By Amended Complaint filed 18 August 2022 the Health Care Complaints Commission (Commission) alleged that Dr Albina Teresa Della Bruna (Practitioner) had engaged in unsatisfactory professional conduct pursuant to s 139B(1)(a) or (l) of the Health Practitioner Regulation National Law (NSW) 2009 (National Law) in that:
1. the Practitioner had engaged in conduct that demonstrated the knowledge, skill or judgement possessed by the Practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; or
2. engaged in improper or unethical conduct relating to the practice or purported practice of medicine.
By her Reply, the Practitioner admitted that she was guilty of some of the unsatisfactory professional conduct alleged by the Commission, but disputed that she was guilty of all of the unsatisfactory professional conduct alleged by the Commission. The Commission alleged that, individually or cumulatively, the unsatisfactory professional conduct of the Practitioner was of a sufficiently serious nature to constitute professional misconduct pursuant to s 139E of the National Law. The Practitioner denied that she was guilty of professional misconduct.
The Commission alleged that the Practitioner failed to make and keep adequate records in relation to ten patients. The Practitioner's prescribing for those patients was alleged to have fallen significantly below the standard of knowledge, skill or judgment reasonably expected of her. The Practitioner denied those allegations. The Practitioner admitted that she was guilty of unsatisfactory professional conduct pursuant to s 139B(1)(b) of the National Law (Complaint 2) in that, by failing to maintain adequate clinical records, she had contravened a provision of the Health Practitioner Regulation (NSW) Regulation 2016 (NSW Regulation).
I have read in draft form the reasons for decision of the other members of the Tribunal who heard this case ("the majority"). I am unable to agree with the decision of the majority with respect to the Commission's disputed complaints. Set out below are the reasons for such disagreement.
The Practitioner graduated MBBS from the University of Melbourne and was first registered as a medical practitioner in 1991. The Practitioner worked as an Emergency Registrar, an Intensive Care Registrar and a Medical Registrar at various hospitals for approximately 10 years. Since 2003, the Practitioner has divided her time between cosmetic and general practice and working as a CMO at Prince of Wales Private Hospital. The Practitioner currently runs her private practice out of two premises in Bondi Junction, where she is the sole medical practitioner, and Pyrmont, where she practices with other contracted medical practitioners.
The Commission's disputed Complaint relates to the Practitioner's prescribing and management of prescriptions of on label and/or "off label" "restricted substances" (as that term is defined in the Poisons and Therapeutic Goods Act 1966 (NSW) (the PTGA)) to the ten patients named in the Complaint. Annexed to the Complaint was a schedule of the drugs prescribed by the Practitioner for each of those ten patients, and the dates on which they were prescribed. The accuracy of that document has not been disputed. The restricted substances prescribed to the Practitioner's patients fell into three categories:
1. drugs contained in Schedule 4 of the Poisons List proclaimed under s 8 of the PTGA (Schedule 4 drugs);
2. drugs contained in Appendix B of the Poisons and Therapeutic Goods Regulation 2008 (NSW) (PTGR) (Schedule 4B drugs); and
3. drugs contained in Appendix D of the Poisons and Therapeutic Goods Regulation 2008 (NSW) (the PTGR) (Schedule 4D drugs).
The Commission alleged that between 1 June 2018 and 30 June 2019 the Practitioner purchased quantities of a Schedule 4D drug, namely Somatotropin/SciTropin (HGH) directly from the wholesaler supplier SciGen (Australia) Pty Limited. Those allegations have not been disputed. The Commission alleged that for the purposes of the particulars of the Complaint the recognised therapeutic standard of what was appropriate in the circumstances included:
"(a) the full prescribing information published by MIMS Australia for the relevant drug at the relevant time;
(b) the product and consumer medicine information published by the Therapeutic Goods Association for the relevant drug at the relevant time;
(c) the Medical Board of Australia "Good medical practice: code of conduct for doctors in Australia" issued March 2014."
The Practitioner did not dispute the details of her prescribing of restricted substances alleged by the Commission. In her Reply the Practitioner said, correctly, that none of the prescribing which gave rise to the Commission's complaint was illegal. The Practitioner also said, correctly, that none of the ten patients referred to in the Commission's complaint had made a complaint about her prescribing for, or treatment of them.
The Practitioner said that her "intention and my interest in anti-ageing and wellness medicine and wellbeing is always directed towards helping" her patients in general, and helping the ten patients whose prescribing is relied upon by the Commission. The Practitioner stated that all her patients were "informed and fully consented to any treatment" which she provided, and were "interested in many aspects of wellness, and non-conventional approaches that cosmetic and other areas of medicine has to offer". There is no evidence contradicting those statements. The Practitioner stated that she kept her patients "under review" and was "alert to any development of adverse reactions or complications". Examination of the Practitioner's "review" of her prescribing for the ten patients formed the focus of forensic inquiry at the hearing of these proceedings.
It is appropriate to record the Commission's allegations, and the Practitioner's response with respect to the ten patients.
[2]
Patient A
The Commission alleged that:
"1 Between 12 December 2017 and 1 July 2019 the Practitioner Inappropriately prescribed the Schedule 4D drug Somatotropin (HGH) and the Schedule 4 drug Pregnenolone to Patient A as recorded in the schedule of prescriptions attached to the Amended Complaint in circumstances where the drugs were prescribed for "off label" purposes.
2 Between 12 December 2017 and 1 July 2019, the Practitioner failed to appropriately manage the prescribing of the drugs listed in particular 2 and/or the Schedule 4B drug Dehydroepiandrosterone (DHEA) to Patient A, in circumstances where they were prescribed for "off label" purposes."
The Practitioner admitted the prescribing, but denied that the prescribing was inappropriate, or that she had failed to appropriately manage the prescribing of the drugs.
[3]
Patient B
The Commission alleged that:
"1 Between 22 March 2018 and 6 November 2019 the Practitioner inappropriately prescribed the Schedule 4D drugs Somatotropin (HGH), Testosterone and Mesterolone to Patient B as set out in the Annexure to the Amended Complaint in circumstances where the drugs were prescribed for "off label" purposes.
2 Between 22 March 2018 and 6 November 2019 the Practitioner failed to appropriately manage the prescribing of the drugs which had been prescribed for Patient B in circumstances where they were prescribed for "off label" purposes."
The Practitioner admitted the alleged prescribing, but denied that the prescribing was inappropriate, or that she had failed to appropriately manage the prescribing of the drugs.
[4]
Patient C
The Commission alleged that:
"1 Between 29 January 2019 and 4 November 2019 the Practitioner inappropriately prescribed the Schedule 4D drug Somatotropin (HCH) and the Schedule 4 drug Anastrozole to Patient C as set out in the schedule of prescribing annexed to the Amended Complaint in circumstances where the drugs were prescribed for "off label" purposes.
2 Between 29 January 2019 and 4 November 2019 the Practitioner failed to appropriately manage the prescribing of the drugs prescribed for Patient C in circumstances where they were prescribed for "off label" purposes."
The Practitioner admitted the alleged prescribing, but denied that the prescribing was inappropriate, or that she had failed to appropriately manage the prescribing of the drugs.
[5]
Patient D
The Commission alleged with respect to Patient D that:
"1 Between 2 June 2017 and 16 October 2019 the Practitioner inappropriately prescribed the Schedule 4D Somatotropin (HGH) and the Schedule 4B Progesterone (DHEA) plus Triest to Patient D as set out in the schedule of prescriptions annexed to the Amended Complaint in circumstances where the drugs were prescribed for "off label" purposes.
2 Between 2 June 2017 and 16 October 2019 the Practitioner failed to appropriately manage the prescribing of the drugs prescribed for Patient D in circumstances where they were prescribed for "off label" purposes."
The Practitioner admitted the alleged prescribing, but denied that the prescribing was inappropriate, or that she had failed to appropriately manage the prescribing of the drugs.
[6]
Patient E
The Commission alleged that:
"1 Between 7 June 2017 and 16 October 2019 the Practitioner inappropriately prescribed the Schedule 4D drug Somatotropin (HGH) to Patient E as set out in the prescribing schedule annexed to the Amended Complaint where the drugs were prescribed for "off label" purposes.
2 Between 7 June 2017 and 16 October 2019 the Practitioner failed to appropriately manage the prescribing of the drugs prescribed for Patient E in circumstances where they were prescribed for "off label" purposes."
The Practitioner admitted the alleged prescribing, but denied that the prescribing was inappropriate, or that she had failed to appropriately manage the prescribing of the drugs.
[7]
Patient F
The Commission alleged that:
"1 Between 11 July 2017 and 18 March 2020 the Practitioner inappropriately prescribed the Schedule 4D drug Somatotropin (HGH) to Patient F as set out in the prescribing schedule annexed to the Amended Complaint in circumstances where the drugs were prescribed for "off label" purposes.
2 Between 11 July 2017 and 18 March 2020 the Practitioner failed to appropriately manage the prescribing of the drugs for Patient F in circumstances where they were prescribed for "off label" purposes."
The Practitioner admitted the alleged prescribing, but denied that the prescribing was inappropriate, or that she had failed to appropriately manage the prescribing of the drugs.
[8]
Patient G
The Commission alleged that:
"1 Between 8 August 2017 and 10 March 2020 the Practitioner inappropriately prescribed the Schedule 4D drug Somatotropin (HGH) and Testosterone plus Dehydroepiandrosterone (DHPA) to Patient G as set out in the prescribing schedule annexed to the Amended Complaint in circumstances where the drugs were prescribed for "off label" purposes.
2 Between 8 August 2017 and 10 March 2020 the Practitioner failed to appropriately manage the prescribing of the drugs for Patient G in circumstances where they were prescribed for "off label" purposes."
The Practitioner admitted the alleged prescribing, but denied that the prescribing was inappropriate, or that she had failed to appropriately manage the prescribing of the drugs.
[9]
Patient H
The Commission alleged that:
"1 Between 3 October 2017 and 14 October 2019 the Practitioner inappropriately prescribed the Schedule 4D drugs Somatotropin (HGH) and Testosterone + DHEA + Mesterolone to Patient H as set out in the prescribing schedule annexed to the Amended Complaint in circumstances where the drugs were prescribed for "off label" purposes.
2 Between 3 October 2017 and 14 October 2019 the Practitioner failed to appropriately manage the prescribing of the drugs for Patient H in circumstances where they were prescribed for "off label" purposes.
The Practitioner admitted the alleged prescribing, but denied that the prescribing was inappropriate, or that she had failed to appropriately manage the prescribing of the drugs.
[10]
Patient I
The Commission alleged that:
"1 Between 19 December 2017 and 7 November 2019 the Practitioner inappropriately prescribed the Schedule 4D drug Somatotropin (HGH) and Mesterolone as well as the Schedule 4 drugs Anastrozole, Fluoxetine and Pregnenolone to Patient I as set out in the prescribing schedule annexed to the Amended Complaint in circumstances where the drugs were prescribed for "off label" purposes.
2 Between 19 December 2017 and 7 November 2019 the Practitioner failed to appropriately manage the prescribing of the drugs for Patient I in circumstances where they were prescribed for "off label" purposes."
The Practitioner admitted the alleged prescribing, but denied that the prescribing was inappropriate, or that she had failed to appropriately manage the prescribing of the drugs.
[11]
Patient J
The Commission alleged that:
"1 Between 8 July 2017 and 4 November 2019 the Practitioner inappropriately prescribed the Schedule 4D drug Dehydroepiandrosterone (DHEA) + Testosterone and Mesterolone to Patient J as set out in the prescribing schedule annexed to the Amended Complaint in circumstances where the drugs were prescribed for "off label" purposes.
2 Between 8 July 2017 and 4 November 2019 the Practitioner failed to appropriately manage the prescribing of the drugs for Patient J in circumstances where they were prescribed for "off label" purposes.
3 During the period of prescribing Patient J with the restricted substances referred to, the Practitioner prescribed Mersyndol Forte and Diazepam that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances, contrary to clause 34 of the PTGR, and having regard to the quantities prescribed, the dosage as prescribed and the frequency and duration of prescribing by the Practitioner."
The Practitioner admitted the prescribing, but denied that the prescribing was inappropriate, or that she had failed to appropriately manage the prescribing of the drugs. The Practitioner denied that it was "significantly below standard to prescribe once, or to prescribe an S4 medication however I concede that it is below standard to have prescribed the pain medication and Valium as often as I did in the circumstances, as breakthrough treatment. I do not admit it is significantly below standard to prescribe the troches".
The case proceeded on the basis that the term "off label" prescribing "occurs when a drug is prescribed for an indication, a route of administration, or a patient group that is not included in the approved production information document for that drug", and that "off label prescribing means that the Therapeutic Goods Administration (TGA) has not approved the indication, route of administration or patient group. It does not mean that the TGA has rejected the indication. Commonly the TGA has not been asked to evaluate the indication" (Practitioner's Exhibit R2 "Off Label Prescribing" the Australian Prescriber dated 2 December 2013). It was also agreed by reference to that article "that there is no legal impediment to prescribing off label, however the onus is on the prescriber to defend their prescription for an indication that is not listed in the product information. If, in the opinion of the prescriber, the off label prescription can be supported by reasonable quality evidence, for example the indication is identified in the Australian Medicines Handbook, the prescriber should proceed if this is in the patient's best interests".
Each of the Commission and the Practitioner relied upon expert opinion evidence, the testing of which preceded cross-examination of the Practitioner.
[12]
The evidence of Professor Carter relied on by the Commission
The Commission filed two volumes containing the documents on which it relied (Exhibit HCCC 1). The redactions in HCCC 1 reflected the Tribunal's earlier rulings on objections. The reports of Professor John Norman Carter, a specialist in endocrinology, comprised a redacted report dated 16 January 2021 (HCCC1, Tab 47), a report dated 23 May 2022 (HCCC1, Tab 52) and a further report dated 17 July 2022 (HCCC1, Tab 54).
In his report of 16 January 2021, after identifying the accepted therapeutic standards in terms of dosage and duration of prescribing Somatotropin, and the prescription of Anastrozole, DHDA, Mesterolone, Pregnenolone, Progesterone and Testosterone, Professor Carter said that it was apparent from the clinical notes provided to him that the Practitioner was not prescribing Somatotropin for GH (growth hormone) deficiency in her patients. He observed that "the actual reasons given vary from improvement in cognition, wellbeing, memory, concentration, sleep patterns, energy, wound healing and pain relief. Somatotropin has not been proven (in double blind, placebo controlled trials) to be of benefit in any of these situations". Professor Carter reiterated that it was "of concern that Dr Della Bruna prescribed Anastrozole, DHEA, Mesterolone, Pregnenolone and Progesterone in situations where there are no double blind, placebo controlled trials indicating benefit".
Annexed to Professor Carter's first report was a schedule relating to each of the ten patients whose prescriptions gave rise to the Commission's disputed complaint. In view of the way in which the case was conducted, I do not consider it necessary to refer to the schedule in detail. Both parties dealt substantially with the prescribing by reference to the drug prescribed, rather than, save with respect to patient J, to individual patients. In my view that approach was appropriate given the absence of evidence from any of the patients whose prescribing gave rise to the complaint, and the admitted deficiencies in the Practitioner's clinical records.
In his second reported dated 23 May 2022, Professor Carter reiterated his view that it was "inappropriate" to prescribe off label Somatotropin to adults on the basis that there were no double blind, placebo controlled clinical trials indicating benefits for adults who are not growth hormone deficient. Professor Carter suggested that "initially" the Practitioner should "have explained why she was prescribing off label GH, and she should have obtained and recorded informed consent in the clinical notes". Professor Carter was justifiably critical of the Practitioner's deficient clinical notes.
Professor Carter said that he held the same opinion with respect to the prescribing of the other drugs referred to in the Complaint as he did for Somatotropin "although some of those drugs (such as DHEA) have had extensive anecdotal usage without any obvious significant side effects".
In his report of 12 July 2022, Professor Carter reiterated his previously expressed concerns, including his view that prescribing Somatotropin and Pregnenolone was "significantly below the standard reasonably expected of a GP with equivalent training or experience". Professor Carter agreed that the Practitioner's clinical notes which he had by that time been shown indicated "that a moderately detailed history was taken and recorded" and that the complaint that resulted in the drug being prescribed was "outlined", although "the postulated reasons for prescribing" some of the drugs were not clearly recorded. Professor Carter reiterated that "the only evidence to suggest a clinical benefit of Somatotropin, Mesterolone, DHEA and Testosterone is anecdotal", and that it was inappropriate to prescribe Somatotropin, Mesterolone and Testosterone.
In cross-examination (Tcpt 28/3/2023 p28), Professor Carter agreed that it was "some 50 years ago or so" since he had been in general practice, his experience in that regard comprising "a couple of locums in general practice lasting 2 weeks". It is not in doubt that the standard required of the Practitioner was that of a general practitioner, not a specialist endocrinologist.
Professor Carter was cross-examined about publications which he considered to be relevant, and supportive of his adverse opinions of the Practitioner's prescribing. Professor Carter agreed (Tcpt 28/3/2023 p32) that, in none of his three reports had he made reference to "any literature, case study, double blinded, controlled placebo test". Although potentially relevant to the weight to be given to them, that absence, of itself, did not mean that, based on his experience and qualifications, Professor Carter could not express expert opinions about the matters requiring determination in these proceedings, or that such opinions were not entitled to significant weight.
Professor Carter agreed (Tcpt 28/3/2023 p33) that he had never practised in "cosmetic medicine" or in anti-ageing medicine". Professor Carter was asked whether he had "attended any national conferences where there were speakers addressing contemporaneous issues in anti-ageing medicine". Professor Carter required "No specific conferences relating to that subject … there have been occasional talks relating to ageing at endocrine conferences. Mainly international endocrine conferences, but I certainly have not attended a specific conference that related to anti-ageing medicines". Professor Carter agreed that he was unable to identify "by author" any journal articles which he had read engaging with "ageing in its context in the endocrine field". Professor Carter said that, prior to preparing his reports in these proceedings, he had "read every piece of information I could find relating to the effects of growth hormone in non-growth hormone deficient patients". With respect to him, although undoubtedly an eminent and respected endocrinologist, Professor Carter's cross-examination suggested that his expertise with respect to off label prescribing was relatively limited.
Professor Carter was referred to the article "Off label use of hormones as an anti-ageing strategy: a review" (Tab 59, HCCC1). Professor Carter was asked (Tcpt 28/3/2023 p38) with respect to the literature which he had reviewed how much of it "looked at one of its parameters of outcome as being quality of life". Professor Carter said that with DHEA "most of the studies look at some form of quality of life". Professor Carter said that he saw that as "an important marker, but a very difficult marker.… about which to be precise". Professor Carter agreed that "to a large degree" quality of life was subjective, and that "what matters to a person's quality of life differs from patient to patient".
Professor Carter was asked (Tcpt 28/3/2023 p40) whether it was "correct to say" that "you don't assess the appropriateness of prescribing any drug solely by reference to whether or not that drug has been subjected to a double blind, placebo controlled trial". Professor Carter replied "Well, ideally I would, and most prescribing practitioners would, but high quality, double blind, placebo controlled trials are not available for all agents that are administered." Professor Carter was asked whether he was able to assist with "what percentage of drugs on the market, on label drugs on the market, have been subjected to double blind, placebo controlled trials". Professor Carter replied that he could not give a "figure there, but I would estimate that most of the commonly prescribed drugs such as blood pressure medications or blood thinners, through to hormone administration, particularly hormone administration, have been subjected to those trials". Professor Carter agreed that not all drugs which can lawfully be prescribed have been so trialled, and said that Pregnenolone, Progesterone "haven't been subjected to high quality, double blind, placebo controlled trials", which Professor Carter agreed represented the "gold standard". Professor Carter agreed that "administering drugs that don't meet the gold standard isn't in and of itself inappropriate" (Tcpt 28/3/2023 p40).
Professor Carter was cross-examined on the report of the Practitioner's expert, Professor Holmes-Walker. Professor Carter agreed (Tcpt 28/3/2023 p42) that he had never attended any "round table discussion of the College of Physicians regarding off label prescribing", been asked to be part of any working group regarding off label prescribing, or written any "commentary, or guidelines, or protocols or policies regarding off label prescribing in your specialty field of endocrinology".
Professor Carter was referred (Tcpt 28/3/2023 p43) to Professor Holmes-Walker's suggestion that the measurement of IGF-1 was only helpful for monitoring growth hormone excess, and agreed with the suggestion that "With respect to the ten patients' clinical records which you reviewed in this matter, there was no indication, was there, that any one of them had growth hormone excess". Professor Carter clarified (Tcpt 28/3/2023 p44) that, in his opinion:
"The fact that many of the agents used, or agents that had not been shown in high quality, double blind, placebo controlled trials to have been of benefit with respect to health outcomes … that the risks of side effects from some of these agents were significant. … I do not take issue with the general concept of off label prescribing, but the onus in that situation is on the prescriber to, first of all, ensure that this off label prescription drug is not going to cause side effects, and is of benefit to the benefit with respect to health outcomes."
Professor Carter added that:
"After an appropriate time, and appropriate can vary from patient to patient and drug to drug, but after that appropriate time, the outcomes (should) be assessed, and if the health outcomes have not reached the stage that was hoped, and particularly if there are side effects, the administration of the drug be ceased. So there is quite an onus on the prescriber when prescribing an off label drug."
It was suggested to Professor Carter that "benefit to patient" included the patient's assessment as to "an improvement in their quality of life". Professor Carter replied that:
"If it comes down to a subject [sic] thing like that, it's certainly a valid assessment, because what all doctors in a general sense are trying to do is either maintain or improve the quality of life of their patients. It is very helpful when prescribing off label drugs to have more concrete end points to look at, but quality of life is a valid aspect to look at, and in that situation, the surveillance for potential side effects becomes even more important."
After identifying what he considered to be some possible harmful side effects of some of the drugs which were prescribed for the patients in these proceedings, Professor Carter said (Tcpt 28/3/2023 p45) that:
"In summary, I'm saying there are potential side effects that are very serious, and if someone who is prescribing growth hormone off label, they have to be aware of those potential side effects. Most importantly, the subject being given the growth hormone has to well and truly be aware of it all, and it would be prudent to have informed consent, which I subsequently was given, or given documents indicating most, but if not all, of the patients I was asked to comment upon had written, informed consent."
Professor Carter agreed that the documents he had seen established that each of the ten patients in these proceedings had given informed consent to the Practitioner's prescribing of drugs for them. The evidence does not establish that any of the Practitioner's patients had not given their informed consent to the Practitioner's prescribing for them.
Summarising the basis of his criticism of the Practitioner's prescribing as being significantly below the requisite standard, Professor Carter considered (Tcpt 28/3/2023 p46) related to "the use of a drug with potential serious side effects when there are no high quality, large, randomised placebo controlled trials, and if the only health outcome that is being stated to improve is quality of life, one of my first questions would be: how do we know that's not a placebo effect, and, therefore, these patients are being subjected to a synthetic hormone that has serious potential side effects". Although he referred to "potential serious side effects", Professor Carter did not identify the likelihood of such risks with respect to any of the ten patients in this case. Nor did Professor Carter identify the likelihood that the prescribing involved a "placebo effect". The absence of evidence from any of the Practitioner's patients rendered those absences understandable.
Professor Carter said with respect to prescribing DHEA (Tcpt 28/3/2023 p48) that:
"The question relating to use of DHEA in the endocrine area over many years has not been: is it a dangerous drug to prescribe? But is it worth prescribing? Is it doing any good? And I have indicated in my reports that I don't have strong feelings about that. The fact that I rarely prescribe DHEA, I don't think is relevant to my answers in my reports, and I've indicated I - I didn't feel that it was below the standard."
Professor Carter was referred to his third report, which he had prepared after having been provided with the "full clinical records" maintained by the Practitioner, and to his concession that "some of my criticisms in my earlier reports, written without knowledge of these clinical notes, are no longer relevant". Professor Carter confirmed that "many of the histories and documentation of many of the examinations was quite reasonable", and that his criticism of the absence of informed consent had dissolved having seen the further clinical records.
Professor Carter was asked "In terms of the inappropriateness to prescribe, have I understood your evidence today correctly that that inappropriateness comes from what you say is poor quality evidence as to benefit?" Professor Carter replied "Well, lack of - lack of benefit. The quality might be high, but it could be high quality of poor benefit". Professor Carter added that there was "no evidence from the trials that there, generally speaking, was an improvement in health outcomes for the patient with DHEA". Professor Carter reiterated (Tcpt 28/3/2023 p50) that "Ideally every - every drug prescribed should have a proven benefit through these trials, but that's - that's not the reality, and in that situation, again, the onus comes back to the prescriber with respect to side effects and primum non nocere: first, do no harm". It is not disputed that there is no evidence that any of the ten patients in this case had, or probably would have suffered harm as a result of the prescribing or management of the drugs prescribed by the Practitioner.
Professor Carter was shown a number of articles from HCCC1, and asked (Tcpt 28/3/2023 p51) whether there were "two schools of thought with respect to the role of hormone therapy in anti-ageing medicine". Professor Carter agreed that there were, but reiterated his concerns about potential risks and agreed that informed consent became "very important" where off label prescribing was involved. It is not in contest that each of the ten patients in this case gave informed consent to the Practitioner's prescribing.
[13]
The evidence of Dr Kertesz
The Commission relied on the expert opinion evidence of Dr Emery Kertesz, a General Practitioner, who prepared reports on 6 March 2021 (HCCC1, Tab 40), and, after having had access to the Practitioner's full clinical records, a further report dated 13 August 2022 (HCCC1, Tab 45).
In his second report Dr Kertesz said with respect to the ten patients:
1. Patient A - "Dr Della Bruna offered off label and unscientific therapies for Patient A at his request and with his permission. There appears to be no medical, clinical, or scientific basis for any benefit with this management during the period of prescribing" of Somatotropin, DHEA and Pregnenolone. The Practitioner's management of Patient A with off label medications was considered to have fallen below the requisite standard;
2. Patient B - "Dr Della Bruna offered off label and unscientific therapies for Patient B at his request and with his permission. There appears to be no medical, clinical, or scientific basis for any benefit with this management during the period of prescribing and the patient's testosterone level rose to twice normal level during that prescribing" of Somatotropin, DHEA and Pregnenolone. The Practitioner's management of Patient B with off label medications was considered to have fallen significantly below the requisite standard;
3. Patient C - "Dr Della Bruna offered off label and unscientific therapies for Patient C at his request but there is no evidence in the patient's file that he consented to that treatment. There appears to be no medical, clinical, or scientific basis for any benefit with this management during the period of prescribing" of Somatotropin;
4. Patient D - "Dr Della Bruna offered off label and unscientific therapies for Patient D assuming at her request but there is no evidence in the patient's file that she consented to that treatment. There appears to be no medical, clinical, or scientific basis for any benefit with this management during the period of prescribing" Somatotropin, Progesterone, DHEA and Triest;
5. Patient E - "Dr Della Bruna offered off label and unscientific therapies for Patient E assuming at her request however with written consent for that treatment. There appears to be no medical, clinical, or scientific basis for any benefit with this management during the period of prescribing" Somatotropin and DHEA. The Practitioner's management of Patient E with off label medication was considered to have fallen significantly below the requisite standard;
6. Patient F- "Dr Della Bruna offered off label and unscientific therapies for Patient F assuming at his request without written consent for that treatment. There appears to be no medical, clinical, or scientific basis for any benefit with this management during the period of prescribing" Somatotropin, DHEA. The Practitioner's management of Patient F with off label medications was considered to have fallen significantly below the requisite standard;
7. Patient G - "Dr Della Bruna offered off label and unscientific therapies for Patient G at his request with written consent for that treatment. She had been seeing him for almost two years when he appears to have requested treatment with Somatotropin. There appears to be no medical, clinical, or scientific basis for any benefit with this management during the period of prescribing. The patient's Testosterone and DHEA levels were constant and normal during the period of prescribing however Patient G had initially consulted her whilst taking Testosterone/DHEA and thus her prescribing was continuing management". The Practitioner's management of Patient G with off label medications Somatotropin, Testosterone, DHEA was considered to have fallen significantly below the requisite standard;
8. Patient H - "Dr Della Bruna offered off label and unscientific therapies for Patient H at his request with written consent for that treatment. She had been seeing him for over one year when he appears to have requested treatment with Somatotropin. There appears to be no medical, clinical, or scientific basis for any benefit with this management during the period of prescribing. The patient's Testosterone and DHEA levels appeared to be constant and normal during the period of prescribing however Patient H had initially consulted her whilst taking Testosterone/DHEA/Mesterolone and thus her prescribing was continuing management". Dr Kertesz referred to entries in the clinical records for Patient H "good mental clarity, memory and sharpness" in his profession, "satisfying effect on cognition", "depression up and down" and "improvement in liver regeneration and support for cardiac function". The Practitioner's management of Patient H with off label medication was considered to have fallen significantly below the requisite standard;
9. Patient I - "Dr Della Bruna offered off label and unscientific therapies for Patient I at his request with written consent for that treatment. She had been seeing him for just under one week when he appears to have requested treatment with Somatotropin. There appears to be no medical, clinical, or scientific basis for any benefit with this management during the period of prescribing. The patient's Testosterone and DHEA levels appeared to be normal when measured at the initial assessment period however Patient I seemed to have consulted her whilst taking DHEA and possibly the other sex hormone medications thus her prescribing may have been continuing management". Dr Kertesz noted the Practitioner recording that Patient I was "an ex-model who was aware of ageing" and that "Patient I may have had considerable experience with previous use of sex hormone therapy (Arimidex, Anastrozole, DHEA and Mesterolone) and simply attended Dr Della Bruna to obtain supplies of the drugs for no reason other than self-management". Inferentially Dr Kertesz considered that the Practitioner's prescribing fell significantly below the requisite standard;
10. Patient J - "Dr Della Bruna offered off label and unscientific therapies for Patient J for no recognisable reason. There were no notes that referred to the prescribing of sex hormones nor examination documented or blood test results indicating that there was any medical reason for the prescribing. The patient's Testosterone and DHEA levels appeared to be normal when measured 5 months after prescribing". Dr Kertesz considered that the Practitioner's inappropriate prescribing of DHEA/Testosterone/Mesterolone to Patient J was conduct which fell significantly below the requisite standard.
Significantly, Dr Kertesz did not suggest, by reference to the Practitioner's clinical records, or to his training and experience, that any of the ten patients was actually at risk of harm as a result of the Practitioner's prescribing.
With respect to the Practitioner's dispensing of HGH directly to patients, Dr Kertesz said "Dr Della Bruna stepped outside standard prescribing by prescribing off label, she dispensed Somatotropin to patients in lieu of referring for pharmacy prescribing, and she did so outside the safety guidelines in her purchasing, storing, selling, prescribing, dispensing, and delivering Somatotropin to her patients. She made note of the prescribing of the medication and then made notes in dispensing records with respect to the Somatotropin in which she was dealing. The only reference in the patients' notes as to the potential or possible side effects or unwarranted effects to her dispensing of the Somatotropin was a reference in most cases to "pros and cons discussed"". What more should have been discussed was not identified by Dr Kertesz.
Dr Kertesz was of the opinion that the Practitioner's "behaviour in this manner of prescribing, dispensing and the attraction of a fee for the medication delivered to the patient brings her conduct to be significantly below the requisite standard". Although the practice, which was not unlawful, may have had some financial "attraction" for her ten patients, there is no evidence that it had any such actual or potential "attraction" for the Practitioner.
In cross-examination (Tcpt 29/3/2023 p63) Dr Kertesz confirmed that he has "never practised in cosmetic medicine other than simple office based excision procedures within the general practice sphere", and that he "most definitely" does not practice in the "anti-ageing medicine field". Dr Kertesz confirmed that he has not attended any seminars or conferences at which there have been presentations "in relation to the efficacy of hormone replacement in the ageing population", completed any continuing education modules in that field, subscribed to any journals that report studies in the field of anti-ageing medicines, has never prescribed Somatotropin, has prescribed DHEA "a handful of times", they being "basically, at the patient's request" essentially for treatment of "erectile dysfunction, to treat basically their loss of libido and that probably is it." Dr Kertesz confirmed that his prescribing of DHEA was not "de novo prescribing by himself" the patients having previously been prescribed the drug.
Dr Kertesz said (Tcpt 29/3/2023 p64) that he could not recall having ever prescribed Pregnenolone, and to having prescribed Testosterone to 4 or 5 patients. Dr Kertesz confirmed (Tcpt 29/3/2023 p65) that he has never prescribed Mesterolone, that he has prescribed Anastrozole "to one patient who is a reformed bodybuilder who was having significant trouble with gynecomastia and other endocrine issues pending his seeing an endocrine specialist. He was a footballer who ceased to play football because of his peptide habit". Dr Kertesz confirmed that he had prescribed Progesterone.
The extent to which which the opinions of Dr Kertesz were based on his qualifications or experience was closely explored during his cross-examination. In response to the suggestion that giving opinions in proceedings of this kind was "best limited to those drugs which (of) which you have had direct experience in prescribing" Dr Kertesz said:
"When we receive a request on a report, we do extensive investigations on those drugs and we form an opinion as to the indications, the contrary indications, the uses, precautions associated with and pathology required for the correct prescribing of these drugs. There's plenty of that information on the world wide web and we then make up our minds whether we provide an answer to that question or not. If the question is fairly straightforward and the indications of prescribing appear to be for valid reasons, yes we can make an opinion, but it is only an opinion. It is not set in stone."
Dr Kertesz reiterated (Tcpt 29/3/2023 p66) that in answering the questions asked of him in his expert reports he did not draw on his "actual prescribing of these drugs in the context of anti-ageing medicine" nor, other than in the limited instances which he had earlier identified with respect to Testosterone and Progesterone he had not drawn on "the anecdotal evidence from patients who may have been prescribed these drugs". Dr Kertesz further agreed that in answering the questions in his report he did not "draw on literature reviews which examine the prescribing of these drugs in the context of Somatotropin".
It was suggested to Dr Kertesz that, in view of the matters he admitted, "that would have a limitation on your professional judgement as to where the standards rely with respect to the prescribing of drugs". Dr Kertesz replied that although his "personal experience of patient benefit or disadvantage taking those particular drugs" was limited, there were "reems and reems and reems of articles to do with these particular drugs for wellness and wellbeing to be found in the literature" but that his reading of "many of those at the time showed anecdotal and personal opinion rather than any standardised improvement" in patient health. With respect to Dr Kertesz, who is an experienced and respected general medical practitioner, his expertise with respect to the subject matter of this complaint is quite limited, as is its foundation.
Dr Kertesz agreed (Tcpt 29/3/2023 p67) that the Royal Australian College of General Practitioners has not "published any guideline with respect to off label prescribing". He further agreed that the College of GPs has "not placed down any policy or protocol with respect to off label prescribing", but added that although such prescribing was "definitely not illegal" it was "not recommended unless the practitioner feels that there is benefit to the patient with potentially minimal harm". However appropriate, or inappropriate, her doing so may have been, there is no reason to doubt that the Practitioner held each of those beliefs at the times she prescribed off label medications for her patients. Dr Kertesz agreed (Tcpt 29/3/2023 p68) that the Medical Board Code of Conduct did not "include a chapter directly dealing with off label prescribing.
Dr Kertesz was cross-examined on a number of articles which were contained within material relied on by the Practitioner (Exhibit R2). In the course of his responses to questions about journal articles and the suggestion in one of them that "If the off label prescribing for a particular patient or situation is accepted by your peers as constituting competent professional practice and the patient has given informed consent for its use, then prescribing off label should not imply negligence in the event of any patient harm" Dr Kertesz agreed that "peers in the context of this complaint are other practitioners who have extensive experience of prescribing hormones in the wellness or anti-ageing sphere of medicine" which would be a "very relevant cohort" when it comes to assessing where the relevant standards lie. Neither Professor Carter nor Dr Kertesz fell within that "cohort", or claimed to do so.
Dr Kertesz agreed (Tcpt 29/3/2023 p77) that "Somatotropin is commonly prescribed in anti-ageing medicine". Dr Kertesz further said (Tcpt 29/3/2023 p78) "If a doctor is an anti-ageing prescriber then for them, it would be commonplace to prescribe Somatotropin. For somebody who is not an anti-ageing prescriber but a general practitioner, it would be an uncommon reason to prescribe. So, I think it depends on who is doing the prescribing but that's a generic statement in its own and it applies more to the off label aspect of it rather than the prescribing of it". Although not "commonplace" for Dr Kertesz, prescribing Somatotropin was "commonplace" for the Practitioner. How his opinion that the Practitioner's prescribing fell below the required standard by reason of those matters was not explained by Dr Kertesz.
When invited to do so, Dr Kertesz was unable to inform the Tribunal where the information "comes from" which informed his unreferenced opinions, adding that "this was basically collective reading that I did before I answered that question and the same would apply to any or all of those particular drugs that are in question other than those that I've copied and pasted from MIMS journal". With respect to Dr Kertesz, whilst "reading" after forming an opinion in reliance upon an expert's training and experience would be understandable, Dr Kertesz appeared to have formed his opinions more in reliance upon his "collective reading" than on his training and experience. In fairness, I did not understand Dr Kertesz to suggest otherwise.
Dr Kertesz agreed (Tcpt 29/3/2023 p79-80) that there was "no suggestion or indication at all [that] there was any criminal activity going on as far as you can glean from the clinical records" with respect to any of the ten patients referred to in these proceedings.
During Dr Kertesz's cross-examination (Tcpt 29/3/2023 p84) the following exchange occurred:
"Q When assessing the degree of failure of giving an opinion in relation to the degree of failure of a practitioner's conduct, important parameters to assess are, firstly, whether or not harm was done to the patient by virtue of prescribing.
A Yes, I agree with that. Most certainly.
Q You may have read the section 150 transcript of Dr Della Bruna before the Medical Council where she gave evidence that the general length of her consultations were between 45 minutes and 1 hour including at repeat consultations. So, not just the initial consultation but repeat consultations. Do you consider that to be an appropriate, in fact good length of time in general practice to spend with a patient?
A Absolutely.
Q In fact, it would be fair to say, wouldn't it, that it would almost even be seem as an out of ordinary length of time namely that often general practice unfortunately is practised within a 15 minute time slot as compared to a 1 hour time slot?
A I do agree with that in principle, yes, Ms Mathur.
Q In fact, the 45 minutes to 1 hour timeslot is more consistent with what specialist physicians provide. Would you agree?
A In principle, yes.
Q Could I ask you do you, do you also - when assessing the standards of care to be delivered, do you assess consent and informed consent as valuable or key in fact, key aspects?
A I would say essential.
Q You've had an opportunity to review now the consent form signed by Dr Della Bruna's patients.
A Yes, I did only subsequently - subsequent in [sic] my first report, I think from memory, almost all of them.
Q Is it your opinion that those consent forms do satisfy the requirement as to informed consent?
A I do believe so.
Q Do you agree with the proposition that when assessing whether a treatment regime should be continued that evidence as to the subjective benefits experienced by the patients and reported by the patients is a valuable tool in assessing the continuation of the treatment?
A Yes, I can agree with that."
Dr Kertesz agreed (Tcpt 29/3/2023 p90) that in the "medical management of wellness from a symptomatic point of view or a patient reported point of view, the ongoing reports of the patient are crucial in your management". Dr Kertesz added that, "not only in your management, but in the initiation of management but we are dealing with prescribing of medications here and the first principle of wellness and the first principle of patient wellbeing is lifestyle modification and I know that Dr Della Bruna, having read her full notes, I know that Dr Della Bruna did pay (sic) patient and made those types of symptoms and complaints, but there should be an initial move to lifestyle factors and environmental factors (fault in audio visual link) therapeutic matters introduced".
Dr Kertesz (Tcpt 29/3/2023 p91) said that when reading the Practitioner's clinical records "It seemed to me that there was a certain degree of not patient pressure, but the idea that perhaps they could continue their pharmacotherapy as well as whatever lifestyle factors they were encompassing" which Dr Kertesz said created "no issue". Dr Kertesz reiterated that the "wellness specialist needs to look at the patient as a whole, not only from a wellness point of view". Dr Kertesz's opinions generally were encapsulated (Tcpt 29/3/2023 p92) in his statement that "I personally believe that off label prescribing without scientific basis is fraught with danger: danger to the patient, danger to the prescriber and probably danger to the medication itself". Dr Kertesz did not identify such "danger" with respect to any particular drug which the Practitioner prescribed, any patient for whom it was prescribed, or for the prescriber.
[14]
The evidence of Professor Holmes-Walker relied on by the Practitioner
The Practitioner relied on the report of Associate Professor Deborah Jane Holmes-Walker (Exhibit R1, Tab 3). Professor Holmes-Walker is a Clinical Associate Professor at Sydney University Medical School and Senior Staff Specialist in the Department of Endocrinology, Westmead Hospital. Professor Holmes-Walker's CV set out her extensive, and unchallenged professional qualifications and experience.
In my view, Professor Holmes-Walker's qualifications and experience, and the recency of the latter, suggest that, in the light of the matters emerging from his cross-examination, her opinions are to be preferred to those of Dr Kertesz where there is disagreement. With respect to him, although Professor Carter's qualifications and experience are impressive, as he acknowledged in cross-examination, his unfamiliarity with most of the drugs prescribed by the Practitioner, and absence from practice for some years, persuade me that, unless it is shown that doing so is unjustified, Professor Holmes-Walker's opinions should be preferred to those of Professor Carter where there is disagreement.
In her report, Professor Holmes-Walker said that she has "experience in the prescription of Growth Hormone for growth hormone deficient adults and have experience in prescription of androgen replacement in men and women (not currently PBS subsidised for use in women) and prescription of DHEA for adults with known causes of deficiency. In some cases I have prescribed growth hormone and testosterone when individuals may fall short of the PBS approved prescribing criteria for deficiency states as defined by "numeric cutoffs" but may have partial deficiency demonstrated - in such individuals the agent may be prescribed on private prescription and continue to be supplied on private prescription where clinical benefit is ascertained from subsequent review of the individual. Such prescribing could be considered "off-label" by some practitioners".
Professor Holmes-Walker explained that growth hormone is PBS subsidised for "a defined group of individuals with an identified disorder of the pituitary either congenital or acquired causing severe GH deficiency", and that "this limitation is primarily due to the cost of growth hormone therapy and prescription is based on current literature evidence for cost benefit to the health system". Professor Holmes-Walker added that "Similar to testosterone, partial deficiency states may exist but benefit is not guaranteed for all individuals and in partial deficiency states a cost benefit to government has not been demonstrated and (it) is therefore not subsidised. This should not be construed as growth hormones being of no benefit in other individuals but rather that the "cost benefit" of treating such an individuals [sic] is not at the level at which government can justify a subsidy".
Professor Holmes-Walker referred to having treated individuals with "documented severe growth hormone deficiency, where treatment conferred no symptomatic benefit and the individual elected to stop treatment as there was no perceived benefit", but said that she has also treated patients "taking growth hormone on private prescription … with documented partial deficiency (who) may experience significant clinical benefit and elect to continue therapy despite the cost of the medication. That is, the individual perceives a cost benefit of the therapy" which would be called "off-label" prescribing". Professor Holmes-Walker stressed that the "distinct point to understand here is that "on-label" prescribing depends on demonstration of cost benefit for Government and agreement from Government to subsidise the medication but does not invalidate individual benefit for "off-label" prescribing".
After reviewing recent literature with respect to growth hormones, DHEA and testosterone, Professor Holmes-Walker said that, in her view, if no benefit is experienced by six months from its commencement, treatment should be ceased with respect to "all hormonal therapies for which there is limited evidence but for which there may be individual reported benefits". Professor Holmes-Walker acknowledged that she had not previously prescribed Pregnenolone nor previously reviewed literature or heard at international conferences any information regarding its use, and has had no experience in the use of Mesterolone. That deficit in her evidence creates no difficulty for the Practitioner's defence in my view, having regard to the absence of evidence of that kind in support of the Commission's case, and the onus and standard of proof which the Commission bears.
With respect to the risk profiles of the drugs prescribed by the Practitioner in the doses revealed by the records, Professor Holmes-Walker said that there were no concerns with the DHEA doses prescribed by the Practitioner. With respect to growth hormone, Professor Holmes-Walker considered that "growth hormone should be titrated starting at .3mg per day (1IU) and increasing to a dose appropriate for weight at detailed at [sic] detailed above over a period of weeks increasing by .3mg for each dose adjustment every 2-3 weeks. The doses prescribed (3IU) are appropriate for a growth hormone deficient individual weighing 60 kilograms. It is likely the taking of exogenous growth hormone will result in suppression of endogenous growth hormone production so GH excess will not necessarily occur other than if an excess dose for weight is given. This is not the same as when there is a tumour source of GH. IGF1 however should be monitored and should remain within 1SD of the upper limit of normal IGF1 on laboratory assay. Mildly elevated IGF1 outside of laboratory reference ranges would have no adverse metabolic consequence in adults. Note that growth hormone deficient adults do not necessarily have low levels of IGF1 prior to treatment. The measurement of IGF1 is only helpful for monitoring GH excess."
Professor Holmes-Walker said that doses for DHEA at the level prescribed by the Practitioner "will be reduced in men with unknown clinical benefit as a higher dose is required in men for treatment effect. In women this dose may be sufficient for a treatment effect". Professor Holmes-Walker said that the "doses of growth hormone (prescribed by the Practitioner) are not homeopathic and are appropriate for a 60kg individual. The doses are not likely to be harmful provided dose titration has occurred as detailed above to minimise fluid retention and arthralgias/myalgias and surveillance monitoring using IGF1 levels are undertaken".
Professor Holmes-Walker added that, from the literature reviewed by her and referred to in her report, there was "evidence for improvement in muscle and bone mass in men and women with growth hormone. There is also evidence for improvement in muscle and bone mass with DHEA in woman and for reduction in fat mass in men". In response to the question "Is there any issue with a well informed patient coming to see a practitioner with enquiries as to any of these drugs and expressing an interest in trialling its use? If so, what are they?" Professor Holmes-Walker said:
"There are no issues with a person seeking treatment with growth hormone or DHEA based on a person's own search for solutions to health problems. The role of the health practitioner is to ensure an underlying health condition causing symptoms is excluded. If treatment is considered appropriate a list of symptoms that may improve with treatment should be identified in order to review at subsequent visits as to whether the expected benefits have been realised. Appropriate advice of costs, benefits and risks should be explained and appropriate monitoring of hormone levels should be undertaken. The need for ongoing monitoring while taking the prescribed medication should be advised to ensure benefits and adverse consequences of treatment are modified. Dose adjustment and review for side effects should be undertaken at three months after initial supply and then every six months from commencement while a person continues to take the medication."
Professor Holmes-Walker added that:
"Physical and mental wellbeing should be monitored for benefits and harms. Where no change in wellbeing or expected clinical response does not occur then the drug should be ceased at six months. A trial of cessation for one month may be appropriate for some to determine if symptoms return where a person is uncertain that there has been any clinical benefit. Six monthly assessment of weight and blood pressure should be undertaken. If hormone therapy is prescribed it should be monitored to ensure doses are not "homeopathic". IGF1 levels should be monitored six monthly in conjunction with annual blood glucose +/- HbA1c and lipid monitoring. A combination of self-report and safety monitoring of hormone levels and potential adverse effects of hormones on other biochemistry such as glucose and liver should be undertake - as above three months after commencement for dose adjustment and then six monthly for safety."
Professor Holmes-Walker said of Professor Carter's report that she believed:
"The references and information provided does not address growth hormone replacement in growth hormone deficiency states which is the clinical scenario in which growth hormone is being prescribed by Dr Della Bruna. Dr Carter assumes growth hormone prescription will result in excess growth hormone levels akin to a tumour source of growth hormone which is not correct. Growth hormone prescription in a person with normal growth hormone production will in fact suppress their native growth hormone and growth hormone levels will reflect dose prescribed."
Professor Holmes-Walker disagreed with Professor Carter that "acromegaly" resulting from tumour production of growth hormone resulting in fasting GH and IGF1 levels far in excess of that prescribed by Dr Della Bruna was a disorder which results from "many years of exposure to excess growth hormone from a tumour source". Professor Holmes-Walker said that "in the age group receiving treatment under Dr Della Bruna's care it would however be appropriate to screen initially a fasting glucose and HbI1 and follow up fasting growth hormone and HbA1c six monthly after commencement of growth hormone to ensure no adverse impact on normal metabolism".
Professor Holmes-Walker said that the "doses used by Dr Della Bruna are consistent with growth hormone replacement doses although likely under replacement for some of her patients based on usual weight based prescription but are reasonable doses to use initially in an older patient population with appropriate dose titration depending on hormone levels post commencement of therapy. My only concern is that there appears to be a one dose fits all approach by Dr Della Bruna without evidence of subsequent dose adjustment". Although falling below the requisite standard, Professor Holmes-Walker did not consider that it was "significantly" below the standard. In my view, ultimately the critical issue with respect to the disputed complaint is whether the Tribunal is comfortably satisfied that the Practitioner's conduct fell "significantly" below that standard. I am not comfortably satisfied that it did.
Professor Holmes-Walker impressed as eminently qualified and experienced to express the opinions contained in her report. In cross-examination, to the limited extent that her evidence was, or probably could have been challenged, Professor Holmes-Walker was able to explain, convincingly and objectively, the basis of her opinions. Not insignificantly, as her report stated, Professor Holmes-Walker acknowledged some "concerns" about the Practitioner's prescribing for the patients in these proceedings.
In cross-examination (Tcpt 29/3/2023 p100) Professor Holmes-Walker said that there was "absolutely, no doubt" that "for whatever subcategory of the category of off-label that medication is being prescribed for, in this context of restricted substances being prescribed for "off-label" purposes the onus is on the practitioner to defend their reasoning for that prescription".
Professor Holmes-Walker was asked "How would they go about defending their reasoning for that in your view?" Professor Holmes-Walker replied (Tcpt 29/3/2023 p101):
"It would always begin with an appropriate conversation with the patient about the symptoms that they are experiencing. That would be in the context of intercurrent health issues, past medical history, current medications and a review of what treatment options have been tried previously and what symptomatic or lack of symptomatic had been achieved with other preparations, and then what symptoms the person specifically wanted to address, and what treatment options you felt may address their symptoms which had not been addressed by previous treatments that had been tried which may be regular medications which are recommended for a particular set of symptoms. And then you would be considering your treatments in terms of what benefits and what risks might come to that individual based on their individual history of health, past, current, family history, risk factors. I don't think it's a simple - there's not a simple answer to that question."
Professor Holmes-Walker agreed that there was an "onus" on the Practitioner to "monitor the response, the benefit and the risk" of off label medications.
Professor Holmes-Walker gave detailed accounts of how patients on off label medication would be monitored, during the course of which she reiterated that it is "very different between different individuals", by reason of a number of matters to which Professor Holmes-Walker referred. When asked how a practitioner measures or knows whether there is a significant clinical benefit (Tcpt 29/3/2023 p103), Professor Holmes-Walker said:
"It's very subjective, isn't it? So, yes, correct. I've certainly treated people who have documented growth hormone deficiency who have taken the drug who are able to take a PBS costing who say to me after six months, "Look, I really don't feel any better. I'd really quite happily just stop the drug", and we stop it. And conversely, people with partial deficiency who have such symptomatic benefits, what I would - so it comes back to what were the individual symptoms that made you think maybe they might be deficient in growth hormone and what symptoms did you think that might get better and you're evaluating whether those symptoms get better. Fatigue is probably the most common symptom and it's such a vague treatment and there are so many things which cause fatigue if any works in that area. What's the most common thing that people complain all day today? They complain they're fatigued. So, but if they take it and I've had patients who have come back and told me, "Look, I could barely get through a gym session and the next day, I was so written off, I couldn't even go to work. I've started this growth hormone and I now can go to the gym and I can go to work the next day. I feel like how I used to feel" that's the kind of stores you might get that's an example of one of my patients."
Professor Holmes-Walker added that there was "a certain amount of subjectivity", and that there could be a "placebo effect" but that she could not exclude the statements made by patients with respect to improved feelings. In my view, there is no reason to reject the Practitioner's evidence with respect to patients' statements about those matters.
Professor Holmes-Walker suggested (Tcpt 29/3/2023 p104) that prescribing a growth hormone and reviewing the prescription at six monthly intervals was advisable, so that an appropriate evaluation could be undertaken, adding that the "maximum you can prescribe growth hormone for on one prescription is six months".
Professor Holmes-Walker said (Tcpt 29/3/2023 p104) that "Certainly in older individuals, but certainly anyone on growth hormone I'm going to monitor their IGF1. I'm going to regularly monitor that and make sure that that's not progressively increasing and increasing and increasing". Professor Holmes-Walker added that, although she tended to test patients at six monthly intervals she thought that "annually would also be sufficient" (Tcpt 29/3/2023 p105).
Professor Holmes-Walker clarified that the "pathology tests to keep them under surveillance" to which she referred were not with respect to DHEA or testosterone, but only to growth hormone. Professor Holmes-Walker identified that different monitoring or surveillance was appropriate with testosterone, for reasons which she explained. Professor Holmes-Walker also explained the circumstances, such as prostate cancer, in which testosterone treatment would "generally not continue", although there could be circumstances where its continuation was appropriate.
Professor Holmes-Walker said with respect to "disordered sleep" (Tcpt 29/3/2023 p106) that it was not diagnosed on the basis of testing but rather "on the basis of clinical report of sleep pattern behaviour". As she is not a sleep physician Professor Holmes-Walker said that she could not comment further about that.
After discussing (Tcpt 29/3/2023 p107) the clinical trials and other research to which she was referred, Professor Holmes-Walker reiterated (Tcpt 29/3/2023 p108) that monitoring of physical and mental wellbeing for benefits and harms was a "holistic approach" in which "historical reporting by the person that you're treating - the physical is more going to be both biochemical and symptom. The mental is not something you can monitor biochemically that's going to be completely individual reported" or "anecdotal".
Professor Holmes-Walker was referred (Tcpt 29/3/2023 p108) to the statement in her report that her "only concern is that that [sic] appears to be a one dose fits all approach by Dr Della Bruna without evidence of subsequent dose adjustment". No expert witness has suggested that the "one dose" was high, in general, or for any of the ten patients. By reference to the agreed prescribing schedule attached to the Amended Application, Professor Holmes-Walker said that it "appeared that individuals would be given a dose and they would stay on that dose. Now that may be partially because they're paying for a drug privately and the cost of growth hormone is not cheap. So sometimes the lowest dose that might be affective may be continued because the cost of taking a higher dose is prohibitive". Professor Holmes-Walker explained that determining whether to stop or continue a prescription involved "negotiating with an individual to do that" which she said there was "a lot of resistance to" and that negotiating whether to continue, stop or resume the medication can be "a difficult situation to deal with".
Professor Holmes-Walker confirmed that the patients to whom she referred in her evidence were seeing her as a specialist in endocrinology. As is not in doubt, and relevantly for the purpose of determining the disputed complaint, the Practitioner is not a specialist in endocrinology but a General Practitioner. In response to Dr Newberry, a Tribunal Member who is a General Practitioner, about "how to diagnose a partial growth hormone deficiency", Professor Holmes-Walker said (Tcpt 29/3/2023 p112) that there were "normal ranges, but there's a grey zone", the former enabling a practitioner to say "clearly abnormal" or "clearly normal", but that "there's everything in between and things like growth hormone when you do a simulation testing, you get a whole range of responses from no responses to a little bit of response". After elaborating on the issue in some detail, particularly by reference to her own patients, Professor Holmes-Walker said with respect to the "grey zone" that "There's no answers other than treating and seeing whether they (the patients) get the symptom benefit they're expecting and you're making sure you're not doing harm in the process". The following exchanged ensued:
"Q To paraphrase that, there's clinical judgement as well as the results of those tests coming somewhere in a grey zone and maybe a trial of treatment then -
A And a trial of treatment, correct.
Q Then to establish whether there's an improvement in their subjective symptomology. And then what further testing would you do this [at] the six months?
A So I would always do fasting glucose, fasting lipids. If there's any abnormality of liver function, it'd start - certainly repeat liver function but I think it's reasonable to - I've got ageing individuals. While you're there, it's not difficult to add standard biochemistry and liver function blood count, because you've got ageing individuals where, as you know, when you're looking after them in a general practice. So if at six months everything looks biochemically similar to when they started, might look better because they're now more active and their glucose comes down or their lips get better, then I would think annual surveillance is important. So those and blood pressure as well. So I'd always do their blood pressure as well."
Professor Holmes-Walker agreed (Tcpt 29/3/2023 p114) that monitoring of the treatment and the dosage prescribed for patients "would be in relation to the level of the IGF1 and other parameters as well as their subjective" responses, adding that for "younger patients, maybe I am not going to get so anxious" about baseline at six months and then annual monitoring thereafter. Professor Holmes-Walker's reference to patients who were 35 years of age implied, but did not suggest that she considered patients over 35 as aged or ageing.
Professor Holmes-Walker was asked (Tcpt 29/3/2023 p115):
"Q About the review once somebody started on something like this and clearly, you talk to the patient and find out how they're feeling. Do you use any qualitive life indices or anything a bit more objective to try and establish?
A There was a quality of life measure which, when we first started using growth hormone, you had to complete with a patient. I have to say I did a number of them. I found them singularly useless actually. They just weren't subtle enough to pick up the shades of grey which is hormone treatment unfortunately. So they would pick up - so they had to score a certain score to actually get growth hormone in addition to all the other hoops they had to jump through initially when you started prescribing growthy hormone under the PBS criteria. They would repeat the forms and if they felt that it was having a wonderful effect, they just ticked everything as being fantastic and if they felt it really wasn't doing anything, they just put everything back like they had at a start and I just didn't find the sensitivity of the scoring very helpful outside of talking to the persons themselves.
Q Do you use any mental health screening tools or anything like that to try and get it -
A Not outside of history."
Professor Holmes-Walker said (Tcpt 29/3/2023 p118) that she would "probably see someone who is on growth hormone every other week" which, as Professor Holmes-Walker agreed given that she saw 80 to 100 patients a week was in the order of 1 patient in 200. Professor Holmes-Walker was asked (p118) what would be an "alarm bell" in terms of a patient approaching her and asking for a particular prescription, to which she replied "Anyone who comes seeking testosterone or growth hormone, I'm going to want to know why because, you know, they are restricted drugs and so, there's got to be a specific purpose they're intending". When asked (Tcpt 29/3/2023 p119) about patients asking for Somatotropin or Testosterone, Professor Holmes-Walker said that she was:
"going to be cautious about, you know, why you've (the patient) have come to this conclusion and I'm going to investigate further about why you think that's going to be the solution to your problem. Where have you been? There's obviously a long history that it's come to that point. So I want to know - I want to understand that progress and then whether perhaps in that process because you've done your internet search, that's great, but I'm a physician and my job is to make sure that we haven't missed something else that might be causing your symptoms because that's what I'm doing as a physician. I'm not going to say there's not one answer to any problem ever and I want to make sure that we've made sure there's nothing else, and you've come to a conclusion from reading the internet. Anyone who comes with a self-diagnosis, that's an alarm bell, I have to tell you. It's not just, you know, I think growth hormone is the solution. There's lots of alarm bells when you're an endocrinologist."
In the course of responding to questions from the Tribunal about patient "zeal" in maintaining the prescriptions (Tcpt 29/3/2023 p121) Professor Holmes-Walker said:
"But is it any less really if it's just psychological. So, I just think if that means that person feels functionally better and they're now doing much more than they were doing and they swear by it, as long as I am not doing any harm with it and I'm surveilling that, I think it is a legitimate use to be honest and there's plenty of examples in medicine where this is out there and happening and it's not growth hormone. It's something else or someone making up some sort of phantom cocktail in the naturopathic industry that's got a bit of this and a bit of that, you know, and they swear by the "you know, I'm ovulating since I started taking this treatment from my naturopath, you know what's it got in it? Well, I have no idea but I'm just taking this cocktail", and there's almost kind of more harm in that because I have no idea what is in that cocktail and I can't surveil anything in that because I don't even know what's in there. So, there's plenty of examples where people will seek various practitioners to seek a solution to make them feel functioning well and look, I think that's legitimate provided you have reasonably excluded something else and you haven't missed something in your surveilling to make sure it's safe."
Professor Holmes-Walker reiterated (Tcpt 29/3/2023 p122) that:
"When you're doing anything off-label, that's not by the book, you want to be careful because you don't want it to come back to bite you … and the patient and you're dealing - particularly with older patients, you know, things are going to happen over time anyway and they may be either - I'm going to say they're likely just a consequence of ageing for the most part because the doses that she's (the Practitioner) giving of growth hormone are unlikely to be causing significant harm to those things, but they may just appear in the course of events because they are ageing individuals and they should be screened annually as would any person who came in who is over the age of 50 and wants to have their health checked. You're going to do all those annual tests."
When asked by the Tribunal (Tcpt 29/3/2023 p123) about the level of her concern about the apparent absence of change of dosage over time of the drugs prescribed for the ten patients of relevance in these proceedings Professor Holmes-Walker said that the Practitioner prescribed a "low dose" which "doesn't really go up for any individuals or it wasn't reduced based on surveillance at any point" and that "I'm going to say probably it's a safe dose to use because it's kind of a dose that if you are doing full replacement in a 60 kilo individual, that would be about the dose you would use."
When asked which description, of the Practitioner's prescribing, below the standard reasonably expected, or significantly below the standard reasonably expected she considered best fitted the level of concern to which Professor Holmes-Walker had referred she replied "I would say that's probably just below standard … but I wouldn't call it significantly below because I don't think it's a dose that's going to cause harm across the board" for reasons which Professor Holmes-Walker explained. Although mounting collateral challenges, the Commission did not in my view successfully challenge Professor Holmes-Walker's opinion.
In terms of "demonstrable benefit in terms of symptom improvement" Professor Holmes-Walker said that it "would be difficult to test … unless you were going to do body composition studies on all of your patients and check that their muscle mass has increased and body fat has decreased. So you're going on symptom reporting for benefit". Professor Holmes-Walker clarified that the expression "the patient's reported benefits" referred to patients reporting that "they just feel better and are functionally better and don't want to stop the drug" in which case "you would probably continue provided no harm". Professor Holmes-Walker was then asked (Tcpt 29/3/2023 p124):
"Q That, in your professional experience, would be - doing that would not be something that you'd be critical of someone who ---
A No, provided they're doing all those other things I've indicated which should be done then, no, I think I could continue it based on that self-report of the individual that - because there is difficulty measuring a benefit. As we've said, quality of life measures are fairly crude. They just don't pick up on how much is the dynamic of the whole relationship, I don't know and you can't measure that either."
Professor Holmes-Walker agreed that patient reports involved "almost a double level of subjectivity", they being "how the patient's feeling" and "how you emotionally relate to the patient. There's a whole dynamic isn't there, that so much of medicine is not measurable frustratingly so for us scientist(s) who just like to measure a number that goes up and down, correlates with every response". With respect to "surveillance" Professor Holmes-Walker said (Tcpt 29/3/2023 p126) that she would "probably monitor blood pressure with commencement and then annually" but that "it comes a little bit back to age of the individual and their other risk factors". Professor Holmes-Walker did not consider pulse rate a relevant marker to monitor, and that although some hormones will be picked up in the course of blood pressure testing she did not "specifically follow on pulse rate". Weight was a matter which Professor Holmes-Walker considered to be relevant to surveillance of patients on off-label medication.
[15]
The evidence of the Practitioner
In her Reply to the Commission's original Application dated 19 May 2022, the Practitioner disputed the allegations of the Commission with respect to her management of each of the patients referred to in the Application. In her Reply to the Amended Complaint dated 19 September 2022 the Practitioner said that:
"The patients I treat, away from my hospital practice, are very largely cosmetic patients with some percentage that I see for more general approach. Of them, the patients for whom I prescribe HGH (Somatotropin) and DHEA are not a large cohort, and are patients I know well. Most are very long term patients. I spend a long time with them, consults are an hour - or longer if necessary. I take a lot of time talking to them and listening to them. I know them, how they feel and what stresses and other things impact on their sense of wellbeing, not just their physical health."
The Practitioner further stated that:
"I know their history and keep track of their progress - which I did not always write down. I do write notes, by hand. I cannot talk to patients and write at the same time but I almost always note the history as best I can and presenting issues and keep track of their progress on anything I prescribe, how they are feeling etc. Many patients have educated themselves about the use of off-label medications and would like to try a different product or treatment - subject always to informed consent being provided. If they do not report a benefit, they cease it. I have not had any adverse reactions or complications arising from my treatment of my patients."
With respect to her ordering medication directly from a pharmaceutical supplier, the Practitioner said, correctly, that she was "permitted to order medication directly from a pharmaceutical supplier", and that she is "permitted to dispense medication … by directly providing and administering medications to a patient onsite. I purchase various substances for use in my cosmetic practice and use them directly on patients, such as Botox and fillers and anaesthetic cream". The Practitioner said that she has not prescribed Somatotropin since 2019 and that, since Covid her practice has "changed very considerably and I now see very few general patients", for the reasons which she outlined. The Practitioner said that her patients "have always expressed their satisfaction with my care and treatment and the feedback I get from them has always been positive, and genuine. My aim has always been to improve their quality of life, to help them feel better about themselves, to have more energy, more confidence, and to get more out of life".
As noted earlier, none of the ten patients whose prescribing gave rise to the Commission's application has made any complaint about any aspect of their treatment by the Practitioner. There is no rational basis for disputing the Practitioner's statement with respect to patients' reports with respect to their quality or enjoyment of life. To the extent that it has been suggested, albeit not as part of a particular of any complaint against her, that the Practitioner has in some way financially benefitted from directly dispensing medication to her patients, the evidence does not establish that any such prescribing has been unlawful or intended to have, or have had, any actual or likely financial benefits for the Practitioner, or any inappropriate financial benefits for her patients.
The Practitioner reiterated that her patients are "intelligent, fully informed and very aware of what is available in the anti-ageing area of medicine. They are fully consented to any medication regime I recommend or administer, whether on-legal or off-label". There is no evidence to the contrary, or, in my view, any reason to reject the Practitioner's assertions.
The Practitioner said that "Somatotropin has a very low risk profile. The amount of information provided for informed consent was, I think, more than sufficient for my patients to gain a good understanding of risks and potential therapeutic benefits". The Practitioner said that her method of prescribing of Somatotropin involved "history, relevant investigations, informed consent etc. As there was a need for a repeated course of injections, the patients were provided with the medication to self-administer". The Practitioner said that "Patients are not prescribed medications in isolation. They get advice, support, follow up, nutritional and exercise guidance, and often they also see me for cosmetic procedures". In my view there is no reason to reject that evidence.
The Practitioner was cross-examined closely by Counsel for the Commission, and questioned at considerable length by the Tribunal. The Practitioner impressed me as being an honest witness. In my view, the Practitioner made appropriate concessions, was responsive to questions asked of her, and did not attempt to embellish her evidence. As noted earlier, the Practitioner admitted the complaint with respect to the adequacy of her clinical records. Necessarily so doing was unhelpful in terms of her defence of the allegations against her with respect to the monitoring of the treatment of the ten patients for whom she prescribed. It does not mean however that, because the Practitioner's records with respect to the treatment of any of the ten patients was deficient, that she failed to manage their treatment in the manner alleged in this complaint. In defending those allegations, the Practitioner can rely to only a limited extent on contemporaneous clinical records which, had they been adequate, may have materially, or decisively assisted her defence.
At the commencement of her cross-examination, the Practitioner confirmed that she had prescribed Somatotropin for all ten of her patients, Anastrozole for one of them, Testosterone for "very few of them", a "compound version of Testosterone with DHEA", Mesterolone once and Pregnenolone for "not many" of her patients. The Practitioner agreed (Tcpt 30/3/2023 p131) that, as she was prescribing drugs for off label purposes there was a "greater need for detailed recording to justify why you prescribe those hormone substances". The Practitioner acknowledged (Tcpt 30/3/2023 p132), consistently with her plea of guilty to the inadequate records complaint, that there were "instances" where she had failed to record any reason for the prescription of medications which gave rise to these proceedings.
In my view, in cross-examination on her medical records and the agreed prescribing schedule, the Practitioner was able to explain why she had prescribed particular medications, and the dosages which she had prescribed. Her evidence had the "ring of truth". Although that removes a possibly fatal basis of the Practitioner's defence, it does not guarantee its success.
The Practitioner was asked (Tcpt 30/3/2023 p144) about her direct dispensing practice. The following exchange occurred (Tcpt 30/3/2023 p141):
"Q Selling something at cost price to a patient, you accept, can be seen as an attraction to getting stock direct from you?
A Not with my patients, no. I screen my patients very carefully. I don't see that that was an issue and never thought of it that way.
Q Will you accept that they're getting the stock cheaper from you than they would if it was retail?
A They wouldn't be able to buy it retail.
Q You accept that they would be getting stock cheaper from you than if they were buying it at a pharmacy?
A They wouldn't be able to get it from a pharmacy.
Q Is it your evidence that they wouldn't be able to get Somatotropin at all from a pharmacy?
A Without a script, no.
Q If you gave them a script and they took it to a pharmacy, you accept that the Somatotropin would be more expensive at the pharmacy - as a general proposition, than it is when buying it wholesale from you?
A I don't know how pharmacists work out their pricing, I'm sorry for something like that."
It was suggested to the Practitioner (Tcpt 30/3/2023 p142) that it "would have been cheaper than buying it from a pharmacy under a script". The Practitioner replied "Okay. I will accept that." The Practitioner was asked to accept that all of her patients had purchased Somatotropin directly from her. The Practitioner agreed with that proposition. There was no evidence of illegality or necessary inappropriateness in doing so.
When asked how she would know that patients were not "diverting" the medicine she directly prescribed, the Practitioner said (Tcpt 30/3/23 p143-144) that she had taken:
"careful history. I always spend an hour with the patients each time, getting to know them, their character. They were often referred by other patients or doctors. So I knew of their character and honourable character. And blood tests would show repeat IGF-1s went up they're just some things that come to mind immediately.
Q In your answer you said blood tests would show their IGF-1s went up?
A Yes.
Q Are you suggesting that there was ongoing monitoring of hormone assessments?
A Yes.
Q In relation to each of those patients?
A I believe so.
Q You accept as a general proposition don't you, don't you, that dispensing directly Somatotropin removes the oversight of the pharmacy as a layer?
A Yes.
Q Do you recall … giving an explanation for the direct dispensing was because patients were embarrassed?
A That was one of the reasons.
Q Did each of them tell you that?
A A few did.
Q But not all of them?
A No.
Q And you made no notes of them being embarrassed?
A This is from years ago not in the timeframe that you have subpoenaed my records.
Q Wouldn't that excuse also apply potentially to the dispensing of testosterone to men or women?
A To some degree, growth hormone seems to have a certain attitude with some pharmacists and they would, unfortunately, put that across to my patients. And also there was a delay because it's not something that's on the shelf or they can readily procure, so there was delays in dispensing. It was problematic. It has to be frozen - not frozen, under ice and directly transported by the company and it's not as straightforward as a normal medication.
Q I suggest your explanations in relation to your reason for direct dispensing are not true but would you disagree with that?
A I do disagree with that."
Nothing to which the Tribunal has been referred by reference to the evidence of the Practitioner or otherwise persuades me that the explanations given by her were not true, inherently implausible, or so unreliable or contradictory as to justify their rejection.
It was suggested to the Practitioner that "The reason that you sought to directly dispense Somatotropin was to reduce the risk of oversight or investigation about it". The Practitioner denied that but agreed (Tcpt 30/3/2023 p144) that "In general terms" it is preferable to encourage dispensing through a pharmacy. The Practitioner explained how she came to directly dispense drugs for her patients. In my view, her explanation was not implausible or inherently improbable. The Practitioner rejected the suggestion that she only knew her patients "in the context of what they tell you in their appointments" stating that "sometimes they're referred by other doctors, specialists. And I have a conference talk with them about the patient before they present. Sometimes they're referred by family and past patients. So I get some background before I meet them." When asked to identify which patients they were, the Practitioner did so. In my view, there is no evidentiary reason to reject what the Practitioner said.
The Practitioner said (Tcpt 30/3/2023 p145) that she placed "minimal" reliance on what somebody else had told her previously about a patient's circumstances, and confirmed everything when talking to patients and "elaborated on the areas that I needed to elaborate and it went from there". In my view, the evidence does not suggest that that did not happen.
The Practitioner said (Tcpt 30/3/2023 p146) that she had not seen any of the ten patients socially, in their "professional contexts", with their "families or their loved ones", and acknowledged that she was not a psychologist or a psychiatrist. In what way having not seen the patients in any of those contexts or the Practitioner's absence of qualifications as a psychologist or psychiatrist was suggested to advance the Commission's case was not then or subsequently identified, or otherwise apparent to me.
The Practitioner explained in detail (Tcpt 30/3/2023 p148) the basis on which she considered her patients to have been "well-informed", and that each of them gave an informed consent to her treatment of them. In my view, there is no reason to reject her evidence about those matters. Not insignificantly, as the Practitioner explained, the consent document which patients executed were "signed on the second consultation" (Tcpt 30/3/2023 p149), they having had the opportunity to take them away to consider after their first consultations.
In cross-examination with respect to the evidence of Professor Holmes-Walker "in relation to exhausting other means that did not involve hormone substances and prescription medicine, before prescribing hormone substances in a wellness sphere" (Tcpt 30/3/2023 p151) the Practitioner acknowledged that she accepted that proposition "because it is correct". The Practitioner was asked "Why do you say it's correct to try all other means before prescribing hormone substances in the wellness sphere?", to which she replied "Because you make a differential diagnosis as to what the best treatment plan is". The Practitioner confirmed that, although consent to the treatment was not given until the second consultation, prescribing Somatotropin for Patient A was "already under consideration at the end of the first consultation with him". Why that was inappropriate was not identified.
The Practitioner was referred to the evidence of Professor Holmes-Walker with respect to monitoring of off label prescriptions. The Practitioner acknowledged (Tcpt 30/3/2023 p158) that Professor Holmes-Walker suggested that "she scripted Somatotropin only every six months as a minimum". The following exchange ensued:
"Q The evidence of both these experts Holmes-Walker and Dr Cortez [sic] was to conduct blood tests at a minimum every six months.
A Initially at the six month mark and then yearly was my understanding.
Q That was holding onto the concept of objective measurement that you're doing no harm to the patient do you agree with that?
A That's one arm, yes.
Q You also heard, no doubt, evidence of the liver and glucose fasting tests needed to be done?
A Yes.
Q And you said earlier you can see the benefit of objective measuring of reported benefit?
A Yes.
Q I take it you held this position - you're now saying this now in your evidence but you knew this at the time that you were treating Patients A to Patients I as well?
A Yes. I found the referral to Dr Buckland in the notes."
In subsequent cross-examination, the Practitioner gave evidence of having reviewed the treatment of off label drugs for patients from time to time during the course of their treatment. In doing so, the Practitioner was able to give considerable, and in my view impressive detail about each patient whose treatment was raised in cross-examination.
The Practitioner's evidence suggests to me that the "one dose fits all" concern that Professor Holmes-Walker recorded was more likely to be coincidental than to result from the absence of ongoing monitoring of the effectiveness of the treatment and any risks to the health of the patient associated with it. If the Practitioner had to prove on the balance of probabilities that the absence of variation of treatment dosages resulted from appropriate ongoing monitoring of prescribing, she would be unlikely to do so. The Practitioner bears no such onus. The onus is on, and remains with the Commission to prove its allegations to the comfortable satisfaction of the Tribunal. The Practitioner in this case need only adduce evidence which "tends to show" that her conduct did not fall significantly below the requisite standard (Rockcote Enterprises Pty Limited v FS Architects Pty Limited [2008] NSWCA 39). In my view, the Practitioner has done so.
The transcript records the cross-examination of the Practitioner by Counsel for the Commission continuing for approximately 60 pages. On completion of that cross-examination (Transcript 30/3/2023 p188) the Practitioner was questioned by Members of the Tribunal. That cross-examination occupied approximately 40 pages of the transcript of 30 March 2023. The Practitioner was recalled for further examination by the Tribunal on 31 March 2023. The transcript records questioning of the Practitioner by the Tribunal on that day occupying a further 20 pages. In my view, although the evidence establishes, as Professor Holmes-Walker suggested, that the Practitioner's prescribing fell below the required standard, having seen and heard the Practitioner's lengthy and probing questioning in the witness box, and reflected on her answers to the questioning, I am not comfortably satisfied that the Commission establishes that her conduct fell "significantly" below the required standard.
Dr Newberry asked the Practitioner (Tcpt 30/3/2023 p188) whether she could explain how, by reference to the agreed prescribing schedule, a script could issue in the absence of any entry in the Practitioner's clinical notes. The Practitioner explained (Tcpt 30/3/2023 p189-190) how that came about, and that her registered nurse either filled out the top part of the prescription and the Practitioner filled out the operative part. In some instances, as emerged later in her evidence, the Practitioner dictated the content of the prescription to the registered nurse before signing the script. The Practitioner said that she was "pretty careful with where I keep my script pad. It's in my office in my desk. But it's not always locked" explaining that her room has "a locked door and I have a locked desk with a filing cabinet, with a key. But during the day that's open so I can get my script pad out and you know, ordering forms etc. So I can't say for sure every time I put the script pad back in the drawer that I lock it during the course of the day but definitely at the end of the day". The Practitioner said that she was not aware of any scripts having been forged.
Nothing before the Tribunal persuades me that the Practitioner's practice was unlawful or inappropriate. In any event, no part of the Commission's Complaints alleges such matters. The evidence does not establish that the Practitioner signed any prescription in blank, or without first checking it. The Practitioner's practice was clearly less than optimal, and, as the evidence makes clear, reasonably gave rise to the concerns which the Commission, and the Tribunal explored with her in detail. In my view, the evidence about those matters does not advance the Commission's case.
In subsequent questioning by Dr Badham and Dr Newberry, the Practitioner explained her practice with respect to writing prescriptions in further detail, and (Tcpt 30/3/2023 p191) explained why she ordered Somatotropin in the quantities in which the agreed prescribing schedule revealed that the Practitioner had. In my view, nothing emerging from that questioning advances the Commission's case, either as pleaded or otherwise. Similar observations apply to questioning of the Practitioner with respect to the supplying and labelling of medications which she prescribed (Tcpt 30/3/2023 p193).
In the course of her evidence, the Practitioner explained (Tcpt 30/3/2023 p194) how she instructed patients with respect to the administration of prescriptions by injection, and the warnings she gave to them, in particular that "they can't have growth hormones with food. If this is the dose, they can't have calories 3 hours before or 1 hour after because it will interfere with - because it is IGF-1. So if you eat you're releasing insulin and it will interfere at the receptor with the growth hormone. So it's less potent. So they have to have it fasting. And I suggest six days and one day off. So they need to have a day off a week. No dose for a day a week". Nothing said by the Practitioner in reply to that questioning persuades me that the Practitioner's evidence should be disbelieved.
The Practitioner was questioned further by Dr Badham (Tcpt 30/3/23 p196-198) with respect to the custody of drugs, scripts and patient records, in the course of which the Practitioner gave detailed explanations, which I do not believe were challenged as inaccurate or inappropriate. I am unable to reasonably reject the Practitioner's evidence about those matters, on credibility or other grounds.
The Practitioner was asked by Dr Newberry (Tcpt 30/3/2023 p198-200) about patients who consulted the Practitioner from places as far away as Queensland and other places outside the Eastern Suburbs of Sydney where the Practitioner practised. The Practitioner was asked whether it raised a "red flag for you when people are coming from out of area". The Practitioner replied "When you speak to them, you know their affiliation with the Eastern Suburbs. Whether they have their business there or family or they have a place in the country but they also have a place in the Eastern Suburbs. So they have one as their registered address but they might have a flat in the Eastern Suburbs and have a country estate or country property which is listed in their residence. Various reasons". Dr Newberry asked (Tcpt 30/3/2023 p200) "If you've got people coming from out of the area and asking for particular medications. That also raises flags. I wonder, particularly these people, are making an effort to come and see you". The Practitioner said that the patients were not asking for Oxycodone, the medication to which Dr Newberry referred in introducing her questions and reiterated that she knows the patients "quite well each time I have an hour interview with them. And I'm comfortable that that's not what they're seeking. It's not their - they're not being duplicitous or anything like that". It was suggested to the Practitioner that some of the patients "might have been seeking you out for prescription". The Practitioner replied:
"You're only getting nine patients - this cohort has already been - of all the patients I have, it's been distilled down to these nine patients that you have. You know, so a lot of other patients that I would see for similar symptoms, perhaps, I'd go down another tack depending on what came out of the initial hour consultation. That's all been eliminated because this investigation is to do with the prescribed [sic] of growth hormones. So you've already just got that cohort of patients. Not the patients that I investigate or see - they can't assume by coming to me that that's what's going to happen. Nor have I had anyone trying and steer me in that direction or put pressure on me".
The Practitioner indicated that she does not "see the young guys. I'm not interested in that patient. That's the dangerous situation".
The "wellness" patients which the Practitioner saw in 2017 was confirmed (Tcpt 30/3/2023 p201) to have been less than five patients per week, not all of whom were prescribed growth hormone. When asked to clarify the percentage of patients prescribed growth hormone (Tcpt 30/3/2023 p202), the Practitioner suggested about 20%, some of whom have or have had a GP, some of whom were "fit and well" and did not have a GP "on the books".
In questions from Dr Badham (Tcpt 30/3/2023 p203-204) about how "the patient ends up on growth hormone, if they weren't coming to the practitioner seeking it", the Practitioner clarified (Tcpt 30/3/2023 p203):
"We have a discussion about the symptoms that they're expressing and what possible treatments there are. Sometimes they are aware of DHEA growth hormone, Pregnenolone, Melatonin. Sometimes they're not. So you have to have more of a discussion about what hormones, how they act. So that's what I mean by well-informed patients. They have an idea of hormones and even receptors or how lock and key, as I say, when you open a door. It's what a hormone does. So depending on how far I have to go into explaining what a hormone does, how it works. Then the risk and benefits and then the patient goes away and decides".
The Practitioner confirmed that "If they're not coming and asking for growth hormone, then it's something that you offer" if it is "appropriate". The Practitioner reiterated, convincingly in my view, that her prescribing of growth hormones was not either at her instigation in the absence of evaluating the appropriateness and safety of doing so, or at the behest of a patient, wherever the patient had come from, and for whatever reason the patient had come to her, if she did not consider that doing so would potentially benefit the patient and was safe.
The Practitioner was asked about her treatment of conditions which were not suggested to arise from or be related to the patients referred to in the Complaints, and was asked (Tcpt 30/3/2023 p206) about the "quite a few prescriptions … for benzodiazepines and analgesics" and how that came about. The Practitioner replied "It's just treating the total patient. I think the Temazepam (one patient) had a bad car accident and she had a cervical injury and a fusion. On and off she would have chronic neck pain and difficulty sleeping and the Temazepam would allow her to sleep and relax her muscles. So it would be a short term when she had an exacerbation of her neck. She is very active and if she's in the wrong position, she aggravates her neck pain. She also has had bilateral knee arthroscopies, from memory. So she has knee pain. She used to be a runner on hard surfaces, so she's worn her knees down. So every now and again they would cause her pain. That's just looking at the patient". The Practitioner agreed that the patient was the "whole person".
The Practitioner rejected (Tcpt 30/3/2023 p207) the suggestion from Dr Badham that "When it comes to pain and sleep you are more happy to provide a script for things that can be addicted [sic]" saying "No. I sometimes use Melatonin. But Melatonin either works well or it doesn't. It's good to try and some people love it and some people say that it did nothing". I am not persuaded that the Practitioner's evidence should be rejected.
The Practitioner was asked about Patient J (Tcpt 30/3/2023 p207) and gave considerable detail about his symptoms, his other treating health professionals and her consultations with them. The Practitioner identified (Tcpt 30/3/2023 p208) a number of letters from other treating health professionals which were corroborative of the Practitioner's evidence. The Practitioner explained (Tcpt 30/3/2023 p210-211) why she prescribed 40 pills in lieu of the more usual 20. In my view, the evidence of the Practitioner about those matters had the ring of truth.
The Practitioner was asked (Tcpt 30/3/2023 p218) about her "protocol" with patients who consult her for "wellness". The Practitioner explained that, if she felt it was necessary, the patient was given a referral for a blood test on the first consultation, and that the consent form was provided to the patient on the first consultation with an invitation to take it away, and consider it before signing or being asked to sign it. The Practitioner clarified (Tcpt 30/3/2023 p219) that, after consulting with them, she would "go straight to" the "lifestyle, vitamins, maybe infusions" treatment rather than to growth hormones.
By reference to the evidence of Professor Holmes-Walker the Tribunal suggested that "that seven out of the ten (patients) … you go straight to Somatotropin.". The Practitioner said "I think there is in some patients. It's just not reflected in these notes". Ms Lovrovich asked "No. I'm saying about these seven. Where's the journey?" The Practitioner replied "Well, it was decided from the consultation that they've tried, they've tried the exercise. He's been fasting. HITS protocol. They're all on these different - tried all these things and they are still left with the symptoms. Some of them are not able to be treated with other modalities. Especially cognition. You know, energy's tough. But you do the blood test because that may lead you down another way". The Practitioner added "They might be iron deficient or something. If the bloods are normal then you can - you can split at any time. If the bloods come, if something's come up. No forget that. We need to go that way. They we'll go that way. Given that that's not the case, then you can continue down that arm of the tree. So it does branch at quite a few points."
Ms Lovrovich asked the Practitioner about her "patient surveillance practices", and whether the Practitioner considered hers to have been consistent with those of Professor Holmes-Walker. The Practitioner said that she "tends to see her patients, more often I don't feel comfortable with giving someone six months' worth of growth hormone and not seeing them, so I want to see them more frequently" than does Professor Holmes-Walker but added "I don't write PBS scripts for growth hormone".
Ms Lovrovich asked (Tcpt 30/3/2023 p220) the Practitioner whether she agreed that Professor Holmes-Walker's "journey was more extensive and her surveillance was more extensive" than that of the Practitioner. The Practitioner replied "Her surveillance in some things would have been more extensive because she's using injectable testosterone and high doses of growth hormone. I wouldn't - you know, she's an expert. So she definitely can push the dose and you know and survey that and probably needs to do because the patients that she sees are growth hormone deficient, more than the patients that I see. My dosing is a lot lower. But I do see the patients more often. I don't do injectable testosterones. So that surveillance is slightly different". In my view, caution needs to be exercised when evaluating the conduct of the Practitioner by reference to the benchmark which the statutory provision relied on by the Commission articulates, which is that of a General Practitioner, not that of a specialist endocrinologist. If the Practitioner's monitoring of her prescribing fell short of that of Professor Holmes-Walker, as it probably did, that does not mean that it fell significantly below the standard required of her.
The following exchange ensured (Tcpt 30/3/2023 - p221):
"LOVROVICH: Do you think your journey is the same is her journey?
WITNESS: No because with minor cognitive impairment, I wished there was a drug that we could give. Like Metformin for diabetes, that would be fantastic, but there isn't. The same for fatigue and just feeling just a bit not your best. Like 90 per cent or 80 per cent instead of 100. There's no magic script for that, unless they're depressed. But even now we've seen antidepressants don't play a part, it's lifestyle now. So we're back to that. So for some of these very difficult symptoms, unfortunately there isn't a script that can be written. I wish there was that would be so easy.
LOVROVICH: But she was talking about lifestyle issues the same as what you were talking about.
WITNESS: Yes, if they need to go down that arm.
LOVROVICH: Is your journey the same as her journey do you think?
WITNESS: Yes, because you haven't seen the patients that were rejected.
LOVROVICH: Okay.
WITNESS: You've only seen the cohort got the growth hormone you haven't seen the patients that I had the initial consultation with, where we went down the lifestyle, the weight loss, the HITS protocol, the intermittent fasting, the micronutrients."
Ms Lovrovich then asked:
"LOVROVICH: Is your surveillance, in your view, as through as her surveillance? This is bearing in mind that we're not talking about - in my question, I'm not talking about injectable testosterone. I'm talking about scripting Somatotropin or giving these ampules of Somatotropin do you feel your surveillance is as through as what Professor Holmes-Walker was suggesting?
WITNESS: It's hard to compare because I see the patients more often.
LOVROVICH: Okay.
WITNESS: Yep. So I'm seeing them maybe two or three times more often than she does.
LOVROVICH: She was talking about scientific surveillance she was talking about
WITNESS: Well that's one arm of it, isn't it. There's the history for the examination and the investigations.
LOVROVICH: No, on things like for example the blood testing and the
WITNESS: But she did to go to it yearly, after the first two.
LOVROVICH: So you feel I see. So you feel there's something there.
WITNESS: Yep."
The Practitioner was asked (Tcpt 30/3/2023 p223-224) about her "view" on purchasing, storing and selling, prescribing, dispensing and delivering the drugs which are relevant in these proceedings. Although I do not consider that this evidence could advance the Commission's case as pleaded or otherwise, in my view, the Practitioner was able to satisfactorily answer Ms Lovrovich's questions. Similar observations apply to Dr Badham's questioning of the Practitioner with respect to the Practitioner's registered nurse's involvement in the writing of scripts (Tcpt 30/3/2023 p226-227).
In further evidence on 31 March 2023 the Practitioner was asked by Dr Newberry whether she agreed with Dr Kertesz that her prescribing was inappropriate (Tcpt 31/3/2023 p242). She did not agree. The Practitioner was asked whether it was inappropriate to be treating an ex-partner with whom she was said to have "continued to have a financial bond … through various businesses". The Practitioner said (Tcpt 31/3/2023 p242) that with "hindsight … it was best that I found a GP immediately but that can be difficult … so in the interim I was treating and time sometimes extends and then specialists were involved, etc, and the treatment became more complicated and I guess time got away, but that's - I definitely did transition him and he now has finally found a GP that he has solely". Importantly in my view, no part of the Commission's Complaint alleges that the Practitioner was in other than a doctor-patient relationship at the time she was treating the patient. To my observation, in demeanour and content, the Practitioner was candid in giving evidence about this issue.
Dr Newberry asked the Practitioner (Tcpt 30/3/2023 p242) whether she agreed with Dr Kertesz that her "prescribing was inappropriate" with respect, inferentially, specifically to Patient J. The Practitioner replied:
"A I discussed it with the specialists and they - and I would often discuss with them his medications, and I have actually written it in the notes that I - which I found, that I did discuss with Dr Yu and Dr Crawford, the pain specialist, what medications he was on so they knew and they were happy with what was necessary for his pain burden, and so I - in that case, having conferred with the pain specialists and the surgeons, what was prescribed was in agreement with all of us.
Q Were they aware of the quantity that you were prescribing?
A I do believe I discussed it because the discussion was do we pivot to an S8 or do we keep him on the Mersyndol Valium combination and there was always this trial of Palexia on and off and it didn't have to escalate to regular and PRN S8s. He was managed - unless he had an acute attack, then things differed, but it didn't have to escalate to him being on permanent S8s or, you know, a Fentanyl patch or anything like that. These were discussions that we had together, but it didn't escalate to that.
Q We have to take your word for that because there is no documentation around that.
A No, no. Not that, but there is documentation about the discussions, and I can highlight those, yep."
The exchange continued:
"Q My experience is usually that a pain specialist will document in the letters about the medications that are appropriate and there are fleeting references to Palexia but no mention of the other things. Were they aware of the amount of Valium that he was having?
A I told them that he was on daily Valium. He was needing - maybe not every day, but most days, yes, as a muscle relaxant and in cumulative - and in combination with the Mersyndol.
Q Were they aware that he was having Valium strips as close as every day or two at some points?
A I can't remember that I had that exact conversation. I don't think I would have had that conversation with them.
Q Would it have been relevant to know that he was using a lot of benzodiazepines at that stage?
A They knew he was using a lot and they were seeing him regularly so they could make their decision seeing him and speaking to him as well.
Q Was he referred to an addiction specialist at all?
A I didn't refer them and nor was that mentioned by any of his specialists."
In response to questions from Dr Badham about Patient J's Valium prescriptions (Tcpt 30/3/2023 p243-245), the Practitioner explained, credibly and logically in my view, why that prescribing had occurred. She was then asked (Tcpt 30/3/2023 p245) "Do you think the repeated prescription may have contributed to dependence of this drug?" The Practitioner replied:
"A It is a drug of dependency. I guess my reasoning is that there was no other combination of medications that seemed to alleviate his pain better than that combination. Gabapentin was tried. Even the Palexia had side effects. So I take your point. I guess in a unique situation, very usual, I - I take that. This combination worked the best, and I guess when something works for you there is an element of ---
Q Dependence that may have developed after repeated use due to
A Well, I guess anyone who has pain is dependent on their medication whether it's an antidepressant or Seroquel or something for insomnia, so you are dependent on that medication for the result, and pain is very difficult to manage in a patient with his pain burden, but I understand what you're saying."
The Practitioner agreed that "It is a drug that can be abused and become dependent". I do not recall any evidence that the patient abused the drug or became dependent on it.
The Practitioner was asked about her writing of prescriptions, and the requirements in that regard (Tcpt 30/3/2023 p245-252) after which I asked (Tcpt 30/3/2023 p253) "Is there anything in the document behind Tab 70 of HCCC1 Tab 70, the "Guide to poisons and therapeutic goods legislation for medical, nurse and midwife practitioners and dentists" that you would point to which in your view supported the approach you've taken with the direct dispense drugs?" The Practitioner replied "I guess, I didn't rely in part on this, but if you look at page 485 it does say sale or supply that's perhaps part of what I read as well, and also page 1 of this document says "This guide is a summary only and should be used in conjunction the Poisons and Therapeutic [sic] Act, the Poisons and Therapeutic Goods Regulation 2008", so it wasn't just this document that I relied upon and also in discussions with colleagues who also dispense the Somatotropin in the manner that I do. There are other doctors who dealt with Scigen directly. I think the HCCC subpoenaed the list of doctors who did so, and I spoke to them as well, and this is what I was told".
The Guide provided that Schedule 4 "restricted substances", in the public interest, should be supplied only upon the written prescription of an authorised practitioner. With respect to Schedule 4 restricted substances the Guide provided that such substances "may be obtained by a medical practitioner or dentist. [I] from a licensed wholesaler on a signed and dated order (on the letterhead) of the medical practitioner or dentist". The Guide provided that the restricted substances "must be stored in a part of the premises which is partitioned off or otherwise separated from the remainder of the premises and to which the public is not permitted to have access (e.g. a cupboard or a drawer in a surgery). The Guide provided that prescriptions for a restricted substance "may be issued by a medical practitioner for use in medical treatment or by a dentist for use in dental treatment". The Guide further provided with respect to sale or supply that:
"Where a medical practitioner or dentist supplies or sells a restricted substance, including clinical samples, a record must be made showing:
(a) the date on which the medicine was supplied;
(b) the name and address of the patient; and
(c) the name strength and quantity of the restricted substance supplied.
This records must be kept at the prescriber's surgery, office or hospital and be made available for inspection if required."
The Guide also made reference to requirements on labels which are not relevant for present purposes.
In response to questions from Ms Lovrovich following upon the Practitioner giving that evidence, the Practitioner confirmed that she had complied with those requirements. Senior Counsel for the Practitioner confirmed that it was an agreed fact that the Pharmaceutical Regulatory Unit (PRU) had not asked to see source documents with respect to the Practitioner's recording of drug purchases from her supplier.
[16]
Principles governing the proceedings
The principles governing the proceedings are not in dispute or in doubt and require only brief reiteration.
The present proceedings are neither wholly civil nor wholly criminal in nature but are "sui generis" (Weaver v Law Society of NSW (1979) 142 CLR 201; [1979] HCA 35). The present proceedings are protective, having regard to the objects and purpose of s 3A of the National Law, which mandate the health and safety of the public as the paramount consideration when jurisdiction pursuant to the National Law is exercised. If the reasons of the majority, at [7] mean to imply that s 3A of the National Law provides a jurisdictional basis for upholding the disputed complaint, I disagree. The Commission has, advisedly, pleaded and prosecuted the disputed complaint in reliance upon s 139B(1)(a) of the National Law. If it proves its case, the Commission does not need to rely on any other statutory provision. If it does not, s 3A does not in my view provide a residual jusridictional basis on which it could do so. I do not understand the Commission to dispute these propositions.
The Tribunal must be comfortably satisfied that the evidence establishes each of the allegations made by the Commission (Briginshaw v Briginshaw (1938) 60 CLR 336 [1938] HCA 34; Re Anderson and the Medical Practitioners Act 1967 85 WN (NSW) 558).
The Practitioner does not have to prove anything in these proceedings. The Commission bears that onus. The Commission's case alleging conduct falling "significantly below" the standard required pursuant to s 139B(1)(a) involves the Tribunal undertaking an evaluative process. A benchmark standard which is expected of practitioners in the relevant field must be ascertained, and then the conduct which has been proven against the Practitioner the subject of the proceedings must be assessed against that standard. If the conduct is found to be below the required standard, then the Tribunal is obliged to make a further evaluation as to whether the conduct is "significantly" below that standard (Health Care Complaints Commission v Amalakumar [2019] NSWCATOD 173; Health Care Complaints Commission v Nguyen [2022] NSWCATOD 127).
It was submitted on behalf of the Practitioner that "significantly" was analogous to adverbs such as "seriously", "pronouncedly", "conspicuously", "markedly", or "substantially", and that phrases such as "more than ordinarily" were also appropriate. I do not understand the Commission to dispute that contention.
The Commission submitted that the Tribunal "is to apply their own specialist (and collective) expertise to the evidence informing opinions about whether there has been a departure from the relevant standard of conduct, with appropriate attention to the expert evidence if there is a genuine difference of view" (Health Care Complaints Commission v Fraser [2014] NSWCATOD 29). That case was decided a decade ago. Although I do not necessarily disagree with the Commission's contention, in my view, and accepting that doing so might not be uncomplicated, the Tribunal must be careful to avoid relying upon its own specialist opinions, particularly where there is expert opinion evidence with respect to an issue, and the parties to the proceedings are not, as a matter of procedural fairness, made aware of the inclination of the Tribunal to rely upon its own specialist expertise or opinions or, consequently, able to question those opinions. In my view, properly confining itself to the evidence before it, the Tribunal is unable to be comfortably satisfied that the Practitioner's conduct fell "significantly" below the required standard.
The parties do not disagree in substance with respect to the definition of "improper or unethical" in s 139B(1)(l) upon which the Commission also relies. In Health Care Complaints Commission v Nguyen [2018] NSWCATOD 168 the Tribunal accepted that impropriety "does not depend on the alleged defender's consciousness of impropriety" but "consists in the breach of the standards of conduct that would be expected of a person in the person of the alleged offender by reasonable persons with knowledge of the duties, powers and authority of the position and the circumstances of the case". That definition has been consistently applied in proceedings in the Tribunal. Whether conduct is improper or unethical involves the application of an objective test (Health Care Complaints Commission v Liu [2016] NSWCATOD 133).
[17]
Submissions of the Parties
Counsel for the Applicant and Senior Counsel for the Respondent provided comprehensive and helpful written submissions to which each spoke.
The Commission submitted that the Tribunal would find the Practitioner guilty of unsatisfactory professional conduct and professional misconduct because:
"(a) of the type of medications being prescribed;
(b) the medications were prescribed outside of therapeutic standards;
(c) the lack of an individualised approach - indicated by the Respondent's medical records which show that the Respondent, typically, in the first consultation with Patients A to I considered prescribing growth hormones and did not explore alternatives; and
(d) the blind/reckless regularity of the prescription of Somatotropin and the ad hoc prescribing of other growth medication for off-label purposes;
(e) the lack of clinical basis for prescription and reliance on subjective anecdotal disclosure of symptoms by patients;
(f) the lack of clinical review or engagement of clinical measures to assess the benefits or detriments of the continued prescription of the restricted substance (and again reliance on subjective anecdotal disclosures);
(g) the lack of consideration of alternatives;
(h) the lack of documentation or detailed reasons given for the prescription or regular prescription of the prescribed substances and restricted substances; and
(i) the fact that the Respondent never discussed with Patients A to I a plan that would see them stop the medication; and
(j) the lack of referrals to specialists."
During her evidence, the Practitioner explained in detail each of those matters. The Practitioner having admitted that her prescribing was below, but not significantly below the required standard, the Commission must establish to the Tribunal's comfortable satisfaction that it was.
The Commission further submitted that the Practitioner directly purchasing products from the supplier (spending almost over $25,000 per month) and directly dispensing the product to patients (even if it was at cost price) significantly impacted her clinical objectivity with respect to Somatotropin and her consideration of it on a case by case basis. Given that there is no issue that the Practitioner made no money out of those transactions, I am unable to accept that, although ill advised, the Practitioner's could reasonably have impacted upon her clinical objectivity.
The Commission criticised the Practitioner for having "considered" Somatotropin for Patients A to I on the first consultation. Given that the Commission abandoned its original complaint alleging that the Practitioner had failed to undertake appropriate assessments of patients before prescribing off label medication to them, it is difficult to see how that submission advances the Commission's claim. In any event, why a practitioner "considering" any possible treatment for a patient at the first consultation fell below, or significantly below the required standard was not explained. I am not persuaded that the Commission's case is advanced by this evidence.
It was submitted that there was "an available inference that the Respondent was known for this aspect of her practice and received referrals on this basis". Unless the Commission establishes that there was something inappropriate about the Practitioner's prescribing to the requisite degree, I cannot accept that this submission cannot advance its case. The fact that patients from places far from her surgery sought out the Practitioner does not establish or imply that there was anything untoward about her method of practising. Many professional people, including lawyers, are approached by clients from far distant places because they are known or believed to be good at what they do. The evidence does not establish that the Practitioner unlawfully prescribed any drug or medication to any of the ten patients referred to in these proceedings. There is no evidence that any of the patients had been refused the prescriptions by other doctors. Inherent in the Commission's submission is that the Practitioner was "known" to prescribe the drugs referred to in the Complaint in circumstances where a responsible practitioner would not have done so. The Commission's expert evidence does not persuade me to draw that inference. Nor does anything emerging from the cross-examination of the Practitioner.
The Commission referred to the "nature" of the Respondent's "wellness" practice which "regularly had patients prescribed Somatotropin", and submitted that the Practitioner's direct dispensing of Somatotropin was inappropriate. The Commission submitted that the "documentation and evidence at the hearing invites the strong inference that the Respondent had an embedded practice and was known for her prescribing of these growth hormones for the wellness sphere". If that were so, and it may have been, that of itself does not advance the Commission's case. It is necessary for the Commission to establish that in the ways alleged by it, the Practitioner's management of the ten patients referred to in these proceedings fell significantly below the standard reasonably expected of her as a General Practitioner with her level of training and experience.
The Commission submitted that the "purported reasons" which the Practitioner gave for her prescribing of the growth hormone substances was in the "wellness sphere", an "off-label" purpose, being a "purpose outside of the accepted or recognised therapeutic purpose for the medication". In my view, the evidence, and particularly the evidence of Professor Holmes-Walker precludes being comfortably satisfied that there was anything illegal about any of the prescribing identified in this case. There is in my view no basis for rejecting the Practitioner's evidence that her prescribing was in the "wellness sphere" which the evidence establishes to have been legal. To the extent that it might be thought that "off-label" prescribing has sinister connotations, the explanation provided by Professor Holmes-Walker with respect to off label prescribing and the PBS, and reality that none of the prescribing is unlawful are significant in my evaluation of the significance of the Practitioner's failure to meet the required standard.
The Commission submitted, correctly having regard to her plea of guilty to the inadequate clinical records complaint, that the Practitioner's records should have contained detailed reasons and/or considered alternatives prior to prescribing and/or engaging in regular monitoring (surveillance) of the patient's treatment or care on these substances by having a "medical, clinical and scientific approach to the repeated prescription of the medication". Although, having acknowledged that her clinical records were deficient, the Practitioner's defence of this complaint is more difficult, it does not mean that her defence must fail. The Practitioner gave detailed explanations in response to extensive cross-examination, and quite extensive questioning by Members of the Tribunal. I do not believe that the Practitioner's explanations were suggested to the Practitioner during cross-examination or questioning by the Tribunal to be erroneous, misconceived or improbable. I do not find them to be, or for there to be a demonstrated basis for rejecting them.
To the extent that the Commission mounted a challenge to the credibility of the evidence of the Practitioner, which it did to only an appropriately limited extent, I do not consider that there is any rational basis for rejecting the Practitioner's evidence, either on the basis of her credibility, or because there is evidence from any patient which is inconsistent with her explanation, or because the Practitioner's explanations themselves were contradictory or inconsistent with any document or other circumstantial evidence in the case.
The Commission made numerous submissions about the Practitioner's assertedly "inappropriate direct dispensing", and the inferences which it invited the Tribunal to draw. There is force in the submission of the Commission that being able to obtain drugs directly from the Practitioner, and probably more cheaply than would have been the case had they been acquired from a pharmacy was probably "an attractive aspect of the Respondent's practice" for her patients. Although, at least superficially fuelling suspicion, the evidence does not persuade me that anything the Practitioner did in that regard was unlawful or inappropriate, or consistent with any inappropriate prescribing or supplying of drugs to the patients. The evidence does not persuade me that the Practitioner did not profit, or stand to profit from the practice.
The Commission submitted that the practice "circumvented pharmaceutical oversight". The evidence is in my view not consistent with that contention. The PRU apparently investigated but did not take any action with respect to the Practitioner's compliance or non-compliance with the relevant regulatory provisions. Moreover, no particular of the Commission's Complaint alleges that the Practitioner's direct dispensing constituted unsatisfactory professional conduct. I accept that, in seeking to establish inappropriate prescribing or managing of the drugs which were prescribed for the ten patients in this case, if it be established, the Commission could rely on the findings it seeks with respect to the Practitioner's direct dispensing, if they are made by the Tribunal. I am not persuaded that such findings should be made.
The Commission submitted that "the evidence shows the required standard that the Respondent gained from this practice of direct dispensing - in reputation - which increased patronage - which is good business". Why a professional person doing things being "good business" is improper was not explained. The Practitioner was submitted to have "lacked objectivity with respect to the medication. This was not just inappropriate but in the circumstances in which it was prescribed, bearing in mind the medication was prescribed outside of accepted therapeutic standards, the conduct amounted to UPC and professional misconduct".
Having regard to the terms in which the Commission pleaded its Complaint, I do not accept that it is open to the Commission to rely upon adverse findings with respect to this issue in isolation to support a finding of unsatisfactory professional conduct. Moreover, none of the allegations relied upon in support of that submission has been established to my comfortable satisfaction. The critical question is whether the Commission can establish that the direct dispensing was inappropriate in some way. The evidence does not persuade me that the practice circumvented appropriate pharmaceutical oversight, or that there was, in the circumstances described by the Practitioner, any risk of patients inappropriately dealing with the drugs which were prescribed by her.
With respect to the alleged inappropriate prescription and management, the Commission submitted that the prescribing of Somatotropin and other growth hormone substances was inappropriate because the Practitioner "failed to explore other non-growth hormone options; and for other growth hormone substances prescribed (testosterone, Pregnenolone, Anastrozole, DHEA, Mesterolone) there were no records as to the Respondent's clinical reasons for their prescription. In the absence of knowing the Respondent's reasons, that prescription was inappropriate". Although the absence of such "knowing" renders the Practitioner being able to adduce evidence which tends to show that the prescribing was not inappropriate, it does necessarily mean that she cannot. The Practitioner gave evidence about her exploration of non-drug options prior to prescribing them. Although I am not convinced that such explorations were as extensive as they might, or should have been, I am unable to reject that evidence, or to find that the conduct fell significantly below the required standard.
The Commission submitted that it was not solely because the prescription was off-label that it was inappropriate, but that "in circumstances where growth hormones are being prescribed for off-label purposes, the prescription was inappropriate because it was prescribed early on in the care/treatment of the patient, without clear scientific, clinical or medical reasons and in circumstances where at times there were no reasons set out for the prescription." Unless the Practitioner's evidence with respect to those matters is unable to be accepted, it tends to show that her failure to meet the required standard did not fall significantly below that standard. Although leaving much room for improvement, I am not comfortably satisfied that the Practitioner's conduct fell significantly below the required standard.
The evidence does not establish to my comfortable satisfaction that the Practitioner failed to explore other non-growth hormone options, as her oral evidence in cross-examination revealed in detail. There is no evidence to contradict what the Practitioner said, and no rational basis in my view for rejecting her explanations.
With respect to inappropriate management, having regard to what the Commission abandoned in its original application, potentially the most significant issue is whether the provision of growth hormone substances for off-label purposes to the ten patients was inappropriate because of "the frequent and regular prescription of Somatotropin, the ad hoc prescription of other growth hormone substances, the absence of ongoing monitoring (surveillance) or referrals and the reliance on anecdotal disclosure of benefits rather than clinical measurements (including clinical reviews to assess whether there were any elevated risk)".
The Commission was critical of the Practitioner's "consent form", asserting that it "lacked an element of objectivity". The consent form must be taken in conjunction with the evidence of the Practitioner, which there is no reason to reject, that there were detailed discussions with each patient at the first and subsequent consultations, prior to the patient subsequently executing the consent form. There is no reason in my view to reject the Practitioner's evidence with respect to the level of intelligence and experience of the patients. It is also relevant in this context that there has been no complaint by any patient about their treatment by the Practitioner. The concessions fairly made by each of the Commission's experts about the Practitioner's consent forms provides further support for my view with respect to this issue.
The Commission relied upon the evidence of Professor Carter, who is an Endocrinologist, with experience relevant to the assessment of the risks of growth hormone medication, accepted dosages and the management and monitoring of patients on growth hormone medication. The Commission conceded, appropriately, that Professor Carter was not a GP and does not practice in the wellness sphere. That has dual relevance in terms of the weight appropriate to be given to Professor Carter's evidence.
As is not in doubt, the standard by which the conduct of the Practitioner falls to be determined is the standard reasonably expected of a general practitioner of an equivalent level of training and experience, and not that of a more highly trained specialist in endocrinology.
The submission of the Commission that Professor Carter's evidence was "critical for the Tribunal to have an appreciation of the risks and side effects associated with the medication, because that must inform the standard that ought to be applied by any practitioner" is not a proposition which I am able to accept without the qualification to which I have referred. In terms of safe dosages and monitoring, Professor Carter was able to, and gave relevant evidence. The Commission referred to deficiencies which Professor Carter identified in the Practitioner's clinical records with respect to the prescribing of drugs of relevance in these proceedings. In isolation from the oral evidence of the Practitioner, which was given after each of the experts was cross-examined, and not the subject of comment by them, it is difficult to reject the criticisms Professor Carter raised with respect to the Practitioner's prescribing which were made solely in reliance upon her medical records. The Commission submitted that, by reference to the Practitioner's clinical records, Professor Carter observed notes which were a "relative contradiction for the continuation of the drug" or that there was a "suggestion" of a condition which rendered prescribing Somatotropin inappropriate. Accepting that contention is consistent with finding that the Practitioner's conduct fell below the required standard, but does not, in my view, advance the Commission's case with respect to the significance of the deficiency.
As the Commission conceded, Professor Carter fairly did not express concerns about numerous aspects of the Practitioner's prescribing, or could not comment on aspects of the prescribing, primarily because of a lack of first-hand experience or familiarity with the drugs. As the submissions of the Commission made clear, pivotal to Professor Carter's adverse opinions about the Practitioner's prescribing and monitoring of the drugs for the ten patients in this case was the absence of double blind placebo controlled trials to which Professor Carter made numerous references throughout his evidence. Although best practice would involve such testing, its absence assumes only limited significance in my view in the light of Professor Holmes-Walker's explanation about the meaning and effect of drugs being "off label".
The Commission referred to the evidence of Professor Holmes-Walker in which Professor Holmes-Walker reiterated the onus on the Practitioner to defend her reasoning for off label prescribing. The Commission relied on the evidence of Professor Holmes-Walker that such reasoning should include:
"a review of what treatment options have been tried previously and what symptomatic or lack of symptomatic had been achieved with other preparations and then what symptoms the person specifically wanted to address, and what treatment options you felt may address their symptoms which had not been addressed by previous treatments that had been tried which may be regular medications which are recommended for a particular set of symptoms. And then you would be considering your treatments in terms of what benefits and what risks might come to that individual based on their individual history of health, past, current, family history, risk factors."
That evidence has earlier been referred to. It is correct to submit as the Commission did that there was little or no indication in the Practitioner's notes of consideration of other treatment options or past treatment before the prescribing of Somatotropin for "wellness" reasons. As my review of the evidence confirms however, and particularly does in response to extensive questioning by Members of the Tribunal, the Practitioner gave evidence addressing each of the matters identified by Professor Holmes-Walker. In my view, there is objectively no rational basis for rejecting that evidence, particularly in circumstances where no patient has complained and there is no other objective evidence which establishes that the Practitioner did not do the things which she said she did, notwithstanding that, as the Practitioner readily acknowledged, her clinical notes failed to record those matters, and her conduct fell below the required standard.
Reliance was placed on Professor Holmes-Walker's evidence that where medication was prescribed off label, the Practitioner should regularly review, it was submitted at least every six months, the clinical response, and for Somatotropin assess the side effects in parallel with measurement of IGF-1 levels. As the Commission submitted, Professor Holmes-Walker suggested monitoring IGF-1 levels at a three month or six month mark and then annually. I have earlier referred to the passages in Professor Holmes-Walker's report in which that was stated. It was submitted that the Practitioner did not follow Professor Holmes-Walker's suggested practice. It is less than entirely clear to what extent the Practitioner did not follow Professor Holmes-Walker's suggested practice having regard to her evidence during extensive questioning on that topic before the Tribunal. The Practitioner suggested that there were material differences between the medication which Professor Holmes-Walker was, or could be expected to have been administering and that which the Practitioner was prescribing.
Although the Practitioner's conduct in not following Professor Holmes-Walker's suggested practice to the letter may constitute conduct which falls below the requisite standard, I am not comfortably satisfied that it fell significantly below that standard. I am not persuaded that the Commission has established that the Practitioner failed to regularly monitor patients for whom the drugs were prescribed. The Practitioner's evidence is to that effect, and there is in my view no rational basis for rejecting it, particularly given that the maximum that Somatotropin growth hormone can be prescribed for on one occasion is six months. In those circumstances, objectively, the Practitioner would have been, whatever its adequacy, reviewing the patients' progress at six monthly intervals. The evidence suggests that the real issue is whether the reviews were in reality reviews in the light of the unchanging prescribing of drugs- "one dose fits all".
The Commission also relied on the emphasis that Professor Carter placed on the absence of Somatotropin having been proven to be of benefit in the wellness sphere and that it has not been the subject of double blind placebo controlled trials. If the Practitioner bore the onus of proving the benefit of her prescribing the drug in the "wellness sphere", she would fail to do so. The Practitioner does not bear that onus. The Commission must comfortably establish the contrary. The Commission relied on the passage of Professor Carter's evidence in cross-examination which I have earlier recorded with respect to the risks associated with Somatotropin and growth hormone medication, and the other risks which he considered to be associated with prescribing growth hormone medication. Professor Carter suggested that guarding against those risks could be monitored by blood tests that measure for IGF-1 levels. The Practitioner gave evidence about blood testing. Her blood testing protocols lacked the rigour expected of the Practitioner, and fell below the requisite standard. Consistent with my preference for the opinions of Professor Holmes-Walker to those of Professor Carter where they conflict, I am unable to accept that the conduct fell significantly below the requisite standard.
The Commission relied upon Professor Carter's opinion that, notwithstanding his absence of experience with them, Mesterolone, Pregnenolone and Progesterone should not have been prescribed "in the first place". The foundation of those opinions, and thus the weight to which they are entitled requires careful consideration. Although the drugs might have been inappropriately prescribed in the first place, in view of the limitations in his evidence which Professor Carter fairly acknowledged, and the absence of knowledge of the particular patients, I am not persuaded to make findings in those terms.
The Commission relied upon the evidence of Professor Holmes-Walker with respect to the need to maintain clinical reviews when off label prescribing is undertaken. The Commission relied, understandably, on the concern Professor Holmes-Walker had about the apparent "one dose fits all approach" of the Practitioner to the prescribing of Somatotropin. The Commission referred to the evidence of Professor Holmes-Walker in cross-examination to this possibly being because of costs issues which it was submitted, correctly, should not be a consideration when prescribing a restricted substance for off label purposes which it was submitted "arguably invites a greater need for pharmaceutical oversight in its dispensing". I do not understand that the cost of off label drugs was relevant to the standard which the Practitioner was required to meet. If the conduct fell significantly below the required standard, cost considerations would not change that.
The Commission relied on the evidence of Dr Kertesz, a General Practitioner (GP), whose expertise was submitted to be relevant to the standard expected of a GP when prescribing the medications the subject of this complaint. The Commission identified the matters of concern raised by Dr Kertesz and referred to his evidence in cross-examination. I have earlier referred to the evidence of Dr Kertesz in cross-examination. With no disrespect to Dr Kertesz, who is a vastly experienced and well respected General Practitioner, I am not greatly assisted by his evidence with respect to the standard which is applicable in this case. In the passages which I have earlier recorded, Dr Kertesz disavowed any experience, or personal familiarity with the practice of anti-ageing or wellness medicine. To the extent that Dr Kertesz read everything he could find which he considered to be of relevance to the topic, that in my view falls short of establishing a sufficient nexus between training and experience and Dr Kertesz's opinions for them to be given significant, much less decisive weight. Having regard to Dr Kertesz's own frank admissions about the limitations of his knowledge of or experience with anti-ageing or wellness medication, his evidence does not in my view advance the Commission's case, particularly with respect to the issue which ultimately requires evaluation.
The Commission submitted that Dr Kertesz "found" that the Practitioner's quantity of prescribing for Patient J was "seriously excessive" given that the patient had his own GP. With respect to Counsel for the Commission, in my view, that reality militates against the Practitioner having prescribed seriously excessive quantities of the drug. No other basis for Dr Kertesz's opinion in that regard was advanced. It was further submitted on behalf of the Commission that Dr Kertesz considered that the Practitioner's regular prescribing of Valium and Mersyndol Forte was significantly below the standard reasonably expected of a GP.
As I have observed earlier, Dr Kertesz made significant concessions with respect to his absence of familiarity with a number of the drugs, including DHEA, Testosterone and Mesterolone. His opinion that the Practitioner's prescribing was "contrary to good practice and below the standard reasonably expected of a GP" was an opinion based on an admitted paucity or absence of qualifications or experience to express those opinions. Dr Kertesz's opinion that the Practitioner's prescribing involved "unsystematic, irregular and haphazard prescribing of each of the (relevant) drugs" is in my view not supported by the evidence of Professor Carter or Professor Holmes-Walker, the evidence of the Practitioner, or any circumstantial evidence. Without suggesting that Dr Kertesz was less than impartial, his comment, and absence of foundation for it, raises some concerns in my mind about his objectivity with respect to the prescribing of anti-ageing or wellness drugs.
The Commission relied on the opinion of Dr Kertesz that the Practitioner "stepped outside standard prescribing by prescribing off-label". As the evidence reveals, it is in the nature of prescribing off label medication that a practitioner is "outside standard prescribing". Doing so is lawful, and does not necessarily have sinister overtones. Dr Kertesz's opinion that the Practitioner prescribed off label medication "outside the safety guidelines in her purchasing, storing, selling, prescribing, dispensing and delivering Somatotropin to her patients" is in my view contradicted by the Practitioner's evidence, which I cannot reasonably reject, and the guidelines to which she referred in the course of oral evidence. If Dr Kertesz was aware of those guidelines, he did not say so in his evidence. I do not criticise Dr Kertesz for comments based upon the Practitioner's admittedly inadequate clinical records. The limitations on the weight which I am comfortable to give his evidence are based on the matters emerging from his cross-examination, to which I have referred earlier. The Tribunal however must determine the case on the totality of the evidence before it. As noted earlier, none of the experts had the benefit which the Tribunal has, of hearing the extensive cross-examination and questioning of the Practitioner.
Dr Kertesz said that the Practitioner's "behaviour" in her "manner of prescribing drugs and the attraction of a fee for the medication delivered to the patient brings her conduct to be below" the required standard, and significantly so. If Dr Kertesz was implying that the Practitioner in some inappropriate way benefitted financially from direct dispensing, the evidence does not establish that. The only matter of possible concern arising from the Practitioner's direct dispensing was with respect to oversight of the prescribing. At least inferentially, the PRU investigated the Practitioner's prescribing and, as is an agreed fact in the proceedings, took no action against her. Inferentially, as no patient has made a complaint about the Practitioner's treatment of him or her, the Commission commenced these proceedings in reliance upon investigations which it and/or the PRU undertook. In its application, the Commission has not made a specific complaint with respect to the Practitioner's direct dispensing of prescribed medications. The practice having not been unlawful, it is difficult to accept that it could advance the Commission's case.
Dr Kertesz's criticism of the Practitioner's "failure to prescribe "off-label" medications to her patients in an acceptable and correct format with registered pharmacy dispensing" as conduct "below the expected standard, and significantly so", is in my view not borne out by the totality of the evidence. What the Practitioner did was lawful. Although it may have had the potential to do so, there is no evidence that her doing so circumvented regulatory oversight. The Practitioner's evidence in cross-examination with respect to the enquiries she made to guard against the risk that patients would inappropriately deal with directly prescribed medications cannot be rejected in my view.
Dr Kertesz's opinion that the Practitioner needed to "monitor patients not only anecdotally but also from a biochemical or a pathology point of view to make sure that the drugs are not detrimental to those patients so that you have a real time monitoring of how that [sic] are going" raises a concern, the seriousness of which is the matter for evaluation in these proceedings. Dr Kertesz said that if the Practitioner was to "continue prescribing a medication for anything other than short term and I guess there's a question of what short term is, then you need to have ongoing history, ongoing examination and ongoing investigations for the justification of that ongoing prescribing and you can't possibly divorce the three issues of what the patient tells you, what you find in examining the patient and what the special tests or the indices that you use to monitor that prescribing can involve". In certain respects, Dr Kertesz's opinions find some support in the evidence of Professor Holmes-Walker, but, in my view, that support is insufficient to support finding that the Practitioner's conduct fell "significantly" below the requisite standard. The evidence does not in my view support a finding that the Practitioner failed to have at least oral "ongoing history", or, though inadequately recorded, "ongoing examination".
The issue is whether, other than her own ongoing monitoring of patients for whom she prescribed the medication fell significantly below the level of "scientific examination" which the Practitioner should have undertaken or procured. Inherent in that concept is that such "scientific examination" was clinically indicated. I am not persuaded that the evidence establishes the latter indicator. Although falling short of the mark, the Practitioner gave evidence, which I cannot reject, that she was alive to, and pursued "scientific" investigations when they were indicated.
The Commission referred to the provisions of the Guide (HCCC1, Tab 70) with respect to direct prescribing of restricted substances and submitted, correctly, that the Code "implicitly implies a need for greater caution where substances are directly dispensed because of the circumvention of pharmaceutical oversight". The Practitioner did not dispute that need.
The Commission relied on the "TGA Medicine Safety Update regarding off-label prescribing" (HCCC1, Tab 73) which "recommends that such use only be considered when other options are unavailable, exhausted, not tolerated or unsuitable" and that "the treatment including its effectiveness and potential adverse events, should be monitored". In my view, although less than compelling, the evidence fails to establish that the Practitioner only directly dispensed medications when other options were "unavailable, exhausted, not tolerated or unsuitable". The evidence suggests that there was a convenience for patients, and perhaps some cost saving in obtaining the medications directly from the Practitioner. The evidence does not comfortably satisfy me that there was anything nefarious in the Practitioner's direct dispensing of prescriptions to patients. Although the Commission's complaints do not make that allegation, the evidence with respect to the issue is capable of being relevant to whether the Practitioner's monitoring of patients for whom she prescribed off label medications fell significantly below standard.
The Commission relied on the Medical Journal of Australia article (HCCC1, Tab 75) which acknowledged that off label prescription was not illegal but that there was a greater onus on practitioners prescribing off label medicines for informed consent, holistic management and for prescription to be justified by evidence based prescribing. The evidence does not in my view establish that the Practitioner prescribed off label medications for the ten patients in this case in the absence of informed consent, or that she failed to provide "holistic management" for them, the issue being whether the prescription was justified by "evidence". It is not suggested that such "evidence" could not include what patients anecdotally told the Practitioner during consultations. It would be surprising if what a patient said about her/his "wellness" could not be relied upon. I am unable to reject the Practitioner's evidence that she did not rely solely, or primarily on what patients told her about their "wellness". The Commission relied significantly on the asserted absence of "scientific examination" in the Practitioner's determination of whether prescribing off label medications for her patients was likely to be of benefit for them and not pose a risk to their health and safety. The Commission did not dispute that there were "lengthy first consultations, blood tests taken, history and investigation" with respect to each of the ten patients. Although the Practitioner's reliance upon "scientific" evidence might usefully have been greater than the evidence suggests that it was to avoid a "one size fits all" approach to her prescribing, I am not persuaded that the Practitioner's management of the prescribing was so lacking in that, or any other regard as to support making the finding urged by the Commission.
The Commission submitted that the evidence "readily shows to a very high standard that the patients came to see the Respondent knowing or expecting to be prescribed this medication for off-label purposes". I am not comfortably satisfied that, whatever the expectations of the patients may have been, as the Commission appears to acknowledge, the Practitioner conducted appropriate investigations before prescribing off-label medications, refused to see certain types of people, and turned away others. In my view, the Practitioner's evidence with respect to those matters cannot rationally be rejected.
The Commission's submission that prescribing off label medications was the Practitioner's "practice and reputation in the wellness sphere" does not advance the Commission's case in my view. A professional person who has a reputation in any lawful field is likely, and entitled to attract patients or clients from beyond their immediate geographic region.
The Commission submitted that there were "no clinical reasons for the prescription of the restricted substances (in particular DHEA, testosterone, Mesterolone, Pregnenolone, Anastrozole and troche medication) there was no ongoing surveillance and scientific monitoring of patients (only anecdotal monitoring and ad hoc blood tests). Referrals were not encouraged or made". Those criticisms are supported by the Practitioner's admittedly inadequate clinical records. The Practitioner gave detailed evidence with respect to individual patients and the prescribing of particular off label medications which, unless rejected, precludes the Tribunal from being comfortably satisfied that these complaints are made out to the requisite standard. Although confirming that she fell short of the mark, I cannot reject the Practitioner's evidence, or find that her conduct fell significantly below the requisite standard. As Professor Holmes-Walker said in her report, there are "concerns" about these matters. I agree that the Practitioner's conduct fell below the standard reasonably expected of her as a General Practitioner.
The Commission submitted that the Practitioner's failure to try to "cease" the prescribing of off label medications for patients was indicative of her failure to adequately monitor the prescribing of those medications. The Commission submitted, without reference to any particular evidence, that the Tribunal would infer that the Practitioner's changed regime with respect to prescribing off label medication subsequent to the PRU inspection of her premises in July 2019 was because the Practitioner's inappropriate prescribing had been discovered. The revelation of the shortcomings in the Practitioner's prescribing was instrumental in her changes to those practices, and implied recognition that they had been below standard. Whether that evidence supports finding that they did significantly requires consideration.
In my view, the Commission has not established that the duration of the prescribing of off label medication for any of the ten patients was inherently unreasonable, or that it was contraindicated. In my view, the evidence does not establish that the Practitioner should have, but failed to persuade or encourage patients to cease using the medications.
The Commission submitted that the Practitioner's "evidence about the way she practises, long consultants, regular management and knowing her patients was designed to veil the real and known reason of her practice. The (Practitioner) knew she had a reputation for providing growth hormone substances without proper consideration of other alternatives or considerations of when to cease it. It was prescribed early on and regularly, without regular surveillance and monitoring". In my view, there is no evidence which establishes that the Practitioner had the reputation alleged, or that her evidence involved any attempt to "veil" any inappropriate or improper prescribing. The Practitioner admitted that her management of the prescribing fell below standard. The Practitioner was closely cross-examined by Counsel for the Commission and questioned at considerable length, particularly by Medical Members of the Tribunal. In my view, the Practitioner was candid in giving evidence, readily making appropriate concessions and impressing as a thoughtful and caring medical practitioner.
The fact that the Practitioner may have had a reputation for providing growth hormone substances does not, without more, support a finding that it occurred without proper consideration of other alternatives or considerations of when to cease it. The Commission has not pointed to any evidence of the Practitioner suggesting that she should have recommended to any patient that they cease taking off label medication. The Practitioner gave evidence in cross-examination, which I do not believe can reasonably be rejected, that she initially considered other alternatives to off label medications and, if off-label medication was not working for patients, recommended, and, in some cases, ceased prescribing it. Although not conclusive, the absence of complaint by any of the ten patients in this case is significant in this context. So is the evidence of Professor Holmes-Walker to which I have earlier referred about patients continuing or ceasing to take off label drugs in the absence of clear clinical indications for doing so.
I agree with the submission of the Commission that the Practitioner's prescribing of off label medication to patients in the absence of notes, including after telephone conversations, established conduct which was less than optimal and fell below the requisite standard. The Commission submitted that the Practitioner's explanation was "unreliable and concerning", particularly as the scripts which the Practitioner issued included scripts for new medication and not repeat scripts. The Commission accordingly submitted that the Tribunal would find "this embedded part of the Respondent's practice was to prescribe these medications, without proper justification or clinical reasons".
[18]
Respondent's submissions
Senior Counsel for the Practitioner identified, accurately in my view, that the determination of this Complaint requires consideration of the standards and appropriateness of:
"(i) off-label prescribing of HGH and other substances;
(ii) management and monitoring of off-label prescribing; and
(iii) directly dispensing prescribed substances."
The Practitioner denied that the Tribunal would be comfortably satisfied that her conduct fell "significantly" below the required standard, or was unethical or improper so as to constitute unsatisfactory professional conduct.
With respect to off label prescribing of HGH and other substances, the Practitioner submitted that the evidence did not comfortably establish that her conduct in prescribing Somatotropin and the other restricted substances off label was significantly below standard. The Practitioner candidly submitted that "the evidence suggests that while her conduct may have fallen below standard in some limited respects, it did not fall significantly below that standard, and it certainly did not fall significantly below standard merely because she prescribed substances off-label". The prescribing of substances off label could not of itself support a finding that the Practitioner's conduct fell significantly below the requisite standard.
The Practitioner submitted that the Tribunal would prefer the evidence of Professor Holmes-Walker over the evidence of Professor Carter and Dr Kertesz with respect to the standard expected of a practitioner in Dr Della Bruna's position and the appropriateness of her off-label prescribing. I have earlier noted the absence of familiarity with, or experience of most of the medications which the Practitioner prescribed off label for the ten patients. Although as she revealed in cross-examination, Professor Holmes-Walker had no experience of a number of the medications, her experience was greater, and more recent than that of Professor Carter or Dr Kertesz. For the reasons recorded earlier, I prefer the evidence of Professor Holmes-Walker to that of the Commission's experts where there is disagreement.
The Practitioner referred to the report of Professor Holmes-Walker (R1, Tab 3) with respect to prescribing of off label medication such as HGH and other restricted substances. It was submitted by reference to Professor Holmes-Walker's written report, and the literature referred to in it, that there was tangible clinical support for the Practitioner's prescribing of the off label medications involved in this case. The Practitioner referred to the oral evidence of Professor Holmes-Walker to which I have earlier referred, and particularly that:
"(i) a medication can be legitimately used off-label when there is evidence to support its use for a given purpose and when there has not yet been an application made to the government to approve the subsidisation of the medicine for that specific purpose;
(ii) the onus is on the practitioner to justify the use of medicines for off-label purposes;
(iii) caution should be exercised when monitoring the prescription of off-label medications;
(iv) HGH has been approved by the government to be used in treatment, but it has strict criteria for when the government will subsidise HGH prescriptions "on-label"".
The Practitioner submitted, accurately in my view, that Professor Holmes-Walker ultimately said that the Practitioner's conduct "fell below but not significantly below" the required standard. It was submitted, again accurately in my view, that Professor Holmes-Walker's criticism, which was expressed as "concern", was "largely limited" to the Practitioner's "one dose fits all approach to dosage of HGH".
The Practitioner referred to the evidence of Professor Carter and particularly to matters which emerged during Professor Carter's cross-examination. The Practitioner referred to Professor Carter's evidence in cross-examination, most if not all of which I have earlier identified and recorded. It was submitted in particular that:
"(i) Professor Carter did not take issue with the general concept of off-label prescribing but suggested, correctly that the onus on the Practitioner when doing so was first to ensure that the drug was not going to cause side effects and is likely to be of benefit to the patient with respect to health outcomes;
(ii) the cost benefit analysis of a drug manufacturer may influence whether a drug is available to be prescribed on-label or off-label, a proposition which is not inconsistent with the evidence of Professor Holmes-Walker in cross-examination about the cost benefit analysis which the TGU undertakes in determining whether medications are on-label or off label;
(iii) Professor Carter's opinion that the Practitioner's conduct fell significantly below the required standard because the drugs prescribed were not the subject of double blind placebo controlled trials and the potential side effects were significant;
(iv) Professor Carter's concession that administering drugs which have not been the subject of double blind placebo controlled trials was not in itself inappropriate;
(v) Professor Carter's evidence that "for many years, adults have had to take HGH off-label";
(vi) Professor Carter's concession that the dosages of HGH in the Practitioner's ten patients were unlikely to put the HGH and IGF-1 levels into the range of risk of acromegaly;
(vii) Professor Carter's concession that he has never practised in cosmetic or anti-ageing medicine;
(viii) Professor Carter's inability to identify a reference for his opinion regarding the accepted therapeutic doses and duration of treatment with Somatotropin;
(ix) Professor Carter's inability to identify a reference for his opinions regarding the accepted doses of Anastrozole, DHEA, Mesterolone, Progesterone or Testosterone other than in "the literature";
(x) Professor Carter's concession that quality of life is an important though subjective marker of the efficacy of an anti-ageing or wellness drug;
(xi) Professor Carter's agreement that the benefit to a patient includes an assessment of their quality of life, but that it is helpful to have "concrete endpoints" to monitor during treatment;
(xii) Professor Carter's concession that the prescription of DHEA was not conduct falling significantly below the required standard."
In my view, reliance upon each of the concessions fairly made by Professor Carter was sound.
The Practitioner submitted, in summary, and accurately in my view, with respect to Professor Carter's evidence that his opinion was that prescribing the off label medications for the Practitioner's ten patients and particularly prescribing HGH was inappropriate "based in large part on the fact that there was poor quality evidence as to patient benefit and that the onus was on the practitioner with respect to side effects and primum non nocere: first, do no harm".
In determining whether the Practitioner's prescribing fell significantly below the required standard, Professor Carter's evidence with respect to the absence of "quality evidence" with respect to patient benefit and risks with off-label prescriptions is relevant in determining the requisite standard- which is that applicable to a general practitioner. The extent to which a general practitioner should know of, and take into consideration that asserted absence has not been established in my view. Understandably in view of his lack of experience or familiarity with this area of practice, Dr Kertesz was unable to advance the Commission's case with respect to this issue.
The Practitioner referred to the evidence of Dr Kertesz in his first report, in which Dr Kertesz said there was no legal impediment to prescribing off label medication but that the onus was on the prescriber to defend their prescription for an indication that is not listed in the product information and that, if there was "reasonable quality evidence", the prescriber should proceed with the prescription if it was in the patient's best interests. The issue is whether the Commission comfortably satisfies the Tribunal that the prescribing was not supported by reasonable quality evidence of which the Practitioner should have been aware to the higher degree of significance.
Dr Kertesz suggested that the rationale for an off label prescription might be more closely scrutinised in the case of a "serious adverse event". There is no evidence that any of the ten patients in this case suffered an adverse or serious adverse event, or that his or her doing so was probable. Dr Kertesz referred to studies which he suggested were equivocal in terms of the presence or absence of benefits of off label medications. Dr Kertesz contended that high levels of HGH over a long period can produce irreversible acromegaly but that even smaller doses could lead to complications. There is no evidence that the levels of HGH prescribed by the Practitioner were high, or any evidence that any of the ten patients in this case experienced "complications" as a consequence of taking off label medications.
Dr Kertesz suggested, and the Practitioner accepted, that it was necessary for regular physical checks and investigations with particular attention to side effects when off label medications were prescribed on a long term basis. The evidence establishes that a number of the Practitioner's patients were prescribed off label medication for periods of two years. The evidence does not in my view establish that to have been inappropriate, or to have placed the patients at risk.
As is not in doubt, and necessarily, Dr Kertesz's opinions were based on the Practitioner's admittedly inadequate clinical records. Dr Kertesz did not hear the Practitioner's evidence during the course of her extensive time in the witness box. As with Professor Carter, his opinions in the light of that evidence are unknown.
The Practitioner submitted that cross-examination of Dr Kertesz, and "several important concessions" made by him during that cross-examination "undermined" his conclusion that the Practitioner's conduct fell significantly below the required standard. The Practitioner referred to a number of passages in the transcript of the proceedings, most of which I have earlier recorded, in which Dr Kertesz made significant concessions or admissions. They included that Dr Kertesz has never practised in cosmetic or anti-ageing medicine, Dr Kertesz has never prescribed Somatrotropin, Pregnanolone, or Mesterolone, Dr Kertesz has only prescribed DHEA "a handful of times", Dr Kertesz has only prescribed Anastrozole once, Dr Kertesz's opinion was not based on anecdotal evidence from patients, except regarding Progesterone and Testosterone, Dr Kertesz has never published in the field of off-label prescribing, the RACGP has not provided any guidelines for off label prescribing, the Medical Board Code of Conduct does not include any chapter on off-label prescribing, the article Dr Kertesz relied on called "what GPs can do for the performance enhancing drug user" was not "on point" regarding the Practitioner's prescribing, the Guide titled "GP Guide to harm minimisation for patients using non-prescribed anabolic androgenous steroids" did not relate to the Practitioner's prescribing practices, Dr Kertesz's reliance in Wikipedia regarding the prescription of DHEA, Dr Kertesz's concession that he "may have cut and pasted" portions of internet searches into his report, when considering off-label prescribing is appropriate a "very relevant cohort of peers are those who regularly prescribe growth hormone in the wellness and anti-ageing field of medicine", Dr Kertesz's concession that off-label prescribing is a "grey area", and Dr Kertesz's opinion that off-label prescribing that "you certainly can do it, but if you do, you have to be able to justify why you did it and it works and it works well and you can show that it works well, that's all and good. But if it doesn't work and you can't show why you did it in the first place and it's detrimental to the patient then you need to be able to show cause … why you did that and against the manufacturer's recommendations". It was further submitted that the evidence did not establish that off label medicines prescribed by the Practitioner did not "work" or was "detrimental to the patient" or "against the manufacturer's recommendations".
By "reasonable quality evidence" in support of off label prescribing, Dr Kertesz was not considering clinical trials but rather "real time assessment of patient improvement". Dr Kertesz did not consider that the article "Off-label use of medicines consensus recommendations for evaluating appropriateness" was a professional guideline, and had not seen the table in it replicated in any guidelines. Dr Kertesz's conceded that, in assessing the degree of a practitioner's failure, it is first important to assess whether harm was done to a patient. In assessing the standard of care to be expected, informed consent is essential. Dr Kertesz agreed that the Practitioner's consent forms complied with the expected standard of informed consent. Dr Kertesz agreed that the subjective benefits of treatment are relevant to determining whether treatment with HGH should be continued. Dr Kertesz also agreed that self-reporting of patients is very important in proper patient management. Dr Kertesz acknowledged that, if the Tribunal found that there was scientific evidence in support of prescribing the drugs in question, he would be "guided" by the Tribunal's decision as to whether the Practitioner's conduct fell below or significantly below the required standard.
Reliance was placed on the passages of Professor Holmes-Walker's critique of Professor Carter's report which I have earlier recorded. In support of her contention that the Tribunal would prefer the evidence of Professor Holmes-Walker to that of the Commission's experts on whether off label prescribing was inappropriate, the Practitioner relied on three particular matters. They were that:
1. Professor Holmes-Walker has the study, training and experience most relevant to the facts in issue in the proceedings, namely prescribing to patients who are deficient in growth hormone or normal individuals using growth hormone, being an Endocrinologist with the most extensive knowledge of the relevant literature in the field and the applicable standard by which the Practitioner's conduct should be assessed. Professor Holmes-Walker's unchallenged view was that off-label prescribing is not inappropriate and that the Practitioner's conduct did not fall significantly below the required standard.
2. There are "several deficits" in the evidence of the Commission's experts to which the Practitioner referred which do not apply to the evidence of Professor Holmes-Walker, particularly by reference to the asserted absence of knowledge or experience of the Commission's experts in the field of anti-ageing or wellness medicine or off label prescribing of the drugs which are relevant to this case.
3. Both the Commission's experts relied on literature that was of unidentified or limited relevance, "including Wikipedia entries and large unidentified extracts from unknown sources".
It was submitted that "several facts become clear from an assessment of the experts' evidence" they being that:
1. Off-label prescribing is not per se inappropriate.
2. Off-label prescribing is a common practice in medicine.
3. Monitoring of patients for serious adverse side effects while prescribing off-label is important to ensure the practitioner does no harm.
4. Prescribing drugs that have not been subjected to double blind placebo controlled trials is not in itself inappropriate.
5. There is some evidence to support the use of HGH.
In my view, the evidence supports each of the contentions of the Practitioner which I have recorded.
Properly, the Practitioner conceded that prescribing off label medication required monitoring to ensure that no harm is done to the patient. There is no evidence that any of Patients A to J suffered any adverse side effects from their medications, or that harm was caused to them. The evidence establishes that the patients were regularly monitored, albeit the quality of the Practitioner's monitoring was less than optimal, and that the doses that were prescribed were sufficiently low that harm was unlikely. There is no evidence that the dosages prescribed by the Practitioner for any of the ten patients was of a level that rendered harm likely or created an unacceptable risk of harm.
The Practitioner relied on her evidence in cross-examination. I have earlier referred to that evidence and my inability to reject the Practitioner's evidence either on the basis of her credibility, or that it was inherently improbable or contradicted by other evidence which could not be rejected.
The Practitioner relied on "the literature on off-label prescribing of HGH", and a number of documents in evidence in the proceedings. I do not consider that it is necessary to refer to that literature in detail. In reliance upon it, the Practitioner submitted that "the literature before the Tribunal, when taken with the evidence of all three experts, demonstrates that there is an extensive (albeit unsettled) scientific basis to the prescription of HGH (specifically Somatotropin) and the other restricted substances, and that there is nothing inherently improper about prescribing those substances off-label. Indeed, off-label prescribing is a common and necessary part of the practice of medicine". Those contentions are well founded on the evidence, and militate against finding that whether, in her prescribing and monitoring of those substances, the conduct of the Practitioner fell significantly below the required standard.
The Practitioner submitted that the Commission's assertion that reliance on anecdotal evidence was an inadequate basis for prescribing off-label had not been made out, and was contrary to the evidence of the experts. Although Professor Carter was not critical of the prescribing of DHEA, even though the evidence for doing so was only anecdotal, the evidence suggests that, during the course of monitoring her prescribing of off label medications, the Practitioner could have been more diligent with respect to "scientific examination" than she appears to have been.
In support of her contention that her prescribing of off label medications did not fall significantly below the required standard, the Practitioner also relied upon the evidence of Professor Holmes-Walker in cross-examination. I have earlier identified and recorded most of the evidence to which the Practitioner referred. The Practitioner identified (paragraph 60 written submissions), accurately in my view, the passages in Professor Holmes-Walker's written report which identified relevant considerations, including Professor Holmes-Walker's opinion that the Practitioner's "dosages appear to demonstrate a one dose fits all approach without evidence of subsequent dose adjustment".
At paragraph 61 of the Practitioner's written submissions, the oral evidence of Professor Holmes-Walker upon which the Practitioner relied was summarised. I have earlier recorded those passages of Professor Holmes-Walker's oral evidence. As the Practitioner noted, although Professor Holmes-Walker expressed a "concern" with respect to the Practitioner's "one dose fits all approach", which did not change over time, Professor Holmes-Walker was of the opinion that the dosage was "probably at a safe level" and was "probably not going to cause harm" and was at a "safe starting point". I accept that evidence. The Practitioner reiterated that Professor Holmes-Walker's ultimate opinion as that the Practitioner's prescribing and monitoring off-label fell "just below standard", but not significantly below.
The Practitioner submitted, correctly, that the admitted failure to maintain adequate clinical records did not mean that she had failed to adequately manage and monitor the prescription of off label medications albeit, the absence of clinical records adequately revealing those matters meant, as was suggested to the Practitioner during her evidence, that the Tribunal is left largely reliant upon the Practitioner's word about those matters. Understandably, the Practitioner relied significantly on the absence of any of the ten patients providing a statement or having made a complaint. It was submitted, correctly, that there was no basis for rejecting the Practitioner's sworn evidence regarding the depth of her discussions with patients, their duration or frequency. It was submitted, accurately, that once fully aware of that information, the Commission experts were largely uncritical of this consultation practice.
The Practitioner submitted, accurately, that there was no evidence of any adverse or serious adverse side effects in any of the ten patients and that the evidence of Professor Holmes-Walker was that the dosages prescribed were probably at a safe level. The Practitioner relied on the evidence that, with respect to anti-ageing and wellness medications, anecdotal evidence, based on in depth discussions with the patients, both with respect to informed consent and ongoing treatment were legitimate considerations. I do not understand the Commission's experts to dispute that, but rather to suggest that, without more scientific monitoring, anecdotal evidence was insufficient. The Practitioner conceded that at times she failed to adhere to the standard suggested by Professor Holmes-Walker with respect to monitoring of pathology results while prescribing off-label medications but submitted, accurately, that she did continue to monitor other important and relevant indices for potential adverse side effects. I understand Professor Holmes-Walker to have been conscious of that when coming to her opinin of the extent to which the Practitioner's conduct fell blow the requisite standard. As with her defence generally, the Practitioner conceded that although her monitoring may at times have been below standard, the Commission could not comfortably satisfy the Tribunal that the Practitioner's conduct fell significantly below the standard required.
The Practitioner submitted with respect to her direct prescribing, correctly, that there was nothing illegal, improper or unethical about direct dispensing. And that it was expressly permitted by the Guide to which the Practitioner referred in cross-examination, passages of her evidence in that regard having been identified and recorded earlier in these reasons.
There is force in the submission on behalf of the Practitioner [86] with respect to the absence of the basis upon which Dr Kertesz formed his adverse opinion of the Practitioner's direct prescribing. It was submitted that the Practitioner provided a "cogent and credible explanation for the direct dispensing of Somatotropin to her patients, namely that it was done to minimise their embarrassment, and was unshaken in cross-examination on this credible explanation". Whilst the Practitioner gave a cogent and credible explanation for her direct dispensing of Somatotropin, the evidence suggests that her reasons for doing so were less than the Guide suggested, and that her conduct in those circumstances may have fallen below the requisite standard. When all of the evidence is considered, and particularly the evidence of absence of adverse effects for patients, of inappropriate use by patients of directly dispensed medications and absence of action by the PRU, I cannot accept that the Commission has proved that the Practitioner's conduct fell significantly below the requisite standard.
With respect to Patient J, and the Commission's allegations that the prescription of Mersyndol Forte and Diazepam (Valium) to Patient J was conduct falling significantly below the required standard because it did not accord with recognised therapeutic standards having regard to the frequency and dosage of the prescription, the Practitioner conceded that her conduct in prescribing those medications fell below the standard because of the frequency with which the pain medication was prescribed, but maintained that it did not fall significantly below that standard.
Dr Kertesz's evidence with respect to the prescribing for Patient J and the significance of Patient J having his own GP has earlier been referred to. The Practitioner relied on her evidence in cross-examination with respect to the reasons for prescribing Diazepam for Patient J, and about transitioning Patient J to another GP. It was submitted, accurately, that there was no evidence that another GP was prescribing to Patient J at the same time. The Practitioner relied upon her evidence that she regularly liaised with Patient J's surgeons and pain specialists and was not concerned in the circumstances that she was over dispensing because although the dispensing increased its frequency did not.
Why Dr Kertesz considered that the Practitioner's conduct fell significantly below the required standard was submitted to not have been explained by reference to an appropriate standard of conduct. It was submitted that Professor Carter did not take issue with the Practitioner's dosage of these medications to Patient J. The Practitioner submitted that, at its most malign, the Tribunal could find that her conduct fell below the requisite standard, but did not fall significantly below that standard.
[19]
Conclusion
Particularly having regard to the concessions made by Professor Holmes-Walker, I am comfortably satisfied that the Practitioner's management of the prescribing of off-label medications to the ten patients referred to in the Commission's application fell below the requisite standard. However, I am not comfortably satisfied that the Practitioner's conduct fell significantly below that standard.
In evaluating whether the Practitioner's conduct fell significantly below the requisite standard, it is relevant to have regard to a number of matters. In the course of reviewing the submissions of the parties, I have recorded my findings with respect to the matters raised on behalf of each of the parties. It is unnecessary to re-state those findings. They inform the evaluation of the extent to which the Practitioner's admitted or proven conduct fell below the required standard.
The Practitioner is not a specialist endocrinologist. The standard required of her is that of a General Practitioner. The expert opinion evidence of Professor Carter and Professor Holmes-Walker, both of whom are specialist Endocrinologists, informs that determination but, given that Professor Carter has, effectively, never been in general practice, and, if so to what extent, Professor Holmes-Walker ever has been is limited, their evidence with respect to the standard is limited. To the extent that Professor Holmes-Walker may have considered the extent of the Practitioner's shortcomings by reference to the standards applicable to specialist endocrinologists, which I do not find that she did, that causes no difficulty in view of her opinion that the shortcomings did not fall significantly below the required standard.
As a General Practitioner, it might be thought that Dr Kertesz was the expert most likely to provide the Tribunal with assistance in determining the standard or benchmark by reference to which the significance of the shortcomings in the Practitioner's monitoring and management of her patients is to be assessed. Notwithstanding Dr Kertesz's experience in general practice, as he frankly conceded in cross-examination, Dr Kertesz's absence of experience in or familiarity with anti-ageing and wellness medicine militates against accepting that his opinions about the required standard have the connection with training and experience necessary to enable me to accept his opinion as to the applicable standard.
As the authorities establish, the standard is not set or determined by reference to the worst cases (Health Care Complaints Commission v Litchfield [1997]), nor is the standard one of excellence. As the section provides, the benchmark is the standard "reasonably expected of a practitioner of an equivalent level of training or experience". Although it is not said critically of the Commission, beyond accepting that the Practitioner should have adequately monitored and managed the treatment of patients for whom she prescribed off label medication, some of the elements of which were identified, considerable uncertainty surrounds attempting to define with sufficient precision what the Practitioner should have done, but failed to do.
Reference in the statute to a standard "reasonably expected of a practitioner of a particular level of training and experience", is an objective standard to be judged according to the standards of the professional generally; (Lucire v Health Care Complaints Commission [2011] NSWCA 99). In Health Care Complaints Commission v Robinson [2022] NSWCA 164 Simpson AJA (with whom Leeming and Kirk JJA agreed) said:
"I would accept that the reasonableness of a medical practitioner's erroneous belief that a medical justification exists for a procedure may be directly relevant to "the knowledge, skills or judgement possessed" by the practitioner all of which are factors in … the definition of unsatisfactory professional conduct, and therefore by extension, whether the unsatisfactory professional conduct in terms of section 139B(1)(a) is sufficiently serious to justify a suspension or cancellation of the practitioner's registration."
As the expert evidence establishes, although the prescribing of anti-ageing and wellness medications of the kind prescribed by the Practitioner in this case was lawful, the practice of anti-ageing and wellness medicine is a something of a "grey" zone or area. That militates against finding that the Practitioner's conduct fell significantly below the required standard.
It is not in contest that the adverb "significantly" should be given its ordinary meaning having regard to the context in which it finds expression in the statute (Project Blue Sky Inc v Australian Broadcasting Association [1998]). Senior Counsel for the Practitioner submitted that adverbs such as "seriously", "pronouncedly", "conspicuously" or "markedly" or "substantially" came "closest to capturing the statutory meaning of the word "significantly". Sensibly, the Commission has not disputed that description of "significantly".
In assessing the significance of the Practitioner's admitted or proven departure from the required standard of knowledge, skill, judgement or care exercised in the prescribing and management of off label medications, it is relevant to have regard to the following findings, none of which, in isolation, is determinative of the critical issue:
1. no patient of the Practitioner has complained about her treatment of him or her;
2. there was no evidence that any patient has suffered any adverse or seriously adverse consequence of the Practitioner's prescribing or management of off-label medications for them;
3. no expert has suggested that, irrespective of the absence of such evidence, anything relating to the Practitioner's prescribing and management of off-label prescriptions for her patients would have been expected to have produced adverse health consequences for any of the ten patients in this case;
4. having seen all of the Practitioner's admittedly inadequate clinical records, Professor Carter made significant concessions about the adequacy of the Practitioner's prescribing and management of off label medications for her patients;
5. after the Commission's experts had seen the Practitioner's clinical records, its application was significantly amended by deleting significant particulars of the Complaint. Comparing what was originally alleged against the Practitioner with what was ultimately alleged, and inferring that, responsibly, the Commission abandoned those particulars because it was satisfied that doing so was appropriate, it can be seen that significant aspects of the Practitioner's prescribing and management of off label medications was conceded to not have fallen below the required standard;
6. the Practitioner gave detailed evidence in cross-examination by Counsel for the Commission and, significantly, in response to probing questions by the Tribunal, particularly by the two Medical Members of the Tribunal. Although in cross-examination Counsel for the Commission disputed that the Practitioner had done certain of the things which she claimed she had, there is in my view no reason to reject the Practitioner's claims with respect to what she did in the course of prescribing or managing off-label medications for the ten patients the subject of these proceedings;
7. the evidence does not establish that the "cohort" of patients of the Practitioner whose treatment gave rise to the present proceedings was disproportionate to the number of anti-ageing or wellness patients who the Practitioner saw over the period covered by the treatment of the ten patients;
8. the Pharmaceutical Regulatory Unit, whose audit of the Practitioner's prescribing apparently caused or influenced the present proceedings, took no action against the Practitioner and no officer of the PRU gave evidence in these proceedings in support of the Commission's case;
9. the claim that there was anything sinister associated with the Practitioner's prescribing or direct dispensing of off-label medication has not been established to my comfortable satisfaction, either with respect to the practice itself or any asserted financial implications of it. The Commission has not in my view proved that the Practitioner attempted to "veil" any inappropriate conduct with respect to prescribing or dispensing off-label medication;
10. during the course of their questioning of the Practitioner, although expressing reservations about the Practitioner's responses to such questions, in my view, the Practitioner was not confronted with documentary or other evidence contradicting what she said about her prescribing and monitoring of off-label medication for the patients in this case;
11. the evidence does not in my view establish that, whatever the shortcomings in her prescribing and management of off label medications, the Practitioner's objectivity or judgement was compromised by financial or any other considerations;
12. the evidence does not in my view establish that any of the Practitioner's patients did not give informed consent to the prescribing of off-label medications, or did not have the maturity to make such a decision, or the opportunity to reflect on the consent form which the Practitioner gave each of them before doing so.
Accepting that, as an evaluative determination, minds can reasonably differ, and that there is a point at which meaningful revelation of the process of reasoning of a decision maker becomes artificial, for the reasons recorded above, I am not comfortably satisfied that the Practitioner's conduct fell significantly below the standard required of her.
As noted earlier, it was submitted by the Commission that the Tribunal should apply its own "specialist (and collective) expertise to the evidence informing opinions about whether there has been a departure from the relevant standard of conduct, with appropriate attention to the expert evidence if there is a genuine difference of view". I have identified and addressed what I perceive to be the differences in the opinions of the experts. Although the Medical Members of the Tribunal have considerable experience in general practice and specialist endocrinology, the Tribunal cannot in my view permissibly rely on their training or experience or opinions in the absence of evidence before the Tribunal upon which findings of fact can be made.
In Ghosh v Health Care Complaints Commission [2022] NSWCA 229 Basten JA (with whom Ward P and Adamson J agreed) said at [10] that:
"While it is true that at least two members of the Tribunal were required to be medical practitioners, and their professional training and expertise constituted an institutional characteristic of the Tribunal, that professional expertise was to be put to effect in assessing the evidence and other material placed before the Tribunal by the parties. Whether the appellant suffered an impairment affecting her ability to practice medicine was an element of the case. However, a psychiatric diagnosis was a matter to be addressed on the basis of expert evidence. The function of assessing the quality and reliability of an expert opinion is, in principle, different from forming one's own expert opinion based on the presentation of a witness in the course of giving evidence."
His Honour said at [11] that:
"Judges may also gain familiarity with particular areas of medicine by hearing similar cases over many years. It is, nevertheless, not appropriate for such a judge to make findings based upon his or her own assessment of the circumstances without relevant expert evidence capable of supporting the conclusion. That principle is not subverted by the circumstance that the dissenting member was a psychiatrist with expertise in forming a psychiatric diagnosis. If not a mistaken view of his function, it was certainly wrong in principle for the dissenting member to rely upon such an opinion without giving notice of his intention to the Commission, which had presented evidence supporting a different conclusion."
I am concerned that, albeit unintentionally, in coming to their findings, the majority may have impermissibly relied upon their own opinions in preference to the expert evidence before the Tribunal, or to fill gaps in that evidence. I am not convinced that such opinions were were sufficiently raised with Professor Holmes-Walker and/or the Practitioner. I accept that minds can reasonably differ when making evaluative determinations, but am not persuaded that the majority could be comfortably satisfied that the conduct of the Practitioner fell significantly below the standard reasonably required of her as a General Practitioner.
For the foregoing reasons I am not comfortably satisfied that the disputed Complaint is made out. Objectively, having regard to my findings, I cannot be comfortably satisfied that the Practitioner's conduct has been unethical or improper. That is particularly so having regard to the meaning of those terms as recorded earlier. It remains to consider whether the Practitioner's admitted unsatisfactory professional conduct with respect to her clinical records is sufficiently serious to constitute professional misconduct. The Commission alleged that it is. The Practitioner denied that it is.
[20]
Professional misconduct
The term "professional misconduct" has no specific meaning, and is merely a category of unsatisfactory professional conduct which is sufficiently serious to justify cancellation or suspension of registration. There is no category of unsatisfactory professional conduct which cannot, depending on the circumstances of the case, constitute professional misconduct, provided that it is "sufficiently serious".
Although the unsatisfactory professional conduct which the Practitioner has admitted is serious in view of the role of adequate clinical records in protecting the health and safety of the public, the evidence does not in my view reveal any "defect of character" on the part of the Practitioner. Nor in my view does it reveal incompetence or inadequate care, or carelessness casting doubt on the suitability of the Practitioner to practise medicine (Chen v Health Care Complaints Commission [2017] NSWCA 186). Something more than "mere deficiencies", including a deliberate departure from accepted standards, "serious negligence" or "indifference" with respect to expected standards is required in order to find professional misconduct (Pillai v Messiter [No 2] (1989) 16 NSWLR 197). Evidence of such matters is absent in this case.
I am not comfortably satisfied that the Practitioner's admitted unsatisfactory professional conduct is sufficiently serious to constitute professional misconduct.
I am not persuaded that the findings of the majority, or the reasons of the majority for so finding, comfortably establish that the Practitioner is guilty of professional misconduct.
The orders I would propose are:
1. The Respondent is guilty of unsatisfactory professional conduct.
2. The proceedings are listed for a Stage 2 hearing on 29 November 2024.
3. The parties are to file and serve any evidence to be relied on at the Stage 2 hearing by 21 November 2024.
Dr C BADAM, Dr C NEWBERRY, S LOVROVICH: We have had the considerable benefit of reviewing the draft judgment of his Honour, Coleman ADCJ, in preparing our reasons for this decision. We agree with his Honour's judgement to a limited extent and will outline in the following reasons where we have respectfully arrived at a different conclusion.
We agree with his Honour's introduction, agreed facts, and statutory framework (paragraphs 1 to 3, 5-8, 10 to 30).
We note section 3A Objective and Guiding Principle of the National Law:
"In the exercise of functions under a NSW provision, the protection of the health and safety of the public must be the paramount consideration."
In addition, we note that the Tribunal is bound by the Civil and Administrative Tribunal 2013 (CAT Act). Section 38 (2) of the CAT Act states:
"(2) The Tribunal is not bound by the rules of evidence and may inquire into and inform itself on any matter in such manner as it thinks fit, subject to the rules of natural justice."
When considering "the paramount consideration" of the National Law together with section 38 (2) of the CAT Act, it is plausible that the manner in which a Tribunal under the National Law may conduct itself may be different to that of other jurisdictions. Accordingly, any judgement that may have been provided in another jurisdiction, may have limited transferability or not be transferable in relation to considerations under the National Law.
In respect of the Tribunal members, there is a great deal of experience that each member brings to the Tribunal. For example, the general practitioner member brings a great deal of practical insight into the policies, procedures and practice of general practitioners. The endocrinologist member similarly brings great experience and knowledge of the use of medicines such as growth hormone.
We contend that the "paramount consideration" of the National Law influences the factors to be taken into account by the Tribunal, in that the protection of the health and safety of the public becomes its primary function.
In reference to the assessment of the evidence for complaints 1, 2 and 3 we have arrived at different conclusions to that of his Honour.
A reference to a numbered paragraph refers to the paragraph numbered within his Honour's minority report.
In relation to paragraph 5, we note that the practitioner is a non-vocationally trained practitioner. This means that she has not undertaken advanced training in any recognised field of medicine. She has crafted a career as a career medical officer in hospitals, cosmetic medicine practitioner and part time non vocationally trained general practice which has incorporated her practice of "wellness medicine".
[21]
Source of originating complaint
We note that the Pharmaceutical Regulatory Unit (PRU) made a mandatory notification to the Medical Council concerning the practitioner's prescribing of human growth hormones (HGH) and as a result the Medical Council imposed conditions on the practitioner's registration under section 150 of the National Law which prohibited her from prescribing growth hormones. The referral of the mandatory compliant to the Medical Council is a significant action, contrary to his Honour's statement in paragraphs 200 and 255, that the PRU "took no action against her."
In reference to paragraph 110, it should be noted that the reason why the practitioner stated that "she has not prescribed Somatropin since 2019" is because the Medical Council imposed conditions on the practitioner's registration under section 150 of the National Law prohibiting her from prescribing growth hormones.
In regard to the extensive redaction of the PRU's report within the Health Care Complaints Commission's (HCCC) brief of evidence, we are highly critical of the HCCC's decision to allow the substantial redaction (some 99% of the report) which effectively left some two lines of text per page available to the Tribunal from the originating complaint. Given the PRU's extensive experience regulating the Poisons and Therapeutic Goods Act 1966 it would have been instructive for the Tribunal to have had the PRU's expertise and comments within their report. If there were any concerns raised in the PRU's report that may have been additional to the particulars of this complaint, it would have been within the ability of this Tribunal to disregard those concerns that were not on point. As this was the originating complaint, the Tribunal should have had access to the PRU's reasoning concerning the prescribing of HGH, not only their one sentence conclusion.
[22]
No complaints from patients
In reference to paragraph 111, his Honour notes:
"…none of the ten patients whose prescribing gave rise to the Commission's application has made any complaint about any aspect of their treatment by the Practitioner."
However, this Tribunal's paramount consideration is the protection of the health and safety of the public and not to monitor or ensure patient satisfaction. In this case our paramount concern in the protection of the health and safety of the public is the potential for harm from very serious side effects caused by the prescribing of growth hormones (variously referred to as somatotropin, growth hormone and HGH throughout the decision) without adequate serological monitoring for side effects.
Human growth hormones are classified by the Poisons and Therapeutic Goods Act 1966 under Schedule 4 of the Poisons List as a "restricted drug" (see paragraph 6 of his Honour's decision).
Under the Pharmaceutical Benefits Scheme (PBS), treatment with growth hormone is indicated for specific conditions. In addition, the prescription must be provided by a medical practitioner in consultation with a nominated specialist and only after obtaining an authority to prescribe from the PBS. However, these controls do not apply if the medical practitioner prescribes "off label". The Australian Register for Therapeutics Goods (ARTG) has the following indications for SciTropin A:
"Growth hormone is intended for the long term treatment of children (above three years of age) with:
• growth disturbance due to insufficient secretion of pituitary growth hormone
• growth disturbance associated with gonadal dysgenesis (Turner syndrome)
• growth disturbance associated with chronic renal insufficiency."
For a medicine to be listed on the ARTG, it undergoes a rigorous evaluation process by the Therapeutic Goods Administration (TGA) to ensure its safety, its quality, and efficacy for use in Australia. When a medication is used "off label", there is limited data on safety, quality and efficacy. Given the practitioner is providing growth hormone directly to patients, without a prescription being dispensed through a pharmacist, off PBS and off label, she is circumventing all safety measures, compromising and endangering public safety.
In the following, the Tribunal accepts the expert evidence of all three expert witnesses. For the evidence of each expert witness, the Tribunal has undertaken an evaluative process in order to determine the benchmark standard which would be expected of a general practitioner who is prescribing HGH medications "off-label" to patients in the context of anti-ageing and/or wellness.
[23]
Evidence of Professor Carter para 33 - 54
In his report dated 23 May 2022, Professor Carter stated:
"In all cases, a basis(sic) tenant of medical practice is "first do no harm". This applies in all situations, but particularly applies when the drug is prescribed for an off-label purpose."
Professor Carter's view is that a medical practitioner is required to satisfy themselves that the benefit of prescribing a HGH outweighs the potential for harm. Professor Carter stated that any benefit attributed to Somatropin was "anecdotal" and that such evidence did not justify the off-label prescribing, especially when the potential for harm outweighs the anecdotal benefit.
When asked for his opinion concerning the anastrozole, DHEA, mesterolone, pregnenolone, progesterone and testosterone, Professor Carter stated that he held the same opinion for each of these drugs as for somatropin, with the exception of DHEA. In relation to DHEA, Professor Carter stated that there were no "obvious significant side effects" and there had been extensive anecdotal usage. In other words, that prescribing DHEA did not have the same potential for harm as did somatropin, anastrozole, mesterolone, pregnenolone, progesterone and testosterone.
The HCCC's submissions quoted Professor Carter who stated that the "dosages and/or duration of testosterone" that the practitioner had prescribed were "significantly above the therapeutic or appropriate standard for the patient." In this respect, he opined that the practitioner's conduct fell significantly below the standard expected."
In relation to paragraph 39, we accept that Professor Carter is a highly qualified endocrinologist and not a general practitioner. However, we note that the on-label prescribing of HGH medications is solely the province of endocrinologists and not that of general practitioners. For this reason, we accept both Professor Carter and Professor Holmes-Walker's opinions concerning the steps required of a medical practitioner prior to prescribing HGHs; and, the ongoing monitoring of patients during treatment.
In relation to paragraph 41, we accept that Professor Carter has never practised in "cosmetic medicine" or in "anti-ageing medicine". We are satisfied that Professor Carter has a substantial understanding of the side effects of either off-label or on-label prescribing of HGHs. Prescribing off-label would occasion the same side effects as prescribing on-label. We note that Professor Carter has provided evidence as to the side effects, the patient assessment required, examination and cautions associated with prescribing HGHs. If a medical practitioner, who is not an endocrinologist, wishes to prescribe HGHs off-label, then it follows that they should undertake the same assessments, examination, cautions and understand the potential for harm to the patients, as stated by Professor Carter. In view of the side effects of prescribing HGHs, any medical practitioner who decided to prescribe off-label HGHs would need to apply the same rigor as an endocrinologist in order to protect the health and safety of the patient.
We are not critical of Professor Carter's evidence on the basis that he does not prescribe HGHs for the same purposes as the practitioner. The views in this section are not limited to the paragraphs listed above but apply to his Honour's decision as a whole. (e.g. paragraphs 185, 186, 187 and 188)
[24]
Quality of life and monitoring for side effects
In relation to paragraph 47 and improvements in patient's quality of life, we accept Professor Carter statement that it was appropriate to consider a patient's subjective assessment and stated: "…but quality of life is a valid aspect to look at, and in that situation, the surveillance for potential side effects becomes even more important."
We note the excerpt quoted in paragraph 50 attributed to Professor Carter oral evidence:
"the use of a drug with potential serious side effects when there are no high quality, large, randomised placebo controlled trials, and if the only health outcome that is being stated to improve is quality of life, one of my first questions would be: how do we know that's not a placebo effect, and, therefore, these patients are being subjected to a synthetic hormone that has serious potential side effects".
This paragraph concludes with his Honour's comments as follows:
"Although he referred to "potential serious side effects", Professor Carter did not identify such risks with respect to any of the ten patients in this case."
With regard to the identification of side effects, we note the report dated 23 May 2022, where Professor Carter outlined the medical conditions which are exacerbated by excess growth hormone, such as somatropin, which include:
"heart disease (and particularly cardiomyopathy), diabetes mellitus, hypertension, arthritis, sleep apnoea and hypothyroidism. There are clinical concerns that occult carcinomas have an increased growth potential when exposed to excess GH; and people with acromegaly are known to have an increased incidence of carcinomas."
We note that the practitioner has not undertaken IGF1 blood tests to determine if any of the ten patients had an excessive of growth hormone, which would be germane to the protection of the health and safety of these patients. From the patient records contained in the HCCC brief of evidence, there is no evidence that any of the ten patients were human growth hormone deficient. The practitioner gave evidence that some of her patients were experiencing "fatigue or brain fog". Fatigue and brain fog are not the key indications for human growth efficiencies.
Contrary to his Honour's comments in paragraphs 47, 234 and 241, the HCCC's submission quoted Professor Carter's report where he observed in the patient record dated 22/03/18 for patient B that there was an enlarged ulnar nerve which in his view was a side-effect of excess growth hormone. Professor Carter's report for patient C stated:
"Additionally, continued prescribing of somatropin should not have occurred as there was a suggestion of a cardiomyopathy (following a referral to a cardiologist) and cardiomyopathy is a recognised complication of GH excess such as patients with acromegaly. Thus prescribing somatropin was inappropriate."
[25]
Double blind placebo controlled trials
In relation to paragraphs 43, 45 and 46 and whether or not "all medications" that are currently available have been subject to double blind, placebo-controlled trials, "all medications" are not included in the particulars and hence this line of questioning strayed well beyond the points contained in the particulars. This matter concerned the prescribing of HGH restricted substances that can produce substantial side effects. In relation to HGHs, the Tribunal agreed with Professor Carter that HGHs should not be prescribed for off-label use unless the medical indication has been scientifically tested to respond positively in double blind, placebo-controlled trials. To prescribe HGHs off-label in this manner without double blind, placebo-controlled trials represented a deliberate departure from standard practice. This view is not limited to the paragraphs listed here but applies to his Honour's decision as a whole (e.g. paragraph 193).
[26]
Failure to monitor the patients
In relation to the ongoing monitoring of the ten patients in this case, in his report dated 23 May 2022 Professor Carter stated:
"Her indications for the prescribing of the GH should've been clearly documented in the notes and the potential side-effects of the medication should also have been outlined to the patient and documented in the notes. Prior to prescribing somatropin, a history and examination relevant to conditions such as heart disease, glucose intolerance, hypertension, sleep apnoea & carpal tunnel syndrome along with history relating to family history, past history, or current history of cancer that should've been undertaken. During the course of treatment with Somatropin, examination regarding these conditions should have been undertaken and documented in the clinical notes, in addition to whether or not the reason for Somatropin injections had been justified on the basis of the clinical response."
As this information was largely missing from the patient records, it can be said that the practitioner did not undertake initial or subsequent assessment relevant to the side effects listed by Professor Carter with respect to the ten patients in this case.
In relation to paragraph 52, we note that after reviewing the full medical record, Professor Carter in his third report dated 12 July 2022 confirmed that "many of the histories and documentation of many of the examinations was quite reasonable".
However, Professor Carter reiterated his previously expressed concerns, including his view that prescribing somatotropin and pregnenolone was "significantly below the standard reasonably expected of a GP with equivalent training or experience". This view is not limited to the paragraphs listed here but applies to his Honour's decision as a whole. (e.g. paragraphs 185) After evaluating the evidence we agreed with Professor Carter that the practitioner's conduct was significantly below the expected standard for a general practitioner.
[27]
Evidence of Dr Kertesz paragraph 55 - 72
Dr Kertesz is an experienced and highly respected general practitioner who is a Fellow of the Royal College of General Practitioners and is thus vocationally trained.
We agree with his Honour's paragraphs 55, 56 (a) to (j).
In relation to paragraph 56 (a) to (j), we note Dr Kertesz's comments that "There appears to be no medical, clinical, or scientific basis for any benefit with this management during the period of prescribing." In relation to patient B, Dr Kertesz noted that this patient's testosterone level rose twice the normal level while being prescribed somatropin, DHEA and pregnenolone. The failure to monitor patient B's testosterone in these circumstances amounts to serious negligence. For all patients (a) to (j), Dr Kertesz stated that the practitioner's management of these patients was significantly below the requisite standard. After evaluating the evidence we agreed with Dr Kertesz that the practitioner's conduct was significantly below the expected standard for a general practitioner.
The following relates to paragraphs 60, 61, 62, 63 and especially 64 in which his Honour stated: "…his expertise with respect to the subject matter of this complaint is quite limited, as is its foundation."
As the practitioner practised as a "general practitioner" during the relevant period, we consider that the general expectations set out in the Medical Board of Australia's Code of Conduct should apply to the practitioner's practice. Accordingly, the practitioner should have had regard to evidence-based treatments, the requirements to clinically assess and manage patients and to maintain medical records that comply with regulatory standards, as would any general practitioner. Patients consulting a registered general practitioner have a reasonable expectation that the general practitioner will comply with the usual professional standards of conduct and competence, and will take into consideration the existing evidenced-based options when providing health care. For these reasons, it is reasonable to hold the practitioner to her compliance obligations as a general practitioner. The Tribunal accepts Dr Kertesz's opinion that the practitioner is a general practitioner. This view is not limited to the paragraphs listed here but applies to his Honour's decision as a whole. (e.g. paragraph 196)
In relation to paragraph 197, and the prescribing of Mersyndol Forte and diazepam to patient J, Dr Kertesz's opinion was that the practitioner's prescribing was "seriously excessive". Dr Kertesz considered that the practitioner's prescribing of Mersyndol Forte and diazepam was considerably below the expected standard of a general practitioner.
At paragraph 244, his Honour noted that the practitioner "conceded that her conduct in prescribing those medications fell below the standard because of the frequency with which the pain medication was prescribed, but maintained that it did not fall significantly below that standard." After evaluating the evidence, we agreed with Dr Kertesz that the practitioner's conduct was significantly below the expected standard and a deliberate departure of the conduct expected of a general practitioner.
While we agree that Dr Kertesz does not have experience in "wellness prescribing", in paragraph 65 his Honour quotes Dr Kertesz in oral evidence as saying in relation to off-label prescribing that it was "not recommended unless the practitioner feels that there is benefit to the patient with potentially minimal harm". As the potential benefit to the patient is anecdotal at best and the potential for harm is significant, it is not surprising that neither Dr Kertesz nor Professor Carter prescribe HGHs and are critical of the practitioner for prescribing HGHs off-label.
The practitioner has stated that she is a "wellness practitioner". However, in our view, this area of practice does not enable her to be less vigilant with regard to using non-evidence-based treatments, nor the requirements to clinically assess and manage patients and to maintain medical records that comply with regulatory standards, as would any general practitioner.
[28]
Financial incentives
In relation to paragraph 65, 111 and 169, the practitioner was spending around $25,000 per month on somatropin (see paragraph 176) and it is plausible that this expensive level of ongoing inventory may have impacted her objectivity as it would have generated considerable pressure on the practitioner to maintain the turnover of her stock of somatropin.
Prescribing and dispensing a restricted substance at cost would be a substantial financial incentive for many patients to consult with the practitioner, thereby raising the number of patients attending her consultations. This view is contrary to the view expressed by his Honour at paragraph 169. There were no receipts issued by the practitioner in evidence and we had to rely on oral evidence from the practitioner in regard to the costs of consultations and prescriptions issued by her.
[29]
Evidence of Professor Holmes-Walker paragraphs 73 - 107
In paragraph 75, his Honour quoted from Professor Holmes-Walker's report:
"experience in the prescription of Growth Hormone for growth hormone deficient adults and have experience in prescription of androgen replacement in men and women (not currently PBS subsidised for use in women) and prescription of DHEA for adults with known causes of deficiency. In some cases I have prescribed growth hormone and testosterone when individuals may fall short of the PBS approved prescribing criteria for deficiency states as defined by "numeric cutoffs" but may have partial deficiency demonstrated - in such individuals the agent may be prescribed on private prescription and continue to be supplied on private prescription where clinical benefit is ascertained from subsequent review of the individual. Such prescribing could be considered "off-label" by some practitioners".
In paragraph 76 Professor Holmes-Walker is quoted as stating in oral evidence that HGH is subsidised by the PBS for an identified disorder of the pituitary gland which causes severe growth hormone deficiency. Professor Holmes-Walker stated that partial deficiency states may exist but there is no guarantee that those patients may experience any benefit from growth hormone. As the benefit to patients with partial deficiency states has not been scientifically demonstrated, the government has not subsidised HGHs.
In paragraph 78 Professor Holmes-Walker is quoted stating that if the patient does not experience a benefit within a six month period from its commencement, treatment should cease with respect to "all hormonal therapies for which there is limited evidence but for which there may be individual reported benefits." Professor Holmes-Walker stated that she has not prescribed pregnenolone or mesterolone. We note that the practitioner prescribed pregnenolone for patients A and I and prescribed mesterolone for patients B, H, I and J. We note that Professor Carter did not express an opinion regarding the prescribing of pregnenolone because there was no scientific data to base a therapeutic standard.
In paragraph 79 Professor Holmes Walker is quoted stating that:
"growth hormone should be titrated starting at .3mg per day (1IU) and increasing to a dose appropriate for weight at detailed at [sic] detailed above over a period of weeks increasing by .3mg for each dose adjustment every 2-3 weeks. The doses prescribed (3IU) are appropriate for a growth hormone deficient individual weighing 60 kilograms."
We note that in the ten patient records produced during the course of this matter, the practitioner has not started any patient on a low dose and titrated upwards.
In paragraph 81 Professor Holmes-Walker is quoted stating that there is no issue with a patient seeking treatment with growth hormone. Professor Holmes -Walker stated:
"The role of the health practitioner is to ensure an underlying health condition causing symptoms is excluded."
In paragraph 189 his Honour quoted the HCCC and Professor Holmes-Walker who stated that: "…the onus [is] on the Practitioner to defend her reasoning for off label prescribing."
Professor Holmes-Walker also stated that:
"Dose adjustment and review for side effects should be undertaken at three months after initial supply and then every six months from commencement while a person continues to take the medication."
We note that there is no evidence of dose adjustments by the practitioner in any of the ten patient records.
At paragraph 82 Professor Holmes-Walker is quoted stating that:
"Where no change in wellbeing or expected clinical response does not occur then the drug should be ceased at six months."
At paragraph 82 Professor Holmes-Walker also stated that:
"IGF1 levels should be monitored six monthly in conjunction with annual blood glucose +/- HbA1c and lipid monitoring."
In relation to paragraph 211, and his Honour's statement that:
"…has not identified evidence establishing that the duration of the prescribing of off label medication for any of the ten patients was inherently unreasonable, or that it was contraindicated."
The Tribunal has already noted above that Professor Carter found that continuing to prescribe somatropin to patients B and C was contraindicated.
The Tribunal note the Commission's submission dated 19 March 2024 which stated that the treatment periods for each of the ten patients ranged from 9 months to 28 months, where the average treatment period was just under 18 months. We note that in the ten patient records produced in relation to this matter, the practitioner has not sought blood tests to measure the IGF1 for any of the patients. In these circumstances, continuing to prescribe HGHs to these patients, without the appropriate serological monitoring amounts to serious negligence. This view is not limited to paragraph 198 and applies to his Honour's decision as a whole.
At paragraph 85 Professor Holmes-Walker is quoted stating that:
"My only concern is that there appears to be a one dose fits all approach by Dr Della Bruna without evidence of subsequent dose adjustment."
At paragraph 101 Professor Holmes-Walker is quoted stating that from a total of 200 patients that she treats during a fortnight, only one patient is treated with growth hormone. Given her experience and training, it is significant that such an eminent endocrinologist treats only one patient with growth hormones during the course of a fortnight. This is in contrast to the practitioner's significant number of patients treated by her with growth hormones. At paragraph 137 the practitioner is quoted stating that she was seeing less than five patients per week or about eight patients per fortnight for growth hormones, although not all were prescribed growth hormones. The practitioner estimated that some 20% of her patients were being prescribed growth hormones.
We acknowledge Professor Holmes-Walker's understanding of: evidence-based treatments for hormone deficiency, the requirements to clinically assess and manage patients and the need to maintain medical records that comply with regulatory standards. During oral evidence, Professor Holmes-Walker stated that in the past she had prescribed "off label" HGH for patients with serologically identified partial human growth deficiencies. However, unlike the practitioner, Professor Holmes-Walker prescribed an individualised starting dose based on the patient's weight, titration of growth hormone over several weeks based on safety, efficacy and tolerability. In addition, Professor Holmes-Walker conducted ongoing monitoring at least six months with IGF - 1, lipids, glucose, blood pressure, weight and body mass index. All of these considerations are missing from the practitioner's patient records.
In Professor Holmes-Walker's report, she states that more clinical trials are needed before growth hormone treatment is considered to be worthwhile in the treatment of ageing.
Professor Holmes-Walker is vigilant in relation to the monitoring of her patients and limits her treatment to six months where there is no clinical response to the treatment. Despite her considerable experience and knowledge, Professor Holmes-Walker has not prescribed pregnenolone or mesterolone, whereas the practitioner has prescribed these restricted substances to some five patients.
In relation to paragraph 192 and 193 we note that Professor Holmes-Walker stated that in her view the practitioner's conduct fell below the required standard but not significantly below. The Tribunal acknowledges and accepts the evidence provided by Professor Holmes-Walker as to the management of patients who are prescribed HGH.
However, the Tribunal is concerned that Professor Holmes-Walker's assessment of the conduct of the practitioner is based on her level of understanding as a senior endocrinologist who is experienced and knowledgeable in the area of human growth deficiencies. As stated above, despite Professor Holmes-Walker extensive experience and training, she prescribes HGH to significantly fewer patients than the practitioner and has never prescribed pregnenolone or mesterolone. Prescribing HGH for an endocrinologist may fall within or below the required standard as an endocrinologist has a greater degree of understanding concerning the prescribing and management of patients on HGHs. However, on this point we prefer the evidence of Dr Kertesz who, as a general practitioner, understands the experience and training that a general practitioner may rely upon. Dr Kertesz acknowledged the limitations of general practice training in area such as growth hormones. This view is not limited to paragraph 180 and applies to his Honour's decision as a whole.
[30]
Anti-aging area of medicine
In regard to paragraphs 111 and 112, practising in the "anti-ageing area of medicine" needs to be carefully measured, for the obvious reason that patients often sense that their bodies are ageing and may be keen to seek anti-ageing medications which offer the "fountain of youth". For these reasons, such patients may have a strong predilection for anti-ageing medications, despite the poor effectiveness of the medication. While the practitioner stated that she had refused to prescribe somatropin to some patients, there was no evidence provided to the Tribunal that indicated that this may have been done.
During the course of the hearing a number of the experts referred to the "placebo effect" associated with growth hormones which is a significant concern especially in the anti-ageing area of medicine where patients are prescribed HGHs. Given that much of the effectiveness of HGH on ageing is anecdotal, it is possible that the anecdotal effects of HGH correspond to a placebo effect. This view is not limited to the paragraphs listed here (e.g. 111 and 112) but applies to his Honour's decision as a whole.
[31]
General statements
In paragraph 113 the practitioner stated:
"Somatotropin has a very low risk profile. The amount of information provided for informed consent was, I think, more than sufficient for my patients to gain a good understanding of risks and potential therapeutic benefits."
This statement that somatropin "has a low risk profile" was concerning given Professor Carter's evidence on the significant side effects associated with prescribing HGHs. This statement reveals either the practitioner's poor knowledge concerning the side effects that are attributed to Somatropin or an indifference to the side effects.
At paragraph 181 his Honour quotes the HCCC (or Commission):
"…in circumstances where growth hormones are being prescribed for off-label purposes, the prescription was inappropriate because it was prescribed early on in the care/treatment of the patient, without clear scientific, clinical or medical reasons and in circumstances where at times there were no reasons set out for the prescription."
The practitioner's evidence with respect to those matters is not accepted by the Tribunal. The HCCC's paragraph correctly describes how the practitioner failed to meet the required standard and how her conduct fell significantly below that standard. This view is not limited to the paragraphs listed here but applies to his Honour's decision as a whole (e.g. paragraph 182, 183).
[32]
Patient records
In relation to paragraph 116, his Honour stated that the practitioner: "was able to explain why she had prescribed particular medications, and the dosages which she had prescribed." However, the patient records did not contain any of the information that the practitioner provided in oral evidence during the hearing.
The Medical Board Good medical practice: a code of conduct for doctors in Australia at section 10.5 states that it is essential for the continuing good care of patients to keep accurate up-to-date and legible records that report relevant details of clinical history, clinical findings, investigations, diagnosis, information given to patients, medications, referral and another management of the patient in the form that can be understood by other health practitioners. This is consistent with the opinion of Dr Kertesz.
The evidence of what occurred or what was undertaken at the time of the consultation is contained in the patient record. Oral evidence pertaining to specific consultations, some three or four years later, cannot replace a patient record which has been contemporaneously recorded and accordingly we reject the practitioner's oral evidence on these points. If it is not in the patient record then the actions, justifications and monitoring did not occur despite the practitioner's ex post facto assertions. This view is not limited to the paragraphs listed here but applies to his Honour's decision as a whole. (e.g. paragraph 209, 235, 240)
[33]
Direct dispensing
In relation to paragraph 121 and her direct dispensing of somatropin to patients, the practitioner engaged in the following dialogue:
"It was suggested to the Practitioner that "The reason that you sought to directly dispense Somatotropin was to reduce the risk of oversight or investigation about it". The Practitioner denied that but agreed (Tcpt 30/3/2023 p144) that "In general terms" it is preferable to encourage dispensing through a pharmacy."
The practitioner stated that she decided to directly dispense somatropin to her patients because they had been "embarrassed" (see paragraph 119 and 243) to obtain the medication from pharmacies. This is not a sufficient reason to circumvent the oversight of a pharmacist, especially where a restricted substance is being directly dispensed. (Consistent also with comments in paragraph 204) Accordingly, the practitioner's evidence at paragraphs 119, 120 and 121 was implausible or inherently improbable contrary to his Honour's assessment. This is also contrary to his Honour's comments in paragraphs 178 and 242. This view is not limited to the paragraphs listed here but applies to his Honour's decision as a whole.
There is insufficient reason to account for the practitioner's need to dispense directly to the patients A to I. The Tribunal noted that it was not illegal for the practitioner to dispense somatropin. However, the increase in the potential for harm associated with a restricted substance correspondingly increases the need for oversight by a pharmacist. By dispensing the somatropin, a restricted substance, directly to patients the practitioner has engaged in a deliberate departure from bench mark standard as stated in Dr Kertesz's report.
[34]
One dose fits all
In relation to paragraph 128 and his Honour's statement that:
"The Practitioner's evidence suggests that the "one dose fits all" concern that Professor Holmes-Walker recorded was more likely to be coincidental than to result from the absence of ongoing monitoring of the effectiveness of the treatment and any risks to the health of the patient associated with it."
We note that all ten patient records recorded the same initial dose of somatropin. This is in line with Professor Holmes-Walker's assessment and is not consistent with a "coincidence". It is not coincidental that all ten patients should receive the same dosage. The Tribunal accepted Professor Holmes-Walker's evidence on this point. The one dose fits all approach suggests an indifference for the need to start low and monitor the effectiveness of the treatment. Such indifference is a risk factor which may impact on the health and safety of the patients. This view is not limited to the paragraphs listed here but applies to his Honour's decision as a whole. (e.g. paragraph 195)
[35]
Red flags
Paragraph 135 contained a dialogue between one of the professional members and the practitioner concerning patients who asked for particular restricted substances and whether this behaviour raised a "red flag" when the patient's address was in Queensland or in western Sydney. In her response the practitioner stated that she was "comfortable" that the patients were not drug seeking. At paragraph 171 his Honour stated:
"The fact that patients from places far from her surgery sought out the Practitioner does not establish or imply that there was anything untoward about her method of practising. Many professional people, including lawyers, are approached by clients from far distant places because they are known or believed to be good at what they do."
And,
"Inherent in the Commission's submission is that the Practitioner was "known" to prescribe the drugs referred to in the Complaint in circumstances where a responsible practitioner would not have done so."
While professionals including lawyers may be approached by persons because they are known to be good at their profession, if a patient approaches a medical practitioner with a request for a particular drug, this behaviour raises a "red flag" as it may indicate "drug seeking behaviour" especially in the field of general practice about which no speciality is held out. In addition, where the patient's residential address is substantially out of the general area of the practice, such as western Sydney or in Queensland, then this would raise additional concerns or red flags. Significantly, Professor Holmes-Walker refers to this type of drug seeking behaviour in the excerpt in paragraph 101 when she says:
"Anyone who comes with a self-diagnosis, that's an alarm bell, I have to tell you. It's not just, you know, I think growth hormone is the solution. There's lots of alarm bells when you're an endocrinologist."
It is evident from her remarks in paragraph 135 that the practitioner did not chose to consider these characteristics of her patients. The practitioner's attitude in relation to red flags suggested an indifference to this risk factor which may impact on the health and safety of the patients. This view is not limited to the paragraphs listed here but applies to his Honour's decision as a whole. (e.g. paragraph 207, 208)
In our evaluative process, acquiescing to drug seeking behaviour has the potential to harm the health and safety of the public.
[36]
Consideration
In relation to paragraph 247, in light of the evidence of Professor Holmes-Walker, concessions made by both Dr Kertesz and Professor Carter and concessions made by the practitioner and the reasons referred to above, the Tribunal disagrees with his Honour and is comfortably satisfied that the practitioner's prescribing and management of the off-label medications to the ten patients referred to in the HCCC's application fell significantly below the requisite standard. The requisite standard has been discussed in some length in the above paragraphs concerning all three expert witness opinions and evidence.
In relation to paragraph 255 and his Honour's findings, the following responds to his Honour's subparagraphs as follows:
(i) while there were no patient complaints there was a mandatory notification from the PRU to the Medical Council which resulted in conditions on the practitioner's registration prohibiting the prescribing of HGHs;
(ii) and (iii) Professor Carter identified side effects in patients B and C that he attributed to excess growth hormone. Professor Carter's evidence was that there was potential for significant side effects in the prescribing of HGHs. Considering the prolonged treatment periods that averaged over 17 months for the ten patients, any potential side effects would have gone unmonitored because of the absence of IGF1 serological analysis;
(iv) The Tribunal accepts the Medical Board Code of Conduct and specifically paragraph 10.5 of that document which requires that contemporaneous complete and accurate medical or patient records be maintained. Oral evidence, some four years after a consultation with a patient, from the practitioner pertaining to specific consultations in lieu of entries in the patient record are rejected by the Tribunal;
(v) The Tribunal decision refers to the Amended Complaint filed on 16 August 2022 and does not include any previous allegations made against the practitioner.
(vi) The Tribunal rejects the practitioner's oral evidence in relation to her prescribing and management of the ten patients who were the subject of the complaint. Patient records are required to be made contemporaneously and in accordance with 10.5 of the Code of Conduct. Ex post facto assertions in respect of patient consultations that occurred some four years prior are inherently unreliable.
(vii) Unknown and not the subject of the particulars;
(viii) Disagree, see comment for (i) above;
(ix) "Sinister" or "veil" were terms that were not included in the particulars and hence not relevant to these proceedings;
(x) It is not the Tribunal members' role to be confronting or to contradict the practitioner. The Tribunal members have undertaken an evaluative process focusing on the evidence of the practitioner and all three expert witnesses, as evidenced by the above reasons. The Tribunal has carefully considered the benchmark standard for this practitioner and has assessed her conduct against that standard;
(xi) Disagreed. The practitioner paid for and stored some $25,000 of Somatropin per month which she dispensed directly to patients. Paying for and storing such a valuable inventory would have been reason to prescribe and create turnover of this inventory thereby influencing her objectivity in prescribing;
(xii) Agreed, with reservations as set out in the reasons under "anti-ageing area of medicine" and the quest for the "fountain of youth".
[37]
Professional misconduct
In respect of paragraph 263, we accept his Honour's characterisation of professional misconduct as: "Something more than "mere deficiencies", including a deliberate departure from accepted standards, "serious negligence" or "indifference" with respect to expected standards is required in order to find professional misconduct (Pillai v Messiter No 2) (1989) 16 NSWLR 197)." However, by contrast to his Honour, we find evidence of a deliberate departure, indifference and serious negligence with respect to the expected standards in this case.
We find the particulars of complaint one with regard to patients A to J proven. We note that complaint two was admitted. We find the particulars of complaint three proven, and when taken together, we find that the finding of professional misconduct is justified.
[38]
Orders
1. The Respondent is guilty of professional misconduct.
2. The proceedings are listed for a Stage 2 hearing on 29 November 2024.
3. The parties are to file and serve any evidence to be relied on at the Stage 2 hearing by 21 November 2024.
[39]
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: 24 October 2024