an impairment
   • The practitioner's registration was improperly obtained because the practitioner or someone else gave the National Board that registered the practitioner information or a document that was false or misleading in a material particular.
2. Unprofessional conduct and professional misconduct are defined in s 5 of the National Law.
3. Unprofessional conduct is defined as:

... Professional conduct that is of a lesser standard than that which might reasonably be expected of the health practitioner by the public or the practitioner's professional peers, and includes -

(a) Unprofessional conduct by the practitioner that amounts to conduct that is substantially below the standard reasonably expected of a registered health practitioner of an equivalent level of training or experience

(b) More than one instance of unprofessional conduct that, when considered together, amounts to conduct that is substantially below the standard reasonably expected of a registered health practitioner of an equivalent level of training or experience

(c) Conduct of the practitioner, whether occurring in connection with the practice of the health practitioner's professional or not, that is inconsistent with the practitioner being a fit and proper person to hold registration in the profession.

1. Under s 196 (2) of the National Law, if the Tribunal decides that the practitioner has engaged in unprofessional conduct or professional misconduct, it may make one or more of a number of determinations.
2. In disciplinary proceedings such as this, there is a two-step process. First the Tribunal makes its findings, which this decision concerns. Depending on the findings, the parties then have an opportunity to make submissions on appropriate determinations.

Drugs, Poisons and Controlled Substances Regulations: Schedule 4 Poisons

1. Testosterone and Somatropin are both Schedule 4 poisons and at the time were regulated under r 8(2)(b) of the Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) (the Regulations) [1], which provided that:

(2) A registered medical practitioner must not administer, prescribe, sell or supply a Schedule 4 poison unless -

(a) that poison is for the medical treatment of a person under his or her care; and

(b) he or she has taken all reasonable steps to ensure a therapeutic need exists for that poison.

1. The requirement under the current, 2017, Regulations is similar:
   1. Issuing prescription for Schedule 4, 8 or 9 poison - registered medical practitioner

A registered medical practitioner must not issue a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison unless -

(a) the prescription is for the medical treatment of a person other than the practitioner; and

(c) the practitioner has taken all reasonable steps to ensure a therapeutic need exists for that poison;

1. We refer to the requirement under both as 'the requirement under the Regulations'.
2. We accept that the requirement under the Regulations, as well as being a legislated obligation, is relevant to a decision about the standard of conduct to be expected of a health practitioner.
3. The issue under the Regulations, raised by the particulars to allegations 1 and 2, is whether Dr Abi Haila, in prescribing testosterone and HGH to the patients concerned, took all reasonable steps to ensure that a therapeutic need existed for those poisons.
4. The Board relies on the requirement in the Regulations in its allegations that Dr Abi Haila has prescribed testosterone and hGH to his patients without proper clinical justification.
5. We accept that in the context of prescribing Schedule 4 poisons, the requirement on the Regulations is relevant to the question of proper clinical justification.
6. We observe that the requirement is to take all reasonable steps, uses the word 'ensure', which means to 'make sure' [2]and refers to therapeutic need.

Approved registration standard: Good Medical Practice: A Code of Conduct for Doctors in Australia

1. The Code of Conduct is an approved registration standard in relation to medical practitioners and operates as a Code in each state and territory under s 39 of the National Law.
2. The purpose of the Code of Conduct is described in 1.1:

[The code] describes what is expected of all doctors registered to practise medicine in Australia. It sets out the principles that characterise good medical practice and makes explicit the standards of ethical and professional conduct expected of doctors by their professional peers and the community.

The code does not set new standards. It brings together, into a single Australian code, standards that have long been at the core of medical practice.

1. In the context of a disciplinary proceeding, by s 41 of the National Law, the Code of Conduct is admissible in proceedings under the National Law against a health practitioner registered by the Board as evidence of what constitutes appropriate professional conduct or practice for the health profession.
2. The Board relies on the paragraphs of the Code of Conduct set out in the particulars under each allegation as requirements of good medical practice.
3. We accept that the Code sets out standards to be taken into account when deciding whether a medical practitioner's conduct falls below the standard reasonably to be expected of a health practitioner by the public or the practitioner's professional peers.

1. The standard of proof is the balance of probabilities. In disciplinary proceedings in which the allegations are serious, as in these proceedings, the Tribunal's approach to the standard of proof is as set out in Briginshaw v Briginshaw.[3] The allegation must be proved to the reasonable, or comfortable, satisfaction of the Tribunal. A finding that a person has engaged in fraudulent, criminal or other serious conduct should not be made lightly - it should not be based on 'inexact proofs, indefinite testimony or indirect inferences'.[4]

EVIDENCE BEFORE US AND OBSERVATIONS ON THE WITNESSES

1. The allegations in this proceeding concerned Dr Abi Haila's treatment of six patients.
2. The evidence before us included:
   • Clinical records obtained from Dr Abi Haila in June 2014, concerning patients he treated at the clinic.
   • Independent expert opinion and additional statements filed on behalf of the Board from Dr Robert Murdoch and Dr David Day, based on the above clinical records and other information provided by Dr Abi Haila during the investigation
   • Dr Abi Haila's witness statements.
   • Independent expert opinion and additional statements filed on behalf of Dr Abi Haila from Associate Professor Dr Christopher Pearce.
3. Also before us was an email from Mr Chris Falcke. It was not a formal witness statement but is relevant as describing the circumstances in which Mr Falcke met and spoke with Dr Abi Haila in 2012. It also makes clear that Dr Abi Haila was not the focus of a broader investigation and notification by the Drugs and Poisons Unit but was peripheral to it.
4. In his email Mr Falcke stated that:
   • When he wrote to AHPRA he had no concerns about Dr Abi Haila's prescribing because, at the time he met with him, he had not commenced practising at the clinic;
   • He met with Dr Abi Haila at Dr Abi Haila's request so that he could inform him of his legislative responsibilities.
   • At the time, Mr Falcke was investigating the activities of a number of other parties at other clinics, including a medical practitioner who preceded Dr Abi Haila at the clinic.
   • Dr Abi Haila was peripheral to the matters about which he was concerned.
   • In light of Dr Abi Haila's efforts to gain awareness and his expressed intention to comply with his legislative responsibilities plus the absence of any information to indicate unlawful activities, Mr Falcke had no reason to subsequently investigate his activities or those of the clinic.

1. Dr Murdoch is a General Practitioner with over 35 years of experience in General Practice. He obtained his MBBS from the University of Melbourne in 1976, with Honours in Medicine and Obstetrics & Gynaecology. He commenced in general practice in Bulleen in 1979 and has continued that general practice to the present. He obtained his Fellowship of the Royal Australian College of General Practitioners (RACGP) in 1985, and has served as Life Examiner for RACGP since 1986. He served on RACGP's National Examination Panel from 1986 to 1996 and RACGP's Victorian Censors Panel from 1998 to 2004.
2. Dr Day is a General Practitioner/Sports Doctor with over 35 years of experience in General Practice and over 20 years' experience as a Sports Doctor, including Sports Medicine Clinical Practice and working as Team Physician for local/state/National sporting teams.
3. Associate Professor Pearce obtained his MBBS from Monash University in 1981. He obtained fellowship of the RACGP in August 1989, fellowship of the Australian College of Rural and Remote Medicine 1999, fellowship of the Australian College of Health Informatics in 2007, a Masters degree in Family Medicine from Monash University in 1998,[5] and was awarded PhD by the University of Melbourne in 2007.[6] Associate Professor Pearce is also an associate member of the Australian Society of Anaesthetists, a member of the American Medical Informatics Association, a member of the Australian Medical Association and a member of the Association for Qualitative Research.
4. His current positions include sessional general practice one day a week with a special interest in the management of skin conditions, visiting medical officer in anaesthetics and emergency medicine at Maroondah Hospital (also private practice anaesthetics), Adjunct Associate Professor in General Practice at Monash University, Adjunct Associate Professor in Health Informatics, University of Melbourne, and is a member of the Victorian Clinical Council. For 14 years, he was a fully procedural rural general practitioner in a relatively isolated rural setting in Victoria, leaving rural practice in 2000.
5. Dr Abi Haila was not, strictly, engaged in general practice while at the clinic, and was specifically engaged in assessing patients who sought hormone therapy. None of the three experts had specialist qualifications in endocrinology or andrology. Nevertheless, we regarded each of the experts as being qualified to express opinions on the reasonably expected standards for non-specialist medical practitioners prescribing testosterone and hGH in the circumstances of the patients concerned.
6. We considered that each of the experts had qualifications and experience relevant to the opinions they expressed. As conceded by Associate Professor Pearce, Drs Day and Murdoch have more experience as general practitioners than he has. He agreed that his area of expertise is in eHealth and health information technology, and that the demands of his senior academic and policy roles meant that he now only saw patients in a GP setting one day a week.
7. Of the three experts, we consider that Dr Murdoch in his reports engaged more fully in a consideration of the case histories and records of the individual patients and the specific allegations made by the Board, including the requirement in the Regulations to take all reasonable steps to ensure that a therapeutic need existed for the medications. Further we consider that his long experience as a Life Examiner for RACGP since 1986 and his service on the RACGP's National Examination Panel adds to the weight of his opinion on reasonably expected standards.
8. Of the three experts, we consider that Associate Professor Pearce engaged the least in the specific content of the allegations focusing more on general philosophical propositions which we refer to below.
9. Taking into account the concessions made by Dr Murdoch under cross examination, where opinions differed, we gave the most weight to his opinion of what would reasonably be expected of a registered medical practitioner in the particular circumstances in this case.
10. In fact, however, on a number of relevant matters, the experts agreed.
11. The opinion of all three experts was that 'andropause' has not been accepted as a medically valid concept; and that none of the six patients had any true clinical hormonal deficiency nor any repeated deficiency.
12. In the precise circumstances of these six patients, none of the three experts would have prescribed testosterone or Somatropin to any of them.
13. It was submitted on behalf of Dr Abi Haila that we should give weight to his greater knowledge of the hormones prescribed and accept his evidence of the benefits, which, it was submitted, was supported by the studies referred to in the materials before us.
14. Dr Abi Haila is, and was at the time of the alleged conduct, a far less experienced, junior doctor than the three expert witnesses. As submitted by the Board, he had had only 22 months experience since his admission to medical practice. He did not yet have a Medicare provider number. The clinic was his first job following his initial hospital training. He worked at the clinic one day a week, whilst at the same time being a medical registrar at Box Hill Hospital.
15. While we accept that he may have developed an interest in endocrinology during his training, and had some exposure to endocrinology practice in a hospital setting, and at the hearing displayed knowledge of such matters as the two forms of testosterone, the distinction between anabolic and androgenic steroids and dosage levels etc., we did not consider him to be in the category equivalent to a general practitioner with special experience and expertise in the area.
16. Nor was he in the category of a physician who is appropriately qualified and experienced in the diagnosis and management of patients with growth hormone deficiency which is relevant to the TGA-approved product information for the hGH he prescribed.
17. For the purpose of determining reasonably expected standards, we did not consider that his expertise or experience elevated the weight of his opinion to that of the three experts.
18. Nor were we satisfied that the articles he provided to us supported the opinions he expressed as to the benefits of testosterone and human growth hormone for men whose tests showed levels within the normal range. To the contrary, they supported a view that risks were established and benefits were not. We say more about that matter below.
19. Relevantly to the definition of professional misconduct in section 5 of the National Law,[7] we consider that, despite his own opinion of his expertise and level of training, he was at the time of the alleged conduct an inexperienced junior practitioner.

1. That between on or about 5 April 2013 to on or about 15 January 2014, Dr Abi Haila engaged in unprofessional conduct and/or professional misconduct within the meaning of the definitions of unprofessional conduct and/or professional misconduct in section 5 of the National Law in that he prescribed Testosterone to his patients, Patient 1 and/or Patient 2 and/or Patient 5 and/or Patient 6, without proper clinical justification.

(a) on or about 5 April 2013, Dr Abi Haila prescribed Testosterone to Patient one in circumstances where there was no proven and/or confirmed deficiency of Testosterone in that:

(i) pathology results in respect of Patient 1's level of Free Testosterone of 332.32 pmo/L, dated 22 March 2013, indicated that Patient 1's Testosterone was within the normal range of 172 670 pmo/L; and/or

(ii) pathology results in respect of Patient 1's Testosterone serum level of 15, dated 22 March 2013, indicated that Patient 1's Testosterone was within the normal range of 9.9 to 27.8 nmo/L; and/or

(iii) Dr Abi Haila did not have pathology results indicating that Patient One had an abnormally low serum level of Testosterone on two separate testing occasions.

(b) on or about 6 September 2013, Dr Abi Haila prescribed Testosterone to Patient One in circumstances where there was no proven and/or confirmed deficiency of Testosterone in that:

(i) pathology results in respect of Patient 1's level of Free Testosterone of 230 pmo/L, dated 28 August 2013, indicated that Patient One's Testosterone was within the normal range of 170 to 670 pmo/L; and/or

(ii) pathology results in respect of Patient One's Testosterone serum level of 9.7, dated 28 August 2013, was insufficient to confirm testosterone deficiency in that it did not constitute pathology results indicating abnormally low serum levels of Testosterone on two separate testing occasions.

(c) on or about 19 April 2013, Dr Abi Haila prescribed Testosterone to Patient 2 in circumstances where:

(i) on or about 10 April 2013, it was Dr Abi Haila's clinical opinion that he could not rule out Patient 2 having Klinefelter's disease; and/or

(ii) on or about 19 April 2013, Dr Abi Haila was aware that Patient 2 had a history of use and/or abuse of anabolic steroids; and/or

(iii) Dr Abi Haila had not yet obtained the clinical opinion of a suitably qualified Endocrinologist and/or Andrologist in respect of Patient 2.

(d) on or about 13 December 2013, Dr Abi Haila, prescribed Testosterone to Patient 5 in circumstances where there was no proven and/or confirmed deficiency of Testosterone in that:

(i) pathology results in respect of Patient 5's level of Free Testosterone of 205 pmo/L, dated 3 December 2013, indicated that Patient 5's Testosterone was within the normal range of 170 to 670 pmo/L; and/or

(ii) pathology results in respect of Patient 5's Testosterone serum level of 10.5 nmol/L, dated 3 December 2013, indicated that Patient 5's Testosterone was within the normal range of 9.9 to 27.8 nmo/L; and/or

(iii) Dr Abi Haila did not have pathology results indicating that Patient 5 had an abnormally low serum level of Testosterone on two separate testing occasions.

(e) on or about 15 January 2014, Dr Abi Haila prescribed Testosterone to Patient 6 in circumstances where there was no proven and/or confirmed deficiency of Testosterone in that:

(i) pathology results in respect of Patient 6's level of Free Testosterone of 395 pmo/L, dated 23 December 2013, indicated that Patient 6's Testosterone:

(A) was within the normal range of 170 t 670pmo/L; and/or

(B) had increased since his previous test results of 311.29 pmo/L, dated 23 April 2009;

(ii) pathology results in respect of Patient 6's Testosterone serum level of 21 nmo/L, dated 23 December 2013, indicated that Patient 6's Testosterone was within the normal range of 9.9 to 27.8 nmo/L; and/or

(iii) Dr Abi Haila did not have pathology results indicating that Patient 6 had an abnormally low serum level of Testosterone on two separate testing occasions.

(f) The Good Medical Practice: A Code of Conduct for Doctors in Australia (as at 5 April 2013 to 15 January 2014) provides that good medical practice involves:

(i) 2.1.1: 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 aspect;

(ii) 2.1.2: formulating and implementing a suitable management plan (including arranging investigations and providing treatment and advice);

(iii) 2.2.10: making responsible and effective use of the resources available; and

(iv) 2.2.6: providing treatment options based on the best available information.

(g) Regulation 8 (2) (b) of the Drugs, Poisons and Control Substances Regulations 2006 (Vic) provides 'A registered medical practitioner must not administer, prescribe, sell or supply a Schedule 4 poison unless - he or she has taken all reasonable steps to ensure a therapeutic need exists for that drug or poison.'

(h) The Poisons Standard 2013 (Cth) provides that Testosterone is a Schedule 4 Poison.

1. We accept that the Code of Conduct and the requirements in the Regulations are relevant to the question of whether Dr Abi Haila prescribed testosterone to his patients without proper clinical justification.
2. Under the Code Dr Abi Haila was required to do a number of things including formulating and implementing a suitable management plan (including arranging investigations and providing treatment and advice), and providing treatment options based on the best available information.
3. Under the Regulations he was required to take all reasonable steps to ensure that a therapeutic need existed for the poisons. We consider that it would not be sufficient, to meet the requirement, that some therapeutic benefit might be experienced by the patient, the requirement is to take all reasonable steps to ensure that a therapeutic need exists
4. We also accept that the PBS guidelines for the prescription of testosterone, referred to by Dr Day, are relevant as submitted by the Board. They provide that prescription should only occur where there is a proven deficiency in serum levels of testosterone, as confirmed by the identification of abnormally low testosterone levels on blood tests conducted on two or more separate occasions.
5. As submitted on behalf of Dr Abi Haila, the PBS guidelines relate to the circumstances in which a prescription will be subsidised under the PBS scheme. While they may not be determinative of proper clinical justification, they are relevant information to be taken into account. We refer below to information provided by the Endocrine Society of Australia about implementation of the PBS guidelines and observations about prescribing when levels fall outside the PBS criteria.

1. Dr Abi Haila stated in summary that:
   • He was aware of a group in the community who would like to easily access growth hormones without having to show a clinical justification for being prescribed. He confirmed with the managers of the clinic that the only patients they would refer to him would meet a number of criteria specified by him.
   • He is aware that in Australia this [testosterone and hGH prescribing] is a controversial area but in other parts of the world the concept of andropause-the hormonal changes which occur in men as they age - is recognised and the treatment of those changes with testosterone and hGH is not controversial. It is an emerging field of endocrinology.
   • In the case of both testosterone and IGF-1, the open 'normal range' is very broad. Being within the normal range does not, in his opinion or experience, mean there is no clinical or therapeutic benefit to patients from being treated with testosterone or human growth hormone. A clinical indication for the use of either hormone does not merely mean the level on a test result.
   • For this reason, he always took a full history. Anyone with a history of cancer was ruled out. He did a rectal exam whenever patients permitted it, and always ordered tests to show testosterone and IGF-1 levels, PSA levels, TSH and FBE. These were done to exclude other possible causes of lethargy and symptoms.
   • Each of his consultations lasted 30 - 40 minutes. All sessions were billed privately: at the time he was still a medical registrar and did not have a Medicare billing number. Sometimes the fact the patients were paying $100 to see him did make him feel some degree of pressure to prescribe them what they were seeking. However with the exception of two cases, he was never influenced by that pressure to prescribe if it was not otherwise appropriate to do so.
   • His prescribing criteria were:
     • Levels of testosterone and IGF-1 that were on the lower side of the normal range (noting that the time of day the test is done can influence the reading)
     • An age of no less than 35
     • Symptoms of male menopause: namely low libido, reduced exercise tolerance, lack of energy, increased fact, dysthymia and erectile dysfunction.
   • In the case of patient 2, who had markedly low testosterone levels, and in respect of whom he had made a note about possible Klinefelter's syndrome, Dr Abi Haila stated that his initial thoughts and assessment were that the patient had probably abused anabolic steroids in the past and because of this had suffered a suppression of his endogenous testosterone production. On examination it was found that the patient had none of the symptoms or signs of Klinefelter's syndrome. For this reason he wrote the letter, which was in the file, to the patients usual GP, for the patient to take to his GP recommending that patient 2 see an endocrinologist urgently.

1. We refer first to the article provided by the Board, published by Andrology Australia, Endocrine Society of Australia, 'PBS criteria for testosterone prescribing: a few suggestions on implementation.' June 2015.
2. As submitted for Dr Abi Haila, the article concerns the suggestions of the ESA for implementing new PBS criteria for supported testosterone prescribing - namely on the authority of a specialist where androgen deficiency is due to established testicular disease or pituitary failure.
3. As submitted, it refers to the difference between PBS criteria and various clinical practice guidelines:

While clinical guidelines provide some flexibility about the use of testosterone in men without established testicular disease or pituitary failure, it is not known if testosterone treatment in this setting is safe or effective. In this situation the PBS criteria reflect a more conservative approach to using public money for health interventions.

1. Because Dr Abi Haila was prescribing testosterone outside PBS guidelines, the views expressed in the article, coming as they do from a specialist endocrinologist society, are relevant to the question of proper clinical justification.
2. In answer to the question 'why might a doctor prescribed testosterone when levels fall outside of the PBS criteria?' the article states:

In consultation with a specialist, sometimes testosterone treatment is recommended when levels do not fall within the PBS criteria but remain within the broader scope of some clinical guidelines. In these circumstances the patient would not be eligible for PBS subsidy.

As mentioned, there are many controversies on the safety and efficacy of testosterone treatment in older men and these are recognised in clinical practice guidelines. Of recent concern is the possible risk of cardiovascular events in older men receiving testosterone treatment, particularly older men with underlying cardiovascular disease. Patients should thoroughly discuss the risks with a specialist who is aware of their overall health.

1. The article supports a conclusion that whether testosterone is prescribed inside or outside of the PBS guidelines, specialist opinion is important and is at the least one of the reasonable steps to take to ensure that a therapeutic need exists for testosterone.
2. Contrary to submissions on his behalf, the two articles provided by Dr Abi Haila obtained by him fromUpToDate.com, to which he subscribes, support a conclusion that there is, at present, insufficient evidence to conclude that testosterone treatment of older men (60 years and over) has any well-established benefit. There are, however, known risks.
3. They also do not support a conclusion that 'andropause' or male menopause is a validly accepted concept, nor that they are able to be treated safely or effectively by the treatment administered by Dr Abi Haila. They do not support the prescription of testosterone before genuine deficiency is established by repeat testing.
4. The first article is 'Endocrine Changes with Aging' [Harman, Schmader, Snyder, Martin 2016]. In its summary of the endocrine changes of ageing [TB 398-399]:

The only endocrine system for which there is a well-defined, abrupt, and universal change in function with age is the hypothalamic-pituitary-gonadal axis access in women (i.e., menopause [TB 398]

The case for routine replacement therapy with GH, sex steroids, or other hormones in older adults remains controversial but, as a generality, the use of such therapy is not supported by the majority of studies to date, and may have unanticipated adverse consequences. That said, the diagnosis and treatment of true hormone deficiency diseases in older adults (such as subclinical hyperthyroidism) remains a challenge and chronic endocrine-related conditions such as "benign" hyponatremia deserve attention and may require treatment.[TB 399]

1. The second article 'Overview of testosterone deficiency in older men [Snyder, Matsumoto, Schmader, Martin 2016], included the following:

As men age, their serum concentrations of testosterone and, to a greater extent, free testosterone, decrease. This decline is sometimes referred to as "andropause" or "late-onset hypogonadism. However, unlike menopause, where complete estrogen deficiency with known clinical consequences occurs, the decline in testosterone in ageing men is modest and the possible clinical consequences have not been well-established.

Changes in body function occur in ageing men that are similar to the manifestations of hypogonadism due to known disease, raising the possibility that the decline in testosterone production with ageing may be a cause of these changes. The question of whether or not testosterone should be administered to older men is difficult to answer because it is not known whether testosterone treatment reverses the age-related decline in any function, nor is it known if testosterone treatment exacerbates any of the testosterone -dependent diseases, such as those of the prostate, to which older men are prone [TB 405].

The Endocrine Society first published evidence-based clinical guidelines for testosterone therapy in adult men with testosterone deficiency in 2006; updated guidelines were published in 2010. We agree with their approach in older men, which is outlined below...:

• In the absence of known pituitary or testicular disease, we suggest testosterone therapy only for men with low serum testosterone concentrations on more than one occasion [emphasis added] and symptoms of testosterone deficiency. Clinicians must discuss the uncertainty about the risks and benefits of testosterone therapy before recommending this approach [TB 409]

Experts disagree as to what level should be considered unequivocally low in older men... all agree, however, that whatever the cut off, the result should be confirmed on multiple occasions early in the morning and accompanied by signs and symptoms of hypogonadism before considering treatment.

When prescribing testosterone to older men, the clinician should discuss with these men the possible risks, including erythrocytosis, exacerbation of prostate cancer, benign prostatic hyperplasia, and possibly cardiovascular disease.

In the men who have symptoms that could be the result of low testosterone (e.g., fatigue) but who do not have repeatedly subnormal serum testosterone concentrations, we strongly recommend against testosterone treatment because there is no reason to think these men would benefit from treatment, and therefore they are subject only to possible risk. [TB 411]

1. At the time Dr Abi Haila prescribed testosterone to patients 5 and 6, each patient's Free Testosterone and Testosterone serum levels were in the normal range. Patient 1's Free Testosterone level was in the normal range and his Testosterone serum level was slightly below normal. In relation to each of the patients, Dr Abi Haila prescribed testosterone in circumstances where he did not have pathology results showing abnormally low testosterone levels on blood tests conducted on two or more separate occasions. He did not obtain specialist opinion before prescribing.
2. The three articles referred to above support the opinion of Dr Murdoch that the conduct departed from reasonably expected standards. They also support Dr Murdoch's opinion that no therapeutic need existed for the administration of testosterone, as none of the patients were suffering from a proven deficiency of testosterone.
3. Further, the article from the Endocrine Society of Australia supports the opinion of Dr Murdoch that Dr Abi Haila did not take all reasonable steps to ensure that a therapeutic need existed to administer testosterone, such steps including referring these patients to a specialist endocrinologist or andrologist to establish therapeutic need.
4. We note also the article [at TB 327-330] 'Pharmacoepidemiology of testosterone prescribing in Australia, 1992 - 2010' [Handelsman 2012].
5. The objective of the article is:

To describe patterns of testosterone prescribing in Australia over the past two decades by state or territory and by product type. The article compares testosterone prescribing data obtained from the PBS scheme and a separate source of commercial pharmaceutical sales data'.

1. It refers to the increase in testosterone prescribing and discusses possible explanations.
2. The following are some of statements made relevant both to the clinical indications for testosterone prescription and the concept of 'andropause':
   • Since... 1935..., the only unequivocal indication for prescribing testosterone has been physiological androgen replacement therapy for men with androgen deficiency due to pathological disorders of the hypothalamic-pituitary-testicular axis [TB 327]
   • A more plausible explanation [than improved diagnosis of Klinefelter's syndrome for the substantial increases in PBS subsidised testosterone prescribing] is the promotion of testosterone prescribing driven opportunistically by new product launches for speculative, non-approved indications such as 'andropause" and male sexual dysfunction. It remains paradoxical that concurrent with under diagnosis and under treatment of genuine androgen deficiency, there is growing overuse of testosterone in older men as an anti-ageing tonic and non-specific treatment for sexual dysfunction, for which sound evidence is lacking.
   • The guidelines [developed by the Endocrine Society of Australia in 2000] support legitimate testosterone prescribing for pathologically based androgen deficiency and deter prescribing for unproven use of testosterone. Crucially, they distinguish pathologically based androgen deficiency from other speculative indications (notably male ageing) that lacks a pathological basis or evidence of testosterone safety and effectiveness. However, testosterone prescribing for andropause has been encouraged by North American guidelines published in 2006 and European-based guidelines published in 2005, both of which have been recently republished without significant changes
   • These differ from the Australian guidelines by blurring the key distinction between pathologically based androgen deficiency and andropause, providing more lax criteria (e.g., high blood testosterone thresholds, encouragement of testosterone treatment trials and use of inaccurate 'free" testosterone calculations) and lacking regulatory enforcement.
   • More recent attempts to define andropause into existence have been criticised on the basis of flawed analysis of observational data, and the cardiovascular risks of prescribing testosterone treatment for older men have been highlighted.
   • Similarly, there has been increasing advocacy of testosterone treatment for male sexual dysfunction during the past decade despite androgen deficiency being a rare cause of primary presentation with male sexual dysfunction.
3. Both Dr Day and Dr Murdoch agreed that testosterone prescribing would be within PBS guidelines for patient 2 given his extremely low testosterone levels, but that such treatment should only occur after obtaining the clinical opinion of a specialist endocrinologist or andrologist. In his clinical notes, Dr Abi Haila recorded that this patient had previously abused anabolic steroids and that he suspected that the patient could be suffering from Klinefelter's syndrome and that further investigation was required.
4. Associate Professor Pearce in his evidence, focused on some general philosophical propositions rather than the specific circumstances of the patients in this case. We discuss those general propositions below.
5. As submitted by the Board, Associate Professor Pearce, like Dr Murdoch and Dr Day, would not have prescribed testosterone to the patients, agreed that none of the six patients had any true clinical deficiency, or any repeated deficiency, and agreed that 'andropause' had not been accepted as a medically valid concept.
6. Associate Professor Pearce also agreed that it was appropriate to explore the adequacy of alternative treatments, such as those for mood disorders, before any prescriptions were made.

1. On behalf of Dr Abi Haila, it was submitted, in summary, that:
   • The fact that someone has a range within normal range does not mean they can derive no therapeutic benefit from the drug, given the broad range of "normal".
   • Dr Abi Haila's evidence of the benefits of testosterone on the symptoms of hormone deficiency in men was not challenged and should be accepted, given the support for the proposition in the various studies referred to in the materials before the tribunal.
   • The question is not whether his diagnosis and treatment plan were the only possible outcome. The Board must prove an absence of clinical justification and it has failed to do so in the face of Dr Abi Haila's evidence to the contrary.
   • The Board's heavy reliance on the potential side effects of testosterone use was misplaced. The evidence of Dr Abi Haila (supported by Dr Day) is that the doses he was prescribing were far too low to produce any of the extreme side-effects associated with heavy and prolonged testosterone use.
   • In any event, it was Dr Abi Haila's evidence that the risks of the treatment were always explained to patients.
   • Patients can choose to be harmed.
2. We discuss here the general propositions raised by Associate Professor Pearce and relied on in submissions on behalf of Dr Abi Haila. They are also relevant to consideration of allegations 2 and 4.
3. As a general proposition, we agree that in medicine, reasonable minds may differ as to what is appropriate treatment in any particular case. That general proposition does not assist us in this case.
4. We also agree, as a general proposition, that informed consent may be given by a patient to a course of treatment that has the risk of harm. We do not, however, agree that patient consent relieved Dr Abi Haila of the obligation to ensure that proper clinical justification existed for the treatment. Nor did it relieve him of his obligation, in prescribing Schedule 4 poisons, to take all reasonable steps to ensure that a therapeutic need existed for the poison.
5. We agree with the general proposition that some now accepted treatments were once regarded as experimental.
6. Before approval, however, they were invariably the subject of clinical trials and studies to establish their safety and efficacy. Dr Abi Haila's patients were not participating in a clinical trial.
7. The general proposition does not justify speculative prescription of Schedule 4 poisons in the belief that they may relieve the symptoms described by the patients, in circumstances where clinical benefits are neither accepted nor established, and there are well-known and established risks.
8. We accept, as a general proposition, that some patients may derive psychosocial benefits from receiving a drug that they seek and believe will help them. We do not agree that this of itself is proper clinical justification for prescribing regulated poisons, without specialist referral, to patients without apparent or established clinical deficiencies.
9. A number of analogies were discussed in submissions at the hearing. As submitted on behalf of Dr Abi Haila, cosmetic surgery is an example of an area of practice, which many doctors do not support, and which is very much driven by subjective assessments by patients rather than established clinical deformities or deficiencies, where the risks of surgery are known and consented to, and where the benefit will usually be an entirely psychosocial benefit.
10. We do not consider that the analogy of cosmetic surgery, which was expressed in broad terms, is a particular assistance in the case before us. Whether or not particular incidents of cosmetic surgery are accepted as within the parameters of good medical practice will very much depend on the circumstances.
11. Further the practice in this case involved the prescription of Schedule 4 poisons. In our view a better analogy would be the example of a patient coming to a doctor seeking morphine, without any pain as such, understanding and consenting to the risk of harm, and persuasive about the psychosocial benefit to be obtained from receiving the drug.
12. The fact that a psychosocial benefit might be obtained by the patient would not relieve the medical practitioner of his or her obligations to comply with standards of good medical practice and, in the case of Schedule 4 and 8 poisons, their obligations under the Regulations.
13. To the extent that the concept of 'patient-centred care' was put forward as justification for the prescribing, Associate Prof Pearce readily agreed that there were limits to that concept, in particular to prescribing substances that a patient seeks. He said that the shared decision making model is not about giving the patient what they want, that there are obviously legislative limits, regulatory requirements, and there are certainly limits associated with what is outside any degree of scientific basis.
14. Associate Professor Pearce also made it clear he was not advocating giving drug addicts Schedule 8 drugs or anything of that nature just because they wanted them, although harm minimisation might be appropriate on a temporary basis.
15. In the event, we did not find these general propositions to be of assistance in this case, which required us to focus on the specific circumstances in which testosterone and hGH were prescribed to these patients.
16. In summary the Board submitted that:
    • The opinion of each of the three experts was that they would not prescribe testosterone in the circumstances of this case.
    • PBS guidelines require that prescription of testosterone occur only where there is a proven deficiency in serum levels of testosterone, as confirmed by the identification of abnormally low testosterone levels on blood tests conducted on two or more separate occasions. This did not occur.
    • Each of the experts agreed that 'andropause' had not been accepted as a medically valid concept. Associate Professor Pearce agreed that he was not in favour of anti-ageing treatment
    • Associate Professor Pearce agreed in response to our questioning, that it was appropriate to explore the adequacy of alternative treatments, such as those for mood disorders, before any prescriptions were made
17. The weight of the evidence before us supports a conclusion that testosterone therapy should only be considered where there are demonstrated and confirmed low levels of testosterone. Even then, other conditions and risk factors should be excluded, and specialist opinion sought.
18. None of the evidence before us supports treatment with testosterone therapy where low levels of testosterone have not been demonstrated and have not been confirmed and where specialist opinion has not be obtained.
19. None of the evidence before us supports treatment with testosterone therapy where testosterone levels are within the broad normal range and the only basis for starting treatment is the patient's desire to try the treatment, a collection of symptoms that might be explained by other conditions, and a belief on the part of the doctor that treatment might help alleviate the symptoms.
20. The weight of the evidence is that risks are well-established and benefit is not.
21. We are comfortably satisfied that Dr Abi Haila prescribed testosterone to his patients as alleged without clinical justification.
22. In particular we find that he did not take all reasonable steps to ensure that a therapeutic need existed for testosterone before prescribing it, he did not comply with his obligation to provide treatment options based on the best available information, and his conduct is below the standard reasonably expected of him as a health practitioner by the public or his professional peers.
23. We are comfortably satisfied that allegation 1 is proven.
24. We discuss in a later section of these reasons the question of whether the conduct proven is unprofessional conduct or professional misconduct.

1. That between on or about 25 March 2013 and on or about 15 January 2014, Dr Abi Haila engaged in unprofessional conduct and/or professional misconduct within the meaning of the definitions of unprofessional conduct and/or professional misconduct in section 5 of the National Law by prescribing SciTropin to His Patients, Patient 1 and/or Patient 2 and/or Patient 3 and/or Patient 4 and/or Patient 5 and/or Patient 6, without proper clinical justification.

(a) On or about 5 April 2013, Dr Abi Haila prescribed Somatropin to Patient 1 in circumstances where:

(ii) pathology results in respect of Patient 1's level of Insulin - like Growth Factor 1 (IGF-1) of 25 nmol/L, dated 22 March 2013, indicated that Patient 1's IGF-1 was within the normal range of 13-35 nmol/L.

(b) On or about 6 September 2013, Dr Abi Haila prescribed Somatropin to patient one Patient 1 in circumstances where:

(ii) pathology results in respect of Patient 1's level of IGF-1 of 47 nmol/L, dated 28 August 2013, indicated that Patient 1's IGF-1 was above the normal range of 13-35 nmol/L.

(c) On or about 10 April 2013, Dr Abi Haila prescribed Somatropin to Patient 2 in circumstances where:

(ii) pathology results in respect of that Patient 2's IGF-1 of 17 nmol/L, dated 2 April 2013, indicated that Patient 2's IGF- 1 was within the normal range of 14-37 nmol/L.

(d) On or around 29 January 2013, prescribed Somatropin to Patient 3 in circumstances where:

(ii) pathology results in respect of Patient 3's level of IGF-1 of 19 nmol/L, dated 29 January 2013, indicated that Patient 3's IGF -1 was within the normal range of 11-31 nmol/L.

(e) On or about 25 March 2013, prescribe Somatropin to Patient 4 in circumstances where it was not clinically indicated.

(f) On or about 13 December 2013, Dr Abi Haila, prescribe Somatropin to Patient 5 in circumstances where:

(ii) pathology results in respect of Patient 5's level of IGF-1 of 24 nmol/L, dated 14 October 2013, indicated that Patient 5's IGF-1 was within the normal range of 12-33 nmol/L.

(g) On or about 15 January 2014, Dr Abi Haila prescribed Somatropin to Patient 6 in circumstances where;

(ii) pathology results in respect of Patient 6's level of IGF-1 of 17 nmol/L, dated 23 December 2013, indicated that Patient 6's IGF-1 was within the normal range of 14-37 nmol/L.

(h) The Good Medical Practice: A Code of Conduct for Doctors in Australia (as at 5 April 2013 to 15 January 2014) provides that good medical practice involves:

(i) 2.1.1: 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 aspect;

(ii) 2.1.2: formulating and implementing a suitable management plan (including arranging investigations and providing treatment and advice);

(iii) 2.2.10: making responsible and effective use of the resources available; and

(iv) 2.2.6: providing treatment options based on the best available information.

(i) Regulation 8 (2) (b) of the Drugs, Poisons and Control Substances Regulations 2006 (Vic) provides 'A registered medical practitioner must not administer, prescribe, sell or supply a Schedule 4 poison unless - he or she has taken all reasonable steps to ensure a therapeutic need exists for that drug or poison.'

(j) the Poisons Standard 2013 (Cth) provides that Somatropin is a Schedule 4 Poison.

1. As with testosterone, Somatropin is a Schedule 4 poison and is subject to the same requirement under the regulations.
2. The provisions of the Code of Conduct referred to in the allegations are also relevant to assessing the reasonable standard required of a medical practitioner prescribing Somatropin.
3. The TGA approved product information for the Somatropin prescribed (brand name SciTropin A) is also relevant to our assessment.
4. In that product information, the indications are described as follows:

Treatment with SciTropin A is intended for the long-term treatment of children (above three years of age) with

• Growth disturbance due to insufficient secretion of pituitary growth hormone
• Growth disturbance associated with gonadal dysgenesis (Turner syndrome)
• Growth disturbance associated with chronic renal insufficiency.

1. The contraindications are described as follows:

• In patients with evidence of malignancies. Intracranial lesions have to be inactive and anti-tumour therapy has to be completed prior to treatment. Treatment with SciTropin A should be discontinued if there is any evidence of recurrent tumour activity.
• For growth promotion in paediatric patients with closed epiphyses.
• In patients with known hypersensitivity to somatropin or to any of the excipients.
• In patients with acute critical illness due to complications following open-heart surgery or abdominal surgery, multiple accident trauma or to patients having acute respiratory failure (referred to Precautions).
• In new-borns, SciTropin A 5mg/1.5 mL Solution for Injection should not be used because of the presence of the preservative, benzyl alcohol.

Therapy with SciTropin A should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with growth hormone deficiency. The maximum recommended daily dose should not be exceeded. (See Dosage and Administration).

1. We discuss below the submission that the Board's case was too narrowly confined to the TGA indications, and the general evidence about 'off label' prescribing (usage not approved by the manufacturer).

1. It was not in dispute that at the time Dr Abi Haila prescribed Somatropin to the six patients, each of their IGF-1 levels were as set out in the allegations. That is, each patient's levels were within the normal range. Nor were repeat tests obtained before prescribing.
2. It was also not in dispute that Dr Abi Haila prescribed outside the TGA approved product information by prescribing Somatropin to adult males. None of his patients were children above three years of age with growth disturbance due to insufficient secretion of pituitary growth hormone; associated with gonadal dysgenesis (Turner syndrome) or associated with chronic renal insufficiency.
3. In Dr Murdoch's opinion, no therapeutic need existed for the administration of Somatropin to the six patients. None of the patients came within the clinical indications in the TGA approved information. Further, in Dr Murdoch's opinion, Dr Abi Haila did not take all reasonable steps to ensure that a therapeutic need existed to administer Somatropin to the patients - such steps including referring those patients to a specialist endocrinologist or andrologist to reasonably establish such therapeutic need.
4. Further, in Dr Murdoch's opinion, such off-label prescription was inappropriate because of the known risk of harm, with unknown safety and effect in relation to administration to adults
5. In Dr Day's opinion, off-label prescribing of hGH might not represent a pronounced departure from reasonably expected standards but only if there were proven deficiency as established by below normal IGF-1 levels.
6. Associate Professor Pearce's evidence focused on his observations about patient expectations, patient centred care, assumption of risk, psycho social benefit, potential therapeutic benefit obtained from receiving the prescription sought, that off-label and unlicensed (purpose not authorised by regulation) prescribing are common even in conventional medical practice, and his view that Dr Abi Haila's role might be seen as 'harm minimisation' - to make sure that the patients understood the risks they were taking, and if they were going to access these drugs, to do so in the safest possible way.
7. All three expert witnesses agreed that no true clinical deficiency existed in respect of any of the patients. None of them would have prescribed Somatropin to any of the patients.
8. Both Dr Murdoch and Dr Day considered that Dr Abi Haila's conduct departed from reasonably expected standards.
9. Dr Abi Haila's evidence included his general evidence, referred to above that the concept of andropause is controversial in Australia but in other parts of the world is recognised and treatment with testosterone and hGH is not controversial. His prescribing criteria were as described above. He prescribed hGH more than he prescribed testosterone. He considered that there was evidence that treatment with hGH would be of benefit to his patients given the symptoms they were experiencing.
10. In relation to the TGA guidelines, Dr Abi Haila said that he would never let the TGA get in the way of what he thought would help and in prescribing outside of the TGA he drew on the whole of his experience.
11. Dr Abi Haila stated that hGH provides a 'kickstart' to all cells in the body. It increases libido and decreases adipose tissue (fat) in the stomach area. It also increases early-morning wakefulness, however, it can also cause cancer cells to grow and it can induce a diabetic state or other pathology.
12. In each case, Dr Abi Haila said that he ensured the patient had no family or previous history of particular cancers, ensured the patient had not previously used hGH or had biological levels that would be contraindicated in the use of exogenous hGH.
13. He said that he delved into the potential abuse of steroids in each patient to ensure that no patient he prescribed hGH to was actively abusing other substances, and that if they had abused steroids in the past, his idea then was to 'find ways to help them move on from this and heal - because past steroid abuse often caused infertility and ostracisation of these men by their respective partners'. He referred to one patient who told him that he had used steroids to help him find the girl of his dreams but that having found the girl of his dreams he was now infertile.
14. In each case he gave his patients short-term (3 months) prescriptions to ensure that they would not be on the medication for too long without having to come back and see him. He fully discussed the risks versus benefits versus side-effects with each patient. He also ensured that each patient was started on a diet and exercise program by the nutritionist and personal trainer team.
15. Dr Abi Haila also filed an additional statement, dated 7 April 2017, in which he provided comments in respect of each patient. We have taken those comments into account. They indicate that in each case, Dr Abi Haila believed he had good reason to prescribed hGH, even where IGF-1 levels were normal, that the symptomology was important in his prescribing decision, and he believed that each of the patients were either entering or within a period of andropause.
16. We note his evidence in relation to patient 1, who was the only patient seen on two occasions. Patient 1's IGF - 1 levels showed a marked rise on his second consultation. Dr Abi Haila said that he questioned the patient about whether he was incorrectly dosing and was assured by the patient that he was not. Dr Abi Haila put the increase down to the patient's body's response to a new drug being introduced into his system, stating 'it's very common to see weird and wonderful reactions when a patient is taking a new medication that you don't see in other patients'. He lowered his daily dose.
17. In relation to patient 1, Dr Abi Haila said the reason he prescribed a second course was 'purely the incredible turnaround that I saw in this patient clinically'. Dr Abi Haila said as a doctor with a patient who has so dramatically responded to a treatment, it is very hard to then refuse to continue the treatment.
18. We note here the observation of Dr Day in his evidence that the patient's apparent turnaround was 'anecdotal', and the possibility that the improvement was due to the diet and exercise program also being delivered by the clinic.
19. The article provided by Dr Abi Haila, 'Endocrine changes with ageing', referred [TB 390-391] to a randomised trial of recombinant hGH replacement therapy and a number of smaller studies suggesting that lean body mass may increase and fat mass decrease, muscle strength may increase, but that adverse effects were also reported. The authors observed, in summary:

Thus, although combined rhGH-sex steroid supplementation appears to exert beneficial effects on body composition in both men and women, and possibly improve muscle strength... Significant adverse effects occur. Of further concern is the fact that mice with disrupted GH secretion or absence GH receptors live longer than normal mice, an observation that challenges the idea that GH is an anti-ageing hormone.

Given the above, RH to administration should be reserved for patients with documented GH deficiency.

1. The article provided does not support the prescribing in this case.

1. The submissions on behalf of Dr Abi Haila were in summary:
   • The Board's case was that the only clinical indication for prescribing SciTropin A was for children, in the circumstances indicated on the product information sheet.
   • The Board's evidence of the lack of clinical indication was accordingly confined to the fact of the IGF-1 readings and to the opinions of Drs Day and Murdoch.
   • That narrow TGA-based approach having been shown to be flawed by evidence that off-label prescribing was common, the Board then failed to engage with the clinical indications which Dr Abi Haila said he relied on in forming his view that the prescription was clinically indicated and would serve a therapeutic purpose.
   • Dr Abi Haila was not challenged on his evidence about the known beneficial effects of hGH for men experiencing age related hormonal changes. His evidence is supported by the studies he referred to, which show, despite controversy, work being done and studies performed which make a case for the treatment being beneficial. It is also clear that in other parts of the world prescribing of this kind is much more standard.
   • There was an absence of relevant expertise in Dr Day and Dr Murdoch about the use and potential effectiveness of hGH. Neither had ever prescribed it.
   • The prescribing was firmly located within an evidence framework and based on the presentation of each patient.
   • The weight of the evidence indicated that at the levels Dr Abi Haila was prescribing the extreme or serious side-effects would not be seen.
   • All drugs are described as having side-effects: as Associate Professor Pearce stated if one read the side-effects one would never take the drug.
   • Prescribing outside TGA guidelines does not of itself mean that there is no proper clinical justification, nor should prescription outside TGA guidelines attract disciplinary consequences.
2. We disagree with the submission that reference to the TGA approved product information for SciTropin A is flawed, in circumstances where a Schedule 4 poison is being prescribed. The information is clearly relevant to a decision as to whether there is proper clinical justification for the prescription.
3. While it is not illegal to prescribe outside TGA guidelines, it is illegal to prescribe Schedule 4 poisons without taking all reasonable steps to ensure therapeutic need.
4. Whether prescription outside TGA guidelines attracts disciplinary consequences will depend on the facts and circumstances of the case.
5. Associate Professor Pearce said that the TGA is not the sole arbiter of how drugs could be safely used, and that other arbiters included guidelines by for example the asthma foundation.
6. Both Dr Murdoch and Dr Day agreed with the general proposition that off- label prescribing occurs and is not always improper. Dr Murdoch said that if a doctor wants to prescribe outside the TGA guidelines they would need to apply to the TGA for approval.
7. An example of off-label prescription discussed at the hearing was Domperidone - which is recommended in information provided by the Royal Women's Hospital in relation to the treatment of low milk supply. Domperidone is a Schedule 4 poison. The TGA indications are for nausea and vomiting and it is not recommended for breastfeeding mothers. One of the side effects, however, is an increase in milk supply.
8. Dr Murdoch agreed that the purpose of improving low milk supply was not the purpose indicated, and not a purpose recommended in the TGA document. Dr Murdoch said that he presumed there was some sort of approval and there was, in any event, a distinction between a recommendation made in a hospital context and the use in this case.
9. We agree that there is a difference between a recommendation by a specialist women's hospital about the off-label use of a Schedule 4 poison and the use in this case. Further, there was no equivalent recommendation of the prescribing practice adopted by Dr Abi Haila in evidence before us.
10. We do not agree with the submission that Dr Abi Haila's prescription of hGH was evidence-based. No articles were provided that supported the prescription of hGH in the particular circumstances here and the articles provided did not support Dr Abi Haila's prescription of hGH to these patients.
11. It was put to Dr Abi Haila in cross examination that passages of the articles he produced were contradictory of his own prescribing pattern. He maintained that his prescribing pattern was supported by other studies which he had read, but not produced.
12. As submitted by the Board, Dr Abi Haila has been aware of the investigation into his prescribing since early 2014. There has, in our view, been sufficient opportunity to provide evidence supporting his prescribing practices.
13. We consider it relevant to the decision we have to make that all three expert witnesses would not prescribe hGH in the circumstances in this case. As submitted, they are not specialist endocrinologists. Nor was Dr Abi Haila.
14. As stated previously, we regarded each of the experts as being qualified to express opinions on the reasonably expected standards for non-specialist medical practitioners considering prescribing hGH in the circumstances of the patients concerned. For the reasons stated, where opinions differed, we gave the most weight to the opinions of Dr Murdoch.
15. None of the three witnesses regarded 'andropause' as a valid, and accepted medical condition.
16. None of them considered it appropriate to prescribe where there is no proven deficiency of hGH, established by below normal levels of IGF-1.
17. We refer also to the precaution in the TGA approved product information that therapy with SciTropin A should be initiated and monitored by physicians who are appropriately qualified and experienced the diagnosis and management of patients with growth hormone deficiency.
18. We note here our view expressed above that Dr Abi Haila was not in that category. Nor did he record any diagnosis, whether of growth hormone deficiency, 'andropause' or otherwise.
19. We accept Dr Murdoch's opinion that a therapeutic need did not exist for the administration of human growth hormone, and that there was a risk of causing harm to the patients to whom Dr Abi Haila prescribed hGH.
20. We accept the opinion of Dr Murdoch, supported by the weight of other evidence, that Dr Abi Haila did not take all reasonable steps to ensure that a therapeutic need existed to administer Somatropin to these patients: such steps included referring these patients to a specialist endocrinologist or andrologist to establish such therapeutic need.
21. We agree with the submission of the Board that the combination of the TGA approved indications, the fact that all six patients presented with test results showing IGF-1 levels within the normal range, the weight of the expert opinion, and the absence of support for prescription of hGH without documented testosterone deficiency, supports a conclusion that Dr Abi Haila prescribed Somatropin to the six patients without proper clinical justification.
22. We are comfortably satisfied that allegation 2 is proven as alleged. There was, in our view, no proper clinical justification for the prescription of Somatropin for any of the six patients.
23. In particular, we find that Dr Abi Haila failed to take all reasonable steps to ensure that a therapeutic need existed for Somatropin, the treatment options provided were not based on the best available information and were, in fact, contrary to the best available information.

1. That between on or about 29 January 2013 to on or about 15 January 2014, Dr Abi Haila engaged in unprofessional conduct and/or professional misconduct within the meaning of the definitions of unprofessional conduct and/or professional misconduct in section 5 of the National Law in that he failed to adequately record his medical treatment of his patients, Patient 1 and/or Patient 2 and/or Patient 3 and/or Patient 4 and/or Patient 5 and/or Patient 6.

(a) Dr Abi Haila failed to take a detailed history and record of symptoms in respect of Patient 1 and/or Patient 2 and/or Patient 3 and/or Patient 4 and/or Patient 5 and Patient 6.

(b) the Good Medical Practice: A Code of Conduct for Doctors in Australia (as at 29 January 2013 to 15 January 2014) provides that good medical practice involves maintaining adequate records, which includes:

(i) 8.4.1: 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;

(ii) 8.4.2: ensuring that medical records are held securely and are not subject to unauthorised access;

(iii) 8.4.3: ensuring that medical records show respect for patients and do not include demeaning or derogatory remarks;

(iv) 8.4.4: ensuring that records are sufficient to facilitate continuity of patient care;

(v) 8.4.5: making records at the time of the events, or as soon as possible afterwards;

(vi) 8.4.6: recognising patients' right to access information contained in the medical records and facilitating that access; and

(vii) 8.4.7: promptly facilitating the transfer of health information when requested by the patient.

1. While Dr Murdoch was originally critical of the notes, he agreed in his evidence at the hearing that they were appropriate in each instance.
2. Associate Prof Pearce considered the notes to be comprehensive, describing them in his oral evidence as 'good notes" and "better than most notes I see".
3. Dr Day's view was that the notes were in each case appropriate and adequate, with a qualification in respect of patient 2.
4. We accept the submission on behalf of Dr Abi Haila that the weight of the evidence in this case does not support the allegations made, with the exception that in each case, the notes do not record a diagnosis. Overall however Dr Abi Haila's notes are adequate and adequately record the treatment given.
5. We find that allegation 3 is not proven.

1. That between on or about 29 January 2013 to on or about 15 January 2014, Dr Abi Haila engaged in unprofessional conduct and/or professional misconduct within the meaning of the definitions of unprofessional conduct and/or professional misconduct in section 5 of the National Law by failing to appropriately clinically manage certain of his patients.

(a) Dr Abi Haila failed to obtain the clinical opinion of a suitably qualified Endocrinologist and/or Andrologist to establish whether a therapeutic need existed prior to initiation of Somatropin and/or Testosterone treatment to his patients, Patient 1 and/or Patient 2 and/or Patient 3 and/or Patient 4 and/or Patient 5 and/or Patient 6.

(b) In circumstances where Dr Abi Haila had formulated a management plan for his patient, Patient 3, which recommended further investigations to be undertaken by Patient 3's treating General Practitioner, Dr Abi Haila failed to take steps to implement that management plan in that he did not:

(i) write to Patient 3's treating General Practitioner recommending further investigations; and/or

(ii) provide Patient 3 with request forms for further investigations, advising on those forms that a copy of the results should be sent to Patient 3's treating General Practitioner.

(c) The Good Medical Practice: A Code of Conduct for Doctors in Australia (as at 29 January 2013 to 15 January 2014) provides that good medical practice involves:

(i) 2.1.2: formulating and implementing a suitable Management plan (including arranging investigations and providing treatment and advice); and

(ii) 2.1.3: facilitating coordination and continuity of care;

(iii) 2.1.4: referring a patient to another Practitioner when this is in the patient's best interests;

(iv) 2.2.1: recognising and working within the limits of your competence and scope of practice; and

(v) 2.2.9: consulting and taking advice from colleagues, where appropriate.

1. Allegation 4 concerns Dr Abi Haila's clinical management of certain of his patients.
2. It is not in dispute that Dr Abi Haila did not obtain the clinical opinion of a suitably qualified endocrinologist or andrologist prior to initiating prescription of Somatropin and/or testosterone to the six patients. The alleged failure in clinical management is failing to do so to establish whether a therapeutic need existed before prescribing.
3. It is also alleged that Dr Abi Haila failed to take steps to implement a management plan in respect of patient 3, who had a significantly elevated Mean Cell Volume, indicative of conditions such as Vitamin B12 deficiency or alcoholism, in respect of further investigations.
4. The Board relies on the section of the Code of Conduct referred to in the particulars and the expert opinions of Dr Murdoch, and Dr Day in relation to Patient 3.
5. Dr Abi Haila contends that specialist opinion was not necessary, he was sufficiently knowledgeable and experienced and sufficiently able to assess therapeutic need for his patients. In effect he relies on his own expertise and opinion.
6. He also relied on the opinion of Associate Professor Pearce that referrals to specialist should be made when a doctor is at the limit of his or her knowledge.

1. It was submitted on behalf of Dr Abi Haila that the allegation proceeds on the premise that the opinion of an endocrinologist was required before a view on a therapeutic need for either Somatropin or testosterone could be formed.
2. On the evidence before us we consider that premise to be well established. Our findings in relation to allegations 1 and 2 include that neither Somatropin nor testosterone should have been prescribed to the patients concerned without first seeking the clinical opinion of a suitably qualified endocrinologist or andrologist, and that obtaining such opinion was one of the reasonable, if not necessary, steps to be taken to ensure that a therapeutic need existed.
3. Associate Professor Pearce's opinion was that referrals to specialists should be made when a doctor is at the limit of his or her knowledge.
4. We do not agree that will be the only situation where a doctor should refer to a specialist. We agree with Dr Day's opinion that referrals may be required in a number of scenarios, including where the doctor has reached the limits of his or her expertise, but also where the treatment or intervention appears to have failed, or where there are complications.
5. We agree with the general proposition discussed above that some general practitioners will develop expertise in a particular area, such as sports medicine, women's health, asthma management. Dr Abi Haila was not an experienced general practitioner. At the time he worked at the clinic one day a week, he had not even commenced general practitioner training. He is not in the category of a general practitioner who has developed expertise in a particular category.
6. Further, we accept the evidence of Dr Murdoch, supported by the other evidence referred to above, than in the case of these particular patients, given their test results, specialist referral was essential.
7. We agree that it was Associate Professor Pearce's opinion that, in the context of this clinic and Dr Abi Haila's role within it, specialist referral was not warranted and would not have been the expectation of the patients, given that there was no sign of true clinical deficiency.
8. We acknowledge that referral to a specialist may not have been the patients' expectation, but we do not regard that as determinative. Nor do we consider the context of an anti-ageing clinic as determinative or as reducing in any way Dr Abi Haila's obligations of good practice.
9. It was submitted on behalf of Dr Abi Haila that his own assessment of his training and experience, and his opinion that he was sufficiently able to assess therapeutic need for his patients should be accepted.
10. We have taken into account the evidence about Dr Abi Haila's training and formal qualifications including that he obtained a bachelor's degree in laboratory medicine from RMIT, that he obtained MBBS from Griffith University, the rotations undertaken in his first and second years after graduating, his experience as a medical registrar in the same year he worked at the clinic, that during his medical registrar year he began studying for what is called the '1000-hour exam' for physicians training, but did not in fact undertake that exam.
11. We do not regard his level of training and experience as sufficient to determine that therapeutic need existed for either Somatropin or testosterone to be prescribed in these particular circumstances. On the contrary, we consider that because of his level of training and experience, it would have been essential for him to obtain specialist opinion before prescribing. We remain concerned by his lack of insight into the fact that he was well outside the limits of his training and experience.
12. We are comfortably satisfied that Dr Abi Haila is in breach of the Code of Conduct 2.1.4: referring a patient to another practitioner when this is in the patient's best interests and 2.2.1: recognising and working within the limits of your competence and scope of practice.
13. In circumstances where Dr Abi Haila was prescribing Schedule 4 Poisons, with known risks and without established benefits in the absence of hormone deficiencies, referral to a specialist was, in our view essential and failure to do so constitutes, at the least, unprofessional conduct. We discuss in the next section whether the conduct can be characterised as professional misconduct in all the circumstances.
14. On the evidence overall, we were not comfortably satisfied that Dr Abi Haila's conduct in failing to implement his management plan in respect of patient 3 constituted either unprofessional conduct or professional misconduct.
15. We are otherwise comfortably satisfied that allegation 4 has been proven.

ALLEGATIONS 1, 2 AND 4: UNPROFESSIONAL CONDUCT OR PROFESSIONAL MISCONDUCT?

1. We have discussed this question in respect of all the allegations proven because we consider that Dr Abi Haila's level of training and experience at the time of the conduct is central to a decision as to whether his conduct constituted unprofessional conduct or professional misconduct.
2. The issue arises because paragraphs (a) and (b) of the definition in s 5 of the National Law define professional misconduct by reference to the standard reasonably expected of a registered health practitioner of an equivalent level of training or experience.
3. In respect of allegations 1, 2 and 4, we are satisfied that Dr Abi Haila has engaged in conduct that is of a lesser standard than that which might reasonably be expected of a health practitioner by the public or the practitioner's professional peers. He has prescribed Schedule 4 Poisons without proper clinical justification and failed to appropriately clinically manage certain his patients.
4. The Board submitted that Dr Abi Haila's conduct met the definition of professional misconduct in that it was unprofessional conduct by the practitioner amounting to conduct substantially below the standard reasonably expected of a registered health practitioner of an equivalent level of training and experience.
5. Dr Murdoch and Dr Day expressed different opinions about the degree to which Dr Abi Haila's conduct under allegations 1, 2 and 4 departed from reasonably expected standards. The Board's written submissions contained a useful table of their opinions in respect of each of the allegations and each of the patients which we refer to without repeating.
6. In his response to Dr Abi Haila's further witness statement, which set out in detail his qualifications, training and experience, Dr Day expressed the view that he may have judged Dr Abi Haila by the standards of a more experienced practitioner, and that it was relevant that he appeared to be only in his third year after graduation.
7. We consider that it is relevant to a decision as to whether the conduct constitutes professional misconduct that Dr Abi Haila was at the time a junior doctor still in training, in his third year post-graduation, and who had not at the time commenced let alone completed general practitioner training.
8. It is appropriate, in our view, to take into account in this case those matters in determining the standard to which Dr Abi Haila should be held for the purposes of characterising the conduct.
9. We do not agree, however, that fact that Dr Abi Haila was working in an anti-ageing clinic is relevant in this case to characterisation of the conduct.
10. Whatever the expectations of the patients or the owners of such a clinic, and whether or not the arrangements in place compromised Dr Abi Haila's clinical independence - a concern expressed by Dr Murdoch, a medical practitioner is to be held to the standards of good medical practice.
11. In characterising the conduct in respect of each of the allegations proven, we have taken into account Dr Abi Haila's level of training and experience and also the consideration that Dr Abi Haila's conduct is not at the extreme end of irresponsible prescribing.
12. He did not prescribe without seeing the patient. He had blood test results, although not repeated results, and not results that warranted the prescribing. He took some care to ensure there were no contraindications. Further, the starting doses were generally low and in the case of testosterone generally topical. He told investigators that he refused to prescribe to 7 patients despite what we accept as the pressure to do so, and to his credit he chose to leave the clinic. In his witness statement he said that on a few occasions he was able to change the patient's mind - when they fully understood the concepts behind these medications and their side effects they chose not to go ahead with it.
13. It is also to his credit that he sought the advice of Chris Falcke, before commencing the role at the clinic, although it appears he did not sufficiently heed the warning of the risks. While he said in his evidence that he was not naive about the clinic, in our assessment he was naive about the arrangement he was entering into and not sufficiently experienced or mature as a practitioner to see clearly the reasons why the arrangement was hazardous for him and potentially hazardous to the patients. All three of the expert witnesses before us identified those hazards. None of the three would have engaged in the prescribing.
14. On the evidence before us, notwithstanding the confidence that Dr Abi Haila maintained about the choices he had made, in our assessment he was well and truly out of his depth.
15. We are comfortably satisfied that the conduct the subject of allegations 1, 2 and 4 is conduct that is of a lesser standard than that which might reasonably be expected of the health practitioner by the public or the practitioner's professional peers and is therefore unprofessional conduct.
16. We have stopped short of making findings of professional misconduct principally because the definition in the National Law refers to 'the standard reasonably expected of a registered health practitioner of an equivalent level of training or experience.
17. It might well be otherwise if the same conduct were engaged in by a practitioner who had finished his or her training and had some years of experience in general practice, or was in specialist practice, or if the conduct were any more serious or involved more patients or a longer period. In such cases, a finding of professional misconduct would more likely be open.
18. Having made our findings, the parties will now have the opportunity to make further submissions as to appropriate determinations. An administrative mention will be listed for the parties to propose orders, whether for a further hearing or for written submissions.

[1] These Regulations were revoked on 23 May 2017 by regulation 4(Schedule 1 item 1) of the Drugs, Poisons and Controlled Substances Regulations 2017, S.R. No. 29/2017. The current regulations contain a similar requirement.

[3] [1938] HCA 34; (1938) 60 CLR 336.

[4] Ibid, also Clark v Stingel [2007] VSCA 292, Neat Holdings Pty Ltd v Karajan Holdings Pty Ltd [1992] HCA 66

[5] Thesis: 'A Questionnaire Study of the habits and attitudes of rural general practitioners towards Continuing Medical Education.

[6] Thesis: 'Doctors, Patients and Computers, the new Consultation - A study into the impact of computers on the Doctor-Patient relationship.

[7] Unprofessional conduct by the practitioner that amounts to conduct that is substantially below the standard reasonably expected of a registered health practitioner of an equivalent level of training or experience