Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Health Care Complaints Commission v Epstein [2015] NSWCATOD 21 Hearing dates: 24-28 November, 1-5 and 8-12 December 2014 and by written submissions received 23 December 2014 and 23 January 2015. Date of orders: 30 March 2015 Decision date: 30 March 2015 Jurisdiction: Occupational Division Before: J Boland ADCJ, Deputy President Professor D Chisholm, Professional Member Dr K Ilbery, Professional Member A Gray, Lay Member Decision: 1.The Stage 2 proceedings are listed for hearing on 16 and 17 April 2015 at 10a.m. 2. The parties shall file and serve written submissions in respect of appropriate protective orders and costs on or before 13 April 2015. 3. The venue for the Stage 2 hearing is HPCA, Level 6, 477 Pitt Street Sydney. Catchwords: ADMINISTRATIVE LAW – Civil and Administrative Tribunal Act 2013 (NSW) – Health Practitioner Regulation National Law. Where asserted practitioner is guilty of unsatisfactory professional conduct and professional misconduct in treating patients for whom anabolic steroids were prescribed – Whether practitioner's treatment in accordance with therapeutic standard and appropriate in circumstances. Where practitioner failed to keep adequate medical records – Where practitioner failed to report to referring doctors – Where practitioner did not carry out physical examinations of patients – where asserted practitioner prescribed for anabolic steroid abusers –where practitioner treated close relative. HELD Unsatisfactory professional conduct and professional misconduct established Legislation Cited: Civil and Administrative Tribunal Act 2013 (NSW) Evidence Act 1995 (NSW) Health Practitioner Regulation National Law Medical Practice Act 1992 (NSW)( repealed) Medical Practice Regulations 2003 (repealed) Medical Practice Regulations 2008 (repealed) NCAT Procedural Direction 3 (Expert Evidence) Poisons and Therapeutic Goods Regulations 2002 (repealed) Poisons and Therapeutic Goods Regulations 2008 Uniform Civil Procedure Rules 2005 Cases Cited: Australian Communications and Media Authority v Today FM (Sydney) Pty Ltd [2015] HCA 7 Briginshaw v Briginshaw [1938] HCA 34; 60 CLR 336 Clyne v NSW Bar Association [1960] HCA 40; 104 CLR 186 Dasreef Pty Ltd v Hawchar [2011] HCA 21; 243 CLR 588 Don Nai Hsi Huang v Walton (Court of Appeal (NSW) 20 April 1993, unreported Donnelly v HCCC [2011] NSWSC7 HCCC v King [2011] NSWCA 353 HCCC v Perroux [2011] NSWDC 99 HCCC v Quach [2015] NSWCATOD 2 Lucire v HCCC [2011] NSWCA 99 Pillai v Messiter (No 2) 1889 16 NSWLR 197 Re Dr Vitols (NSWMT) unreported 4 May 2010 Texts Cited: HIV Clinical Trials (2010) 11(4) 220-229 Perry-Keene, D "Low testosterone in men" Australian Prescriber (Vol 37 Number 6 December 2014) Sonksen Prof P J.Clin.Edocrinol. Metab 2013,98;2270-73 Category: Principal judgment Parties: Health Care Complaints Commission (Applicant) Dr Julie Epstein (Respondent) Representation: Counsel: K Eastman SC with L Ferendaz (Applicant) P Greenwood SC with C Melis (Respondent) Solicitors: Health Care Complaints Commission (Applicant) Dibbs Barker (Respondent) File Number(s): 1420064 Publication restriction: A non-publication order restricting the publication by any person of the names of the patients appearing in the Schedule to the Complaint except the parties to these proceedings and the Medical Council of NSW was made on 24 November 2014 REASONS FOR DECISION Introduction 1. Dr Julie Epstein (the practitioner) is a general physician of many years' standing. She was admitted to the Royal Australasian College of Physicians in 1985. 2. In the late 1990s, the practitioner developed an interest in a non-mainstream area of practice, namely anti-ageing medicine. She first practised in the area of anti-ageing medicine for approximately one year in 1999, in partnership with a gynaecologist. Their practice also engaged the services of other specialists, including an endocrinologist and a nutritionist. By 2000, she had ceased practising in partnership and had established a solo practice at Double Bay. In 2006, she moved her practice to Moore Park. In late 2010, she moved her practice to its present location at Artarmon. 3. Two events brought the practitioner's treatment of her patients to the attention of first, the Pharmaceutical Branch of the NSW Department of Health (the PSB) and later, the former NSW Medical Board. Both events have their genesis in the prescribing and supplying by the practitioner of drugs, registered on the Australian Register of Therapeutic Goods, but for a purpose other than their prescribed indicated use. This manner of prescribing is known as "off-label" prescribing. It is not illegal. 4. The first event was a visit to the practitioner's Moore Park premises by officers of the PSB in June and July 2007. The practitioner had sought advice from the PSB as to whether or not she required a licence to store, and subsequently supply, drugs prescribed off-label, including particularly human growth hormone and anabolic/androgenic steroids, to her patients from a small area at her rooms at Moore Park. The relevant officers advised the practitioner that, as she was not supplying the scheduled goods by wholesale, she did not need a licence. But the officers then discussed with the practitioner issues relating to the supply of anabolic steroids and human growth hormone, and stressed to her the need to exhibit caution when prescribing these drugs off-label. 5. The second event occurred when one of the practitioner's patients, who had obtained a significant quantity of anabolic steroids from the practitioner, had the drugs seized on his entry to Switzerland, where he was to take up residence. The Swiss authorities notified the Commonwealth Therapeutic Goods Administration (the TGA) about the seizure of drugs that were labelled as dispensed by the practitioner. 6. In 2009, following investigations of the practitioner's prescribing history, the PSB referred their results to the former NSW Medical Board, and proceedings were instituted under s 66 of the now repealed Medical Practice Act 1992 (NSW). Some 90 patient files were identified as disclosing matters of concern, including particularly asserted poor or inadequate record keeping, failure to conduct clinical examinations of patients prior to prescribing and asserted inappropriate prescribing of drugs including human growth hormone and testosterone. The s 66 inquiry led to conditions being placed on the practitioner's registration. There have been subsequent audits conducted of her records. There is no suggestion in these proceedings that the practitioner failed to comply with the conditions imposed following the s 66 inquiry. 7. In these proceedings, the treatment of the practitioner's patients, about whom complaint is made by the Health Care Complaints Commission (HCCC), is narrowed down to 40 patients. The HCCC asserts, in broad terms, that the practitioner is, by reason of her prescribing and care of these 40 patients, guilty of unsatisfactory professional conduct, and that the particulars pleaded establish that the incidents of unsatisfactory professional conduct, either individually or cumulatively, constitute professional misconduct. 8. The particulars in the complaint, amongst other matters, allege the practitioner failed to keep proper clinical records, failed to carry out proper investigations prior to prescribing and dispensing drugs, that there was no proper indication for prescribing and supplying the drugs off-label for the patients, and that the practitioner treated patients she knew were anabolic steroid abusers without proper clinical investigation. 9. The 40 patients named in the complaint comprise 2 women and 38 men. It is the practitioner's evidence that the cohort of approximately 90 to 126 patients originally identified in the s 66 proceedings represented about 50 per cent of her patient population at the relevant time. 10. Both senior counsel for the HCCC and the practitioner sought this hearing should be conducted in two stages, namely that we publish our reasons in respect of the myriad of particulars pleaded in respect of the 40 patients, and that we then conduct a "Stage 2" hearing in accordance with the procedure referred to in HCCC v King [2011] NSWCA 353. 11. At the commencement of the hearing no particulars of the complaint were conceded by the practitioner. During the course of the hearing, a document was tendered (Ex 13), in which the practitioner made some generalised admissions in respect of some unidentified patients, including an admission that her records in the relevant period "are below accepted standards". She also admits she did not conduct physical examinations, in the relevant period, of patients prior to prescribing and that this failure was below accepted standards. The practitioner concedes, in respect of the majority of relevant patients, she did not provide reports to referring practitioners and that this too was below the accepted standard. She also concedes she accepted "her patients' accounts of their symptoms and did not require verification, such as scans for musculoskeletal injuries before providing treatment". She further admits that "she accepted patients' account of their responses to treatment and took them into account when deciding on what treatment, if any, should be given". 12. The practitioner admitted one particular in respect of the patient identified in a schedule to the complaint as Patient BW, namely that she prescribed excessive doses of testosterone to this patient. She further conceded she did not conduct an adequate investigation of Patient B prior to prescribing medications, that she did not follow up creatinine levels of Patient Z (particular 14) and that she prescribed testosterone to Patient CK when he had polycythaemia (Particular 6(j)). She also made some concessions in her oral evidence. She acknowledged prescribing simultaneously different testosterone preparations. This practice, she conceded, was not clinically warranted. She also freely conceded that her record keeping was inadequate, and explained she had changed her practice in respect of record keeping, She explained that she now conducts physical examinations of her patients. 13. Ms K Eastman SC (Ms Eastman), senior counsel for the HCCC, emphasised that these proceedings did not involve the Tribunal in a determination of the validity or otherwise of the practice of anti-ageing medicine. Rather, she emphasised that the Tribunal's task was to examine the assertions made by the HCCC of the practitioner's inappropriate clinical practices in respect of each of the identified patients. 14. By contrast, Mr P Greenwood SC (Mr Greenwood), senior counsel for the practitioner, submitted that we should not judge the practitioner's practice of "anti-ageing" medicine by reference to conventional or "mainstream" practice with the drugs in question only being prescribed in accordance with guidelines adopted by the Endocrine Society of Australia, or based on the results of empirical peer reviewed studies. He did, however, refer to a number of studies asserted to support the practitioner's prescribing practices and emphasised that medicine cannot, and should not, stay stagnant. He pointed out that innovation has led to substantial changes in the practice of medicine to the benefit of society. 15. As our reasons set out below demonstrate, we find a substantial number of the particulars of the complaints established and, as a consequence of our findings, we are satisfied that the practitioner's conduct constitutes unsatisfactory professional conduct and professional misconduct. The transitional provisions 1. As a consequence of the enactment of the Civil and Administrative Tribunal Act 2013, the Medical Tribunal of NSW was abolished effective on 31 December 2013: Sch 1, Div 2, cl 3. The Medical Tribunal's functions were taken over by the Tribunal. Pursuant to the transitional provisions in the Civil and Administrative Tribunal Act (see Schedule 1, Div 3 Sub-Div 2, cl 7 (2) and (3)), the matter is now in the Tribunal for finalisation. Clause 7(3)(b) provides that the provisions of any Act, statutory rule or other law which would have applied to, or in respect of, the proceedings had the Civil and Administrative Tribunal Act and the relevant amending Acts not been enacted, continue to apply. As a consequence, the law to be applied is the Health Practitioner Regulation National Law (NSW) (National Law) in force up to 31 December 2013. The hearing and the structure of these reasons The hearing and submissions 1. These proceedings were conducted over 21 hearing days, and written submissions were provided following the conclusion of the hearing. By agreement between the parties, and with the consent of the Tribunal, the two principal expert witnesses (Associate Professor A Conway and Dr J Coleman) gave their evidence simultaneously at the commencement of the hearing. During the hearing, Associate Professor Conway agreed, for convenience, she should be addressed as "Dr Conway". Again for convenience, and without wishing to cause any offence or disrespect, we have adopted that mode of address in these reasons. Associate Professor Amanda McBride gave evidence by telephone on the discrete topic of treatment by a practitioner of a close relative. The only other witness was the practitioner. She was extensively cross-examined over seven hearing days. 2. There was a vast amount of material tendered to the Tribunal (in excess of 20 volumes), including folders of articles from the literature in medical journals and other publications, as well as patient records for 39 of the 40 patients. We also admitted into evidence a folder of testimonials from a number of the practitioner's patients. The Tribunal accepted the evidence before it that Patient BH's file had been mistakenly destroyed. 3. During the course of the hearing, the Tribunal granted leave to the HCCC to file an Amended Notice of Complaint (the complaint). The complaint refers to the practitioner's practice of medicine during a discrete period (1 August 2007 and 6 August 2009). The complaint contains two Schedules. Schedule A discloses the names of the 40 individual patients. Schedule B sets out the drug prescribed, date of prescription and quantity dispensed by the practitioner in respect of each patient. Mr Greenwood conceded that Schedule B is accurate in all respects. 4. The Tribunal was provided with extensive and helpful written submissions from each party for which we record our thanks. However, the parties took a different approach, or changed approach during the hearing, to the manner of dealing with the particulars in the complaint. 5. Although Ms Eastman adduced oral evidence from Dr Conway and cross-examined Dr Coleman about the practitioner's treatment and prescribing for each individual patient, in her final oral submissions Ms Eastman addressed issues in dispute by reference to the specific particulars in the complaint, rather than reviewing the evidence in respect of the individual patient seriatim. This approach is readily understandable and was adopted by her to assist our task, given the discussion by Basten JA in Health Care Complaints Commission v Lucire [2011] NSWCA 99, about making necessary factual findings about particulars in the complaint. Mr Greenwood, consistently with the manner in which the hearing proceeded and the way the experts gave evidence, adopted the approach of considering each of the 40 individual patients and, in so doing, considered the particulars of the complaint asserted in respect of the particular patient. We have determined to adopt a hybrid approach which we detail below. Structure of these reasons 1. We will first refer to the relevant statutory provisions in the National Law, against which we must determine this complaint. After setting out some relevant background material, we think it aids understanding of these reasons to briefly explain the drugs in issue in the proceedings, their mainstream and off-label use and to relevant Department of Health and other publications dealing with the prescribing of the particular drugs. We also refer to the practitioner's use of a graph known as a nomogram as a diagnostic aid. Thereafter, we will refer, in general terms, to the evidence of the two experts, Dr Conway and Dr Coleman, and that of the practitioner. We examine, as do the respondent's submissions, the particulars in the complaint by considering the evidence, including the expert evidence, about each individual patient and conclude by summarising our findings by reference to the particulars in the complaint under the headings of "Unsatisfactory Professional Conduct and Professional Misconduct". The relevant law 1. The complaint asserts the practitioner is guilty of unsatisfactory professional misconduct under s 139B(1)(a), (b) and (l) of the National Law. By reason of transitional provisions, which came into operation on the commencement of the National Law, s 139B(1)(b) "picks up" the repealed Medical Practice Regulations 2003 and 2008 (NSW). The relevant provisions are as follows: (1) "Unsatisfactory professional conduct" of a registered health practitioner includes each of the following-- (a) Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of the practitioner's profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. … (b) 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. … (l) Any other improper or unethical conduct relating to the practice or purported practice of the practitioner's profession. 1. The Medical Practice Regulation 2003 relevantly provides: Schedule 2 Records relating to patients 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: (a) any information known to the medical practitioner who provides the medical treatment or other medical services to the patient that is relevant to his or her 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 perform on the patient and information concerning allergies or other factors that may require special consideration when treating the patient), and (b) particulars of any clinical opinion reached by the relevant medical practitioner, and (c) any plan of treatment for the patient, and (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 registered 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 registered 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, … (f) the results or finding made in relation to the treatment. (5) Any written consent given by a patient to any medical treatment (including any medical or surgical procedure) proposed by the registered medical practitioner who treats the patient must be kept as party of the record keeping relating to the patient. (These provisions are substantially identical to those in the Medical Practice Regulation 2008, Sch 1) 1. The relevant regulations also provide (cl 2) that the level of detail must be appropriate to the patient's case and contain sufficient information to allow another registered medical practitioner to continue management of the patient's case. 2. A practitioner, who is prescribing drugs, is obliged to do so in accordance with the law. In this case, the relevant regulations during the period of the complaint are found in cl 33 of the Poisons and Therapeutic Goods Regulations 2002, or after 1 September 2008, in cl 34 of the Poisons and Therapeutic Goods Regulations 2008. These regulations prescribe that a practitioner must not issue a prescription for a restricted substance, in a quantity, or for a purpose "that does not accord with the recognised therapeutic standard of what is considered appropriate in the circumstances". 3. The complaint also asserts the practitioner is guilty of professional misconduct. The statutory definition of professional misconduct is found in s 139E of the Health Practitioner Regulation National Law (NSW) as follows: For the purposes of this Law, "professional misconduct" of a registered health practitioner means-- (a) unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or (b) 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 suspension or cancellation of the practitioner's registration. 1. Section 3 of the National Law sets out the objectives and guiding principles of the law, as those objectives and principles apply to the national registration scheme. Section 3A of the National Law, in force at the date of the hearing, sets out the objective and guiding principle to be applied by a Tribunal in New South Wales conducting an inquiry into a complaint and, if appropriate to do so, when making protective orders. The relevant parts of s 3, for the purposes of this hearing, are as follows: (2) The objectives of the national registration and accreditation scheme are-- (a) to provide for the protection of the public by ensuring that only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered; and … (e) to facilitate access to services provided by health practitioners in accordance with the public interest; and ……. (3) The guiding principles of the national registration and accreditation scheme are as follows-- (a) the scheme is to operate in a transparent, accountable, efficient, effective and fair way; … (c) restrictions on the practice of a health profession are to be imposed under the scheme only if it is necessary to ensure health services are provided safely and are of an appropriate quality. 1. Section 3A, which has particular relevance in the circumstances of this matter, provides as follows: In the exercise of functions under a NSW provision, the protection of the health and safety of the public must be the paramount consideration. 1. It is relevant at this point the Tribunal records that protective orders made at the end of a hearing are not intended to punish the practitioner, but to protect the public (see Clyne v NSW Bar Association [1960] HCA 40; 104 CLR 186). The onus or burden of proof 1. The onus or burden of proof is that of the HCCC. It is well established, due to the protective nature of the jurisdiction and the seriousness of the complaints both for the practitioner and the public, that the standard of proof is on the balance of probabilities, but to the level of satisfaction described by the High Court in Briginshaw v Briginshaw [1938] HCA 34; 60 CLR 336. The drugs, MIMS and NSW Health publications 1. In an attempt to reduce hearing time at a directions hearing conducted on 6 February 2014, the presiding member ordered that the parties lodge an agreed statement of facts by 20 March 2014. A statement, which included a description and purpose for each of the drugs referred to in the complaint, was filed. On 20 March 2014, the presiding member noted that the statement was an agreed statement. However, the practitioner's consent to that agreement was withdrawn at the hearing. As a consequence, for the purpose of these reasons, we will refer to those parts of Dr Conway's first report relating to the drugs which were accepted by Mr Greenwood (and by Dr Coleman) as correct, as well as other documentary evidence adduced before us. 2. The complaint deals with five drugs namely anastrozole, Human Chorionic Gonadotrophin (HCG), Human Growth Hormone (HGH), nandrolone decanoate, and testosterone (being testosterone enanthate and/or other testosterone esters for non-approved purposes). Anastrozole (Arimidex) 1. Dr Conway describes anastrozole as: A potent and highly selective non-steroidal aromatase inhibitor which significantly lowers serum oestradiol concentrations. 1. Dr Conway refers to anastrozole being indicated as "adjuvant treatment in some cases of breast carcinoma". She states there is no approved indication in men. She also notes that "since there is no established indication for anastrozole use in males there are no relevant investigations". She also notes that anastrozole is used occasionally off-label in males to treat gynecomastia (male breast development). 2. In her closing submissions, Ms Eastman referred, by reference to the information found in the relevant MIMS entry, to anastrozole as being a drug which was, and is, "used to treat post-menopausal women with advanced breast cancer". 3. The practitioner stated she used anastrozole to modulate oestrogen in some men for whom she prescribed testosterone "if [oestrogen] levels rise". 4. The proprietary name under which anastrozole is marketed is Arimidex. As that was the name by which the drug was most commonly referred to throughout the proceedings, for convenience, we have used that proprietary name in these reasons. HCG (Pregnyl) 1. HCG is described by Dr Conway in these terms: HCG stimulates steroidogenesis in the gonads by virtue of a biological effect similar to that of LH [luteinising hormone]. In males it stimulates the production of testosterone by the testes. The most commonly used HCG in males is a product prepared by purification from the urine of pregnant women. 1. The indicated use for HCG in males and females is for the treatment of hypogonadotrophic hypogonadism. Dr Conway explains its use as follows: In men HCG is used either to induce puberty or in conjunction with FSH [follicle stimulating hormone] to induce spermatogenesis. 1. HCG is marketed under the proprietary name Pregnyl. Again, for convenience we will use that name in these reasons. 2. The MIMS entry for Pregnyl indicates its prescribing is contraindicated in suspected cases of sex hormone dependent tumour, including prostate cancer in males. 3. The practitioner in her statement at [110] and [111] noted that use of Pregnyl "is more appropriate in younger patients with hypothalamic/pituitary dysfunction causing low testosterone". She went on to note that treatment with Pregnyl to combat testicular atrophy is commonplace in patients receiving exogenous testosterone. Human Growth Hormone (Omnitrope, Nutropin and SciTropin) 1. The complaint asserts the practitioner inappropriately prescribed HGH for a number of patients. HGH prescribed off-label is expensive. Dr Conway explained treatment costs are approximately $12,000 per year for an adult patient. It is sold under proprietary names (Omnitrope, Nutropin and SciTropin). 2. Dr Conway describes the properties of HGH as: Various recombinant somatotropins are identical in structure to human growth hormone of pituitary origin. In growth hormone deficient children HGH stimulates linear growth. In growth hormone deficient adults HGH increases lipolysis and reduces fat mass with some increase in lean body mass and in some, but not all, studies improves quality of life. 1. Dr Conway notes the contraindications for prescribing HGH to be for patients with active tumours or evidence of tumour growth. In referring to off-label use of HGH, Dr Conway opined: Since HGH does not have a registered indication for adults with HGH deficiency, despite some studies demonstrating a quality of life benefit, endocrinologists do prescribe HGH to some GH deficient adults who feel the benefits outweigh the significant costs involved. There is some evidence to support this practice. There is a significant black market use of HGH by body builders and athletes…[footnote omitted] 1. At [80] of her statement, the practitioner explains: I sometimes use growth hormone as part of a comprehensive hormone modulation program. Indications are varied and include social isolation, depressed mood, decreased libido, obesity, maintenance of muscle mass in HIV and ageing, healing of musculoskeletal injuries and treatment for muscle disease. 1. In describing her prescribing practices at [81], the practitioner explains: There is a philosophical argument that growth hormone and other hormones could be replaced even in the symptomless ageing adult to prevent the development of some age related decline. I do not adopt this practice, and only prescribe growth hormone if that patient has symptoms which I know, either from knowledge or experience, may respond to its use. 1. In her oral evidence the practitioner explained that whether she prescribed Omnitrope, Nutropin or SciTropin depended upon availability of the drug and price. For convenience, and to avoid confusion regardless of the proprietary name of the HGH prescribed, we will refer to the drug as HGH. 2. It is also relevant to note that the practitioner disclosed, in her oral evidence , that in the USA, regulations require that anti-ageing practitioners may only prescribe HGH for their patients after provocative testing.(transcript 4 December 2014 p670-671). 3. Nandrolone Decanoate (Deca-Durabolin) 4. Nandrolone Decanoate is described by Dr Conway as: An injectable androgen which is not measured in standard testosterone immunoassays. Its effects are similar to all androgens with increased virilisation, increased bone mineral density and lean body mass, and decreased body fat mass. 1. Dr Conway notes that the drug was historically used for treatment of anaemia associated with chronic renal failure and also osteoporosis. However, more specific treatments for these conditions have meant that it now has no real indication in these clinical situations. Dr Conway notes the major contraindications are testosterone dependent tumours, particularly prostate carcinoma. The side effects of the drug are noted to be virilisation in women, polycythaemia and occasionally fluid retention. 2. Dr Conway comments that the drug is widely used by body builders. 3. Nandrolone is marketed under the proprietary name "Deca-Durabolin". We refer to it by that name in these reasons. Testosterone Enanthate and Mixed Testosterone Ester Preparations (Primoteston and Sustanon) 1. The other drugs which feature in the complaint are testosterone enanthate and mixed testosterone ester preparations. These drugs are marketed under the proprietary names of Primoteston and Sustanon respectively. We refer to these drugs as "testosterone". 2. Dr Conway describes Primoteston and Sustanon in the following way: These are injectable androgens whose effects are increased virilisation, increased bone mineral density and lean body mass, and decreased body fat mass. 1. The approved and accepted therapeutic use for Primoteston and Sustanon is for "confirmed testosterone deficiency in males". She notes side effects include polycythaemia. Dr Conway also notes "exogenous testosterone reduces spermatogenesis, resulting in reduced testicular size and infertility. Although this is usually reversible, it may persist after prolonged therapy. Existing prostate disease, both benign and malignant may worsen with testosterone treatment" In her oral evidence Dr Conway did not seek to comment on or contradict oral evidence given by Dr Coleman about recent studies which suggest prescribing testosterone for men with benign prostate disease may not impose a risk (transcript 27 November 2014 page 281). 2. Dr Conway referred to the diagnostic testing to establish androgen deficiency being a prerequisite before prescribing. The testing is noted by Dr Conway to involve: …clinical assessment of symptoms and physical examination and measurement, where clinically indicated, of testosterone, SHBG and gonadotrophin levels. A low testosterone level must be documented on more than one occasion since 30% of men with a slightly reduced testosterone level may be normal on repeat and 15% of healthy young men may have a testosterone level below normal in a 24 hour period. Examination of testicular volumes using an orchidometer is essential since sustained androgen deficiency is highly unlikely in the presence of normal testicular volumes. 1. We pause to note that during the hearing of the expert evidence and the practitioner's cross-examination, the issue of the "correct" criterion to be applied to assess levels of testosterone was subject of debate. It is not in dispute that the measurement applied by Dr Conway in her report is that adopted by the Australian Endocrine Society. It is a slightly more conservative range than that adopted in Europe or the USA. 2. During the course of the hearing, and after Dr Conway and Dr Coleman had given their evidence, adduced into evidence before us was a medical journal, Australian Prescriber, (Vol 37 Number 6 December 2014). This well-regarded publication contained an article "Low Testosterone in men" by Donald Perry-Keene, Endocrinologist, Department of Endocrinology and Diabetes, Royal Brisbane and Women's Hospital, Brisbane. In the article the author referred to the "gold standard" for measurement of total serum testosterone and he opined: The need for a high volume output and lower costs has resulted in laboratories using automated immunoassays which have variable sensitivity, accuracy and reproducibility. 1. The author went on to explain: There is less accuracy and greater variability for results in the hypogonadal range, with some significant discrepancies. Reference standards and manufacturers' reference ranges are not always well defined. Given these caveats, defining a reference range, particularly the lower limit of normal, is fraught with difficulty. American consensus statements say above 11.1nmol/L is normal, below 6.9nmol/L is diagnostic of hypogonadism, and 6.9-11.1nmol/L is equivocal. In Europe those figures are respectively 12, 8 and 8-12nmol/L. 1. At page 198, the author sets out the criteria for a male to be entitled to obtain a rebate on the Pharmaceutical Benefits Scheme (PBS) for testosterone. (i.e for men over 40, without established pituitary or testicular disease, the serum total testosterone must be below 8nmol/L, or below 15nmol/L in association with concentrations of serum luteinising hormone more than 1.5 times the upper limit or normal). He also notes to qualify for subsidised treatment, the patient must have had low testosterone levels on at least two occasions. It is not suggested that the cohort of patients to whom the practitioner prescribed testosterone obtained benefits under the PBS. 2. In summary, the evidence before us demonstrates that first, there are different ranges employed for definition purposes in Europe, the USA and Australia, and some unreliability in the results obtained. Greater certainly of diagnosis of testosterone deficiency is obtained by two separate assays being conducted with such samples being collected in the early morning when testosterone levels are at their highest and/or an accompanying elevated LH level. The so called "range" assumed importance in this hearing because of the practitioner's treatment of patients she described or found to be in the low borderline range. Guidelines, Codes of Conduct, and publications 1. It is also appropriate at this point we refer in a summary way to the publications referred to and relied on by the HCCC. 2. The HCCC adduced before us two policies, namely the NSW Medical Board's Code of Conduct and its guidelines on treating relatives. We will consider the latter document when discussing the specific complaint about the practitioner treating her de facto partner, Patient H. The other relevant policy documents adduced before us include the NSWH Facts Sheet for persons using or thinking of using anabolic steroids (named drugs include Sustanon and Deca-Durabolin). The publication notes "There is no 'safe' dose of an anabolic steroid". The publication also notes that a user may become psychologically dependent on anabolic steroids. The publication states "It is illegal for your doctor to prescribe anabolic steroids, unless they are to be used for medical reasons". It is not in dispute the target audience for this publication is the general public, not medical practitioners. 3. In March 2006, the NSW Medical Board published a document described as "Prescribing or Supplying Performance Enhancing Drugs". The document carried a clear and unambiguous warning about inappropriate prescribing of anabolic steroids to sportsmen and body builders. 4. The HCCC also relied on the PSB publication dated June 2006. That publication, entitled "Recognising and Handling the Misuse of Anabolic-Androgenic Steroids: Notes for Medical Practitioners", recommends that the most effective method of minimising harm to a patient is not to prescribe androgenic-anabolic steroids. The publication notes that endocrinologists consider it unnecessary for a high level user to be weaned off the drugs, but explained that many patients will experience difficulty in ceasing their use of these drugs. The publication says "General practitioners have an important role in providing non-judgmental medical care, support and advice in a long term strategy comparable to smoking cessation". The nomogram used by the practitioner 1. The practitioner does not refer in her statement to a document found in the clinical notes for the majority of her male patients. Its origin is referred to in the written submissions filed on her behalf. This document was regularly referred to during expert evidence and the practitioner's oral evidence. The explanation at [92] of the practitioner's submissions is as follows: [T]he practitioner uses a nomogram to plot free calculated testosterone as outlined in the Journal of Clinical Endocrinology and Metalolism [sic] (1988,85,3666-72). This nomogram is produced from the Vermuellen calculation. What the nomogram helps to show patients is that whilst a single reading of total testosterone may appear within a laboratory's quoted reference range, when considering the SHBG it may actually be deficient or at the lower end of the reference range. It is this free calculated testosterone level that [the practitioner] uses both in initiating treatment and monitoring a patient on treatment. She started using the nomogram after she attended a workshop in December 2007 with Dr Eugene Shippen. Prior to that time she used the SHBG level and total testosterone level to assess the free testosterone level and sometimes, where available, the free androgen index. 1. The genesis of the practitioner's use of the document is explained by her in answer to questions posed by Ms Eastman in cross-examination. The practitioner explained she attended a conference on 11 December 2007 at which Dr Eugene Shippen conducted a one day workshop on testosterone replacement. At this conference, her attention was drawn to "a nomogram" which was a handout at the conference. 2. How the nomogram was used by the practitioner may be derived from the following exchange between Ms Eastman and the practitioner: Q. I want to ask you about the nomogram. I think you may have mentioned yesterday or the day before that the dots on the document that you used was as a result of attending a conference with Dr Shippen is that right? A. That's right. … MS EASTMAN Q. There's a one day workshop on testosterone replacement with Dr Eugene Shippen on 11 December 07, is that the conference you're referring to? A. That's where I was drawn attention to the nomogram, yes. Q. There was a handout. In terms of the handout, members of the Tribunal just for convenience I'll just use one of the patient files, so in terms of order of appearance in the patient clinical records, volume 1 tab B, it's page 43 and page 45, you'll see pages 45 and 44 in the file are two copies of the nomogram? A. Right. Q. If we just use the document at page 43, the words "deficient borderline" and does that say "mid normal"? A. Yes Q. That's your handwriting? A. No that was on the handout. Q. Did it occur something like this, that you attended the conference and during the course of the conference somebody gave a seminar or had a discussion about the nomogram and this document with the handwriting and the dots on it was handed out to participants at the conference? A. Correct. Q. Do you know who is the author of the dots and the handwriting, do you know who did that? A. I believe it's Dr Shippen. Q. Is that something that you saw happen at the conference, was it up on a screen or was it just handed out and you've assumed it's Dr Shippen? A. Dr Shippen ran the whole conference and I 'm making an assumption that that was Dr Shippen's handwriting and the dots. Q. But you can't be sure about that? A. I can't be sure about that. Q. Is it the case that you've then taken this handout back to your practice and you've made photocopies of it and the photocopies are what we see included in the patient records? A. That's right. … Q. How is it that if we just use [Patient B], that you've got a record for results in 2006 and up to July 2007? A. It's very simple, I went back on some patients' results and I saw where they were when they were first seen, so it was in retrospect. Q. To the extent that in the records there are nomograms that have dates prior to December 07, is the Tribunal and am I right in understanding that you weren't using the nomogram to assist you as a diagnostic tool before December 07? A. That's absolutely right. I was having great difficulty interpreting testosterone tests prior to that time, and when I got the nomogram, I took the opportunity of retrospectively charting some of the testosterone values, the free calculated testosterone. Q. Before December ‑ I'll just use December, I won't hold you to whether it's 12th or 13th, but before December 07 if you were not using the nomogram to work out from your perspective what was low normal or deficient or borderline, what were you using as a diagnostic tool prior to December 07? A. It was mainly the free androgen index and then occasionally free testosterone would be ordered which didn't correlate with the free androgen index at all so it was mainly the free androgen index which really isn't recommended anymore. … Q. When you had the nomogram, you've used that to plot the results so that you can make a visual assessment of where the patient's results might fall, mid, normal, high, borderline, and before that time, if you were just using for example the results as they appear on page 49, did you have any particular figure in mind or number in mind that you were looking at in the reference range to assist you to make the decision to start testosterone treatment? A. I didn't have a particular figure. I would have assessed this combination of testosterone as SHBG to be on the lower side, just by looking at the two figures and in combination with the symptoms of the patient, a decision would then have been made to treat. (transcript 5 December 2014 p 769-770) 1. Later the practitioner gave evidence about the use of the nomogram after 2007 as follows: Q. After December 07 when you had the nomogram with the words and the dots on it, did that change your approach at all? Did you adopt a different approach after you'd received this document? A. It was a good visualisation I thought for myself and the patients, to see where they fell, either towards the top or the bottom or in the middle. I don't think it actually changed my approach but it was a very solid ‑ for me a very solid thing to have compared to what I had previously which was free testosterone levels which were totally difficult to interpret and free androgen indexes which didn't seem to correlate with free testosterone at all. Q. Has anybody explained to you what deficient means on the nomogram and the basis on which the indication of deficient was calculated or reached? A. No, Dr Carruthers in his book has a lower limit that he says ‑ and I forget where it is but it's pretty close to that bottom dot, but the other dots, I made the assumption when I adopted that, right or wrong, that that was the normal range from Dr Shippen's lab that he used and that was just a guide. Q. At any time have you looked at the nomogram with the indication of mid normal, borderline and deficient and matched it against the clinical guidelines from the United States, from Europe or from Australia? A. The clinical guidelines are more to do with total testosterone. These were merely statistics, give you an idea of what calculated testosterone, but you don't get a normal range for pre‑calculated testosterone unless maybe you do a..(not transcribable).. but I don't know about that sort of thing. Q. In terms of the word "borderline"? A. Yes. Q. Has anybody explained to you what that means? A. It was never explained to me, no. Q. You have heard, I think Dr Coleman used the expression, "low normal"? A. Yes. Q. I think that's an expression that you have used in some of the material as well? A. Yes. Q. This nomogram doesn't have a low normal either as a narrative descriptor or dot, do you agree with that? A. There's ‑ no, it doesn't say low normal, no. Q. Where does low, for you, where does low normal come from, what does that mean and what's the source of low normal? A. It's looking at the middle line and just making an assessment where the pre‑calculated testosterone falls. I've used Dr Shippen's dots as a guide and I think Dr Coleman probably was too, and so if it is falling in the lower third, between the top and the bottom dot, I would be saying that that's low normal. Q. Based on your assessment of low normal, that would then indicate appropriate to commence treatment? A. Yeah well Dr Carruthers himself doesn't believe in dots, he doesn't think there is a top and bottom of the range, and this is the feeling that is coming out now, at least of Europe, and I just recently watched a seminar for ‑ a seven hour webinar, and it's not a hard and fast rule, what the normal range is. The whole thing about testosterone enanthate is we have done ‑ gone through this before, is that they are not very good and so you cannot base everything on what a testosterone level is.(transcript 5 December 2014 pp 771) 1. In her report Dr Conway expressed strong criticism about Dr Carruthers, the author of a book that advocates calculating free testosterone levels by use of a nomogram. While she qualified her evidence in cross-examination acknowledging that she had not made independent inquiries about Dr Carruther's reputation, she did not depart from her criticisms of the methodology. 2. Dr Conway, in answer to questions posed by Mr Greenwood, explained that the nomogram was based on research conducted by Vermeulen, in a very small sample of approximately 28 patients. She explained that the research was "widely quoted" (transcript 24 November 2014 p 61). 3. We are satisfied, even without reliance on Dr Conway's evidence on this topic, based on the practitioner's own evidence that the nomogram is not a scientifically proved or a reliable, accurate diagnostic tool. We do accept Dr Conway's evidence that its unreliability stems in part from the issue of some binding protein other than by SHBG and in part from the variability between the reference ranges from one laboratory to another and results require, as explained by Dr Conway, "re-establishment in the actual laboratory in which the testing is done and for example the Douglass Hanly Moir results for her patients they have quoted a range in their laboratory of estimated or free testosterone or free testosterone index based on their own assays and they don't correlate well with the vermeulen figures that she has calculated out". (transcript 24 November 2014 p 60). Background 1. The following matters, unless noted by us to be an assertion are facts established to the requisite civil standard. 2. In 1976, the practitioner obtained her MBBS degree from the University of New South Wales, and in 1985 she became a Fellow of the Royal Australasian College of Physicians. 3. In 1999, the practitioner established the Australian Centre of Anti-Ageing Medicine. She practised at this centre in partnership with a gynaecologist and engaged the services of other health professionals. In 2000, she ceased practising at this centre and commenced her own solo practice at Double Bay NSW. 4. In 2007 the practitioner moved her practice to Moore Park where her rooms included a separate space where she sold supplements, and from where patients obtained supplies of the drugs earlier prescribed off-label by the practitioner, rather than the drugs being dispensed by a pharmacist. The drugs dispensed were recorded by the practitioner, or her Practice Manager, in a "prescription diary". 5. The practitioner commenced seeing some of the patients named in the complaint in the period 2000-2006 (i.e. outside the period relevant to the complaint). Those patients were patients identified as Patients AP, AF, BV, AR, CJ, J, BB, BJ and BH. 6. On 28 June 2007, officers of the PSB, (Mr Szwarchberg, and Mr Battye) met with the practitioner at her rooms at Moore Park. The practitioner had sought advice about whether she was required to hold a Poisons License. 7. On 3 July 2007 the practitioner spoke to Dr Alison Reid of the then NSW Medical Board about policies relevant to the prescribing of anabolic steroids off-label. Dr Reid noted in a file note that "problem cases have involved the administration of these preparations [Human Growth Hormone] in the absence of proven deficiency; mostly for body building purposes". Dr Reid also advised the practitioner to fully document her procedures, to keep comprehensive medical records and, if she was in doubt about a patient, to "err on the side of caution". Finally, Dr Reid advised the practitioner she should be "alert to the possibility of manipulation by patients". 8. In March 2008, the practitioner first prescribed for Patient AB. 9. On 5 July 2008, Mr Battye wrote to the practitioner confirming in writing information provided at their "recent meeting". Amongst other matters, Mr Battye said: Although it is not suggested that you are supplying anabolic-androgenic steroids to the body-building community, I have also enclosed a copy of the Department's "Recognising and Handling the Misuse of Anabolic-Androgenic Steriods [sic]: Noted for Medical Practitioners, TG 197/2". In particular, your attention is drawn to Page 6 of this guide. 1. On 28 July 2008, a second meeting between the practitioner and the officers of the PSB was held. The practitioner's de facto partner, Patient H, was present at the meeting. Until his illness and subsequent untimely death in 2014, Patient H acted as the practitioner's Practice Manager. 2. On 15 April 2009, the practitioner wrote a letter addressed "To whom it may concern". She stated that Patient AB was under her care for hormone deficiency and was carrying drugs (20 boxes with 1 vial each of SciTropin 5mg/1.5ml, 35 boxes of Deca-Durabolin 50mg/ml, up to 6 boxes of Adroderm 5mg patches and 35 boxes of Sustanon 250mg). This patient was intercepted by Swiss authorities on entry to that country. The Swiss authorities are asserted to have contacted the TGA. 3. On 16 June 2009 Mr Hislop, Investigator, TGA, sent an email to Mr Battye at the PSB, with a copy to the practitioner, expressing concern about the practitioner's prescribing practices. He said: Recently [the practitioner] provided a patient of hers with a number of controlled substances. Since this time the patient has departed Australia for Switzerland. 1. On 17 August 2009, Mr Battye, on behalf of the PSB, served a notice on the practitioner under s 35 of the Poisons & Therapeutic Goods Act 1966 (NSW) requiring her to furnish particulars in respect of eight named substances including dates of receipt of the drugs, quantity received and the manner and date of supply together with details of the name and address of persons to whom supply was made. By letter dated 21 September 2009, the practitioner responded to the PSB notice. 2. In 2009, the PSB referred the practitioner's prescribing conduct to the NSW Medical Board. A s 66 inquiry was held in March 2010 and conditions were placed on the practitioner's registration. 3. In August 2012, an inquiry into a complaint, which had been referred to the then Medical Tribunal of NSW, was listed before Blanch CJ for directions. After a number of directions hearings in that Tribunal, the matter was transferred to this Tribunal on 1 January 2015. The hearing dates were not immediately allocated due to Patient H's illness and subsequent death. The practitioner's documentary and oral evidence 1. The practitioner's statement sets out her qualifications and practice history. That history, so far as is relevant to these proceedings, is summarised by us under "background" and it is unnecessary that we repeat it. 2. In her oral evidence, the practitioner referred to her practice history prior to 1999. She explains she practised as a general physician treating patients with respiratory ailments and held positions in hospitals including Royal North Shore Hospital. Both in her oral evidence and in her statement, the practitioner sets out her interest in "preventative medicine". She explains in her statement at [6]: "I developed an interest in the philosophy of a "health span" rather than "life span" and the steps being taken internationally to improve general health with simple and safe interventions". At [16] of her statement the practitioner says: My area of interest and expertise might be described as "anti-ageing" medicine but this label is often misunderstood in the general community. I have found that it has come to be associated more with cosmetic appearance than improving the long term health of patients. It is also unfortunate that it has become wrongly associated with the gym and sports enhancement culture. 1. The practitioner goes on at [17] and [18] to explain: I treat my patients with a view to preventing health decline, lost function and loss of mobility and cognition that is common in the last decades of life today. To achieve that, my colleagues, and there are tens of thousands of us around the world, look to the optimization of nutrition and lifestyle, combined with judicious replacement of hormones. The theory is a simple one. Our wellbeing hormones such a growth hormone, testosterone, DHEA, oestrogen and melatonin decline with age, reducing by up to 12% per decade from around age 25. Attendant with this decline are the symptoms of ageing including loss of muscle mass, increase in visceral fat, skin changes, decrease in bone mass, and failing mobility, and decreasing cognitive abilities. The side effects are few and in any event far less than many commonly prescribed drugs. 1. The practitioner records that she is a member of the American Academy for Anti-Aging Medicine (A4M) and was formerly a member of the Age Management Medicine Group and regularly attends, at least on an annual basis, the conferences organised by these associations. She explains she has recently joined the Institute for Functional Medicine. Later in her statement at [23], the practitioner records that she has attended more than 20 conferences since 1999. 2. In her oral evidence, the practitioner said that she was not a member of the Australian Academy of Anti-Ageing Medicine because she did not agree with the professional stance of the President. Her evidence is that she is the only practitioner in Australia engaged in the particular type of anti-ageing medicine she practises. 3. At [44] of her statement, the practitioner refers to the fact that six audits have been conducted of her patient files since the s 66 proceedings. She says: Not one of these audits has raised questions about my note keeping .my communication with referring practitioners or my conduct of physical examinations, reflecting the implementation of changes to my practice that I acknowledge have improved the overall high standard of patient care… 1. We deal in greater detail later in these reasons, when discussing individual patients, some of the practitioner's responses in a spread sheet document she prepared and annexed to her statement ( Ex 5). Associate Professor Ann Conway 1. Dr Conway is the Senior Staff Specialist, Department of Andrology, Concord Hospital. She is Clinical Associate Professor, University of Sydney and Member, Human Ethics Committee, Concord Hospital. She has published many peer reviewed papers in highly regarded journals including a number of papers co-authored with Professor DJ Handelsman. Dr Conway was a member of the Committee of the Endocrine Society whose recommendations have been adopted by the TGA as the prescribing criteria for eligibility for PBS benefits in respect of androgenic steroids. 2. In her initial report (undated) but received by the HCCC on 5 May 2013, after setting out the properties of the drugs involved in the complaint, Dr Conway refers to the practitioner's clinical records. In summary, she opines that the records are deficient and below the standard reasonably expected of a practitioner of the practitioner's experience and expertise. 3. In summary, Dr Conway is critical of the practitioner's prescribing for the cohort of patients named in the complaint, on the basis that their clinical symptoms, and particularly pathology results, do not indicate the patients fall within the ranges prescribed in the Endocrine Society Guidelines which justify prescribing. She opines, as we will shortly set out, in respect of the relevant patients named in the complaint, that the practitioner's conduct in prescribing demonstrates that her skill, judgment possessed or care exercised is significantly below the standard reasonably expected of a practitioner of equivalent level of training or expertise and attracts her strong criticism. Dr Jeremy Coleman 1. Dr Coleman holds the degrees of MBBS. He is a fellow of the Royal Australasian College of Physicians and the Australian Counselling Association. He trained as a general physician with a sub-speciality in Immunology and Allergy. He notes his special interest "in hormone deregulation (hormone deficiencies) which are involved in a variety of inflammatory diseases that lead to an array of symptoms including malaise, weight gain, cognitive function, sexual dysfunction, depression, arthropathy, autoimmune disease, allergies and poor healing". He stated that his involvement with hormone therapy related mainly [but by no means exclusively] to female patients and did not involve HGH therapy, mainly because of affordability. 2. Dr Coleman's curriculum vitae discloses that he has been in private practice since 1985 as a general physician. Over the past 29 years, Dr Coleman states in his report that he has been referred "to close on 40,000 patients from GP's and fellow specialists". He also states that for the past 14 years he has been particularly interested in optimising health through integrated programs. He has attended many conferences following his interest in endocrinology, hormones, ageing and optimising health and preventing disease. 3. Dr Coleman provided a report at the request of the practitioner's solicitors dated 18 March 2014. In his report, after setting out his qualifications and experience, he refers to the fact that he prescribes testosterone to both men and women. 4. Dr Coleman, in preparing his report, due to a misunderstanding, examined the complete patient records for the 40 patients. That examination included periods outside those specified in the complaint and in some cases the opinions expressed in his report refer to treatment of the relevant patient outside the complaint period. 5. Weight to be afforded to the expert evidence 6. In her closing oral and written submissions, Ms Eastman submitted that we should place no reliance, or at best very limited reliance, on Dr Coleman's expertise to give an expert opinion on matters in issue other than matters such as treating a relative or record keeping. 7. Ms Eastman submitted that, as the rules of evidence do not apply to proceedings in the Tribunal, the HCCC had properly not objected to the admission of Dr Coleman's report (and, we would say, his oral evidence). Rather, she submitted that the Tribunal's Expert Witness Code (Practice Direction 3), which is effective from 7 February 2014, applied. She submitted Dr Coleman did not have the relevant expertise as identified in the Code and also by reference to the principles referred to by the High Court in Dasreef Pty Ltd v Hawchar [2011] HCA 21; 243 CLR 588. 8. Mr Greenwood, in his final submissions, strongly disagreed with the stance adopted by Ms Eastman. 9. To consider Ms Eastman's submission, it is necessary that we refer to the relevant legislation and the Tribunal's procedural direction. The starting point is Sch 5D, cl 2 of the National Law. It provides as follows: In proceedings before it, a Committee or the Tribunal is not bound to observe the rules of law governing the admission of evidence, but may inform itself of any matter in the way it thinks fit. 1. Section 26 of the Civil and Administrative Tribunal Act empowers the President of the Tribunal to make procedural directions. Section 26(4) requires "Each member, and the parties to proceedings and their representatives, [to] comply with any applicable procedural directions". 2. NCAT Procedural Direction 3 (the direction) was published with an effective date of 7 February 2014. It replaces an earlier procedural direction. The direction is titled "Expert Witnesses". Paragraph 1 of the introduction of the direction states: The Tribunal may rely on evidence from expert witnesses to reach a conclusion about a technical matter or area of specialist knowledge that is relevant to an issue to be determined in proceedings. It is important that experts' opinions are soundly based, complete and reliable. 1. The direction, in paragraph 2 of the introduction, notes that the direction sets out a code of conduct for expert witnesses (based on Schedule 7 to the Uniform Civil Procedure Rules 2005). 2. The direction defines an expert witness as follows: A person who has specialised knowledge based on the person's training, study or experience and who give evidence of an opinion based wholly or substantially on that knowledge. 1. The direction applies to "any evidence given by an expert witness in the Tribunal". 2. In Dasreef Pty Ltd v Hawchar, the High Court dealt with an appeal by a company that had been found liable by the Dust Diseases Tribunal to pay compensation to a stonemason who contracted silicosis. In the New South Wales Court of Appeal, the company argued unsuccessfully that the Dust Diseases Tribunal had erred in admitting the evidence of a chartered chemist and engineer, Dr Basden, as an expert on levels of silica dust. The company was granted special leave to appeal to the High Court. The first basis of the appellant's case was that Dr Basden's evidence was not "wholly or substantially based" on "specialist knowledge based on [his] training, study or experience". The appellant's second argument was that the primary judge had impermissibly placed reliance on his experience as a Judge in a special tribunal to determine the stonemason's silicosis had been caused by exposure to silica dust. 3. In Dasreef Pty Ltd v Hawchar, the plurality emphasised the requirement for an expert's expertise and opinion to conform with the wording of s 79(1) of the Evidence Act 1995 (NSW). Section 79(1) is an exception to the exclusionary rule found in s 76 (1) of that Act. Section 79(1) is drafted in the following terms: If a person has specialised knowledge based on the person's training, study or experience, the opinion rule does not apply to evidence of an opinion of that person that is wholly or substantially based on that knowledge. 1. It will be observed that the core elements of the direction are based on very similar wording to s 79(1). 2. At [37] the plurality in Dasreef Pty. Ltd v Hawchar explained: It should be unnecessary, but it is nonetheless important, to emphasise that what was said by Gleeson CJ in HG (and later by Heydon JA in the Court of Appeal in Makita (Australia) Pty Ltd v Sprowles) is to be read with one basic proposition at the forefront of consideration. The admissibility of opinion evidence is to be determined by application of the requirements of the Evidence Act rather than by any attempt to parse and analyse particular statements in decided cases divorced from the context in which those statements were made. Accepting that to be so, it remains useful to record that it is ordinarily the case, as Heydon JA said in Makita, that "the expert's evidence must explain how the field of 'specialised knowledge' in which the witness is expert by reason of 'training, study or experience', and on which the opinion is 'wholly or substantially based', applies to the facts assumed or observed so as to produce the opinion propounded". The way in which s 79(1) is drafted necessarily makes the description of these requirements very long. But that is not to say that the requirements cannot be met in many, perhaps most, cases very quickly and easily. That a specialist medical practitioner expressing a diagnostic opinion in his or her relevant field of specialisation is applying "specialised knowledge" based on his or her "training, study or experience", being an opinion "wholly or substantially based" on that "specialised knowledge", will require little explicit articulation or amplification once the witness has described his or her qualifications and experience, and has identified the subject matter about which the opinion is proffered. [footnotes omitted] 1. In his Honour's dissenting reasons, albeit not on this point, Heydon J said at [99]: The Full Court of the Federal Court of Australia has rightly rejected the respondent's riposte. So has the Court of Appeal of the Supreme Court of New South Wales: it held that the links between the expert's training, study and experience and the opinion should be spelt out unless they are apparent from the nature of the specialised knowledge. And in this Court, Gleeson CJ, in dealing with an expert whose opinion was not based on specialised knowledge but on "a combination of speculation, inference, personal and second-hand views as to the credibility of the complainant", said: "[I]t is important that the opinions of expert witnesses be confined, in accordance with s 79, to opinions which are wholly or substantially based on their specialised knowledge. Experts who venture 'opinions' (sometimes merely their own inference of fact), outside their field of specialised knowledge may invest those opinions with a spurious appearance of authority, and legitimate processes of fact-finding may be subverted". [footnotes omitted] 1. It is also relevant that we note both the plurality at [18]-[20] and Heydon J at [124] stressed the importance of a trial judge determining, at an early stage in the proceedings, whether an expert's report should or should not be admitted into evidence. A failure to rule on the admissibility of an expert report, particularly in circumstances such as the instant case where the HCCC submits no or very limited weight should be given to Dr Coleman's evidence, can result in unnecessary lengthy cross-examination, or procedural unfairness to the party relying on the report. If the report is not to be admitted, as Heydon J notes, "the tendering party may have lost an opportunity to repair the position before its case closed, either by calling further witnesses…" 2. Both the plurality and Heydon J rejected as impermissible the primary judge's application of experience in a specialist tribunal in determining the stonemason suffered silicosis caused by his workplace conditions. That determination was based on the fact the Evidence Act 1995 (NSW) does apply in the Dust Diseases Tribunal, and the wording of the relevant legislation. 3. In considering the principles enunciated by the High Court in Dasreef Pty Ltd v Hawchar, two important differences in the facts in that matter and these proceedings must be borne in mind. First, as Ms Eastman noted, this Tribunal is not bound to apply the provisions of the Evidence Act 1995 (NSW), and this Tribunal has the benefit, subject to observing the rules of natural justice, of specialist medical practitioners to assess and weigh the evidence before it. 4. As the transcript readily discloses, the HCCC's position in respect of Dr Coleman's qualifications or his specialised knowledge based on his training study or experience was averted to in the opening submissions, but no application was made at that time, or indeed throughout the six days the experts gave concurrent evidence for us to reject the evidence of Dr Coleman on that basis that his evidence did not satisfy the criteria in the procedural direction. While Sch 5D cl 2 gives the Tribunal a discretion as to whether or not evidence should be admitted, the overarching requirement is that proceedings in the Tribunal comply with the rules of natural justice and procedural fairness. We think, in accordance with the comments of the High Court in Dasreef Pty Ltd v Hawchar, if the question of Dr Coleman's specialised knowledge had been subject of an early application and subsequent ruling, any potential prejudice to the practitioner could have been avoided. We note that such a procedure was adopted by this Tribunal in HCCC v Quach [2015] NSWCATOD 2. 5. As presently informed, we distinguish the circumstances of this statutory tribunal exercising its functions under the National Law from those of the Dust Diseases Tribunal. The composition of the Tribunal as proscribed in the National Law is designed to ensure that professional disciplinary proceedings against a practitioner are heard and determined with a panel having the expertise of two suitably qualified medical practitioners nominated by the Medical Council and appointed as occasional members by the President or his delegate. Those practitioners bring to the determination of facts their respective skill, knowledge and experience. Thus, while the Tribunal is regularly assisted by the provision of expert evidence, that evidence may, in certain cases be rejected, in whole or in part, by the Tribunal which can, with due notice, make its own findings of fact on questions such as those confronting this Tribunal for determination. 6. We note that later in her oral submissions, Ms Eastman somewhat modified her submission that we should reject Dr Coleman's evidence in its totality. She accepted he had, by reason of his training and experience, the necessary qualifications to give an expert opinion on the practitioner's record keeping, her failure to conduct clinical examinations, correspondence with referring doctors and treatment of a family member. We agree. We do not, however, accept that Dr Coleman's remaining evidence should be rejected in its totality. In so determining, we have taken into account that the prescribing, either off-label or otherwise, of anabolic steroids/hormones is not limited to endocrinologists, although such specialist expertise in this area is not in doubt. Dr Coleman's evidence is that he does prescribe such drugs, as do many other physicians including those involved in the treatment of HIV patients. Further, he is a specialist with similar qualifications to those of the practitioner and he is knowledgeable about testosterone and other anabolics from his ongoing professional development. Rather than rejecting his evidence, we have assessed the evidence given by each expert in respect of relevant patients, weighed that evidence and reached our conclusions. Orthodox prescribing, off-label prescribing and the relevant Poisons and Therapeutic Goods Regulations 1. Just as the HCCC is critical of Dr Coleman's qualifications and expertise to voice opinions on the prescribing of the named relevant drugs to the named patients, so too is the practitioner in respect of Dr Conway. 2. The criticisms of Dr Conway's evidence are directed to the fact that she is critical of the practitioner's treatment of every patient named in the complaint (practitioner's submissions [130]), and that she rigidly adheres to the principle that treatment should not be instituted except in the case of proven androgen deficiency. 3. The practitioner's submissions note that "in the main, the patient's [sic] treated with testosterone…can be described as having less severe androgen deficiency". 4. At [38] of the practitioner's submissions it is noted: There are two limbs to the test under the Regulations. The first concerns that which is the recognised therapeutic standard; and the second concerns that which is appropriate in the circumstances of each patient. 1. The submissions go on to advance the proposition that "the very wording of the relevant clauses of the Regulations accommodates for differences of opinion with regards to what is the recognised therapeutic standard". It is submitted on behalf of the practitioner that the purpose for which the practitioner was prescribing is a medical purpose. At [40] it is submitted "[t]his was in accordance with the recognised therapeutic standard that a practitioner help a patient as per the Hippocratic oath". 2. Before addressing this divergence in opinions of the experts (and the approach to the Poisons and Therapeutic Goods Regulation), it is important that we recognise the complaint as pleaded encompassed more than prescribing in breach of the Poisons and Therapeutic Goods Regulations in force at the relevant time. There are three aspects to the practitioner's asserted unsatisfactory professional conduct (that her knowledge, skill or judgment possessed or care exercised was significantly below the standard expected of a practitioner of an equivalent level of training or experience; that she engaged in improper and unethical conduct; and that she contravened Regulations). It is only particulars 1 to 5 inclusive which bring into play the Poisons and Therapeutic Goods Regulations and those particulars also contain a second limb namely "and without exercising responsible medical judgment". 3. We note for the purpose of making our findings it is appropriate that we consider whether the practitioner has contravened the relevant regulations based on the civil standard of proof (see Australian Communications and Media Authority v Today FM (Sydney) Pty Ltd [2015] HCA 7). 4. The parties' submissions diverge on what constitutes the recognised therapeutic standard. The HCCC relies on the MIMS prescribing criteria as the recognised therapeutic standard. On a strict reading of the regulation it is hard to argue with that proposition, as the MIMS criteria are the therapeutic standard recognised Australia wide. The regulation does not refer to "a" recognised therapeutic standard or standards. But we do not think the words "the recognised therapeutic standard" can be read in isolation from what follows, namely "of what is considered appropriate in the circumstance". 5. There can be no doubt that the MIMS criteria do set out the recognised therapeutic standard for each of the relevant drugs prescribed "on-label" (that is, for their approved use by the TGA). But many drugs, including many prescribed for paediatric use, are prescribed "off-label", to a standard recognised generally as appropriate by the profession. So too we accept, in appropriate clinical circumstances and with proper examination and investigation, off-label prescribing may be appropriate if an informed and trained minority cohort of practitioners support the practice for a particular condition or a particular set of conditions. In this regard we are guided by the discussion by Kirby P (as his Honour then was) in Don Nai Hsi Huang v Walton (Court of Appeal (NSW), 30 April 1993, unrep). His Honour said: The conduct of a medical practitioner does not, within s27(1)(a) of the Act, demonstrate a lack of adequate knowledge, experience, skill, judgment or care in the practice of medicine, simply because a course of therapy is embarked upon which does not conform to a given professional norm. So long as the practitioner is acting lawfully and conscientiously and is pursuing, in the treatment of his or her patient, a "respectable, though minority, view" in such treatment, no misconduct exists as will attract discipline under the law [citations omitted] In Childs v Walton, as the Tribunal itself noted, Samuels JA said at 10): A departure from a generally accepted procedure does not necessarily constitute professional misconduct. There may be different schools of medicine and disputes between them. Adherence to the practice of a minority group does not alone entail professional misconduct 'Every innovation has to be performed for a first time. That something has not been done is not proof that it ought not to be done' (per Hutley in Qidwai at 1010). 1. In regard to the appropriateness or otherwise of the practitioner's prescribing of hormone treatments, we note, as indicated by Dr Conway, that virtually non of the prescribing indications are supported by long term randomised clinical trials of efficacy or safety, or by prescribing guidelines from national or international endocrine societies. However, there is, as documented in the references submitted on behalf of the practitioner, some short term clinical evidence for benefits, including weight and fat reduction, muscle gain, tissue repair and increased libido and sexual function with androgens, in males who do not meet clear criteria of HGH or testosterone deficiency; this could provide some rationale for an 'off-label' trial in some patients. Amongst the references submitted (and highlighted by Mr Greenwood) we gave particular weight of an editorial by Prof P Sonksen (J. Clin. Endocrinol. Metab 2013,98: 2270-73). Professor Sonksen is an acknowledged international expert in HGH therapy, who argues that prescribing outside accepted guidelines may be justifiable (for HGH) as a "trial of one" when "anthropometric, functional, psychological and biochemical baseline information" is obtained and there is careful "monitoring of measured variables, looking for benefit objectively". 2. As we later discuss when considering the topic of unsatisfactory professional conduct and professional misconduct, the lack of adequate baseline information (particularly physical examination) and very poor documentation of measurable response parameters, as well as simultaneous introduction of two or more hormone therapies (clouding interpretations of benefit of each) and sometimes excessive doses of androgens make it difficult to find the practitioner's off-label prescribing as conforming to acceptable medical practice. We also consider that off-label prescribing as a "trial" would place more importance than usual on adequate communication with the referring or other involved practitioners, which was generally absent. 3. In reaching our discrete findings in respect of each patient and the relevant drugs prescribed, we have considered and weighed all evidence before reaching a conclusion that the particular is proved including, where relevant, consideration of whether the prescribing was contrary to "the therapeutic standard of what is considered appropriate in the circumstance" and without exercising responsible medical judgment. The patients Patient A 1. Patient A was, at the time period specified in the complaint, a 42 year old married woman and the mother of two children. She was referred to the practitioner by a cosmetic surgeon, prior to planned liposuction. She was only seen by the practitioner on three occasions, after which she discontinued any treatment by the practitioner. 2. Patient A had gained weight after the birth of her two children. The children were aged 12 and 9 at the date of first consultation. Patient A suffered gestational diabetes during her second pregnancy. She weighed 75 kg and reported exercising regularly, but that she had a problem with meal portion sizes. Patient A reported she had gained 6kg after a surgical procedure in the past year. 3. The practitioner ordered blood tests, and prescribed HGH. She also prescribed Vitamin D to address the patient's Vitamin D deficiency. 4. The complaint contains five particulars in respect of Patient A. They may be summarised as follows: 1. Inappropriately prescribing HGH (particular 3); 2. Prescribing HGH inappropriately when Patient A had a history of gestational diabetes (particular 6 a); 3. Failing to conduct adequate investigations prior to prescribing medication (particular 9); 4. Failing to send a report to the referring practitioner (particular 22); and 5. Failing to maintained proper clinical records (particular 24). 1. It is not in dispute that the practitioner did not conduct a physical examination of Patient A. Further, the practitioner acknowledged that Patient A's blood tests did not reveal she was deficient in HGH according to "accepted tests". She agreed in cross-examination that the sole purpose of prescribing of HGH was to address Patient A's weight gain. 2. Patient A's blood results disclosed a normal IGF1 and IGF BP 3. 3. The HCCC submits in our consideration of the practitioner's treatment of this patient we should take into account that the reason for Patient A's presentation was weight loss of visceral fat which would not be removed by liposuction. It her submissions, Ms Eastman notes the practitioner's records do not disclose that she weighed the patient. Further, she notes in cross-examination the practitioner conceded she did not take the patient's body mass index. The evidence including relevant expert evidence 1. Dr Conway's opinion in respect of the practitioner's treatment of this patient is that it is significantly below the standard expected of a practitioner of equivalent experience and expertise. Her principal criticism of the practitioner's treatment of this patient is the prescribing of HGH for which she opines there was no indication. She is also critical of the practitioner's failure to keep proper clinical records. 2. Dr Coleman, while not criticising the practitioner's prescribing of HGH for Patient A, records in his report: While I understand the use of growth hormone for weight loss is a treatment modality used elsewhere, it is not a treatment modality that I personally chose to use, although there is good scientific evidence for its use under these circumstances. 1. Dr Coleman also refers in his report to Patient A's history of gestational diabetes which he described as "a cautionary note", but he goes on to record that prior to the practitioner prescribing HGH for Patient A, she was aware that her insulin levels were within the normal range and suggested the patient was not a diabetic. Discussion 1. Given the practitioner's concessions about her clinical record keeping during the period of the complaint, it is unnecessary we discuss this particular in respect of this patient and the other patients of the practitioner in any depth. For the most part, the practitioner's records are scant, although we accept that the practitioner did require her patients to complete a questionnaire prior to the first consultation. The records were inadequate for another practitioner to take over the treatment of the patient. They did not comply with the relevant regulation, a fact acknowledged by Mr Greenwood in his submissions. Although Patient A's records contain slightly more detail than some other patients, the records are inadequate. We are satisfied that particular 24 is established in respect of Patient A. 2. We are also satisfied that particular 22 is established, as it is not in dispute that the practitioner did not report to the referring cosmetic surgeon her asserted trialling of HGH with diet and exercise for weight loss. Conclusions Patient A 1. The nub of the complaint about this patient centres on particulars 3 and 5. While Dr Conway gives some support to it being contra-indicated to prescribe for this patient because of a history of gestational diabetes, we are not satisfied this particular is established. We accept Dr Coleman's evidence that the practitioner did obtain appropriate blood tests which did not disclose any abnormality in the patient's glucose or insulin levels such that, if otherwise proper, the prescribing of HGH was contraindicated. We are not satisfied that particular 6 is established. 2. However, we are unable to accept Dr Coleman's tacit acceptance of the practitioner's prescribing for this patient. We accept and prefer the evidence of Dr Conway, based as it was on the fact that the patient had normal IGF levels that the prescribing of HGH for this patient demonstrated a lack of proper clinical judgment. We are satisfied that particular 3 is established. Patient B 1. Patient B is a male who was aged 34 years when first seen by the practitioner in 2006 (outside the complaint period). He was referred to the practitioner by a Dr Dick Quan. In his referring letter Dr Quan said: Thank you for seeing [Patient B] who has had previous AAS. He would like to discuss with you the use of HGH and be monitored when he uses it. I am happy to monitor bloods for him if you find him appropriate for its use. 1. In her clinical notes of her first consultation with this patient the practitioner noted that he was a boxer, did weights and swimming (but not professionally). She also recorded he had "used Stanazole years ago under a doctor's supervision". She recorded a history of low energy, low concentration, low libido, high stress job and weight "an issue". In her treatment plan the practitioner noted "GH 12 IU weekly, Primoteston 3 weekly, bloods" and that the patient was to be reviewed in three weeks. 2. The complaint asserts eight particulars in respect of this patient during the relevant period. They are inappropriately prescribing Arimidix (particular 1), HGH (Particular 3) and Testosterone (particular 5). 3. The particulars also include failure to conduct adequate investigations prior to prescribing (Particular 9) and prescribing when the patient had a history of abusing anabolic steroids (Particular 16). 4. The particulars pleaded further include particulars 22 and 24 which we have discussed in respect of Patient A. We make similar findings in respect of these two particulars for Patient B. 5. In the submissions in reply of the HCCC it is noted that prior to the period of the complaint the practitioner had prescribed two testosterones (Primotestin and Sustanon) to this patient. The practitioner has conceded the simultaneous prescriptions of testosterone for her patients was inappropriate. As a result of the patient's use of the two testosterones, he was then prescribed Arimidix. The HCCC submits, having regard to Dr Conway's evidence, we should accept the sole purpose for prescribing Arimidix is to counter the effect of other drugs prescribed for Patient B. 6. The HCCC further submits the referring doctor's letter in 2006 put the practitioner on notice that the patient had a history of anabolic steroid abuse by reference to "AAS", and that she failed to conduct any investigations prior to prescribing for the patient. The submissions also assert we should find, although the practitioner had obtained blood tests in 2006 which disclosed the patient had an IGF 1 level in a range of 14-48, she failed to conduct provocative testing in the complaint period prior to prescribing HGH. It is further asserted in respect of the prescribing of testosterone that we should find "the patient wanted to use testosterone and the practitioner was willing to comply with his request". 7. In the closing written submissions provided on behalf of the practitioner it is submitted that the practitioner's treatment of this patient was to address his reported symptoms, and although he was receiving testosterone at a high level he was being monitored on a fortnightly basis. 8. We note the submission on behalf of the practitioner at [182] is inconsistent with the evidence given by the practitioner in her oral evidence in response to a question posed by Professor Chisholm. The evidence including relevant expert evidence 1. Dr Conway is very critical of the practitioner's conduct in respect of this patient. Although Dr Coleman notes that the patient reported receiving a benefit when on treatment, and he referred to the practitioner's prescribing as "a trial" and "reasonable", we find those conclusions inconsistent with other parts of his evidence. The evidence indicate that, as a consequence of the practitioner's prescribing of HGH and testosterone when Patient B's oestrogen levels were elevated, it was necessary for the patient to be put on Arimidex, and that he developed testicular atrophy requiring treatment with Pregnyl. Conclusions Patient B 1. We are conscious that in Ex 13 the practitioner conceded that her prescribing relied substantially on patient's reports to her, and that she did not "go behind" the patient's reports. We also note that Dr Coleman's report and the opinion he expressed about Patient B, pre-dated the practitioner's concessions in Ex 13 and in her oral evidence. 2. Noting the practitioner's own concession that her simultaneous prescribing of testosterones to avoid patient's suffering what she referred to as a "crash" was inappropriate, and we would say experimental, we are satisfied that particular 8 is established. We also, having examined the practitioner's records in respect of this patient, find particulars 22 and 24 are established. 3. We reject in these circumstances Dr Coleman's evidence that the prescribing as "reasonable", nor do we find given the period of prescribing, that it constituted a "trial". We are satisfied that the referring letter to the practitioner squarely put her on notice that this relatively young man had a history of anabolic steroid abuse. In accordance with Dr Reid's advice and the PSB Guideline, the practitioner should have not accepted this patient's claims at face value during the complaint period, and exercised caution before considering supplying him with the prescribed drugs. We are satisfied that particulars 9 and 16 are established. 4. We accept and prefer Dr Conway's evidence in respect of the prescribing of Arimidex, and HGH to that of Dr Coleman. We are satisfied her prescribing history for Patient B was inappropriate. We are satisfied particulars 1, 3 and 5 are established. 5. In summary, we are satisfied, accepting as we do Dr Conway's evidence in respect of this patient, that the practitioner's conduct demonstrated a lack of clinical judgment and skill which was significantly below the standard of a practitioner of equivalent qualifications and experience. Patient C 1. Patient C is a man who has a HIV diagnosis. At first presentation to the practitioner he was aged 33. Patient C is asserted to have complained of an inability to maintain muscle mass. 2. The HCCC relies on six particulars in respect of Patient C. They may be summarised as inappropriate prescribing of Deca-Durabolin (particular 4) and Testosterone. The particulars also assert failing to report to the patient's general practitioner (particular 22) and failure to keep proper clinical records (particular 24). This particular is conceded by the practitioner to be proven. 3. The complaint further asserts Patient C was prescribed excessive doses of testosterone (particular 8) and that the practitioner failed to conduct appropriate investigations when prescribing for the patient not having seen him for a period of slightly less than two years (particular 9). We note he was first seen by the practitioner in 2005 when she ordered blood tests, but he was not seen in the period October 2005 and July 2007. Patient C saw the practitioner intermittently in 2008 ceasing use of Deca-Durabolin sometime after April that year but recommenced treatment in 2008. 4. Dr Coleman's report refers to pathology reports obtained in the period outside the complaint. He opines: It is well recognised in the medical literature that testosterone and growth hormone including adrenal hormones (DHEA), help to maintain weight and vigour in HIV positive patients. 1. In Mr Greenwood's written submissions it is noted, by reference to a paper published in the publication HIV Clinical Trials (2010) 11(4) 220-229 (Ex 7.87) that Deca-Durabolin provides positive benefits in maintaining muscle mass for HIV patients taking anti-retrovirals. 2. At [199] of Mr Greenwood's submissions it is submitted in respect of the practitioner's prescribing of testosterone that, when the patient returned to see her in February 2008, blood tests revealed he had a high total testosterone but "also a high sex hormone binding globulin count." The submissions then refer the practitioner's use of a "nomogram" to plot the results which the practitioner calculated to indicate a "mid-normal" result. This tool, together with patient's self report of symptoms (and benefits) she used as a basis for her prescribing. 3. Neither expert was able to comment on the source of handwriting on the nomogram which showed "deficient", "mid-normal" and "borderline". We refer to our earlier recording of the practitioner's oral evidence that the handwritten terms on the nomogram had been inserted on the handout provided at the conference. 4. It is also relevant at this point to better understand the issue of total testosterone that we refer to the following questions posed by Ms Eastman and answered by Dr Coleman (transcript 25 November 2014 p 148): MS EASTMAN: I'm looking at this document, it's described as, "nomogram for calculating free testosterone from total testosterone (TT) and sex hormone binding globulin (SHBP)". SHBH hasn't been the subject of discussion thus far, so before we look at the nomogram, could you explain for the benefit of the Tribunal, probably more likely the lawyers in the room, SHBG and its relevance to testing free testosterone and total testosterone? WITNESS CONWAY: SHBG is sex hormone binding globulin which is present in both males and females and is a transport protein produced by the liver which is – transports testosterone and oestradiol in the circulation. Testosterone is bound both to SHBG and to albumin, and if you get very abnormal SHBG levels it can influence the total testosterone estimation because your're measuring total testosterone. For example, if the SHBG is particularly high, then the total testosterone may appear artificially high; if the SHGB is very low, the total testosterone may measure lower. The relevance, if the level is normal really it's a matter of checking that it's normal and therefore you can say that the total testosterone estimation is likely to be reliable. 1. Ms Eastman then asked Dr Conway to explain the relevance of calculating free testosterone. Dr Conway explained: The free testosterone is the unbound testosterone, and the argument for measuring free testosterone levels is that that is somehow more biologically available and therefore a more accurate reflection of androgenic status than measuring total testosterone, that's not well substantiated, and the anti-ageing proponents have very strongly pushed the idea that there is an advantage in measuring free over total testosterone. Unfortunately …the assays not available for measuring it accurately and therefore these formulae have been developed. …There are no studies … showing men who have that sort of free testosterone benefit from testosterone treatment The studies show – have been based on total testosterone measurements. (transcript 25 November 2014 p 140). 1. Dr Coleman opined that, based on his education, that free testosterone "is important in the whole clinical decision making process". However, he said, "it's not an absolute measure you know". He further explained "I think it's important, but its one - just one of many measures that we use along with symptoms, along with total testosterone and I do believe it's important". 2. The submission concedes that when Patient C consulted the practitioner in April 2008 she prescribed high doses of testosterone and Deca-Durabolin. It is also conceded her notes are deficient in that they do not explain the rationale for these prescriptions. Although the submissions appear to defend the practitioner's dual prescribing of androgens that appears to be inconsistent with the general concession made by the practitioner in her oral evidence. It is noteworthy that both in the submissions and in her oral evidence the practitioner concedes she no longer adopts such a practice. 3. The practitioner does not dispute she did not inform Patient C's treating specialists of her prescribing. She also accepts that when Patient C returned to see her after a gap of almost two years she did not conduct any further clinical examinations "and to that extent the complaint is proven". Conclusions Patient C 1. We accept that peer reviewed literature does support the prescribing, in appropriate circumstances and with proper clinical evaluation, of Deca-Durabolin for some HIV patients on anti-retrovirals. 2. We are not satisfied to the requisite civil standard that the HCCC has proved particular 4. In so finding we accept the evidence of the studies of HIV patients, and Dr Coleman's explanation that it was not unreasonable to take into account the patient's reported well-being following this treatment. 3. The prescribing of testosterone raises different issues which are inextricably linked with the practitioner's acknowledged failure to obtain a further appropriate clinical history when this patient represented after an absence of almost two years. Dr Coleman did not support the prescribing without a physical examination to see if the patient had small testes (transcript 26 November 2014 p 206). We note the practitioner's concessions in respect of particulars 8 and 9. We are satisfied in those circumstances it was not appropriate to prescribe testosterone, particularly when the practitioner prescribed two androgens resulting in a high weekly dose. Accordingly we are satisfied particular 5 is established. 4. The practitioner did not concede particular 22 in respect of this patient noting he was not referred to her by a general practitioner. She however candidly conceded that she should have communicated her prescribing to Patient C's treating HIV specialist or clinic. We agree the patient's proper care made it most important that those treating him at the HIV clinic were aware of what the practitioner was prescribing. But that is not how the particular is pleaded. This particular in respect of Patient C is not established. Patient D 1. Patient D was aged 51 years at the time of his first consultation with the practitioner. His presenting history included a recent weight gain of 20kgs in four months and decreased sexual function. He also reported hypertension, and coronary heart disease for which he had stents inserted in 2003. 2. There are six particulars set out in the complaint in respect of this patient. It is asserted the practitioner inappropriately prescribed Arimidex (particular 1), HGH (particular 3) and testosterone (particular 5). It is also asserted the practitioner failed to conduct adequate investigations prior to prescribing for Patient D (particular 9), failed to report to the referring doctor (particular 22) and failed to keep proper medical records (particular 9). 3. In the submissions filed on behalf of the practitioner, it is conceded that she failed to report to the referring doctor. In respect of the clinical records complaint it is submitted on behalf of the practitioner at [222] of the written submissions in respect of this patient and a number of other patients: An adequate history is recorded.. [the practitioner] accepts that her record of clinical judgment could have been clearer. Drugs and doses during the complaint period did not adhere to the Regulations on every occasion in which she prescribed. The complaint is proven in respect of these two matters. 1. In the HCCC's submissions it is asserted that the prescribing of Arimidex was not appropriate. The submissions (Part 2 [46]) note "[t]he only apparent purpose for prescribing Arimidex was to prevent possible effects of other treatment". 2. On behalf of the practitioner it is asserted the patient had a low level of IGF-1 and IGFBP3 and this justified a trial of a low dose of HGH. It is further asserted that the patient recorded a low level of testosterone and that results plotted on a nomogram "revealed testosterone deficiency". 3. The practitioner acknowledges in her submissions that the patient had sleep apnoea and was using a CPAP machine, but that the practitioner was not treating this condition. 4. Dr Conway gave evidence that patients with sleep apnoea tend to have slightly lower testosterone levels and when treated for the sleep apnoea testosterone levels increase. She opined that the patient should have been managed by first treating his sleep apnoea rather than being prescribed testosterone. Dr Coleman agreed with this proposition (transcript 26 November 2014 p 213). However, he did in his report in respect of this patient, and in respect of the practitioner's prescribing for a number of the other patients named in the complaint, assert there was some justification for her prescribing. His opinion is exemplified in his oral evidence about this patient when the following evidence was given: MS EASTMAN: Dr Coleman, when you prepared your report at line 346 through to 360, you refer to the International Hormone Society consensus group and that extract appears to reflect the document that we looked at yesterday being consensus 5 which is in exhibit 7.1 at page 5. Do you still rely on the consensus statement to support these contentions? WITNESS COLEMAN: They're part of my thinking. I think if you have experts in this area getting together and saying look, we think that giving the evidence that if we are treating men or women who are on the lower end of normal, all the evidence supports an increase in wellbeing over the long haul. I think experts' opinions are useful but we have to acknowledge that they're definitely not always right and I think the issue really is the last sentence, "And it should be restricted to physiological doses and it should be accompanied by careful and regular follow ups". This is not about bodybuilding, this is not about increasing athletic performance. This is about optimising wellbeing, optimising body function, decreasing the risks that we all face in this modern age of obesity, diabetes, cardiovascular disease and cancer and it's important that we recognise I think that these issues are worth debating and I don't think you know, as with testosterone in men in cardiovascular disease, we have the answer and I think we all have to take a precautionary stand on this. 1. While Dr Conway referred to the "jury still being out" as to whether or not testosterone supplementation can assist patients such as Patient D who suffer symptoms consistent with androgen deficiency and whose blood results demonstrate a borderline testosterone level. But she strongly expressed the view that the prescribing of HGH for this patient was not appropriate. 2. After the experts had concluded their evidence we were provided with a statement of the US Food and Drug Administration (FDA) to the effect that while there is evidence which contraindicates the prescribing of anabolic steroids for patients with cardiovascular disease, that evidence is not of such a conclusive nature that a warning should be prescribed for such drugs. 3. Both experts agreed that the practitioner had acted appropriately in ceasing to prescribe HGH when the patient's blood sugar levels became elevated. 4. Dr Conway opined it was inappropriate to give IM injections to a patient such as Patient D on anti-platelet drugs. She later modified this evidence as relevant only to patients on Warfarin. Dr Coleman found the practitioner's use of a fine needle, and application of pressure when injecting Patient D appropriate. However, Dr Coleman's own practise is not to use IM injections but rather testosterone patches when he prescribes testosterone. Patient D – conclusions 1. We found Dr Conway's evidence that prescribing Arimidex was only necessary because of the other drugs prescribed compelling. We are satisfied that the appropriate treatment regime for the patient was the proper investigation and treatment of his sleep apnoea prior to commencement of either HGH or testosterone. We are satisfied that particulars 1, 3 and 5 are established and we agree with Dr Conway that the practitioner's conduct in this respect fell significantly below the standard of a practitioner of a similar level of experience and expertise. 2. As noted above the practitioner has conceded she failed to carry out a physical examination of this patient with complex medical problems although she obtained blood tests, and recorded his height, and weight. Overall we are satisfied that a lack of physical examination prior to prescribing was a serious deficit in the practitioner's conduct. Particular 9 is established on this basis. 3. In summary we find each of the particulars (1,3,5,9,22 and 24) in respect of this patient are proven. Patient H 1. Patient H is the practitioner's deceased partner and her former practice manager. The particulars in respect of Patient H focus, not only on the practitioner's prescribing practices, and lack of reporting to his general practitioner, but significantly deal with her treatment of her partner, a close family member. 2. It is asserted that the practitioner inappropriately prescribed Arimidex (particular 1), Deca-Durabolin (particular 4) and testosterone (particular 5). It is further asserted that practitioner failed to conduct proper investigations before prescribing (particular 9), failed to report to the patient's treating general practitioner (particular 22), and acted contrary to the Medical Board's policy in force at the relevant time in treatment her partner (particular 23). Particulars 22 and 23 – evidence and discussion 1. It is convenient that we deal with particulars 22 and 23 before turning to the general prescribing complaints. 2. We record at the outset that the practitioner gave oral evidence that, while she did not formally write to Patient H's general practitioner, she did accompanying him to many of his consultations with his general practitioner and discuss his treatment. This evidence is in contrast to the practitioner's own summary of her treatment in Schedule B to her statement. There she stated "When [the practitioner] treated [Patient H] she was aware that [Patient H] had discussed with his general practitioner, the issues and proposed treatment with his general practitioner". 3. We accept that the relatively recent death of Patient H, and the stress of these lengthy proceedings have placed a significant emotional burden on the practitioner. 4. While a significant amount of material, including testimonials, was adduced by the practitioner, she did not adduce any evidence from Patient H's general practitioner. However, we are cognisant it is the HCCC who carries the burden of proving the particulars of the complaint. 5. We further take into account that while, in many instances, we have rejected the practitioner's rationale for treatment of her patients explained in her oral evidence, we generally found the practitioner to be candid and honest in her evidence to the Tribunal. We had no hesitation in accepting the practitioner was genuine when she expressed her gratitude to the Medical Council for enabling her to continue to practice albeit with conditions. We also accept her evidence that many aspects of her practice of medicine have altered since the s 66 proceedings. 6. Although there are contradictions in the practitioner's statement in Schedule B and her oral evidence, we accept that she did accompany Patient H to visit his general practitioner from time to time. While we accept she did not report her treatment of her partner to his general practitioner, we accept her evidence that the general practitioner knew by reason of oral reports from the practitioner, at least in general terms, of her prescribing. 7. Particular 22 is framed in the following language: On various dates …the practitioner failed to provide reports to the referring practitioner during her treatment. Conclusions – particular 22 1. First, we accept that Patient H's clinical records demonstrate that an ongoing and indefinite referral from the patient's general practitioner was obtained on 23 April 2008, but his file contains no reporting to that general practitioner. Nor, when she referred the patient to Mater Imaging, after two episodes of ankle sprain and swelling, is there any evidence a copy of the report was sent to the general practitioner. However, there is evidence, which we have accepted, that oral discussions of Patient H's treatment occurred in consultations between him and his general practitioner at which the practitioner was present. 2. It would have been preferable if the practitioner, knowing her partner's care was managed and supervised by his general practitioner, to report her treatment in writing so that the general practitioner was fully and accurately informed about her patient's treatment. The practitioner concedes the particular is proved. We too are satisfied that Particular 22 is established to the requisite standard. Particular 23 – evidence and discussion 1. No separate expert evidence was relied on by the HCCC in support of this particular. The practitioner relied on the expert report of Associate Professor McBride. Associate Professor McBride gave brief oral evidence to the Tribunal by telephone. 2. Associate Professor McBride's written report is brief. She was provided with Patient H's medical records and the practitioner's treatment summary for her partner and the Medical Board's policy addressed to practitioners treating themselves or immediate family members. 3. Associate Professor McBride in her report, under the heading "History", recorded that the practitioner provided "medical care" to her partner between 2007 and 2009 and that she "kept a medical record of these occurrences". She also noted "I note some of these occurrences were for acute injury or illness". She recorded that Patient H also consulted a general practitioner. 4. Associate Professor McBride did not comment on whether it was appropriate for the practitioner to prescribe anabolic steroids for her partner, or the duration of her prescribing. She opined that she "reserved mild criticism for [the practitioner] as she was not in contact with [Patient H's] general practitioner about the medical care provided". 5. The expert's report sets out [2.4] the Medical Board policy noting that this policy remained unchanged in the Medical Council of NSW's policy. It is as follow: It is not advisable for medical practitioners to serve as primary care or regular care providers for immediate family members, although there are circumstances in which they may work together with an independent medical practitioner to maintain established treatment. Discussion 1. Associate Professor McBride had not seen a copy of the complaint, and in her oral evidence she limited her answers to matters discussed in her brief report. In these circumstances we were unable to give any significant weight to her evidence. 2. In Re Dr Vitols (NSW Medical Tribunal 4 May 2010) the Tribunal said: Good medical practice dictates that doctors keep an appropriate professional distance from the patients they treat. Save in emergencies, doctors of good standing do not treat members of their immediate families or their friends or their friend's children. A significant reason for that is the need for a medical practitioner to be and remain objective. Without objectivity the practitioner may lack the ability to give appropriate advice and render the right treatment. 1. The submissions in respect of this particular provided by on behalf of the practitioner are wide ranging. It is asserted, amongst other matters, that the practitioner had experience in prescribing Deca-Durabolin with good effect for musclo-skeletal injuries an experience not shared by other medical practitioners, and that Patient H was an intelligent man, who by reason of his work in the practice, was fully aware of the treatment. It is further pointed out that the practitioner did refer Patient H to other practitioners. The submissions at [240] are as follows: [t]he practitioner] treated [Patient H] like her other patients. She heard his complaints, assessed his blood results and recommended a trial to see the benefits. She then monitored his progress. And as Dr Coleman commented, [the practitioner] was best placed to observe [Patient H's] symptomology, particularly with respect to libido, cognitive function, depression and a lack of motivation and similarly notice any change whilst on treatment. Discussion and conclusions 1. We are unable to accept the submissions made on behalf of the practitioner as justifying her treatment and ongoing treatment of her partner. In rejecting the submissions we are satisfied there is merit in the matters advanced by the HCCC in support of this particular namely: 1. Patient H was a patient with complex health problems; 2. the patient's overall care was being managed by his general practitioner. The general practitioner did not refer Patient H to the practitioner for specialised treatment; 3. the treatment provided was ongoing and was not rendered in an emergency situation or in a situation where the patient could not access care by another medical practitioner; 4. it was non standard medical treatment; and 5. the close intimate personal relationship between the practitioner and Patient H was likely to have clouded the practitioner's ability to provide a balanced, objective view of his symptoms and appropriate treatment for them. 1. The application of the Policy does not impose an absolute bar on a practitioner treating a close family member. However, in the circumstances we have found above, we are satisfied this was not one of the routine or emergency matters where it is permissible for a practitioner to treat a family member. We are satisfied that this particular is established to the requisite civil standard. Particulars 1, 4 5 and 9 – discussions and evidence 1. The HCCC relies on Dr Conway's evidence that the prescription of Arimidex for Patient H was solely as a result of his oestradiol levels becoming elevated as a result of the practitioner's prescribing of testosterone for this patient. As a result of the somewhat artificial manner in which particular drugs are dealt with in isolation in specific particulars, it is difficult to divorce discussion of the prescription of testosterone from the prescribing of Arimidex. It follows if the prescribing of testosterone was clinically appropriate there may well have been justification for the short term prescription of Arimidex. Thus we defer our conclusions in respect of this particular until we consider particular 5. 2. The practitioner prescribed Deca-Durabolin to treat Patient H's sprained ankle. 3. Dr Conway agreed (transcript 1 December 2014 p 489) that while she had in her report criticised the practitioner's prescribing of Deca-Durabolin for her partner, she made a limited concession in respect of this drug, but not testosterone, as follows: PRINCIPAL MEMBER: May I suggest to you doctor that you might like to refer first to those parts of your report where you deal with this. WITNESS CONWAY: I have it in front of me, your Honour, and what I said was that Dr McBride commented on Dr Epstein's treatment of a partner, she refers to principle 2.2 which she believes Dr Epstein has not breached, which it is not advisable for medical practitioners to serve as primary or regular providers et cetera although there are circumstances in which they may work as an independent medical practitioner to maintain established treatment, and I comment that she doesn't refer to principle 2.2, it's not advisable for medical practitioners to initiate treatment, including prescribing for themselves or immediate family members. And I made the comment that, and I'm afraid we're all guilty of occasionally writing an antibiotic prescription for a partner, much as that might be inadvisable, I'm afraid we all do do it, and I made the comment that even if short term treatment for musculoskeletal injury was appropriate, which I personally don't think it was, but then chronic treatment with testosterone really I'm quite clear in my mind breaches that principle of ongoing treatment or continuing treatment for family members, for the very good reasons outlined in 1 with the background to that Act where objectivity is absolutely impossible in that setting. 1. Dr Coleman was firm in his support of the practitioner's short term prescribing of Deca-Durabolin for Patient H's sprained ankle by reference to a number of clinical studies. In this instance, we accept and prefer his evidence to that in Dr Conway's report. In short, we are not satisfied to the requisite standard that the practitioner's limited prescribing of Deca-Durabolin was clinically unsound. While other practitioners may have treated this injury, at least at first instance, conservatively with ice, strapping and rest, there was some clinical justification for the treatment provided. In so finding, we are cognisant that the practitioner had the benefit of a radiological report from Mater Imaging which disclosed Patient H had suffered a torn ligament. 2. It is convenient that we now turn to the question of the practitioner's prescribing of testosterone for her partner. It is only necessary we address particulars 5 and 9 briefly. Dr Coleman candidly explained he was unable to discern the clinical rationale which guided the practitioner in her treatment of this patient. He substantially relied heavily on Schedule B to the practitioner's statement, namely her subjective view to support her prescribing. 3. Our examination of the clinical notes reveals their brevity. We accept and prefer the evidence of Dr Conway. We are satisfied that the practitioner, during the relevant period, relied on the patient's subjective reporting to support her prescribing of testosterone with "low borderline´ testosterone based on his blood results using a nomogram. We further accept her evidence in respect of the prescribing of Arimidex Conclusions particulars 1, 4, 5 and 9 1. In summary, we are satisfied, for the reasons enunciated above that Particulars1, 5 and 9 are established. As earlier explained, we are not satisfied Particular 4 is established. Patient I 1. The HCCC agitates six particulars in the complaint with reference to this patient. The practitioner has conceded that she failed to report to the practitioner's referring practitioner and particular 22 is conceded. We accept that concession is appropriately made. The practitioner also concedes, in part, that she failed to keep proper records although it is noted that she recorded a clinical history at the first consultation and recorded some drugs and doses prescribed in the clinical records. We are independently satisfied from our examination of the clinical records that they do not comply in all respects with the regulations during the period of the complaint. We are satisfied particular 24 is established. 2. The remaining contentious particulars relate to inappropriate prescribing of Arimidex, HGH and testosterone. 3. Patient I was aged 49 years at his first consultation with the practitioner. His employment is as a security consultant. He noted on the questionnaire provided to the practitioner that he had been referred to her by a colleague at the gym. He described his current medications as DEAH [semble DHEA] 25mg x 2 daily, and under the heading vitamins, health supplements etc he recorded "everything". He noted his current health problems as "injuries, fatigue, stress". At her initial consultation the practitioner noted the patient reported "high libido", "but no testosterone". He was noted in a report dated 24 May 2004 from the Prince of Wales Hospital to have genetic haemochromatosis. The practitioner continued to treat this patient after the complaint period. 4. As with Patient H, the practitioner has conceded her failure to report to the patient's general practitioner, and also made similar concessions in respect of particulars 9 and 24, although not conceding these particulars in their entirety. 5. We repeat our findings in respect of Patient H for particulars 22, and 24. We accept that the practitioner's records in respect of this patient include the patient questionnaire, and there is a record of her clinical judgment at places in the notes. Given the practitioner's concessions, including particularly her failure to conduct a full physical examination prior to prescribing, we find Particular 9 is established in part. 6. This patient presented with a complex medical history and had seen many practitioners. He reported benefits from the prescribing regime of the practitioner, and provided a testimonial which was tendered before us. 7. In both her report and her oral evidence Dr Conway opined that this patient, by reason of his diagnosis of hemochromatosis, could suffer from secondary hypogonadism (androgen deficiency) because of non treatment. But she noted that his testosterone level was not "particularly low" (transcript 26 November 2014 p 224). Furthermore, in her schedule to her report Dr Conway records the absence of examination of the patient's testes, makes androgen deficiency difficult to establish as a diagnosis. However, in respect of the dosages prescribed Dr Conway opined "testosterone dose appears appropriate for patient with androgen deficiency". She did not support, for reasons earlier discussed, the prescribing of Arimidex. Nor did she approve of the practitioner's prescribing HGH. She concluded her report noting: Testosterone possibly indicated but as far as general management [the practitioner's] practice is significantly below the standards reasonably expected of a practitioner with equivalent training and invites my strong criticism. Discussion and conclusions – particulars 1, 3 and 5. 1. Given the views of both Dr Conway and Dr Coleman in respect of the practitioner's prescribing of testosterone for Patient I we are not satisfied that particular 5 is established. Having made this finding, it follows that our general finding about the inappropriate prescribing of Arimidex in the case of patients earlier discussed cannot be maintained. We are not satisfied that particular 1 is established in the case of Patient I. 2. Dr Coleman's support for the practitioner's prescribing of HGH is confined to the patient's subjective reporting of improvement of knee and shoulder injuries. 3. The evidence before us in respect of particular 3 is difficult to assess. Dr Conway notes that the dosages prescribed were not excessive, and that the duration of the treatment was probably appropriate. As we perceive it the thrust of Dr Conway's criticism of the practitioner's prescribing HGH is that it is expensive but she notes some endocrinologists "do prescribe HGH to some GH deficient patients who feel the benefit outweighs the significant costs involved". She, rightly, however adds a cautionary note "There is a significant black market use of HGH by body builders and athletes. This is not supported by clinical evidence and is not an accepted practice". We are not satisfied this particular is established. Patient J 1. Patient J is the other female patient named in the complaint. She was aged 67 years when first seen by the practitioner. The practitioner noted in Schedule B that the patient's presenting symptoms were low weight, less energy and a long history of anorexia. She was also being treated for osteoporosis. 2. The practitioner prescribed HGH and DHEA for this patient. Her stated rationale for prescribing was "to improve mood, self-confidence, energy levels, and lethargy". 3. The HCCC agitates four complaints in respect of Patient J. The practitioner concedes particular 22 (failure to report to the patient's treating general practitioner). She also concedes particular 24 (failure to keep proper clinical records) in part. She acknowledges that, to the extent she failed to conduct a physical examination of this patient, particular 9 is proven. The practitioner also concedes in her submissions that she should have taken and recorded the patient's weight, in particular at the time of prescribing the medication. 4. The nub of the complaint in respect of this patient relates to the practitioner's off label prescribing of HGH (particular 3). 5. In her oral evidence the practitioner asserted that her rationale for prescribing HGH for this patient was to improve her mood, but a possible beneficial effect on appetite was also mentioned – this seemed in conflict with the use in other patients for weight loss. Discussion and conclusions 1. We agree the practitioner's concession in respect of particular 22 is properly made. 2. We are satisfied that the practitioner's investigations prior to treating this vulnerable patient were woefully inadequate. It is particularly concerning, given the patient's history, that her weight was not taken and recorded before she was prescribed HGH. We are satisfied that particular 9 is proven. Although the practitioner did obtain a questionnaire from the patient and ordered blood tests, we are satisfied that her investigations fell far short of that required by a physician of her training and experience. We are satisfied that Particular 9 is established. 3. In his report Dr Coleman did not isolate the practitioner's prescribing of HGH to this patient from her prescribing of DHEA (describing the latter as '"the mother" hormone because it is the precursor to all the sex steroid hormones"). 4. In the HCCC's submissions, it is pointed out that the practitioner did not instigate any investigations of the patient's depression. Rather it is submitted that, because the patient wanted HGH, the practitioner acceded to her request. We agree with that submission which is open on the evidence before us, including the practitioner's own evidence. 5. We agree with, and accept in their entirety the views of Dr Conway of the lack of any proper basis for prescribing HGH for this underweight and vulnerable woman. It is of particular concern that this experienced practitioner did not seek to refer the patient to a suitably qualified specialist to investigate her depression. We are satisfied that particular 3 is established. Patient K 1. This patient was referred to the practitioner by his general practitioner who noted, "Thank you for seeing Patient R who has requested this referral for ongoing care. His medications were noted to include Deca-Durabolin, Valium, Panadeine Forte and Xanax. The patient is a former member of the SAS who had suffered injuries in that service. In his questionnaire, he reported he was using Deca-Durabolin at the time of his first consultation. He came to the practitioner requesting HGH treatment. 2. Six particulars are asserted in respect of this patient. These include particulars 9, 22 and 24. Consistent with her earlier response to these particulars in respect of other patients the practitioner has conceded particular 22 and particulars 9 and 24 in part. We repeat our earlier findings in respect of these particulars. We are satisfied those particulars are established. 3. The remaining particulars relate to the practitioner's asserted inappropriate prescribing of Arimidex (particular 1), HGH (particular 3) and testosterone (particular 5). 4. Dr Coleman supports the practitioner's prescribing on the basis it is "reasonable". He notes, but does not address, the significance of the patient's reporting of anabolic steroid use or his extremely low testosterone at 2.2 other than noting "correcting this patient's testosterone is a reasoned decision". 5. The practitioner's oral evidence in respect of this patient is illuminating. She explained, because the patient had been a member of the SAS and had received anabolic steroids during that service, it was reasonable to prescribe for him based on his reports. 6. Dr Conway was extremely critical of the practitioner's prescribing for this patient. She indicated that, as with an alcoholic, "weaning" off steroids is not the appropriate treatment modality, rather she opined this patient required cessation of treatment and a "wash out" period. She pointed out that the blood results, when obtained by the practitioner (which she received after she had first prescribed for him), should have caused her alarm. Dr Conway (transcript 26 November 2014 p 236) opined that those results disclosed that the patient was undoubtedly hypogonadal, with the presumed cause being that he was using anabolics. Discussion and conclusions 1. We are satisfied that the submissions relied on by the practitioner disclose no proper basis for this patient being prescribed Arimidex. The rationale in the submissions is that the patient's "oestrogen level was likely to arise because he was being prescribed testosterone". There was no indicated basis for the prescription of this drug. We are satisfied particular 1 is established. 2. The practitioner's evidence is that she prescribed HGH because the patient said he experienced severe pain. Dr Conway opined it was likely the patient's reporting of improvement after he received HGH was a "placebo effect". 3. We are satisfied that, both in respect of particular 3 and 5, the practitioner was, perhaps naively, emotionally swayed by this patient's service record and her management of this patient demonstrates a lack of appropriate clinical objectivity and judgment in his treatment. The practitioner effectively acquiesced to his demands. Her actions demonstrate an inability, at the relevant time, to objectively assess the patient's history and his proper clinical needs. We agree with and accept Dr Conway's evidence about what was appropriate treatment for this patient. We find particulars 3 and 5 proved. Patient R 1. Patient R was a relatively young man, aged 29, when he first presented to the practitioner. He had suffered a serious assault in 2003 which resulted in facial trauma. He subsequently underwent a number of operations. He was reported to suffer with severe pain, trauma and depression and was taking a cocktail of medications. He was first seen by the practitioner in 2007 and continued as her patient until 2011 when he relocated to Melbourne. During the periods the patient consulted the practitioner he travelled from Darwin for visits. 2. Seven particulars of complaint are asserted in respect of this patient. The practitioner denies all particulars pleaded although she concedes her record keeping did not, in all respects, comply with the regulations in that she failed to record discussions regarding the patient's fertility when prescribing testosterone, and drugs prescribed and their dosage on each occasion. 3. As with many of the other patients, Dr Conway was critical of the practitioner's prescribing of Arimidex on a "preventative" basis to stop a foreshadowed potential rise in oestradiol levels as a result of the patient using IM testosterone. 4. Both experts agreed in their oral evidence (transcript 26 November 2014 p 242-243) that the patient's blood results disclosed his testosterone levels were in the normal range. 5. Dr Conway opined that it was unwarranted to prescribe HGH without an established diagnosis of growth hormone deficiency. She explained: [t]his is a man in his 20s. I think it is important if you think he may [be] growth hormone deficient to substantiate that diagnosis because you may be looking at his recommending he be on lifelong growth hormone therapy at some $12,500 a year. An insulin tolerance test is a safe test, there are some small risks with it but any young healthy person ‑ those risks are insignificant and you would really want to substantiate a diagnosis. (transcript 26 November 2014 p 244). 1. Dr Coleman agreed with the opinion expressed by Dr Conway. Although later in his oral evidence he supported the treatment, which he candidly acknowledged he would not have thought of, on the basis the patient reported a positive improvement in his well-being when receiving both HGH and testosterone. 2. Patient R had undergone many "standard" medical treatments without benefit. He suffered considerable pain and was taking a cocktail of medications which he was able to reduce by 50 per cent after using HGH. 3. We accept Dr Conway's opinion about establishing a diagnosis before prescribing this expensive drug is sound orthodox practice. However, we consider, after weighing all the evidence, that in the circumstances of this patient, where conventional medicine did not provide a positive outcome, the practitioner's clinical judgment in prescribing was not inappropriate. Particular 3 is not established. 4. The practitioner's submissions refer to the practitioner's decision to prescribe testosterone for Patient R, who wanted to lose more weight, because "she considered the addition of testosterone might assist this patient with his quality of life". 5. Dr Conway pointed out Patient R did not have an androgen deficiency at the time the practitioner commenced prescribing testosterone for him. She opined "the fact he had a symptomatic response to either growth hormone or to testosterone [was inadequate] as evidence that the treatment was appropriate." 6. The failure of conventional medical treatment for this patient was a predominant factor in his referral to the practitioner. While we accept the assessment of improvement by the patient was subjective, one objective fact was that whilst on treatment he was able reduce his dependence on pain killers by 50 per cent. Overall, consistent with our findings in respect of HGH, we are not satisfied this particular or Particular 1 is established to the requisite standard. 7. Particular 6 asserted that the practitioner prescribed testosterone when it was contra-indicated while his partner may have been trying to get pregnant. The practitioner's notes record that Patient R wanted to have a large family and that his partner had suffered a miscarriage. There is no dispute that the practitioner did not record in her notes any discussion about the effects of testosterone on Patient's R's fertility. 8. In her oral evidence the practitioner related the circumstances of her discussion with Patient R and his partner (by reference to the partner's first name). She explained that Patient R and his partner jointly informed her that they felt the benefits of the treatment outweighed the adverse impact on the patient's fertility, and that his untreated circumstances were such that he could not care for children. 9. The practitioner's advice to the patient and his informed consent to the treatment were imperative. Good practice requires such vital information and consent to be properly recorded in a patient's notes. The practitioner's deficiency in this regard deserves criticism and is significantly below acceptable standards. But we had no reason to reject the practitioner's oral evidence on this topic which we accept as truthful. Thus, we find particular 24 is established. However, we do not find that particular 6(f) is proven. 10. Particular 22 is not in this case conceded by the practitioner. She acknowledges she did not report to the patient's referring practitioner Dr Foreman at the patient's request, but said she reported to the practitioner with whom she made arrangements to give the patient IM injections of testosterone. 11. Dr Foreman referred the patient by referral dated 12 February 2007 and he was seen and treated by the practitioner with HGH in March, 2007 and seen again in May 2008. It was not until July 2008 that the practitioner records a request not to write to the referring general practitioner. 12. Good practice required the practitioner to write to the general practitioner after she saw the patient in March 2007. She did not write after she saw the patient in May 2008 (within the complaint period). We do not accept the practitioner's explanation for her failure to report to the referring practitioner so that he was aware of the patient's treatment. We are satisfied that particular 22 is established. 13. The final particular asserted in respect of this patient is particular 9 (failure to conduct proper investigations prior to prescribing for Patient R). Although the practitioner's submissions refer to the records supplied by the patient, and his referring practitioner, the pathology ordered and her receipt of a detailed questionnaire, there is nothing in the records to suggest she conducted a physical examination of this patient. We find that while in the case of this patient the records contain more material than for many other patients, the particular is established because of the failure to conduct a proper physical examination. We are satisfied to that extent the particular is established. Patient T 1. This patient was referred to the practitioner and treatment commenced prior to the complaint period in 2006 when the patient was aged 59 years. He had a diagnosis of inflammatory demyelinating polyneuropathy. The practitioner described Patient T in Schedule B to her statement as "a fitness fanatic". Her treatment rationale, as noted in the schedule, "was to use growth hormone, testosterone, DHEA as a trial to help the patient with his symptoms, to improve his muscular and immune function where other treatment had failed". 2. There was no dispute between the experts that Patient T's testosterone levels at the time of treatment were in the high/normal range and his IGF1 was in the mid-normal range. The patient had, during the course of treatment, raised PSA levels. It is not in dispute that the practitioner did not conduct a physical examination of the patient, and in particular, she did not conduct a digital rectal examination, or refer him to his general practitioner for such examination. 3. Six particulars are relied on by the HCCC in respect of this patient. The practitioner concedes Particular 22, and that Particular 24 is proven in part. As with our earlier findings in respect of these two particulars we are satisfied they are established. 4. The critical particulars are Particulars 3, 5, 9 and 10. It is convenient that we deal with Particulars 3, 5 and 9 together, as the evidence and our findings in respect of these particulars is interwoven. We then consider separately Particular 10. 5. The case advanced for the practitioner in respect of this particular is that it was reasonable to treat the patient with HGH and testosterone because he was unable to obtain any benefit from other treatment, and those treatments carried greater risks. She also relied on the patient's subjective reporting to her. We accept, on its face, the practitioner's rationale does not appear unreasonable. However, that gives an over simplistic view of the matters in issue in respect of this particular patient. 6. Dr Conway's evidence on the topic of subjective reporting given in response to a question from Mr Greenwood is germane to these two particulars: MR GREENWOOD: Do you not accept that that outcome for this man demonstrates a basis for prescribing as Dr Epstein did? WITNESS CONWAY: No. As we've discussed before, the fact that he felt better doesn't prove cause and effect between treatment and result, and if ‑ I mean, you repeatedly come back to a patient's symptoms. I might just, at this point, just mention a comment by a very wise endocrinologist at a conference I attended a couple of years ago, who made the point that no number of anecdotes is medical evidence or constitutes a series. You cannot conclude from anecdotes that treatment is effective. MR GREENWOOD: That's because it could be a placebo effect with [Patient T]? WITNESS CONWAY: It could be. It could be other lifestyle changes. It could be many things. I think when you're prescribing somebody an expensive treatment, there is a very strong motivation for them to feel better in the case of growth hormone, particularly if you give them convincing evidence or can ‑ try to persuade them of the likely benefits of the treatment before you start them on treatment and then sell them an expensive treatment, low and behold they feel better. 1. Dr Coleman acknowledged that the basis for prescribing HGH and/or testosterone was not by reference to clinically established results, but rather was based on a theoretical basis the treatment may be of assistance. The following exchange between the experts and the Tribunal's professional members is relevant to our findings in respect of these two particulars: DR ILBERY: I suppose it was a broad brush, looking with compassion at a patient who has a lot of problem ‑ he clearly has a lot of problems and is seeking to assist with the tools that you have and your experience. WITNESS CONWAY: Yes. I mean, you can feel very sorry for the patient. I don't think that extends to treating him as a guinea pig, especially, and trialling them on something for which there is no scientific basis. If that is going to ‑ that sort of treatment should be done, it should be done in a clinical trial setting by a neurologist presumably. DR ILBERY: Further on that point, Dr Coleman said it was unlikely within the small cohort that such a trial would be‑‑ WITNESS CONWAY: I can't quote the prevalence of the disorder. I mean, I ‑ clinical trials are done in conditions that are quite rare. It does make it a little more difficult in terms of recruiting patients. You would have to ask the neurologist, I think, what the feasibility of that was. DR CHISHOLM: Dr Coleman, if I understood correctly, you've said there are theoretical grounds on which testosterone or particularly growth hormone might help this condition, therefore you think it wasn't unreasonable when there's little else to offer but if you were managing this patient and you decided to implement this sort of treatment, would you not think it's reasonable that you make some objective measures or [sic] nerve or muscle function so that you could actually have some objective measures of the response rather than simply going on the patient's symptoms and, in fact, if the patient has been assessed by a neurologist, would you not think it would be wise to refer it back to the neurologist to see if the neurologist could confirm? WITNESS COLEMAN: I agree with that. I agree with that. I think that would be really ‑ I was going to use the term nice thing to do, but I think it would be an appropriate thing to do and I can it would be a very interesting point for the neurologist to be involved with a novel therapy, to see whether he felt objectively there was an improvement. (transcript 27 November 2014 p 283) 1. We are satisfied that the practitioner's prescribing for this patient, whilst probably motivated by her compassion for the patient, lacked objectivity and clinical rigor. While the treatment regime may have been appropriate if conducted in association with the patient's treating neurologist and results objectively assessed that did not occur. In fact, the practitioner did not communicate at all with the patient's treating neurologist or his general practitioner. We are satisfied her prescribing of testosterone and HGH in these circumstances was not appropriate. It lacked appropriate clinical judgment and assessment. We are satisfied that particulars 3, 5 and 9 are proven. 2. There was no significant disagreement between the experts in respect of the practitioner's failure to follow up appropriately the patient's elevated PSA. The practitioner said she did not conduct digital rectal examinations (or in fact during the relevant period, any physical examinations of her patients) she did not contact the practitioner's referring general practitioner and arrange for his elevated levels to be appropriately investigated. We are satisfied this particular is proved. 3. Overall, we agree with Dr Conway that the practitioner's treatment of this patient was significantly below the level expected of a practitioner of the same level of training and experience as this very senior physician. Patient U 1. This patient, aged 49 years at the relevant time, was first referred to the practitioner in June 2008. He was a chronic cannabis user, had been diagnosed with Graves Disease, and was taking a number of other drugs including anti-depressants. The patient reported poor memory, lack of motivation and decreased libido. He had musculo skeletal problems with his left shoulder, left brachioradialis tendon and right elbow. Blood tests revealed normal testosterone levels and normal IGF 1. 2. In the practitioner's submissions it is noted of this patient "Essentially [patient U] was feeling down and miserable and was experiencing aches and pains". 3. The HCCC agitates six particulars of complaint in respect of this patient. During the course of her oral evidence the practitioner conceded her dual prescribing of Deca-Durabolin and testosterone was inappropriate in respect of all patients whom she treated in this manner. We agree that treatment was experimental, unproven and inappropriate. Thus particular 7 (a) is established. We also note the practitioner's concessions in respect of particular 22 in the submissions filed on her half. This is inconsistent with the recording in Schedule B in which the practitioner asserts there is a handwritten copy of a letter to the general practitioner in her file. and partial concession in respect of particular 24. On examination of the records we are unable to locate any letter to Dr Sharrad, the referring doctor, from the practitioner, and think the reference in the submission is in error. We note that Dr Sharrad asked for the practitioner's opinion regarding hormone and life style assessment. No such opinion was provided. For the reasons earlier discussed, we are satisfied these particulars are established. 4. The remaining particulars (1,3,5 and 9) are intrinsically linked. We propose to discuss them globally. The practitioner prescribed HGH, Deca-Durabolin and testosterone for the patient. 5. While Dr Coleman supported the practitioner's conduct as being "reasonable" he conceded in his oral evidence that it was impossible for the practitioner to assess the patient's reported well-being because he had ceased or modified his cannabis use. It was not clear whether his improved status was simply attributable to his cessation of cannabis, rather than the prescribed medications. Dr Conway advocated a withdrawal of cannabis and assessment of results before prescribing "off-label" for this patient. We agree the approach she advocated was the appropriate one. We repeat our earlier conclusions about the circumstances in which it was necessary, or thought desirable, by the practitioner to prescribe Arimidex. We are satisfied that, without deciding, it was potentially appropriate to trial the drugs prescribed off label, but that the practitioner's action in so doing was premature. Particulars 1, 3, 4, 5 and 9 are established. Patient V 1. This patient disclosed to the practitioner that he was a retired body builder who had been a national title holder in an overseas country in 1990. He was aged 43 at the date of his first consultation in March 2007. 2. The referral letter to the practitioner from Dr Michael Lowy is important. Dr Lowy said: [patient's first name] is insistent on following his need for HRT against medical advice. I refer him to you for supervision and control. 1. Dr Coleman readily conceded that this patient's testosterone levels were "off the chart" and indicated that he was obtaining testosterone therapy from somewhere at the time of presentation. 2. The HCCC asserts 8 particulars in the complaint about this patient. As with a number of other patients, the practitioner concedes she did not communicate with the patient's referring doctor, she also concedes, in part, her inadequate record keeping. She also concedes, in part, her failure to conduct adequate investigations prior to prescribing. 3. Particular 17 pleaded in respect of this patient is an assertion that the practitioner prescribed medication to a patient who may have been abusing anabolic steroids and without sufficient clinically indicated investigation. 4. The remaining particulars (1,2,3, 5 and 7) assert inappropriate prescribing of Arimidex, HCG, HGH, testosterone, and simultaneously prescribing of Deca-Durabolin and testosterone. 5. Dr Conway in both her oral evidence and her reports was strongly critical of the practitioner's treatment of this patient. In her supplementary report in answer to the question "Any other comments you wish to make" Dr Conway opined: One recorded testosterone soon after stopping treatment was extremely low (1.3nmol/L) with low/normal LH. Probably due to chronic suppression of axis but treatment should have been withheld and if level stayed as low as this a pituitary tumour should have been excluded. 1. In her oral evidence, when referred by Mr Greenwood to the patient's blood tests in September 2009, when the patient had finished treatment, Dr Conway said "so it showed that his axis had recovered from the suppressive effect of the androgens he'd been using. So there wasn't any indication to put him back on treatment" (transcript 27 November 2014 page 301). 2. Dr Conway's responses to a questions posed by Professor Chisholm and the presiding Judge and a following question posed by Mr Greenwood have significant relevance We now set out the questions and answers in full: DR CHISHOLM: Could I just address a point of clarification to Dr Conway. When this man first presented in the notes he's noted to have reduced libido and reduced energy but the recorded testosterone at that time is significantly above the normal range, what would that lead you to conclude about the relationship of his symptoms to testosterone? WITNESS CONWAY: It would make me conclude that his symptoms were unrelated to his testosterone levels. PRINCIPAL MEMBER: Or he could be lying? WITNESS CONWAY: He had been taking much more testosterone than he was actually admitted to, which is pretty much the norm, yeah, anabolic users. MR GREENWAY: May I follow that question up and so not prescribing to him at that stage, and indeed moving to try and get him off for five weeks would be appropriate course of action? WITNESS CONWAY: Yes, I wouldn't prescribe to him. 1. Dr Coleman gave some support in his report for the treatment of this patient based essentially on the subjective reporting of the patient. However it must be remembered that Dr Coleman's report was written having regard to the totality of the clinical notes, including those outside time period of the complaint. It is not in dispute the practitioner continued treatment of this patient after August 2009. It is also appropriate to note that Dr Coleman did not have a copy of the referral letter at the time he wrote his report. 2. In his oral evidence, Dr Coleman readily conceded he had made an error in his report about the patient's testosterone level at first presentation and said "if you go to the first letter with the set of results it looks like he has actually been on testosterone". He also said that the patient's blood results indicated that he had been on testosterone shortly before he came in to see the practitioner. He also noted that a physical examination of the patient would have revealed a lot – "whether he was muscled up". Discussion and conclusions 1. As discussed in our earlier findings, we are satisfied that the prescription of Arimidex was necessary only because the patient's oestradiol levels became elevated as a result of the treatment regime prescribed by the practitioner. As set out below we found that treatment to be inappropriate. We are satisfied particular 1 is established. 2. Again with this patient, there is a large degree of artificiality in looking at each drug prescribed in isolation, rather than examining holistically the treatment regime employed by the practitioner. Particular 2 relates to the prescription of Pregnyl. We accept and prefer Dr Conway's opinion about inappropriate prescribing for this patient. We accept the only clinical justification for prescribing Pregnyl was for testicular atrophy caused by the patient's testosterone use. No clinical examination was conducted to confirm the reported condition, which in any event, had its likely causation in his other anabolic use, or more properly, his anabolic abuse. We are satisfied particular 2 is established. 3. We similarly find particular 3 is established. This treatment regime was based on the patient's reported symptoms, but those symptoms were in respect of a period when he was not using anabolics. 4. Particular 5 relates to inappropriate prescribing of testosterone. We accept Dr Conway's opinion, as confirmed in the referring doctor's letter, was that this patient sought anabolics contrary to medical advice. He was referred for management and control. We agree with Dr Conway what this patient required was a "wash out" and thereafter a proper clinically review. The practitioner did not investigate any psychological addiction the patient may be suffering because of his long term usage of anabolic steroids. 5. We think it is also relevant to note that Dr Coleman (transcript 27 November 2014 p 313) agreed that a patient's report of wellbeing whilst being treated was not always reliable (or as Professor Chisholm posed the question "as an indication of the success of the therapy"). 6. We find on the evidence before us, including the practitioner's responses to questions posed in cross-examination, that she was ill-equipped, for whatever reason, to exercise proper objectivity and management of this long term steroid abuser. We are satisfied that particular 5 is established. 7. Dr Coleman's evidence revealed the importance before treating this patient of a full physical examination. We are satisfied in the absence of such examination that the practitioner did not conduct adequate investigations and that particular 9 is established. 8. Particular 17 is framed as follows: On various dates between 7 August 2007 and 8 July 2009 the practitioner prescribed HGH, anastrozole [Arimidex], testosterone enanthate and chorionic gonadotrophin [Pregnyl] to Patient V in circumstances where he had a history of abusing anabolic steroids and without sufficient clinically indicated investigation. 1. Although the practitioner made a general concession that prescribing two different testosterones and/or testosterone and Deca-Durabolin simultaneously was inappropriate (particulars 7 and 8) she did not make a concession in respect of particular 17. 2. Mr Greenwood notes in his submission that during the period of the complaint period testosterone doses were standard (three weekly) until February 2009 when there was a change to fortnightly. After that he notes mini SQ was prescribed. He asserts the nub of this complaint was not put to the practitioner. 3. The HCCC seeks to support this particular of the complaint noting at [155] of the submissions in reply that the patient had a history of excessive use and possible underlying depression. The submissions go on to note "It also appears that the patient may have been obtaining steroid from a source/s other than the Respondent". 4. We reject the submissions made on behalf of the practitioner that there was no evidence before the practitioner that this patient had been abusing anabolic steroids. The patient presented with a history which should have sounded alarm bells to the practitioner. His reason for seeking treatment and his blood tests were strong indicators that this was likely to be a patient who had been abusing anabolic steroids in the recent past. We find particular 17 proven. 5. For reasons discussed earlier we are satisfied particulars 22 and 24 are established. 6. Overall, we agree with Dr Conway's opinion that the practitioner's treatment and management of this patient was significantly below the expected standard and invites strong criticism. Patient Y 1. Patient Y is a psychiatrist who self referred to the practitioner. At the date of his first consultation he was aged 40 years. His medical history included a four year history of inner ear problems following an accident when he walked into a glass door. He reported suffering chronic dizziness, some tinnituis and slight hearing loss. The patient also reported lethargy, erectile dysfunction, and decreased libido. He reported being unable to work full-time. He sought advice about hormone balancing. The patient remained a patient of the practitioner outside the complaint period. 2. Seven particulars are relied on by the HCCC in the complaint concerning this patient. These include inappropriate prescribing of Arimidex, Pregnyl, HGH and testosterone. Other particulars include an asserted failure to conduct adequate investigations prior to prescribing, failing to report to the referring practitioner and failure to keep proper clinical records. 3. It is convenient to note at the outset we do not find particular 22 established. There was no referring doctor, rather the medical practitioner self referred. We also note the practitioner's concession, in part, concerning her records. We are independently satisfied from our examination of the notes, which in many places are scant, and the failure to conduct a physical examination, that particulars 9 and 24 are established. 4. Dr Conway's position in respect of this patient was straightforward. She noted that blood results revealed his testosterone levels were normal. Consequently, she opined there was no indication for the drugs prescribed. 5. By contrast, Dr Coleman, based on the practitioner's assessment (by use of the nomogram) that the patient's testosterone levels were "borderline low" opined that it was reasonable and safe to supplement this patient. 6. Neither expert was aware of any clinical trial which supported the prescribing of hormones for the treatment of dizziness. Dr Coleman in his oral evidence said, that while he would not prescribe Pregnyl in the circumstances, that the patient did not stay on it for very long, and its use was safe, though expensive. While Dr Coleman indicated the patient could have been commenced on either testosterone or Pregnyl, he explained that Pregnyl had been prescribed at Patient Y's specific request. Dr Coleman supported the prescription of Pregnyl as "a reasonable call" because this drug would be less likely to result in testicular suppression noting the patient's age. 7. The practitioner, in support of her treatment of this patient, relied on his subjective reporting to her of reduction in dizziness and improvement in his wellbeing enabling, after 12 month's treatment, a return to work. 8. Professor Chisholm asked Dr Coleman to comment on whether or not he agreed that "taking symptomatic benefit as an indication of the success of therapy can have pitfalls." He replied: …you can't always use as a sign of benefit of wellbeing, whatever form you define that, particularly if you're talking about a drug like hydrocortisone or prednisone. Discussion and conclusions 1. There is no doubt that Patient Y, on his own reporting, experienced improvements in his symptoms, and continued to receive treatment from the practitioner outside the complaint period. He provided a glowing testimonial supporting the practitioner. 2. We are satisfied that particular 24 is established. The practitioner's clinical records do not accord with the regulations. 3. As noted above, particular 22 is not established. 4. We accept, adopting orthodox prescribing practices, this patient's blood results did not support the prescribing of Pregnyl, HGH, or testosterone with the attendant result that Arimidex was used to combat resulting rising of oestradiol levels. 5. We also accept that the testosterone calculation as borderline low is not a recognised method and that, although not currently widely available, complete accuracy of measurement of free testosterone levels may only be obtained using mass spectrometry. Nor, as the experts concluded, is there any clinical trial which supports the prescribing of hormones for the treatment of inner ear conditions. 6. It is unclear on the evidence before us whether the patient's reported increased wellbeing, relief from dizziness and ability to return to work were the result of the practitioner's treatment regime, or some other reason/s. 7. We find the evidence relied on by the HCCC, based on Dr Conway's view gives support to the establishment of particulars 1, 2, and 5. It is particularly relevant that the patient himself requested Pregnyl and the practitioner acquiesced in his request. 8. We are unable to find the practitioner's prescribing of the relevant drugs was, in all the circumstances, appropriate. We are satisfied on the facts of this patient's presenting history, careful and monitored departure from a strictly orthodox prescribing regime could be considered appropriate. We agree with Dr Coleman that, given the patient's reported complaints, it was not unreasonable for a trial of the drugs. The drugs were prescribed in low dosages and are drugs that have a long history of use without adverse side effects. However, simultaneous or overlapping use of several agents makes interpretation of benefit from a particular agent problematic. While were are conscious of the risks inherent in a patient's subjective reporting to validate treatment, this patient is a medically trained specialist whose symptoms, particularly those related to his ear condition, markedly improved under the practitioner's care. 9. Balancing the relevant evidence, we find particulars 1,2, 3 and 5 proved. We note Dr Conway's overall strong criticism of the practitioner's treatment and management of Patient Y. We depart from her opinion only insofar as the prescribing practices of the practitioner attract her strong criticism. This intelligent, medically trained practitioner was suffering a debilitating condition preventing him from practising. We accept there was a borderline basis in these circumstances for a trial of one or more the prescribed drugs when other treatment modalities were unsuccessful but find the approach taken by the practitioner lacked rigour and was inappropriate. Patient Z 1. Patient Z is a solicitor and academic who was referred to the practitioner by his general practitioner in July 2008 when he was aged 28 years. The referring practitioner noted "[Patient's first name] is keen to find out more about anti-ageing therapies". The practitioner noted on his questionnaire that his current medication at presentation was "testosterone every two weeks". In his recorded history the practitioner noted he had been having oral and injected testosterone in the UK for "symptoms". The practitioner's treatment rationale was because the patient reported depression, lack of motivation and weight gain. The patient moved to Queensland in September 2008. 2. Six particulars are asserted in the complaint in respect of this patient. 3. As with other patients, Particular 22 is conceded, as in part, are 9 and 24. Again, consistent with our earlier findings about these particulars, we are satisfied in each case the particular is established. 4. A specific particular (Particular 14) is pleaded in respect of this patient. It deals with an asserted failure by the practitioner to investigate the patient's high creatinine levels. While the practitioner, in Schedule B to her statement, defended this particular, in the written submissions Mr Greenwood noted that the particular is proven. We agree with the practitioner's concession. Our finding is supported by Dr Conway's evidence on this topic, which we accept. 5. The remaining particulars deal with the asserted inappropriate prescribing by the practitioner of HGH and testosterone. 6. Dr Conway in her supplementary report notes that as the practitioner did not have the patient's blood tests from the UK it was impossible to know if he was androgen deficient. However this report was prepared before Dr Conway had access to the practitioner's "reconstituted" clinical notes. In her oral evidence she noted that the blood results were normal and did not support the treatment regime. Dr Coleman simply notes the patient had symptoms consistent with low androgen levels. 7. Both experts agreed it was surprising for a 28 year old to be referred to find out more about anti-ageing therapies. 8. The evidence revealed this patient had obtained testosterone from a pharmacist friend in South Australia. In response to this evidence Dr Coleman opined: WITNESS COLEMAN: So I'd want to monitor him very carefully and make sure ‑ which she's done, to make sure that he's not over cooking himself and taking testosterone from other sources. PRINCIPAL MEMBER: Whether Dr Conway wanted to; she wasn't asked to respond on those issues. WITNESS CONWAY: Well, just that he's clearly been obtaining androgens from other sources other than medically prescribed which, I guess, fits in with him coming along wanting growth hormone. The profiling, I think, in that way is not particularly useful. If you're going to ‑ testosterone levels vary greatly with the short acting testosterone ester injections, and if you're going to sample, the time would be just prior to the next dose to see if the trough level is adequate. His levels on 1 August 2008 showed his axis was suppressed at that point by the exogenous testosterone he was having. With a patient like this, if you didn't have clear evidence of his pre treatment testosterone levels which apparently either were there or came later, you would certainly examine him to see what his testicular size was. If his testicular size was normal, you would have a great deal of scepticism about the diagnosis and you would want to take him off treatment and see what happened to his testicular function off treatment. As it turned out, the levels that turned up from the UK were normal so I guess that made the diagnosis ‑ or disproved the diagnosis. 1. We accept Dr Conway's evidence that prescribing HGH and testosterone for this patient was not appropriate. We are satisfied that particulars 3 and 5 are established. 2. It is relevant that we note in Mr Greenwood's submissions he acknowledged on behalf of the practitioner at [404] "[the practitioner] acknowledges that regular monitoring of the patient is important and she no longer is willing to prescribe to people she does not see regularly". Patient AB 1. Patient AB was initially a patient at the Australian Centre for Anti-Ageing Medicine where he was treated in 2000 by the practitioner's then partner and intermittently by the practitioner. He then received androgen patches and HGH. At that time his presenting symptoms are asserted to have been low libido, a general lack of vitality, need for more sleep, slower work speed, lack of confidence and irritability. He was employed as a hedge fund manager, an occupation the patient reported as stressful. 2. He was subsequently seen by the practitioner in 2005 and 2006. During the complaint period Patient AB was living in Switzerland. Drugs prescribed by the practitioner were seized by Swiss immigration authorities and contact was made by those authorities with the TGA. 3. During the complaint period the patient complained of problems associated with his knee and shoulder, which he had injured. He had used Deca-Durabolin prior to seeing the practitioner and reported positive results. During the complaint period he complained of irritability, and mood changes, lack of vitality, increased need for sleep and melancholy. Because he said he had benefit in the past from treatment he wished to continue it. 4. The HCCC pleads six particulars in respect of this Patient. As with other patients, the practitioner concedes Particular 22, and Particulars 9 and 24 in part. Consistent with our earlier findings we are satisfied each of those particulars are established. 5. The remaining three particulars relate to the asserted inappropriate prescribing of HGH, Deca-Durabolin and testosterone. 6. In respect of the prescribing of HGH, the HCCC submits that the practitioner simply continued prescribing HGH for this patient at his request without exercising any judgment. The submissions further note that the records did not contain relevant pathology reports "and the patient's ad hoc attendance and overseas residence meant he could not be monitored". Notwithstanding these difficulties it is noted that the practitioner "continued to prescribe significant quantities to please the patient and comply with his wishes". 7. Both experts experienced difficulty, as did we, in working their way through the practitioner's notes for this patient. 8. Significantly Dr Coleman explained that, prior to prescribing Deca-Durabolin, the practitioner should have first examined the patient to establish the degree of injury for which the prescription was sought. 9. We are satisfied there was no objective evidence to support the practitioner's prescribing of HGH, Deca-Durabolin or testosterone. The blood tests in the records were ones obtained in 2000. That is, some seven years before the practitioner used the nomogram to justify, in addition to the patient's reported symptoms, her prescribing regime. 10. We accept Dr Conway's oral evidence, given after she had the benefit of the reconstituted clinical records, that Particulars 3, 4 and 5 are established. In making our findings we note the concessions made by Dr Coleman and in particular his evidence, summarised above, about the need to conduct a physical examination prior to prescribing Deca-Durabolin for an asserted injury. 11. Overall, we are satisfied that the practitioner's treatment of this patient demonstrated an acquiesance to his requests and was not supported by any relevant blood tests or clinical examination. We are satisfied the treatment provided constitutes a significant departure from the expected standard. Patient AF 1. Patient AF presented with a complex medical history. He was first seen by the practitioner in July 2000 when aged 53 years. At that time he was depressed, had a shoulder injury, poor sleep and poor quality of life following a mini stroke. He returned to see the practitioner on a referral from his general practitioner in August 2008 when he was aged 60 years. A year previously he was diagnosed as suffering Charcot-Marie Tooth Disease. Dr Coleman describes this disease as "a congenital wasting disease of the muscles in the lower limbs". 2. Five particulars are asserted in the complaint about the practitioner. As with other referred patients, the practitioner concedes she did not report to the patient's referring practitioner. 3. The practitioner concedes Particular 24, in part, in that she did not comply with the regulation and to that extent the complaint is conceded. Again, consistent with our earlier findings we are satisfied that Particulars 22 and 24 are proved. 4. Particular 5 asserts inappropriate prescribing of testosterone for this patient. Particular 6 asserts that the practitioner prescribed injectable testosterone on named dates when an injection was contra-indicated. It is not in dispute that this patient was on anti platet medication. 5. In her supplementary report Dr Conway is critical of the prescription of testosterone for this patient whose blood tests revealed a normal testosterone level. 6. Dr Coleman in his report opined the patient's testosterone and DHEA were at the bottom end of the range and he considered treatment was reasonable. He noted the patient appeared to be monitored fairly carefully, but as there was no improvement after a few months, that appropriately, treatment was discontinued. In his oral evidence he most appropriately conceded that his report was referring to results outside the period in the complaint and at the relevant period the patient's testosterone levels were mid range. 7. Dr Coleman also commented on the practitioner's use of injectable testosterone for this patient who was on anticoagulants. He explained There is always an increased risk of bruising with IMI in patients on anticoagulants. Suitable care and prolonged pressure over the injected site, after the injection, seldom causing bleeding issues. I also note that finer gauge needles were used by [the practitioner] suggesting she was cognisant of the risks and took appropriate care. 1. The practitioner's evidence is that she wanted to provide support for this patient when no other treatment was available. Discussion and conclusions 1. Dr Conway is critical of the practitioner's treatment of this patient based on orthodox prescribing protocols because he did not present with low testosterone results. 2. The practitioner's rationale for prescribing referred to in the written submissions notes the difficulties experienced by the patient as a result of his Charcot-Marie Tooth syndrome as "to prescribe a trial of testosterone to see if it helped with [patient AF's] muscle wasting disease and assist with his low libido and fatigue". The agreed schedule B to the complaint discloses this patient was prescribed testosterone or testosterone enanthate on seven occasions during a five month period when the treatment was discontinued. 3. While we accept orthodox prescribing rationale would contraindicate prescribing for this patient, we are not satisfied that the practitioner prescribing testosterone on a trial basis for a limited period could be considered without some rationale. Her clinical assessment and rationale for prescribing testosterone was, in our view, borderline, but we are not satisfied to the requisite civil standard Particular 5 is established in the unique circumstances of this patient. 4. We are also not satisfied that Particular 6 (c) is established. The practitioner gave evidence of the care she exercised in respect of each patient who was on anticoagulant medication. We accept she exercised care and used fine gauge needles. While Dr Coleman readily admitted he did not use IM injections of testosterone but relied on transdermal preparations, his opinion supports the practitioner's practice for this cohort of patients. Patient AH 1. This patient was aged 35 years at the date of first consultation. He was a steel worker with a history of previous anabolic usage. He disclosed in answering the practitioner's questionnaire that "he used some energy supplements". He also disclosed that he participated in weight lifting for fifteen years. His desired outcome from visiting the practitioner was "I want to have more energy. I work hard". 2. The complaint includes Particular 9 (failure to conduct adequate investigations before prescribing) and Particulars 22 and 24. The practitioner does not concede Particular 22 and asserts there was no referring doctor. 3. As with her response to particulars 9 and 24 the practitioner concedes these particulars in part. We repeat our earlier findings in respect of each of these particulars in respect of this patient. 4. There are three other particulars in the complaint in respect of this patient. The particulars assert inappropriate prescribing of Arimidex, HGH and testosterone. 5. In her oral evidence Dr Conway confirmed her opinion that there was no indication, either in the patient's presentation or symptoms, or his blood tests to require the prescribing of Arimidex, HGH or testosterone. 6. Dr Coleman, in answer to questions posed by Ms Eastman, agreed that from the practitioner's records, he appeared to have tried Sustanon and that in the middle of the year before he consulted the practitioner he had something plus Deca-Durabolin. He also agreed from the information in the notes this patient may be in the cohort who are body builders. He also conceded the patient's testosterone levels were well within the normal range. When pressed by Ms Eastman, Dr Coleman explained that, in opining a trial of treatment was reasonable, he had taken into account the patient's reported symptoms which were consistent with low androgens or low growth hormone based on the fact that nomogram calculations disclosed a result in, or just above, the borderline range. 7. We accept and prefer the evidence of Dr Conway in respect of the practitioner's prescribing for Patient AH. We are accordingly satisfied that particulars 1, 3 and 5 are established. In reaching this finding we also have regard to the guidelines for practitioners prescribing anabolic steroids. The practitioner was clearly on notice that this 34 year old steel worker had been lifting weights for 13 years and had a history of anabolic steroid use. The practitioner in these circumstances ought to have been scrupulous in her investigations before prescribing for this patient. We agree with Dr Conway that her treatment and management of patient AF is deserving of strong criticism. Patient AK 1. This patient, who was a former Mr Universe, was aged 68 years when he consulted the practitioner. His questionnaire revealed he engaged in long term body building, wresting and amateur sports only. Blood results disclosed he had a borderline testosterone level but his LH was normal. He complained of arthritis. The patient noted he wished to improve his skin, joints, muscle tone, libido and general feeling of wellbeing. 2. Five particulars of complaint are asserted in respect of this patient. They include inappropriate prescribing of HGH and testosterone. Although a complaint of failing to report to a referring doctor is included, we accept the practitioner's notes disclose this patient noted he was referred by an acquaintance. We accept that particular is not proved. The remaining particulars relate to failing to conduct adequate investigations before prescribing and failure to keep proper clinical records. These two particulars are conceded in part by the practitioner. 3. Consistent with our earlier findings we are satisfied particulars 9 and 24 are established. We note particularly in respect of this patient that his body builder history should have put the practitioner on high alert to carry out thorough investigations prior to prescribing. 4. Dr Conway was critical of the practitioner's prescribing of both HGH and testosterone for this patient. 5. Dr Coleman, in support of his opinion that the practitioner's prescribing was justified, referred to two papers, one of which was co-authored by Dr Conway. We accept Dr Conway's evidence about how the results of that study should be interpreted and that the research does not support the practitioner's prescribing regime. 6. Dr Coleman also referred to the benefit of testosterone for men with low range testosterone who suffers arthritis. He said: MS EASTMAN: Dr Coleman, can I just ask you about the paragraph that starts at line 716. You make the point that the treatment with testosterone in both showed no improvement and you say that's understandable in a patient with arthritis, weight issues and low libido? WITNESS COLEMAN: Because it's what we see. We see that a lot of men if you replace their testosterone if it's in the low range they should have an overall full sense of improvement in their wellbeing and I see it myself in my own practice in men who have got arthritis, if you support them with testosterone. I prefer for them to have low testosterone levels and you would argue whether Patient AK had a low testosterone level for his age, but until you're actually given the benefit of a trial of treatment you will never know whether or not his problem relates to low levels of androgen. MS EASTMAN: Would not the fact that this person describes himself as a bodybuilder forever be a relevant factor to take into account as to whether he was reflective of the cohort of patients you're just describing? WITNESS COLEMAN: I would have expected even if he had been a bodybuilder and exercised and maintained his diet and his testosterone levels I would have an expectation his levels would be higher. 1. In the HCCC's submissions at [204], it is noted that one rationale for the practitioner prescribing testosterone was to "improve levels and assist with low libido". The paragraph goes on to note "However, low libido does not appear one of the symptoms complained of by this patient". We note however in the questionnaire the patient responded to the question "Are there any other problems that may be affecting your quality of life" saying "skin itch, low libido". 2. We accept and prefer Dr Conway's opinion that the prescribing of HGH and testosterone was not appropriate for this patient. We observe that at paragraph [725] of his report Dr Coleman suggests that Deca-Durabolin may have been more appropriate treatment given the patient's age and arthritic problems. He also notes the patient reported no benefit from the treatment, although he opines this may be because he was experiencing side effects from his drug therapy. We accept that evidence is speculative and we cannot place any significant weight on it. We are satisfied particulars 3 and 5 are established. Patient AN 1. This patient was first seen by the practitioner in 2006 when aged 41 years. He consulted the practitioner at that time because he was suffering gynecomastia and sought mesotherapy which the practitioner then practised. He represented in 2008 when referred by his general practitioner complaining of decreased energy and increased weight (symptoms described by Dr Coleman in his oral evidence as "soft symptoms"). Blood tests conducted by the practitioner showed normal testosterone levels. However, the practitioner used the nomogram plotting the testosterone and SHBH to substantiate her treatment calculating the patient's results as "the bottom on the borderline range". He was prescribed Pregnyl and Arimidex to counter rising oestradiol levels. 2. Five particulars in the complaint are relied on by the HCCC. The practitioner concedes Particular 22, and, in part, concedes Particulars 9 and 24. Consistent with our earlier findings we are satisfied those particulars are established. 3. Also, consistent with our earlier findings, we are satisfied that the prescribing of Arimidex was as a consequence of the prescribing of Pregnyl without which Arimidex would have been unnecessary. 4. The patient was only treated with Pregnyl for a short period after which the practitioner noted that he reported low libido and weight gain. He continued to be prescribed Arimidex but did not present for review. 5. We note that in preparing his report Dr Coleman mistakenly took into account the patient's presenting symptoms in 2006 which are not relevant to the complaint. We accept and prefer Dr Conway's evidence that treatment with Pregnyl was not appropriate. Accordingly we are satisfied that particulars1 and 2 are established. Patient AP 1. This patient, who is a nightclub operator and a heavy drinker, was first referred to the practitioner by an endocrinologist in 2000. At that time the referring specialist noted the patient's excess drinking, and that his wife who was significantly younger than the patient, was undergoing IVF treatment. The specialist noted, at that time, treatment with testosterone was contraindicated. The patient was seen intermittently until 2004 and then represented with a referral from his general practitioner in June 2007. At first consultation he was aged 55. 2. During the patient's treatment by the practitioner during the complaint period he had rising PSA levels. The practitioner did not personally conduct a digital rectal examination but referred the patient to his general practitioner for that examination. He later underwent an ultrasound and was under the care of an urologist. 3. Six particulars are pleaded in the complaint in respect of Patient AP. They are two inappropriate prescribing Particulars, 3 and 5, (Pregnyl and testosterone), asserted failure to conduct adequate investigations before prescribing (Particular 9), failing to exclude prostate disease prior to prescribing (Particular 11), failing to report to the referring doctor (Particular 22) which is conceded, and failure to keep proper medical records (particular 24) which is conceded in part. 4. We do not propose to discuss Particular 22 or Particular 24. In respect of the latter particular we refer to, and rely on, our findings in respect of other patients. Those findings are replicated in respect of this patient. 5. Dr Conway is critical of the practitioner's prescribing for this patient. Both Dr Conway and Dr Coleman, by reference to the reconstituted medical records comment on the practitioner's treatment outside the relevant complaint period. We have disregarded those parts of their reports. The principal basis of Dr Conway's criticism of the prescribing is because the patient had a mid normal IGF-1, and normal testosterone. 6. It is convenient that we first deal with particular 11. Both experts agreed that the practitioner had taken appropriate steps in referring the patient to his general practitioner for a digital rectal examination, that she was aware he was attending a urologist, and had a copy of the patient's ultrasound. 7. It is important that we turn to the specific language of this particular. It is framed as follows: On 7 October 2008, 9 December 2008 and 12 May 2009 the practitioner failed to exclude prostate disease in Patient AP who was seeing a urologist for an enlarged prostate, prior to prescribing him testosterone enanthate. 1. This particular implies, on a literal reading, that the prescribing of testosterone is contraindicated in the case of any prostate disease. Dr Coleman notes in his report "There are studies that show where low testosterone levels appear to increase the risk of prostate cancer". He cites two reports at [755]. At [766] he opines: The available evidence indicates that testosterone therapy does not increase the risk of prostate cancer diagnosis. It neither affects the progression of prostate cancer nor the prostate recurrence in men who have undergone definitive treatment without residual disease (our emphasis). 1. We discern the thrust of Dr Conway's criticism of the practitioner's prescribing for this patient, when he had a rise in PSA levels, was because of her failure to communicate her treatment to his urologist, or to ascertain what treatment the urologist was prescribing. But that criticism does not sit within the perimeters of the particular as pleaded. 2. The practitioner's senior counsel notes at [493] of his submission that, in February 2007, the patient's reference range was normal but had become elevated by February 2008 when he was referred to his general practitioner and an ultra sound arranged. Schedule B to the complaint discloses that in March 2008 the practitioner prescribed HGH (somatropin) and simultaneously prescribed testosterone enanthate. That prescribing regime continued through May to September that year. The patient records disclose by 1 April 2008 the practitioner was aware from the patient's report that he had undergone a digital rectal examination and was still to have an ultrasound. By report dated 4 April 2008 Balmain Imaging reported the patient had a Grade 11 prostastic enlargement but no significant outflow obstruction. This report is noted in the patient's records by the practitioner on 22 April 2014. In short, these results, which did not disclose prostate cancer were in the practitioner's possession when she prescribed testosterone in October 2008, December 2008 and May 2009. However good medical practice would suggest communication with the urologist over the prescribing of testosterone before proceeding. We are not satisfied this particular as pleaded is established. 3. The rationale for the practitioner's prescribing of Pregnyl (in combination with testosterone) was because of the patient's heavy drinking, rising cholesterol levels, weight gain and ingestion of multiple vitamins. HGH was prescribed because of its known use in "improving age related quality of life markers and weight loss". 4. We agree with and accept Dr Conway's evidence that such prescribing was not appropriate for this man who had normal testosterone levels. We note by way of comment that the patient reported a decline in sexual function when he was drinking excessively in 2000. We are satisfied particular 3 is established. 5. The HCCC's submissions in reply note that this patient's testosterone level when he represented to the practitioner in February 2007 was well within the range at 11.09. Thus, it is submitted treatment was simply continued without any objective reassessment. Again, we accept and adopt Dr Conway's view that prescribing testosterone for this patient in the complaint period was not appropriate. Particular 5 is established. Patient AR 1. This patient, a solicitor, was first seen by the practitioner in 2001 when he was aged 73. She continued to treat the patient up to, and beyond the complaint period. The practitioner's rationale for her treatment regime was to treat sexual symptoms, to treat lethargy and to improve quality of life. The patient also sought to reduce weight. It is not in dispute that the patient developed polycythaemia secondary to testosterone treatment. 2. The complaint contains seven particulars relevant to this patient. In addition to particulars asserting failure to report to the patient's general practitioner, (which is conceded), failing to keep proper medical records (conceded in part) and failing to conduct adequate investigations prior to prescribing (also conceded in part), it is asserted: 1. The practitioner inappropriate prescribed Arimidex and testosterone (Particulars 1 and 5); 2. Prescribing testosterone when the patient developed polycythaemia during treatment (Particular 6(h)); and 3. Prescribing excessive doses of testosterone (Particular 8). 1. Dr Conway is strongly critical of the practitioner's treatment of this patient. She noted the patient had a borderline low testosterone, but a mid-normal LH. She opined that, because the patient was on Warfarin, there was a risk of haematoma for IM injections. However, her strongest criticism was direction to particulars 6(h) and 8. She opined in her supplementary report: Haematology shows that this patient developed polycythaemia on testosterone. Testorerone was continued with no reduction in very high doses and no referral to a haematologist for management of polycythaemia. At one point PCV was 0.57 which is of great concern in an elderly patient. 1. In her oral evidence Dr Conway conceded that after the practitioner had reduced the patient's testosterone when his PCV was elevated four months later it had reduced to the upper limit of the normal range. However, she opined that she would not have left a patient aged 80 for four months without retesting because the patient may have "stroked out" (transcript 28 November 2015 p 358). 2. Dr Coleman supported the practitioner's prescribing but his report was based on the patient's complete records not just within the complaint period. He opined: This patient was a 73 year old man with low testosterone and symptoms to indicate low androgens (lethargy, slow gait, loss of social pleasure, erectile dysfunction and a history of cardiovascular disease). All these symptoms may improve with restoration of testosterone to mid or high normal levels. 1. There is a considerable degree of artificiality in making separate findings in respect of particulars 1, 7, 6(h) and 8 as they are closely related. We note that the practitioner in her oral evidence conceded that the simultaneous prescribing of two testosterones was inappropriate, experimental and a practice she abandoned. That concession however is not reflected in the submissions made on her behalf at [514]. We are satisfied based on both the expert evidence of Dr Conway, and the practitioner's response to a question posed by Professor Chisholm that particular 8 is established. 2. We are also satisfied that the causation of the patient's secondary polycythaemia was a result of excessive prescribing of testosterone. We find the practitioner's response in schedule B to the criticism that the patient should have been referred to a haematologist extraordinary and lacking in insight. She said: The patient was too old for venesection. A haematologist may not have done anything. 1. We take into account the practitioner did reduce the patient's combined excessive testosterones when the patient developed polycythemia, but she nevertheless continued to prescribe reduced dosages and did not arrange for further testing for a period of four months. We accept Dr Conway's criticism of the practitioner's management of this patient is cogent and properly made. We are satisfied that particular 6 (h) is established. 2. It follows from our discussion that this patient was only prescribed Arimidex to counteract the effect of his receipt of testosterone. 3. Overall, we accept Dr Conway's view that the practitoner's treatment of the patient, her failure to report to his referring practitioner and in prescribing excessive does of testosterone was significantly below the relevant standard and attracts strong criticism. Patient AS 1. This patient, who is a Hedge Trader, was aged 34 years. At his first appointment he expressed interest in anti-ageing medicine. The practitioner ordered blood results which disclosed that the patient had a markedly elevated testosterone with suppressed PH and FSH. On his second visit he confessed to the practitioner he was obtaining testosterone and Pregnyl from another source. The practitioner notes, we would say appropriately, that with hindsight she should not have treated this patient. 2. The HCCC asserts seven particulars in respect of this patient. We can deal shortly with particular 22. The practitioner asserts there was no referring practitioner. We accept that assertion. This particular is not established. 3. As with other patients the practitioner concedes particular 24 in respect of her records. We are satisfied that the records did not comply with the regulations and this particular is established. 4. Although the practitioner submits that she conducted adequate investigations prior to prescribing for this patient we are unable to accept that submission. The clinical notes are scant, and notwithstanding the practitioner obtained blood tests and was aware at the second consultation that the patient was untruthful and obtaining drugs elsewhere, she prescribed for him. We are satisfied Particular 9 is established. 5. The crux of the particulars relating to this patient is whether or not the practitioner's ongoing prescription of HGH, and testosterone was an appropriate way of managing this drug abusing patient, or whether once the practitioner had received the patient's blood results, which clearly indicated drug abuse, she should have refused to further prescribe for him, and enabled him to "wash out" under her supervision. The practitioner's notes record that at a consultation on 8 October 2009 she planned to stop testosterone and monitor, but again prescribed for the patient. 6. We note we have difficulty reconciling the practitioner's clinical notes and the Schedule to the complaint in relation to the last prescription for this patient. Our consideration of these matters touch upon the evidence relevant to Particulars 1, 3 and 5 (inappropriate prescribing of Arimidex, HGH (Scitropin) and testosterone). 7. Dr Conway is strongly critical of the practitioner's treatment of this patient noting the patient had a clear history of anabolic and HGH abuse with a very high testosterone at presentation. 8. Dr Coleman, while explaining in his oral evidence that as a specialist he would not see a patient without a referral from another practitioner, sought to draw to our attention the difficulties of dealing with a drug seeking patient. We accept such patients present real challenges to practitioners, and their treatment calls for objectivity and extreme care. The need for extreme care is highlighted in the PSB publication referred to earlier in this reasons. 9. We are satisfied that many aspects of this patient's presentation should have rung alarm bells with the practitioner. He came, aged 34 expressing an interest in anti-ageing medicine, including HRT and HGH. His responses to the questionnaire were scant. He lied to the practitioner at the first consultation and his blood results obtained immediately after that consultation disclosed markedly elevated testosterone. Subsequent consultations revealed the patient was self-administering drugs obtained other than from the practitioner. 10. We note that notwithstanding his opinion that patients such as Patient AS are difficult to treat it is instructive that Dr Coleman's evidence is that he would have ceased treating this patient far earlier than did the practitioner. The practitioner had no specialised training in dealing with patients with a drug addiction. Whether by reason of naivety or a misplaced sense of responsibility, we are satisfied the practitioner's conduct demonstrates a lack of the necessary objectivity to ensure this patient received proper and appropriate care. We agree with, and adopt, Dr Conway's opinion that the practitioner's overall conduct in respect of Patient AS attracts strong criticism. Particular 21 is established. Patient AT 1. AT was aged 41 years at the date of his first consultation. He reported a history of two serious motor cycle accidents resulting in the need for multiple surgeries. The practitioner does not dispute the patient's blood tests were consistent with self-administration of testosterone. She prescribed HGH, Deca-Durabolin and testosterone. Her summary of her rationale for the treatment plan for this patient is set out in Schedule B to the practitioner's statement. She says: The patient was not being treated for deficiency, or even insufficiency of either HGH or testosterone. These agents were prescribed to deal with the symptoms, with success. 1. The practitioner also notes: … If there had been withdrawal of treatment for this patient, such action would have exacerbated his pain and significantly impacted on his quality of life. 1. The complaint asserts 7 particulars in respect of this patient. The practitioner disputes particular 22 and asserts there was no referring practitioner, rather the patient self referred. We accept that the clinical notes for this patient do not contain any referral letter.This particular is not established. 2. As with other patients the practitioner concedes, in part, particulars 9 and 24. We repeat our earlier findings in respect of these particulars. Further, in concluding that particular 9 is established, we note that the practitioner conceded in cross- examination that she had not received the results of blood tests before prescribing for this patient (transcript December 2014 p 951). Dr Coleman agreed in his oral evidence that further enquires or investigations as to the nature of the patient's previous treatment were warranted. We accept his opinion on this point. 3. The remaining four particulars relate to inappropriate prescribing of Arimidex (particular 1), HGH (particular 3), Deca-Durabolin (particular 4) and testosterone (particular 5). 4. Dr Conway's opinion on the appropriate treatment for this patient was unequivocal. She strongly maintained the only appropriate treatment regime for this man, who was already on testosterone treatment at the time of presentation, was to "stop treatment, allow washout and evaluate need". In her oral evidence Dr Conway explained that her view would be different if there was a clear history of androgen deficiency having been diagnosed in the past. Dr Conway's expressed strong criticism of practitioner's conduct in respect of this patient. 5. Dr Coleman, who supported the practitioner's treatment of this patient, in his report opines at [845] of his report: In normal circumstances it would be hard to argue for the use of testosterone supplements in Patient AT with high normal testosterone. The use of DecaDurabolin is understandable as a targeted therapy for Patient AT who had significant musculoskeletal injuries, for its previously mention noted benefits in post-injury. Discussion and conclusions 1. As with our earlier findings we are satisfied the prescription of Arimidex was required only because of the other drugs prescribed by the practitioner. Given our findings in respect of those drugs, which we shortly discuss, we are satisfied this particular is established. 2. It is convenient we consider particulars 3, 4 and 5 together. We accept that there is some basis for prescribing Deca-Durabolin for musculoskeletal injuries. However, we are satisfied the appropriate time to do so, if at all, for this patient was after washout and thorough assessment of his status at that time. In finding the practitioner's treatment was inappropriate we accept Dr Conway's evidence. We note it is consistent with the material published by the PSB referred to earlier in these reasons, and available to practitioners at the time this patient first consulted the practitioner. We are therefore satisfied that Particulars 3, 4 and 5 are established. Patient AX 1. Patient AX is a physician who self referred to the practitioner. At first consultation in December 2008 he was aged 70 years. He was treated for a period of approximately 9 months. The patient was under the care of a urologist and a cardiologist. He was taking Warfarin. 2. The patient's testosterone at first presentation was normal (22.9 nmol/L) with normal LH and FSH. His SHBG was high. Using the Vermulllen equation plotted on a nomogram the practitioner assessed his free calculated testosterone as "borderline deficient". 3. The practitioner asserts in Schedule B that, during the course of treatment the patient made a comment, that "life wasn't worth living". At the first consultation he was noted to be experiencing decreased libido and strength, mild depression, irritability, decreased cognition and high blood pressure. 4. There are eight particulars pleaded in respect of this patient. In addition to Particulars 9, 22 and 24 the HCCC asserts inappropriate prescribing of Arimidex, (Particular 1), HGH (Particular 3), and testosterone (Particular 5). The HCCC also asserted that the practitioner should not have prescribed injectable hormone when the patient, was on antiplatelet or anticoagulant medication (Particular 6 (d)), nor should she have prescribed testosterone when the patient had prostate hyperplasia (Particular 6 (g)). 5. In her supplementary report, Dr Conway was mildly critical of the practitioner's prescribing because of the patient's known prostate hyperplasia. In her oral evidence, Dr Conway modified earlier evidence she had given about prescribing when a patient was on anti-platelet medication, but distinguished that evidence from patients on Warfarin. She explained, at her hospital, when a patient on Warfarin is treated with injectable testosterone she refers the patient to the haematology department. The patient's Warfarin is discontinued for several days prior to receipt of the injection to reduce risk of excessive bleeding. Both Dr Conway and Dr Coleman supported the use of transdermal preparations rather than an injectable medication. 6. As with a great number of the patients, Dr Conway and Dr Coleman expressed different views about whether or not the practitioner's treatment of her patient was clinically appropriate. 7. In support of the position adopted by Dr Coleman we were referred to an article in the New England Journal of Medicine published during the course of the hearing (Ex 12). The article presents a "for" and "against" case for supplementing aged male patients with testosterone for a trial period of six months with reassessment of the patient at that time. 8. In her supplementary report Dr Conway noted "Even though SHBG high (probably congenital) and so testosterone level is less reliable reflection of production rate than it would normally be the normal LH rules out androgen deficiency". She also noted that the practitioner had prescribed Danazol (a weak androgen) to lower SHBG. She opined "There is no logic behind this". 9. In his report, and confirmed in his oral evidence Dr Coleman, said at [860] referring to the patient's reported symptoms: These symptoms suggest androgen depletion and given his age, Patient AX is likely to fall into the lowest quartile for IGF-1. Given the known benefits of androgen supplementation, particularly with IGF1 (synergistic effects) in the clinical setting of patients with androgen deficiency, a trial of testosterone and HGH seem justified and the results gratifying. Discussion and conclusions 1. It is again convenient that we consider the particulars relative to the prescribing of Arimidex, HGH and testosterone together as the treatment is intrinsically linked. 2. The HCCC put in issue the practitioner's recording of the patient's IGF-1 level being at the bottom end of the range and assert, by reference to the clinical notes at page 54, that he was not at the bottom end of the range. Accordingly, it is submitted that there were no symptoms that indicated the patient required HGH. We accept that submission. It is consistent with the patient records. We also repeat the concern about discerning which agent creates benefit when 2 or 3 agents are prescribed simultaneously. 3. We accept, having regard to the New England Journal article, that there is a body of doctors who support the replacement of testosterone aged men with relatively low testosterone levels. Prima facie, this finding supports a conclusion that the practitioner's prescribing for this physician was not inappropriate, and not significantly below the standard expected of a practitioner of her experience. We note however that the male the subject of comment in the article had a testosterone level lower than Patient AX. We also note that Patient AX was simultaneously prescribed HGH. 4. However, we are not satisfied, having regard to both Dr Coleman's evidence, and the discussion in the New England Journal of Medicine, that a prescription of testosterone per se was inappropriate. But as we will shortly explain, because it was injectable testosterone in a patient on Warfarin when transdermal preparations are readily available we are not satisfied it was ideal. Also, we consider the prescribing of testosterone cannot be divorced from the prescribing of HGH and Armidex. 5. We agree with Dr Conway's view that the prescription of Arimidex was a consequence of the other drugs prescribed. We also accept her view that prescribing HGH was not appropriate. We also accept that the patient's IGF-1 level (page 52) of the clinical notes was not at the bottom of the quoted range and hence not a justification for prescribing HGH. 6. We have set out above Dr Conway's concession in respect of the treatment of patients on anti-platelet medication, but also her careful explanation of how patients, who suffer androgen deficiencies and require injectable testosterone and are taking Warfarin and treated in the public hospital where she practises. We accept this is manner of treating such patients minimises the risk of bleeding following injection. 7. In this case we take into account the patient was a physician who was well able himself to assess the risk of receiving injectable testosterone and to give informed consent to such injections. We also accept that the practitioner used fine gauge needles, applied pressure to the injection site and the patient suffered no adverse consequences. We are not satisfied this particular is established. 8. Particular 6(g) relates to prescribing testosterone when the patient had benign prostatic hypertrophy. While we find some criticism could be levelled at the practitioner for her failure to communicate with the patient's urologist, that is not how the particular is framed. We accept that the practitioner did monitor the patient's PSA levels during and following the period identified in the complaint. 9. Finally in respect of this particular, we accept Dr Coleman's evidence that the treatment was not contraindicated in this patient who did not have prostate cancer. 10. In summary, we find particulars 1, 3, 9, and 24 are established in respect of this patient. Patient AY 1. This patient, who was referred to the practitioner by his trainer was aged 49 at the date of his first consultation. He reported a history of depression extending over 20 years. In his questionnaire he reported problems with energy levels and libido. In response to the question "What are your hopes regarding the outcome of this visit with [the practitioner]", he responded "turn back the clock". 2. The patient's testosterone level was normal when first assessed (21.39 nmol/L with normal LH and high normal IGF-1). However, using a nomogram the practitioner calculated the patient's free testosterone at below mid-range. 3. In cross examination Dr Coleman agreed that the patient was neither deficient in growth hormone or testosterone. 4. The complaint asserts 8 particulars in respect of this patient. Included in the particulars is particular 22. We accept that the patient was not referred by a doctor and this particular is not established. We note and agree with the practitioner's concession that she prescribed excessive does of testosterone (Particular 7). Her introduction of both Primoteston and Sustanon simultaneously substantially increased the dosage beyond recognised safe prescribing and the use of two different preparations of the same hormone lacked logic. 5. As with other patients, the practitioner conceded, in part, Particulars 9 (failure to conduct adequate investigations before prescribing) and Particular 24 failure to keep proper medical records. Dr Coleman readily conceded that, given this patient's history of depression, it was incumbent on the practitioner as part of her investigation to explore who had, or was, treating him for this condition and to record any anti-depressant medication. We find Dr Coleman's concession was most appropriate. Taking into account this evidence and for reasons enunciated earlier in respect of other patients, we are satisfied these particulars are established. 6. Dr Conway found no clinical justification for the drugs prescribed for this patient. 7. Dr Coleman's support in his report for the treatment regime is brief. Essentially, he supported the treatment on the basis of the patient's report of increased well-being. 8. In cross-examination Dr Coleman candidly explained, given the patient's testosterone levels on presentation, he would not have treated the patient with testosterone. Later in his cross-examination he also agreed he would not have treated the patient with HGH. 9. We accept Dr Conway's view that prescribing Arimidex, HCG, HGH and testosterone for this patient in light of his history and his blood tests results was inappropriate. We are satisfied that Particulars 1, 2, 3 and 5 are established. Patient BA 1. Patient BA was referred by a female friend and, during the complaint period, by his diabetes specialist. He was aged 80 at the date of his first consultation, and had multiple health problems including diabetes, atrial fibrillation, was on Warfarin and had hypertension. Significantly, the practitioner reported he had cognitive difficulties. In her oral evidence she explained she had assisted the patient to complete the questionnaire as he was incapable of doing so himself. 2. The patient was on a large number of medications including Pravochol, Karvea, Zanidip, Losec, Motilium Betaloc, and Avapro. He suffered erectile dysfunction and had undergone 3 penile pump operations. 3. Six particulars in the complaint are asserted in respect of this patient. The practitioner concedes she did not report to the referring specialist (particular 22). She concedes, in part, particulars 9 and 24. 4. In the submissions in reply, the HCCC asserts at 254: The patient reported feeling very fit on initial presentation. He made no complaints about the particular claimed symptoms. He appears not to have been seeking specific treatment and was referred by his friend [first name]. In circumstances where the patient had clear and obvious cognitive problems, the [practitioner] should have proceeded with the greatest of caution. 1. Dr Conway notes Patient BA's blood tests revealed his testosterone levels were within the normal range as was his LH. This is disputed by the practitioner in Schedule B where she states: The reference to LH highlights the unrealistic and unsupported standard of Dr Conway's guidelines, in that it would be extremely rare for any male of this age to present with high LH such that they would qualify under her unrealistic rules. The patient's calculated testosterone level was well below normal on the Carruthers nomogram (based on the Vermeullen statistics). 1. The HCCC's submissions at [257] state: The Tribunal should find this conduct involves a departure of the most serious kind. The [practitioner] has taken advantage of an impaired elderly man who appears to have had little understanding of the nature and effect of the treatment she decided to implement. 1. Dr Coleman agreed in cross-examination (transcript 28 November 2014 p 389) that the patient's testosterone was in the normal range but with an elevated LH. We also note that FSH was mildly elevated supporting some degree of testicular dysfunction. 2. It is relevant at this point to note in her oral evidence in cross-examination the practitioner admitted that she had reacted adversely to some of the language in Dr Conway's report. It is also relevant to note that Dr Conway agreed some of the language in her report was inappropriate and she withdrew or amended some aspects of her commentary. We also note that the practitioner's reference to Dr Conway's guidelines is in fact a reference to the Endocrine Society Guidelines. Dr Conway was but one of a number of specialists who authored the guidelines. Discussion and Conclusions 1. We agree with and adopt the submissions of the HCCC in respect of this elderly patient with cognitive deficits. We are satisfied the practitioner did not conduct appropriate investigations before prescribing for this patient or assess the patient for complications of diabetes which may have been very relevant. She failed to report to his referring specialist. Both experts agree that treatment with testosterone would have not have had any effect on the patient's erectile dysfunction in the context of prior penile surgery. 2. We perceive prescribing injectable testosterone to this patient was potentially unsafe notwithstanding the practitioner's use of fine needles and the application of pressure. There is nothing to indicate in the clinical notes, or indeed in the practitioner's statement, that this patient understood the inherent risk of bleeding after an injection whilst he was on Warfarin or that he was able to give a fully informed consent to that treatment modality. We are satisfied that particular 6 (e) is established. 3. As to particulars 1 and 5, we agree with and adopt Dr Conway's evidence in its entirety, despite some evidence of borderline testicular dysfunction, in respect of Patient BA. We are therefore satisfied these particulars are established. Patient BB 1. This patient was aged 34 at first presentation outside the complaint period in 2004. He was a former boxer, a sport he reported engaging in recreationally for eighteen years. He did not complete the practitioner's questionnaire. At his first consultation (outside the complaint period) the practitioner noted he had six months previously tried Scitropin (HGH) 12 IU weekly. Blood tests revealed a low level of testosterone. The practitioner prescribed HCG, HGH, testosterone and Arimidex. 2. Nine particulars are pleaded in the complaint relevant to this patient. The patient was not referred by a doctor. Accordingly the practitioner does not concede particular 22. We accept that particular is not established. The practitioner does concede, in part, particular 24 in respect of her medical records. She also concedes particular 9 in part. The concession in respect of this particular, namely that the practitioner did not carry out a physical examination of the patient, is also relevant to particular 13 (failure to exclude pituitary disease before prescribing HGH). The practitioner also concedes particular 8 (excessive prescribing of testosterone). We refer to our earlier findings about this particular in respect of Patient B and repeat those findings. 3. Dr Conway was firm in her opinion that it was inappropriate to treat this patient with HCG. She also criticised the practitioner for excessive prescribing of testosterone, but in her oral evidence confirmed that she could not be certain about the prescribing of testosterone. She stressed the practitioner should have carried out a testicular examination to see if the patient had testicular atrophy to exclude the possibility of a pituitary lesion being responsible for the low testosterone. Her speculative view was that the patient had been abusing androgens causing suppression of his testosterone levels. 4. Dr Coleman referred to the association between head injuries (which may have been sustained by this patient as a boxer) and low testosterone. Discussion and conclusions 1. We agree with and accept Dr Conway's evidence that there was no justification for the prescription of HCG. We also accept her opinion that Arimidex was only prescribed to treat the side effects of the other prescribed drugs. 2. We also accept Dr Conway's evidence that, given the patient's presenting symptoms, it was important that a physical examination be conducted to check for testicular atrophy, and to look for indications of pituitary disease. 3. Given Dr Conway's stance that she was unable to determine whether or not the prescription of testosterone was clinically appropriate we do not find particular 3 proved. 4. However, whether or not it was appropriate for this patient to receive testosterone enanthate and/or testosterone, we agree with the concession made by the practitioner, for the reasons earlier explained, her prescribing of two testosterone resulting in excessive doses was inappropriate. Thus we are satisfied that Particulars 1, 2, 8, 9 and 13 are established. Patient BD 1. This patient, a solicitor and former police officer, who had suffered many injuries including a severe head injury was referred to the practitioner in 2007 when aged 37 years. His presenting symptoms were noted to be decreased sexual function, fatigue, muscle weakness and weight gain. He reported snoring when he gained weight and that he ate "anything". He also reported irritability and decreased concentration. He continued to be treated by the practitioner outside the complaint period. 2. Dr Conway notes that the patient had a borderline low testosterone and SHBG with normal LH in obese patient. 3. The practitioner notes she did not do the original blood tests. She records that by 29 November 2007, the patient's testosterone was 10.8 (normal range 10-28) and that plotted on a nomogram his free testosterone was borderline deficient. 4. Five particulars are asserted in the complaint in respect of this patient. The practitioner disputes Particular 22 as there was no referring doctor. She concedes, in part, her medical records are deficient (Particular 24). We repeat our earlier findings in respect of this particular. 5. While the practitioner concedes, in part, she did not carry out adequate investigations before prescribing (Particular 9) because she did not carry out a physical examination, she explains that she did take a history, obtain the patient questionnaire and that, very properly, she referred this patient for an MRI which did not show evidence of pituitary disease. We accept, if the practitioner had conducted a physical examination of this patient, and investigated past possible anabolic use or abuse, we may not have found the particular proven. We note that it is the practitioner's evidence that she now always conducts a physical examination of her patients when they first consult her. 6. The remaining particulars are directed to the practitioner's prescribing of Arimidex (Particular 1) and HCG (Particular 2) 7. It is relevant to note that the practitioner disclosed in Schedule B to her statement the following: Referred by GP to endocrinologist after seeing [the practitioner]. Dr Rob Coles was not supportive of testosterone enhancement, nor obviously of the clinical outcome. He called the patient "a cheat". 1. Dr Conway opines that the indications for the prescription of Pregnyl and Arimidex were not present in the patient. 2. In his report Dr Coleman, having referred to the patient's symptoms, said "Initial treatment with Pregnyl and growth hormones seems rational". In cross-examination he agreed it was appropriate to give weight to a specialist (Dr Coles' opinion) explaining I would always expect someone who wasn't a specialist endocrinologist to take note of what the endocrinologist said. 1. In her oral evidence Dr Conway expanded her evidence in her report about the patient's blood results. She said: WITNESS CONWAY: Yes, I noticed in my schedule I've said borderline low testosterone SHB with a normal LH, but looking back at the first bloods that I can see there on 28/11/07 on p 49 he had an undetectable LH. I'm not quite sure where I got the normal LH from. I mean, I guess that would make me wonder, in light of what Ron Coles said, that perhaps he was using anabolics, or had been using anabolics but if he hadn't then you would certainly have to wonder about pituitary disease with an undetectable LH, and if he had had severe head injury you could speculate about that, but you would certainly want to be sure he didn't have a structural pituitary lesion or an infiltrative disorder such as hemochromatosis. MR GREENWOOD: Dr Conway, so appropriate to refer this patient for a scan? WITNESS CONWAY: Well, if he hadn't been using anabolics and his levels remained the same ‑ and I note there was a comment. I think there were two different comments about scanning. I think in schedule B it said he had had a CT scan and I think in the patient notes it said he had an MRI scan and they had been said to be normal so, yes, I does appear a scan was undertaken. 1. The clinical records contain a report of an MRI conducted at Westmead Hospital in December 2007 shortly after the patient was first seen. This MRI revealed no pituitary abnormality. We accept that the practitioner did conduct some investigations to exclude a pituitary lesion, and her conduct in that regard was appropriate. However, she was clearly on notice of a specialist's concerns about this patient's bona fides, but proceeded nevertheless to treat him. Her notes do not suggest she inquired about previous anabolic use before prescribing. Having regard to the evidence of Dr Coleman on this point, Dr Conway's evidence and the advice of Dr Coles, we are satisfied both Particular 1 and Particular 2 are proven. Patient BH 1. Some details about this patient are contained in Schedule B to the practitioner's statement. It is not in dispute that the patient's records were accidently destroyed. 2. In these circumstances neither expert was able to assert an opinion by reference to the clinical notes. In these circumstances it would be unsafe for us to make findings in respect of the adequacy or otherwise of the practitioner's investigations prior to prescribing, or her clinical notes. We note however that there is a computer generated letter dated 14 July 2007 which simply reads "Dear Doctor". The letter contains no named doctor or address and simply reports "I have prescribed [first name] primoteston" and lists a schedule of injections. We cannot be certain having regard to this letter that particular 22 is established. 3. The two particulars still pursued by the HCCC are inappropriate prescribing of HGH and testosterone. 4. Dr Conway comments in the schedule to her report that the pathology results (which are in the patient's file) disclose a normal testosterone and normal IGF-1. In his report Dr Coleman refers to the patient's IGF-1 being "in the bottom 1/3rd". 5. The practitioner using a nomogram (not available in evidence before us) noted in Schedule B that the patient's free calculated testosterone was below mid-range. 6. Although there is a paucity of evidence before us, the pathology results are indisputable. We accept Dr Conway's evidence that this patient's normal testosterone and normal IGF-1 at the relevant time did not support the treatment regime prescribed. Rather, we are satisfied the practitioner's prescribing regime was geared to the patient's subjective reporting of symptoms. Patient BJ 1. This patient, a member of the Australian Federal Police (AFP), was aged 28 when he first consulted the practitioner. He had previously worked as a "bouncer" and sustained head injuries. The patient had used testosterone, testosterone stimulation, and HGH prior to seeing the practitioner. Mr Greenwood's submissions are frank. He noted "this patient was knowledgeable about hormones and their effects. The practitioner acknowledged the patient kept supplies of drugs at various locations purportedly because of travel commitments associated with his duties with the AFP". 2. The patient's testosterone level off treatment is noted by the practitioner in Schedule B to her statement to be 11.2 and IGF-1 at 16.1. Both results are described by the practitioner as "low normal", Dr Conway notes, correctly that patient admitted prior use of testosterone, and that his testosterone and IGF-1 were normal. 3. Seven particulars are agitated in the complaint. The practitioner concedes Particular 9 in part as set out below. She denies Particular 22 noting there was no referring doctor, and also concedes, in part, Particular 24 in respect of her records. We are satisfied on the evidence before us and previously discussed that Particular 24, but not Particular 22 is established. 4. The remaining particulars refer to the prescribing of Pregnyl, HGH, Deca-Durabolin, and testosterone. 5. The practitioner makes a significant concession in respect of this patient. Ex 12 contains the following statement: She accepts that she did not conduct an adequate investigation of [patient BJ] between 11 September 2007 and 5 December 2007 prior to prescribing medications – particular 9. 1. In Mr Greenwood's submissions at [650] he notes: Having reviewed [patient BJ's] records [the practitioner] now accepts that she should have managed and monitored this patient better. 1. However, in Mr Greenwood's submissions prepared at or immediately after the close of evidence, the practitioner sets out bases to support her treatment of this patient. 2. Unsurprisingly, Dr Conway is extremely critical of the practitioner's conduct. She opines: Patient clearly an anabolic abuser who was taking much more testosterone than the already very high prescribed doses. [the practitioner] has attempted to rationalise her overprescribing on basis of possible androgen insensitivity for which there is no evidence (pre-treatment testosterone was at low end of normal range not high as would occur in AIS. 1. In commenting on the dosages of HGH, Pregnyl, testosterone and Deca-Durabolin prescribed Dr Conway noted that they were "markedly excessive". 2. Dr Coleman provided support for the practitioner's treatment noting: The major issue arose because of Patient BJ's deceit over his use of prescribed androgens and the conniving way he sought to maximise his supply by deceiving [the practitioner]. However I believe the rationale for treating him was on the basis of low normal androgens, in the face of symptoms consistent with low androgens and growth hormone is appropriate. 1. Dr Conway's evidence, both in her report and oral evidence, in respect of each of the prescribed drugs was clear and compelling. We accept it in its entirety. We also found the concessions made by Dr Coleman in response to a question about the patient's drug seeking behaviour to be most appropriate. Finally, we note Dr Coleman's response to the question posed by Professor Chisholm about the patient continuing to receive both deca-durablin and testosterone for nearly a year after the patient was recognised as abusing drugs demonstrated some acknowledgment that it was inappropriate for the practitioner to continue prescribing. 2. Given our findings about Dr Conway's evidence we are satisfied that particulars 2, 3, 4 and 5 are established. Further we accept the submissions in reply to the effect that the practitioner agreed to prescribe HGH at the request of the patient. Patient BV 1. This patient, a restaurateur, was aged 52 years when referred to the practitioner by a specialist in 2000. He was HIV positive. He continued to see the practitioner after the complaint period. 2. Six particulars are asserted in respect of this patient. The practitioner concedes that she did not report to the referring doctor (Particular 22). She also concedes, in part, the failure to keep proper medical records. She does not concede that she failed to conduct adequate investigations before prescribing for the patient. In this regard the practitioner relies on the fact that she had performed physical examinations in the earlier years of the patient's treatment. Accordingly, she says, because the patient had a treatment plan she did not consider further physical examinations were necessary. She also notes that during the complaint period blood tests were performed. The remaining particulars relate to asserted inappropriate prescribing of Pregnyl, HGH, and Deca-Durabolin. 3. It is relevant that we note leave was granted to the HCCC on the twenty-first day of the hearing to amended the complaint as, in several instances, a patient's name, identified by initials, was not included in certain particulars in the complaint but the prescribing for that patient was included in Schedule B to the complaint. That schedule was acknowledged by the practitioner's lawyers to be correct in all respects. It was substantially on the basis that the contents of the schedule were well known to the practitioner and her advisors that the amendment very late in the day was permitted. The leave granted was subject to the right of the parties to recall, if either wished to do so, the experts. 4. In the submissions filed on behalf of the practitioner it is submitted that it is unfair for the HCCC to rely on the amended complaint insofar as it includes a particular relating to Pregnyl in respect of this patient. The basis of the complaint is that neither expert was cross examined on this particular, and that, at the time the experts were giving evidence, Ms Eastman expressly stated that the particular was not subject of the complaint. At [675] of the submissions it is noted that no questions were put to the practitioner, and the amendment was not sought until her evidence was completed. It is asserted "in these circumstances it is open to the prosecution to make the submission of improper purpose or failure to exercise proper clinical judgment with respect of this aspect of the complaint and the complaint is not proven". 5. In response to this submission the HCCC submits: The [practitioner] seeks to make a point of the Commission's error in circumstances where it was clear on the written material that this patient was prescribed HCG. It is a highly adversarial approach in an inquisitorial forum. It is a point of form over substance in a forum where there are no rules of pleading. 1. In granting the leave to amend the complaint in this matter the presiding member noted, and took into account, that the opposition to the amendment was framed principally on the basis the two expert witnesses had not commented on the particular in their oral evidence. To overcome any prejudice that may be caused by that circumstance, the leave granted was conditional on the right to recall the experts. Further, the presiding member noted in her oral reasons that particular was addressed by the experts in their respective reports and the practitioner had the opportunity to and did respond to the particular in respect of Pregnyl in her statement and in Schedule B to her statement. In these circumstances we do not discern any prejudice to the practitioner by permitting the HCCC to rely on this particular. 2. Dr Conway is critical of the practitioner's prescribing for this patient on the basis that he had a normal testosterone level, and IGF-1. She also refers to the fact that the patient reported previous use of Deca-Durabolin obtained from his gym with good results. 3. Dr Coleman, whose report was based on the totality of the patient's clinical notes, records the patient presented in 2000 with symptoms "consistent with low testosterone and/or low growth hormone. He was noted to have been diagnosed as HIV positive since 1988 and was on anti-virals". 4. We note that it is on two results obtained in 2000 and 2001 that the practitioner relies as the basis for saying the patient had a low testosterone. 5. This patient's history included the prescribing of Deca-Durabolin by his HIV physician, Professor Cooper, was noted by Dr Coleman. He also recorded that the patient had first (outside the complaint period) been prescribed a testosterone patch and HGH and was then trialled on Pregnyl. We note there is no complaint for this patient in respect of inappropriate prescribing of testosterone. 6. Dr Coleman, by reference to two published papers then opines: This form of treatment modality employed the [sic] maintain optimal function in HIV positive patients is well referenced. 1. Dr Coleman discussed the use of both testosterone and HGH together noting "there are complementary effects". He opined that "there were no contraindications to testosterone preparations, HCG and HGH off label in these clinical circumstances" but added a cautionary note "so long as the patient is followed carefully with the usual caveat". Discussion and Conclusions 1. In his cross-examination, Dr Coleman agreed that, given the gaps between the dates the practitioner treated the patient, that a full clinical review of this HIV positive patient was warranted. We agree with and accept Dr Coleman's evidence on this point. We are satisfied that particular 9 is established. 2. Our consideration of the inappropriate prescribing particulars is difficult. We do not consider that this patient's reporting in 2000 that he had received Deca-Durabolin from a gym was of particular relevance to his treatment during the period in the complaint. In saying this we are conscious that this patient was receiving Deca-Durabolin from his HIV specialist. We also accept that the literature referred to by Dr Coleman does give support for the use of combined therapies in the context of HIV. 3. Here, the patient, outside the complaint period, had stressed he was keen to prevent muscle wasting. However, we do note during the complaint period there is no record of the patient having muscle wasting in the clinical notes. 4. While we find that the practitioner's failing to make an adequate clinical assessment before prescribing for this patient proved, and we are satisfied that her failure to communicate with his specialist was a serious deficiency, the evidence before us in respect of the inappropriate prescribing of Pregnyl and Deca-Durabolin is inconclusive. We accept Dr Coleman's referenced evidence that there is some literature support for use of androgens and HGH in HIV patients. We are not satisfied that Particulars, 3 and 4 are established. 5. The HCCC in its submissions in reply submits that the prescription of Pregnyl was only to address possible side effects of other drugs. We note that in her statement at [111] the practitioner refers to prescribing Pregnyl to prevent testicular atrophy. She gives no other plausible rationale for the prescribing. We are satisfied particular 2 is established. Patient BW 1. This patient first saw the practitioner in 2006 when aged 31 years. His occupation as a garage door installer was reported to require heavy lifting. At that time he received advice from the practitioner but did not pursue treatment. In 2006 the patient described the desired outcome from consulting the practitioner to be "More energy, recover better from training". He returned in 2008 when he said he was facing knee surgery. At that time he revealed he had used testosterone (Sustanon) 11 weeks previously. Pathology reports at that time reveal his testosterone was 12.6 nmol/L (12,0 -32) and his IGF-1 was 39 nmol/L (15-64). 2. At his first visit the patient disclosed to the practitioner he had taken testosterone (Sustanon) Deca-Durabolin, HGH and veterinary steroids. Blood tests in 2006 revealed low testosterone and undetectable LH. 3. The complaint contains nine particulars in respect of this patient. The practitioner denies Particular 22 (reporting to referring doctor) and notes that there was no referring doctor. We accept this particular is not proved. She concedes particular 9 is proved in part on the basis that she acknowledges she should have conducted a full physical examination of the patient when he returned in 2008. We agree with this concession. We also note that the practitioner's records do not disclose any inquiry about the patient's previous anabolic use, the source of the drugs, or prescribing. The practitioner had no objective evidence of the patient's reported injuries including his knee injury. It was this injury, and other reported symptoms, which the practitioner described as her rationale for prescribing for this patient. 4. The practitioner also concedes, in part, the failure to keep proper medical records. For reasons earlier explained, we are satisfied this particular is proved. 5. Particular 8, prescribing excessive doses of testosterone, is also conceded by the practitioner. Again, for reasons earlier explained, we are satisfied that this particular too is proven. 6. Dr Conway, by reference to the patient's blood results in 2006, opines that the "most likely explanation" for those results is anabolic steroid abuse …otherwise pituitary lesion should have been excluded". She further opines that testosterone should not have been prescribed to a known anabolic abuser. 7. Dr Coleman, appropriately we would say, noted in his report that this patient "had a past history of the use of anabolic steroids and growth hormone". In his oral evidence he said the patient's past anabolic use should have raised a "red flag" to the practitioner, but he supported the practitioner's treatment regime on the basis that, based on the patient's reporting, his knee improved obviating the need for surgery. He referred to a study about injecting patients' knees with HGH resulted in positive benefits. In response to a question from Dr Conway he clarified this aspect of his evidence explaining the HGH had been injected directly into the patient's cartilage. That treatment modality was not employed by the practitioner. Discussion and conclusions 1. We commence our discussion of this patient's treatment by the practitioner by reference to the PSB publication. Its messages to practitioners is clear and unequivocal. Practitioners are squarely put on notice of the care which must be exercised when prescribing anabolics to known anabolic users. The practitioner could have been in no doubt when she first saw Patient BW that he had been abusing anabolics including veterinary products. He had again had Sustanon from an unknown source 11 weeks before he represented to the practitioner, but she recorded no inquiries made about that use. She prescribed for symptoms reported by the patient with no objective orthopaedic, or in fact any objective support. It is against this background, which the practitioner seemed in schedule B reluctant to concede, we find it was inappropriate that she prescribed for this relatively young man. We are satisfied Particular 18 is established. 2. We find that the prescription of Arimidex was to address the side effects, or potential side effects, of the other drugs prescribed. We are satisfied, given our findings about the other drugs prescribed that this particular is proved. 3. The practitioner's rationale for prescribing HGH was to try and lessen the patient's reported symptoms of low energy and pain associated with his back and knee problems. As noted above, the practitioner treated this patient, who she knew had a recent history of anabolic abuse, based entirely on his subjective reporting of complaints. We accept Dr Conway's view that prescribing for this patient in the circumstances known to the practitioner was inappropriate. 4. Our findings in respect of the prescribing of HGH apply equally to the practitioner's prescribing of Deca-Durabolin and testosterone. Accordingly we are satisfied that particulars 4 and 5 are proved. Patient BY 1. This patient has a colourful history; He was a former marathon runner in a middle eastern country. In Australia he operated a night club. When he first presented to the practitioner he had, two weeks before the consultation, been shot in the leg. He was aged 55 years when he first saw the practitioner. She treated him for 8 months in 2008, but the patient did not return after that period. 2. There are eight particulars asserted in respect of this patient in the complaint. 3. The practitioner concedes particular 22, namely, that she failed to report to the referring doctor. As with other patients, she concedes, in part, particulars 9 and 24, but in respect of the latter particular, explains that she relied on the patient's questionnaire and history recorded at the first consultation, and that she did a physical examination when the patient reported shortness of breath and recent bronchitis. We accept this part of the practitioner's treatment is recorded as she asserts, but we find the records did not otherwise comply adequately with the regulation. We are satisfied Particular 24 is proven. 4. The further particulars relied on address inappropriate prescribing of Pregnyl, HGH, and testosterone. There is a specific particular dealing with asserted failure to investigate high creatinine levels between 20 March 2008 and 10 December 2008 (particular 15). The practitioner does not dispute that she did not copy the relevant pathology reports she obtained to the patient's general practitioner, but does not otherwise admit this particular. 5. In the schedule to her report, Dr Conway records that the patient's testosterone levels were normal, as was his LH, FSH and IGF-1. She opines there was no basis for prescribing Arimidex, Pregnyl, HGH or testosterone. In her oral evidence she explained that Pregnyl had been prescribed because the patient reported, in October 2008, that his testes were shrinking and the appropriate treatment was to stop treatment with testosterone. Dr Coleman also agreed the most likely cause of the patient's testicular atrophy was because of the testosterone injections received he whilst under the care of the practitioner. He too said he supported, as the preferred approach, cessation of the testosterone treatment (transcript 1 December 2015 p 432). 6. In his report Dr Coleman refers to the patient's testosterone being in the low normal range with the IGF in the normal range. He records that the patient's presenting symptoms were low libido, erectile dysfunction, decreased energy increasing fatigue and increasing weight gain. He notes the outcome for this patient, as reported by the practitioner, "suggests there was a definite clinical improvement in terms of his presenting symptoms". 7. In his oral evidence Dr Coleman, while noting the patient's testosterone and free testosterone were in the bottom quartile in March 2008, conceded they still fell within the deemed normal range. He also agreed, by September 2008 the patient's testosterone was above the normal limit. 8. Dr Coleman also agreed the patient's rising creatinine levels required investigation either by the practitioner, his general practitioner, or that the patient should be referred to a urologist or nephrologist. Discussion and conclusions 1. We are satisfied, having regard to Dr Conway's evidence, which we accept, that the prescription of Arimidex was only necessary to combat rising oestradiol levels because of other drugs prescribed. Given our findings about HGH and testosterone which we address below, we are satisfied that this particular (Particular 1) is established. 2. We are satisfied that the introduction of Pregnyl to the patient's drug regime when the patient reported his testes shrinking was not appropriate. We accept and adopt the oral evidence of both experts, discussed above, on this particular. The need for Pregnyl to address testicular atrophy was a consequence of the practitioner's other inappropriate prescribing. We find Particular 2 is established. 3. We also find that the prescribing of HGH and testosterone, based on the patient's results plotted on a nomogram, and his subjective reporting without any recorded consideration of how long he asserted he suffered lack of energy and low libido, was inappropriate. We are satisfied particulars 3 and 5 are established. 4. It is asserted by the practitioner that, although she did not record a discussion with the patient about his blood test results, such a conversation took place. Notwithstanding the asserted discussion the practitioner did not refer the patient to his general practitioner, or a specialist, nor did she even send a copy of his pathology reports to his referring general practitioner. Rather, she relied on the patient's reporting, at his last consultation with her, that his general practitioner had told him his blood and urine test results were ok. 5. We find that the practitioner's stance in respect of her treatment of this patient is a matter of concern. She failed to refer him for investigation, or to investigate him adequately herself, when she became aware of his raised creatinine, rather than relying on an assumption that his increased levels were due to exercise, nor did she copy his pathology results to his general practitioner. We are satisfied her treatment was significantly below the standard expected of a physician of her experience. Patient CA 1. This patient, a medical practitioner, was, according to the clinical notes (Volume 10), first seen by the practitioner in 2001. He represented in August 2008 when he was aged 50. He had been in good health until 2000 after which he suffered a series of accidents including a fractured ankle, a fall causing injury to his right shoulder, dislocation of his thumbs, bilateral arthropathies from use of crutches, back injury causing L4 and L5 prolapse and a head injury from plane turbulence. 2. The patient had treated his own patients with bio-identical hormones. He used Deca-Durabolin on two occasions, but ceased when he suffered hair loss. He also reported to the practitioner he had used HGH "on and off commencing in 2004". The records do not indicate who prescribed the Deca-Durabolin or the HGH. 3. There are four particulars in the complaint in respect of this patient. The practitioner notes that the patient self-referred and therefore disputes Particular 22. We accept the practitioner's evidence on this point. Particular 22 is not established. 4. In respect of Particular 9, the practitioner says she had regard to CT scans and an MRI, which relate to her 2001 consultation. She also submits that she obtained blood results before prescribing for the patient. This assertion implies her prescribing was based on blood test results, but in schedule B to her statement the practitioner explicitly denies she was treating this patient for pituitary disease, rather to provide pain relief for his musculoskeletal injuries when anti-inflammatories and other medications were unsuccessful. The practitioner concedes she did not conduct any physical examination of the patient. 5. We note that the reports relied by the practitioner during the complaint period were not current reports having been obtained in the period 2002-2004. We accept to the extent there was no physical examination of the patient, or reported investigation of his prescriber of Deca-Durabolin and HGH, the investigations were inadequate. 6. The practitioner concedes the complaint in respect of her medical records (in part). Consistent with our earlier findings we are satisfied Particular 24 is established. We note that there are inconsistencies between the practitioner's handwritten notes and her typewritten notes of the consultation which she said she thought were prepared later from her original handwritten notes. The former refer to the patient's current treatment as "nil" but the latter refer to the patient's current treatment as HGH. The practitioner was unable to explain the discrepancies. However, we note these were notes made in 2008 and we accept that precise recollection of the circumstances of the notes made is readily understandable. 7. The remaining particular relates to the asserted inappropriate prescribing of HGH. We note that the practitioner recorded in her records that the patient presented for management of his prescribing and the practitioner advised him she was not a general practitioner. Nevertheless, she continued treating the patient until at least 2011. 8. Dr Conway is critical of the practitioner's treatment of this patient. She notes that the practitioner was aware of the patient's prior use of HGH and for a brief period, Deca-Durabolin. She opines "No indication for IGF-1 mid normal". 9. Dr Coleman in his report opines that the practitioner's approach "seems reasonable" but noted the patient would have achieved a better result if his treatment had been on a continued basis. In his oral evidence Dr Coleman referred to the difficulties in managing a patient who is a medical practitioner if that practitioner had been self-prescribing. Discussion and conclusions. 1. Careful regard to the practitioner's evidence in cross-examination is necessary to determine Particular 3. 2. Her evidence disclosed that, at some point in her treatment of the patient, she was aware that he was subject to proceedings before a Professional Standards Committee (PSC). She explained because of the PSC proceedings it was very unlikely the patient would self-prescribe. 3. The practitioner explained that she accepted the patient's evidence that other treatments, including anti-inflammatories, had not helped his pain, and that she wished to assist with his pain management. She agreed in cross-examination that by her recording of the patient's IGF-1 as low, she meant "low normal". 4. The exchange between the practitioner and Professor Chisholm is enlightening: DR CHISHOLM Q. Dr Epstein, at the top of page 18 where we discussed before that he in fact got an exacerbation of his symptoms when he was on Sytropin? [semble Syntropin] A. Yes. Q. He felt it might have been because it wasn't as good as Nutropin? A. Yes. Q. Do you believe there is a real difference between those two preferences?[semble "preparations"] A. No. Q. Did that not suggest to you that his symptoms may have nothing to do with his growth hormone treatment? A. So you are suggesting it could be a placebo affect? Q. Not necessarily placebos, musculoskeletal problems wax and wane, it may have just been coincidental? A. They do wax and wane. Q. But I am making the point that your reason for treating him was his symptomatology? A. Yes. Q. Musculoskeletal problems? A. Yes. Q. But you have recorded that he got worse while he was taking growth hormones? A. Yes. MR GREENWOOD: With respect, there is an assumption that he was taking, that at that time, the dose that he had been given in September had long since run out if he was taking it regularly, so‑‑ DR CHISHOLM: If Dr Epstein feels that was the situation, she could inform us of that. WITNESS: What I have written here, "Exacerbation of pain in back, was on bed rest, want s to try Nutropin instead of Sytropin", so in a way, that infers that he was on the Sytropin but he has still got a bad back. Whether that is the truth or not, I can't recall, but when you look at him historically, in every other circumstance he improves when he goes back on growth hormone and he uses Nutropin now, but that's all I can say. 1. We accept that this patient's blood results did not, as Dr Conway explained, of themselves, provide a rationale for prescribing. The HCCC in its submissions refers to the practitioner failing to bring any appropriate judgment or assessment before deciding to prescribe for the patient who the practitioner was aware was the subject of a Medical Board inquiry for inappropriate prescribing of anabolics. 2. We find it is not clear at what point in the practitioner's treatment of the patient she became aware of any disciplinary proceedings. Absent the practitioner's answers given cross-examination, we would have had difficulty in finding this particular proved. We accept that there is some support in the literature for the prescribing of HGH for injuries when other modalities have no benefit. But the practitioner's evidence, set out above, in our view, demonstrates that she did not objectively assess the patient's reporting, but rather was prepared to prescribe without exercising independent judgment. We are satisfied that Particular 3 is proved. Patient CD 1. The practitioner first saw this patient in August 2007 when he was aged 47 years. He worked as a martial arts instructor and reported suffering many injuries. When first seen by the practitioner in 2004 (outside the complaint period) he recorded that his hopes regarding the outcome of his visit to the practitioner was to "reduce body fat, increase vitality". He was recorded as suffering Hepatitis C. He was physically examined by the practitioner outside the complaint period when he had injured his right shoulder. 2. The patient was treated with Pregnyl, HGH, and Deca-Durabolin. 3. The practitioner describes her treatment rationale for this patient as "to improve musculoskeletal injuries with Deca-Durabolin for approximately 1 year". She further records in schedule B to her statement "[t]he original plan was for ten weeks but he kept re-injuring himself and [the practitioner] continued treatment". She also notes he had "intermittent treatment" with HGH and was prescribed Pregnyl to restore testicular function. 4. There are six particulars in the complaint for this patient. The practitioner denies failing to report to a referring doctor on the basis there was no referring doctor. We accept this particular (22) is not proven. She concedes, in part, Particular 9 in that she acknowledges she failed to conduct a physical examination before prescribing Pregnyl, but otherwise submits she exercised adequate investigations prior to prescribing. 5. Insofar as her medical records are concerned the practitioner maintains that she kept proper medical records, except for recording when the patient's HGH changed from omnitrope to nutropin and again from nutropin to scitropin. 6. The remaining particulars assert inappropriate prescribing of Pregnyl, HGH, and Deca-Durabolin. 7. Dr Conway is critical of the practitioner's treatment of this patient. She notes in the schedule to her supplementary report that the patient's blood results disclosed normal testosterone and IGF-1 with no history of pituitary disease. She further notes: Rationale for [Pregnyl] was to correct central hypogonadism induced by inappropriate [Deca-Durabolin] treatment. 1. In her oral evidence Dr Conway pointed out that when measured in April 2009 the patient's testosterone level was low after a long course of Deca-Durabolin, but that it could be expected to recover in one month ascertained by blood tests. However, she stated that "There is no record of symptoms which warranted [Pregnyl] beyond this point". (transcript 1 December 2014 page 44). 2. In his report Dr Coleman acknowledges the treatment with Pregnyl after twelve months treatment with Deca-Durabolin "accords with known practice to restore testicular size and function". In his oral evidence Dr Coleman corrected this statement to withdraw his comment about testicular size, and relied only on restoration of testicular function as the justification for the prescription of Pregnyl. Discussion and conclusions 1. As with a number of other patients it is somewhat artificial to attempt to extrapolate and make finding about each drug given the correlation between the symptoms caused by one drug necessitating the prescribing of a remedial drug. 2. It is appropriate we commence our discussion by referring to the practitioner's prescribing of HGH. The HCCC refers to the submissions filed on behalf of the practitioner which seek to justify the prescribing of HGH to reduce body fat, increase vitality and decrease pain cause by the patient's various musculoskeletal injuries. The HCCC submits that the practitioner's responses are a 'retro-fit' justification. 3. In respect of her prescribing of Deca-Durabolin, which occurred over an extensive period, it is noteworthy that the practitioner's notes disclose that she had no scans or reports about the nature and extent of the patient's injuries. She did not, in the complaint period, conduct a physical examination of the patient. In other words, we are satisfied that her prescribing in these circumstances was in response to the patient's reporting and was not objectively assessed. 4. While we accept that Deca-Durabolin may be appropriate to prescribe off-label in some cases after thorough investigation, and with proper review, this did not occur in respect of Patient CD. 5. We accept Dr Conway's evidence that Pregnyl was prescribed to counter-act the effects of the long prescribing of Deca-Durabolin and was more probably than not continued unnecessarily. 6. We also accept Dr Conway's evidence that there was no basis for prescribing HGH. 7. The practitioner's evidence about this patient did not, in the assertions made in schedule B to her statement, the written submissions, her answers given in cross-examination or the clinical records convince us that her medical record keeping was in accordance with the regulations. 8. In summary, we are satisfied Particulars 2 3, 4, and 24 are established. Patient CF 1. Patient CF, then aged 36 years, was first seen by the practitioner in June 2008. He had been diagnosed as HIV positive and had a history of anabolic steroid abuse. The patient is described by the practitioner as being under house arrest at the time of his first consultation with her. She records that she saw him at the request of one of his solicitors who said he needed help. He had been arrested for importing anabolic steroids and was awaiting trial. The practitioner treated Patient CF for one year after which he returned to China. The patient's pathology reports indicate that he had suffered acute renal failure in 2007. 2. The practitioner's submissions record that the patient was from Thailand, and was referred by Dr Quan. She explains that he told her that when he contracted HIV "he put himself on a number of supplements including HGH and testosterone". The submissions further note the patient accessed testosterone from a gym and self-injected every seven to eight days. 3. The blood results for this patient obtained after his first consultation showed a low testosterone level of 3. It is submitted the practitioner's rationale for treating the patient was because she considered he would benefit from more careful supervision and monitoring. She says in schedule B to her statement "The treatment substantially improved his quality of life". 4. Seven particulars are agitated in the complaint in respect of this patient. 5. As with many other patients, the practitioner concedes, in part, that she did not conduct adequate investigations before prescribing acknowledging she conducted no physical examination. However, she notes that the patient underwent a "wash out" period of three months and that pathology was obtained before prescribing. As will be clear from our following discussion we are satisfied this particular (Particular 9) is established. 6. The practitioner also concedes that a report should have been sent to the referring doctor. She refers to the fact that she did communicate with the patient's case manager, who was, it appears, either supervising bail or parole conditions. She asserts that the patient's general practitioner knew he was being treated by the practitioner. We are satisfied the practitioner failed her fundamental responsibility to inform the referring doctor of the treatment she was providing. We are satisfied Particular 22 is established. 7. The practitioner concedes Particular 8, namely that she prescribed excessive doses of testosterone. We accept that concession is consistent with the evidence contained in the medical records. 8. The practitioner disputes the particular which asserts she failed to keep proper medical records in accordance with the regulation. Neither expert commented in either their report or their oral evidence about the patient's records in respect of this patient. Our examination of the patient records confirm that the practitioner appears to have recorded each injection given and the dose. We also accept that the patient questionnaire contains not only the patient's reporting but also details recorded by of the practitioner. But the record contains, understandably given the practitioner's lack of physical examinations no record of such examinations. We are satisfied in the case of this patient that particular 24 is proven in part. 9. The remaining particulars assert inappropriate prescribing of Arimidex (Particular 1), and testosterone (Particular 5). The final particular relied on is Particular 19. This particular asserts as follows: On various dates between 19 September 2008 and 5 August 2009 the practitioner prescribed [Arimidex] testosterone and testosterone enanthate to Patient CF in circumstances where he had a history of abusing anabolic steroids and without sufficient clinically indicated investigation. 1. Dr Conway, in both her report and oral evidence, raised a number of criticisms about the practitioner's treatment of this patient. She notes in the schedule to her supplementary report in responding to the question "were the indications for testosterone and [Arimidex] present in this patient? If so please specify which were present" as follows: HIV positive. Previously took testosterone and HGH from supplies obtained in Thailand and from a gym. This patient was on home detention with regular drug testing for "steroids" suggesting a conviction relating to anabolics. At presentation testosterone high with suppressed LH and FSH suggesting recent testosterone use. 3 months later testosterone low and testosterone prescribed. This is an inadequate washout period to allow HPT axis to recover. 1. Dr Coleman's opinion, as set out in his report, is brief and we infer provides limited support for the practitioner's treatment of this patient. He opined: I don't consider a history of anabolic steroid abuse or over-use a reason to deny Patient CF treatment when clearly symptomatic of testosterone. Discussion and conclusions 1. Dr Conway maintained her opinion in respect of this patient that a period of "wash out" of three months was an inadequate period of time for this patient's own testosterone levels to recover before the practitioner commenced testosterone injections. 2. Dr Coleman made a number of appropriate concessions to questions posed by Ms Eastman about this patient. He agreed this patient, if treated by the practitioner, needed careful management. He acknowledged the practitioner's treatment plan in June 2008, which noted the patient could benefit from HGH and testosterone, was not appropriate at that time. He also agreed, if the inference that the patient was coming to the practitioner as, due to his house arrest he could not obtain supplies of testosterone from his gym, was correct, that it would be "highly inappropriate for the practitioner to treat him" (transcript 1 December 2014 pp 451-452). 3. Dr Coleman also agreed that the pathology reports for this patient did not support a letter written by the practitioner addressed "To whom it may concern" that the patient had a "documented testosterone deficiency". 4. Dr Coleman also agreed that the patient's testosterone levels revealed in blood tests taken in July 2009 (at a time when the patient had been released on parole for approximately seven months) indicated he was obtaining supplies of steroids other than from the practitioner. He agreed she should have investigated further and documented her investigations. 5. Dr Coleman agreed at least a discussion with the patient should have occurred in July 2009. He described the patient's elevated haemoglobin levels as being "a red flag". He also agreed with the proposition that the clinical notes did not indicate that the patient received any benefit from the practitioner's treatment. 6. The HCCC's submissions at [322] refer to the patient's oestradiol levels at various times and note that there is no investigation of the possible cause for the rise which occurred in December 2008. We accept the clinical records do not disclose any such investigation. As with other patients, and consistent with our findings that Arimidex was prescribed for a condition caused by the testosterone injections we find this particular proved. 7. Even if Dr Conway's view that the practitioner should have allowed a longer period of washout of three months is rejected, based on her earlier evidence of appropriate washout periods, the particular is not limited to June 2008 but rather various dates between August 2008 and August 2009. Even though we acknowledge there is some limited literature support for the use of androgens in HIV, accepting as proper the evidence given by Dr Coleman in response to questions in cross-examination by Ms Eastman, we are satisfied Particular 5 is established. It follows, for reasons earlier given, we also find particular 1 established. 8. In considering particular 19, we think it is important to note the practitioner's evidence to questions in cross-examination relevant to this particular as follows: Q. Did he tell you on this occasion or was it sometime later that the nature of his home detention meant that he could only go to the city gym under supervision? . Q. That appears on 11/9/08 on page 17? A. Yes. Q. But he had told you, hadn't he that his source of supply of the anabolics had come from the gym? A. I think he did ‑ is it written down somewhere? MR GREENWOOD: I think your Honour that's documented about a third of way down page 14 in your typewritten notes. MS EASTMAN Q. "He does obtain testosterone, Primoteston, Sustanon, from the gym"? A. Well, then he would have told me that, or he used to. Q. Did it occur to you that if that was the source of his supply and that he could only attend the gym under supervision, that he was looking to you as a substitute to supply with the anabolics that he wanted, that he would otherwise get from the gym, did that occur to you? A. The reason I took ‑ oh look I ‑ answering that question, all right, let me just answer it: I knew that he couldn't get it from the gym because he was under supervision and I took him on to help him during this difficult time of his. Q. By helping him you mean giving him the steroids that he couldn't otherwise get from the gym? A. Yeah, and therefore improving his symptoms which were quite marked. I don't discriminate, I don't want to discriminate against patients just because they have done something wrong or ‑ I basically wanted to help him. I really didn't see that this was a problem. (transcript 8 December p 840) 1. It is also relevant that we refer to the answers given later in cross-examination by the practitioner. The following exchange occurred between the practitioner and Ms Eastman about the practitioner's rationale for treating this patient: Q. Did not that information that he had been a body builder over that period of time cause you further alarm that this is a person who was and had been an anabolic abuser? A. I don't know what more to say except that he freely gave me that information about his steroid abuse. I saw that he was having real problems not being on steroids, and I wanted to support him during this difficult time. Now if you think I should have just let him go and suffer, and that could have been an approach, you know, I prefer to help him. Q. At this point in time, so September 08, had you had any clinical experience in helping a person cease anabolics in the sense that you had experience treating past anabolic abusers, and worked with them in a program to clean them out and to cease their use of anabolics, had you had any experience? A. Not really. (transcript 8 December 2014 at 845) 1. The practitioner's own evidence set out above demonstrated to us that she lacked appropriate judgment and objectivity in her treatment of this patient. We find her conduct in prescribing for this patient after his initial washout period, and particularly after she must have known he was obtaining drugs from other sources in July 2009, was not, as described by Dr Coleman "brave". Taking the practitioner's evidence at its highest she was naïve and her compassion was misplaced. Her treatment showed a lack of sensible objectivity which should be expected of a specialist of this practitioner's training and experience. We are satisfied, having regard to the clinical records and the practitioner's own evidence in response to questions in cross examination, that Particular 19 is established. Patient CG 1. This patient was seen first by the practitioner in February 2007, but later returned to consult the practitioner who treated him for a period of three months. At this time he was aged 42 years. The patient presented with a history of using testosterone from an unknown source for the previous five years. In the questionnaire completed when he first attended the practitioner the patient explained that he hoped from his visit to the practitioner that he would "become fitter, healthier and bigger". 2. The complaint contains seven particulars in respect of this patient. 3. The practitioner notes that there was no referring practitioner. We accept that assertion is consistent with the clinical records. Particular 22 is not established. 4. The practitioner also concedes in part Particulars 9 and Particular 24. 5. We note that the practitioner asserts she was treating this patient for difficulties flexing and rotating his right elbow but she concedes she carried out no physical examination. The notes also disclose that she prescribed HGH prior to the receipt of blood results. Having regard to these two factors and the practitioner's concessions that her notes do not adequately disclose her clinical judgment for the treatment regime we are satisfied that Particulars 9 and 24 are established. 6. No concessions are made by the practitioner in respect of the remaining four particulars. Particulars 3 and 5 assert inappropriate prescribing of HGH and testosterone. Particular 12 asserts the practitioner failed to exclude pituitary disease before prescribing HGH. Particular 20 asserts the practitioner, between defined dates, prescribed HGH and testosterone enanthate to Patient CG in circumstances where he had a history of using anabolic steroids and without sufficient clinically indicated investigation. 7. In response to the question "were the indications for HGH and testosterone enanthate present in this patient" Dr Conway in the schedule to her supplementary report noted: No. Inadequate history and no examination. However original notes state he had been using weekly Sustanon and nandrolone [Deca-Durabolin] for 5 years so appears to be an anabolic steroid abuser. No documented indication for HGH. 1. Dr Conway pointed out that the patient's marked polycythaemia was a contraindication for HGH and testosterone enanthate. She noted the prescribing was excessive (a fact conceded by the practitioner). She also comments: There is one almost undetectable testosterone level with undectable LH and FSH. Comment that patient has been on both Sustanon and Primoteston so these probably reflect that but if not suggest hypothalamic or pituitary disease which should have been investigated. Patient was polycythaemic at presentation and no evidence that this was investigated or treated. 1. Dr Conway corrected this statement in her oral evidence acknowledging she had made a mistake and the patient was only prescribed Primosteston every three weeks. She also expanded her earlier evidence about investigation for pituitary disease explaining: WITNESS CONWAY: Right, thank you, Dr Coleman. Yes, a PCV of March 08 point 56, hematocrit PCV .56. Which is certainly up there and something which you would need to consider whether venesection was necessary, although appropriate treatment would be to withdraw the testosterone or reduce the testosterone if it wasn't indicated. 1. Dr Coleman only makes brief reference to this patient in his report. Having noted the patient had low levels of LH and testosterone on 5 consultations, most likely due to testosterone injections two weeks prior to blood count, he opined a pituitary cause would therefore be unlikely. 2. In his oral evidence Dr Coleman opined, based on the patient's blood results obtained before the first consultation that "the results were consistent with someone who has been on long term anabolic steroids". 3. Dr Coleman's answers given in cross examination and in response to questions asked by Mr Greenwood were candid and we would say appropriate. He gave minimal support for the practitioner's treatment of this patient. He said: WITNESS COLEMAN: I would have thought that after five years of weekly Nandrolone and Sustanon that if those problems were going to actually improve with anabolic steroids they should have done by now and maybe there was some other way of regarding him. But in terms of the additional use of growth hormone, his levels were in the bottom quartile. I think it's very unlikely that he's going to have pituitary disease given the other results that we've got and you could make a case for giving him growth hormone for those symptoms but you know, I think that he has done as much as he can with anabolic steroid replacement and I think it's appropriate to start reducing the dose from weekly to three weekly. Discussion and conclusions 1. It is convenient that we deal with Particulars 3 and 5 concurrently. We find, accepting Dr Conway's evidence and the general tenor of Dr Coleman's evidence, that there was no clinical justification to prescribe HGH or testosterone for this patient, a known long term anabolic user. The treatment rationale is hard to reconcile with the patient's report of why he was seeking treatment set out in his questionnaire. 2. Dr Coleman agreed that prescribing for a previous testosterone user for the purpose of becoming fitter, healthier was not a proper clinical basis for prescribing HGH and testosterone. We agree. That evidence is consistent with Dr Conway's evidence, as corrected, which we accept in its entirety in respect of this patient. 3. We agree with the submissions of the HCCC at [335] that this was a patient who wanted HGH and testosterone, and who reported feeling terrific when he got want he wanted. 4. We are also satisfied that Particular 20 is established. The evidence, or more relevantly lack thereof, in the clinical records provides ample support for finding this particular proved. 5. We had some difficulty in light of Dr Conway's oral evidence and that of Dr Coleman about excluding pituitary disease before prescribing HGH for this patient. Both experts were firm in their views that the most likely cause of the patient's blood results was because of his long term anabolic use. Those views are consistent with the practitioner's response to Dr Conway's criticisms in Schedule B to her statement. Dr Conway noted the need to assess testicular volumes as part of the necessary investigation. It is clear that did not occur. Dr Conway did recommend a period of washout, and then assessment prior to investigation of pituitary disease. We also note the practitioner's concession made in response to a question from Professor Chisholm that a longer washout period could have occurred. We accept this was the appropriate prudent clinical management of this patient. Accepting that evidence we are satisfied that Particular 12 is established. 6. We find the patient's presenting blood results, history and questionnaire plainly put the practitioner on notice that this patient was an anabolic abuser. Particular 20 is established Patient CH 1. This patient was aged 31 years when seen by the practitioner in 2007. He did not complete a questionnaire at that time. He had consulted the practitioner initially in 2001 and was seen by her intermittently up to 2004. He returned to consult the patient again 2008. 2. Like the experts we had difficulty in determining the complaints about this patient because this patient's notes during the relevant period were sparse for many relevant dates. 3. There are six particulars in the complaint relevant to this patient. The practitioner disputes there was a referring doctor and that Particular 22 is not established. However the clinical notes at page 57 contain a referral from Dr Quan. We find the particular is established. 4. The practitioner concedes, in part, the particular relevant to her clinical notes. Consistent with our earlier findings about the practitioner's records and their noncompliance with the regulation, we are satisfied that particular 24 is established. We are also satisfied Particular 9 which relates to inadequate investigations prior to prescribing and which is conceded, in part, by the practitioner is proved. 5. The practitioner also concedes Particular 8 which relates to excessive prescribing of testosterone. Again, consistent with our earlier findings on this topic we accept this concession is an appropriate one and that the particular is established to the requisite civil standard. 6. The remaining two particulars relate to the practitioner's prescribing of HGH and testosterone for this patient. 7. The practitioner asserts in Schedule B to her statement that the patient's presenting problems were low mood, lack of motivation, weight gain, decreased energy, decreased libido, erectile dysfunction and self-doubting. In the submissions filed on behalf of the practitioner it is asserted HGH was prescribed to help increase the patient's energy levels "and hopefully start feeling better and eating better". The submissions go on, inconsistently with the Schedule to the practitioner' statement to note "[b]eing a slight man, he was happy with some weight gain experienced on the treatment". 8. Dr Conway notes that the patient's records were difficult to interpret. She also notes "[f]irst recorded testosterone is high, normal IGF-1 with no history of pituitary disease". 9. Dr Coleman, after noting the patient's original notes were not available, explained in the past the patient had received intermittent treatment with HGH and testosterone "but the prescribing doctor was not made clear from the notes". He also explained that the patient's blood results showed an elevated oestrogen and low LH "suggesting recent treatment". He also noted "[o]n 1 February 2007 he had an elevated testosterone secondary to exogenous treatment". Discussion and conclusions 1. It is convenient that we discussed the two inappropriate prescribing complaints concurrently. 2. As a starting point of our discussion about this patient we note that in cross-examination Dr Coleman agreed that when the patient represented in 2007 and his blood results indicated he had been on treatment that he had assumed there had been a prescribing doctor rather than the fact the patient may have been self-managing. Absent any conclusive evidence about the patient's history in the two years preceding 2007 it would be unsafe for us to make any finding he was illegally obtained anabolics in that period. 3. The practitioner's evidence about this patient was vague and she understandably lacked recollection of her treatment given six or seven years previously. 4. The HCCC submits in respect of the practitioner's prescribing of HGH that "the available evidence points to the [practitioner] simply continuing without any review or investigations of changed circumstances or symptoms since the previous period of treatment (for which there are limited records)". Similar submissions are made in respect of the practitioner's prescription of testosterone also noting that "the Tribunal should be slow to accept the changing justifications advanced by the [practitioner] with respect to her treatment of this patient". 5. Like the experts we found it difficult to interpret the clinical notes for this patient, and there was little relevant evidence, including expert evidence, before us. While it is likely, particularly in light of the particulars conceded by the practitioner in respect of this patient, that the prescribing was inappropriate, we find it would be unsafe for us to conclude to the Briginshaw standard that these particulars are established. Patient CJ 1. This patient was first seen by the practitioner in 2001 when he was aged 46. He continued to be treated by her until 2005. He was again referred to the practitioner by Dr Quan in 2007. The referring doctor provided information about the patient's then medications and that he was using Viagra. He was treated until 2007. The patient developed polycythaemia whilst being treated during this period. 2. The complaint contains five particulars in respect of this patient. 3. The practitioner concedes, in part, Particular 9 (failing to conduct adequate investigations before prescribing). We find this particular is proved. The practitioner did not conduct a physical examination of the patient when he represented in 2007. We find she simply continued treatment without adequate investigation of whether the patient was lying to her, or properly investigating inconsistencies in his reporting about prior testosterone use. 4. The practitioner concedes she did not report to the referring doctor. We accept the practitioner's concession in respect of this particular is properly made. 5. The practitioner also acknowledges the deficiencies in her medical records. She notes that she did not take a full history when the patient returned in 2007, and that "the rationale for her treatment with testosterone from April 2007 could have been more clearly stated". Consistent with our earlier findings we are satisfied that the medical records in respect of this patient did not comply with the regulation and this particular is established. 6. The two disputed particulars are Particular 5 (asserted inappropriate prescribing of testosterone) and Particular 6(j). This latter particular relates to the asserted prescribing testosterone enanthate when contraindicated because the patient had polycythaemia or developed polycythaemia during the practitioner's treatment of him. 7. Dr Conway opines in the schedule to her supplementary report that there were no indications for the prescribing of testosterone for this patient who had a normal testosterone (13.1 nmol/L at presentation with normal LH). We pause to note the blood tests referred to in the practitioner's schedule are those for 2001. 8. Dr Conway commented in her schedule as follows: This patient became markedly polycythaemic on treatment, and when this occurred, suggested that he arrange for a friend working at the Blood Bank to organise venesection. In treating genuine androgen deficiency appropriate management is to refer to haematologist to establish cause of polycythaemia and then reasonable to continue treatment with venesection. If diagnosis of androgen deficiency is not well established as appears to be the case in this man treatment should be stopped. 1. Dr Coleman, relying on the practitioner's summary in the schedule to her statement, explained that the patient "seemed to do well from the primary presenting symptoms". However, he noted as "standard procedure" monitoring for increased haematocrit for those on testosterone supplementation. He went on to opine "[r]educing the dose of testosterone supplementation and carefully monitoring the patient in this setting is the optimal approach". 2. In his oral evidence (transcript 1 December 2014 p 480) Dr Coleman agreed that the practitioner's treatment log for the patient was "an inadequate note for prescribing [testosterone] on each occasion". He also indicated earlier in his evidence that the patient's history indicated that the practitioner should herself have made enquiries about risk of cardiovascular disease. 3. Dr Coleman, while supporting a treatment rationale for the patient's symptoms reported in 2001, said, referring to the clinical notes, "but it's really hard to follow progress" (transcript 1 December 2014 page 481). 4. In an exchange with Dr Ilbery, Dr Coleman pointed out the risks of "not following up" if the patient's haemoglobin and haematocrit remained elevated included missing a diagnosis and increasing risk of clot-ability which could lead to stroke or an infarct "particularly if he became dehydrated on a setting of a high haematocrit" (transcript 1 December 2014 page 485). Discussion and conclusions 1. The practitioner explains in the schedule to her statement that her rationale for treating this patient was "to repeat the outcome from the 2001 treatment". She also notes her treatment was to "improve vitality, mood, fatigue and sexual function". 2. In support of its assertions in respect of Particular 5, the HCCC disputes the practitioner's claim that the patient had a low level of testosterone when he returned for further treatment in 2007. It is noted that the patient's testosterone level was at 14.3 in a range of (7-30.00). It is further noted, although the practitioner did not use a nomogram as a diagnostic tool in 2007, when the patient's results were retrospectively plotted on a nomogram the range was between borderline and mid-normal. 3. The HCCC notes the submissions filed on behalf of the practitioner at [803] record that the practitioner considered that "supplementation might assist [Patient CJ] with his overall health and help motivate him to train and lose some weight which were some of his complaints". It is submitted by the HCCC that these were not appropriate or proper grounds for prescribing testosterone. The submissions go on to note that the practitioner seeks to justify her treatment by subjective comments of the patient three weeks after treatment first resumed, but then feedback is limited to recording comments such as "feels great" or "feels very well". 4. We are satisfied that from our examination of the clinical notes, and accepting as we do, the evidence of Dr Conway, that this particular is established. In so finding and rejecting Dr Coleman's opinion on this topic, we note in fairness that his evidence must be considered in the light of the fact that Dr Coleman, in reaching his conclusions, took into account presenting symptoms in 2001 and the practitioner's explanations in her statement. We are satisfied Particular 5 is established. 5. In considering Particular 6(i) we place significant weight on Dr Conway's evidence about what is appropriate treatment for a patient with polycythaemia. Her evidence was generally supported by that of Dr Coleman in his oral evidence. 6. We find that the practitioner's justification for not referring the patient to a specialist, or ceasing to administer testosterone, is not established. The practitioner sought to support her clinical management of this patient, who refused venesection on the basis he would not be accepted as a blood donor, by supporting the patient's suggestion he rely on seeing a "friend" at the blood bank. This was, in our view, entirely inadequate management of this patient's polycythaemia. We accept Dr Conway's evidence that the testosterone treatment should have stopped. This particular is established. Patient CK 1. Patient CK first saw the practitioner in June 2009 when he was aged 50 years. His history disclosed that he suffered weight loss subsequent to treatment for Hepatitis C during the twelve months prior to seeing the practitioner. He reported decreased energy and erectile dysfunction. He reported being a boxer in the past. 2. The patient was only seen by the practitioner for a short time. She prescribed Arimidex, HGH, and testosterone. 3. This patient's blood tests revealed a low testosterone 2.6 (reference range 10-28) and undetectable LH and FSH. Both the practitioner and Dr Conway agree these tests were suggestive of recent testosterone administration. Further the patient's results revealed he was suffering polycythaemia at presentation. 4. There are seven particulars in the complaint in respect of this patient. The practitioner disputes that the patient was referred by a referring doctor. That assertion accords with the clinical records. We accept this particular is not established. The practitioner also concedes she was in error in not allowing a washout period before prescribing testosterone for this patient who was described by Dr Conway as "markedly polycythaemic at presentation". We accept that the concession by the practitioner is appropriate and that Particular 6(j) is established. 5. As with other patients, the practitioner makes partial concessions concerning her failure to make adequate investigations prior to prescribing. In the case of this patient we are satisfied the complaint is proved. This patient presented, as recognised by the practitioner, with blood results which indicated recent anabolic use and polycythaemia, but no proper investigation or inquiry was pursued by the practitioner. We are satisfied that Particular 9 is established. We are also satisfied that the practitioner's records were deficient and did not comply with the regulations. We are satisfied that Particular 24 is established. 6. The remaining three particulars relate to the practitioner's asserted inappropriate prescribing of Armidex, HGH and testosterone. 7. Dr Conway noted in the schedule to her report there was no clinical rationale for prescribing in the manner conducted by the practitioner for this patient. 8. Dr Coleman's report does little more than set out the facts. He does, however, opine that the patient's blood results "suggest he had probably been excessively treated with testosterone." In his oral evidence Dr Coleman agreed the patient's blood results indicated at the time of first treatment he was "certainly an anabolic user at that time". Discussion and conclusions 1. We accept Dr Conway's evidence that there was no rational clinical basis for prescribing for this patient who was clearly an anabolic user at presentation. 2. We accept the submission of the HCCC at [352] of the written submissions, which is consistent with the clinical records, that the practitioner did not examine the patient. There was no suggestion he was suffering gynecomastia, but the practitioner did not explore why the patient's oestradiol levels were elevated, but simply prescribed Armidex as part of the treatment regime for him. 3. We are satisfied that Particular 1 is established. 4. The expert evidence in respect of the practitioner's prescribing of HGH was scant. 5. The HCCC refers to the submissions filed on behalf of the practitioner which state "[the practitioner] considered hormone supplementation might help [Patient CK] to regain some mass and strength after being on treatment for Hepatitis C" and that he might benefit from a boost to his immune function. The HCCC submits there is no evidence that HGH has any relevant benefit for a patient suffering Hepatitis C. It is also submitted that, as the patient's weight was recorded at 103kg, there was no evidence to support an assertion of wasting. It is also submitted that there is no evidence of HGH "boosting" immune function. 6. While we note the matters raised in the HCCC's submissions were not put to either expert, nor was the practitioner's rationale for prescribing HGH the subject of any questioning of Dr Conway, she did state in her report that HGH was not indicated. We find that the practitioner's claim that the rationale of HGH increasing the patient's weight, given his recorded weight, is not sustainable on the evidence. 7. Balancing the rather scant evidence on this particular in respect of immune function, and the concise opinion of Dr Conway, and the issue of the patient's weight, we conclude the evidence is just sufficient to establish the particular. 8. There was significantly more evidence available to us about the practitioner's prescribing of testosterone. We commence our discussion by noting the practitioner's concession that it was inappropriate to prescribe testosterone for this patient when she concedes Particular 9 in respect of the diagnosis of polycythaemia. 9. We accept Dr Conway's evidence and that of Dr Coleman that the patient's blood results clearly supported a finding this patient had been using anabolics when he presented to the practitioner and that extreme caution and a proper clinical assessment was required before prescribing to such a patient. 10. We agree with the submissions made on behalf of the HCCC that the practitioner's assertion that the patient may have had a traumatic brain injury to justify her prescribing is speculative. It is not a matter the practitioner's clinical notes suggest she investigated in any proper way before prescribing testosterone. We are satisfied that Particular 5 is established. Consistent with our earlier findings we are also satisfied that Particular 1 is established Conclusions in respect of the particulars set out in the complaint. 1. At the commencement of these reasons we explained, that we have, for clarity and ease of dealing with the voluminous patient records and the sheer number of particulars requiring factual findings, adopted a hybrid approach to the particulars. As is apparent from our findings, on many occasions evaluating the evidence and making findings about individual particulars in respect of named drugs was an artificial exercise because of the need to "stand back" and look at the practitioner's overall clinical treatment of a particular patient, and the interaction or co-dependence of the drugs prescribed. A clear example of the latter is the practitioner's prescribing of Arimidex in conjunction with the prescribing of testosterone. 2. We now summarise our findings in respect of each of the 24 particulars as they relate to the named patients for each particular. 3. Given there are some particulars where up to all forty patients are named it is practical to only refer to those named patients where, based on our detailed findings in respect of that patient, we find the particular was not established. 4. Particular 1 was established in respect of all patients set out in the particular except for patient I. 5. Particular 2, which relates to the prescribing of Pregnyl, was established in respect of all patients named in the complaint. 6. Particular 3, which relates to both prescribing and establishing the patient had growth hormone deficiency by reference to accepted tests, before prescribing HGH was established in respect of all patients named in the complaint except Patients BV and CH. 7. Particular 4, which asserts to the prescribing of Deca-Durabolin which did not accord with a recognised therapeutic standard of what was appropriate in the circumstances in breach of the relevant standard and without exercising responsible medical judgment, was established in respect of all patients named in the complaint except Patients H and BV. 8. Particular 5, which asserts to the prescribing of testosterone and or testosterone enanthate on the same basis as asserted in particular 4, is established in respect of all patients named in the complaint except CH. 9. Particular 6(a) which relates to prescribing for HGH for Patient A when she had a history of non gestational diabetes is not established. 10. Particular 6(b) was abandoned in the amended complaint 11. Particular 6(c), which relates to prescribing injectable hormonal agents (testosterone or testosterone enanthate) to Patient AF when he was on anticoagulant medication, is not established. 12. Particular 6(d), which relates to Patient AX being prescribed injectable testosterone enanthate, whilst the Patient was on Warfarin, is not established. 13. Particular 6(e), which relates to the practitioner prescribing injectable testosterone enanthate to Patient BA, is established. 14. Particular 6(f), which relates to the practitioner prescribing testosterone enanthate to Patient R while his female partner may have been trying to get pregnant and when the clinical notes indicate the partner had suffered a miscarriage, is not established. 15. Particular 6(g), which relates to the practitioner's asserted inappropriate prescribing of testosterone enanthate to Patient AX when he had a known prostate hyperplasia, is not established. 16. Particular 6(h) which relates to the practitoner's asserted inappropriate prescribing of testosterone or testosterone enanthe to Patient AR when he had, or developed polycythaemia during treatment, is established. 17. Particular 6(i), which relates to the practitioner's prescribing testosterone enanthate to Patient CJ when he had polycythaemia, is established. 18. Particular 6(j), which relates to the practitioner's prescribing of testosterone enanthate to Patient CK when he had polycythaemia, is admitted by the practitioner and found proved by us. 19. Particular 7 relates to excessive doses of testosterone in respect of Patients B, C, V, AR, AY, BB, BW, CF and CH. The practitioner in her oral evidence conceded this particular was established. We were independently satisfied that the particular is established in respect of each of the named patients. 20. Particular 9 relates to failure to adequately conduct investigations in respect of all forty patients named in the complaint prior to prescribing for them. We note the practitioner's concessions in part in respect of this particular. We have found the particular established in respect of all forty patients. The practitioner's conduct as asserted in this particular attracted Dr Conway's strong criticism. We agree with and accept that criticism is warranted. The practitioner did not conduct physical examinations, did not inquire to any satisfactory degree about patients in respect of whom she should, in accordance with the Medical Board policy and the PSB statement, have exercised extreme diligence and care. 21. Particular 10 relates to the asserted failure to exclude prostate disease before prescribing for Patient T who had a high PSA prior to the practitioner prescribing testosterone enanthate for him. This particular is established. 22. Particular 11 relates to the asserted failure to exclude prostate disease in respect of Patient AP, who was seeing a urologist for an enlarged prostate prior to prescribing testosterone enanthate. This particular is not established. 23. Particular 12 relates to the asserted failure to exclude pituitary disease in Patient CG prior to prescribing HGH for the patient. This particular is established. 24. Particular 13 asserts the practitioner failed, between specified dates, to exclude pituitary disease in Patient BY prior to prescribing HGH. We find this particular is established. 25. Particular 14 asserts the practitioner failed, between specified dates, to investigate high creatinine levels in Patient Z. This particular is conceded by the practitioner. We independently find it is established. 26. Particular 15 asserts the practitioner failed, between specified dates, to investigate high creatinine levels in Patient BY is established. 27. Particulars 16, 17, 18, 19, 20 and 21 each assert between various named dates the practitioner prescribed various drugs (Armidex, HGH or HCG, and testosterone to Patients B, V, BW, CF and CG when each of these patients had a history of anabolic steroid abuse and without sufficient clinically indicated investigation. 28. We note the practitioner make an objection to the HCCC's reliance on these particulars noting for example in respect of Patient B he had a history of anabolic use rather than a history of anabolic abuse. It is unfortunate that complaint as framed is somewhat misleading. The heading to Particulars 16 to 21 is in the following terms "Prescribing medications to patients who may have been abusing anabolic steroids" (our emphasis) but the particular is framed as "in circumstances where he[the patient] had a history of abusing anabolic steroids and without sufficient clinically indicated investigation." (our emphasis) 29. We are conscious of the comments of McColl J in HCCC v King about the lack of strict pleadings in this jurisdiction, but note her Honour's emphasis on the necessity for a practitioner to know the case he or she has to meet from the complaint document. Given the time which has elapsed since the investigation of this complaint, the extensive hearing time, and particularly the consequences for the practitioner it is concerning that a discrepancy such as we have highlighted exists in the complaint. However, we here found in respect of this cohort of named patients that the distinction sought to be drawn in the practitioner's submissions is without practical merit for two reasons. First, we note the particular requires the satisfaction of two aspects of fact finding. It requires that the Tribunal is satisfied to the Briginshaw standard that the patient's history reasonably discloses the patient had abused anabolics before seeing or during the period of treatment by the practitioner. We find that illegal, or probable, illegal use of anabolics may be classified as "abuse" as the drug is not prescribed for a therapeutic purposes. Secondly, it is necessary that the Tribunal find that practitioner's prescribing for these named patients was without sufficient clinically indicated investigation. We find each limb of the particular is established in respect of Patients B, V, BW, CF, CG and AS. 30. Particular 22 relates to failure to provide reports to the referring practitioners for all forty patients. It is clear from the clinical notes that, in respect of many patients they self-referred or were referred by an acquaintance to the practitioner. The practitioner has readily conceded in the written submissions provided on her behalf Particular 22 in respect of those patients who were referred by doctors and we accept, with one exception, the concessions are appropriately made. Thus we accept this particular is established for all patients named in the complaint except Patients C, Y, AH, AK, AS, AT, AY, BB, BD, BH, BJ, BW, CA, CD, CG, CH, and CK. 31. Again, we note it is unfortunate that when the complaint was amended at the conclusion of the proceedings and leave was granted to that amendment that this particular was not also amended in conformity with the clinical notes. 32. Particular 23 relates to the practitioner's treatment of her partner "contrary to the NSW Medical Board Policy 'Medical Practitioners Treating Relatives and self". This particular is established. 33. Particular 24 asserts the practitioner failed to keep adequate medical records in accordance with the cited regulations in that she failed to record an adequate clinical history and/or results of a physical examination, to record her clinical judgment clearly in the records for prescribing for all patients named in the complaint, and to record either the drug and or the dose prescribed in the clinical records of all patients named in the complaint except her recording of drugs for Patient CF, and in respect of whom she was reporting to his Case Manager. We find this particular established in respect of each patient named in Particular 24. Unsatisfactory professional conduct 1. We commence our discussion of this aspect topic by noting that both in her oral evidence and in the submissions filed on her behalf that the practitioner acknowledged significant aspects of her conduct in treating of the cohort of named patients did not comply with s 139B(1)(b) of the National Law, namely that she failed to report to referring doctors and that she failed to keep proper medical records. 2. We have earlier in these reasons noted the concessions made by the practitioner in Ex 13 and later in her oral evidence particularly in relation to prescribing excessive doses of testosterone. She stated she does not now prescribe Sustanon and Primotestin simultaneously. The practitioner also stated she no longer prescribes Deca-Durabolin. 3. In her oral evidence (transcript 10 December 2014) the practitioner explained the nature of her present practice and said: Q. There'd be some patients that come with those symptoms, the general lethargy and low libido, who wouldn't get hormones? A. I think so, yes. My practice isn't the complaint period, my practice has evolved to a very positive practice, and I have changed my ways a lot. And I'm trying to make it as scientific as possible, and I'm just trying my best to help patients. 1. We infer from this and other similar statements made by the practitioner an acknowledgement that her treatment of patients named in the complaint during the complaint period was not always appropriate or necessarily scientifically based. 2. In assessing the practitioner's knowledge and skill to treat these forty patients as she did we accept she has no specialist qualifications in endocrinology, and that she has not worked since the early 2000's in conjunction with such a specialist. Nor does she have qualifications or experience in managing patients who are detoxifying, or ceasing anabolic steroid abuse. We are satisfied that at the relevant time she was ill equipped to treat a number of the patients who she purported to "manage". 3. We accept and agree with [48] of the HCCC's submissions which is as follows: Choosing to practice outside the mainstream does not absolve the practitioner from practising in accordance with the standards relevant to the field of speciality. 1. We accept Dr Conway's evidence of the standards applicable to a doctor who elects to practice in the diagnosis and treatment of hormone deficiency and/or imbalance. We add to Dr Conway's standards the words "whether on- or off-label, noting the standards assume particular importance for off-label prescribing". These standard require: 1. taking a full and relevant clinical history; 2. making a physical examination of the patient; 3. obtaining relevant pathology, including repeat tests to determine whether the patient has hormone or androgen deficiency; 4. investigating symptoms beyond generalised non-specific symptoms; 5. taking appropriate steps to investigate hypothalamic-pituitary tumour; 6. taking appropriate steps to exclude underlying conditions prior to commencing treatment; 7. appropriate monitoring and ongoing review, particularly for patients with known prostate disease; elevated creatinine levels or PSA levels; 8. communication with referring GP's and other specialists; 9. being aware of the practitioner's limitations and referring patients to appropriate specialists; 10. not acceding to the patient's wishes or demand for particular treatment (we would add "unless appropriate to do so"); 11. being aware of drug seeking behaviours and to refuse treatment to anabolic abusers (we would add "and if appropriate referring such patients to a practitioner experienced in drug withdrawal and/or a psychologist"); 12. identifying and understanding relevant regulatory obligations and clinical standards; 13. treating the patient on recognised evidence based medicine (we would add "or evidence based medicine recognised by a reputable minority of the profession"); 14. keeping appropriate clinical records including treatment plans (we would add "including to record drugs and quantity dispensed on each occasion"); 15. not prescribing in excessive quantities; 16. advising patients of risks, side effects ( we would add "and costs") of treatment ("and obtaining informed consent from the patient"); and 17. discontinuing ineffective treatment. Discussion and conclusions – unsatisfactory professional conduct 1. It is clear from our specific findings in respect of each particular that the practitioner frequently did not take a full clinical history for each patient, but rather relied on the questionnaire. We note particularly, where relevant, her failure to record weight gains and loss. We have also found for some patients she continued treating although the patient was non-compliant in having blood tests done when ordered. Before prescribing testosterone in some patients with a low testosterone level the practitioner failed to conduct an adequate washout to exclude pituitary disease. 2. It is significant that the practitioner failed to communicate with referring doctors, a practice she had previously observed. Those doctors were necessarily ignorant of the drugs prescribed by the practitioner, which could have led to adverse outcomes. 3. Our findings demonstrate that on many occasions patients who came to the practitioner knowing she prescribed hormones received them without proper clinical judgment and at the patient's request. The practitioner's assertion that she wanted to "help" these patients is not a proper rationale for her treatment of them. 4. It is only with hindsight that the practitioner is now prepared to acknowledge she should not have prescribed for one patient, an anabolic steroid abuser. We are satisfied that the practitioner ignored or turned a "blind eye" to patients' pathology results which raised "red flags" or when they self-reported steroid abuse. 5. The practitioner has acknowledged the deficiency in her clinical records. Those records during the relevant period were frequently woefully inadequate. We note that on occasions neither expert could comment effectively on a patient's treatment because of the poor state of the records. 6. It was only late in her cross-examination, and when pressed by Professor Chisholm, that the practitioner conceded that using both Sustanon and Primotestin simultaneously had the effect the relevant patients were receiving excessive doses of testosterone. The practitioner's conduct in this regard was, as we have earlier noted, at best experimental and was not based on any clinical study. Although the practitioner has abandoned this practice, her reluctance to concede excessive doses until late in the day was troubling to us. 7. We were particularly concerned that the practitioner treated Patient BA in the full knowledge of his cognitive difficulties in circumstances where he could not have properly assessed the risks and benefit from the proposed treatment. We find the practitioner's conduct in respect of this patient was improper and unethical. 8. Our specific findings, and our summary of our conclusions about the deficiencies in the practitioner's practices, satisfies us that the complaint of unsatisfactory professional conduct is established both in respect of the identified individual findings, but more particularly, in respect of the cumulative effect of those findings. That is, the conduct satisfied the meaning set out in s 139B(1), (a), (b) and (l) of the National Law. Professional misconduct 1. We have already set out the statutory definition of professional misconduct as found in the National Law. 2. Prior to the introduction of the National Law the concept of professional misconduct was discussed and its ramifications explained by Kirby P (as his Honour then was) in Pillai v Messiter (No 2) 1989 16 NSWLR 197. In that case the NSW Court of Appeal was dealing with an appeal from a decision of the Medical Tribunal of NSW. The Medical Tribunal had found a medical practitioner should be removed from the register for "misconduct in a professional sense" (the then relevant statutory provision). At the time of the hearing of the appeal against the Medical Tribunal's decision a new legislative provision had been enacted dealing with "professional misconduct". The new provision was inapplicable to the appeal. His Honour explained, without deciding, that then new statutory test for "professional misconduct" "may introduce a wider class of conduct than has hitherto been regarded as relevant". Kirby P went on to explain that the concept of "misconduct" may include: "gross negligence …particularly if accompanied by indifference to, or lack of concern for, the welfare of the patient". 3. His Honour further explained at 200: Departures from elementary and generally accepted standards, of which a medical practitioner could scarcely be heard to say that he or she was ignorant could amount to professional misconduct. But the statutory test is not met by mere professional incompetence or by deficiencies in the practice of the profession. Something more is required. It includes a deliberate departure from accepted standards or such serious negligence as, although not deliberate, to portray indifference and an abuse of the privileges which accompany registration as a medical practitioner. [citations omitted] 1. The recent cases discussing unsatisfactory professional conduct and professional misconduct focus on the wording of the relevant statute and have moved away from "the language of moral obloquy" referred to in earlier decisions with peers expressing their views "in terms of strong criticism rather than 'strong reprobation'" (see Lucire v Health Care Complaints Commission [2011] NSWCA 99; Donnelly v Health Care Complaints Commission (NSW) [2011] NSWSC 7). 2. We are also guided by, and respectfully adopt, the discussion of what constitutes professional misconduct in HCCC v Dr Denise Perroux [2011] NSWDC 99. At [18] the former Medical Tribunal said: The issue is whether, when the respondent's contraventions are considered as a whole, they are of a sufficiently serious nature to justify suspension or deregistration …s139E Heath Practitioner Regulation National Law (NSW). Characterisation is not to be determined by backward reasoning, first determining the appropriate outcome and then characterising the conduct based on the outcome. The definition of professional misconduct is focused on the nature of the conduct, which must have the capacity to justify such an order, whether or not such an order should be made in a particular case : Health Care Complaints Commission v Karalasingham [2007} NSWCA. 1. We are satisfied that the practitioner's unsatisfactory conduct in respect of this cohort of patients was serious. While the practitioner asserts no patient has complained or been injured as a result of the treatment, that is not the test. What is relevant is the nature of her conduct, its potential to place the public at risk, and that it constituted a serious departure in many respects from the appropriate standard of care to be expected of a practitioner of this doctor's specialist training and long experience. The breaches by the practitioner of the relevant regulations and codes were numerous. Those matters coupled with her failure to report to referring doctors, placed her patients at risk of adverse outcomes. We are satisfied the serious nature of her conduct, based on our findings in respect of unsatisfactory professional conduct, constitutes professional misconduct within the meaning set out in the National Law. The future conduct of the proceedings 1. We have not commented on the testimonials provided by the practitioner as we determined their relevance is best determined at the time we consider appropriate protective orders (Stage 2 proceedings). 2. We propose that this matter which deals with complaints in the period 2007-2009, should be listed as soon as possible to finalise the proceedings. ORDERS 1. The Stage 2 proceedings are listed for hearing on 16 and 17 April 2015 at 10am 2. The parties shall file and serve written submissions in respect of appropriate protective orders and costs on or before 13 April 2015. 3. The venue for the Stage 2 hearing is HPCA, Level 6, 477 Pitt Street Sydney. 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: 30 March 2015