Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Health Care Complaints Commission v Grygiel [2021] NSWCATOD 28 Hearing dates: 15, 29, 30, 31 July 2019, 1, 2, 5, 6, 8, 9, 12, 13, 14 August 2019, 16, 17, 20, 23 March 2020, 9 April 2020, 23 and 27 November 2020. Date of orders: 17 March 2021 Decision date: 17 March 2021 Jurisdiction: Occupational Division Before: Boland AM ADCJ, Deputy President Prof M Links, Senior Member Dr A Reid, Senior Member J Barker, General Member Decision: (1) Pursuant to s 149C(4)(a) of the Health Practitioner Regulation National Law (the National Law) the Tribunal determines that if John Joseph Grygiel (the practitioner) was still registered it would have cancelled his registration. (2) The practitioner is precluded under s 149C(4)(b) of the National Law from seeking a re-instatement order for a period of two years from the date of these orders. (3) The Medical Board of Australia is requested to record under s 149C(4)(c) in the register the fact that the Tribunal would have cancelled the practitioner's registration. (4) Pursuant to s 163 of the National Law the Tribunal is the appropriate review body. (5) The practitioner shall pay 70 per cent of the Health Care Complaints Commission's costs of and incidental to these proceedings as agreed and failing agreement as assessed under the Legal Profession Uniform Law Application Act 2014 (NSW). Catchwords: HEALTH — professional registration and discipline — unsatisfactory professional conduct — professional misconduct Legislation Cited: Health Care Complaints Act 1993 (NSW) Health Practitioner Regulation National Law Health Practitioner Regulation (New South Wales) Regulation 2010 (repealed) Health Services Act 1997 (NSW) Cases Cited: Briginshaw v Briginshaw (1938) 60 CLR 336 Chappel v Hart [1998] HCA 55 Chen v Health Care Complaints Commission [2017] NSWCA 186 Childs v Walton [1990] NSWCA 41 Clyne v New South Wales Bar Association (1960) 104 CLR 186 Don Nai Hsi Huang v Walton [1993] NSWCA 139 Health Care Complaints Commission v Karalasingham [2007] NSWCA 267 Health Care Complaints Commission v Ahmad [2015] NSWCATOD 103 Health Care Complaints Commission v Do [2014] NSWCA 307 Health Care Complaints Commission v Grygiel (Termination Application) [2020] NSWCATOD 53 Health Care Complaints Commission v Jamieson [2014] NSWCATOD 56 Health Care Complaints Commission v Kazeme [2020] NSWCATOD 25 Health Care Complaints Commission v Litchfield (1997) 41 NSWLR 630 Health Care Complaints Commission v Reid [2018] NSWCATOD 162 Health Care Complaints Commission v Street [2014] NSWCATOD 124 Health Care Complaints Commission v Von Marburg (No 4) [2019] NSWCATOD 92 Lucire v Health Care Complaints Commission [2011] NSWCA 99 Montgomery v Lanarkshire Health Board [2015] UKSC 11 Project Blue Sky v Australian Broadcasting Authority (1998) 194 CLR 35 Qidwai v Brown [1984] 1 NSWLR 100 Richards v Rahilly [2015] NSWSC 352 Rogers v Whitaker (1992) 175 CLR 479; [1992] HCA 58 Rosenberg v Percival [2001] HCA 18 Sabag v Health Care Complaints Commission [2001] NSWCA 411 Sullivan v Civil Aviation Authority (2014) 226 FCR 555 Texts Cited: Budach et al, "A meta-analysis of hyperfractionated and accelerated radiotherapy and combined chemotherapy and radiotherapy regimens in unresected locally advanced squamous cell carcinoma of the head and neck" (2006) 6 BMC Cancer 28. D C Pearce and R S Geddes, Statutory Interpretation in Australia (8th ed, 2014, LexisNexis Butterworths). Pignon et al, "Chemotherapy added to locoregional treatment for head and neck squamous-cell carcinoma: three meta-analyses of updated individual data" (2000) 355 (9208) The Lancet 949. Pignon et al, "Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 93 randomised trials and 17,346 patients" (2009) 92 (1) Radiotherapy and Oncology 4. Category: Principal judgment Parties: Health Care Complaints Commission (Applicant) John Joseph Grygiel (Respondent) Representation: Counsel: K Stern SC with L Coleman (Applicant) D Graham SC with R Mathur (Respondent) Solicitors: Health Care Complaints Commission (Applicant) Avant Law (Respondent) File Number(s): 2018/00058188 Publication restriction: On 28 June 2019 an order was made under clause 7 of Schedule 5D of the Health Practitioner Regulation National Law prohibiting the publication of the names of the patients set out in the schedule to the complaint. Introduction The conduct of the hearing after 23 November 2020 Definitive and Adjunct Chemoradiotherapy What is definitive and adjuvant chemoradiotherapy? What are the bases for making a recommendation about chemotherapy? What is an MDT and what is its role in chemoradiotherapy? The composition of the MDT The application of MDT recommendations Applications to Head and Neck Cancers How are recommendations about chemotherapy doses made? AUC dosing of carboplatin Application to Head and Neck Cancer What is the impact of age and HPV positive status (P 16+ status)? Prescribing protocols Background Relevant statutory provisions and principles applicable to disciplinary proceedings under the National Law Matters in issue in these proceedings Technical Papers including peer reviewed papers and expert evidence - an overview Peer reviewed papers The experts Separate answers to conclave questions undated received 5 March 2020 The joint expert reports following the expert conclaves The practitioner's evidence Patient identification Inappropriate treatment of the cohort of non HNSCC patients The eleven clinical complaints The HCCC's submissions The submissions on behalf of the practitioner The eleven patients Patient M8 The practitioner The expert evidence Dr Stein Professor Clarke Joint expert reports Consideration Patient M8 Patient M9 The practitioner's evidence The expert evidence Dr Stein Professor Clarke Professor Fox The first joint report The second joint report Consideration Patient M9 Patient M10 The practitioner Dr Stein Professor Clarke The Joint Reports Consideration Patient M10 Patient S4 The practitioner's reply The expert evidence Dr Stein Professor Clarke Joint Report Consideration Patient S4 Patient S6 The practitioner's replies Dr Stein Professor Clarke The Joint Reports Consideration Patient S6 Patient W4 The practitioner's Replies Dr Stein Professor Clarke Professor Fox Joint Report Consideration Patient W4 Patient W5 The practitioner's Replies Dr Stein Professor Clarke Professor Fox The Joint Report Consideration Patient W5 Patient W6 The practitioner's Reply Dr Stein Professor Clarke Consideration Patient W6 Patient W7 The practitioner's reply Dr Stein Professor Clarke Professor Fox Consideration Patient W7 Patient W10 The practitioner Consideration Patient W10 Patient W18 The practitioner's Reply Dr Stein Professor Clarke Professor Fox Consideration Patient W18 Lack of adequate information to enable a patient to give a proper consent Relevant Case Law The practitioner's evidence The expert evidence Dr Stein Professor Clarke Professor Fox The second Joint Report Informed consent – specific patients Patient S5 The practitioner's first Reply Patient M9 Patient S8 Patient S18 Patient S22 The patient's evidence The practitioner's Reply and evidence The expert evidence Dr Stein Professor Clarke Consideration Patient S22 Patient S19 Patient S13 Patient S11 Patient S16 Patient S14 Consideration – failure to obtain adequate and informed consent from patients The HCCC's submissions The practitioner's submissions The record keeping complaints The practitioner's submissions Consideration – record keeping complaint Standard practice complaints The HCCC submissions The practitioner's submissions Consideration Professional misconduct The HCCC's submissions The practitioner's submissions Consideration professional misconduct Appropriate protective orders Reprimand or cancellation The practitioner's affidavit relied on in the termination proceedings Media articles Cancer Council Australia documentation Medical Oncology Group of Australia Character references Consideration appropriate protective orders Cancellation and Disqualification period or Reprimand? Prohibition Order Costs ORDERS APPENDIX A APPENDIX B REASONS FOR DECISION Introduction 1. John Joseph Grygiel (the practitioner) was a practising registered medical practitioner for over thirty-five years. He practised as a specialist medical oncologist until 2016 when he changed his registration to that of a non-practising practitioner. In 2020 he relinquished his non-practising registration. In the period 2012 to 2016, in his capacity as Senior Staff Oncologist and Associate Professor of Medicine, he treated cancer patients at St Vincent's Hospital, Darlinghurst. While on leave from St Vincent's Hospital between 2010 and 2012 he engaged in practice at Macquarie University Hospital. Between 1989 and 2012 the practitioner was employed as a Visiting Medical Officer and/or as Honorary Medical Officer and treated cancer patients at Bathurst and Orange (Greater Western Area Health Service). The majority of the patients treated by the practitioner, and subject of these proceedings, suffered from head or neck squamous cell carcinomas (HNSSC). 2. In 2015 an investigation was conducted at St Vincent's Hospital into the practitioner's prescribing practices. The inquiry focused particularly on the prescribing of the chemotherapy drug carboplatin in a flat dose of 100mg for a number of patients receiving definitive or adjuvant chemoradiotherapy as part of their treatment for cancer. An investigation of the practitioner's treatment for his patients at Macquarie University Hospital followed. The Chief Executive Officer of that hospital lodged a complaint with the Health Care Complaints Commission (HCCC) about the practitioner's prescribing. 3. In February 2018 the HCCC commenced proceedings in this Tribunal seeking protective orders under the Health Practitioner Regulation National Law (the National Law). On 29 July 2019, the HCCC sought leave to rely on an amended complaint. On 8 August 2019 leave was granted to amend the complaint to add a further particular in respect of asserted improper and unethical conduct. A further amended complaint document was admitted, without objection, on 14 August 2019. That complaint was further amended in a complaint filed on 21 August 2019 when the complaints about certain patients (W1, 2, 9 and 11) were removed from the complaint. A hearing to determine the complaints commenced in August 2019 and was adjourned part-heard until March 2020. 4. As we shortly explain, the proceedings were further adjourned due to the COVID-19 pandemic, and just prior to the resumption of the proceedings on 23 November 2020, the HCCC indicated it proposed to rely on yet another further amended complaint. Leave was granted by the Tribunal on 23 November 2020 to the HCCC to file the further amended complaint (the complaint). The complaint withdraws all of what we will describe as the individual clinical complaints in respect of the HNSCC patients, but retains clinical complaints concerning 11 patients, principally those treated in the Western Area Health Service. Further, the complaint continues to agitate an assertion that the practitioner failed to obtain a proper informed consent from patients, and that he failed to maintain proper records as required by the Health Practitioner Regulation (New South Wales) Regulation 2010 (repealed) (the regulation). 5. Complaint 58 of the complaint asserts, in broad terms, that the practitioner adopted a standard practice of prescribing a flat dose of 100mg carboplatin for HNSCC patients, including seven patients treated at Macquarie University Hospital, and 26 patients treated at St Vincent's Hospital, even though these patients may have been eligible for an alternate chemotherapy regimen. It is asserted that the standard practice adopted by the practitioner demonstrates he had a firmly held view about treatment, and as a result there was a risk that patients did not receive treatment they were otherwise eligible to receive, and received a regimen not supported by published trials or meta-analysis. It is also asserted that the practitioner did not give comprehensive advice to this group of patients which would have enabled them to give a properly informed consent. 6. Complaint 59 asserts the practitioner is guilty of professional misconduct. Because of the significant number of amendments to the complaint, and in order to understand the admissions now made by the practitioner, we annex to these reasons as Appendix "A" a copy of the complaint. 7. The practitioner filed a Reply to the complaint in which he admits all the particulars of the complaint. He also admits he is guilty of unsatisfactory professional conduct and professional misconduct, but the parties remained in dispute as to the appropriate protective orders to be made. However, broad agreement was reached in respect of costs of the proceedings. 8. By way of protective orders the HCCC seek that we make an order that, if the practitioner had been registered, we would have cancelled his registration (see s 149C(4)(a)). Further, that the practitioner be disqualified for a period of 8 years (see s 149C(4)(b)), and a prohibition order be made precluding the practitioner from engaging in health education services (see s 149C(5)). It is submitted on behalf of the practitioner the orders sought by the HCCC are punitive and that the appropriate order is a reprimand under s 149A(1). 9. For convenience only, and in conformity with the complaint, in these reasons we refer to St Vincent's Hospital, Darlinghurst as "SV", Macquarie University Hospital as "MUH", Orange and Bathurst Hospitals in the Western Area Health District as "WH". The conduct of the hearing after 23 November 2020 1. Before us on 23 November 2020, Ms K Stern SC (Ms Stern) on behalf of the HCCC submitted, as the practitioner has now conceded the complaints made against him in writing, that pursuant to s 149 we have a discretion to exercise any power provided in Sub-division 6 of Part 8 of the National Law. Accordingly, she submitted that we could approach the matter in a similar manner to that adopted by the Tribunal in Health Care Complaints Commission v Jamieson [2014] NSWCATOD 56. At [6] in Jamieson the Tribunal noted that it was neither appropriate or necessary to conduct the hearing in two stages, and the hearing focused on what protective orders should be made. The Tribunal explained at [6]-[7]: ..For this purpose the Tribunal considered the documentary evidence in relation to the complaints, heard oral evidence from Dr Jamieson and from Dr Read, a psychiatrist responsible for supervising Dr Jamieson and who had provided a report which was tendered without objection by Dr Jamieson, and received oral and written submissions from the parties. In carrying out its functions in this matter and to the extent relevant, the Tribunal has taken into account the seriousness of the allegations made by the HCCC and the gravity of the consequences of the protective orders the Tribunal might make. The matter has been approached having regard to the principles in Briginshaw v Briginshaw (1938) 60 CLR 336 at 361 and 362. 1. Ms Stern submitted we should rely only on s 149 to make protective orders, not s 165H of the National Law. The latter provision deals with circumstances where admissions are made prior to any inquiry being held, which is not what has occurred in this matter. Here, save and except for the completion of the cross-examination of the experts, the inquiry had been completed. 2. On 23 November 2020 we indicated that, on the basis of the admissions made by the practitioner, we were satisfied having regard to the evidence before us that the admissions were properly made. In reaching that determination we took into account the fact we had the benefit of all the material exhibited before us, that we also had the benefit of hearing the practitioner's oral evidence in chief (in addition to his statements), observing his extensive cross-examination, seeing 12 witnesses required for cross-examination, particularly patients on the issue of informed consent, and the benefit of the joint statements of the experts following two expert conclaves. The experts conferred in conference in accordance with the Tribunal's procedural direction on expert evidence and produced a statement of points of agreement and disagreement. The conference is referred to in these reasons as "the Joint Conclave". 3. In accepting the practitioner's admissions, and in assessing the seriousness of the conduct for the purpose of determining appropriate protective orders, we have carefully considered the weight to be afforded to the individual expert reports. This is because the experts' evidence in their individual reports was not fully tested in cross-examination or clarified to the extent that may have been necessary in re-examination. We note the parties advocated for this approach, namely to forgo cross-examination and re-examination, in their oral submissions on 27 November 2020. We have further taken into account the requirements of s 165M of the National Law. That section provides as follows: 165M Tribunal to provide details of decisions [NSW] (1) As soon as practicable after making a decision on an inquiry or an appeal under this Law (bearing in mind the public welfare and seriousness of the matter), the Tribunal must give a written statement of the decision to— (a) the parties; and (b) the Council for the health profession in which the practitioner or student is registered (regardless of whether it is a party). (2) The statement of a decision must— (a) set out any findings on material questions of fact; and (b) refer to any evidence or other material on which the findings were based; and (c) give the reasons for the decision. (3) The Tribunal may also provide the statement of a decision to the persons the Tribunal thinks fit. (4) Unless the Tribunal has ordered otherwise, the Tribunal is to make publicly available a statement of a decision given by it under this section if the decision is in respect of a complaint that has been proved or admitted in whole or in part. (5) This section applies to a decision on an inquiry that is conducted into a complaint referred to the Tribunal under this Law where the subject-matter of the complaint is admitted in writing to the Tribunal. 1. On 27 November 2020 we received into evidence, without objection, a further bundle of documents on behalf of the practitioner. This bundle included various media articles, an affidavit sworn by the practitioner and filed in support of his withdrawal application in March 2020 together with a document prepared by the Cancer Council of Australia about communicating and documenting treatment plans. The bundle also included a number of statements/papers of the Medical Oncology Group of Australia. 2. We also received extensive and helpful written submissions from both parties directed to appropriate protective orders. Definitive and Adjunct Chemoradiotherapy 1. In order to better understand these reasons, it is useful we commence with some agreed facts, and highlight the major issues in dispute about the practitioner's prescribing. We do so by reference to the evidence before us, including the Joint Report following the expert conclave of Dr Stein and Professor Clarke. What is definitive and adjuvant chemoradiotherapy? 1. The majority of the patients the subject of this complaint received chemo-radiotherapy. This term describes treatment which involves chemotherapy and radiation. Chemotherapy is used as a radio sensitiser to enhance the efficacy of radiation treatment. Chemotherapy is administered under the direction of an oncologist and radiation under the direction of a specialist radiologist. Most often, the decision about what type of treatment a patient would receive was made after a multi-disciplinary team meeting (MDT) at a Head and Neck Cancer Clinic. Members of the MDT generally included surgeons, radiation oncologists, medical oncologists, radiologists, registrars, residents, speech pathologists as well dieticians and social workers. 2. There are two main classifications of treatment. The first type of treatment is called "primary chemoradiotherapy". It is also referred to as "definitive chemoradiotherapy". In this treatment mode chemoradiotherapy is used to directly treat and cure the disease. The second type of treatment is known as "adjuvant chemoradiotherapy". This type of treatment is administered after surgery, but where there is a likelihood of recurrence of the disease. Adjuvant chemoradiotherapy aims to improve chances of disease control. 3. There are two main chemotherapy agents that are principally used in primary chemoradiotherapy and adjuvant chemoradiotherapy for patients suffering head and neck cancers. They are cisplatin and carboplatin. These two chemotherapy drugs are at the centre of the majority of the complaints in this matter. Carboplatin, as is cisplatin, is a platinum derivative chemotherapy agent. Both platinum drugs are used with a drug of the fluoropyrimidine class: fluorouracil (fluoropyrimidine), 5-FU or its oral version, capecitabine, as a primary chemoradiotherapy drug. Cetuximbab is another drug used in primary chemoradiotherapy. What are the bases for making a recommendation about chemotherapy? 1. The experts agree that three factors are relevant in determining an appropriate standard of patient care. The treatment recommended consists of a mixture of best evidence, clinical judgment regarding individual patient factors and patient preference. Clinicians have regard to individual patient factors. Individual patients will make decisions or "trade-offs" between toxicity and effectiveness. 2. "Best evidence" is established by large randomised trials or systemic review. Lower level evidence may be used in conjunction with evidence from trials or systemic reviews to determine best practice. 3. It is accepted by each of the experts that large randomised trials establish the effectiveness and toxicity of treatment in a selected population. However, because of patient selection criteria, such trials do not give specific guidance in respect of all patients such as the elderly or for sub-types of cancers such as patients suffering HPV positive HNSSC (P 16+ status). 4. It is in this context that "guidelines" for standards of care are established by the process of peer review and consensus reached after considering all of the evidence. Guidelines make recommendations about preferred treatment choices. Chemotherapy protocols are "recipes" for how to safely administer treatment. They contain some guidance as to treatment selection, but they do not dictate what treatment (recipe) should be used. 5. In Australia, the evidence behind specific protocols has been peer reviewed and combined with advice on how to safely give these treatments. This advice is found in a resource provided by the New South Wales government and known as "eviQ". We discuss the development of eviQ shortly. 6. eviQ is not an exhaustive list of appropriate protocols, but the protocols within it have been through a rigorous review process. 7. The need for adaption of eviQ protocols to individual patient's circumstances is not in dispute. The protocols describe doses that are appropriate starting doses for evidence based practice and provide guidance for when doses need to be reduced. What is an MDT and what is its role in chemoradiotherapy? The composition of the MDT 1. The practitioner in his statement dated 7 December 2018 described the multi-disciplinary team (MDT) at SV. He explains, at para 30, that the MDT comprised surgeons, radiation oncologists, medical oncologists, radiologists, anatomical pathologists, registrars, residents, specialist nurses, speech pathologists, dieticians and social workers. He describes patients "more often than not" being seen by a surgeon or radiation oncologist for review and then referral to the Head and Nick clinic which was a MDT. The application of MDT recommendations 1. Decisions regarding the "philosophy" or policy of treatment (described by the practitioner as "the management plan") are often made at the MDT based on a consensus of members. The MDT, after deliberations at which the patient is not present, may recommend an approach based on maximising the chance of cure, a palliative approach or compromise. The MDT should have a common understanding of the intent of treatment particularly when combined treatments are being administered. Implementation of a treatment plan is the responsibility of the treating clinician. Deviation from the plan may arise as a result of new information, a more specialised assessment or patient preference. Applications to Head and Neck Cancers 1. The experts agree that in HNSCC a large body of evidence has established that the concomitant administration of chemotherapy with radiation results in a small increase in survival. This has been estimated as being in the order of 5-6%. The optimal drug, dose and scheme to achieve this remains unclear. 2. The sum of the evidence, particularly from randomised controlled trials, shows that the addition of chemotherapy increases toxicity, and the toxicity profile depends on the drugs chosen and the dose. In this setting, the "trade-off" between survival and toxicity is one that requires high level expertise and careful consideration of individual patient factors and preferences. 3. The consensus standard of care in HNSCC for concurrent chemoradiation is cisplatin. This is because cisplatin was the predominant drug used in the largest trials to demonstrate efficacy, and there were concerns carboplatin might be less effective. It is recognised, because of increased toxicity associated with cisplatin, that carboplatin is a reasonable alternative. eviQ has both carboplatin and cisplatin based protocols for HNSCC, that is, there is implied peer endorsement of carboplatin when cisplatin is contraindicated. A MDT recommendation of chemoradiation is generally aimed at maximising cure and that the chemotherapy is consistent with that aim, and with practice at other centres. How are recommendations about chemotherapy doses made? 1. The drug doses in a chemotherapy protocol derive from the evidence demonstrating a clinical benefit. Adherence to such doses supports potential treatment effectiveness, but adjustment of doses because of individual patients' factors is standard. The eviQ protocols recommend dosages lower than that used in the clinical trials where there is a consensus of peer-experts that the trial doses were too high. However, dose reductions are associated with the possibility (risk) that effectiveness will be lost. AUC dosing of carboplatin 1. Drug doses are an estimate of the typical dose required. The aim of chemotherapy dosing is to give a predictable exposure to the drug and therefore a predictable effect. Carboplatin is almost entirely excreted by the kidneys so there has been a recommendation since the 1980's that carboplatin doses be adjusted according to renal function (AUC: Area under the Curve) rather than as a fixed dose or one adjusted by patient size (mg/m2). This has become a standard approach to dosing carboplatin. The issue of dose (low versus high) is potentially separate from how that dose is calculated (mg/m2 versus AUC). Application to Head and Neck Cancer 1. As earlier noted, the optimal dosing for platinum drugs in conjunction with radiotherapy has not been determined. The dose is also influenced by the frequency of administration. There is a consensus that the dose intensity is an important issue. Doses of cisplatin (100mg/m2 over 3 weeks or 40mg/m2 weekly) deliver a dose intensity of 33-40mg/m2 per week and are considered appropriate doses of cisplatin as determined by the eviQ protocol. 2. 35 Doses of carboplatin - a single dose (AUC = 6) every 3 weeks or a weekly dose (AUC = 2) - deliver an equivalent dose intensity of AUC= 2 per week and have been considered appropriate doses as determined by the eviQ protocol. At the time under consideration in the complaint, the protocol of AUC = 2 was considered acceptable. We note it was not in dispute that, by the time of the conclusion of the hearing before us, the protocol was withdrawn as having only low level evidence to support it. The dose of AUC=2 weekly was selected for evaluation in clinical trials by Australian experts. There is no clinical evidence to support routine doses lower than AUC = 2. What is the impact of age and HPV positive status (P 16+ status)? 1. Two of the factors considered relevant to modification of a treatment regimen are age and P 16+ status. Age is a relevant factor because the evidence supports the theory that the benefit of adding chemotherapy is reduced with advancing age and toxicity is increased. While there is consensus that age is one of the factors that should be considered, there is not an absolute cut-off. Relevant factors to be considered include a patient's physical condition, co-morbidities or results of a geriatric assessment. 2. HPV positive status is a feature of tumour pathology. HPV positive status is associated with a good prognosis and it is possible that adding chemotherapy in these circumstances is not required. Over the time period of this complaint the consensus was that HPV status alone should not be used as a reason for not giving chemotherapy. Prescribing protocols 1. Prior to 2005 there were, and still are, many prescribing protocols or regimes developed both overseas and in Australia for the administration of chemotherapy drugs. However, there was no widely distributed Australian prescribing protocol for chemotherapy drugs to be used in definitive chemoradiotherapy or adjuvant chemoradiotherapy until 2009 when eviQ was launched. 2. In 2014 the eviQ protocol was launched online. The protocol is described as: eviQ Cancer Treatments Online is a point of care clinical information resource that provides health professionals with current evidence based, peer reviewed, best practice cancer treatment protocols and information. eviQ's primary audience is health professionals, but anyone may access the information on eviQ once they have registered for a username and password. eviQ is designated to meet the needs of Australian clinical environment and supports a busy work flow in any clinical setting. This allows rural, remote and metropolitan health professionals, patients, carers and their families to access the same standard evidence based cancer treatment information. 1. The origins of the protocol are explained in eviQ as follows: In 2004 the Cancer Institute NSW assumed responsibility for an intranet cancer treatment resource that was developed by Professor Robyn Ward and utilised in the South Eastern Sydney Area Health Service. The resource detailed medical oncology and haematology treatment information for medical officers, nurses and pharmacists involved in cancer care and was created to reduce cancer treatment variation and provide patient information on cancer treatments. The Cancer Institute NSW made the resource available as an internet website in August 2005 and named it Cancer Institute's Standard Cancer Treatments Program (CI-SCaT). Due to its popularity and the need for greater functionality and additional content, CI-SCaT was rebuilt and rebranded eviQ Cancer Treatments Online. eviQ was launched in October 2009. 1. The eviQ protocol was incorporated into "MOSAIQ", SV's electronic prescribing system in 2015. 2. In response to a question posed by the HCCC to its expert, Dr Brian Stein, to advise whether the eviQ protocol is considered a guideline only by practitioners, in his first report, Dr Stein explains: Because many chemotherapy drugs have been in routine use for decades there are hundreds if not thousands of chemotherapy regimens or protocols that have been developed and evaluated. In some areas a broad international consensus has developed as to the "reference" regimen(s), in others there are strong data but choice is a regional preference. In yet other areas the data are low quality or conflict substantially and do not allow consensus. eviQ is best considered as a curated selection of regimens from this vast literature. eviQ answers the questions: "What are some regimens used in this disease" "I want to use regimen… What are the doses, how do I administer it, what standard supportive therapies (e.g. anti-emetics) are needed, and what is the supporting data". eviQ does not answer the question "what regimen is best for this patient". 1. It is not in dispute that, for the majority of his patients, the practitioner's prescribing did not adopt prescribing based on published trials or meta-analyses. The practitioner determined that his patients should, for the most part, receive a flat dose of 100mg carboplatin. The practitioner prescribed this regimen on the basis that a patient would suffer less toxicity than with other regimens, and hence would be more likely to complete their radiation treatment. Background 1. The practitioner graduated from the University of Sydney with a Bachelor of Pharmacy degree in 1967. He graduated with an MBBS from the same university in 1974. 2. In 1980 the practitioner became a fellow of the Royal Australian College of Physicians. 3. In 1984 the practitioner was awarded a doctorate degree in pharmacology at Flinders University, South Australia. Thereafter the practitioner held a post-doctoral position for two years at the National Cancer Institute, National Institutes of Health in the United States of America. 4. On his return to Australia from the USA, the practitioner engaged in practice as a pharmacologist and oncologist at the Mater Misericordiae Hospital, Newcastle. 5. In 1989 the practitioner became a staff specialist at Royal Prince Alfred Hospital, Sydney. 6. In 1991 the practitioner became a Senior Staff Oncologist at SV, and took up the post of conjoint Associate Professor of Medicine at the University of NSW. 7. In July 2009, SV adopted the use of eviQ (Evidence + Quality) protocols including protocols for the prescribing of cisplatin and carboplatin based on AUC calculations. There were separate protocols for HNSCC for primary chemoradiotherapy and post-operative (adjuvant) chemoradiotherapy. eviQ at para 1.3 noted "when there is a need to vary an eviQ policy or procedure for local use, the local service will develop an exception business rule". 8. In 2011 the then head of the Oncology department at SV, Dr Dalley, retired. Sometime prior to that date the practitioner took over the care of the majority of the HNSCC patients for their chemotherapy needs. The practitioner asserts he and Dr Dalley discussed the differences in their prescribing philosophy for HNSCC patients. The practitioner asserts Dr Dalley did not oppose him continuing his then practise of administering a flat dose of carboplatin for radio sensitivity rather than the eviQ recommended treatment. 9. On 31 August 2015 the practitioner attended a meeting at SV. He asserts he was told there was no concern about his prescribing, but he was asked, and agreed, to follow the eviQ protocol prescribing recommendations. 10. On 18 February 2016 the ABC's 7.30 television program broadcast a report which raised criticisms of the practitioner's treatment of patients. The practitioner asserts that no criticism of his practices had been raised by SV about his treatment of patients prior to this report. On 2 April 2019 the ABC notified the practitioner it had published the following on its website: On 18 February 2016, the ABC broadcast an episode of 7:30 about oncologist Dr John Grygiel in relation to chemotherapy dosing amounts. Dr Grygiel has complained that some viewers of the broadcast could have understood the ABC as having accused him of having physically harmed patients. The ABC did not intend to convey any such accusation. If any viewer understood the broadcast in that way, the ABC withdraws it and apologises for any harm or distress suffered by Dr Grygiel as a result. Dr Grygiel brought defamation proceedings against the ABC in relation to the broadcast and those proceedings have now been settled on confidential terms. 1. On 19 February 2016 the then relevant official instituted an enquiry under s 122 of the Health Services Act 1997 (NSW) into "Off-protocol prescribing of chemotherapy for head and neck cancers". The enquiry focussed principally on the organisational response at SV to allegations made against the practitioner. 2. On 31 March 2016 an interim report was published by the s 122 Committee. 3. On 26 May 2016, following proceedings under s 150 of the National Law, conditions were placed on the practitioner's registration by the Medical Council of New South Wales. In summary, the conditions required that he prescribe in accordance with the eviQ protocol and practise under "Level C" supervision in accordance with the Medical Council of NSW supervision policy. 4. In July 2016 the University of New South Wales wrote to the practitioner. The practitioner says he was advised he had been "stripped of [his] UNSW Associate Professor title". 5. In August 2016 the practitioner's employment at SV was terminated. 6. The final report of the s 122 Committee was released on 2 August 2016. 7. On 1 November 2016 a second hearing of four hearings of the Parliamentary Select Committee on "Off Protocol Prescribing of Chemotherapy in NSW" was convened. The chair of the Committee explained its purpose was to examine the capability of SV to comply with NSW Health Policy directives and guidelines for staff to raise concerns about the practice of clinicians and breaches of the Code of Conduct at SV. The Committee heard evidence from the practitioner on that day. 8. On 9 November 2019 the practitioner's registration category was changed to that of a non-practising practitioner. 9. On 8 April 2020 the practitioner signed a statutory declaration in which he declared he did not intend to ever practise again, and surrendered his registration on the register maintained by the Australian Health Practitioner Regulation Agency. 10. On 23 March 2020 senior counsel for the practitioner, Mr D Graham SC (Mr Graham), made an oral application for the proceedings to be withdrawn pursuant to Cl 12 of Schedule 5D of the National Law. The presiding member made orders for the filing of written submissions and on 13 May 2020 published reasons for decision dismissing the application (see Health Care Complaints Commission v Grygiel (Termination Application) [2020] NSWCATOD 53). Relevant statutory provisions and principles applicable to disciplinary proceedings under the National Law 1. These disciplinary proceedings are brought under Part 8 of the National Law. The complaint asserts the practitioner is guilty of unsatisfactory professional conduct under s 139B(1)(a) and (b) of the National Law. 2. Section 139B(1)(a) and (b) provide as follows: 139B Meaning of "unsatisfactory professional conduct" of registered health practitioner generally [NSW] (1) Unsatisfactory professional conduct of a registered health practitioner includes each of the following— (a) Conduct significantly below reasonable standard Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of the practitioner's profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience (b) Contravention of this Law or regulations A contravention by the practitioner (whether by act or omission) of a provision of this Law, or the regulations under this Law or under the NSW regulations, whether or not the practitioner has been prosecuted for or convicted of an offence in respect of the contravention. 1. The HCCC also assert, and the practitioner admits, that he is guilty of professional misconduct. Professional misconduct is defined in s 139E of the National Law as follows: 139E Meaning of "professional misconduct" [NSW] For the purposes of this Law, professional misconduct of a registered health practitioner means— (a) unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or (b) more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration. 1. The objects of the National Law which guide and inform the Tribunal are found in ss 3 and 3A. The practitioner, in opposing the orders sought by the HCCC, relies particularly on s 3. Section 3 provides as follows: 3 Objectives and guiding principles (1) The object of this Law is to establish a national registration and accreditation scheme for— (a) the regulation of health practitioners; and (b) the registration of students undertaking— (i) programs of study that provide a qualification for registration in a health profession; or (ii) clinical training in a health profession. (2) The objectives of the national registration and accreditation scheme are— (a) to provide for the protection of the public by ensuring that only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered; and (b) to facilitate workforce mobility across Australia by reducing the administrative burden for health practitioners wishing to move between participating jurisdictions or to practise in more than one participating jurisdiction; and (c) to facilitate the provision of high quality education and training of health practitioners; and (d) to facilitate the rigorous and responsive assessment of overseas-trained health practitioners; and (e) to facilitate access to services provided by health practitioners in accordance with the public interest; and (f) to enable the continuous development of a flexible, responsive and sustainable Australian health workforce and to enable innovation in the education of, and service delivery by, health practitioners. (3) The guiding principles of the national registration and accreditation scheme are as follows— (a) the scheme is to operate in a transparent, accountable, efficient, effective and fair way; (b) fees required to be paid under the scheme are to be reasonable having regard to the efficient and effective operation of the scheme; (c) restrictions on the practice of a health profession are to be imposed under the scheme only if it is necessary to ensure health services are provided safely and are of an appropriate quality. 1. The HCCC place particular emphasis on s 3A in support of the orders sought. Section 3A provides as follows: 3A Objective and guiding principle [NSW] In the exercise of functions under a NSW provision, the protection of the health and safety of the public must be the paramount consideration. 1. It is also useful at this point in our reasons to set out the summary of the scheme and underlying principles relating to protective orders explained by Meagher JA in Health Care Complaints Commission v Do [2014] NSWCA 307 at [34]-[35], as follows: The National Law establishes a registration and accreditation scheme. That scheme, by Div 3 of Pt 8, includes provisions for the making of complaints about registered health practitioners and the determination of those complaints, including in relation to serious complaints, by the Tribunal. The objectives of that scheme, as described in s 3(2), include to "provide for the protection of the public by ensuring that only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered" and to "facilitate access to services provided by health practitioners in accordance with the public interest". The provisions in Pt 8 concerning the making and dealing with of complaints are provisions substituted in the National Law by the Health Practitioner Regulation (Adoption of National Law) Act 2009 (NSW). Section 3A of the Law provides that in the exercise of those functions "the protection of the health and safety of the public must be the paramount consideration". Section 4, which applies to the National Law as in force in New South Wales, also requires that an entity having functions under it "is to exercise its functions having regard to the objectives and guiding principles" set out in s 3. The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It includes protecting the public from the similar misconduct or incompetence of other practitioners and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining those standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operates both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise. 1. The authorities make it clear that protective orders which may be imposed at the conclusion of disciplinary proceedings are not to punish the practitioner but to protect the public (see Clyne v New South Wales Bar Association (1960 104 CLR 186). 2. The HCCC bears the onus of proof in these proceedings. The standard of proof in professional disciplinary proceedings conducted under the National Law and its predecessors has generally been accepted to be on the balance of probabilities, as explained in Briginshaw v Briginshaw (1938) 60 CLR 336. The Full Court of the Federal Court in Sullivan v Civil Aviation Authority (2014) 226 FCR 555 has emphasised that a tribunal, as distinct from a court, is not bound to apply the Briginshaw standard to fact finding. Notwithstanding this observation, we must reflect, in making our findings on the evidence before us, the serious nature of those findings and their consequences. 3. It is appropriate that we also note that the gravity of professional misconduct, if established, is not to be measured by reference to the worst cases, but by the extent to which it departs from proper standards (see Health Care Complaints Commission v Litchfield (1997) 41 NSWLR 630). Matters in issue in these proceedings 1. As a result of the admissions by the practitioner, our task is to evaluate the seriousness of the practitioner's conduct and, informed by the objectives and principles in s 3 and s 3A, determine what protective orders are appropriate. In undertaking this exercise we are guided by the authorities including the exposition of the law by Basten JA in Chen v Health Care Complaints Commission [2017] NSWCA 186 at [18]-[22]. We note in those paragraphs, his Honour explains that all of the powers in Part 8 Div 3 are available. At [20] and [21] his Honour states: There is no category of unsatisfactory professional conduct which is not capable, depending on the circumstances, of giving rise to professional misconduct and hence engaging the power of either suspension or cancellation of registration. The only requirement is that it be "sufficiently serious" to justify such an order, a characterisation which must depend upon an evaluative judgment made by the Tribunal. Some, perhaps all, categories include conduct which may reveal a defect of character as to which the Tribunal may conclude that the person should not be allowed to practise his or her profession unless at some future date the practitioner is able to satisfy the Tribunal that the defect has been overcome. Incompetence or inadequate care may in some circumstances be remediable by specific steps; in other circumstances the Tribunal may be concerned that the carelessness, for example, is such as to cast doubt on the suitability of the person to practise medicine. Each of the criteria for cancellation or suspension may be analysed in this way. Each case will depend upon an evaluative judgment to be made by the Tribunal as to the nature and seriousness of the conduct. It follows that the legislative scheme is inconsistent with the implication of the abstract condition sought to be imposed by the practitioner on the language of s 149C(1). Finally, in determining whether to suspend the practitioner's registration or cancel it, it is entirely appropriate for the Tribunal to take into account the consequences of the order being considered … 1. Basten JA discusses the imposition of a disqualification period at [22]: The fixing of a period within which re-registration may not be sought may be seen to have a twofold operation. On the one hand, it indicates the minimum period within which the Tribunal considers the person should not be able to practise his or her profession; on the other hand, it holds open the possibility that an application for re-registration thereafter will at least be considered. It is entirely proper for the Tribunal to consider all aspects of the possible orders available to it in determining what order to make…. 1. We also note that in determining to impose a period of disqualification, that such an order is not only a protective one but also one of deterrence. This is made clear by Payne JA in Chen at [88]. There his Honour explains: The Tribunal was permitted by s 149C(7) to identify a period of a time during which a re-registration application could not be made. Doing so indicated the seriousness, from the Tribunal's perspective, of the conduct. A practitioner wishing to challenge that period may do so by way of appeal. Contrary to the appellant's submission, a time fixed under s 149C(7) does not necessarily mean that the Tribunal has formed a view that things will have changed by the end of the period which has been fixed. The Tribunal is permitted by s 149C(7) to make clear in its orders the seriousness with which it views the conduct of the practitioner reflected in the complaints which have been proven. Such an order plays a part in the general deterrence reflected by the order. 1. We discern our evaluative task requires that we assess and weigh the following matters to properly determine appropriate protective orders: 1. The practitioner's failure to provide adequate care and treatment for 11 (non HNSCC) patients undergoing chemoradiotherapy for various cancers (Patients M8, M9, M10, S4, S6, W4, W5, W7, W8, W10 and W18). 2. The practitioner's failure to provide adequate information to 52 patients in order that the patients could give informed consent; 3. The practitioner's failure to make and keep adequate records for 52 of the 53 patients, such that he was in breach of the regulation; and 4. The adoption by the practitioner of a standard practice of prescribing a flat dose of 100mg carboplatin for the 33 HNSCC patients particularised in complaint 58 which demonstrated a firmly held view in relation to treatment of HNSCC: 5. (a) resulting in a risk these patients did not receive chemotherapy they were otherwise eligible to receive, and which treatment was supported by published trials or meta-analysis; and 6. (b) the patients did not receive comprehensive advice such that they were able to give an informed consent. (We note the overlap in this sub-particular to the issue of informed consent identified at (2)). 1. For convenience, we will adopt the description used by the HCCC to the matters summarised in (4) as "the standard practice complaint". Technical Papers including peer reviewed papers and expert evidence - an overview Peer reviewed papers 1. We were provided with a significant number of papers, mostly peer reviewed, which were relied on by the experts in support of their reports. The practitioner was cross-examined about his clinical decisions by reference to these papers. 2. We have taken these reports into account, in particular, when evaluating the seriousness of the standard practice complaint. The experts 1. The Tribunal had the benefit of the evidence from three eminently qualified experts (Dr Brian Stein, Professor Stephen Clarke and Professor Richard Fox AM). The experts met in conclave and produced two Joint Reports. We were assisted by their expertise and points of agreement in the Joint Reports. We pause to note the parties agreed that we could place reliance on the Joint Reports in finding the admissions of the practitioner were properly made. 2. As earlier noted, the manner in which this hearing was conducted over three hearing phases and without complete cross-examination of the experts means we must be cautious in any findings we independently make on the incomplete expert evidence before us. We accept the submissions of senior counsel for the practitioner, Mr Graham, that any findings made must be to the relevant standard given the serious consequences of our findings. 3. We therefore preface our comments about the expert evidence by noting the following matters about which they agree: 1. the lack of any definitive clinical trial examining the efficacy, or otherwise, of a flat dose of carboplatin 100mg x 6 as a radiosensitiser in definitive or adjuvant chemoradiotherapy and acceptance of the fact that it is unlikely such a trial will ever be conducted because of expense and lack of utility; 2. that participants in clinical trials are selected on the basis of age and health status and are not representative of all patients who are the subject of these complaints; 3. the weight to be given to clinical experience, noting the experts agreement about the practitioner's extensive clinical experience; and 4. the reliance or weight to be placed on prescribing protocols (evidence based medicine), in particular eviQ, and when there should be departure from such protocols. 1. It is important also that we note at this point this is not a case where a small number of oncologists in Australia have adopted a course which is different to that of the mainstream oncology profession (see Don Nai Hsi Huang v Walton (NSW Court of Appeal, 30 April 1993, unrep); Childs v Walton [1990] NSWCA 41; Qidwai v Brown [1984] 1 NSWLR 100). The practitioner acknowledges that, so far as he was aware, he was the only practitioner in Australia at the relevant time prescribing a flat dose of 100mg carboplatin, although the practitioner said the practice had been common in the 1980's in other centres, including at Royal Prince Alfred Hospital. Separate answers to conclave questions undated received 5 March 2020 1. The parties' legal representatives independently framed questions to be considered by the three experts in conclave. The lawyers asked that the experts address eight topics and answer fourteen questions. Annexed to these reasons and marked "Appendix B" are a list of the topics the experts were asked to address as well as the list of questions posed to them. 2. In the earlier conclave held between Professor Clarke and Dr Stein, a similar list of topics and questions were posed to these two experts as those listed in Appendix B. 3. Although Professor Fox noted in his report dated 13 December 2019 that he agreed with the views of Professor Clarke, he provided separate answers to the questions posed to the three experts for the purpose of the conclave. The joint expert reports following the expert conclaves 1. A first Joint Report in two parts was provided by Dr Stein and Professor Clark and dated 22 August 2020. 2. Following the first joint conclave, Dr Stein and Professor Clarke each provided answers to the fourteen questions posed to them. They note that in a separate document they have set out their points of agreement and disagreement. We have not attempted to summarise Dr Stein's separate replies to the practitioner's evidence nor to Professor Clarke's report given the experts' points of agreement/disagreement. 3. We note the experts agree on a number of matters including the following which are directly relevant to the complaint. They recorded: 1. "First, we would like to say that we do not think there is any evidence on the balance of probabilities that any patient was harmed by the treatments administered by the practitioner …"; 2. "We also felt [the practitioner's] letters indicated a caring attitude towards the patients and the use of reduced doses was probably aimed at reducing toxicity rather than due to ignorance, laziness or disregard for the patients' well-being" 3. if the practitioner wished to evaluate differing schedules of treatment, this would have been better done in the circumstances of a phase II clinical trial; 4. that the practitioner has "probably the single greatest experience of any Australian Medical Oncologist after over 20 years of travelling to Bathurst and Orange clinics". The experts noted issues and difficulties associated with treating patients in a rural setting. 5. that guidelines alone should not be considered the standard way of prescribing chemotherapy, but rather they should be used as a treatment template adjusted by the clinician based on their experience, clinical features of the patient and circumstances of the treatment administration; 6. compliance with guidelines should not be used as an indicator of treatment adequacy; 7. the practitioner's treatment of patients was below standard; 8. that the evidence for informed consent and in depth discussion of treatment was generally lacking in the information provided; 9. patients were not treated in accordance with standard protocols; 10. treatments were adjusted to reduce the potential of toxicity; and 11. both treatment efficacy and risk of toxicity need to be considered and balanced. 1. In dealing with the points of disagreement, Dr Stein and Professor Clarke prefaced their comments noting disagreements reflect different backgrounds and training and that "they have different expectations of what the standard expected is". Reference is made to points of disagreement in their individual reports and it is noted that not all points of disagreement are covered in the joint statement. 2. The two experts are in disagreement about: 1. outcome data being reliable indicator of effectiveness of therapy; 2. carboplatin v cisplatin efficacy (they agree there are limitations in the studies); 3. whether carboplatin 100mg is acceptable as a standard or routine treatment for a significant proportion of patients in the original complaint (Professor Clarke's opinion is that this is below standard but not significantly below. Dr Stein maintains this treatment is significantly below the standard expected); 4. whether low dose capecitabine chemoradiotherapy is acceptable as standard treatment offered to a significant proportion of patients (Professor Clarke's opinion is that this is below standard but not significantly below. Again, Dr Stein maintains this treatment is significantly below the standard expected); 5. whether low dose capecitabine chemotherapy in the adjuvant setting is acceptable as standard or routine treatment offered to a significant proportion of patients (again Professor Clarke opines the adjustments and dosage schedule to be below standard, but not significantly below. Dr Stein, although accepting the treatment will be better tolerated, concludes that dose intensity is critical). 1. Ultimately the two experts reached agreement that the practitioner's treatment of patients was below standard, but Professor Clarke did not share Dr Stein's opinion that it was significantly below standard. The two experts reached a similar conclusion about the practitioner's documentation and consent process. 2. A second Joint Report was prepared by Dr Stein, Professor Clarke and Professor Fox dated 5 March 2020. That report repeats matters set out in the first joint report, and the three experts provide additional comments, in particular Professor Fox explains his view that the practitioner's use of reduced doses was aimed at reducing toxicity 3. The experts produced a table to demonstrate the benefits of the addition of chemotherapy to standard treatment. We now reproduce this table: 1. The three experts include a note on post-operative HNSCC chemoradiotherapy and explain that "it is generally accepted that the benefit is largely confined to patients with positive margins or extra-capsular spread (ECE+) from lymph nodes". They also record that "Patients who were not in the high-risk group derived no benefit". 2. In noting the points of agreement and disagreement, the experts added Professor Fox's comments to those set out in the first joint report. 3. Professor Fox is noted as agreeing with Professor Clarke that the treatment was below the standard expected but not significantly below. Professor Fox opines that the general benefit of adjuvant chemotherapy added to radiation to be "of very dubious benefit". 4. Professor Fox also agrees with Professor Clarke that it was difficult to ascertain whether consent discussion was adequate because of lack of documentation. Again, Professor Fox agrees with Professor Clarke that the practitioner's documentation was below standard, but not significantly below standard. 5. The experts agree that it is appropriate to consider the treatment received by various patients in groups. 6. The experts all agree that neither they nor any other medical oncologists know what the optimal drug and/or treatment and/or schedule of chemoradiotherapy is. 7. The experts agree that the dose of carboplatin was unusual, that it did not make sense to use a flat dose "as it is the one chemotherapy drug for which we have a simple and reliable means of controlling variations in blood levels", and that they believe the practitioner should have used AUC. Professor Clarke repeats his concerns about the non-use of AUC because of the potential to overdose in patients with renal impairment. However, Professor Fox is noted to be of the view that use of the flat dose was reasonable based on the data of Eckhart et al. 8. The experts record that taking renal function into account and converting to AUC doses or mg/m2 doses the dose does overlap with doses tested in early phase trials. However, they note caveats to those trials (small number of patients treated, and the trials did not compare chemoradiotherapy with radiotherapy alone with the result that efficacy or toxicity cannot be estimated). 9. The experts agree that the dosing of capecitabine was unusual. They agree that they would not object to using dose bands or similar techniques such as body surface area ("BSA") dosing. The experts note that such dosing would be "substantially higher" than those used by the practitioner. They also note that the doses used in chemoradiotherapy do overlap with doses uses in early phase trials, but note that the trials involved a small number of patients treated with the same dose of radiation and increasing doses of chemotherapy. The aim of the trials was to assess tolerability of treatment. The experts explain that the trials did demonstrate similar doses to those used by the practitioner. However, the trials did not directly compare chemoradiotherapy with radiotherapy alone with the consequence that the overall result (either efficacy of toxicity) cannot be determined. 10. The experts' further note that low dose capecitabine has not been directly demonstrated to be better than radiotherapy alone "although differences have been small in all evaluated settings to date". 11. The experts agreed that the doses of capecitabine used in adjuvant therapy were below those usually initiated. Dr Stein opined this was "highly significant". In the opinion of Professor Clarke and Professor Fox there is only a small difference. 12. The experts also observe that lower doses of capecitabine were administered in a rural setting where there may have been concerns about local abilities to manage toxicities. They note, however, this was not clearly documented in the available patient records, nor was there evidence it was discussed with the patient. 13. The experts also observe that the rationale for choosing "this dose" (of carboplatin or capecitabine) for patients was not clearly articulated either in contemporaneous notes or subsequently. 14. We pause to observe that the experts conclude their Joint Report by highlighting two issues. First, they discuss the consent process and set out what they "ideally" would like to see. Secondly, they deal with the topic of governance noting that they were not tasked to specifically examine this topic, but explaining they considered it important. 15. We appreciate that the experts, who have invested significant professional time to assist the Tribunal, wish to use these proceedings to raise standards of practice and to ensure adequate resources are provided to patients from rural areas to ensure they receive comparable treatment if practitioners working in those areas are to be held to the same standards as those practising in major cities. 16. The issues raised by the experts are significant and important. However, it is not our task in these disciplinary proceedings to conduct an investigation of hospital governance or to make recommendations about the allocation of health resources, rather we are required to address the complaint agitated by the HCCC and admitted by practitioner. 17. At the end of the second Joint Report the experts discuss their areas of disagreement. They note: 1. Professor Clarke and Professor Fox regard outcome data as a reliable indicator of the effectiveness of the practitioner's treatment. Dr Stein is noted to have significant reservations. 2. In considering cisplatin vs carboplatin efficacy they agree data is limited by heterogeneous studies sometimes using poor methodologies. Dr Stein maintains on the basis of probabilities that carboplatin is inferior. Professors Clarke and Fox considering in weighing the evidence there is not enough (data) to conclude inferiority. 3. Professors Clarke and Fox opine that the relative effectiveness of carboplatin monotherapy with radiation is equivalent or not significantly different to cisplatin monotherapy; Dr Stein opines on the balance of probabilities carboplatin is inferior. 4. Dr Stein maintains his position that there is a lack of direct evidence to support a flat dose of 100mg carboplatin and that this is significant. Professor Clarke maintains that the dosage was below standard but not significantly so "because 100mg carboplatin is not so different from other schedules with demonstrated effectiveness". He confirms his support for AUC dosage (as earlier noted in these reasons). Professor Fox opines a flat dose was acceptable and relies on the Eckhart et al but otherwise agrees with Professor Clarke. 5. Professor Fox agrees with Professor Clarke's earlier expressed opinion that low dose capecitabine chemoradiotherapy as standard or routine treatment was below standard but not significantly below standard. Dr Stein again disagreed with this position. 6. Professor Clarke and Professor Fox agree that the low dose of capecitabine therapy in the adjuvant setting as routine treatment was below standard but not significantly below. By contrast, Dr Stein regards the retrospective evidence in a number of malignancies including colon and rectal cancer that dose intensity is critical. He opines the dose reductions resulted in inferior treatment. He accepts however that the treatment will be "better tolerated". 1. Overall, there is no difference in the conclusions reached by Dr Stein and Professor Clarke and documented in the first Joint Report, and the differing conclusions of Dr Stein on the one hand and Professor Clarke and Professor Fox on the other in the second expert report. 2. The major point of difference between the experts is whether the conduct is below standard or significantly below the expected standard. There is no doubt that to satisfy the definition of unsatisfactory professional conduct under s 139B(1)(a) it was necessary for us to accept the practitioner's concession that the practitioner engaged in conduct that demonstrates his knowledge, skill or judgment possessed was significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience was an appropriate one. 3. It is abundantly clear from the practitioner's curriculum vitae that, at the time of these complaints, he was a very senior, widely experienced and credentialed practitioner and the author of many published papers. Thus, his conduct had to be assessed against that of his like peers. It is not suggested that the practitioner was unaware of prescribing protocols including eviQ and we accept that he discussed his prescribing philosophy with Dr Dalley. We do not consider this is a case where the practitioner's knowledge is called into account. Rather, what is in issue is his clinical judgment, the care he exercised in prescribing and what was reasonably expected of him. 4. We turn then to the meaning to be attributed to the word "significantly" in the context of the relevant statue (the National Law). In carrying out this task we have taken into account the principles of statutory construction (see DC Pearce and RS Geddes, Statutory Interpretation in Australia (LexisNexis Butterworths, 8th ed., 2014) and the comments of the High Court in Project Blue Sky v Australian Broadcasting Authority (1998) 194 CLR 35 at [384] per McHugh, Gummow, Kirby and Hayne JJ: to give the words of a statutory provision the meaning which the legislature is taken to have intended them to have. 1. We commence by examining the ordinary and natural meaning of the word "significantly". Significant is defined in the Macquarie Dictionary as follows: adjective 1. important; of consequence. 2. expressing a meaning; indicative. 3. having a special or covert meaning; suggestive. –noun 4. Obsolete something significant; a sign. [Latin significans, present participle, signifying] –significantly, adverb adjective 1. important; of consequence. 1. In Health Care Complaints Commission v Lucire, Basten JA at [83] refers to the situation where a different standard of care is adopted by a respectable minority of the profession and the standard generally accepted by reputable and experienced practitioners. His Honour noted however that the practitioner in that case did not seek to justify her treatment on the basis it was acceptable clinical judgment that would be adopted by a reputable minority of the profession. Nor we note is it suggested in this case that the practitioner was acting in accordance with a reputable minority of the profession. 2. We note that in Don Nai His Huang v Walton (Court of Appeal (NSW) 30 April 1993) Kirby P as his Honour then was said: The conduct of a medical practitioner does not, within s27(1)(a) of the Act, demonstrate a lack of adequate knowledge, experience, skill, judgment or care in the practice of medicine, simply because a course of therapy is embarked upon which does not conform to a given professional norm. So long as the practitioner is acting lawfully and conscientiously and is pursuing, in the treatment of his or her patient, a "respectable, though minority, view" in such treatment, no misconduct exists as will attract discipline under the law [citations omitted] In Childs v Walton, as the Tribunal itself noted, Samuels JA said at 10): A departure from a generally accepted procedure does not necessarily constitute professional misconduct. There may be different schools of medicine and disputes between them. Adherence to the practice of a minority group does not alone entail professional misconduct 'Every innovation has to be performed for a first time. That something has not been done is not proof that it ought not to be done' (per Hutley in Qidwai at 1010). 1. We further observed, although not appearing in the definition of unsatisfactory professional conduct in s 139B(1)(a), experts are regularly asked to say whether, in their view, the conduct under discussion attracts their "strong" criticism. Basten JA at [84] in Health Care Complaints Commission v Lucire explains the foundation of the use of the adjective "strong" noting that former "somewhat archaic statutory language" in earlier decisions referred professional misconduct attracting "strong reprobation". His Honour goes on to note: Whether such language in the reports was intended to imply sufficiently serious conduct to warrant a finding of professional misconduct is unclear. It was, in any event, sufficiently adverse to support a conclusion of departure from reasonably expected standards, so as to warrant a finding of unsatisfactory professional conduct. 1. Thus, we conclude to reach the threshold of conduct that is significantly below the standard reasonably expected, the conduct must be of an important kind or departure from accepted standards or conduct that has consequences. It must be not conduct that is merely somewhat less than the ideal or the norm. Consequently, the conduct in question must be objectively assessed and, generally, if it is to satisfy the definition of professional misconduct, attract a peer's strong criticism such that it satisfies the definition in s 139E of the National Law. The practitioner's evidence 1. The practitioner now relies on his Reply filed in response to the complaint. He earlier relied on an Interim Reply dated 3 August 2018, a Reply dated 7 December 2018 (the first Reply), and his specific replies to particulars asserted in respect of Patients M1-M10, S1-S28, and W1-19. We mention these earlier replies in the context of a submission by the HCCC that in evaluating the seriousness of the complaints we should have regard to the late admissions by the practitioner in respect of his now admitted conduct. 2. We consider the HCCC's submission on this topic must be treated with some care. First, the admissions now made by the practitioner are to a substantially different complaint to earlier complaints. Secondly, at the commencement of the proceedings in 2019 the HCCC had only shortly prior to the hearing disclosed the report it had obtained from Professor Fox in 2017, and thirdly we do not know the basis of the negotiations which led to the filing of the complaint now before us and the consequent admissions by the practitioner. 3. We do, however, consider aspects of the practitioner's earlier Replies have some relevance to our evaluative task and in particular to whether his treatment of the patients in the standard treatment complaint demonstrates a firmly held view about prescribing for HNSCC patients. 4. The practitioner in his Interim Reply denies the complaints, and in respect of a number of patients, does not admit that he contravened the regulation. He does not dispute the background to the complaints for the majority of the complaints, and for some (for example, Patient S25) he acknowledges the "Background is agreed in principle". 5. The practitioner also relies on a statement dated 7 December 2018 with his Curriculum Vitae annexed. Annexures to his statement are the replies to the particulars asserted in respect of each patient in the earlier complaint. 6. The practitioner commences his statement with the following explanation: I have devoted my entire career to the ethical treatment of cancer patients. I very much regret the distress my patients have suffered as a result of the publicity surrounding this inquiry. I have always provided the best clinical management for each patient I have treated. I have always been open and honest in my discussions with my patients, their families and my colleagues concerning proposed treatment. 1. The practitioner was extensively cross-examined by Ms Stern, over four days in August 2019 (8 August 2019, 9 August 2019, 12 August 2019, and 13 August 2019). On 13 August 2019, after the practitioner had been cross-examined about his treatment of twenty-four patients, senior counsel for both parties advised agreement had been reached to conclude the practitioner's cross-examination. Ms Stern submitted there was "relatively little dispute as to the basic facts" [transcript 13 August 2019 p 629], that there was difficulty in ascertaining the practitioner's knowledge at the relevant time, and why he used one medication rather than another was based on reconstruction by reference to the records. It was further submitted by Ms Stern that the record keeping claim would stand or fall on the documents. Finally, it was asserted that issues relative to informed consent were "probably inevitably based on reconstruction". 2. Mr Graham supported curtailing the cross-examination on two bases. First, concerns about the practitioner's stamina in terms of going forward, and secondly that there was a lack of utility in canvassing each patient when similar evidence would be given. 3. The Tribunal determined, as a matter of procedural fairness, that the practitioner should be cross-examined about the remaining patients who gave evidence on the issue of informed consent, (S16, 18 and 22) and those patients in the WH cohort (patients W5, W6 and W8) about whom Professor Clarke did not express an opinion. 4. At para 5 of his statement, the practitioner repeats in substance evidence he gave to the select committee. He explains that he "has practised medicine with the following guiding principles in mind: Firstly, my clinical practice has always been for the best interest of each of my patients. Secondly, I believe that the most effective treatment is based on a combination of scientific evidence and clinical judgment. Thirdly, it is important to distinguish chemotherapy as a radio-sensitiser and as a tumouricidal therapy. When treating head and neck patients it is intended as a radio-sensitiser and not to kill cancer cells, which is the purpose of radiotherapy. Fourthly, the guidelines are important but the weight given to the guidelines depends on the level of scientific evidence behind them. Fifthly, in the cases that have prompted this inquiry (and now the Complaint before NCAT) there is no evidence that the guideline dose would have led to a better outcome. Indeed, in many cases I believe it could have had a negative impact as it would have discouraged patients from continuing treatment due to the adverse effects of increased toxicity." 1. At para 9 of his statement, the practitioner explains that, for the majority of patients with breast, bowel and gastro-oesophageal cancer, where doses were tumouricidal (to kill cancer cells) it was his practice to treat those patients with doses consistent with the eviQ protocol. 2. In relation to the role of chemotherapy in head and neck cancers, the practitioner at para 10 of his statement explains: The role of chemotherapy is to sensitise the area to make the radiotherapy more effective. Then, as now, there were studies, which showed a very modest advantage in overall survival of patients treated with chemo-radiotherapy, compared to those treated with radiotherapy alone. 1. The practitioner explains there are two primary chemotherapy drugs used to treat head and neck cancer patients (including those who are inoperable) namely carboplatin and cisplatin. The practitioner says that carboplatin "which is a less toxic drug" in his experience is more commonly used in Australia, and cisplatin "which is far more toxic" is favoured in the United States. 2. At para 14 the practitioner says: Both drugs can be toxic. Higher doses can lead to counterproductive side effects including infection, death, renal failure, and pain or bleeding. The role of an oncologist is to balance the efficacy of the chemotherapy dosage with acceptable side effects in the patients. There is a perception (although not clearly proven in any clinical trials) that Cisplatin is a more effective sensitiser than Carboplatin, although given its increased systemic toxicity it cannot be appropriate for all patients. 1. The practitioner also says that, due to the lack of definitive trials, the optimum dosing for carboplatin for head and neck cancers is not known and is subject of debate within the profession. He further asserts that prior to the "Area Under the Curve" (AUC) era, a flat dose of 100mg carboplatin was used across Australia". 2. The practitioner states his rationale for prescribing 100mg flat dose carboplatin in para 16 of his statement, where he says: There is no evidence that a 100mg dose of Carboplatin is in any way inferior as a radio-sensitiser than other doses of Carboplatin used in clinical trials with radiotherapy 1. At para 20, the practitioner explains that he saw no need to increase the dosage of carboplatin from 100mg to AUC "in circumstances where was no evidence that this would increase the efficacy of treatment, but would increase the side effects my patients suffered". 2. The practitioner earlier, at para 19, highlights part of the eviQ protocol as follows: 'There is limited evidence for this protocol, but it is reasonable practice when Cisplatin contraindicated.' 'Outcomes were similar with the Carboplatin and Cisplatin arms, however the small cohort size precludes drawing any conclusions about the relative efficacy of the 2 platinum compounds in this setting.' [practitioner's emphasis] Patient identification 1. During the course of the proceedings, to protect the privacy of the patients, an order was made prohibiting the publication of the names of the patients. The patients who were treated at MUH are identified by the prefix M, those treated at SV are identified by the prefix "S", and those who were treated in the WH area (at Orange or Bathurst Hospitals) are identified by the prefix "W". Inappropriate treatment of the cohort of non HNSCC patients 1. The practitioner admits his care and treatment of the 11 identified patients (M8, M9, S4, S6, W4, W5, W6, W7, W8, W10 and W18) was significantly below the expected standard. 2. We commence our discussion of this topic (and the other three identified topics) by referring to the unusual circumstances in which we are now asked to determine the relevant protective orders. As earlier noted, on 23 November 2020, we accepted on the evidence which had been adduced before us in this then part-heard matter, that the practitioner's admissions in his Reply were appropriately made. 3. This was not a matter, as is often the case, that prior to the Tribunal commencing an inquiry into a complaint, admissions had been made in writing so that the Tribunal could determine not to conduct an inquiry into a complaint (see s 165H). In such a case the Tribunal's sole focus is on making appropriate protective orders having regard to the seriousness of the admitted complaints. 4. In this case, unusually, we commenced the conduct of the inquiry into the complaint, heard evidence from lay witnesses particularly patients required for cross-examination as well as the practitioner. As earlier noted, the HCCC sought that we deal with the complaint under s 149 of the National Law. That section provides as follows: 149 Powers may be exercised if complaint proved or admitted [NSW] The Tribunal may exercise any power conferred on it by this Subdivision in relation to a registered health practitioner or student if— (a) it finds the subject-matter of a complaint against the practitioner or student to have been proved; or (b) the practitioner or student admits to it in writing to the Tribunal. 1. We were not directed to any authority except Health Care Complaints Commission v Jamieson about necessary findings, nor were any submissions addressed on the requirements of s 165M. 2. It appears to us that, as we commenced hearing the inquiry into the complaint, albeit the hearing was curtailed, that we are bound to comply with the provisions of s 165M. Accordingly, we will now set out our findings about the four categories into which the complaints are now agitated, and thereafter discuss how the practitioner's admissions and our findings should be evaluated to determine appropriate protective orders. In conducting this exercise we are explaining why we agree that the practitioner's admissions are properly made. The eleven clinical complaints The HCCC's submissions 1. The HCCC's submissions in respect of the clinical complaints highlight the fact that some patients "received a dose of chemotherapy that was significantly below that established to be effective" and specific reference is made to Patient W18. It is also submitted that some patients received a chemotherapy regimen where there was no published data to support its use (namely Patient M8, M9, M10, S4, S6, W4, W5, W7 and W8). It is further submitted that: a subset of those patients received that regimen in circumstances where a high-evidence regimen (that is, a regimen based on large scale clinical trials or meta-analysis of trials) were (sic) not contraindicated, as in the case of Patients M8, W4, W5 or where systemically active doses of chemotherapy ought to have been prescribed 1. The submissions advance the proposition that the prescribing of an untested regimen (when a tested regime supported by published clinical trials and or meta-analysis was available) and without advice to the patients that the proposed treatment was untested "ought properly to be categorised as a serious breach of the professional and ethical obligations to which [the practitioner] was subject". The submissions on behalf of the practitioner 1. We commence by noting the submissions on behalf of the practitioner assert, after the abandonment by the HCCC of a claim of improper or unethical conduct, that the gravamen of the complaint now before us is "about consent". It is submitted that the practitioner's concession of professional misconduct must be viewed in the context of the cumulative effect of his failures. But it is submitted: However, any consideration of the relative gravity of that professional misconduct and appropriate protective order cannot be fairly assessed without giving full consideration, and weight, to the context in which the failures occurred. [original emphasis] 1. In addressing the 11 clinical complaints the practitioner's submissions at para 5 focus on: 1. the limited efficacy of all chemotherapy regimens when used as a radiosensitiser; 2. insoluble problems with the scientific studies in the area; 3. the systemic issues at play in the consent process for patients in the head and neck MDT setting; 4. the systemic challenges faced by a fly-in, fly-out specialist in delivering oncology services in rural NSW. 1. It is submitted on behalf of the practitioner that we should first have regard to the limited oral evidence given by the experts, an assertion that Dr Stein made "telling concessions", and that we should give significant weight to the evidence of Professor Clarke in his oral evidence which was consistent with his expert report. The eleven patients Patient M8 1. The background information set out in the complaint is not subject of challenge. The complaint records: Patient M8 was diagnosed with SCC of the oesophagus in 2010. Patient M8 was 71 years of age at the date of diagnosis. Patient M8 was referred to the Practitioner for concurrent radiotherapy with chemotherapy in or about September 2010 1. The clinical particulars asserted in respect of this patient are: Complaint Eight A 1. The practitioner failed to provide appropriate care and treatment to Patient M8 in that he prescribed Patient M8 with a flat dose of 100mg Carboplatin on six occasions between 29 September 2010 and 3 November 2010 inclusive in circumstances where: (a) there was no published data supporting the use of a flat dose of 100mg Carboplatin; (b) a high-evidence regimen was not contraindicated; (c) Patient M8 had a very high risk of systemic disease, that is, there was a high risk the disease could spread throughout the body, if it had not done so already; (d) a regimen with systemic activity, for which there was high evidence that such treatment would achieve clinically relevant results, was not contraindicated. 2. The practitioner failed to obtain adequate and informed consent from Patient M8 for the prescribed chemotherapy regimen in circumstances where: (a) the Practitioner failed to advise Patient M8 prior to chemotherapy of the lack of any published data supporting a flat dose of 100mg Carboplatin as a single agent in the context of oesophageal cancer; (b) the Practitioner failed to advise Patient M8 adequately or at all of the availability of alternative treatment options or the relative efficacy of those alternative treatment options. The practitioner 1. The practitioner initially denied failing to provide appropriate care and treatment for this patient but now admits this complaint. In his first Reply he admits he prescribed a flat dose of carboplatin 100mg on six occasions in late 2010. He also notes that the eviQ guidelines for definitive treatment of oesophageal cancer involve concurrent chemoradiotherapy with cisplatin and 5-FU. 2. In answers posed to him in cross-examination, the practitioner defended his prescribing. He emphasised the patient's physical condition (low weight and kyphoscoliosis). We note that on 11 March 2011 Dr Cooper wrote to Dr Henry Hook and recorded that Patient M8's weight had increased by one or two kilograms to 43kg. The expert evidence Dr Stein 1. Dr Stein notes Patient M8 had very advanced oesophageal cancer with significant obstruction requiring a stent. He explains: In these circumstances where the patient has a very high risk (if they do not already have it) of systemic disease the decision to use a regimen without systemic activity goes against the principle of treating in accordance with the natural history of the disease. Dr Stein goes on to explain: The decision to use carboplatin per se is acceptable, but carboplatin as a single agent is below the standard (but does not attract my strong criticism), and when used in a low dose with the intent of avoiding any significant systemic exposure falls significantly below the standard and it attracts my strong criticism as per part 1 section C 3.5. Professor Clarke 1. Professor Clarke in the table to his report notes that Patient M8 was probably incurable, and notes that she was approximately 40kg at diagnosis. He opines that the treatment was palliative, was appropriate in the circumstances, and does not attract his criticism. Joint expert reports 1. In the Joint Report Dr Stein and Professor Clarke note in the table provided that it is unclear to them whether the patient was palliative. They state the patient's disease appears incurable with bilateral nodes, but that the patient was given intensive radiotherapy schedule typical of curative therapy. Consideration Patient M8 1. We are satisfied that, on the evidence before us, the practitioner's concessions about this patient's treatment are appropriately made. We concur with and adopt Dr Stein's opinion that this patient should have received treatment with systemic activity. In reaching this and other findings, we observe that this Tribunal is a specialist tribunal and as such able to bring its own expertise to the assessment process (see Health Care Complaints Commission v Fraser [2014] NSWCATOD 29 at [238]). This fact is particularly relevant in the circumstances of this inquiry where the expert evidence was not subject to completed cross-examination. 2. As we discuss later, we accept that this patient was not afforded the opportunity to decide on availability of alternate treatment options or about the lack of published data supporting a flat dose of carboplatin as a single agent in the case of oesophageal cancer. Patient M9 1. The unchallenged background facts about this patient are: Patient M9 was diagnosed with metaplastic breast cancer in November 2010. Patient M9 was 55 years of age at the date of diagnosis. On 15 November 2010, Patient M9 had a left mastectomy. In or about December 2010, Patient M9 was referred to the practitioner for adjuvant chemoradiotherapy treatment. Patient M9 is now deceased. 1. The clinical particulars now asserted in respect of this patient are as follows: Complaint Nine A 1. The practitioner failed to provide appropriate care and treatment to Patient M9 in that he prescribed a flat dose of 100mg Carboplatin as a single agent on six occasions between 6 January 2011 and to February 2011 inclusive in circumstances where: (a) there was no published data supporting the use of a flat dose of 100mg Carboplatin; (b) Patient M9 presented with very high risk features for failure of treatment locally (in the breast) and throughout the body (systemic); (c) the prescribed regimen is predicted to have low systemic activity, that is, it was not effective in treating systemic disease. 2. The practitioner failed to obtain adequate and informed consent from Patient M9 for the prescribed chemotherapy regimen in circumstances where: (c) the practitioner failed to advise Patient M9 that there is no published data supporting a flat dose of 100mg Carboplatin as a single agent in the context of breast cancer; (d) the practitioner failed to advise Patient M9 adequately or at all of the availability of alternative treatment options or the relative efficacy of those alternative treatment options. The practitioner's evidence 1. In his first Reply the practitioner refers to the "characteristic specific to Patient M9 was her extremely rare diagnosis of metaplastic breast cancer which does not have evidence based pathways for adjuvant chemotherapy treatment". He also states: I was unsure as to whether systemic chemotherapy would assist as metaplastic breast cancer is actually squamous cell carcinoma which does not have oestrogen or progesterone receptors and has normal HER-2 expression. …. Patient M9 had large primary tumour and 13 out of 15 nodes involved with metastatic disease at time of regional operation. It was thus a very difficult case, which involved balancing competing factors. These factors would predict for a likelihood of systemic spread. Whilst there was no evidence that adjuvant systemic chemo would reduce the risk of recurrence of this disease there was experience of likelihood of local recurrence of chest wall necessitating adjuvant radiotherapy, Whilst I was pondering the role of systemic chemotherapy it was decided to administer 6 weeks of adjuvant radiotherapy with low dose Carboplatin as a radiosensitiser. Following completion of this radio adjuvant therapy she then went on to have 6 cycles of FEC system chemotherapy in the hope that this might reduce the risk of disease recurrence. 1. In his oral evidence the practitioner explained the circumstances in which he remembered this patient and her husband. He related that in his conversations with the patient and her husband he said would conduct research of the literature "to make sure things had not changed about the treatment of – about the adjuvant treatment of metaplastic breast cancer" and because this would take some time it was decided to "give some chest wall irradiation to try and prevent localised recurrence". That evidence is confirmed in a letter to the HCCC from the late Patient M9's husband. 2. In answer to questions posed by Professor Links the practitioner explained he had not discussed the patient's treatment with a breast MDT because to the best of his recollection there was no MDT available in Orange at the time. However, he said he consulted colleagues at SV in medical oncology and that he was advised by Dr Richard Epstein and Dr Dalley that this "was an evidence free zone, the idea that chemo – adjuvant chemotherapy had any beneficial role" [transcript 12 August 2019 p 561]. The expert evidence Dr Stein 1. In his first report Dr Stein notes disease such as Patient M9's is uncommon and the outcome is generally poor. 2. Dr Stein opines that "using general principles of therapy for breast cancer it would be reasonable to offer systemic therapy and adjuvant chest wall and supraclavicular radiation therapy". He goes on to explain that, in his opinion, the choice of carboplatin per se was reasonable, but that the choice of a single agent was significantly below standard and attracts his strong criticism. He notes the patient did receive a systemically active regime, but this was "later in the piece". He explains: There is data demonstrating the importance of early systemic therapy in breast cancer: outcomes were superior if chemotherapy was given prior to radiotherapy rather than after. Whilst one could defend the decision to embark on a chemoradiotherapy program given the concern for local recurrence, the decision to use radiotherapy without a systemically active regimen was on the balance of probabilities an inferior choice [foot-note omitted] Professor Clarke 1. In the table to his report, Professor Clarke very appropriately notes that this patient's condition and treatment are outside his "comfort zone". He does note the uncommon nature of the patient's tumour. Having recorded that the patient suffered recurrence of her disease, Professor Clarke says "This probably provides greater insight about the type of tumour rather than the treatment received as local failure and RT portends a bad prognosis". Professor Clarke refers to the patient's subsequent treatment as "a standard breast cancer protocol". Professor Fox 1. Professor Fox was not requested to provide an opinion about this patient. The first joint report 1. In reply to the questions posed to the experts, Dr Stein referred to M9 being in the group of patients "for whom any chemotherapy was a dubious proposition". He opined the treatment proposed no better outcome but a risk of increased toxicity. The second joint report 1. The experts to do not specifically comment on Patient M9 in the report. Professors Clarke and Fox however include this patient in a group noted as "Miscellaneous". Consideration Patient M9 1. We prefer and accept Dr Stein's opinion about this patient's treatment. That opinion accords with the practitioner's concession about his treatment of this patient. 2. We accept the practitioner's evidence that he had a clear recollection of this patient and seeing her with her husband. The patient's husband in his letter to the HCCC explained that the practitioner made it clear from the outset that his wife's cancer was uncommon, had already spread to her lymph nodes and the prognosis was poor. He explains that he does not recollect the practitioner discussing the exact dose of carboplatin with his wife and him. Rather he says "perhaps he erred towards under-dosage to try and balance efficacy with safety and lifestyle. [Wife's name]'s case may have been one of many that affirmed his overall approach". 3. We are satisfied that the practitioner did not inform Patient M9 that there was no published data supporting a flat dose of carboplatin as a single agent in the context of breast cancer. Patient M10 1. The background information about this patient is as follows: Patient M10 was diagnosed with metastatic SCC of the lung with brain stem metastases in October 2010. Patient M10 was 61 years of age at the date of diagnosis. Patient M10 was referred to the practitioner in or about November 2010 for concurrent radiotherapy with chemotherapy. In March 2011 Patient M10 was referred for palliative chemotherapy. In May 2011, Patient M10 was sent to palliative care. Patient M10 is now deceased. 1. The clinical particulars now asserted in respect of this patient are as follows: Complaint Ten A 1. The practitioner failed to provide appropriate care and treatment to Patient M10 in that he prescribed a flat dose of 100mg Carboplatin on four occasions between 10 November 2010 and 1 December 2010 in circumstances where: (a) there was no published data supporting the use of a flat dose of 100mg Carboplatin; (b) a systemically active regimen, that is, a regimen which provided effective treatment throughout the body, was not contraindicated. 2. The practitioner failed to obtain adequate and informed consent from Patient M10 for the prescribed chemotherapy regimen in circumstances where: (a) the practitioner failed to inform Patient M10 of the risks of a flat dose of 100mg Carboplatin as a single agent or the lack of any published data supporting that regimen in the treatment of lung cancer; (b) the practitioner failed to advise Patient M10 of the alternative treatment options including systemic chemotherapy alone, radiation alone and supportive care, and the relative efficacy of the available treatment options. The practitioner 1. As with other patients in this cohort, the practitioner now admits the complaints about this patient. In his first Reply the practitioner denied failing to provide appropriate care and treatment to this patient. He did admit a systemically active regimen was not contraindicated, but says that he followed the wishes of the patient who was reluctant for any further therapy. Dr Stein 1. In the table to his report Dr Stein notes the patient's case was a difficult one with an unusual pattern of disease. He notes the different regimens which could have been implemented and ultimately concludes that the practitioner's prescription of carboplatin was inappropriate, but "as part of polychemotherapy it could be considered". 2. In his further comments on this patient, Dr Stein opines the case could have been approached in several ways, all of them palliative. He explains the patient had multiple evidence-based options available including radiotherapy alone. Although he acknowledges the practitioner "suggests" that the patient was reluctant to have any further treatment as a rationale for not giving systemic therapy that did not mean the patient should have received a treatment regime of unknown effectiveness. He states "carboplatin monotherapy in conventional doses has no proven efficacy". Professor Clarke 1. In his report Professor Clarke explains that this patient's treatment was always going to be palliative. He opines the treatment was reasonable and acceptable. The Joint Reports 1. In the table to their first Joint Report the experts agree that M10 was a palliative patient (and this conclusion is repeated in the second Joint Report). The experts agree that 100mg carboplatin has not been directly demonstrated to be better than radiotherapy alone or to other doses of carboplatin in conjunction with radiotherapy. Consideration Patient M10 1. Again, we find the practitioner's admission of this complaint is appropriate. It is consistent with the opinions expressed by Dr Stein. We accept the expert opinion of both Dr Stein and Professor Clarke that this patient's case was a difficult one, and that her treatment was palliative. While we accept it was appropriate for the practitioner to take into account the patient's wishes, we independently find there was no published evidence supporting a flat dose of carboplatin for treatment of this patient's condition and that she did not initially receive a systemically active regimen when such a regimen was not contraindicated. 2. The practitioner's report to the patient's radiation oncologist notes there was some discussion with the patient and her brothers about the "possibility of her having some combination chemotherapy and radiotherapy to the primary site in the right lung" but there is no evidence that the patient was advised of the risks of a flat dose of carboplatin or the lack of published data supporting the regimen proposed. Thus, we are independently satisfied the complaints are established. Patient S4 1. Patient S4 was another patient with an unusual diagnosis (metastatic SCC of the skin diagnosed in 2013). This patient underwent a parotidectomy and modified neck dissection also in 2013. In 2014 he had a skin recurrence and was referred for palliative care after ceasing chemotherapy early due to thrombocytopaenia. This patient received a flat dose of 100mg carboplatin on two occasions. The particulars of the complaint assert: 1. The practitioner failed to provide appropriate care and treatment to Patient S4 in that he prescribed Patient S4 with a flat dose of 100mg Carboplatin on two occasions between January and February 2014 in circumstances where: (a) chemotherapy of any form was contraindicated on the basis of Patient S4's myelodysplasia and his age at diagnosis; (b) there was no published data supporting the use of a flat dose of 100mg Carboplatin; (c) there was no published data to demonstrate any benefit from the addition of chemotherapy to radiotherapy in the context of an SCC of cutaneous origin. 2. The practitioner failed to obtain adequate and informed consent from Patient S4 for the prescribed chemotherapy regimen in circumstances where: (a) the practitioner failed to inform Patient S4 prior to chemotherapy of the risks of a flat dose of 100mg Carboplatin or the lack of any published data supporting that regimen; (b) the practitioner failed to advise Patient S4 adequately or at all prior to chemotherapy of the alternative treatment options or the relative efficacy of the alternative treatment options; (c) the practitioner failed to advise Patient S4 of the significant increase in risk of toxicity by reason of Patient S4's myelodysplasia, and the consequent risk that Patient S4 would fail to complete radiotherapy treatment; (d) the practitioner failed to advise Patient S4 of the lack of published data on the benefit of adding chemotherapy to radiotherapy when treating SCC of the skin; (e) the practitioner failed to advise Patient S4 of the decreasing benefit to be derived from any form of chemotherapy by reason of the patient's age. The practitioner's reply 1. In his first Reply the practitioner acknowledged the patient had myelodysplasia (increasing the risk of toxicity) but said he agreed with the MDT that some chemoradiotherapy should be administered "given there were positive margins". The practitioner admitted he failed to advise Patient S4 of a lack of published data on the benefit of adding chemotherapy to radiotherapy when treating SCC of the skin. The practitioner stated he could not recall whether he informed S4 of the decreasing benefit to be derived from any form of chemotherapy by reason of the patient's age. The expert evidence Dr Stein 1. Dr Stein opined both in his initial report and further comments that the practitioner's treatment for this patient was inappropriate. He did explain because the patient had a terrible prognosis a non-evidence based option could have been considered if the patient had not had multiple issues and had been informed that the practitioner did not know if the treatment would work in the patient's situation "and the benefit may well be nothing". Professor Clarke 1. Professor Clarke also noted the patient's multiple medical problems, and opined the attempt to give adjuvant treatment was because of the positive margins. He opined the practitioner's conduct was "trying to improve a poor prognosis". Joint Report 1. The experts did not agree whether this patient was palliative. Dr Stein maintained his opinion that the practitioner probably treated the patient with curative intent and Professor Clarke considered the treatment administered to have been palliative. Consideration Patient S4 1. First, we note the practitioner's admission to the particulars now pleaded in respect of this patient. Having regard to the evidence, we are independently satisfied that the particulars are established. Although there is disputation among the experts as to whether the practitioner's treatment rationale was curative or by way of palliation, it is clear from Dr Stein's evidence, and the clinical records disclosing Patient S4's presenting co-morbidities, that the regimen prescribed was contraindicated. 2. Secondly, the practitioner's own records and evidence makes it clear that the type of discussion outlined by Dr Stein as appropriate for the patient to give informed consent did not occur. We are satisfied that the particulars in respect of consent are established. Patient S6 1. This patient's circumstances are set out in the background to the complaint as follows: Patient S6 was diagnosed with neuroendocrine cancer of the oral cavity in or about November 2013. Patient S6 was 51 years of age at the date of diagnosis. Patient S6 underwent a right partial hemiglossectomy and right modified neck dissection in December 2013. In January 2014, Patient S6 was referred to the practitioner for adjuvant chemoradiotherapy treatment. Patient S6 is now deceased. 1. The particulars of Complaint Sixteen A are as follows: 1. The practitioner failed to provide appropriate care and treatment to Patient S6 in that he prescribed Patient S6 with a flat dose of 100mg Carboplatin from January to March 2014 in circumstances where: (a) there was no published data supporting the use of a flat dose of 100mg Carboplatin; (b) Patient S6 had a high risk of systemic failure (relating to the entire body) and ought to have been treated with systemically active doses of chemotherapy, that is, chemotherapy treatment which was effective in providing clinically relevant treatment to the entire body. 2. The practitioner failed to obtain adequate and informed consent from Patient S6 for the prescribed chemotherapy regimen in circumstances where: (a) the practitioner failed to inform Patient S6 prior to chemotherapy of the risks of a flat dose of 100mg Carboplatin or the lack of any published data supporting that regimen; (b) the practitioner failed to inform Patient S6 either adequately or at all prior to chemotherapy of the alternative treatment options or the relative efficacy of the available treatment options; (c) the practitioner failed to advise Patient S6 of the importance of using systemically active doses of chemotherapy to treat aggressive neuroendocrine cancer. The practitioner's replies 1. In his first Reply the practitioner noted that the patient's cancer was a rare one, "so that the eviQ protocol did not apply". He further set out in detail the patient's pre-existing health conditions. He admitted that the patient had a high risk of systemic failure. Dr Stein 1. In his report Dr Stein noted that the patient had an uncommon disease with "no clear standard of care". He notes that multimodal therapy is usually proposed. Professor Clarke 1. Professor Clarke, after referring to the patient's cancer type and aggressive surgery, explained the treatment regime he would have adopted. He explained 'this is a bad prognosis tumour". The Joint Reports 1. The experts to do not discuss this patient other than Dr Stein and Professor Clarke identifying her as falling into a miscellaneous category. Consideration Patient S6 1. We find the practitioner's admissions in respect of this patient to be appropriately made. We find that the consensus of the expert evidence was that the treatment the patient received was non-standard and without support for the regimen prescribed. It was not a systemically active regimen. Further, we accept the practitioner's admission about the lack of advice provided to Patient S6 is appropriately made. In his first Reply the practitioner refers to what he "would" have said to the patient. That explanation did not refer to alternative treatment options or the efficacy of the available treatment options. Patient W4 1. The details of this patient's diagnosis and treatment are as follows: Patient W4 was diagnosed with urothelial carcinoma of urethra in December 2010, at the age of 71. Patient W4 declined surgical intervention and was referred to the practitioner for definitive chemoradiotherapy treatment in April 2012. Patient W4 subsequently underwent brachytherapy at Westmead Hospital. 1. The particulars of Complaint Forty-Two A are as follows: 1. The practitioner failed to provide appropriate care and treatment to Patient W4 in that he prescribed Patient W4 with a flat dose of 100mg Carboplatin on six occasions between May 2012 and July 2012 inclusive, concurrently with daily external beam radiation treatment in circumstances where: (a) there was no published data supporting the use of a flat dose of 100mg Carboplatin; (b) a high-evidence regimen such as treatment with Cisplatin-Fluorouracil or Mitomycin-Fluorouracil was not contraindicated; (c) urothelial cancer is more sensitive to Cisplatin than Carboplatin, with contemporaneous guidelines not supporting substitution of Cisplatin with Carboplatin in patients with normal renal function; (d) Patient W4 had a high risk of systemic failure and ought to have been treated with systemically active doses of chemotherapy. 2. The practitioner failed to obtain adequate and informed consent from Patient W4 for the prescribed chemotherapy regimen in circumstances where: (a) the practitioner failed to inform Patient W4 prior to chemotherapy of the risks of the prescribed regimen and the non-standard character of that regimen; The practitioner's Replies 1. This complaint is now admitted in full by the practitioner. In his first Reply, the practitioner notes that he was not the prescriber of the external beam radiation treatment. He also notes the patient was initially referred for palliative care in February 2012 but the recommendation changed to curative intent in March 2012. The practitioner denied particular 1(b) namely that a high level regimen "such as treatment with Cisplatin-Fluorouracil or Mitomycin-Fluoroucil were not contraindicated" and noted the patient's severe ischaemic heart disease, was of more concern than her poor renal function. As with other patients, the practitioner asserted he had provided an adequate informed consent and relied on a notation of "chemotherapy education" contained in the patient's progress notes. Dr Stein 1. In his initial report, Dr Stein explains that "the natural history of urothelial cancer includes significant rates of systemic failure". He notes the recommended regimens for combination with radiotherapy were cisplatin-fluorouracil and mitomycin-fluorouracil. In his subsequent report, Dr Stein notes that the practitioner relied on a published report supporting carboplatin but explains this report was published six years after the patient was treated by the practitioner. Professor Clarke 1. Professor Clarke notes this was "not a tumour type I treat and I will refrain from providing an 'expert' opinion". Professor Fox 1. In his report on this patient, Professor Fox explains there is "extensive information regarding the treatment of transitional cell carcinoma of the bladder with the combination of Carboplatin and Gemcitabine. This has been an alternative to Cisplatin/Gemcitabine regime for many years". 2. Professor Fox disagrees with Dr Stein's views. Joint Report 1. In their reply to questions Dr Stein and Professor Clarke noted that Patient W4 was a patient for whom there were disease specific considerations or alternatives existed. 2. In the second Joint Report the experts classified Patient W4 in the "miscellaneous" category. We note their agreed positions as set out earlier in these reasons including the conclusion that the dose of carboplatin was unusual. Professor Fox maintained that using a flat dose of carboplatin was reasonable based on the data of Ekhart et al. but went on to note the dose was low. Consideration Patient W4 1. We accept this patient had co-morbidities which contraindicated the use of cisplatin. We note there are difficulties inherent with forming a concluded view about the appropriateness of this patient's treatment without the benefit of a physical examination. In this case we give considerable weight to the fact the practitioner himself has admitted he failed to provide appropriate care and treatment to the patient. Additionally, we do not consider the progress notes demonstrate that the patient received adequate information to provide informed consent to the treatment. Patient W5 1. This patient's diagnosis is set out in Complaint Forty-Three A as follows: Patient W5 was diagnosed with SCC of the cervix stage B1 with millimetre of extra-capsular spread following a radical hysterectomy in or about November 2011, at the age of 47. She was referred to the practitioner for adjuvant chemoradiotherapy treatment. 1. The particulars of Complaint Forty-Three A are as follows: 1. The practitioner failed to provide appropriate care and treatment to Patient W5 in that he prescribed Patient W5 with a flat dose of 100mg Carboplatin, as a single agent, on six occasions between February and March 2012 in circumstances where: (a) there was no published data supporting the use of a flat dose of 100mg Carboplatin as a single agent in the adjuvant treatment of cervical cancer; (b) a high-evidence regimen such as treatment with Cisplatin or 5-FU was not contraindicated. 2. The practitioner failed to obtain adequate and informed consent from Patient W5 for the prescribed chemotherapy regimen in circumstances where: (a) the practitioner failed to inform Patient W5 prior to chemotherapy of the risks of a flat dose of 100mg Carboplatin as a single agent and the absence of any published data supporting that regimen in the adjuvant treatment of cervical cancer; (b) the practitioner failed to advise Patient W5 adequately or at all prior to chemotherapy of the availability and relative efficacy of alternative treatment options such as Cisplatin or 5-FU. The practitioner's Replies 1. As with other patients in this cohort, the practitioner admits this complaint. In his earlier Reply the practitioner admits that treatment with cisplatin or 5-FU was not contraindicated. He says the patient was wary of toxicity and initially declined adjuvant post-operative treatment. He says "by way of compromise" he suggested carboplatin as a radiosensitiser due to lower toxicity and side effect profile and the patient agreed. He also says that 5-FU had to be administered continually via a lengthy intravenous catheter, involving a large amount of manipulation of the patient. He says "this was not easy to do in Orange and was not practical for the patient". 2. In his first Reply the practitioner says that treatment options were discussed with the patient with her taking some time to decide that she wanted to proceed with adjuvant treatment. Dr Stein 1. Dr Stein is strongly critical of the practitioner's treatment regimen for this patient. He explains that the meta-analysis reported in 2008 had only one small trial using single agent carboplatin and that trial demonstrated no benefit. He goes on to note that retrospective data describe the use of single agent carboplatin, but a large Australian experience demonstrates no significant difference to radiation alone with patients receiving carboplatin having worse outcomes. While noting the patient had no contraindications to cisplatin, "then regimens based around 5-FU have similar efficacy to cisplatin and a far better evidence base than single agent carboplatin". Professor Clarke 1. Professor Clarke did not proffer an expert opinion on this patient, her diagnosis and treatment being outside his area of expertise. Professor Fox 1. Professor Fox explains that eviQ has a locally advanced squamous cell carcinoma of the cervix chemo/radiation protocol which involves cisplatin. He notes that carboplatin has been used by others with suggestions for a clinical trial. He states that the dose in clinical trials has been 100mg/m2. 2. Professor Fox acknowledges that the practitioner used a lower dose than usual and says "presumably this reflects his concern that he is treating these patients at a distance". He notes that toxicities can be severe and that the practitioner would have to rely on local doctors who may not be experienced in managing these side effects. He also notes the patient lived 200km from the treatment centre and was of indigenous ethnic background "with potential difficulty in dealing with treatment induced toxicity". 3. Professor Fox was unable to comment on the adequacy of the consent process because of the lack of relevant records. The Joint Report 1. The experts in the Joint Report agreed that patient W5 was cisplatin eligible. We again note the agreement of the experts that the dose of carboplatin was unusual. The experts agree this was a patient where alternatives existed. Dr Stein again records that there is no data in cervical cancer to demonstrate that carboplatin per se is effective. In his supplementary report Professor Clarke explains that, having reviewed the patients, including W4 and W5, that he cannot identify outcomes that are poorer than expected for the disease stage of the patients involved. Again, this patient is placed in the miscellaneous category by all experts. Consideration Patient W5 1. We accept on the evidence before us that even if this patient declined cisplatin because of toxicity concerns she later agreed to chemoradiation and underwent treatment at Westmead Hospital. She should have been offered a high evidence regimen. If the patient had been fully informed of treatment options and declined a high evidence regimen that should have been fully documented. We find the practitioner's admission of this complaint is an appropriate one and not inconsistent with the expert evidence. 2. In reaching this conclusion, we have had regard to the fact of the patient's residence and the difficulties which presented to a fly-in, fly-out practitioner in the practitioner's situation in 2011. We have taken into account the realities of rural practice in 2011 in our assessment of appropriate protective orders. However, we note this patient received her radiation treatment in Sydney and could also have received chemotherapy in a supported environment. The patient should have been made fully aware of alternate treatments and if she rejected treatments with the most efficacy supported by meta-analysis or published data this should have been documented in reporting letters. Patient W6 1. The background facts about this patient from the WH cohort background is as follows: Patient W6 underwent a resection of a left frontal Oligodendroglioma (OGD) in 2003. In October 2011, Patient W6 was diagnosed with a grade 3 OGD following a left frontal craniotomy, at the age of 42. He was referred to the practitioner for adjuvant chemoradiotherapy treatment. 1. The particulars now asserted in respect of this patient have been substantially amended in the complaint so that only a single particular is relied on namely: (c) the practitioner failed to advise Patient W6 adequately or at all prior to chemotherapy of the availability or relative efficacy of alternate treatment options such as radiotherapy alone or sequential therapy. The practitioner's Reply 1. We find we can place little weight on the practitioner's first Reply in respect of this patient as he was responding to different particulars. Further, our examination of the patient records does not disclose any record of a discussion of alternate treatments with the patient. There are a number of referring letters in the clinical notes to the practitioner. Dr Stein 1. Dr Stein also notes that he is unable to comment on the practitioner's advice to the patient by reason of lack of records. Professor Clarke 1. In this instance, Professor Clarke agrees with Dr Stein based on the lack of records. Consideration Patient W6 1. As we later discuss in dealing with the issue of adequate information to patients to provide an informed consent, we infer the practitioner adopted his usual consent process of recommending a low dose of carboplatin with a view to minimising toxicity. We are satisfied that the practitioner's admission of this complaint is appropriately made. Patient W7 1. The background to the complaint about this patient is as follows: Patient W7 was diagnosed with high grade urothelial carcinoma of the bladder in October 2011, at the age of 63. He was referred to the Practitioner for chemoradiotherapy treatment. 1. The particulars relied on in support of this complaint are as follows: 1. The practitioner failed to provide appropriate care and treatment to Patient W7 in that he prescribed Patient W7 with a flat dose of 100mg Carboplatin on six occasions between 4 January 2012 and 15 February 2012 inclusive in circumstances where: (a) there was no published data supporting the use of a flat dose of 100mg Carboplatin as a single agent in the treatment of bladder cancer; (b) the systemic pattern of failure associated with bladder cancer required the use of systemically active doses of chemotherapy; (c) if Cisplatin was contraindicated, then either fractionated Cisplatin, Mitomycin-Fluorouracil or Paclitaxel-Carboplatin should have been recommended. 2. The practitioner failed to obtain adequate and informed consent from Patient W7 for the prescribed chemotherapy regimen in circumstances where: (a) the practitioner failed to inform Patient W7 prior to chemotherapy of the risks of the low dose regimen prescribed, and the lack of any published data supporting the use or efficacy of that regimen in the treatment of bladder cancer; (b) the practitioner failed to advise Patient W7 adequately or at all prior to chemotherapy of the availability and relative efficacy of alternative treatment options, including fractionated Cisplatin, Mitomycin-Fluorouracil or Paclitaxel-Carboplatin. The practitioner's reply 1. In his first Reply the practitioner explains that the patient was referred to him for palliative chemoradiotherapy treatment. He notes the patient's pre-existing conditions (severe hypertension, ischaemic heart disease and myocardial infarction, severe vascular path and impaired renal function). The practitioner admitted there was no published data to support the use of 100mg carboplatin as a single agent in the treatment of bladder cancer. He did not admit it was obligatory to prescribe systemic doses of chemotherapy. He says that cisplatin was contradicted because of the patient's heart condition. 2. The practitioner maintained that the listed treatments in the particular "should not have necessarily been recommended over the others". 3. The practitioner says the patient had a limited choice in terms of chemotherapy agents and this was discussed with the patient. Dr Stein 1. Dr Stein notes the patient's pre-existing conditions and accepts that cisplatin was contraindicated. However, he maintains, because the natural history of bladder cancer was well understood at the time (two patterns of loco-regional and systemic failure), that a low dose regimen was "suspect" because it "completely neglects the systemic pattern of failure". Professor Clarke 1. Professor Clarke noted this patient's condition was not within his area of expertise. Professor Fox 1. Professor Fox explains in his report that there is limited literature on the value of chemo/radiation in bladder cancer. He notes the usual dose would be "of the order of 100mg/m2 or moving to a selective dose based on creatinine clearance" (i.e. AUC). 2. Professor Fox in responding to the question "whether this chemotherapy consolidation regime was prescribed according to relevant guidelines and was an appropriate choice for this type of cancer?" opined "There do not appear to be specific guidelines in this instance. It would be an appropriate drug as an alternative to Cisplatinum given the fact it is less toxic". 3. Again, Professor Fox notes the lack of documentation precluding him from commenting on the adequacy of information provided to the patient. Consideration Patient W7 1. The experts all listed Patient W7 in the miscellaneous category in the second Joint Report. Again we refer to and rely on the points of agreement between the experts particularly in respect of the unusual flat dose of 100mg carboplatin. 2. We again find no documentary evidence to support a finding that the practitioner provided advice about the risks of the proposed treatment or the efficacy of alternate treatment options. We agree, on the evidence before us, that the practitioner's admission of this complaint is appropriate. Patient W10 1. The background information about this patient as set out in Complaint Forty-Eight A is as follows: Patient W10 was diagnosed with rectal cancer and underwent a laparoscopic abdominal perineal resection in July 2011, aged 56. A Dukes C rectal cancer T3N1M0 was defined. She was referred to the practitioner for adjuvant chemotherapy treatment in September 2011. Patient W10 subsequently underwent a resection of a left lung nodule in October 2012. 1. The particulars relied on in respect of this patient are as follows: 1. The practitioner failed to provide appropriate care and treatment to Patient W10 in that he prescribed Patient W10 with a flat dose of 2400mg 5-FU in circumstances where: (a) Patient W10 had normal renal function and ought to have been given a dose of 2400mg/m2 5-FU (equating to 3480mg); (b) there was no documented or apparent basis for a dose reduction of 5-FU to a dose intensity of approximately 68%. The practitioner 1. In his Reply the practitioner admits the patient had a normal renal function. However, he does not admit that renal function is a consideration in determining 5-FU dosage. He denied the patient ought to have been given a dose of 3,480mg 5-FU. 2. It is important to note in the case of this patient that the practitioner conceded in cross-examination that what had occurred was a transcribing error which resulted in the patient's under-dose. Consideration Patient W10 1. We accept that the dose of 5-FU the patient received was the result of an unfortunate transcribing error, and not as a result of lack of clinical judgment. We find the practitioner's admission of the complaint in these circumstances is an appropriate one. Patient W18 1. The background to this patient is as follows: Patient W18 was diagnosed with T3N2 colon cancer following a right hemicolectomy in December 2007, at the age of 59. She was referred to the practitioner for adjuvant chemotherapy treatment in January 2008. Patient W18 suffered a relapse 3 months after the completion of adjuvant treatment. 1. The particulars of complaint in respect of this patient are: 1. The practitioner failed to provide appropriate care and treatment to Patient W18 in that he prescribed Patient W18 with eight cycles of with [sic] Capecitabine 1g twice daily from January 2008 to July 2008, representing a dose intensity of approximately 44%, in circumstances where: (a) Patient W18 had normal renal function and a body surface area of approximately 1.8m2 and should therefore have been given a dose of approximately 2275 mg twice daily; (b) there is no documented or apparent basis for prescribing Capecitabine with a dose intensity of approximately 44%; (c) Patient W18 was at high risk of metastatic disease and should have been treated at optimal dose intensity or, alternatively, with Oxaliplatin-based chemotherapy; (d) the prescribed dose of Capecitabine was significantly below that established to be effective. 2. The practitioner failed to obtain adequate and informed consent from Patient W18 for the prescribed chemotherapy regimen in circumstances where: (a) the practitioner failed to inform Patient W18 prior to chemotherapy of the risks and possible implications of the low prescribed dose of Capecitabine; (b) the practitioner failed to inform Patient W18 prior to chemotherapy of the lack of any published data supporting the efficacy of the prescribed dose; (c) the practitioner failed to advise Patient W18 adequately or at all prior to chemotherapy of the availability or relative efficacy of alternative treatment options, including a different dosage of Capecitabine or alternatively Oxaliplatin-based chemotherapy. The practitioner's Reply 1. In his first Reply the practitioner admits this patient had normal renal function and a BSA of 1.8m2. He did not admit that the patient should necessarily have been given a dose of 2,275mg capecitabine twice daily "as there is no universal consensus on what constitutes the most appropriate treatment". He refers to the patient having dermatomyositis the treatment for which "may have strong overlapping side effects with Fluorouacil". He also explains that the patient's tumour showed microsatellite instability and this condition is associated with a dramatically more favourable prognosis than other colo-rectal cancers but resistance to conventional chemotherapy. 2. The practitioner denied the patient was at high risk of metastatic disease or that she should have been treated with the "optimal dose" or oxaliplatin. 3. The practitioner denied failing to advise of alternatives. Dr Stein 1. Dr Stein explains the patient's dose intensity was approximately 44%. He says he "can find no reason from the data supplied to give her a dose associated with a significantly worse outcome". He also notes the patient's high risk of metastatic disease and opines it was inappropriate not to offer the option of oxaliplatin based chemotherapy. He does however note that although this is significantly more toxic, the survival benefits made it a very reasonable alternative. Professor Clarke 1. Professor Clarke does not support the practitioner's treatment for this patient opining it was below standard (but not significantly below). He says the patient should have received oxalipatin. Professor Fox 1. In his report on this patient Professor Fox notes her diagnoses and explains that "she was treated with Xeloda (capecitabine) as adjuvant chemotherapy at lower than recommended dose". He also notes that the patient's disease "relapsed". He also notes a temporary response but that the patient's disease proved fatal. 2. Professor Fox opines that Xeloda "could have been satisfactory if used in an appropriate dose". He goes on however to explain: However, as it is a fluoropyrimidine, its value in a MSI tumour would be questionable. 1. Professor Fox explains that other alternative adjuvants were available (oxaliplation or Ironotecan). 2. Professor Fox opines that the initial choice of medication was inappropriate and that it was also inappropriate to continue Xeloda "given she had relapsed and then progressive disease". Professor Fox agrees with Dr Stein the treatment was below standard but departs from his view that it was significantly below the standard. 3. On the question of consent, Professor Fox notes that there is no recording of information. Consideration Patient W18 1. It is clear that all experts are critical of the practitioner's prescribing for this patient. Although Professors Clarke and Fox found the practitioner's prescribing below standard they did not find it to be significantly below standard. We have taken into account that, although the experts did not complete their oral evidence before us, they did put forward the positions on which they agreed and disagreed in the joint statements. Overall, having regard to the opinions of the experts and the expertise of this specialist tribunal, we are satisfied, given the evidence of the inappropriate chemotherapy agent chosen, that the practitioner's concession of unsatisfactory professional conduct in respect of this complaint is appropriately made. Lack of adequate information to enable a patient to give a proper consent 1. It is convenient that we commence our discussion about Patient M1 and the other 51 patients in respect of whom it is asserted the practitioner failed to provide adequate advice of the existence of alternate treatment options to the patient to enable that patient to provide "informed consent" by reference to the authorities on this topic. Relevant Case Law 1. The High Court's seminal discussion on the topic is found Rogers v Whitaker [1992] HCA 58; (1992) 175 CLR 479 as follows: 14. The duty of a medical practitioner to exercise reasonable care and skill in the provision of professional advice and treatment is a single comprehensive duty. However, the factors according to which a court determines whether a medical practitioner is in breach of the requisite standard of care will vary according to whether it is a case involving diagnosis, treatment or the provision of information or advice; the different cases raise varying difficulties which require consideration of different factors ((32) F v. R. (1983) 33 SASR, at p 191). Examination of the nature of a doctor-patient relationship compels this conclusion. There is a fundamental difference between, on the one hand, diagnosis and treatment and, on the other hand, the provision of advice or information to a patient. In diagnosis and treatment, the patient's contribution is limited to the narration of symptoms and relevant history; the medical practitioner provides diagnosis and treatment according to his or her level of skill. However, except in cases of emergency or necessity, all medical treatment is preceded by the patient's choice to undergo it. In legal terms, the patient's consent to the treatment may be valid once he or she is informed in broad terms of the nature of the procedure which is intended ((33) Chatterton v. Gerson (1981) QB 432, at p 443). But the choice is, in reality, meaningless unless it is made on the basis of relevant information and advice. Because the choice to be made calls for a decision by the patient on information known to the medical practitioner but not to the patient, it would be illogical to hold that the amount of information to be provided by the medical practitioner can be determined from the perspective of the practitioner alone or, for that matter, of the medical profession. Whether a medical practitioner carries out a particular form of treatment in accordance with the appropriate standard of care is a question in the resolution of which responsible professional opinion will have an influential, often a decisive, role to play; whether the patient has been given all the relevant information to choose between undergoing and not undergoing the treatment is a question of a different order. Generally speaking, it is not a question the answer to which depends upon medical standards or practices. Except in those cases where there is a particular danger that the provision of all relevant information will harm an unusually nervous, disturbed or volatile patient, no special medical skill is involved in disclosing the information, including the risks attending the proposed treatment ((34) See Fleming, The Law of Torts, 7th ed. (1987), p 110). Rather, the skill is in communicating the relevant information to the patient in terms which are reasonably adequate for that purpose having regard to the patient's apprehended capacity to understand that information. 15. In this context, nothing is to be gained by reiterating the expressions used in American authorities, such as "the patient's right of self-determination" ((35) See, for example, Canterbury v. Spence (1972) 464 F 2d, at p 784) or even the oft-used and somewhat amorphous phrase "informed consent". The right of self-determination is an expression which is, perhaps, suitable to cases where the issue is whether a person has agreed to the general surgical procedure or treatment, but is of little assistance in the balancing process that is involved in the determination of whether there has been a breach of the duty of disclosure. Likewise, the phrase "informed consent" is apt to mislead as it suggests a test of the validity of a patient's consent ((36) Reibl v. Hughes (1980) 114 DLR (3d), at p 11). Moreover, consent is relevant to actions framed in trespass, not in negligence. Anglo-Australian law has rightly taken the view that an allegation that the risks inherent in a medical procedure have not been disclosed to the patient can only found an action in negligence and not in trespass; the consent necessary to negative the offence of battery is satisfied by the patient being advised in broad terms of the nature of the procedure to be performed ((37) Chatterton v. Gerson (1981) QB, at p 443). In Reibl v. Hughes the Supreme Court of Canada was cautious in its use of the term "informed consent" ((38) (1980) 114 DLR (3d), at pp 8-11). 16. We agree that the factors referred to in F v. R. by King C.J. ((39) (1983) 33 SASR, at pp 192-193) must all be considered by a medical practitioner in deciding whether to disclose or advise of some risk in a proposed procedure. The law should recognize that a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment; a risk is material if, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. This duty is subject to the therapeutic privilege. [foot-notes omitted] [our emphasis] 1. It is to be remembered that the discussion in Rogers v Whitaker and later cases such as Chappel v Hart [1998] HCA 55 and Rosenberg v Percival [2001] HCA 18 is in the context of actions for negligence, not professional disciplinary proceedings. However, the principles enunciated remain relevant to proceedings such as these. 2. Recent decisions, including those of the United Kingdom Supreme Court, refer to the requirement for a practitioner to advise of alternate treatment options. We discuss this development in the law shortly. 3. In reaching our conclusion on this topic we are informed and guided by the experts' evidence including general background relevant to how the consent process is conducted in the MDT environment. The practitioner's evidence 1. The practitioner in his Reply admits the lack of adequate advice allegation in respect of all 52 patients. In his earlier Reply the practitioner explains that he did not advise the patient before treatment of an absence of published data to support a 100mg dose of carboplatin as appropriate. He says that he discussed with Patient M1 why he believed cisplatin was not the best choice, and then discussed why a "low dose" of carboplatin was appropriate. 2. In his oral evidence, the practitioner very fairly conceded that he did not have a specific recollection of the consenting consultation with each patient [transcript 8 August 2019 p 364]. However, he explained that, having had the opportunity of reviewing the patient records, those records had, in some cases, refreshed his recollection about what occurred at the "consenting consultations". 3. The practitioner confirmed the only record he maintained, other than flow sheets or prescription records, of the consenting process in respect of the patients from SV, MUH and WH was that contained in his reporting letters dictated following consultations, and the consent form itself. We pause to note in each case the consent form is a generic document without specific notations. Often, in respect of the patients the subject of these complaints, it is a document prepared and witnessed by the practitioner's registrar, not the practitioner. 4. In answers posed to him by senior counsel for the HCCC in cross-examination, the following exchange occurred in respect of the consent process: Q. You have been asked a question specifically about how you obtained consent for your hundred milligram prescribing, and you have been very clear in your answer that you tell the patient what you've recommended, you tell them what you hoped to achieve, but you don't tell them that it's a smaller dose than the recommendation in the guideline. Having seen this evidence that you gave in 2016, do you not accept that the truth is that you did not give any of the patients an explanation that the dose that you were prescribing was smaller than that recommended in the guideline? A. I deny that I did not indicate that it was a smaller dose. The issue of smaller than what is something that didn't always come up. As I've indicated before, if patients took up that issue of smaller than what, then guidelines would be mentioned. These patients generally accepted "smaller" to mean exactly what I said in relation to the nature of the interaction between chemotherapy and radiation therapy meaning that the dose of chemotherapy was smaller because it was required to sensitise the cells to radiotherapy and get more killing power from the radiotherapy. I would give them all of that information if they did not specifically pick up lower than what, I wouldn't mentioned guidelines. If they did, I would. Q. You gave them no choice, did you? A. I deny that. Q. You never gave a patient a choice or one of the patients the subject of the cohort a choice between carboplatin or cisplatin, did you? A. I deny that. Q. If you back to page 3511 which was the first of those two pages, to the extent that you referred to the small dose, that was drawing a distinction between a dose to help with the radiation and a dose that was big enough to kill cancer cells, wasn't it? A. Yes. Q. You never indicated that it was smaller than a dose that was recommended for the purpose of helping radiation killing the cancer cells, did you? A. No, I didn't, because I don't believe that it was smaller than would be useful to help the radiation. Q. So you never explained to any patient the subject of the cohort that the treatment you were proposing differed from that which was standard when carboplatin was being prescribed as a radiosensitiser. A. I deny that in that I always told them that it was a lower dose. The key issue is lower than what, and if they question that, I would explain to them the guidelines and why I thought they were problematic and why I thought that my practice over the years had led me to believe that there had been no published evidence to suggest that any advances in the use of carboplatin in relation to doses of carboplatin used as a radiosensitiser were better than mine. So therefore it's very unlikely that I would say to them, "I am giving you something that I don't believe is useful". Q. Why didn't you tell any of these patients that there was no published evidence of which you were aware that showed the dose that you were prescribing was efficacious as a radiosensitiser? A. Because I don't believe that there is no evidence. There is evidence of the use of doses of a hundred milligrams scattered throughout the literature and we have reviewed them. [transcript 12 August 2019 p 505] 1. Later on the same topic, the following exchange occurred between the practitioner and Ms Stern: Q. Why would it not have been helpful to give a patient a choice between receiving the AUC dosage and the dosage you recommended? A. Because I felt that the patient, given those raw numbers, 100 versus 300, would not be able to comprehend the difference in terms of the efficacy and toxicity. 300, 100 - it doesn't mean anything to a patient. Q. But surely it was a choice for the patient to make. Either they wanted the recommended dosage or they wanted your dosage. A. I have never denied a patient the choice. I've given them what I perceive is a reasonable explanation that allows them to pick up the notion that another dose might be available as I am using a lower dose, and if that stimulates any inquiry from the patient, guidelines would be mentioned and the deficiencies of the guidelines would be mentioned. Q. But, associate professor, if you don't tell the patient that there's an alternative regime, surely you are denying them a choice. A. I deny that. 1. We also found highly relevant to this topic the exchange which occurred between the practitioner and Professor Links. 2. The questions posed by Professor Links were to elicit from the practitioner his knowledge of likely increased survival rates (or the likely superior efficacy of chemoradiation) when cisplatin in accordance with the eviQ protocol is prescribed compared to carboplatin in a flat dose or area under the curve. Professor Links further sought to elicit from the practitioner whose decision it should be about which regimen should be adopted. We found the practitioner's response to be candid and enlightening. Accordingly we now set out the relevant exchange: Q. So in discussing the option of adding cisplatin to radiation in such a patient, would you discuss with them what survival advantage would be attributable for that treatment? A. Yes, I would. And I would be using that data that came out of Pinyon (sic) and the data that came out Budach, that had in common the idea that cisplatin was, as a single agent, a major contributor, because it was also well represented in the trials that they examined. I think that there was some interesting issues from Budach that went along the lines of cisplatin has this sort of disease free period, and overall survival benefit in our review of the meta-analysis, but then went along to say, well our evaluation of radio sensitisers was shown in a pictorial graph, and they had a different order of merit for each radiotherapy drug. Was quite different from Pinyon (sic). Q. So what survival advantage would you quote a patient for the addition of cisplatin..(not transcribable)..in this situation? A. In this situation, 4 to 6%. Q. What survival advantage would you quote to a patient for the administration of weekly - full dose weekly carboplatin to such a patient? A. Different to be absolutely sure. Q. What would you tell them? A. I would tell them that I thought that cisplatin had the data to be reasonably confident of those figures. It was rather a lack of solid data that would enable you to say that it was - the carbo was inferior, and so it's unknown, but will be of the same order of magnitude. Q. And what would you say to - for the survival advantage of low dose, or fixed dose 100 milligram carboplatin? A. I would say that there was - from my practice, I felt that there was no evidence that it was inferior to area under the curve, for example. Q. Who do you believe gets to decide whether 6% is important? A. Patient. 1. The practitioner conceded that very rarely had a patient specifically questioned why he was prescribing a regimen that was different from the guideline set out in eviQ. The practitioner agreed that balancing the efficacy of treatment and toxicity was required, and also agreed that if there are two regimens, both of which would be clinically acceptable, that this was a decision that a patient was entitled to make for himself/herself. [transcript 12 August 2019 p 507]. 2. When questioned specifically about Patient M1, the practitioner conceded he agreed with the opinion expressed by Dr Stein, namely that the data suggested little evidence of any benefit to a patient aged over 71 in having chemoradiotherapy. We note this patient was aged 81 years at the date of treatment. The practitioner agreed this patient should have been given the choice of radiotherapy alone. The expert evidence Dr Stein 1. Dr Stein's opinion about this patient is set out in the table to his report, which was, as is the usual practice, prepared before the practitioner gave his oral evidence. 2. Dr Stein is critical of the practitioner's process of obtaining informed consent from Patient M1 and other patients. This is because he is unable, from the correspondence or the practitioner's Reply, to confirm that all risks and benefits had been provided to the patient. He opines "it would seem to fully inform a patient they should be made aware that alternative regimens are available and how they differ from the proposed one. In the current situation this would include stating that it [cisplatin] was more effective and better studied". Dr Stein goes on to note his remarks are universal to all the patients examined and can be "considered so in all the subsequent discussions". Professor Clarke 1. In his report, Professor Clarke provides a general overview about the process of obtaining consent from patients diagnosed with cancer. He explains: Consent for chemotherapy in my experience has tended to be more general in nature but is gradually improving as we are provided with more essential resources including treatment specific written information from eviQ and Cancer Council NSW and with the belated introduction of Oncology Management Information Systems (OMIS) in which we can record process in a consistent and easily recorded fashion. Given the condition of the patients with life threatening disease, it is not always in their interest to receive detailed information, particularly as suggested by Dr Stein. It would be highly unusual for the medical oncologist to spell out all the various options and this would only happen if the patient or relative had expressed further concern or raised questions from their own research. There has to be a realisation that we are dealing with people with critical illness. To inform a patient that the proposed treatment was not compliant with a protocol or guideline poses the risk that they will not consent to treatment that is in their best interest, and will only consent to protocol treatment that may put them at risk. It was uncommon at the time in question to use eviQ guidelines. It was common to refer to locally determined and approved regimens by local Drug Committees (Chemotherapy protocol books) and explain the reasons as to why this treatment was chosen, without routinely providing information about other options and the scientific literature supporting or not supporting their use. One needs to tailor the information provided to the individual patient, in some circumstances it would be deleterious to the relationship to provide excess information that might confuse of (sic) frighten an already anxious patient. A prescriptive or standardised consent process is not one size fits all, as with guidelines. During the relevant time period the subject of this complaint, there was no routine provision of written consent for chemotherapy specifically by the medical oncologist- let alone the ability to record discussions of alternate treatments; uncommon acute and long term toxicities of therapies or whether the treatment was compliant or not with local, national or international guidelines. The standard process was for the clinician to sit with the patient (with or without their supporters) and describe the planned treatment and then have these concepts repeated by nursing staff (usually care co-ordinators, senior cancer nursing staff (CNC, CNS or NUM or chemotherapy team members). Frequently, but not universally, the patient signed a consent form. 1. In the table to his report in considering Patient M1 Professor Clarke opines the consent process "Appears consistent with other Sydney Units in which I have worked. It was reasonable and within acceptable practise [sic]". 2. In an overview of the first conclave, Dr Stein and Professor Clarke both agreed the evidence for informed consent and in-depth discussion was generally lacking in information. The experts disagreed to the extent to which the informed consent process was below standard practice. Professor Clarke did not suggest that the consent process was ideal, but was consistent with his own centre and other NSW centres, particularly in circumstances involving multi-disciplinary teams and rural settings. He noted the near impossibility of having in depth discussions with patients and to record the nature and extent of the discussions. The experts agreed that "ideally" there should be adequate discussion with patients which demonstrated they had been informed the treatment proposed was not "standard therapy", a discussion of what standard therapy would be (e.g. radiation alone, an evidence based chemoradiation schedule) and how this differs from that proposed, and thirdly the specific rationale for proposing a particular schedule. Professor Fox 1. Professor Fox explained that he was unable to provide his opinion on the consent process because of the lack of available records. The second Joint Report 1. In this report, Professor Fox expressed similar views to Professor Clarke about the issue of informed consent. Professor Fox is noted as expressing the view that there is little documentation and the practitioner did not adequately document the contents of his discussion with a patient or the rationale for his prescribing, and although he finds the consent process below the standard expected, he does not find it to be significantly below the standard. Informed consent – specific patients 1. We turn now to the question of "informed consent". We commence our discussion by reference to Patient M1. There was no evidence before us from Patient M1. We did have the benefit of a file note of a telephone conversation between Patient M1 and Ms A Hadley of the HCCC. In that file note Patient M1 says he does not recollect being told anything by the practitioner about a reduced dose. 2. As a result of the practitioner's lack of records, other than his reporting letters for this and other patients, we cannot be sure of whether the efficacy or otherwise of a flat dose of Carboplatin or other treatment alternatives were discussed. 3. In considering this topic, we think it is important to refer to the evidence of patients who were required for cross-examination on this topic, and also to refer to those patients who provided statements but were not required for cross-examination. Patient S5 1. Patient S5 provided an affidavit and was required for cross-examination. He signed a generic consent form in which he acknowledged he had discussed his diagnosis with Dr Teng (the practitioner's registrar) who had recommended chemotherapy. The patient's clinical notes disclose that he suffered adverse reactions during his chemoradiotherapy treatment, and was admitted to a local country hospital during his last week of treatment. He suffered a 10 per cent weight loss during treatment. The practitioner's first Reply 1. The practitioner does not admit this particular in respect of Patient S5. The practitioner asserts his letter of 2 February 2011 records his discussion with the patient. He also states: My standard consent form also outlines my usual practise in terms of discussion and I can see no reason in this case why I would have deviated from my usual practise. 1. The practitioner acknowledges that the consent form is not in the MUH hospital records but explains that a patient could not receive chemotherapy in the absence of a signed consent form. He explains that after a patient signed the consent form that form would remain in the chemotherapy unit of MUH. We pause to note the consent form was produced under Summons after the filing of the practitioner's first Reply. 2. The practitioner admits there is no record of his clinical opinion that cisplatin was contraindicated because of the patient's age. The practitioner does not admit this is contrary to clauses 1(2)(a), 1(3), 1(5), 2(1) and 2(2) of Schedule 2 of the Regulation. 3. Patient S5's affidavit evidence is broadly consistent with the practitioner's Reply. He deposes to receiving advice about the general effects of chemotherapy, that he was told there were different types of chemotherapy but "this one (carboplatin) is right for you". However, Patient S5 is clear that the only time the dose of 100mg was discussed was during his treatment when a nurse checked his name and said the dosage. 4. At para 11 of his affidavit, Patient S5 explains: I definitely would have wanted to know that the dose Dr Grygiel was prescribing for me was lower than the standard dose recommended in the protocols or guidelines. If I had been told by Dr Grygiel, I believe I would have asked him why I was receiving a lower dose. That would be my natural reaction. I believe I would also have asked him what the benefits of a lower dose were, particularly in circumstances where I had a recurrence. Ultimately, I think I would still have accepted Dr Grygiel's recommendation, subject to discussing with both Drs Gallagher and Cooper. As a patient I felt very vulnerable and overwhelmed by the prospects of my treatment generally just went with what I was told by my doctors. 1. Patient S5 was a credible witness. He did not embellish his evidence and made appropriate concessions including a concession that he did not have any clear recollection of what the practitioner had told him "apart from [his] firm belief that he had not mentioned the off-protocol dosing of Carboplatin". 2. Patient S5 was a relatively young man at the time of the recurrence of his HNSCC some eight months after his initial surgery. He was a non-smoker who had six children. We had no hesitation in accepting his evidence that, if presented with the opportunity to do so, he would have asked the practitioner questions about why a dose lower than the standard or protocol was being prescribed, and made a decision after discussion not only with the practitioner but also Dr Richard Gallagher and Dr Stephen Cooper. He refers in his affidavit to relying of each of his doctors "wholeheartedly" and having had a recurrence that "I was putting my life in their hands". 3. In the case of this patient, we are required to assess whether the information he received about alternate treatment options was adequate. We do not find that there was an overall failure to explain about cisplatin to this patient. It would be devoid from reality to ignore the fact that the patient received advice about the treatment regime not only from the practitioner but also his registrar who completed the generic consent form. Further, in this case, the practitioner's reporting letter was co-signed by the registrar. 4. However, this was a relatively young man who the treating doctors described as a "salvage case". It was therefore imperative in his life threatening situation that he should be able to make an informed choice about his own treatment after appropriate advice. Notwithstanding he placed enormous faith in his treating doctors at SV, and as he concedes himself would probably, after full explanation, have accepted the practitioner's proposed regime, he was entitled to know about the efficacy of cisplatin established in the meta-analysis trials compared to the paucity of evidence supporting a flat dose of carboplatin. We are satisfied that sub-particular (c) is established. Overall, we agree with and accept Dr Stein's opinion that the practitioner failed to obtain a proper informed consent from Patient S5. Patient M9 1. We turn to the circumstances of Patient M9. We have earlier in these reasons referred to the issue of informed consent and we repeat our earlier findings. We note on the practitioner's own evidence he had not come across a similar patient for decades. 2. We accept the practitioner's evidence that he had a clear recollection of this patient and seeing her with her husband. As earlier noted, the patient's husband in his letter to the HCCC explained that the practitioner made it clear from the outset that his wife's cancer was uncommon, had already spread to her lymph nodes and the prognosis was poor. He explains that he does not recollect the practitioner discussing the exact dose of carboplatin with his wife and him. Rather he says "perhaps he erred towards under-dosage to try and balance efficacy with safety and lifestyle. [Wife name]'s case may have been one of many that affirmed his overall approach". 3. We accept that the practitioner did not inform Patient M9 that there was no published data supporting a flat dose of carboplatin as a single agent in the context of breast cancer. The practitioner's evidence is clear, he told Patient M9 that he was not aware of any developments in treatment for her rare cancer and undertook to conduct a literature search which he did. Patient S8 1. Patient S8 was interviewed for the s 122 Inquiry. In these proceedings, Patient S8 provided an affidavit and was required for cross-examination. He also made a formal complaint to the HCCC. We commence our discussion of this patient's evidence by noting that prior to his retirement he was engaged in a professional occupation with significant responsibilities. He is a highly intelligent man who gave careful and considered answers to questions put to him by senior counsel for the practitioner. We had no hesitation in accepting his evidence in its entirety. 2. As a result of his surgery and radiation, Patient S8's voice has been severely impacted. He is unable to swallow food or ingest beverages through his mouth and he receives sustenance through a tube in his stomach. 3. Patient S8 deposes that he first had radiation and chemotherapy in March and April 2014, and that this treatment according to a PET Scan extinguished his carcinoma in July 2014. However, a year later he was diagnosed with nasopharyngeal cancer, cancer in his lymph nodes and laryngeal cancer. He underwent surgery and commenced concurrent radiation and chemotherapy in September 2015. 4. In respect of his first chemotherapy in 2014 Patient S8 deposed: At the time I saw Dr Grygiel in March 2014 before the chemotherapy commenced, no mention was made of the terms carboplatin, cisplatin or what was protocol as against off-protocol. I only became aware of the term "carboplatin" during the course of it being administered to me by the staff at The Kinghorn Centre during March/April 2014. 1. At para 6 (2) and (3) of his affidavit, Patient S8 rejects the practitioner's statement that he had discussed carboplatin with him in March 2014 while acknowledging the practitioner may have mentioned that chemotherapy was for the purpose of acting as a radiosensitiser. In a letter addressed to the HCCC and annexed to his affidavit, Patient S8 says: My complaint against Dr Grygiel is that he did not inform me that the dosage of chemotherapy he was going to administer to me was off-protocol so as to give me the opportunity to raise the issue with Drs Cooper and Bova before submitting to such treatment. I was effectively denied the opportunity of getting a second opinion. 1. We found Patient S8 was an impressive and compelling witness. We accept and prefer his version of the conversation with the practitioner to the practitioner's version. This version is corroborated, in part, by the practitioner's reporting letter dated 3 March 2014 in which he refers to discussing carboplatin with the patient as a radiosensitiser. We accept, based on the records, that Dr Stephen Cooper in his reporting letter of 26 February 2014, provided Patient S8 "with extensive printed material on radiation therapy, chemotherapy and head and neck cancer". We note that this letter was copied to the practitioner. But it was the practitioner's responsibility, to provide adequate information about the chemotherapy prescribed. 2. We are satisfied that Patient S8 would have availed himself of the opportunity to seek an opinion from another specialist or specialists had he been aware that a flat dose of carboplatin was non-standard treatment. Patient S18 1. We also refer to the evidence of Patient S18. We found Patient S18 to be an honest witness who gave his answers in a straight forward manner. 2. This patient deposed that he did not have a strong recollection of the conversation he had with the practitioner at his first appointment. That appears a most appropriate concession noting that the appointment was in February 2012 and the patient provided an affidavit over six years later. He recollects the practitioner telling him that the "chemo may make you feel nauseous". 3. Patient S18 was however adamant that the practitioner did not discuss prescribing protocols with him. 4. We find that even if the practitioner did discuss treatment options with the patient, which we doubt, he did not record those conversations, nor did he annotate the generic consent form. We infer from his reporting letter that he did not contemplate cisplatin for this patient and simply advised the patient he would receive a low dose of carboplatin as a radiosensitiser. We are satisfied the consent given was not a fully informed consent. Patient S22 1. Patient S22 was contacted by SV staff after the broadcast of the 7.30 Report. Patient S22 made a complaint to the HCCC in December 2016. Patient S22 provided an affidavit sworn 10 August 2018. He gave oral evidence before us and was cross-examined by senior counsel for the practitioner. It is not in dispute that Patient S22 received carboplatin 100mg on six occasions in conjunction with his radiation treatment. The patient's evidence 1. In his affidavit Patient S22 explains that he saw the practitioner in a cubicle at the hospital prior to his attendance at the Head and Neck Clinic. The consultation was brief. He records at para 5 of his affidavit as follows: Dr Grygiel told me that I had cancer, using words to the following effect: "You have cancer. You will be having chemotherapy as an adjunct to your radiotherapy treatment. It won't be a major part of the treatment. This is what you will be having". 1. The patient deposes that the practitioner then handed him a small sheet of paper "not much larger than a post-it note … Dr Grygiel had written the words "d100mg Carboplatin." 2. At para 9 Patient S22 says he was shocked on hearing his cancer diagnosis, that he had no discussion at all with the practitioner about alternative treatment options or about "any hierarchy of chemotherapy drugs". He deposes that the practitioner did not tell him why he was recommending 100mg carboplatin and whether that dose was a high or low dose. 3. Patient S22 signed a generic consent form for the administration of chemotherapy. The practitioner's Reply and evidence 1. The practitioner provides detailed reasons why, in the exercise of his clinical judgment, he says a dose of 100mg carboplatin was the appropriate chemotherapy for this patient. 2. The practitioner conceded in cross-examination that he may not have offered Patient S22 any options other than carboplatin on the basis he may not be able to tolerate "it with his well-controlled HIV disease". The practitioner was unable to recall whether he had given the patient an option of a higher dose of carboplatin. 3. The following exchange occurred between the practitioner and senior counsel for the HCCC: Q. [Patient S22]'s account is that you didn't discuss with him at all the consequences or risks of the prescribed dose of carboplatin or the side-effects of that drug or of any potentially available drug. Sitting here now, you accept, don't you, that it's entirely possible that his account is accurate? A. No, I don't accept that. Q. You have no recollection of any such discussion, though, do you? A. I have recollection of a discussion based around my concerns for his HIV and relating any problems that may come of his treatment of his squamous cell carcinoma, so there is a lot of discussion about what – why the treatment was necessary and what the treatment might do. Q. I suggest that when you talk about these discussions that you say you recall, you in fact have no recollection of what you said to him on those occasions, and this is more in the way of reconstruction. A. The – the – a patient that presents with a significant immunosuppressive problem is always going to make a bigger impression on you than a patient that has no comorbidities, so I reject the idea that I – I have no recollection of my discussions with [Patient S 22]. My discussions with [Patient S 22] were surrounded by the idea that his HIV may become- control may become compromised and the selection of his treatment was based around considerations of his HIV. 1. The practitioner says at page 152 of his Interim Reply: I do not admit that Cisplatin was not contraindicated. HIV/AIDS has been listed as an absolute contraindication to Cisplatin due to the weakening of the immune system. There were several factors in reaching my clinical judgment that the best course of treatment would be that with fewest side effects. Firstly, the purpose of the chemotherapy was to act as a radiosensitiser, not as a cure in and of itself. Secondly, the patient worked as a graphic designer and university lecturer and Cisplatin can cause nerve damage. I was cautious to not prescribe a treatment that could affect the patient's professional capacity. Thirdly, the patient had P16 positive SCC, which was likely to respond just as well to Carboplatin as to Cisplatin. Fourthly, the patient was HIV+ and receiving treatment, HIV treatment can have similar side effects to chemotherapy and as such it was reasonable to pursue a regime of chemotherapy which would yield the least side effects with the same efficacy. HIV being suppressed by antivirals, bone marrow can run out of resilience, In my opinion a cautious approach with chemotherapy was indicated. [footnotes omitted] 1. In addressing the issue of informed consent, the practitioner refers to the fact that in his reporting letter he says "after some discussion" as providing corroboration of his recollection that a discussion about the patient's HIV status and the problems with Cisplatin regarding peripheral neuropathy and VIII nerve deafness. The expert evidence Dr Stein 1. Dr Stein is strongly critical of the practitioner's conduct in obtaining informed consent from this patient. He relies on his general statement about informed consent provided in respect of Patient M1. Professor Clarke 1. As with other patients, Professor Clarke opines that the process for obtaining informed consent was consistent with practice in other institutions at the relevant time. We refer to our earlier discussion where we have recorded Professor Clarke's opinion on this topic. Consideration Patient S22 1. Patient S22 was subject to rigorous cross-examination by senior counsel for the practitioner. He conceded there had been some discussion of his HIV status and that he had been told 100mg carboplatin was the right dose for him. 2. Patient S22 was clear that his consultation with the practitioner was brief as there were about 50 patients assessed on that day. We found Patient S22 to be a reliable witness with a clear recollection of his consultation with the practitioner despite his distress at learning of his cancer diagnosis. He presented as an intelligent, measured individual who gave careful answers and impressed as an honest witness. 3. Without being unduly critical of the practitioner, we are satisfied that while he may well remember this patient because of his HIV status, we find that his evidence is substantially based on reconstruction. We accept and prefer Patient S22's evidence on the advice provided by the practitioner to that of the practitioner. 4. Although Patient S22 now says, if advised, he would have opted for a more rigorous chemotherapy regimen, we must balance that evidence with at least two factors. First, understandably Patient S22 was very upset by the 7.30 Report and his subsequent conversation with Dr Gallagher. His knowledge that he was one of the cohort of patients who were asserted to have received a lower than efficacious dose of chemotherapy must affect his present view. Secondly, if he had weighed up the fact that, because of his depressed immune system as a result of his HIV status, he may not have been able to complete his radiotherapy if he had received cisplatin or AUC carboplatin, he may have opted for 100mg carboplatin. 5. Notwithstanding our conclusions about whether Patient S22 may not have consented to treatment with 100mg carboplatin but pursued cisplatin or carboplatin AUC, we are satisfied he was deprived of the opportunity to make that choice. 6. The explanation of proposed treatment to a patient such as S22 is one which requires careful discussion particularly if active treatment is to be withheld because of HIV status. We find that the practitioner, in the environment in 2014 at SV, was no doubt pressured in the time he could devote to explanations to patients in the circumstances of a very busy clinic. This factor goes in some measure to the perfunctory explanations given to patients. It is clear that it was common practice for the Cancer Care Co-ordinator to obtain signed "generic" consent forms. Such forms are not and do not absolve a practitioner from explaining a material risk to a patient so that patient may or may not agree to the treatment proposed. Patient S19 1. An affidavit from this patient was also read in these proceedings. Patient S19also gave oral evidence before us and was cross-examined. He was not shaken in his evidence which was to the effect he was only told by the practitioner that he would receive a low dose of chemotherapy. Patient S13 1. This patient too provided an affidavit in these proceedings and was cross-examined. We accept that he first became aware of the issue of dosing of carboplatin when contacted by SV's staff. We also accept after that notification he had contact with Patient S5 who he had met at SV's during their respective treatments. Notwithstanding these potential influences on his recollection he was not shaken in his evidence that he only saw the practitioner briefly and the explanation he received was that he would receive a low dose of chemotherapy with a view to avoiding nausea. 2. In his affidavit Patient S13 explained that if he had been told about the dose he was receiving he would have "asked more questions because it would have worried me". He also said he would have spoken to his other treating doctors (Dr Cooper and Dr Bova). Patient S11 1. Patient S11 was extensively cross-examined about his recollection of his consultations with the practitioner. He was clearly aggrieved and hostile to the practitioner, no doubt to a significant degree because of an interaction with the practitioner about his eligibility or lack thereof for a clinical trial. Patient S11 refers to seeking a second opinion after his second relapse in July 2015 and subsequent treatment by another specialist in 2015/2016. 2. While we accept this patient has been influenced by media reports and his conversation with Dr Gallagher, and exhibited hostility to the practitioner, we found his evidence that he was not advised of alternative treatments to be credible. Patient S16 1. This patient deposed to the fact that the practitioner did not suggest to her that there was any other "treatment option than what he had recommended". This patient described wanting "everything possible to be thrown at me, because I wanted the best chance of a cure". 2. We found Patient S16 to be a credible witness. She explained that "I was of the understanding that the team had decided what was best for me and I put myself in their hands" [transcript 2 August 2019 p 259]. Patient S16 also gave oral evidence "and I made my feelings very clear that I wanted them to give me everything they had at their disposal". Her evidence about the information provided by the practitioner is consistent with the practitioner's own statements about the information provided. Patient S14 1. Patient S14 provided an affidavit which was relied on by the HCCC. He was not required for cross-examination. His evidence discloses he is a well-educated man who holds a position as Chair of the Board of an ASX listed company and is a person with knowledge of clinical trials, combination drug treatments, survival rates and drug toxicities. Patient S14 refers to his consultations with Dr Richard Gallagher and Dr Cooper. He refers to his first consultation with the practitioner when he says they discussed the pros and cons of proceeding with chemotherapy and radiotherapy, as distinct from surgery alone. He deposes that, after the practitioner spoke about wanting to get him through the full dose of radiotherapy, he asked about cisplatin which he had read about in the literature. He says the practitioner recommended carboplatin rather than cisplatin "as it is less toxic". He deposes that the practitioner said the dose he was recommending would get Patient S14 through the treatment program without the more toxic effects of a higher dose. He states "There was no other discussion about the risks or benefits of different doses of Carboplatin". At para 11 of his affidavit Patient S14 states: However, at no time did Dr Grygiel tell me that there was a recommended or standard dose of Carboplatin, or that there were any applicable guidelines for Carboplatin, or that the dose he was prescribing for me departed from the recommended or standard dose. If Dr Grygiel had said something to that effect, then I believe I would have initiated a more detailed discussion with him about the reason for the prescribed dose, the percentage survival rates associated with that dose, the toxicity of the dose and the evidence supporting it. I would have wanted to know whether the percentage survival rates that Dr Cooper had quoted to me were still valid. I would have asked Dr Grygiel why I was not having the full dose of Carboplatin, and would have suggested having the full dose and seeing how I went with it. 1. We observe that Patient S14's evidence is unchallenged. We accept this man was not provided with adequate information from the practitioner to give a properly informed consent to his treatment with a flat dose of 100mg carboplatin. Consideration – failure to obtain adequate and informed consent from patients The HCCC's submissions 1. At para 22 of their submissions counsel for the HCCC note that the patients affected by the practitioner's conduct "were a particularly vulnerable cohort". The submissions note, and we agree, that each patient was in a state of "significant ill health at the time" that they consulted the practitioner, and that we could draw the inference that they placed trust in him. The submissions set out parts of the evidence of the patients who were cross-examined and explained their reliance on the practitioner whom they regarded as the expert. The practitioner's submissions 1. The gist of the submissions made on behalf of the practitioner is that what is now left in the complaint is about the adequacy of the consent process. 2. At para 33, it is submitted that the practitioner's failure to inform patients regarding treatment alternatives "is understandable given the complexities and contentiousness around the science underpinning each agent, dose and schedule". It is further submitted that the evidence before us, including over 100 technical articles and the evidence of the three experts, demonstrates how little is known "regarding the actual efficacy of radiosensitising chemotherapy generally, and in relation to each specific regime". Reference is made to the limitation in clinical trials namely that they are conducted selecting suitable or fitter patients. 3. Reference is also made to Professor Clarke's evidence to the effect it is not always in the patient's interest to receive detailed information. Reference is also made to the practitioner's statement that he tried not to overload patients or to heighten their anxiety. 4. At para 63, it is submitted that the practitioner's failure was a failure to give comprehensive advice regarding alternative treatment options prior to obtaining consent. 5. The submissions emphasise that the current Australian authorities, which are binding on us, do not impose a requirement on a practitioner to provide information to a patient of all alternative treatment options, although it is noted there are isolated obiter remarks to the contrary in the case law. The submissions note the relatively recent decision of the UK Supreme Court in Montgomery v Lanarkshire Health Board [2015] UKSC 11. 6. The position adopted by the Supreme Court in Montgomery is succinctly summarised by Lady Hale in her separate reasons as follows: An important consequence of this is that it is not possible to consider a particular medical procedure in isolation from its alternatives. Most decisions about medical care are not simple yes/no answers. There are choices to be made, arguments for and against each of the options to be considered, and sufficient information must be given so that this can be done: see the approach of the General Medical Council in Consent: patients and doctors making decisions together (2008), para 5, quoted by Lord Kerr and Lord Reed at para 77 and approved by them at paras 83 to 85. 1. We were referred to the decision of Hoeben J in Richards v Rahilly [2015] NSWSC 352. Here his Honour was considering whether there was negligence by a children's hospital in failing to advise the parents of a minor about the efficacy of a particular drug in circumstances where another drug was provided for the child. His Honour explained at [223]-[224]: The second question is even if the treatment provided by the hospital was appropriate did the hospital still depart from appropriate standards by not discussing the use of Vigabatrin with Rhiannon's parents. Some guidance on this issue is provided by Rogers v Whitaker: "There is a fundamental difference between, on the one hand, diagnosis and treatment and, on the other hand, the provision of advice or information to the patient. In diagnosis and treatment, the patient's contribution is limited to the narration of symptoms and relevant history; the medical practitioner provides diagnosis and treatment according to his or her level of skill." (p 489) The submission runs somewhat contrary to that guidance in that if it is correct, there is no fundamental difference between diagnosis and treatment on the one hand, and the provision of advice or information on the other. Implicit in the submission is that the provision of advice should take place before a decision as to treatment is made and the patient should make the decision as to what treatment should be provided. 1. His Honour held at [225]: If the submission is correct, its implications are far-reaching. No longer would a doctor be required before embarking on treatment to warn a patient of its risks, but at an earlier point in time the doctor would be required to discuss with the patient the various treatment options, raising in relation to each its advantages and disadvantages and then allowing the patient to choose his or her particular treatment option. That, it seems to me, would involve a substantial abrogation by the doctor concerned of his expertise as a doctor and to blur the clear distinction identified by the High Court in Rogers v Whitaker between diagnosis and treatment on the one hand and the provision of information. 1. At [234]-[236] his Honour explained: In such circumstances it seems to me that a doctor is not only entitled but bound to recommend to patients (in this case the parents) that treatment which the doctor considers most appropriate in the circumstances. It is not a question of that choice involving the personal preference of the doctor but rather the doctor performing the fundamental duty for which he or she has been retained, ie to diagnose and treat. Once the doctor has recommended a treatment then it is incumbent upon him or her to explain fully to the patient the risks involved in that treatment. The submission is put in such broad terms as to make its implementation unworkable as a matter of practicality. In essence it is submitted that Vigabatrin should have been discussed because it was a "legitimate" treatment that "could have worked". It would impose an impossible burden on the medical profession if a doctor was bound to offer a patient every "legitimate" treatment option that "could work" and discuss the advantages and disadvantages of each option with the patient and then allow the patient to choose his or her option. On the facts of this case, the Hospital would have been obliged before deciding upon any treatment for Rhiannon, to have discussed all of the medications which were legitimate treatment options which could have worked (Dr Manson says at least five) and then request the parents to choose the treatment option which they preferred. Such an approach is unrealistic, involves enormous practical difficulties and unfairly imposes on patients/parents a decision which they are unqualified to make. It is quite different to the situation where a certain form of treatment has been recommended, but before undergoing the treatment the patient has the advantages and disadvantages of the treatment fully explained. Finally, the submission not only is not authorised by Rogers v Whitaker but runs contrary to that decision. An obligation to warn of a "material" risk inherent in a proposed treatment is a significantly different obligation to one requiring the provision of full information concerning a number of treatment options preparatory to the patient choosing his or her treatment. [emphasis added] 1. While it would be unrealistic to ignore the constraints of time and resources facing practitioners, these proceedings highlight the need, particularly where patients are treated in a multi-disciplinary setting, for proper consent and recording processes rather than reliance on generic consent forms. The vast majority of patients should be afforded an explanation where treatment proposed is non-standard with unknown efficacy and/or not supported by published data, and there should be sufficient place in pro forma consent forms for annotation of relevant information provided to the patient including particularly any material risk. 2. In making this observation we accept that there will from time to time be a very limited number of patients who, either by their distress at their diagnosis, or other psychological factors, may be incapable of fully appreciating explanations provided. But such patients are the minority. The days of the practitioner determining what the patient should or should not know or consent to about their treatment are long gone. Further, as recognised by the High Court in Rogers v Whitaker, it is a patient's fundamental right to make their own choice about undergoing treatment if that treatment involves a material risk. 3. We accept we are bound by the Australian authorities and note the following. First, the practitioner was not prescribing a standard treatment supported by clinical data. There were inherent risks in such a regimen. Secondly, he was on his own evidence the only practitioner in Australia prescribing a flat dose of 100mg carboplatin in the primary and adjuvant setting. Thirdly, in many instances, other established regimens supported by evidence were available for patients' treatment. We note that in Richards failure to provide adequate information to the child's parents was not considered reasonable where there were five drugs without any one having a clearly established clinical efficacy over the other. That was not the case for this cohort of patients. Fourthly, the practitioner's failure to provide adequate advice deprived patients of the opportunity of obtaining a second opinion or consulting with other members of the MDT and finally and importantly, the cohort were facing a serious diagnosis with life threatening consequences. They had a right to receive adequate information about the proposed treatment. 4. In addition, we consider in the circumstances of the patients such as those the subject of the complaint, there is a fundamental responsibility for a clinician to negotiate with the patient appropriate goals of treatment. A patient may elect to accept treatment toxicity if it will improve survival or may accept a compromise in efficacy to reduce toxicity. These very different treatment philosophies cannot be determined without the input of the patient. Clinicians have a responsibility to invite and respect patient preferences so that treatment recommendations are congruent with the patient's own goals. 5. In summary, as we later discuss when considering appropriate protective orders we found, even if the practitioner's desire was to shelter his seriously ill patients from additional stress, that did not obviate his duty to provide adequate information to his patients. In saying this, we accept Professor Clarke's opinion that some patients may be further stressed by the provision of detailed information prior to treatment. But here, as is aptly illustrated by the patients we have discussed, they were men and women well able to absorb basic information and agree to or not agree to a flat dose of carboplatin. The patient's right to know that the regimen the practitioner proposed was unusual and was not supported by meta-analysis or relevant clinical trials was paramount. Provision of that information inexorably should have led to advice that other established regimens were available. 6. We find that the practitioner's concession of unsatisfactory conduct in respect of this category of conduct is properly made. The record keeping complaints 1. The practitioner has admitted he is guilty of unsatisfactory professional conduct by reason of his failure to comply with the regulation. 2. Clause 7 of the regulation provides as follows: 7 Records relating to patients (1) A medical practitioner or medical corporation must, in accordance with this Part and Schedule 2, make and keep a record, or ensure that a record is made and kept, for each patient of the medical practitioner or medical corporation. (2) A contravention of subsection (1) by a medical practitioner does not constitute an offence but may constitute behaviour for which health, conduct or performance action may be taken. (3) Subclause (1) does not apply to the following: (a) a public health organisation within the meaning of the Health Services Act 1997, (b) a private health facility within the meaning of the Private Health Facilities Act 2007, (c) a nursing home within the meaning of the Public Health Act 1991. (4) Subclause (3) does not affect the application of subclause (1) to a medical practitioner appointed, employed, contracted or otherwise engaged by a medical corporation referred to in subclause (3). Schedule 2 Records kept by medical practitioners and medical corporations in relation to patients (Clauses 7 (1) and 8 (4)) 1 Information to be included in record (1) A record must contain sufficient information to identify the patient to whom it relates. (2) A record must include the following: (a) any information known to the medical practitioner who provides the medical treatment or other medical services to the patient that is relevant to the patient's diagnosis or treatment (for example, information concerning the patient's medical history, the results of any physical examination of the patient, information obtained concerning the patient's mental state, the results of any tests performed on the patient and information concerning allergies or other factors that may require special consideration when treating the patient), (b) particulars of any clinical opinion reached by the medical practitioner, (c) any plan of treatment for the patient, (d) particulars of any medication prescribed for the patient. (3) The record must include notes as to information or advice given to the patient in relation to any medical treatment proposed by the medical practitioner who is treating the patient. (4) A record must include the following particulars of any medical treatment (including any medical or surgical procedure) that is given to or performed on the patient by the medical practitioner who is treating the patient: (a) the date of the treatment, (b) the nature of the treatment, (c) the name of any person who gave or performed the treatment, (d) the type of anaesthetic, if any, given to the patient, (e) the tissues, if any, sent to pathology, (f) the results or findings made in relation to the treatment. (5) Any written consent given by a patient to medical treatment (including any medical or surgical procedure) proposed by the medical practitioner who treats the patient must be kept as part of the record relating to that patient. 2 General requirements as to content (1) In general, the level of detail contained in a record must be appropriate to the patient's case and to the medical practice concerned. (2) A record must include sufficient information concerning the patient's case to allow another medical practitioner to continue management of the patient's case. (3) All entries in the record must be accurate statements of fact or statements of clinical judgment. 3 Form of records (1) An abbreviation or shorthand expression may be used in a record only if the abbreviation or expression is generally understood in the medical profession in the context of the patient's case or generally understood in the broader medical community. (2) Each entry in a record must be dated and must identify clearly the person who made the entry. (3) A record may be made and kept in the form of a computer database or other electronic form, but only if it is capable of being printed on paper. 4 Alteration and correction of records A medical practitioner or medical corporation must not alter a record, or cause or permit another person to alter a record, in a way that obliterates, obscures or renders illegible information that is already contained in the record. 5 Delegation If a person is provided with medical treatment or other medical services by a medical practitioner in a hospital, the function of making and keeping a record in respect of the patient may be delegated to a person other than the medical practitioner, but only if: (a) the record is made and kept in accordance with the rules and protocols of the hospital, and (b) the medical practitioner ensures the record is made and kept in accordance with this Schedule. The HCCC's submissions 1. The thrust of the submissions on behalf of the HCCC was to the effect that the failure of the practitioner to document his discussions of alternative treatment options deprived another practitioner who may treat the patient of appropriate information (submissions at para 26). The practitioner's submissions 1. The practitioner's submissions explain that "self-evidently" if the practitioner did not discuss alternative treatment regimens with patients then a record of alternative treatments could, it follows, not have been documented. Consideration – record keeping complaint 1. We accept that the practitioner's records comprise his reporting letters to other practitioners. The consent forms which patients signed were generic consent forms. These forms were not annotated to record any discussion the practitioner had with a patient. We agree with the experts in their statement in the second joint expert report that best practice would see a generic consent form annotated with brief details of proposed treatment and alternatives discussed. 2. We find that, in the circumstances of the fly-in, fly-out management of the WH cohort of patients, the practitioner had very limited time for record keeping. In this regard we have given weight to the evidence of the nurse with whom the practitioner worked for many years at Orange Hospital about his long hours and that he made himself available for after-hours telephone advice when requested by her. The time constraints imposed in the fly-in, fly-out situation while relevant for consideration as to the seriousness of the practitioner's conduct, do not absolve non-compliance with the mandatory requirements of the regulation. 3. While we note that Professor Fox found the practitioner's record keeping lacking, we had no reason to doubt Professor Clarke's evidence on this topic, namely that the record keeping was in conformity with other institutions at the relevant time. It appears to us, and as documented in the practitioner's submissions, that the s 122 inquiry, and media coverage about the practitioner has usefully and appropriately led to improved practices in record keeping. We note the practitioner's submissions quote from the Cancer Council of Australia's document "What is the best practice for documenting and communicating the treatment plan" namely: Deviations from accepted protocol and dosing schedules must be documented in the plan and include clinical justification for a deviation or alteration. Published references supporting a deviation or change to the original protocol must be cited where applicable. 1. The practitioner's record keeping was not in accord with the Cancer Council's recommendation, nor did it comply with the regulation. In summary, we accept the practitioner's admissions about his record keeping are properly made. Standard practice complaints 1. This complaint involves the practitioner's treatment of 33 patients for whom the practitioner prescribed a flat dose of 100mg carboplatin. The HCCC submissions 1. The submissions at para 29 note that the practitioner has admitted: inter alia as a result of his adoption of the standard practice in Particular 1 of Complaint 58 there is a risk that his HNSSC patients treated with carboplatin did not receive chemotherapy they were otherwise eligible to receive and whose efficacy was supported by published trials or meta-analyses. 1. The submissions, supported by transcript reference, note that the practitioner admitted: 1. at all times and relevantly throughout the period 2006 to 2015 he was not aware of any trial or published data that showed or sought to show that 100mg carboplatin was an effective radiosensitising dose; 2. there is no published study that tests a protocol or guideline of 100mg carboplatin as part of chemoradiation for head and neck cancer, and he had never seen any published data involving a cohort of patients who had been prescribed with a flat dose of 100mg carboplatin; and 3. there is no study testing whether 100mg carboplatin is more efficacious than radiation alone, or more efficacious than AUC dosing of carboplatin, or more effective than cisplatin. 1. The submissions note that the practitioner accepted he was aware of some evidence to support the efficacy of the AUC carboplatin regimen. Attention is drawn to the fact that the practitioner agreed that he was instructing his registrars to prescribe carboplatin in accordance with eviQ protocol for his patients as this was "a recognised standard method of treatment". It is also noted that the practitioner explained in his oral evidence in answer to a question in cross-examination that he allowed his registrars to give the AUC dose "because the toxicity that is induced by chemotherapy is well managed". 2. The submissions highlight the fact that the practitioner readily agreed to change his prescribing practice and to prescribe carboplatin AUC "upon instructions from Dr Gallagher in June and August 2015 with the proviso that he would be free to make dose adjustments if required by toxicity". 3. The submissions also refer to the fact the practitioner admitted in relation to locally advanced HNSCC that cisplatin is the "gold standard" and that there is more evidence from the clinical trials of cisplatin being efficacious compared to carboplatin. It is further noted that the practitioner confirmed, as at 2016, his own view was that cisplatin was the better drug based on the two Pignon meta-analyses. 4. The submissions highlight the following from the Joint Reports that: 1. that 100mg carboplatin chemotherapy has not been directly demonstrated to be better than radiotherapy alone; 2. Professor Clarke and Dr Stein opined it did not make sense to use a flat dose of carboplatin because of the simple and reliable method of controlling variations in blood levels (using dosing AUC) (we note that Professor Clarke's support for carboplatin AUC was principally directed to patients with impaired renal function). 1. We independently note and adopt the experts' agreement that if 100mg carboplatin was prescribed it should have occurred in the setting of a clinical trial (with all the ethical safeguards encompassed in such trials). The practitioner's submissions 1. The practitioner's submissions refer at para 29 to the expert evidence and advance the proposition that the "joint evidence established that the science underpinning the choices available in chemoradiation treatment are far from clear and in no way definitive" 2. The submissions seek to rely on the limited cross-examination of the experts which occurred on 17 March 2020. We find we must use extreme care in the weight we give to this evidence noting it was incomplete and limited to questions posed by senior counsel for the practitioner. 3. The submissions, at para 31, refer to Professor Clarke's opinion that there is no definitive "optimal means of combining chemotherapy with irradiation" this being a neglected area of cancer research. 4. Emphasis is placed in the submissions on the caution which must be exercised in reliance upon on clinical trials. It is acknowledged such trials are "useful" (para 33) but subject to limitations by reason of the fact that the participants in such trials are selected using fitness criteria including exclusion of patients with co-morbidities. 5. At para 37, reference is made to the fact that Dr Stein "ultimately conceded the practitioner's practice of prescribing a flat dose of 100mg carboplatin had a foundation in the scientific literature". It is submitted that it is false to assert there is no published data supporting a cumulative dose of 600mg carboplatin. Reference is also made to Dr Stein's agreement in questions posed to him that there is no large trial showing that cisplatin is superior to carboplatin, and that reliance should not be placed on the authors of the Budach meta-analysis to conclude that cisplatin was superior, "given that the authors concluded that carboplatin and cisplatin were both active agents". 6. At para 38, the submissions seek to explain that to highlight Dr Stein's evidence "as it ultimately fell is not an attempt to resile from the respondent's admission to his misconduct or Complaint 58." 7. Because submissions at para 38 on this topic are relevant both to this complaint and to our overall seriousness of the practitioner's conduct we think it important to record the relevant portion of what is said in that paragraph: What it does is demonstrate that Associate Professor Grygiel's 'standard practice' and 'firm views' regarding the prescribing of carboplatin in the cohort of 33 HNSCC was not speculative and had a sound scientific basis. Complaint 58 does not allege and cannot allege that the standard practice of 100mg carboplatin was in some way deficient, caused harm or ran the risk of causing harm. The evidence does not support such allegations and such suspicions should not in any way be implied. As Complaint 58 makes clear, professional misconduct is alleged and admitted based on the inseparable link between Associate Professor Grygiel's practice in relation to 33 patients and his corresponding failure comprehensively to advise his patients of other efficacious treatment regimens. Consideration 1. There can be no doubt that this complaint was, as the inquiry progressed before us, (albeit pleaded in a different manner to that now relied on) integral to the disciplinary proceedings. 2. We find Professor Clarke's discussion in the Appendix to the first joint report entitled "Comments on chemotherapy prescribing" raises critical issues. He notes the chemotherapy prescription process is a flawed one explaining "it does not allow for incorporation of all the intrinsic factors that might influence an individual patient's capacity to metabolise cytotoxic drugs" and lists relevant factors including ethnicity, levels of drug metabolizing enzymes, organ function, age, ingestion of other concomitant medications, nutritional status and level of plasma inflammatory markers. He further notes that the dose based on patient size (per metre squared) has repeatedly been shown to be invalid. He also explains that trials that evaluate protocols of chemotherapy use younger fitter patients who "typically fulfil restrictive inclusion/exclusion criteria". 3. Professor Clarke says: The ability to apply all the above concepts to an individual patient and prescribe a safe and effective dose of chemoradiotherapy involves clinical acumen and experience. 1. Professor Clarke goes on to explain that "guidelines" are derived from atypical studies and opines: To suggest that clinical experience and acumen can be simply replaced by following guidelines and that compliance with guidelines is some quasi index of clinical appropriateness is insulting to Medical Oncologists, including me, who have spent years in clinical practice, undertaking higher degrees, applying for research grants, completing clinical trials and working on government drug assessment committees to refine our knowledge of effective drug use and evaluation of clinical data that have informed and improved our clinical practice. 1. We are cognisant of all the factors referred to by Professor Clarke in the appendix to the first joint report, particularly the selection of patients for participation in clinical trials, and the importance of clinical experience and judgment. We find his lack of strong criticism of the practitioner's prescribing appears to be based, at least in part, on his retrospective analysis of the patient cohort. We accept such analysis has relevance in assessing post-treatment the efficacy of the treatment prescribed particularly if conducted in the framework of a clinical trial. But here we are called to assess the practitioner's judgment and clinical decision making taking into account the state of medical knowledge when the patients were treated. 2. It is useful to refer to the particulars in respect of Patient M1 when considering Complaint 58. 3. We found the practitioner's evidence why he rejected prescribing cisplatin for this relatively young man difficult to accept. Rather than individualised clinical judgment, the practitioner followed a practice he had adopted in the 1980s without consideration of prescribing based on an evidence based regime. We were unable to accept that his flat dose prescribing of carboplatin was based, at least in part, on the Homma or other studies. Even if he had regard to published papers, it is difficult to understand why he would not have prescribed carboplatin AUC. We found it significant that all the experts agreed this patient was cisplatin eligible, and that Professor Clark is critical of the practitioner's clinical judgment in not prescribing carboplatin AUC. Overall, in the case of this patient, we find Dr Stein's view that the conduct was significantly below the standard reasonably expected is to be preferred to that of Professor Clark and Professor Fox. 4. We are satisfied Dr Stein's view is to be preferred to the other experts for the following reasons. First, he finds this relatively young man was cisplatin eligible. Second, the practitioner agrees cisplatin is the "gold standard" for treatment and that he further agreed in cross-examination at the time of the patient's referral there were no contraindications to cisplatin. Third, the regimen chosen was not an evidenced based regimen, and finally and significantly the patient could have experienced a less satisfactory outcome because of the regimen chosen. 5. We note and adopt the Presiding Member's discussion on this topic in Health Care Complaints Commission v Grygiel (Termination Application) at [169]-[175] which we now set out: As both parties acknowledge following the conclave a number of agreed statements of opinion were expressed by Dr Stein and Professor Clarke. The statements are important both in the context of the substantive proceedings and this application. The experts acknowledge: (1) That they do not think "there is evidence on the balance of probabilities to suggest that any patient was harmed by [the practitioner] in any centres in which he worked"; (2) That the practitioner "has probably the single greatest experience of any Australian Medical Oncologist after over twenty years of travelling to Bathurst and Orange clinics"; (3) They were "concerned that the use of guidelines alone should not be considered the standard way of prescribing chemotherapy, but rather they should be used as a treatment template that should be adjusted by a clinician based on their clinical experience, the clinical features of the patient and the circumstances of the treatment". They said "we thought compliance with guidelines should not be used as an indicator of treatment adequacy"; (4) Both experts agreed the treatment was "below the standard expected". They disagreed as to whether it was significantly below (Dr Stein's position) or simply below standard (Professor Clarke); (5) Patients were not treated according to standard protocols; (6) That treatment efficacy and toxicity need to be balanced; (7) That a number of patients who received 100mg flat dose carboplatin were cisplatin eligible; (8) That neither they, or any other oncologist, knows what is the optimal drug and/or schedule of chemoradiation; (9) The dose of carboplatin was unusual; (10) Taking renal function into account and converting to AUC doses or mg/m2 doses the dose does overlap with doses tested in early phase trials; (11) 100mg carboplatin chemoradiotherapy has not been directly demonstrated to be better than radiotherapy alone or to other doses of carboplatin in conjunction with radiotherapy. Professor Clarke and Dr Stein disagreed about the reliance to be placed on outcome data, carboplatin vs cisplatin efficacy, whether carboplatin 100mg is acceptable as a standard or routine treatment offered to a significant portion of patients. Professor Clarke opined this aspect of prescribing was below standard, but not significantly below. Following the conclave of all three experts a further joint report was prepared. While Professor Fox agreed with a number of the opinions earlier expressed by Professor Clarke, all experts agreed that if the practitioner wished to evaluate different schedules of treatment, this would have been better done in a clinical trial. Significantly, all experts agreed the treatment was below standard, however Professor Clarke opined that he considered it to be not significantly below standard because of the generally favourable outcomes of patients treated, and because some of the treatments especially carboplatin and radiotherapy had been subject of clinical trials in similar doses and the fact that "many aspects of the practice were similar to multiple other practitioners he had worked with/and or observed during practice at multiple sites in Sydney". Professor Fox generally agreed with Professor Clarke but further stated he found the "general benefit of adjuvant chemo added to radiotherapy to be of very dubious benefit given the significant toxicity". All experts agreed that both treatment efficacy and risk of toxicity need to be considered and balanced. All experts agreed on the need for direct patient evaluation including clinical judgment to adjust dose to individual circumstances. Secondly, they agree "if a priori dose reductions are being made to reduce toxicity their impact on efficacy must be considered" and thirdly, "if there were a significant risk of reduced efficacy they would expect this to be discussed with the patient and where possible and appropriate that evidence of the discussion should be available in medical records and patient letters while noting the ability to do this may be negatively impacted by the use of Oncology Management Information Systems". The further joint report emphasised if the treatment had occurred in a formally approved phase 11 trial, there would have been no objection. In commenting on the opinions expressed in the Joint Expert Report, including that the dose of carboplatin was unusual, Professor Fox is recorded as saying he "agrees with this with the exception of the flat dose section; he is of the opinion that the means for the choice of these regimens is unclear apart from the avoidance of toxicity". Of significance is the fact that all experts agreed that the practitioner should have used AUC dosing to "standardize exposure to drug, and that doing so was below the standard expected". Further Professor Clarke expressed his concern relating, not to underdosing, but "rather the potential for overdose in patients with severe renal impairment such as a dialysis patient". 1. We place emphasis on the fact that Dr Stein's cross-examination was incomplete, the reliance on the data supporting 100mg carboplatin was a limited trial, extrapolating results from AUC dosing and did not directly compare carboplatin with radiation and radiation alone. 2. Overall, we find merit in the submissions of the HCCC which we adopt. We are satisfied that the complaint is established. Our observation of the practitioner's oral evidence left us in no doubt of his view about prescribing a flat dose of 100mg carboplatin was a firmly held view. The HCCC's submissions broadly align with our conclusions based on the expert evidence. Professional misconduct 1. The practitioner has admitted that he is guilty of professional misconduct based on the cumulative effect of his concessions of unsatisfactory professional conduct, in particular, relating to consent. The HCCC's submissions 1. At para 17 the HCCC summarise why it is asserted that the practitioner's conceded conduct demonstrates a "serious breach of the professional and ethical obligations to which the respondent was subject". In summary, the HCCC rely on: 1. the prescription of an untested regimen when a regimen supported by published trials or meta-analysis was available; 2. in circumstances where patients were not advised of the untested character of their proposed treatment; 3. patients were not given adequate information namely that the treatment proposed was not standard therapy, specific discussion of what was standard therapy, and how what was proposed differed; 4. the fact the cohort of patients were vulnerable by reason of their diagnoses; 5. patients placed trust in the practitioner; 6. in some cases the prescribing of a toxic drug in circumstances where such prescribing potentially had no benefit; 7. that some patients were deprived of the opportunity to receive different chemotherapy regimens 8. that the prescribing occurred over a long period; and 9. the lack of appropriate documentation. 1. It is submitted that the seriousness of the practitioner's conduct is not diminished although it is not possible to say on the balance of probabilities that any one patient was harmed by the practitioner's conduct. 2. The HCCC also assert that trust was placed in the practitioner by other members of the MDT. Reliance is placed on certain paragraphs in the statement of Dr Cooper provided in response to a notice under s 34A of the Health Care Complaints Act 1993 (NSW). Dr Cooper was not required for cross-examination. 3. At para 1.1 of his statement Dr Cooper noted that he had no direct involvement in the delivery of chemotherapy and "This is the sole responsibility of Dr Grygiel and the medical oncology team". At para 2.1 of his statement Dr Cooper explains: I was not aware at the time of the patients' treatment that Dr Grygiel was using a flat dose of 100mg carboplatin for all patients. My expectation was that as an appropriately trained and credentialed specialist physician in the field of Medical Oncology that Dr Grygiel was prescribing a dose consistent with best practice. 1. Dr Cooper also explained that the practitioner had the sole responsibility "to consent patients for the treatment he administered, that is the chemotherapy". 2. The submissions emphasise that the seriousness of the conduct involved in the standard practice complaint of itself "would be itself sufficient to justify a substantial period of cancellation of the practitioner's registration". The practitioner's submissions 1. It is convenient that before we commence our consideration of the HCCC's submissions that we refer to the position adopted by the practitioner in respect of the MDT. The practitioner's submissions advocate the position that the practitioner was not "operating in a rogue fashion" by prescribing 100mg carboplatin without the knowledge of the MDT. It is asserted the evidence supports a finding that SV's specialists Dr Cooper, Dr Dalley, and Dr Gallagher, medical oncology registrars, the dispensing pharmacist and the nurse unit manager were aware of the practitioner's prescribing practice in relation to carboplatin and the consent process, and that no issue was raised until mid-2015 at a time there was disharmony in the medical oncology department. 2. The submissions acknowledge that the practitioner takes "full responsibility for his standard prescribing regime" but say the fact that his conduct was known and not questioned or stopped for years, "is a relevant issue in assessing why the failures occurred, and were repeated'. 3. We accept the practitioner's evidence that he did discuss his prescribing with Dr Dalley. However, Dr Dalley was on leave prior to retirement in 2011. We find the evidence about when Dr Cooper became aware of the practitioner's prescribing is unclear. On the one hand the practitioner says had had discussions with Dr Cooper when they were working together at Orange as early as 2010. But Dr Cooper's unchallenged evidence is that he was not aware that the carboplatin dose being prescribed "may not be in accordance with common practice" until sometime during the second quarter of 2015. 4. We also accept that the practitioner did, in some limited instances, refer to his prescribed dose of carboplatin in his reporting letters. However, the transcript of Dr Gallagher's evidence reveals that he also had no recollection of awareness of the practitioner's prescribing when the issue surfaced in 2015 (statement 7 April 2016 para 4). We also accept that others in the medical oncology department were aware of the practitioner's prescribing. We note that the practitioner instructed his registrars to prescribe carboplatin AUC for patients they were treating, but it appears the registrars did not raise the issue of the practitioner's different prescribing practice. This is hardly surprising given the power imbalance inherent in their position viz a viz that of the practitioner. 5. We conclude, at the relevant time, and particularly after the practitioner assumed responsibility for Dr Dalley's patients, there was not a vigilant, collegiate, cohesive culture operating in the MDT at SV. This circumstance, no doubt, contributed to the practitioner's practises remaining undiscussed or unchallenged until mid-2015. Consideration professional misconduct 1. At the commencement of these reasons we set out the definition of professional misconduct. The practitioner concedes that a finding of professional misconduct is appropriate based on the cumulative admitted complaints (treatment of the 11 named patients, the consent process, record keeping which does not accord with the regulation and the standard practice complaint). 2. The gravamen of the practitioner's submissions is that what is now at the centre of the complaint is the question of the consent process. We agree that is a fundamental plank on which our findings of professional misconduct are based for the reasons earlier articulated under this topic. But we also find significant weight must be afforded to the standard practice complaint and our conclusions in respect of the treatment of the 11 identified patients. 3. In reaching our conclusion that a finding of professional misconduct should be made, we repeat our findings in respect of the 11 clinical complaints. Of themselves, these complaints are of such a serious nature as to justify a finding of professional misconduct. Taken together with our findings in respect of the failure to provide sufficient information to the large cohort of patients for those patients to give an informed consent, and our findings and conclusions about the standard practice complaint, we are satisfied professional misconduct as defined in s 139E is established. We are satisfied that the instances of unsatisfactory professional conduct are of sufficient seriousness to warrant the cancellation of the practitioner's registration, if he was still registered. Appropriate protective orders Reprimand or cancellation 1. It is fair to say that the parties are at wide variance about the protective orders which should flow from the practitioner's admissions, and our acceptance based on the evidence before us, of the correctness of those admissions. 2. The practitioner's submissions commence as follows: [The practitioner] submits that the only appropriate disciplinary order in this case is a reprimand. A clear statement correcting at least the public misinformation about his treatment of head and neck cancer patients should accompany that order. 1. By contrast, the HCCC seeks orders including recording on the register that we would have cancelled the practitioner's registration if he was still practising, impose an 8 year disqualification period and make a prohibition order. 2. There is no dispute about the principles explained in the authorities which guide and inform us in formulating our orders and the reasons for them. We have earlier in these reasons set out the relevant passages from the decisions in Health Care Complaints Commission v Do and Chen. 3. The HCCC submissions note that we exercise a "wide discretion" in relation to appropriate protective orders and that the circumstances of the case will determine the appropriate disposition. This submission is supported by reference to the reasons of Basten JA in HCCC v Karalasingham [2007] NWCA 267 at [67]. The submissions cite the summary of relevant principles to be applied as set out in Health Care Complaints Commission v Ahmad [2015] NSWCATOD 103 at [278]-[280]. We note those principles include a reference to the decision in Sabag v Health Care Complaints Commission [2001] NSWCA 411 at [82]. That reference is not directly apposite in this matter as the relevant paragraph deals with circumstances involving improper and unethical conduct which do not feature in this complaint. 4. We are informed and guided by Basten JA's discussion in Chen at [20], set out earlier in these reasons. 5. The thrust of the submissions on behalf of the practitioner is directed to s 3 of the National Law, not as frequently is the case, s 3A. It is submitted that s 3A cannot exist in isolation It is submitted that relying on s 3(3) of the National Law that the expression "health profession" in s 3(3)(c) must encompass health practitioners. Reference is made to the definition section of the National Law. We note that "health profession "means the following professions, and includes a recognised speciality in any of the following professions" – (and lists relevant professions including medical). A health practitioner means an individual who practises a health profession. Reference is also made to the definition of "health service". We note the definition includes "services provided by registered health practitioners". 6. It is asserted on behalf of the practitioner that the use of the term "health profession": Presumably allows for a broad interpretation which encompasses common law principles of general deterrence, preservation of the good repute of the profession and public confidence. It is not possible to restrict a health profession or ensure the provision of health services unless the orders relate to a health professional. Restrictive orders purporting to have a general field of operation on the health profession are covered by s 3(3)(c). 1. It is submitted in this statutory context that the health and safety of the public will be protected if restrictions on the practice of a health professional are "imposed only if it is necessary to ensure health services are provided safely and are of an appropriate quality" [original emphasis]. 2. It is further submitted that the restrictions the HCCC seeks under s 149(4) "cannot be imposed" unless the HCCC "proves to the requisite standard that they are necessary to ensure health services are provided safely and are of an appropriate standard. The submissions advance the proposition that "there must be no other way of ensuring health services are provided safely and are of appropriate quality". 3. The practitioner's submissions point out that, as the practitioner is no longer registered, the imposition of orders under s 149C "can only relate to the general provision of health services". It is submitted that the National Law requires a causal connection between the imposition of orders and the ensuring of health services of an appropriate quality. 4. It is further submitted that the HCCC "has to prove that the orders sought will cause ('necessary to ensure') the provision of health services are of an appropriate quality". 5. At para 24 the practitioner's submissions state: As the Commission cannot prove that the restrictive orders will by necessity ensure the provision of safe health services of an appropriate quality, the only order available is that of a reprimand or caution under s 149A (1) (a). This is an appropriate outcome given the limited scope for findings in an individual case affecting the medical profession at large. The general leverage that can be gained from an individual case is frequently overstated. 1. We address the parties' disparate submissions below. The practitioner's affidavit relied on in the termination proceedings 1. We were provided with a bundle of documents on the last day of the hearing entitled "Stage 2 – Respondent's evidence". No objection was taken to the admission into evidence of this bundle. 2. Included in the bundle is an affidavit of the practitioner sworn on 23 March 2020. This affidavit was also relied on by the practitioner in support of his termination application. The practitioner deposes to the stress and disruption to his life and that of his late wife and children as a result of media attention following the broadcast of the 7.30 Report. He relates receiving two death threats over the telephone which was answered by his son. 3. The practitioner explains that he found the Senate Committee hearing in 2016 to be a very distressing experience and that he "felt personally attacked". 4. The practitioner also deposes to his mental health suffering following the 7.30 Report and that he was diagnosed with reactive depression and underwent treatment from a consultant psychiatrist for a period of 12 months. He also deposes, at para 20, that he has been "plagued with stress and sadness at the uncertainty, fear and anger that has needlessly been experienced by my former patients and their families, who not only have been through the cancer journey but also had to question the treatment they received". 5. The practitioner also deposes to the fact that in July 2016 he was "stripped of his UNSW Associate Professor title". 6. At paras 23 and 24 the practitioner refers to the termination of his employment at SV and defamation proceedings he instituted against the ABC which were settled. 7. The practitioner also refers to the untimely death of his wife in 2017 following her cancer diagnosis and his inability to conclude the grieving process due to this matter. 8. In concluding his affidavit the practitioner refers to these proceedings and the changes in the various complaints. He states "I have always shown respect for the proceedings, but I do not think I can cope much longer. I am exhausted. Media articles 1. It is unnecessary that we set out details of the media articles relied on by the practitioner. We accept that throughout 2016 after the broadcast by the ABC of the 7.30 Report there were a plethora of media articles about the practitioner which referred, inter alia, to "wrong chemo" and "chemo dosing errors". Cancer Council Australia documentation 1. The practitioner's material also includes a Cancer Council Australia publication "Clinical question: What is best for documenting and communicating the treatment plan?". It is noted in this document that it is the consensus outcome of a multidisciplinary meeting discussion. It recommends when an MDT is not in existence that clinicians link into a centre that does hold such meetings. 2. We have earlier in these reasons noted the recommendations on documenting the consent process. We infer this document is provided to establish that any educative effect our reasons may have to benefit the health and safety of the public generally has already been addressed. Medical Oncology Group of Australia 1. We were also provided with two documents from the Medical Oncology Group of Australia (dated 23 October 2016 and 6 December 2016). These documents were prepared to address media concerns after the s 122 inquiry and to address the difference between systemic alteration of a protocol and individual adjustment of a protocol. 2. We were also provided with a copy of a paper by the Medical Oncology group "Nine Steps to Personalised Therapy: The Art and Science of Anti-Cancer Drug Dosing". We note that Professor Clarke is one of the authors of this paper. The paper is not dated, and we were not told if it had been accepted for publication in a peer reviewed journal. It has not been considered by the experts in their joint report and we find in the circumstances it came before us we can place little weight on its contents. In reaching this conclusion we do not wish to be seen to be suggesting its contents are not accurate and relevant to prescribing in 2020, but rather our focus is on the matters we have been required to determine in these proceedings. Character references 1. The practitioner relied on character references from Dr Graham Beaumont, (Ph.D), a golfing companion of the practitioner, Dr David Bell, Consultant Physician in Medical Oncology, Mr Paul Diks, licensed real estate agent, Dr Robert Eckstein, Clinical Associate Professor of Pathology at the University of Sydney, a friend of the practitioner for over 40 years, Dr Christopher Halloway, a retired obstetrician and gynaecologist who practised in Dubbo and Bathurst and who referred patients to the practitioner, Mr Steven Hartman, a long-time friend of the practitioner, Philip J Harvey, a friend who first met the practitioner when their daughters attended the same school, Dr Michael Izard, radiation oncologist and Clinical Associate Professor, Macquarie University Hospital, Mr Geoff Kinghorn, retired accountant, a social friend of the practitioner, Dr Adrian Pokorny, medical oncologist, former registrar between October 2015 and January 2016, Dr David Quinn, Associate Professor of Medicine, University of Southern California, Adjunct Associate Professor Craig M Stamp, Professor Michael Green, medical oncologist and Clinical Professor of Medicine at the University of Melbourne, Dr Peter Harper, specialist medical oncologist, Consultant Medical Oncologist, Guy's Hospital, London. 2. All of the professional referees who have worked with the practitioner hold him in high regard. His personal referees also referred to his integrity and trustworthiness. No referee was required for cross-examination. We accept the referees' opinions expressed in their letters. 3. We note however, as the HCCC observe, that none of the referees refer to the practitioner disclosing insight or remorse for his conduct. Consideration appropriate protective orders Cancellation and Disqualification period or Reprimand? 1. The HCCC seeks a cancellation order to be recorded on the register and a disqualification period of 8 years imposed. The practitioner's submissions assert to make such an order would be unreasonable in the sense that no reasonable decision maker would make such an order. 2. The HCCC note that the Tribunal in Health Care Complaints Commission v Von Marburg (No 4) [2019] NSWCATOD 92 imposed a disqualification period of 8 years on a practitioner who was unregistered and who had not practised for 20 months and stated he did not intend to seek registration or resume practice. In that case the Tribunal referred to the gravity of the practitioner's conduct. Reference is also made to the fact that in Health Care Complaints Commission v Street [2014] NSWCATOD 124 the Tribunal took into account in framing protective orders the extent to which a practitioner has co-operated with the disciplinary process, and has, by admissions and acceptance of guilt contributed to the speedy disposition of proceedings. 3. The HCCC note the voluminous material filed in these proceedings (approximately thirty-five volumes by the HCCC and an additional thirteen volumes by the practitioner), the evidence of patients, the expert evidence and joint conclaves, over fourteen hearing days and with a further ten days allocated to complete the expert evidence and submissions. 4. The submissions note that until recently the practitioner denied the allegations against him, and sought to justify his standard practice, as well as his consent and record keeping practices. It is submitted that, although the practitioner has made the concessions in his Reply, "there is nothing before the Tribunal to suggest that the Respondent has in any way rehabilitated or achieved insight into the seriousness of his conduct and its impact on the many patients affected". It is submitted that the period of time that may have passed is not, on its own, capable of proving a reformation of character. It is submitted, having regard to the lack of insight or contrition expressed by the practitioner, that we should find the practitioner poses a substantial risk to the public, that is, the risk is real or apparent on the evidence, as distinct from one that is without substance or which is fanciful or speculative. 5. We do not accept the submissions made on behalf of the practitioner that a reprimand is the only available appropriate protective order. It appears to us that this submission relies almost entirely on an expansive construction of s 3(3)(c). Even if that provision, which refers to a health profession, is broadly read in conformity with Schedule 7 Clause 7 of the National Law, we do not agree protective orders should be limited in the manner suggested in the practitioner's submissions. 6. In rejecting the practitioner's submission on protective orders we have taken into account the following matters: 1. We must in any proceedings under the National Law take into account the requirements of s 3A as our paramount consideration. 2. The health and safety of the public is not limited by actions which may be taken by this practitioner. It involves ensuring orders made inform and educate other practitioners to exercise appropriate clinical judgment, to observe proper consent processes and record the advice given to patients. The provision of such education and information can only enhance better professional practice thus promoting the health and safety of the public. Publication of disciplinary decisions and orders also promotes public confidence in the profession, and empowers patients to appreciate and understand their role in the consent process. It further involves an educative process to ensure that practitioners are aware of their mandatory responsibilities under the regulation to keep proper records. This too has a health and safety aspect because it enables any subsequent practitioner to understand the treatment given by an earlier practitioner. 3. We have found the practitioner's prescribing for the 11 named patients constituted unsatisfactory professional conduct as was his prescribing referred to as the standard practice complaint. Notwithstanding the practitioner may have had good intentions and believed he was correct in prescribing as he did with the aim of reducing toxicity or potential adverse toxicity he was isolated in his beliefs and practices, being the only Australian practitioner prescribing as he did. He did not conform to well recognised prescribing supported by appropriate peer reviewed studies and/or meta-analysis or even prescribing adopted by a small but reputable body of the profession. If he wished to prescribe as did, he should have done so in a clinical trial setting with all the necessary ethical safeguards in place. 4. the practitioner's own submissions acknowledge that the failure to adhere to a proper consent process lies at the heart of these proceedings. We do not think the practitioner can rely on his admission in respect of this aspect of the complaint but resile from the consequences of his action on the basis that the common law does not require an explanation of alternative treatments. At the heart of the explanation given by the practitioner to patients was the failure to explain the treatment he proposed was "non-standard", not supported by relevant studies, and not prescribed by any other Australian practitioner. His lack of explanation denied his patients the opportunity to enquire about standard treatments or to seek a second opinion. The consent process has a wider application than just these proceedings. That is a fact recognised by all the experts in this matter. 5. We also give some weight to the fact that the practitioner provided only what may be described as a bare response to the complaint. He did not seek to give evidence at the Stage 2 hearing. We have taken into account in his affidavit that he acknowledges that the publicity surrounding the 7.30 Report and subsequent publicity and the public inquiries have caused distress and anxiety to his patients which he regrets. However, he does not express regret about how he conducted the consent process. 6. We have endeavoured to balance the matters referred to above with the fact that there was division among the eminently qualified experts about whether the practitioner's conduct at the relevant time was significantly below the standard expected, or just below the expected standard. We have also taken into account the experts' opinion that there is no evidence that any patient was harmed, or we would say, conversely not harmed, by the practitioner's prescribing and it is unlikely that his prescribing regimen will ever by tested by clinical trial. These matters require a careful balancing to achieve a fair and appropriate outcome. 1. Ultimately, we have concluded, given the serious nature of the admissions made by the practitioner, and the need to ensure similar conduct does not occur in the future, requires that an order be recorded in the register that, if the practitioner had been registered at the date of this hearing, we would have cancelled his registration. 2. We have found the question of a period of disqualification under s 149C(4)(b) to be a difficult one. This case is distinguishable from matters such as Health Care Complaints Commission v Von Marburg and/or HCCC v Reid [2018] NSWCAT 162. In the latter case the Tribunal found the practitioner had flagrantly ignored conditions on his registration, had at least in one case, carried out surgical procedures without the patient's consent, held himself out to have an academic position which had been withdrawn and that the practitioner's conduct was at the most serious end of the spectrum. This supported the making of a substantial disqualification period by way of deterrence. In the former case the Tribunal in cancelling the practitioner's registration and imposing a period of 8 years disqualification found: The practitioner's misconduct is not confined to merely one aspect of his practice. The Tribunal has found that the practitioner has engaged in 18 proven instances of clinical incompetence, such as performing surgery when no surgical intervention was indicated; creating false clinical records, concealing the fact that he had damaged one patient; failing to obtain informed consent from patients before performing surgery; failing to provide adequate advice to patients following surgery; preparing false reports for the patient's general practitioner, which have concealed the malpractice of the practitioner and have portrayed the surgical procedure as being successful when the contrary was the case; preparing false letters, backdated several years, so as to give the impression that he had taken all appropriate steps in reporting to a general practitioner; making false declarations for the purpose of admission of patients to the Aubrey-Wodonga hospital [sic]; stating that he had consulted with patients when in fact he had never seen them; and making false claims on Medicare which were unjustified. Further, the practitioner was dishonest in his dealings with the Medical Council and the applicant. The practitioner blatantly contravened the conditions on his registration in regard to attending a counsellor and self-prescribing. Accordingly it is not only medical malpractice in issue in these proceedings: there is dishonesty and deception at a professional level which the Tribunal considers is egregious conduct. The practitioner has shown no remorse and negligible insight into his conduct. 1. Here there is no suggestion of dishonesty, to the contrary, the practitioner is regarded by a number of eminent peers and acquaintances to be a person of the utmost honesty and integrity. He has treated many hundreds if not thousands of patients over a 35 year career, and was diligent in his responses to staff in the demanding role of a fly-in, fly-out specialist. 2. While the practitioner did not make admissions until what may be described as "late in the piece" those admissions were made to a very different complaint to that presented to us at the commencement of the inquiry. 3. We accept by reason of the practitioner's age, the stress he has suffered since 2016 including the sad death of his wife, and strain imposed on his family by the media, inquires and these proceedings, that it is highly unlikely he would ever seek re-registration. Thus, the only purpose of the disqualification order sought is to act as a deterrent to other practitioners and to demonstrate the unacceptability of the practitioner's conduct. We discern that those purposes will be more than adequately addressed by the imposition of a disqualification period of two years. Prohibition Order 1. The HCCC seek a prohibition order under s 149C(5) and (5A) of the National Law. The prohibition sought is to restrain the practitioner from providing "health education services" for the period during which he is remains subject to the Tribunal's orders. To understand the import of the order sought it is appropriate that we set out those provisions: (5) If the Tribunal suspends or cancels a registered health practitioner's or student's registration and it is satisfied the person poses a substantial risk to the health of members of the public, it may by order (a prohibition order) do any one or more of the following— (a) prohibit the person from providing health services or specified health services for the period specified in the order or permanently; (b) place specified conditions on the provision of health services or specified health services by the person for the period specified in the order or permanently. Note— Section 102(3) of the Public Health Act 2010 provides that it is an offence for a person to provide a health service in contravention of a prohibition order. (5A) The power of the Tribunal to make a prohibition order under subsection (5) extends to a person who is no longer registered if the Tribunal decides under subsection (4) that it would have suspended or cancelled the person's registration if the person were still registered. 1. We were not satisfied there was any evidence before us which suggested that the practitioner presently poses a substantial risk to the public (see Health Care Complaints Commission v Kazeme [2020] NSWCATOD 25 at [138]). To the contrary, we find it is highly unlikely that the practitioner who was in his language "stripped" of his academic position would be invited to provide health education services. He has not, on the evidence before us, attempted to, or provided, such services since he ceased practising. We decline to make a prohibition order as sought. Costs 1. We were informed that the parties had reached agreement as to costs and were requested, by consent, to make an order that the practitioner pay 70 per cent of the HCCC's costs as agreed and failing agreement as assessed under the Legal Profession Uniform Law Application Act 2014 (NSW). We will so order. ORDERS 1. Pursuant to s 149C(4)(a) of the Health Practitioner Regulation National Law (the National Law) the Tribunal determines that if John Joseph Grygiel (the practitioner) was still registered it would have cancelled his registration. 2. The practitioner is precluded under s 149C(4)(b) of the National Law from seeking a re-instatement order for a period of two years from the date of these orders. 3. The Medical Board of Australia is requested to record under s 149C(4)(c) in the register the fact that the Tribunal would have cancelled the practitioner's registration. 4. Pursuant to s 163 of the National Law the Tribunal is the appropriate review body. 5. The practitioner shall pay 70 per cent of the Health Care Complaints Commission's costs of and incidental to these proceedings as agreed and failing agreement as assessed under the Legal Profession Uniform Law Application Act 2014 (NSW). ********** APPENDIX A (957706, pdf) APPENDIX B (160887, pdf) 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 Amendments 17 March 2021 - Par 347 removed Typographical errors amended throughout 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: 17 March 2021