'Innovative' dementia treatment: An Australian Coroner's recommendations in the Sheila Drysdale Inquest 1

Transcription

1 'Innovative' dementia treatment: An Australian Coroner's recommendations in the Sheila Drysdale Inquest 1 "Mrs Drysdale died from blood loss following a liposuction / stem cell procedure for her dementia. An Australian Coroner, expressing concern regarding aspects of the treatment, made recommendations including the development of guidelines to ensure that experimental or innovative medical procedures conform with scientifically respectable clinical practice. A Inquest findings The findings in the Inquest into the death of Sheila Drysdale were published about two months ago, by the New South Wales Deputy State Coroner, Hugh Dillon. 2 Mrs Sheila Drysdale suffered severe dementia, which was first diagnosed in She died in late 2013 aged 75 years, due to blood loss following a liposuction stem cell procedure which, it was claimed, might improve her quality of life by reducing her symptoms. In March 2013 the husband of Sheila, Kenneth Drysdale, had heard a radio advertisement for Macquarie Stem Cells. It stated that stem cell therapy could assist arthritic patients. Mr Drysdale consulted Dr Ralph Bright, the principal of Macquarie Stem Cells, and in August 2013 was treated for arthritis. He formed the view that he had derived some benefit from that treatment. 3 1 Bill Madden is a lawyer in private practice in Australia and is an Adjunct Professor, Australian Centre for Health Law Research, Queensland University of Technology. He is a co-author of the books Health Care & the Law (Thomson Reuters), Australian Medical Liability (Lexis Nexis) and writes about health and medical law issues online at Findings at [12] 1

2 Mr Drysdale spoke to Dr Bright regarding treatment for his wife s dementia. There was apparently no formal referral from Mrs Drysdale s usual general practitioner. The process, which ultimately took place in late 2013, was one whereby after the application of local anaesthetic, an incision is made and liposuction is used to extract about 500 ml of fat from the flanks and buttocks of the patient. The fat is processed, stem cells are extracted then re-infused into the patient s body via an intravenous drip. 4 Given Mrs Drysdale s dementia, consent was provided by her husband who signed a form which included the following: The possible complications associated with moving cells from one part of your body to another are not fully known due to the extent that the procedure involves the reinjection of this particular form of highly process lipoaspirate, the procedure may be classified as innovative or experimental. The experimental component of the procedure has only recently been performed in humans. The first case in Australia was on 17th April From what we have seen in dogs and from what we have read in our literature searches the procedure would appear to be safe. Our safety survey spans 3 years and has not uncovered any problems. The procedure may provide health benefits. 5 A medication list was provided to Dr Bright which listed medications including aspirin 100mg in the morning, krill oil and coconut oil. Aspirin has the effect of thinning the blood as does krill oil and possibly coconut oil. She was also using Cymbalta, an anti-depressant with a minor blood-thinning effect. 6 Dr Bright stated that four days prior to the procedure, he had an (apparently undocumented) conversation with Mr Drysdale and told 4 Findings at [14] 5 Findings at [18] 6 Findings at [19] 2

3 him that Mrs Drysdale should stop taking the aspirin. Mr Drysdale did not recall that conversation. The aspirin and krill oil were not stopped. Expert evidence was given that, in any event, aspirin and other anticoagulants should be stopped at least 7-10 days before a surgical procedure. 7 Mrs Drysdale was discharged from the clinic before 5 30 pm and driven by her husband back to her nursing home. Despite some concerns about her low blood pressure, she was not taken to a hospital. She died shortly before 7 45 pm that evening. 8 B Comments by the Coroner The Coroner s disquiet about the form of treatment is apparent from his language in a few passages drawn from the inquest findings. At [38] [40]: The reasonableness or appropriateness of applying this experimental procedure to Sheila Drysdale is highly questionable. On the evidence available to me, it seems highly unlikely to have been significantly beneficial to Sheila even if she had lived. The operation is unproven scientifically. It has not been the subject of rigorous clinical trials in humans. It was described even by Macquarie Stem Cells own literature as experimental but the procedure was not conducted in accordance with protocols for the conduct of clinical trials or scientific experiments. No explanation is given in the materials supplied to the patient or to this court as to how the stem-cell therapy may work to improve serious brain lesions such as the Frontal Lobe Dementia from which Sheila Drysdale suffered. As far as it is possible to tell, Dr Bright appears to have no idea whether 7 Findings at [20] 8 Findings at [29], [37]. 3

4 the procedure has any genuine therapeutic value for the treatment of brain lesions. He is not a specialist in neurology or neuropathology or geriatric medicine. No scientific literature has been presented to the court by Dr Bright justifying his use of the procedure upon Sheila Drysdale. Nor have independent specialists from whom this court has received reports provided any such material. While all medical and surgical procedures necessarily start off experimentally, there is a world of difference between rigorously and ethically conducted clinical trials that are reviewed at every stage by qualified peers and this procedure which, in relation to treatment of dementia at least, has some of the troubling hallmarks of quack medicine: desperate patients, pseudo-science and large amounts of money being charged for unproven therapies. And later at [88]: On a broader scale, it is disturbing that he 9 (and presumably others) would market this experimental or innovative therapy for profit to vulnerable and desperate people in the full knowledge both that there is little scientific support for the therapy in relation to dementia and that he is not conducting a clinical trial of any scientific standing or worth. The obvious potential for the providers of such purported remedies and therapies to exploit such consumers is great and therefore troubling. So too is the potential conflict of interest between the principle of harm minimisation and commercial medicine. 9 Referring to Dr Bright. 4

5 C Informed consent Informed consent is to be the subject of a presentation 10 by Dr Bernadette Richards, so it is sufficient to note in passing that the Coroner commented on the adequacy of disclosure of risks 11, the failure to mention haemorrhage 12 and the absence of discussion of alternatives to the treatment 13. D The recommendations The Coroner s recommendations are set out at [93]: To the Health Care Complaints Commission I recommend that the Health Care Complaints Commission investigates the conduct of Dr Bright in relation to this case. To the Commonwealth Minister for Health and the NSW Minister for Health I recommend that the Therapeutic Goods Administration (Commonwealth) and the NSW Ministry of Health consider how best to manage and regulate the provision of experimental or innovative medical or surgical procedures that have not yet been approved following clinical trials or other recognised peer-reviewed evaluation processes. Among the issues to considered, I recommend that the questions of potential conflict of interest and informed consent be given high priority. I recommend that National Health and Medical Research Council and NSW Clinical Excellence Commission consider formulating guidelines and protocols to ensure that 10 Liability v Innovation: Unpacking key connections, Seminar 3, 15 September Findings at [46] 12 Findings at [48] 13 Findings at [49] 5

6 experimental or innovative medical procedures conform with scientifically respectable clinical practice. To the Cosmetic Physicians College of Australasia I recommend that the College consider formulating guidelines and protocols to ensure that experimental or innovative medical procedures performed by cosmetic physicians in Australia conform with scientifically respectable clinical practice. Among the issues to considered, I recommend that the questions of potential conflict of interest and informed consent be given high priority. To Macquarie Stem Cells I recommend that Macquarie Stem Cells develops and introduces a pre-operative preparation checklist that is given to patients, their carers and the relevant health professionals at some appropriate time before it carries out any procedures. I further recommend that Macquarie Stem Cells develops and implements another checklist for internal use to ensure that all appropriate preparations have been made before it commences any invasive procedure. That checklist should include a check that blood-thinning medications have been stopped a minimum of 7-10 days before the procedure is conducted. I also recommend that Macquarie Stem Cells undertake no invasive procedures in respect of any patient unless it is satisfied that the pre-operative preparations have been carried out. Finally, I recommend that Macquarie Stem Cells amends its patient consent form to ensure that it outlines in detail for the patient (or his/her carer) the procedure together with the alternatives to the procedure, and the risks and benefits of the procedure. 6

7 To Leading Age Services Australia and the Royal Australian College of Physicians I recommend that Leading Age Services Australia and the Royal Australian College of Physicians consider working together and with providers in the nursing home segment of the industry towards the development and implementation of an appropriate patient observation chart of the type used by NSW Health under its Between the Flags protocols. E The guidelines recommendation In Australia, the legislative framework for registered health practitioners (known in a shorthand way as the National Law) at section 41) is such that a code approved by a National Board is admissible in proceedings against a health practitioner registered by the Board as evidence of what constitutes appropriate professional conduct or practice for the health profession. 14 Of particular interest therefore is the Coroner s recommendation that the National Health and Medical Research Council 15 and the New South Wales Clinical Excellence Commission 16 consider formulating guidelines and protocols to ensure that experimental or innovative medical procedures conform with scientifically respectable clinical practice. 14 See for example the discussion in Woollard v The Medical Board of Australia [2016] WASCA 151, NHMRC is Australia's leading expert body for supporting health and medical research; developing health advice for the Australian community, health professionals and governments and providing advice on ethical behaviour in health care and in the conduct of health and medical research The Clinical Excellence Commission (CEC) was established in 2004 as one of the five key structural reforms outlined in the NSW Health Patient Safety and Clinical Quality Program (PSCQP) and as an evolution of the Institute for Clinical Excellence. Emerging in the midst of system-wide patient and safety concerns, the primary focus of the CEC has been to promote and support improved clinical care, safety and quality across the NSW public health system, and to meet functions specified by the Minister for Health. 7

8 In May 2016 the Medical Board of Australia issued guidelines for medical practitioners who perform cosmetic medical and surgical procedures, which are to come into effect on 1 October The cosmetic surgery guideline makes express reference to section 41 of the National Law. Focused as they are on cosmetic procedures, the guidelines provide definitions for: Cosmetic medical and surgical procedures Major cosmetic medical and surgical procedures; and Minor (non-surgical) cosmetic medical procedures The following aspects of the guidelines warrant attention as potentially being applied in a broader way for what might be called entrepreneurial medicine: Patient assessment 2.3 The medical practitioner who will perform the procedure should discuss and assess the patient s reasons and motivation for requesting the procedure including external reasons (e.g. a perceived need to please others) and internal reasons (e.g. strong feelings about appearance). The patient s expectations of the procedure should be discussed to ensure they are realistic. 2.4 The patient should be referred for evaluation to a psychologist, psychiatrist or general practitioner, who works independently of the medical practitioner who will perform the procedure, if there are indications that the patient has significant underlying psychological problems which may make them an unsuitable candidate for the procedure. 2.5 Other than for minor procedures that do not involve cutting beneath the skin, there should be a cooling off period

9 of at least seven days between the patient giving informed consent and the procedure. The duration of the cooling off period should take into consideration the nature of the procedure and the associated risks. 2.6 The medical practitioner who will perform the procedure should discuss other options with the patient, including medical procedures or treatment offered by other health practitioners and the option of not having the procedure. 2.7 A medical practitioner should decline to perform a cosmetic procedure if they believe that it is not in the best interests of the patient. Consent 4.1 The medical practitioner who will perform the procedure must provide the patient with enough information for them to make an informed decision about whether to have the procedure. The practitioner should also provide written information in plain language. The information must include: what the procedure involves whether the procedure is new or experimental the range of possible outcomes of the procedure the risks and possible complications associated with the procedure the possibility of the need for revision surgery or further treatment in the short term (e.g. rejection of implants) or the long term (e.g. replacement of implants after expiry date) 9

10 recovery times and specific requirements during the recovery period the medical practitioner s qualifications and experience total cost including details of deposits required and payment dates, refund of deposits, payments for follow-up care and possible further costs for revision surgery or additional treatment, and the complaints process and how to access it. 4.2 Informed consent must be obtained by the medical practitioner who will perform the procedure. Training and experience 8.1 Procedures should only be provided if the medical practitioner has the appropriate training, expertise, and experience to perform the procedure and deal with all routine aspects of care and any likely complications. 8.2 A medical practitioner who is changing their scope of practice to include cosmetic medical and surgical procedures is expected to undertake the necessary training before providing cosmetic medical and surgical procedures. Advertising and marketing 10.2 Advertising content and patient information material should not glamorise procedures, minimise the complexity of a procedure, overstate results or imply patients can achieve outcomes that are not realistic. Financial arrangements 12.3 The medical practitioner should not provide or offer to provide financial inducements (e.g. a commission) to agents for recruitment of patients. 10

11 12.4 The medical practitioner should not offer financing schemes to patients (other than credit card facilities), either directly or through a third party, such as loans or commercial payment plans, as part of the cosmetic medical or surgical services Medical practitioners should not offer patients additional products or services that could act as an incentive to treatment (e.g. free or discounted flights or accommodation) Medical practitioners should ensure that they do not have a financial conflict of interest that may influence the advice that they provide to their patients. F Outcomes for Dr Bright and Macquarie Stem Cells Dr Bright s current website indicates that he obtained his medical qualifications in New Zealand in 1973, but is not a Fellow of the College of Surgeons. 18 His website also indicates that Dr Bright received a New South Wales Parliamentary Commendation in 2013 for his contribution to Stem Cell therapy and research. 19 He had published a paper Adipose Derived Stromal Cells to Treat Joint Disease, JCSM vol5, No3, He remains in practice today, but the Australian Health Practitioner Regulation Agency indicates that Dr Bright now has four conditions on his registration 21 : 1. To only practise stem cell therapy for: (a) New patients presenting for treatment of osteoarthritis; Journal of Cosmetic Surgery & Medicine; Practitioners.aspx?q=MED &t=GA47Z3GPuy1A09U60iSj 11

12 (b) New patients participating in research studies approved by a Human Research Ethics Committee; (c) Existing patients returning for remaining injections of stored cells (i) Existing patients are only those patients with stored cells included in the log at condition 2, 2. To provide to the Medical Council of NSW a log of all existing patients with stored cells within 14 days of 30 August To practise under category C supervision in accordance with the Medical Council of NSW s Compliance Policy Supervision (as varied from time to time) and as subsequently determined by the Council. (a) At each supervision meeting the practitioner is to review and discuss: (i) The supervisor s random selection of at least 6 patients treated with stem cell therapy pursuant to Practice Condition 1 and 2 (ii) Patient records (iii) Informed consent (iv) Pre-operative, intra-operative and postoperative assessment of patients (v) Patient discharge (b) To authorise the Council to provide proposed and approved supervisors with: (i) A copy of any relevant decisions (ii) A log of existing patients 4. To submit to an audit of his medical practice, by a random selection of his medical records by a person or persons nominated by the Medical Council of NSW and: 12

13 (a) The audit is to be held within 3 months from 30 August 2016 and subsequently as required by the Council. (b) The auditor/s will assess his compliance with his conditions and compliance with good medical record keeping standard and legislative requirements. (c) To authorise the auditor/s to prove the Council with a report of their findings. (d) To meet all costs associated with the audit/s and any subsequent reports. Macquarie Stem Cells remains in operation today, operating a clinic in a western suburb of Sydney, which appears to be the address of Dr Bright s practice. 22 It s website appears to make no mention of dementia treatment. A website footer states Macquarie Stem Cell Centres of Excellence can neither predict or guarantee success for individual patients who undergo the stromal cell therapy procedure. There are potential risks associated with any medical procedure END